MICROVISION SCLERAL BUCKLING COMPONENTS

K023481 · Microvision, Inc. · HQX · Jan 8, 2003 · Ophthalmic

Device Facts

• Record ID: K023481
• Device Name: MICROVISION SCLERAL BUCKLING COMPONENTS
• Applicant: Microvision, Inc.
• Product Code: HQX · Ophthalmic
• Decision Date: Jan 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3340
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MicroVision Scleral Buckling Components are solid silicone and silicone sponge implants intended for intrascleral and episcleral buckling in the surgical treatment of retinal detachments.

Device Story

MicroVision Scleral Buckling Components are molded solid silicone and silicone sponge implants used in retinal reattachment surgery. These devices are implanted by ophthalmic surgeons during surgical procedures to provide intrascleral or episcleral buckling. The implants are provided sterile for single use and are available in various shapes and sizes to accommodate different surgical needs. By providing structural support to the sclera, the implants facilitate the reattachment of the retina. The device is a passive implant; it does not involve electronic processing, software, or automated decision-making.

Clinical Evidence

No clinical data. Bench testing only to demonstrate dimensional and physical property equivalence to predicate devices. Biocompatibility testing conducted per ISO 10993.

Technological Characteristics

Materials: Molded solid silicone and silicone sponge. Form factor: Various shapes and sizes. Sterilization: Provided sterile for single use. Biocompatibility: Confirmed per ISO 10993. No electronic, software, or energy-based components.

Indications for Use

Indicated for patients requiring surgical treatment of retinal detachment via intrascleral or episcleral buckling.

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.

Predicate Devices

• Mira, Inc. (K950806)
• Storz Ophthalmics, Inc. (K832481)
• Storz Ophthalmics, Inc. (K950599)
• Labtician Ophthalmics, Inc. (K875014)

Submission Summary (Full Text)

{0}------------------------------------------------

# KO23481

## 510(k) Summary

### for

## MicroVision Scleral Buckling Components

#### 1. SPONSOR

MicroVision, Inc. 34 Folly Mill Road, Suite 200 P.O. Box 1651 Seabrook, NH 03874

Contact Person: Leonard Kastrilevich 603-474-5566 Telephone:

Date Prepared: October 16, 2002

#### 2. DEVICE NAME

| Proprietary Name: | MicroVision Scleral Buckling Components |
|----------------------|--------------------------------------------|
| Common/Usual Name: | Scleral Buckling Components |
| Classification Name: | Nonresorbable Extraocular Orbital Implants |

#### 3. PREDICATE DEVICES

MicroVision, Inc. claims substantial equivalence to the solid silicone and silicone sponge implants cleared for marketing under the following 510(k)s:

- Mira, Inc. . (K950806)
- Storz Ophthalmics, Inc. (K832481, K950599) .
- Labtician Ophthalmics, Inc. (K875014) .

#### INTENDED USE 4.

The MicroVision Scleral Buckling Components are solid silicone and silicone sponge implants intended for intrascleral and episcleral buckling in the surgical treatment of retinal detachments.

#### 5. DEVICE DESCRIPTION

The MicroVision Scleral Buckling Components are molded solid silicone and silicone sponge devices available in a variety of shapes and sizes. The components

{1}------------------------------------------------

# KO23481

are provided as sterile for single use only. Biocompatibility testing conducted according to ISO 10993 confirmed that the components are biocompatible and nontoxic.

#### BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The MicroVision Scleral Buckling Components have the same intended use as the listed predicate products, that is, for scleral buckling in retinal reattachment surgery. All of the products are made of molded silicone, either in solid or sponge form, are provided sterile for single use only, and are available in a wide variety of shapes and sizes. All products have been demonstrated to be biocompatible and non-toxic. Bench testing was conducted to demonstrate that the MicroVision products are substantially equivalent to the predicates with respect to dimensional and physical properties.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem depicts a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The overall design is simple and conveys a sense of authority and professionalism.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 0 8 2003

MicroVision, Inc. Sheila Hemeon-Heyer, JD, RAC c/o Medical Device Consultants, Inc. (MDCI) 49 Plain Street North Attleboro, MA 02760

Re: K023481

Trade Name: MicroVision Scleral Buckling Components Classification Regulation Number: 886.3340 Regulatory Class: II Product Code: HQX Dated: October 16, 2002 Received: October 17, 2002

Dear Dr. Hemeon-Heyer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Sheila Hemeon-Heyer, JD, RAC

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
A. Ralph Rosenthal

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

{4}------------------------------------------------

510(k) Number (if known): ¥02 348 |

Device Name: MicroVision Scleral Buckling Components

Indications for Use:

The MicroVision Scleral Buckling Components are solid silicone and silicone sponge implants intended for intrascleral and episcleral buckling in the surgical treatment of retinal detachment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ausannand Jones

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K 033981

L Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

October 16, 2002