(92 days)
Not Found
No
The description focuses on mechanical automation (DC motor) and preset parameters, with no mention of AI/ML terms or data-driven learning.
No
The device is described as a surgical instrument used for cutting the cornea, which is a preparatory step in keratoplasty procedures. While it's used in a therapeutic context, it is not therapeutic itself, as it does not directly treat a disease or condition but rather facilitates a surgical intervention. Its function is to create a precise cut, analogous to a surgical scalpel with added automation and precision features. The predicate device also suggests it's a surgical tool, not a therapeutic device.
No
The device is described as a surgical tool used for preparing corneas for transplantation, not for diagnosing medical conditions.
No
The device description explicitly states it is a physical, disposable trephine made of plastic and stainless steel with a DC motor, indicating it is a hardware device.
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 preparation of corneal tissue for surgical procedures (keratoplasty). This is a surgical tool used on the patient's tissue, not a test performed on a sample of the patient's tissue outside the body to diagnose a condition.
- Device Description: The description details a surgical instrument with a blade for cutting tissue. It does not describe a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue samples, or any other biological material to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical instrument used to prepare tissue for transplantation.
N/A
Intended Use / Indications for Use
The Automated Corneal Trephine is intended for preparation of recipient and donor comeas for lamellar and penetrating keratoplasty.
Indications For Usc:
- Lamellar keratoplasty
- Penetrating Keratoplasty
Product codes
86 HRG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
recipient and donor corneas
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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 .
2
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) |