GAYHEART CORNEAL EXCISION DEVICE

K022843 · Stephens Instruments · HRH · Nov 1, 2002 · Ophthalmic

Device Facts

• Record ID: K022843
• Device Name: GAYHEART CORNEAL EXCISION DEVICE
• Applicant: Stephens Instruments
• Product Code: HRH · Ophthalmic
• Decision Date: Nov 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4350
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Trephine made for single use and for the extraction of the cornea.

Device Story

Gayheart™ Corneal Excision Device is a single-use ophthalmic trephine used for corneal extraction. Device functions as a manual surgical instrument. Operated by ophthalmologists in clinical or surgical settings. Provides mechanical excision of corneal tissue. Benefits include reduced risk of cross-contamination due to single-use design.

Clinical Evidence

No clinical data. Bench testing only, including dimensional equivalency testing and sharpness testing (number of cuts and initial cutting sharpness).

Technological Characteristics

Manual ophthalmic trephine. Materials: 420 stainless steel and polystyrene. Single-use design. Mechanical cutting principle.

Indications for Use

Indicated for single use extraction of the cornea.

Regulatory Classification

Identification

A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

Predicate Devices

• Katena Ophthalmic Trephine
• Storz Ophthalmic Trephine
• Rhein Ophthalmic Trephine
• Stephens Ophthalmic Trephine

Submission Summary (Full Text)

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K022843

1 2002 NOV

Page 5

# 510 (k) Summary

Device Trade or Proprietary Name: Gayheart™ Corncal Excision Device

Device Common or Usual Name or Classification: Ophthalmic Trephines

Classification Name/Product Code(s): 86HRH, Ophthalmic Trephines

Predicate Devices: Katena Ophthalmic Treplines, Storz Ophthalmic Trephines, Rhein Ophthalmic Trephines, Stephens Ophthalmic Trephines

Device Description: A single use ophthalmic device designed to extract the cornea.

Device Use: Designed for single use extraction of the cornea.

Classification: Class I

## Comparison to Predicate Devices:

| Device Name | Katena<br>Ophthalmic<br>Trephine | Storz Ophthalmic<br>Trephine | Rhein Ophthalmic<br>Trephine | Stephens<br>Ophthalmic<br>Trephine |
|--------------|----------------------------------|------------------------------|------------------------------|--------------------------------------|
| Intended Use | Corneal Extraction | Corneal Extraction | Corneal Extraction | Corneal Extraction |
| Performance | Compatible | Compatible | Compatible | Same |
| Material | 420 Stainless Steel | 420 Stainless Steel | 420 Stainless Steel | 420 Stainless Steel<br>& Polystyrene |

### Performance Tests and Conclusions:

- 1.0 Dimensional Equivalency Test - The measurements of the trephines was substantially equivalent to the measurements of the predicate devices listed above.
- 2.0 Sharpness Tests-The sharpness tests were performed both by number of cuts and initial cutting sharpness of the trephines. It was found that Stophens trephines perform as well as the predicate devices.

Clinical Tests: None
Adverse S & E Information: None

Dhaval K. Shukla

10/25/02
Date

te

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20350

1 2002 NOV

Stephens Instruments c/o Ms. Archana Johnson 2500 Sandersville Road Lexington, KY 40511

Re: K022843

:

Trade Name: Gayheart™ Corneal Excision Device Classification Regulation Number: 886.4350 Regulatory Class: I Product Code: HRH Dated: August 21, 2002 Received: August 27, 2002

Dear Ms. Johnson:

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 (OS) 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 -- Ms. Archana Johnson

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 and additionally 21 CFR Part 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" (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 vours.

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

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510(k) Number : K022843

Device Name : Ophthalmic Trephine

Indications For Use :

Trephine made for single use and for the extraction of the cornea.

. .

Debmah Falls

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises 510(k) Number.

Prescription Use
(Per 21 CFR 801.109)