The Yasargil Aneurysm Clips are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner. They are applied with Aesculap clip appliers, which contain titanium alloy or phynox jaws.

Device Description

The Yasargil Aneurysm Clips are designed for temporary or permanent occlusion of vessels during neurosurgical procedures. They are manufactured from either titanium alloy according to ISO 5832/3 or phynox (cobalt alloy) per ISO 5832/7. The clips range in size from 3 mm to 40 mm and are available in straight, curved, angled, bayonet. T-bar, offset T-bar, concave T-bar, fenestrated, and non-fenestrated styles.

The Yasargil Clip Appliers are manufactured from stainless steel (body) with either a titanium allov or phynox jaw. The appliers are available in short (50mm), standard (90 mm) and long (110 mm) lengths, as well as straight, angled and bayonet shapes.

AI/ML Overview

The provided text describes a 510(k) summary for Aesculap Yasargil Aneurysm Clips and Clip Appliers (K131500). This document is a premarket notification for a medical device, asserting its substantial equivalence to previously marketed devices. It focuses on the manufacturing and biomechanical properties of the clips and appliers, rather than a clinical study evaluating diagnostic accuracy or a human-in-the-loop AI system. Therefore, many of the requested categories for AI/diagnostic device studies are not applicable.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ISO 9713 / ASTM Standards)	Reported Device Performance
Biomechanical Testing (ISO 9713):
Titanium clip closing force tolerance within 7.5% of nominal closing force	Titanium clip closing force tolerance was within 7.5% of the nominal closing force.
Phynox clip closing force tolerance	Phynox clip closing force tolerance deviated from the standard; it was outside the 7.5% nominal closing force. (Note: While it deviated, the document implies this was acceptable given overall performance and safety.)
Tensile strength for Phynox T-bar clips	Phynox clips withstand 400N.
Tensile strength for Titanium T-bar clips	Titanium clips withstand 210N.
Weld strength (tensile testing to simulate applied force)	Weld withstands 30N of force.
MRI Compatibility (ASTM Standards):
ASTM F2119 Evaluation of MR Image Artifacts	Completed (implied satisfactory results to reach MR Conditional status)
ASTM F2182 Measurement of Radio Frequency Induced Heating During Magnetic Resonance Imaging	Completed (implied satisfactory results to reach MR Conditional status)
ASTM F2213 Qualitative Measurement of Magnetically Induced Torque in the Magnetic Resonance Environment	Completed (implied satisfactory results to reach MR Conditional status)
ASTM F2052 Measurement of Magnetically Induced Displacement Force on the in the Magnetic Resonance Environment	Completed (implied satisfactory results to reach MR Conditional status)
Overall MRI Safety Status (per ASTM F 2503)	Device is MR Conditional in 3-Tesla Magnetic Resonance Imaging (MRI) systems.

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

Sample Size: Not applicable. The "test set" here refers to physical components of the device (clips and appliers) that underwent biomechanical and MRI compatibility testing, not a dataset of patient information. The document does not specify the number of individual clips or appliers tested.
Data Provenance: Not applicable in the context of clinical data. The tests were performed on manufactured devices.

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

Not applicable. Ground truth as typically defined for diagnostic or AI studies (e.g., expert consensus on medical images) is not relevant here. The "truth" for this device's performance is established by compliance with engineering and material science standards (ISO, ASTM). The expertise involved would be in manufacturing, materials science, and biomedical engineering.

4. Adjudication method for the test set

Not applicable. There was no expert adjudication process for this type of device performance testing. Performance was measured against predefined engineering and material standards.

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 is not an AI-assisted diagnostic device. It is a surgical instrument.

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

Not applicable. This is not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for this device is based on pre-defined engineering standards (ISO 9713, ASTM F2119, F2182, F2213, F2052, F2503) and the physical properties of the materials and design of the device. The testing aimed to demonstrate that the device met these established standards for biomechanical performance and MRI compatibility.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

Summary

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510(k) SUMMARY (as required by 21 CFR 807.92) Yasargil Aneruysm Clips and Clip Appliers

K131500

JAN 2 4 2014

COMPANY:

Aesculapp, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714

CONTACT:	Kathy A. Racosky610-984-9291 (phone)610-791-6882 (fax)kathy.racosky@aesculap.com
TRADE NAME:	Aesculap Yasargil Aneurysm Clips and Clip Appliers
COMMON NAME:	Aneurysm Clip and Clip Applier
REGULATION NUMBER:	882.5200- Clip, Aneurysm882.4175- Applier, Aneurysm Clip
PRODUCT CODE:	HCH, HCI
REVIEW PANEL:	Neurology

SUBSTANTIAL EQUIVALENCE

Aesculap, Inc. believes that the Aesculap Yasargil Aneurysm Clips and Clip Appliers are substantially to Aesculap's current Yasargil Aneurvsm Clips and Clip Appliers (K043041, K003519. K002871. K984109. K983758. K970050. K922272. K913765. K833652. K833651 and K833650).

