(269 days)
The Aortic Spoon Jaw Clamp is for use in the coronary bypass operations without application of an aortic clamp. It provides a mechanical means to isolate a 10 x 8mm area of the aortic wall from blood flow.
Aortic Spoon Jaw Clamp
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Aortic Spoon-Jaw Clamp" (K992174). This letter grants clearance based on substantial equivalence to a legally marketed predicate device.
This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it predates the modern requirements for clinical performance studies in many device clearances.
The 510(k) pathway, especially in the year 2000, primarily focused on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a device already on the market. This often relied on bench testing, materials characterization, and comparisons of technological characteristics and intended use, rather than extensive clinical studies with specific performance metrics against pre-defined acceptance criteria.
Therefore, I cannot provide the requested information based on the given text.
To answer your specific points, based on the provided document:
- A table of acceptance criteria and the reported device performance: Not available in this document.
- Sample size used for the test set and the data provenance: Not available in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
- Adjudication method for the test set: Not available in this document.
- 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 device is a surgical clamp, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical clamp, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available in this document. Substantial equivalence for this type of device would likely have been based on comparison of design, materials, and functional performance with a predicate device, rather than detailed clinical ground truth.
- The sample size for the training set: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2000
Mr. Richard G. Jones Pilling Weck Surgical 420 Delaware Drive Fort Washington, PA 19034
Re: K992174 Aortic Spoon-Jaw Clamp Requlatory Class: II (two) Product Code: DXC January 21, 2000 Dated: Received: January 24, 2000
Dear Mr. Jones:
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 legally marketed predicate 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 requlation (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 requlatory 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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MAR 2 3 2000
Page 2 - Mr. Richard G. Jones
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) 594-4648. 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/dsma/dsmamain.html".
Sincerely yours,
Sincerely yours,
Chitrmy thita
James E. Dillard III Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) Number (if known):
Device Name: Aortic Spoon Jaw Clamp
Indications for Use:
The Aortic Spoon Jaw Clamp is for use in the coronary bypass operations without application of an aortic clamp. It provides a mechanical means to isolate a 10 x 8mm area of the aortic wall from blood flow.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chitophem. Hunfor.
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K992174
The-Counter Use
Prescription Use or Over-
(Per 21 CFR 801.1 09)
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).