Bi-Blade®
Bi-Blade is a pneumatically actuated vitrectomy cutter that removes vitreous and other intraocular tissue during eye surgery. It combines aspiration with a guillotine-style cutting action…
Bi-Blade is a pneumatically actuated vitrectomy cutter that removes vitreous and other intraocular tissue during eye surgery. It combines aspiration with a guillotine-style cutting action and is used with the MID Labs Ultimate Vit Enhancer.
A second port creates two cutting edges. Tissue is cut as the cutter extends and again as it retracts, giving two cuts per operating cycle. The added opening permits aspiration to continue while the cutter is extended.
Listed Item
23 Gauge BB Vitreous Cutter, 23.1 psi, Taper Posterior PVC Tubing Set, Sterile, Single Use
Host Equipment
The Ultimate Vit Enhancer connects to ophthalmic surgical equipment serving as the host, typically a phacoemulsification or vitreoretinal surgery system. The cutter must be labeled for use with the enhancer; the assembly operates alongside the host rather than functioning as a complete surgical console itself.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Medical Instrument Development Laboratories, Inc., United States |
|---|---|
| FDA product code | HQE |
| Device type | Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4150 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K153168 |
| Record published | 2023-08-14 |
| Record revised | 2023-05-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -40 to 70 °C; Storage environment humidity -40 to 70 °C; Handling environment temperature -40 to 70 °C; Handling environment humidity -40 to 70 °C |
| Packaging | Carton of 6 |
| Sizes | Needle gauge 23 to 27 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2310BB | Needle Gauge 27 G | In distribution |
| 2390BB | Needle Gauge 25 G | In distribution |
| 2470BB | Needle Gauge 23 G | In distribution |
| 2720BB | Needle Gauge 23 G | In distribution |
| 2410BB | Needle Gauge 27 G | In distribution |
| 2560BB | Needle Gauge 27 G | In distribution |
| 2320BB | Needle Gauge 23 G | In distribution |
| 2740BB | Needle Gauge 25 G | In distribution |
| 2920BB | Needle Gauge 23 G | In distribution |
| 2360BB | Needle Gauge 27 G | In distribution |
| 2370BB | Needle Gauge 23 G | In distribution |
| 2510BB | Needle Gauge 27 G | In distribution |
| 2410QB | Needle Gauge 27 G | In distribution |
| 2860BB | Needle Gauge 27 G | In distribution |
| 2540BB | Needle Gauge 25 G | In distribution |
| 2840BB | Needle Gauge 25 G | In distribution |
| 2490QB | Needle Gauge 25 G | In distribution |
| 2820BB | Needle Gauge 23 G | In distribution |
| 2520BB | Needle Gauge 23 G | In distribution |
| 2470QB | Needle Gauge 23 G | In distribution |
| 2420BB | Needle Gauge 23 G | In distribution |
| 2340BB | Needle Gauge 25 G | In distribution |
| 2960BB | Needle Gauge 27 G | In distribution |
| 2440BB | Needle Gauge 25 G | In distribution |
| 2760BB | Needle Gauge 27 G | In distribution |
| 2490BB | Needle Gauge 25 G | In distribution |
| 2940BB | Needle Gauge 25 G | In distribution |
| 2460BB | Needle Gauge 27 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 108 |
| Unity | Alcon Laboratories, Inc. | 47 |
| Synergetics | Synergetics USA, Inc. | 44 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Medical Instrument Development Laboratories, Inc. | 21 |
| Alcon | Alcon Laboratories, Inc. | 14 |
| Constellation | Alcon Laboratories, Inc. | 9 |
| Stellaris | Bausch & Lomb Incorporated | 6 |
| EVA Nexus™ Posterior 25G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| EVA Nexus™ Posterior 23G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| EVA Nexus™ Posterior 27G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| Engauge, Vektor | Alcon Laboratories, Inc. | 3 |
| Alcon, Engauge | Alcon Laboratories, Inc. | 3 |
Showing 12 of 65. All products under Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153168 | 2016-04-29 |
| K102222 | 2011-04-08 |
| K020911 | 2002-04-29 |
| K992943 | 1999-12-10 |
| K934600 | 1994-07-27 |
| K932669 | 1994-06-03 |
| K924222 | 1993-01-27 |
| K851610 | 1985-07-22 |
| K850857 | 1985-03-29 |
| K842793 | 1984-12-19 |
| K843391 | 1984-12-19 |
| K842471 | 1984-11-21 |
| K831584 | 1983-08-12 |
| K820026 | 1982-02-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.