(70 days)
Codman Slim Line Standard Clip is used for permanent occlusion of intracranial aneurysm.
Codman Slim Line Mini Clip is used for the occlusion of small vessels when controlling bleeding on arteriovenous malformations or other similar venous structures.
Codman Slim-Line Graft clip is used to encircle an artery in which a hole has developed as a result of a traumatic injury to the vessel or from an aneurysm tearing at its base that cannot be sutured as the hole is in such a position that it is difficult for the surgeon to rotate a needle.
Codman Slim-Line Reinforcing clip is used to reinforce aneurysm clips that may not be of adequate strength to occlude the aneurysm.
Codman Slim-Line Temporary Aneurysm Clip is used for the occlusion of small vessels when controlling bleeding on arteriovenous malformations or other similar venous structure.
Codman AVM Micro Clip System is designed for occlusion of small vessels when controlling bleeding on arteriovenous malformation or other smaller venous structures.
Aneurysm clips have two parts, a spring section and two blades. The spring section determines the strength of the clip. The blades grasp the aneurysm.
The provided text describes a 510(k) premarket notification for various aneurysm clips from Codman & Shurtleff, Inc. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria with a novel study design for AI/ML devices. Therefore, much of the requested information (like acceptance criteria tables, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not applicable or explicitly stated in the document as it pertains to a different type of regulatory submission (medical device approval for physical devices, not AI/ML software).
Here's a breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable in the context of this 510(k) submission. A 510(k) for physical devices like aneurysm clips focuses on substantial equivalence to predicate devices, meaning the new device is as safe and effective as a legally marketed device. It does not typically involve pre-defined performance metrics and acceptance criteria in the way an AI/ML device might. The "performance" here is demonstrating that the device functions as intended and is comparable to existing devices.
2. Sample size used for the test set and the data provenance:
Not explicitly stated. The submission mentions "Bench testing has been completed," but does not specify the sample sizes of devices tested or the data provenance (e.g., how many clips were tested under what conditions).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of AI/ML, refers to a validated reference standard against which an algorithm's output is compared. For a physical device like an aneurysm clip, "ground truth" is established through engineering specifications and the functional demonstration of the device (e.g., successful occlusion, strength tests). There's no mention of experts establishing a ground truth for a "test set" in the sense of data labeling.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is relevant for studies involving human interpretation or AI output, where disagreements need to be resolved. For bench testing of physical devices, the results are typically direct measurements or observations.
5. 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. MRMC studies are used for evaluating diagnostic performance, often comparing human performance with and without AI assistance. This submission is for a physical medical device (aneurysm clips), not an AI/ML diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no algorithm or software component being evaluated in this submission for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for these physical devices would be their conformance to design specifications and mechanical properties that are historically proven safe and effective for aneurysm occlusion or vessel coarctation. This is established through engineering design, material testing, and functional bench testing.
8. The sample size for the training set:
Not applicable. There is no AI/ML model involved in this submission that would require a training set.
9. How the ground truth for the training set was established:
Not applicable.
What the study does mention regarding acceptance and proof:
- Acceptance Criteria/Performance Goal (Implied): The implied acceptance criterion is "substantial equivalence" to predicate devices. This means the new devices (Codman Slim-Line Standard Aneurysm Clip, Mini Clip, Graft Clip, Reinforcing Clip, Temporary Aneurysm Clip, Codman AVM Micro Clip System) must perform as safely and effectively as previously cleared devices.
- Study That Proves Substantial Equivalence: "Bench testing has been completed and demonstrates that the device performs according to its description and intended use which is the same as the predicate device."
- Study Outcome: "All test results demonstrated the substantial equivalence of the products to the previously cleared products from the FDA and the safety and effectiveness has not been compromised."
In essence, this 510(k) demonstrates that the Codman aneurysm clips are very similar in design, materials, and intended use to existing, cleared clips, and bench testing confirmed they function comparably.
