(110 days)
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No
The summary describes replacement blades for a microkeratome, a mechanical surgical device. There is 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 microkeratome, which is a surgical tool used for lamellar resection of the cornea. It is an accessory to a surgical device, not a therapeutic device itself.
No
The device is described as replacement blades for a microkeratome used for "lamellar resection of the cornea," which indicates a surgical, not diagnostic, function.
No
The device is described as replacement blades, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Surgin Inc. AccuBlade is a replacement blade for a microkeratome, which is a surgical instrument used to cut a flap in the cornea during eye surgery. It is used directly on the patient's body, not for testing specimens outside the body.
- Intended Use: The intended use clearly states it's for "lamellar resection of the cornea," which is a surgical procedure.
Therefore, based on the provided information, the AccuBlade is a surgical instrument component, not an IVD.
N/A
Intended Use / Indications for Use
The Surgin Inc. AccuBlade (ACS Model MK8507 and Hansatome Model MK8508) are designed as replacement blades for the Chiron Vision Corp. Model ACS Keratome and Chiron Hansatome microkeratome for lamellar resection of the cornea
Product codes
86 HNO
Device Description
The Surgin Inc. AccuBlade (ACS Model MK8507 and Hansatome Model MK8508) are designed as replacement blades for the Chiron Vision Corp. Model ACS Keratome and Chiron Hansatome microkeratome for lamellar resection of the cornea
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
cornea
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2000
Mr. Don W. Haar Surgin Surgical Inc. 14762 Bentley Circle Tustin, Ca 92780
K994015 Re:
Trade Name: Surgin AccuBlade™ Microkeratome Blade (ACS Model MK 8507 and Hansatome Model MK 8508)
Regulatory Class: I Product Code: 86 HNO Regulation: 886.4370 Dated: February 24, 2000 Received: February 24, 2000
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 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 .
1
Page 2 - Mr. Don W. Haar
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. Ralph 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
K994015 510(k) Number (if Known):_
AccuBladc Device Name:__
Indications For Use:
The Surgin Inc. AccuBlade(ACS Model MK8507 and Hansatome Model MK8508) are designed as replacement blades for the Chiron Vision Corp. Model ACS Keratomo and Chiron Hansatome microkeratome for lamellar resection of the cornea
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUF ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daryl Kaufmer
Division Sign-Off) Division of Ophthalmic Devices 199401. 510(k) Number.
. . .
(Optional Format 3-10-98)