The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurysms. They are also intended to be applied exclusively with the Kirwan 45.XXX and 65.XXX Series Appliers.

Device Description

The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurvsms. They are also intended to be applied exclusively with the 45.XXX and 65.XXX Series Appliers.

AI/ML Overview

The provided 510(k) summary for the Kirwan Series of Aneurysm Clips and Appliers does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a study proving those criteria. This type of regulatory submission typically focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting novel clinical study data or detailed performance metrics against specific acceptance criteria.

However, based on the available information, I can fill in what is present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
No new technological risks or characteristics compared to legally marketed predicate devices.	"Technological safety and effectiveness is established by the fact that these clips do not contain any new technological risks or characteristics when compared to the legally marketed devices offered here as predicates."
Compliance with specific standards and guidelines.	"Kirwan aneurysm clips and appliers have been found to comply with the requirements of the applicable sections within the following standards and quidelines:" - ISO 9713 - ISO 5832-2 - ISO 5832-3 - ISO 5832-7 - F 67 - 95 - F 1058 - 97 - F 136 - 98
Hazard conditions for clips and appliers.	"Safety and hazard analysis has determined that the hazard conditions for the 45.XXX and 65.XXX Aneurysm Clips and Appliers range in the low-to-moderate level and for this reason are acceptable."
Substantial equivalence to predicate devices in intended use, technological safety, effectiveness, and performance.	"Therefore, the 45.XXX and 65.XXX Aneurysm Clips and Appliers are substantially equivalent in intended use, technological safety and effectiveness and performance to the following predicates; - 65.XXX /T Series, REBSTOCK Implant Steel Aneurysm Clips & Titanium Aneurysm Clips. - 55XXX Series, PERNECZKY ANEURYSM CLIP. - FT XXX T Series / FE XXX K Series, AESCULAP YASARGIL ANEURYSM CLIP, (TITANIUM or PHYNOX)."

2. Sample size used for the test set and the data provenance:

Not provided. The document describes a technical assessment based on comparison to predicate devices and compliance with standards, not a clinical study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No test set or ground truth establishment by experts is described in this regulatory summary.

4. Adjudication method for the test set:

Not applicable. No test set or adjudication method is described.

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. This device is a surgical implant/tool (aneurysm clips and appliers), not an AI-assisted diagnostic or decision support system. Therefore, an MRMC study related to human readers and AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical surgical product, not an algorithm.

7. The type of ground truth used:

Not applicable. The "ground truth" in this context is adherence to manufacturing standards, material specifications, and a hazard analysis, rather than clinical outcomes or expert consensus on diagnostic data. The primary "truth" being established is substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable. There is no training set mentioned.

Summary

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Ko60915

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APR 1 7 2007

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

{as required by 21 CFR, section 807.92( c )}

FOR

KIRWAN SERIES of ANEURYSM CLIPS and APPLIERS

MODELS: 45.XXX, SERIES of KIRWAN L-ANEURYSM-CLIPS and APPLIERS, and 65.XXX, SERIES of KIRWAN YASARGIL-TYPE ANEURYSM CLIPS and APPLIERS.

Common name: Aneurysm Clip / Aneurysm Clip Applier.

Classification name: Aneurysm Clip / Aneurysm Clip Applier (§882.5200 & 882.4175, respectively)

Product code: HCH & HCI, respectively.

Devices Class: Class II

Technological safety and effectiveness is established by the fact that these clips do not contain any new technological risks or characteristics when compared to the legally marketed devices offered here as predicates. They are manufactured according to prevailing standards with the technological characteristics of each clip listed on its labeling.

Kirwan Surgical Products, Inc. 180 Enterprise Drive Marshfield, MA 02050 Phone: (781) 834-9500 Fax: (781) 834-0022 Contact: Kevin P. Prario, Regulatory Affairs Manager Date prepared: 3/24/2006

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K060915
2/2

There are no applicable performance standards listed for these devices under
Section 514 of the Food, drug and Cosmotio Act, Nonotheloco, Kinyon 45, XXX Section 514 of the Food, drug and Cosmetic Act. Nonetheless. Kirwan 45.XXX and 65.XXX series devices have been tested and manufactured in accordance with prevailing standards and quidelines in order to assure safety and efficacy. Kirwan aneurysm clips and appliers have been found to comply with the requirements of the applicable sections within the following standards and quidelines;

= ISO 9713, Neurosurgical implants Self-closing intracranial aneurysm clips.
트 ISO 5832-2, Metallic Materials - Part 2: Unalloyed titanium.
ISO 5832-3, Metallic Materials Part 3: Wrought titanium 6-aluminium 4-에 vanadium allov for surqical implant applications.
ISO 5832-7. Metallic Materials Part 2: Forgeable and cold-formed E cobalt-chromium-nickel-molybdenum-iron alloy.
내 F 67 - 95, Standard Specification for unalloyed Titanium for Surgical Implant Applications.
F 1058 97, Standard Specification for, Wrought Cobalt-Chromium-트 Nickel-Molybdenum-Iron Alloys for Surgical Implant Applications.
F 136 98, Standard Specification for; Wrought Titanium 6Aluminum l 4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

Safety and hazard analysis has determined that the hazard conditions for the 45.XXX and 65.XXX Aneurysm Clips and Appliers range in the low-tomoderate level and for this reason are acceptable.

Therefore, the 45.XXX and 65.XXX Aneurysm Clips and Appliers are substantially equivalent in intended use, technological safety and effectiveness and performance to the following predicates;

65.XXX /T Series, REBSTOCK Implant Steel Aneurysm Clips & Titanium 트 Aneurysm Clips.
55XXX Series, PERNECZKY ANEURYSM CLIP. 트
트 FT XXX T Series / FE XXX K Series, AESCULAP YASARGIL ANEURYSM CLIP, (TITANIUM or PHYNOX).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the department's name around the perimeter. In the center of the seal is the HHS logo, which consists of a stylized caduceus, a symbol often associated with healthcare. The caduceus has three snakes intertwined around a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kirwan Surgical Products, Inc. % Mr. Kevin Prario Regulatory Affairs Manager 180 Enterprise Drive Marshfield. Massachusetts 05050

APR 1 7 2007

Re: K060915

Trade/Device Name: Models: 45.XXX, Series of Kirwan L-Aneurysm-Clips and Appliers, and 65.XXX, Series of Kirwan Yasargil-Type Aneurysm Clips and Appliers

Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm clip Regulatory Class: II Product Code: HCH Dated: January 16, 2007 Received: January 17, 2007

Dear Mr. Prario:

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

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Page 2 - Mr. Kevin Prario

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.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Koboqut

Indications for Use

510(k) Number (if known): _____________________

Device Name:

Models: 45.XXX, Series of Kirwan L-Aneurysm-Clips and Appliers, and 65.XXX, Series of Kirwan Yasargil-Type Aneurysm Clips and Appliers.

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter 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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number	1060918

Page 1 of 1

Regulation Number and Section

§ 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).