(70 days)
Not Found
No
The document describes mechanical aneurysm clips and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for permanent occlusion of intracranial aneurysms and occlusion of small vessels to control bleeding, which are therapeutic interventions.
No
Explanation: The device, Codman Slim Line Standard Clip, is used for the occlusion of intracranial aneurysms and vessels to control bleeding, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly indicates it is a physical medical device (aneurysm clips with a spring section and blades) and there is no mention of software as a component or the primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the permanent occlusion of intracranial aneurysms, occlusion of small vessels, and reinforcing aneurysm clips. These are all surgical procedures performed directly on the patient's body.
- Device Description: The device is described as having a spring section and blades that grasp the aneurysm. This is a physical device used for mechanical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical intervention.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HCH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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).
0
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
1
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.
2
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.
3
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
4
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)
(Division Sign-Off
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jeffrey Toy
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K091921