RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES

K980816 · Fci Ophthalmics, Inc. · HQX · Sep 18, 1998 · Ophthalmic

Device Facts

• Record ID: K980816
• Device Name: RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
• Applicant: Fci Ophthalmics, Inc.
• Product Code: HQX · Ophthalmic
• Decision Date: Sep 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3340
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Retinal detachment requiring surgical intervention to reattach the retina and preserve/reserve the patient's vision

Device Story

Retinal detachment implants used during ophthalmic surgery to reattach the retina. Device implanted by ophthalmologist in surgical setting. Provides structural support to facilitate retinal reattachment and vision preservation. Mechanical device; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Retinal detachment implant; mechanical device. No electronic, software, or energy-based components. Materials and sterilization methods not specified in provided text.

Indications for Use

Indicated for patients requiring surgical intervention for retinal detachment to reattach the retina and preserve vision.

Regulatory Classification

Identification

An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 8 1998

Ms. Anne Bohsack Vice President, General Manager FCI Ophthalmics, INC. P.O. Box 465 Marshfield Hills, MA 02051

K980816 Re: Trade Name: Retinal Detachment Implants Regulatory Class: II Product Code: 86 HQX Dated: July 31, 1998 Received: August 3, 1998

## Dear Ms. Bohsack:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 310(ts) noticelly equivalent (for the indications for above and we have determined the ocvice is seed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been the enactment unte of the Medical Device 11.1.6 Easy of Food, Drug, and Cosmetic Act reclassified in accordance with the provisions on the general controls provisions of the (Act). You may, therefore, market the actives requirements for annual registration,
Act. The general controls provisions of the Act include requirements for annual mishanding Act. I he general controls provisions of ractice, 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 (I remarket reproval), it they be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Farls 600 to 0731 11 Jacouning Practice requirements, as set forth in the Quality System Current Good Hamanaceaning Frices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such periodio Q . Inspections 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 - Ms. Anne Bohsack

This letter will allow you to hegin 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Roerl. lorenttal

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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K980816 . 510(k) Number (if known): _ Retinal Detachment Implants - :: Device Name:

Indications For Use:

Retinal detachment requiring surgical intervention to reattach the retina and preserve/reserve the patient's vision

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------|---------|
| Division of Ophthalmic Devices | |
| 510(k) Number | K980816 |

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align: center;">X</div> | OR | Over-The-Counter Use |
|------------------------------------------|------------------------------------------|----|----------------------|
|------------------------------------------|------------------------------------------|----|----------------------|

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