(84 days)
The Aesculap AVM Microclips are intended for intracranial vascular occlusion (permanent or temporary) of small vessels.
The Aesculap AVM Microclip Applier is intended for holding and applying intracranial AVM Microclips.
The Aesculap AVM Microclips are designed for temporary or permanent occlusion of small vessels during neurosurgical procedures. They are made from Phynox (cobalt alloy) per ISO 5832/7 and are available with either straight or curved blades. The AVM Microclip Applier is constructed from Titanium Alloy per ISO 5832/3 with Phynox jaws.
The provided text describes the 510(k) summary for the "Aesculap AVM Microclips and Applier." It states that the device received FDA clearance (K024349) in 2003.
However, the document does not contain the information requested in the prompt regarding a study that proves the device meets specific acceptance criteria.
The section titled "PERFORMANCE DATA" only states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Aesculap AVM Microclips were completed. Biomechanical testing results demonstrate the Aesculap AVM Microclips and Applier are substantially equivalent to other AVM Microclips and Appliers currently on the market."
This indicates that internal biomechanical testing was performed to demonstrate substantial equivalence to existing predicate devices, which is a regulatory pathway for clearance, but it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size for test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results (effect size).
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on regulatory compliance and substantial equivalence, not on a detailed clinical or performance study as might be expected for an AI-powered device or one with specific performance acceptance criteria measured in a clinical context.
Therefore, I cannot fulfill your request for items 1-9 based on the provided text. The device described (AVM Microclips) is a physical surgical instrument, not an AI/software device that would typically involve the types of studies mentioned in your prompt (e.g., MRMC, standalone algorithm performance, ground truth establishment with experts for image analysis).
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KO24345
Page 1 of 1
C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (in Accordance with SMDA of 1990)
MAR 2 4 2003
AESCULAP AVM MICROCLIPS
December , 2002
| COMPANY: | Aesculap®, Inc. |
|---|---|
| 3773 Corporate Parkway | |
| Center Valley, PA 18034 | |
| Establishment Registration Number: 2916714 |
CONTACT: Matthew M. Hull 800-258-1946 x 5072 (phone) 610-791-6882 (fax)
- TRADE NAME: Aesculap Kopitnik AVM Microclips and Applier
- COMMON NAME: AVM Clips and AVM Clip Applier
- DEVICE CLASS: Class II
- PRODUCT CODE: 84 HCH and 84 HCI
- CLASSIFICATION: 882.5200 - Clip, Aneurysm 882.4175 - Applier, Aneurysm Clip
REVIEW PANEL: Neurology
INDICATIONS FOR USE
The Aesculap AVM Microclips are intended for intracranial vascular occlusion (permanent or temporary) of small vessels.
The Aesculap AVM Microclip Applier is intended for holding and applying intracranial AVM Microclips.
DEVICE DESCRIPTION
The Aesculap AVM Microclips are designed for temporary or permanent occlusion of small vessels during neurosurgical procedures. They are made from Phynox (cobalt alloy) per ISO 5832/7 and are available with either straight or curved blades. The AVM Microclip Applier is constructed from Titanium Alloy per ISO 5832/3 with Phynox jaws.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Aesculap AVM Microclips were completed. Biomechanical testing results demonstrate the Aesculap AVM Microclips and Applier are substantially equivalent to other AVM Microclips and Appliers currently on the market.
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Aesculap AVM Microclips and Applier are substantially equivalent to our currently marketed Aneurysm Clips and Appliers in addition to the Sugita AVM Microclips marketed by Mizuho.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The figure is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Matthew M. Hull, RAC Senior Regulatory Affairs Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
MAR 2 4 2003
Re: K024349
Trade/Device Name: AVM Microclips and Applier Regulation Number: 21 CFR 882.5200, 21 CFR 882.4175 Regulation Name: Aneurysm clip, Aneurysm clip applier Regulatory Class: II Product Code: HCH. HCI Dated: December 27, 2002 Received: December 30, 2002
Dear Mr. Hull:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Matthew M. Hull, RAC
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and 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,
Miriam C. Provost
tos Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT B.
510(k) Number:_
Device Name: Aesculap AVM Microclips and Applier
Indication for Use:
The Aesculap AVM Microclips are intended for intracranial vascular occlusion (permanent or temporary) of small vessels.
The Aesculap AVM Microclip Applier is intended for holding and applying intracranial AVM Microclips.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K024349
Prescription Use or Over-the-Counter Use
(per 21 CFR 801.109)
§ 882.5200 Aneurysm clip.
(a)
Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.(b)
Classification. Class II (performance standards).