(66 days)
Not Found
Not Found
No
The summary describes a manual surgical instrument (trephine) and its performance is evaluated based on physical characteristics like dimensions and sharpness, not data analysis or algorithmic performance. There is no mention of AI, ML, image processing, or data sets.
No.
The device is a surgical instrument for extracting the cornea, which is an intervention rather than a therapeutic treatment in itself. Its function is to perform a surgical step, not to alleviate or cure a condition.
No
Explanation: The device is described as a trephine used for extraction of the cornea, and its performance studies relate to dimensional equivalency and sharpness, indicating a surgical tool rather than a diagnostic one.
No
The device description clearly states it is a "single use ophthalmic device designed to extract the cornea," which is a physical instrument, not software. The performance studies also focus on physical characteristics like dimensional equivalency and sharpness.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the extraction of the cornea." This is a surgical procedure performed on a living patient, not a test performed on a sample taken from a patient in vitro (outside the body).
- Device Description: The description confirms it's an "ophthalmic device designed to extract the cornea," reinforcing its surgical nature.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or any of the typical characteristics of an IVD.
Therefore, this device is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Trephine made for single use and for the extraction of the cornea.
Product codes (comma separated list FDA assigned to the subject device)
86HRH
Device Description
A single use ophthalmic device designed to extract the cornea.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Katena Ophthalmic Treplines, Storz Ophthalmic Trephines, Rhein Ophthalmic Trephines, Stephens Ophthalmic Trephines
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
1 2002 NOV
Page 5
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 | Katena
Ophthalmic
Trephine | Storz Ophthalmic
Trephine | Rhein Ophthalmic
Trephine | Stephens
Ophthalmic
Trephine |
|--------------|----------------------------------|------------------------------|------------------------------|--------------------------------------|
| 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
1
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.
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 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
3
Pg 13 of 13
.
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)