STEPHENS DISPOSABLE SCISSORS

K022840 · Stephens Instruments · HNF · Nov 1, 2002 · Ophthalmic

Device Facts

• Record ID: K022840
• Device Name: STEPHENS DISPOSABLE SCISSORS
• Applicant: Stephens Instruments
• Product Code: HNF · Ophthalmic
• Decision Date: Nov 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4350
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Scissors made for single use in the cutting of tissue in various ophthalmic procedures.

Device Story

Stephens Disposable Scissors are single-use ophthalmic instruments designed for cutting tissue during various ophthalmic procedures. The device consists of 420 stainless steel blades and a polystyrene handle. It is intended for use by clinicians in a clinical or surgical setting. The device functions as a manual surgical tool; it does not involve electronic inputs, software, or automated processing. Performance is verified through dimensional equivalency and sharpness testing compared to predicate ophthalmic scissors. The single-use design eliminates the need for reprocessing, potentially reducing the risk of cross-contamination.

Clinical Evidence

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

Technological Characteristics

Materials: 420 stainless steel blades, polystyrene handle. Manual surgical instrument. No energy source. Single-use. No software or connectivity.

Indications for Use

Indicated for use in patients undergoing ophthalmic procedures requiring tissue cutting.

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 Scissors
• Storz Ophthalmic Scissors
• Rhein Ophthalmic Scissors
• Stephens Ophthalmic Scissors

Submission Summary (Full Text)

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K022840

1 2002 NOV

Page 5

# 510 (k) Summary

Device Trade or Proprietary Name: Stephens Disposable Scissors

Device Common or Usual Name or Classification: Ophthalmic Scissors

Classification Name/Product Code(s): 86HNF, Ophthalmic Scissors

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

Device Description: A single use ophthalmic device designed for cutting tissues.

Device Use: Designed for single use cutting in various ophthalmic procedures.

Classification: Class I

### Comparison to Predicate Devices:

| Device Name | Katena<br>Ophthalmic<br>Scissors | Storz Ophthalmic<br>Scissors | Rhein Ophthalmic<br>Scissors | Stephens<br>Ophthalmic<br>Scissors |
|--------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|
| Intended Use | Cutting of tissue in<br>various ophthalmic<br>procedures | Cutting of tissue in<br>various ophthalmic<br>procedures | Cutting of tissue in<br>various ophthalmic<br>procedures | Cutting of tissue in<br>various ophthalmic<br>procedures |
| Performance | Compatible | Compatible | Compatible | Same |
| Material | 420 Stainless Steel | 420 Stainless Steel | 420 Stainless Steel | 420 Stainless Steel<br>& Polystyrene |

## Performance Tests and Conclusions:

- Dimensional Equivalency Test -- The blade measurements of the scissors were substantially 1.0 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 scissors. It was found that Stephens scissors perform as well as the predicate devices.

Clinical Tests: None Adverse S & E Information: None

A. Johnson

10.4.02
Date

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

K022840 Re:

> Trade Name: Stephens Disposable Scissors Classification Regulation Number: 886.4350 Regulatory Class: I Product Code: HNF 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 (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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510(k) Number : K022840

Device Name : Ophthalmic Scissors

Indications For Use :

Scissors made for single use in the cutting of tissue in various ophthalmic procedures.

Debnah Faus

(Division Slon-Off) ision of Ophthalmic E Nose and Throat Devis 510(k) Number

Prescription Use
(Per 21 CFR 801.109)