STEPHENS DISPOSABLE HOOKS

K022842 · Stephens Instruments · HNQ · Nov 1, 2002 · Ophthalmic

Device Facts

• Record ID: K022842
• Device Name: STEPHENS DISPOSABLE HOOKS
• Applicant: Stephens Instruments
• Product Code: HNQ · Ophthalmic
• Decision Date: Nov 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4350
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The hook is a single use instrument for the retraction of eye muscles in various ophthalmic procedures.

Device Story

Stephens Disposable Hooks are single-use ophthalmic instruments designed for retracting eye muscles during ophthalmic procedures. The device consists of a hook component used by surgeons to manipulate muscle tissue. It is intended for use in clinical settings by qualified healthcare professionals. The device functions as a manual surgical tool; it does not involve electronic inputs, automated processing, or software. Its primary benefit is providing a sterile, single-use alternative to reusable hooks, reducing the risk of cross-contamination.

Clinical Evidence

No clinical data. Bench testing only, including dimensional equivalency tests and retraction tension tests, demonstrated performance equivalent to predicate devices.

Technological Characteristics

Materials: 420 stainless steel and polystyrene. Form factor: Manual ophthalmic hook. Single-use design. No energy source, connectivity, or software.

Indications for Use

Indicated for the retraction of eye muscles in various ophthalmic procedures. Intended for prescription use.

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 Hooks
• Storz Ophthalmic Hooks
• Rhein Ophthalmic Hooks
• Stephens Ophthalmic Hooks

Submission Summary (Full Text)

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K022842

NOV 1 2002

Page 5

## 510 (k) Summary

Device Trade or Proprietary Name: Stephens Disposable Hooks

Device Common or Usual Name or Classification: Ophthalmic Hooks

Classification Name/Product Code(s): 86HNQ, Ophthalmic Hooks

Predicate Devices: Katena Ophthalmic Hooks, Storz Ophthalmic Hooks, Rhein Ophthalmic Hooks, Stephens Ophthalmic Hooks

Device Description: A single use ophthalmic device designed to retract eye muscles.

Device Use: Designed for single use retracting of eye muscles in various ophthalmic procedures.

Classification: Class I

## Comparison to Predicate Devices:

| Device Name | Katena<br>Ophthalmic Hooks | Storz Ophthalmic<br>Hooks | Rhein Ophthalmic<br>Hooks | Stephens<br>Ophthalmic Hooks |
|--------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|
| Intended Use | Retraction of eye<br>muscles in various<br>ophthalmic<br>procedures | Retraction of eye<br>muscles in various<br>ophthalmic<br>procedures | Retraction of eye<br>muscles in various<br>ophthalmic<br>procedures | Retraction of eye<br>muscles in various<br>ophthalmic<br>procedures |
| Performance | Compatible | Compatible | Compatible | Same |
| Material | 420 Stainless Steel | 420 Stainless Steel | 420 Stainless Steel | 420 Stainless Steel<br>& Polystyren |

## Performance Tests and Conclusions:

- 1.0 Dirnensional Equivalency Test - The hook measurements of the instruments were substantially equivalent to the measurements of the predicate devices listed above.
- 2.0 Retraction Tension Tests-The mechanism and holding ability of the Stephens hooks were found to perform as well as the predicate devices.

Clinical Tests: None Adverse S & E Information: None

Archana Johnson

10-4-02
Date

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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od and Drug Administration 200 Corporate Boulevard Rockville MD 20850

NOV 1 200

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

Re: K022842

Trade Name: Stephens Disposable Hooks Classification Regulation Number: 886.4350 Regulatory Class: I Product Code: HNQ Dated: May 3, 2002 Received: May 24, 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 (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 - 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 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

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Pg 13 of 13

510(k) Number : K022842

Device Name : Ophthalmic Hooks

Indications For Use :

The hook is a single use instrument for the retraction of eye muscles in various ophthalmic procedures.

Debnah Falls

islon Sign-Off) riston of Ophthalm Nose and Throat De 510(k) Number.

Prescription Use
(Per 21 CFR 801.109)