(88 days)
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.
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.
This submission for the Hansatome™ Microkeratome is a 510(k) premarket notification, claiming substantial equivalence to a predicate device (Automatic Corneal Shaper, K913697). As such, it focuses on demonstrating that the new device is as safe and effective as the predicate, rather than providing extensive de novo clinical study data to meet specific acceptance criteria for performance. The summary explicitly states that the technological changes "do not raise any new issues of safety, effectiveness or performance of the product," relying on the predicate's established performance.
Therefore, the "acceptance criteria" here are primarily about demonstrating equivalence in performance to the predicate device in non-clinical tests.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent intended use | Same |
| Equivalent operating principle | Same |
| Equivalent patient contact portion | Same |
| Equivalent materials | Same |
| Equivalent ability to create corneal resections | "found to perform equivalently to the predicate device, Automatic Corneal Shaper (ACS) with respect to the creation of corneal resections." |
| No new safety, effectiveness, or performance issues | "the technological changes... do not raise any new issues of safety, effectiveness or performance of the product." |
Study Proving Device Meets Acceptance Criteria:
The study described is a non-clinical comparative test.
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Sample size used for the test set and the data provenance: Not specified. The document states "will be tested" and "was found to perform equivalently," implying non-clinical testing was conducted, but details on sample size or data provenance (e.g., in-vitro tests on cadaver eyes, animal models) are not provided. It is considered retrospective as per the K913697.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was a non-clinical comparison focusing on mechanical performance (creation of corneal resections) and material equivalence, not expert-adjudicated clinical outcomes.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human adjudication of clinical data is described.
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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 is a mechanical surgical device, not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical surgical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" implicitly refers to the established performance characteristics and specifications of the predicate device. The performance of the new device was compared against these. For the "creation of corneal resections," the ground truth would likely be quantitative measurements of the consistency, thickness, and diameter of resections performed by the device on an appropriate test medium (e.g., cadaveric eyes, synthetic cornea models).
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The sample size for the training set: Not applicable. As a non-AI mechanical device, there is no "training set."
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How the ground truth for the training set was established: Not applicable.
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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.
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- 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 |
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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 CORNEALSHAPER (PREDICATE) | Hansatome™ |
|---|---|---|
| Intended Use | Intended for use in performing initiallamellar resections of the cornea. | Same |
| Operating Principle | Electrically driven oscillating bladehoused in head which guides bladeacross the cornea within controlledparameters | 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 withsingle linear gear tracks• 1 head with interchangeable | • Single arcuate gear rack withtemporal pivot pin• 2 interchangeable heads with fixed |
Comparative Technological Characteristics
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| 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.
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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.
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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
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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
§ 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.