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SEP 0 8 2009
SECTION 5. 510(k) Summary
Company Name: Codman & Shurtleff, Inc. Company Address: 325 Paramount Drive Raynham, MA 02767 1226348 Establishment Registration No.: Medos Sarl Manufacturing Facility: Rue Girardet 29 CH 2400 Le Locle, Switzerland Establishment Registration No .: 8031062 Paul Amaral Submitted By: 325 Paramount Drive Raynham, MA 02767 (508) 828-3393 Phone Number: Facsimile Number: (508) 828-2777 Codman Slim-Line Standard Aneurysm Clip Device Proprietary Name: Codman Slim-Line Mini Clips Codman Slim-Line Graft Clip Codman Slim-Line Reinforcing Clip Codman Slim-Line Temporary Aneurysm Clip Codman AVM Micro Clip System Aneurysm Clips Common Name: Device Classification Name: Clip, Aneurysm Classification Panel Name: Neurology 84 FDA Panel Number: Product Code: нсн
Proposed Device Class: HCH: Class II per 21 CFR § 882.5200 Clip, Aneurysm
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K912456 SUNDT SLIM-LINE GRAFT CLIPS K902544 SUNDT AVM MICRO CLIP SYSTEM
Aneurysm clips have two parts, a spring section and two blades. The Device Description: spring section determines the strength of the clip. The blades grasp the aneurysm.
Intended Use:
Predicate Device(s):
Codman Slim Line Standard Aneurysm Clip is used for permanent occlusion of intracranial aneurysm.
Codman Slim Line Mini Clip is used for the occlusion of small vessels when controlling bleeding on arteriovenous malformations or other similar venous structures.
Codman Slim-Line Graft clip is used to encircle an artery in which a hole has developed as a result of a traumatic injury to the vessel or from an aneurysm tearing at its base that cannot be sutured as the hole is in such a position that it is difficult for the surgeon to rotate a needle.
Codman Slim-Line Reinforcing clip is used to reinforce aneurysm clips that may not be of adequate strength to occlude the aneurysm.
Codman Slim-Line Temporary Aneurysm Clip is used for the occlusion of small vessels when controlling bleeding on arteriovenous malformations or other similar venous structure.
Codman AVM Micro Clip System is designed for occlusion of small vessels when controlling bleeding on arteriovenous malformation or other smaller venous structures.
Summary of non-clinical testing; Bench testing has been completed and demonstrates that the device performs according to its description and intended use which is the same as the predicate device. All test results demonstrated the substantial equivalence of the products to the previously cleared products from the FDA and the safety and effectiveness has not been compromised.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, clutching a staff with a snake wrapped around it.
SEP 0 8 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Codman & Shurtleff, Inc. c/o Paul Amaral Regulatory Affairs Sr. International Specialist 325 Paramount Drive Raynham, Massachusetts 02767
Re: K091921
Trade/Device Name: Codman® Aneurysm Clips, Codman® AVM Micro Clip system, Codman® Slimline Graft, Reinforcing, Mini Aneurysm Clip Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm Clip Regulatory Class: II Product Code: HCH Dated: August 17, 2009 Received: August 18, 2009
Dear Mr. Amaral:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Kenia Alexander Jr
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K091921
Device Name: Aneurysm Clips
Indications For Use:
Codman Slim Line Standard Clip is used for permanent occlusion of intracranial aneurysm.
Codman Slim Line Mini Clip is used for the occlusion of small vessels when controlling bleeding on arteriovenous malformations or other similar venous structures.
Codman Slim-Line Graft clip is used to encircle an artery in which a hole has developed as a result of a traumatic injury to the vessel or from an aneurysm tearing at its base that cannot be sutured as the hole is in such a position that it is difficult for the surgeon to rotate a needle.
Codman Slim-Line Reinforcing clip is used to reinforce aneurysm clips that may not be of adequate strength to occlude the aneurysm.
Codman Slim-Line Temporary Aneurysm Clip is used for the occlusion of small vessels when controlling bleeding on arteriovenous malformations or other similar venous structure.
Codman AVM Micro Clip System is designed for occlusion of small vessels when controlling bleeding on arteriovenous malformation or other smaller venous structures.
OR Over-The-Counter Use: Prescription Use: (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Jeffrey Toy
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K091921
§ 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).