(66 days)
The hook is a single use instrument for the retraction of eye muscles in various ophthalmic procedures.
A single use ophthalmic device designed to retract eye muscles.
The Stephens Disposable Hooks are Class I ophthalmic devices intended for single-use retraction of eye muscles in various ophthalmic procedures. The device's acceptance criteria are based on demonstrating substantial equivalence to predicate devices, namely Katena Ophthalmic Hooks, Storz Ophthalmic Hooks, Rhein Ophthalmic Hooks, and previous Stephens Ophthalmic Hooks. The summary outlines performance tests conducted to prove this equivalence.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 1.0 Dimensional Equivalency | Hook measurements were substantially equivalent to the predicate devices. |
| 2.0 Retraction Tension | The mechanism and holding ability performed as well as the predicate devices. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not specified in the provided text. The document only states that "the instrument's" measurements were compared and "the Stephens hooks" were tested, implying a single sample or a small, unspecified number used for performance evaluation against predicates.
- Data Provenance: Not specified, but generally, such tests are conducted internally by the manufacturer. No indication of country of origin is given. The data would be considered retrospective in the sense that it's a comparison to existing devices.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. The study did not involve establishing ground truth from expert consensus in a clinical setting. It was a physical performance and dimensional comparison.
4. Adjudication Method for Test Set
- Not applicable. This was not a study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. No MRMC study was conducted as this device is a surgical instrument and not an AI or imaging diagnostic tool.
6. Standalone Algorithm Performance
- Not applicable. This device is a manual surgical instrument, not an algorithm or software.
7. Type of Ground Truth Used
- Dimensional measurements and performance characteristics (retraction tension) of legally marketed predicate devices. The ground truth for the "Dimensional Equivalency Test" was the measurements of the predicate devices. For the "Retraction Tension Tests," the ground truth was the performance of the predicate devices.
8. Sample Size for Training Set
- Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How Ground Truth for Training Set was Established
- Not applicable. This device is not an AI/ML algorithm.
{0}------------------------------------------------
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 | KatenaOphthalmic Hooks | Storz OphthalmicHooks | Rhein OphthalmicHooks | StephensOphthalmic Hooks |
|---|---|---|---|---|
| Intended Use | Retraction of eyemuscles in variousophthalmicprocedures | Retraction of eyemuscles in variousophthalmicprocedures | Retraction of eyemuscles in variousophthalmicprocedures | Retraction of eyemuscles in variousophthalmicprocedures |
| Performance | Compatible | Compatible | Compatible | Same |
| Material | 420 Stainless Steel | 420 Stainless Steel | 420 Stainless Steel | 420 Stainless Steel& 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
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
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.
{2}------------------------------------------------
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{3}------------------------------------------------
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)
§ 886.4350 Manual ophthalmic surgical instrument.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.