(88 days)
Not Found
No
The summary describes a mechanical surgical instrument and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a surgical instrument for cutting a precise corneal disc. While it is used in a medical procedure, its function is mechanical preparation rather than directly providing a therapeutic effect to treat or cure a disease.
No
The device is described as an instrument for cutting tissue (lamellar resection of the cornea), which is a surgical tool, not a diagnostic one. Its function is to perform a physical action on the cornea, not to detect, identify, or monitor a medical condition.
No
The device description explicitly states it is a "precision-manufactured instrument" and describes its function as "cutting a precise corneal disc," which are characteristics of a physical hardware device, not software.
Based on the provided information, the Hansatome™ microkeratome is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Hansatome™ Function: The description clearly states the Hansatome™ is a surgical instrument used for lamellar resection of the cornea in patients undergoing surgery. This is a procedure performed directly on the patient's body, not on a sample taken from the body.
Therefore, the Hansatome™ microkeratome is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hansatome™ microkeratome is a precision-manufactured instrument indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.
Product codes
86 HNO
Device Description
The Hansatome™ microkeratome is a precision-manufactured instrument designed for cutting a precise corneal disc of preselected thickness and diameter. The device is intended for use in performing lamellar corneal resections. The Hansatome™ Microkeratome materials are similar to those used in the predicate device.
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
The Hansatome™ microkeratome has been designed and will be tested to applicable safety standards. In addition, the Hansatome™ microkeratome was found to perform equivalently to the predicate device, Automatic Corneal Shaper (ACS) with respect to the creation of corneal resections. Thus, the technological changes in the Hansatome™ microkeratome do not raise any new issues of safety, effectiveness or performance of the product.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4370 Keratome.
(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.
0
Hansa Research & Development, Inc. HANSATOME™ Microkeratome
July 25, 1997 Premarket Notification
OCT 2 4 1997
SECTION 15
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. Submitter's name, address, telephone number, contact person, and date summary prepared:
- Hansa Research and Development, Inc. a. 7790 N. W. 55th Street Miami, FL 33166
b. Contact Person:
Brigitta Hellenkamp Vice President
Brigitte Hesselberg
Date Summary Prepared: C.
July 25, 1997
2. Name of device, including trade name and classification name:
- Hansatome™ microkeratome Trade/Proprietary Name: ટા.
- Classification Name: Keratome b.
-
- Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
| Company: | Hansa Research & Development, Inc |
|---|---|
| Device: | Automatic Corneal Shaper |
| 510(k) : | K913697 |
1
Date Cleared:
November 5, 1991
A description of the device that is the subject of the 510(k), including explanation of 4. how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The Hansatome™ microkeratome is a precision-manufactured instrument designed for cutting a precise corneal disc of preselected thickness and diameter. The device is intended for use in performing lamellar corneal resections. The Hansatome™ Microkeratome materials are similar to those used in the predicate device.
ક. Statement of intended use:
The Hansatome™ microkeratome is a precision-manufactured instrument intended for use in performing initial lamellar corneal resections.
Statement of how the technological characteristics of the device compare to those 6. of the predicate or legally marketed device.
| CHARACTERISTICS | AUTOMATIC CORNEAL
SHAPER (PREDICATE) | Hansatome™ |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Intended Use | Intended for use in performing initial
lamellar resections of the cornea. | Same |
| Operating Principle | Electrically driven oscillating blade
housed in head which guides blade
across the cornea within controlled
parameters | Same |
| Patient contact portion of device* | • Suction Ring
• Microkeratome Head
• Blade | • Same
• Same
• Same |
| Materials | • Stainless Steel
• Stainless Steel
• Low Carbon Stainless Steel | • Same
• Same
• Same |
| Sterilization method (blade) | Radiation (GAMMA) | EO |
| Keratome Mechanism | • Dual linear guideways with
single linear gear tracks
• 1 head with interchangeable | • Single arcuate gear rack with
temporal pivot pin
• 2 interchangeable heads with fixed |
Comparative Technological Characteristics
2
| Head/Thickness Plate Electric motor Control Mechanism Cutting Principle Footswitch | thickness plates DC Powered, 12 volt Footswitch Blade Oscillation Electric | thickness plates DC Powered, 6-9 volt Same Same Same |
|---|---|---|
| ------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------- | ------------------------------------------------------- |
7. Brief summary of nonclinical tests and results:
The Hansatome™ microkeratome has been designed and will be tested to applicable safety standards. In addition, the Hansatome™ microkeratome was found to perform equivalently to the predicate device, Automatic Corneal Shaper (ACS) with respect to the creation of corneal resections. Thus, the technological changes in the Hansatome™ microkeratome do not raise any new issues of safety, effectiveness or performance of the product.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three wavy lines forming the profile of a face and body. The text is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 24 1997
Judy F. Gordon, D.V.M. Vice President, Scientific Affairs Chiron Vision Corporation 9342 Jeronimo Road Irvine, CA 92618-1903
Re: K972808 Trade Name: Hansatome™ Microkeratome Regulatory Class: I Product Code: 86 HNO Dated: July 25, 1997 Received: July 28, 1997
Dear Dr. Gordon:
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.
4
Page 2 - Judy F. Gordon, D.V.M.
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 Roerl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Hansa Research & Development, Inc. HANSATOME™ Microkeratome
July 25, 1997
Premarket Notification
SECTION 6
INDICATIONS FOR USE
The Hansatome™ microkeratome is a precision-manufactured instrument indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.
Prescription Use
(Per 21 CFR 801.109)
Eunetto Reem
(Division Sign-Off)
ivision of Ophthalmic Devices KT 10(k) Number 2509