BAYERS BIMANUAL I/A HANDPIECES

K971064 · Visioncare Devices, Inc. · HQC · Jun 9, 1997 · Ophthalmic

Device Facts

• Record ID: K971064
• Device Name: BAYERS BIMANUAL I/A HANDPIECES
• Applicant: Visioncare Devices, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Jun 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Anterior Phaco emulsification cortex clean up.

Device Story

Bayers Bimanual I/A Handpieces are surgical instruments used during anterior phacoemulsification procedures. Operated by ophthalmologists in an operating room setting, these handpieces facilitate the irrigation and aspiration (I/A) of lens cortex material from the eye. The device functions as a manual tool for fluid management and tissue removal during cataract surgery, aiding in the cleaning of the capsular bag. It provides a mechanical means for the surgeon to maintain anterior chamber stability while removing residual cortex, thereby supporting successful lens implantation and patient recovery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual ophthalmic surgical handpiece for irrigation and aspiration. Form factor designed for bimanual phacoemulsification procedures. Non-powered, mechanical instrument.

Indications for Use

Indicated for anterior phacoemulsification cortex clean up during ophthalmic surgery.

Regulatory Classification

Identification

A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 9 1997

Mr. Chet Cracchiolo
President
VisionCare Devices, Inc.
1246 Redwood Boulevard
Redding, CA 96003

Re: K971064
Trade Name: Bayers Bimanual I/A Handpieces
Regulatory Class: II
Product Code: 86 HQC
Dated: March 17, 1997
Received: March 24, 1997

Dear Mr. Cracchiolo:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Chet Cracchiolo

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone].

Sincerely yours,


A. Ralph Rosenthal, M.D.
Director
Division of Ophthalmic Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K971064

Device Name: BAYERS BIMANUAL I/A HANDPIECES

Indications For Use: Anterior Phaco emulsification cortex clean up.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dennis L. McCarthy
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K971064

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☐
(Optional Format 1-2-96)

$$c_k = 80$$