(35 days)
The Aesculap T-Bar Aneurysm Clips are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner.
The Aesculap T-Bar Aneurysm Clips are designed for temporary or permanent occlusion of vessels during neurosurgical procedures. They are made from either Phynox (oobalt alloy) per ISO 5832/7 or Titanium Alloy per ISO 5832/3. The clips are a fennstrated design with the jaws at 90 and 45 degree angles. They are applied with previously cleared Aesculap aneurysm clip appliers.
The provided text is a 510(k) summary for the Aesculap T-Bar Aneurysm Clips. This document asserts substantial equivalence to a predicate device rather than presenting a study against specific acceptance criteria for a novel device. Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not applicable or cannot be extracted from this document.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biomechanical Testing | Not explicitly stated (implied to be in line with "Draft Guidance for the Preparation of Premarket Notifications (510(k)s)") | "...demonstrate the Aesculap T-Bar Aneurysm Clips are substantially equivalent to our current aneurysm clips currently on the market." |
| Material Composition | Not explicitly stated (implied to meet ISO standards) | Made from Phynox (cobalt alloy) per ISO 5832/7 or Titanium Alloy per ISO 5832/3. |
| Design Characteristics | Not explicitly stated | Fenestrated design with jaws at 90 and 45-degree angles. |
| Applicability | Compatibility with existing appliers | Applied with previously cleared Aesculap aneurysm clip appliers. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a specific test set. The performance data refers to biomechanical testing, not clinical data from patients. Therefore, information regarding sample size for a test set (e.g., number of patients or images) and data provenance (country of origin, retrospective/prospective) is not applicable in this context. The testing was likely conducted in a lab setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since this is not a study involving human-interpreted data, there were likely no experts used to establish ground truth in the way envisioned for software performance evaluation. The "ground truth" for biomechanical testing would be defined by engineering standards, test methodologies, and material specifications.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable, as there was no test set of human-interpreted data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not performed, nor is it relevant for this type of medical device (physical aneurysm clips). The device is not an AI-assisted diagnostic tool for human readers.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No, a standalone algorithm study was not performed. This device is a physical medical implant, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of the Aesculap T-Bar Aneurysm Clips, based on the description, would be established through engineering standards, material specifications (ISO 5832/7, ISO 5832/3), and biomechanical testing protocols outlined in the "Draft Guidance for the Preparation of Premarket Notifications (510(k)s)". It is not expert consensus, pathology, or outcomes data in the typical sense of a clinical study.
8. Sample Size for the Training Set
There is no training set in the context of this device. This is a physical product, not a machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
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C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (in Accordance with SMDA of 1990)
DEC - 9 2004
Aesculap T-Bar Aneurysm Clips October 2004
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714 |
|---|---|
| CONTACT: | Matthew M. Hull800-258-1946 x 5072 (phone)610-791-6882 (fax) |
| TRADE NAME: | Aesculap T-Bar Aneurysm Clips |
| COMMON NAME: | Aneurysm Clips |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 84 HCH |
| CLASSIFICATION: | 882.5200 - Clip, Aneurysm |
| REVIEW PANEL: | Neurology |
INDICATIONS FOR USE
The Aesculap T-Bar Aneurysm Clips are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner.
DEVICE DESCRIPTION
The Aesculap T-Bar Aneurysm Clips are designed for temporary or permanent occlusion of vessels during neurosurgical procedures. They are made from either Phynox (oobalt alloy) per ISO 5832/7 or Titanium Alloy per ISO 5832/3. The clips are a fennstrated design with the jaws at 90 and 45 degree angles. They are applied with previously cleared Aesculap aneurysm clip appliers.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s)" was completed for Aesculap T-Bar Aneurysm Clips. Biomechanical testing results demonstrate the Aesculap T-Bar Aneurysm Clips are substantially equivalent to our current aneurysm clips currently on the market.
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Aesculap T-Bar Aneurysm Clips are substantially equivalent to our currently marketed Aneurysm Clips.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 2004
Mr. Matthew M. Hull, RAC Regulatory Affairs Manager Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K043041
Trade/Device Name: Aesculap T-Bar Aneurysm Clips Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm Clip Regulatory Class: II Product Code: HCH Dated: November 1, 2004 Received: November 9, 2004
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 (240) 276-0115. 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 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,
Muriam C. Provost
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.
K043041 510(k) Number:
Device Name: Aesculap T-Bar Aneurysm Clips
Indication for Use:
The Aesculap T-Bar Aneurysm Clips are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
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510(k) Number K043041
§ 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).