(92 days)
The Automated Corneal Trephine is intended for preparation of recipient and donor comeas for lamellar and penetrating keratoplasty.
The Automated Corneal Trephine consists of a sterile, single use, disposable corneal trephine made of medical grade injection-molded plastic and stainless steel. The trephine is used to create a partial or full-thickness circular cut for lamellar or penetrating keratoplasty. This trephine features a DC motor which automatically rotates the trephine, eliminating cumbersome manual rotation. The blade depth is preset at the factory so that the extent of penetration is very precise.
The provided text is a 510(k) summary for the Automated Corneal Trephine (K981063) and an FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria, detailed study designs, or performance results in the way typically expected for answering your request.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria and detailed statistical analysis, especially for Class I devices like this one.
Therefore, I cannot fully answer your request with the information provided. I can only report what is directly stated or inferred from the document.
Here's a breakdown of what can be extracted or inferred, and what is missing:
The core of the submission for K981063 is based on substantial equivalence to the Barron-Hessburg manual corneal trephine (K864520). The performance criteria are implicitly met by demonstrating that the new device operates similarly and achieves the same intended purpose as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied/Inferred from Substantial Equivalence) | Reported Device Performance (Implied/Inferred from Substantial Equivalence) |
|---|---|
| Safety: Device operates without undue harm to the patient. | Presumed safe, as no new safety concerns are raised compared to predicate. |
| Effectiveness: Capable of creating a partial or full-thickness circular cut for lamellar or penetrating keratoplasty. | "The trephine is used to create a partial or full-thickness circular cut for lamellar or penetrating keratoplasty." "The blade depth is preset at the factory so that the extent of penetration is very precise." |
| Similar Mechanism of Action: Creates a cut using a rotating blade. | "features a DC motor which automatically rotates the trephine, eliminating cumbersome manual rotation." (Compared to manual rotation of predicate) |
| Material Biocompatibility: Made of medical grade materials. | "made of medical grade injection-molded plastic and stainless steel." |
| Sterility: Provided sterile. | "sterile, single use, disposable corneal trephine." |
Note: The document does not provide specific quantitative acceptance criteria (e.g., "blade depth variability must be less than X microns") or quantitative performance data from a specific study. The "reported device performance" is descriptive and aims to show functional equivalence to the predicate.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. It is highly unlikely a "test set" in the context of clinical data was used for this type of submission. Performance was likely demonstrated through pre-clinical testing, engineering specifications, and comparison to the predicate.
- Data Provenance: Not specified. Given the nature of the device and the submission type, any data would likely be from engineering tests or simulated use, not human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The document does not describe a study involving expert assessment of device outputs or "ground truth" derived from experts in the context of a diagnostic or subjective assessment device. The "ground truth" for a surgical instrument would be its ability to perform its mechanical function consistently and accurately, which is typically assessed through engineering measurements and bench testing.
4. Adjudication method for the test set
- Not Applicable. No human adjudication method is described as there's no mention of subjective assessment or an expert panel reviewing test results in this document.
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 surgical instrument (corneal trephine), not an AI-powered diagnostic or image analysis tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical surgical instrument, not an algorithm or AI system. There is no "standalone algorithm only" performance to evaluate.
7. The type of ground truth used
- Implied Mechanical/Engineering Specifications and Performance: For a surgical instrument like a trephine, the "ground truth" would relate to its ability to create a precise, circular cut of a specified depth and diameter, its sharpness, sterility, material integrity, and safety during use. This would be established through engineering measurements, material testing, and simulated use models, not expert consensus, pathology, or outcomes data in the clinical sense mentioned.
8. The sample size for the training set
- Not Applicable. This is a mechanical device, not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth established for it.
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JUN 2 3 1998
510(k) Summary
SUBMITTED:
Submitted on behalf of:
Company Name: Address:
Phone: Fax:
Laser Center Development Corporation 709 The Hamptons Lane Town & Country, MO 63017 314-514-1478 314-434-7030
CONTACT PERSON:
Francis E. O'Donnell, Jr., M.D.
OFFICIAL CORRESPONDENT:
Firm Name: Address:
:
Phone: Fax:
Francis E. O'Donnell, Jr., M.D. Laser Center Development Corporation 709 The Hamptons Lane Town & Country, MO 63017 314-514-1478 314-434-7030
DATE SUMMARY PREPARED:
June 2, 1998
Automated Corneal Trephine
COMMON NAME:
TRADE NAME:
Corneal Trephine
SUBSTANTIALLY EQUIVALENT TO: The Automated Corneal Trephine, by I.aser Center Development Corporation, is substantially equivalent to the Barron-Hessburg manual corneal trephine (K864520).
DESCRIPTION OF THE DEVICE: The Automated Corneal Trephine consists of a sterile, single use, disposable corneal trephine made of medical grade injection-molded plastic and stainless steel. The trephine is used to create a partial or full-thickness circular cut for lamellar or penetrating keratoplasty. This trephine features a DC motor which automatically rotates the trephine, eliminating cumbersome manual rotation. The blade depth is preset at the factory so that the extent of penetration is very precise.
INDICATIONS FOR USE: The Automated Corneal Trephine is intended for preparation of recipient and donor comeas for lamellar and penetrating keratoplasty.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the HHS logo, which consists of a stylized caduceus-like symbol with three figures intertwined. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 1998
Francis E. O'Donnell, Ir., M.D. President Laser Center Development Corporation 1028 South Kirkwood Road, Suite A St. Louis, MO 63122
Re: K981063 Trade Name: Automated Corneal Trephine Regulatory Class: I Product Code: 86 HRG Dated: June 2, 1998 Received: June 2, 1998
Dear Dr. O'Donnell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. Francis E. O'Donnell, Jr., M.D.
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. RoepL. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Usc:
.
- Lamellar keratoplasty
- Penetrating Keratoplasty
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| C. Callaway (Division Sign-Off) Division of Ophthalmic Devices | ||
|---|---|---|
| 510(k) Number | K981063 | |
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
§ 886.4070 Powered corneal burr.
(a)
Identification. A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.(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.