SUPER VIEW DISPOSABLE BIOM LENS SET

K051630 · Insight Instruments, Inc. · HJK · Jun 29, 2005 · Ophthalmic

Device Facts

• Record ID: K051630
• Device Name: SUPER VIEW DISPOSABLE BIOM LENS SET
• Applicant: Insight Instruments, Inc.
• Product Code: HJK · Ophthalmic
• Decision Date: Jun 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1385
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Diagnostic Lenses are intended to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures. Diagnostic lenses are indicated for use during vitreoretinal surgical procedures.

Device Story

Super View Disposable BIOM Lens Set consists of sterile, disposable thermoplastic lenses; used in conjunction with operating microscope equipped with BIOM wide-angle viewing system. Lenses provide surgical optics to improve visualization of ocular fundus, vitreous, and retinal structures during vitreoretinal surgery. Operated by surgeons in clinical/surgical settings. Device provides direct optical enhancement of the surgical field, aiding surgeon in performing vitreoretinal procedures; benefits patient through improved visualization during surgery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Thermoplastics. Design: Contact lenses (concave/flat surfaces) and non-contact lenses (spheric/aspheric surfaces). Energy source: None (passive optical). Connectivity: None. Sterilization: Sterile disposable.

Indications for Use

Indicated for visualization of the ocular fundus, vitreous, and retinal structures during vitreoretinal surgery.

Regulatory Classification

Identification

A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.

Predicate Devices

• Ocular Instrument, Inc. Vitrectomy Lenses (K012096)

Submission Summary (Full Text)

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JUN 2 9 2005

K051630

Insight Instruments, Inc.

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## 3. 510(k) Summary

| 3.1 Date Prepared: | April 19, 2005 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3.2 Applicant: | Insight Instruments, Inc.<br>5400 S. Bryant Avenue<br>Sanford, FL 32773, USA<br>Phone: [phone]<br>Fax: [phone]<br>Contact: Michael Annen, VP Engineering & Mfg. |
| 3.3 Device Name | Proprietary Name: Super View Disposable BIOM Lens Set<br>Common Name: Diagnostic Lens<br>Classification Name: Lens, Contact, Polymethylmethacrylate, Diagnostic |
| 3.4 Device Classification | HJK, Class II, 21 CFR 886.1385 |
| 3.5 Device Description | The Super View Disposable BIOM Lens Set(s) consists of multiple sterile,<br>disposable, thermoplastic lenses for both contact and non-contact use in<br>conjunction with an operating microscope equipped with a BIOM wide-<br>angle viewing system. |
| 3.6 Intended Use | The Diagnostic Lenses are intended to be used in conjunction with an<br>operating microscope as a surgical optic to improve visualization of the<br>ocular fundus, vitreous and retinal structures. Diagnostic lenses are<br>indicated for use during vitreoretinal surgical procedures. |

3.7 Summary and comparison of technological characteristics:

| Insight Instruments, Inc.<br>Diagnostic Lenses | Ocular Instrument, Inc. Vitrectomy<br>Lenses | |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | PMMA, Polystyrene, other thermoplastics | PMMA, Silicone, Glass, Quartz |
| Design | Contact lens has concave surface with corneal<br>radius on one side, flat surface on other side.<br>Non-contact lenses have spheric and aspheric<br>surfaces and thermoplastic housings. | Contact lens has concave surface with<br>corneal radius on one side, flat surface<br>on other side.<br>Other designs include biconcave, 20°<br>and 30° prism lenses. Some designs may<br>be used with a handle or scleral ring. |
| Sterility | Sterile disposable | Sterile disposable and Non-sterile<br>reusable |

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The Insight Instruments, Inc. Diagnostic Lenses are equivalent in design, 3.6 Substantial Equivalence The might interamions, and intended use and indications to vitrectorny materials, chasilibation on the ments, Inc. cleared via 510(k) number K012096, 8/24/01.

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JUN 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Insight Instruments, Inc. c/o Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Rd. Boxborough, MA 01719

Re: K051630

Trade/Device Name: Super View Disposable BIOM Lens Set Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate (PMMA) diagnostic contact lens Regulatory Class: Class II Product Code: HJK Dated: June 16, 2005 Received: June 17, 2005

Dear Lehtonen:

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 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.

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Page 2 - Daniel W. Lehtonen

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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 2. Statement of Indications for Use

510(k) Number (if known): _ KO SKO SKO SKO

Device Name: Diagnostic Lenses

## Indications for Use:

Allow visualization of the ocular fundus, vitreous, and retinal structures during vitreoretinal surgery.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Soveria

tvision Sign-Off ision of Ophthalmic Ear. Nose and Throat Devise

510(k) Number K051630