(66 days)
Trephine made for single use and for the extraction of the cornea.
A single use ophthalmic device designed to extract the cornea.
The Gayheart™ Corncal Excision Device (K022843) is an ophthalmic trephine, a single-use device designed for corneal extraction. Its acceptance criteria and performance were assessed through non-clinical tests demonstrating substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimensional Equivalency | Measurements of the Gayheart™ Corneal Excision Device (trephines) were substantially equivalent to the measurements of the predicate devices (Katena, Storz, Rhein, Stephens Ophthalmic Trephines). |
| Sharpness | Sharpness tests (number of cuts and initial cutting sharpness) showed that Stephens trephines perform as well as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test set. The tests involved "measurements of the trephines" and "sharpness tests" on the Gayheart™ Corneal Excision Device and a comparison to predicate devices, implying a sufficient number of devices were tested to draw a comparison. The data provenance is not explicitly stated but is implicitly from an internal test by Stephens Instruments as part of their 510(k) submission. This is considered retrospective data from the manufacturer's testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No direct mention of experts or their qualifications for establishing ground truth is provided. The performance tests (dimensional equivalency and sharpness) appear to be objective measurements, likely conducted in a lab setting by technical personnel rather than clinical experts.
4. Adjudication Method for the Test Set
No adjudication method is described. The tests were objective measurements (dimensions, sharpness), not subjective interpretations that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The device is a Class I ophthalmic trephine, and the submission does not mention any clinical studies or human reader involvement in its evaluation for this 510(k).
6. If a Standalone (algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The Gayheart™ Corneal Excision Device is a physical surgical instrument, not an algorithm or AI-powered device. Therefore, the concept of "standalone performance" in the context of AI does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims was based on:
- Objective Measurements: Directly measured dimensions, number of cuts, and initial cutting sharpness of the devices.
- Comparison to Predicate Devices: The performance was assessed against established predicate devices, implying that the performance of these legally marketed devices served as the benchmark or "ground truth" for acceptable performance for this type of device.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical surgical instrument and does not involve any artificial intelligence or machine learning algorithms that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this device.
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1 2002 NOV
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510 (k) Summary
Device Trade or Proprietary Name: Gayheart™ Corncal Excision Device
Device Common or Usual Name or Classification: Ophthalmic Trephines
Classification Name/Product Code(s): 86HRH, Ophthalmic Trephines
Predicate Devices: Katena Ophthalmic Treplines, Storz Ophthalmic Trephines, Rhein Ophthalmic Trephines, Stephens Ophthalmic Trephines
Device Description: A single use ophthalmic device designed to extract the cornea.
Device Use: Designed for single use extraction of the cornea.
Classification: Class I
Comparison to Predicate Devices:
| Device Name | KatenaOphthalmicTrephine | Storz OphthalmicTrephine | Rhein OphthalmicTrephine | StephensOphthalmicTrephine |
|---|---|---|---|---|
| Intended Use | Corneal Extraction | Corneal Extraction | Corneal Extraction | Corneal Extraction |
| Performance | Compatible | Compatible | Compatible | Same |
| Material | 420 Stainless Steel | 420 Stainless Steel | 420 Stainless Steel | 420 Stainless Steel& Polystyrene |
Performance Tests and Conclusions:
- 1.0 Dimensional Equivalency Test - The measurements of the trephines was substantially 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 trephines. It was found that Stophens trephines perform as well as the predicate devices.
Clinical Tests: None
Adverse S & E Information: None
Dhaval K. Shukla
10/25/02
Date
te
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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: K022843
:
Trade Name: Gayheart™ Corneal Excision Device Classification Regulation Number: 886.4350 Regulatory Class: I Product Code: HRH 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 (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 vours.
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 : K022843
Device Name : Ophthalmic Trephine
Indications For Use :
Trephine made for single use and for the extraction of the cornea.
. .
Debmah Falls
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises 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.