(66 days)
Forceps for single use designed for the manipulation of tissue or muscles in various ophthalmic procedures.
A single use ophthalmic device designed to manipulate eye tissues or muscles.
The provided text describes a 510(k) premarket notification for the Stephens Disposable Forceps, a Class I ophthalmic device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a complex AI-driven system. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimensional Equivalency | The teeth measurements of the forceps were substantially equivalent to the measurements of the predicate devices. |
| Manipulation (Mechanism & Holding Ability) | The mechanism and holding ability of the Stephens forceps were found to perform as well as the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a separate "test set" in the context of clinical trials or data analysis. The performance tests ("Dimensional Equivalency Test" and "Manipulation Tests") likely involved a sample of the manufactured forceps.
- Data Provenance: Not applicable in the traditional sense of patient data. The tests were likely conducted in a laboratory setting on prototypes or production samples of the device and predicate devices. No country of origin for specific "data" is mentioned other than the company's location (Lexington, KY, USA). The studies are not considered "retrospective" or "prospective" as they are performance tests, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance tests described (dimensional and manipulation) would be assessed against engineering specifications or by direct comparison to the physical characteristics and function of the predicate devices, not by expert clinical consensus for "ground truth."
4. Adjudication method for the test set
Not applicable. There's no mention of a formal adjudication process for interpreting test results, as these are objective engineering and performance comparisons.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical ophthalmic forceps, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI performance metrics are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used
For dimensional equivalency, the ground truth would be the measurements of the predicate devices' teeth. For manipulation tests, the ground truth would be the observed performance (mechanism and holding ability) of the predicate devices. Neither is "expert consensus," "pathology," or "outcomes data."
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.
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1 2002 NOV
Page 5
510 (k) Summary
Device Trade or Proprietary Name: Stephens Disposable Forceps
Device Common or Usual Name or Classification: Ophthalmic Forceps
Classification Name/Product Code(s): 86HNR, Ophthalmic Forceps
Predicate Devices: Katena Ophthalmic Forceps, Storz Ophthalmic Forceps, Rhein Ophthalmic Forceps, Stephens Ophthalmic Forceps
Device Description: A single use ophthalmic device designed to manipulate eye tissues or muscles.
Device Use: Designed for single use manipulating of eye tissues or muscles in various ophthalmic procedures.
Classification: Class I
Comparison to Predicate Devices:
| Device Name | KatenaOphthalmicForceps | Storz OphthalmicForceps | Rhein OphthalmicForceps | StephensOphthalmicForceps |
|---|---|---|---|---|
| Intended Use | Manipulation ofeye tissues ormuscles in variousophthalmicprocedures | Manipulation ofeye tissues ormuscles in variousophthalmicprocedures | Manipulation ofeye tissues ormuscles in variousophthalmicprocedures | Manipulation ofeye tissues ormuscles 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:
- Dimensional Equivalency Test The teeth measurements of the forceps were substantially 1.0 equivalent to the measurements of the predicate devices listed above.
- 2.0 Manipulation Tests-The mechanism and holding ability of the Stephens forceps were found to perform as well as the predicate devices.
Clinical Tests: None Adverse S & E Information: None
L. Johnson
Archana 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a series of waving lines.
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: K022835
Trade Name: Stephens Disposable Forceps Classification Regulation Number: 886.4350 Regulatory Class: I Product Code: HNR 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 (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
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510(k) Number : K022835
Device Name : Ophthalmic Forceps
:
Indications for Use :
Forceps for single use designed for the manipulation of tissue or muscles in various ophthalmic procedures.
Debnah Falls
Division Sign-Off) sion of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K022835
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.