STEPHENS DISPOSABLE SPECULUM

K022836 · Stephens Instruments · HNC · Nov 1, 2002 · Ophthalmic

Device Facts

• Record ID: K022836
• Device Name: STEPHENS DISPOSABLE SPECULUM
• Applicant: Stephens Instruments
• Product Code: HNC · Ophthalmic
• Decision Date: Nov 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4350
• Device Class: Class 1

Intended Use

Speculum made for single use in the retraction of eyelids in various ophthalmic procedures.

Device Story

The Stephens Disposable Speculum is a single-use ophthalmic instrument designed to retract eyelids during various ophthalmic procedures. It functions as a mechanical retractor to maintain eyelid opening, providing exposure for the clinician. The device is intended for use in clinical settings by ophthalmic professionals. It is constructed from stainless steel and polystyrene. The device is manually operated by the clinician to hold the eyelids in a retracted position, facilitating surgical or diagnostic access to the eye. It provides a disposable alternative to reusable metal specula, reducing the risk of cross-contamination.

Clinical Evidence

No clinical data. Bench testing only, including dimensional equivalency testing and retraction tension/holding ability performance testing.

Technological Characteristics

Single-use ophthalmic speculum. Materials: 420 stainless steel and polystyrene. Mechanical retraction principle. Manual operation. Non-powered. Dimensions equivalent to predicate devices.

Indications for Use

Indicated for use in patients undergoing ophthalmic procedures requiring eyelid retraction.

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 Speculum
• Storz Ophthalmic Speculum
• Rhein Ophthalmic Speculum
• Stephens Ophthalmic Speculum

Submission Summary (Full Text)

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K022836

1 2002 NOV

Page 5

## 510 (k) Summary

Device Trade or Proprietary Name: Stephens Disposable Speculum

Device Common or Usual Name or Classification: Ophthalmic Speculum

Classification Name/Product Code(s): 86HNC, Ophthalmic Speculum

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

Device Description: A single use ophthalmic device designed to retract the eyelids.

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

Classification: Class I

### Comparison to Predicate Devices:

| Device Name | Katena<br>Ophthalmic<br>Speculum | Storz Ophthalmic<br>Speculum | Rhein Ophthalmic<br>Speculum | Stephens<br>Ophthalmic<br>Speculum |
|--------------|-----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| Intended Use | Retraction of<br>eyelids in various<br>ophthalmic<br>procedures | Retraction of<br>eyelids in various<br>ophthalmic<br>procedures | Retraction of<br>eyelids in various<br>ophthalmic<br>procedures | Retraction of<br>eyelids 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:

- Dimensional Equivalency Test The blade measurements of the speculum were substantially 1.0 equivalent to the measurements of the predicate devices listed above.
- 2.0 Retraction Tension Tests-The mechanism and holding ability of the Stephens speculum was found to perform as well as the predicate devices.

Clinical Tests: None Adverse S & E Information: None

H. Johnson
Archana Johnson

10-4-02
Date

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2002 NOV

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

K022836 Re:

Trade Name: Stephens Disposable Speculum Classification Regulation Number: 886.4350 Regulatory Class: I Product Code: HNC 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 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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:

510(k) Number : K022836

Device Name : Ophthalmic Speculum

Indications For Use :

Speculum made for single use in the retraction of eyelids in various ophthalmic procedures.

Debra Falls

Unision Slan-Division of Ophthalmic I and Throat Dev

510(k) Number K022836

Prescription Use
(Per 21 CFR 801.109)