(65 days)
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No
The 510(k) summary describes replacement blades for a keratome and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as replacement blades for a keratome, which is a surgical instrument. Replacement blades themselves are not considered therapeutic devices, but rather components of a surgical tool.
No
The device, Surgin's Prizm Blades, is described as replacement blades for a keratome, which is a surgical instrument. There is no indication from the provided text that it performs any diagnostic function, such as identifying or detecting diseases or conditions.
No
The 510(k) summary describes "Prizm Blades," which are physical replacement blades for a keratome (a surgical instrument). This clearly indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "replacement blades for the Nidek Model MK2000 keratome." A keratome is a surgical instrument used for cutting the cornea during eye surgery. This is a surgical device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, based solely on the provided text, Surgin's Prizm Blades are a surgical accessory and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Surgin's Prizm Blades are designed as replacement blades for the Nidek Model MK2000 keratome.
Product codes
HNO
Device Description
Prizm Keratome Blade (Nidek Model MK 2000)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2001
Mr. Don W. Haar Q.A. / Regulatory Manager Surgin, Inc. 14762 Bentley Circle Tustin, CA 92680
Re: K013337
Trade/Device Name: Prizm Keratome Blade (Nidek Model MK 2000) Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: October 9, 2001 Received: October 9, 2001
Dear Mr. Haar:
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 stared in also encreater) to ical 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.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally premaired nothication. The PDA midning of bacomman or 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 If you desire specific advice for your avitro diagnostic devices), please contact the Office of additionally 21 CFN Fall 807.10 for mirrato atagonomics and advertising of Compliance at (301) 594-4017. Tidnitionally 16. questions . 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 Other general intormation on your respend on 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 yours,
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
2
Surgin, Inc
DEC 1 3 2001
14762 Bentley Circle Tustin, CA 92680 Tel: 714 832 6300
INDICATIONS FOR USE STATEMENT
510(k) Number (1 known): K013337
Device Name: Prizm Keratomo Blade
Indications For Use:
Surgin's Prizm Blades are designed as replacement blades for the Nidek Model MK2000 keratome.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrance of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic Ear, | |
| Nose and Throat Devises | |
| 510(k) Number | K013337 |
| Prescription Use (Per 21 CFR 801.109) | ✓ OR Over-The-Counter Use |
(Optional Format 1-2-96)