DEVICE DESCRIPTION

The Yasargil Aneurysm Clips are designed for temporary or permanent occlusion of vessels during neurosurgical procedures. Thev are manufactured from either titanium alloy according to ISO 5832/3 or phynox (cobalt alloy) per ISO 5832/7. The clips range in size from 3 mm to 40 mm and are available in straight, curved, angled, bayonet. T-bar, offset T-bar, concave T-bar, fenestrated, and non-fenestrated styles.

INDICATIONS FOR USE

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TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The Yasargil Aneruysm Clip Appliers are substantially equivalent to the predicate Aesculap Yasargil Aneruysm Clips and Clip Appliers. The subject device is shown to be substantially equivalent and has the same performance characteristic to its predicate devices through comparison in design, principles of operation, intended use, and materials. The Yasargil Aneruysm Clips and Clip Appliers device characteristics are summarized below.

	New device	Predicate device Yasargil
	Yasargil Aneruysm Clips andClip Appliers	Aneruysm Clips and ClipAppliersK043041nc003519/K002871 K984109/K983758nc970050K940970/K922272nc913765K833652/K833651nc833650
Indications	The Yasargil Aneurysm Clipsare intended for occlusion ofcerebral aneurysms in either atemporary or permanentmanner. They are appliedwith Aesculap clip appliers,which contain titanium alloyor phynox jaws.	The Yasargil Aneurysm Clipsare intended for occlusion ofcerebral aneurysms in either atemporary or permanentmanner. They are applied withAesculap clip appliers, whichcontain titanium alloy orphynox jaws.
Aneurysm Clip:
Material	Titanium Alloy (Ti6Al6V) orPhynox (CoCr)	Titanium Alloy (Ti6Al6V) orPhynox (CoCr)
Sizes	3-40 mm (blade length)	2.8-40 mm (blade length)
Design	Fenestrated and non-fenestrated	Fenestrated and non-fenestrated
Blade Style	Straight, curved, offset T-bar,convex T-bar, concave T-bar,or angled	Straight, curved, bayonet, T-bar or angled
Clip Applier:
Jaw Material	Titanium Alloy (Ti6Al6V) orPhynox (CoCr)	Titanium Alloy (Ti6Al6V) orPhynox (CoCr)
Body Material	Stainless Steel	Stainless Steel
Style	Straight, angled, bayonet	Straight, angled
Length	50 mm, 90mm, and 110 mm	50 mm, 90mm, and 110 mm

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PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s)" was completed for Aesculap Yasargil Aneruysm Clips and Clip Appliers. Biomechanical testing results demonstrate the Aesculap Aneruysm Clips and Clip Appliers are substantially equivalent when compared to our aneurvsm clips and clip appliers currently on the market. Preclinical testing was performed to demonstrate that the Yasargil Aneruvsm Clips and Clip Appliers performs as intended and is safe, as effective, and performs as well as the predicate devices. Testing was conducted in accordance with ISO 9713. The titanium clip closing force tolerance was within 7.5% of the nominal closing force. The Phynox clip closing force tolerance deviated from the standard, as a result, the Phynox clip closing force tolerance was outside the 7.5% nominal closing force. Tensile testing was conducted to validate the T-bar clip strength of the bond between the blade and the spring wire. The Phynox clips withstand 400N and the titanium clips withstand 210N. The tensile test failure is at the closing loop which is the thinnest point of the clip. Tensile testing was performed to simulate the applied force to the weld. The weld withstands 30N of force. In addition testing was performed according to the following MRI standards:

. ASTM F2119 Evaluation ofMR Image Artifacts
. ASTM F2182 Measurement of Radio Frequency Induced Heating During Magnetic Resonance Imaging
. ASTM F2213 Qualitative Measurement of Magnetically Induced Torque in the Magnetic Resonance Environment
ASTM F2052 Measurement of Magnetically Induced Displacement Force on the in . the Magnetic Resonance Environment

The results and evaluation conclude that the device is MR Conditional in 3-Tesla Magnetic . Resonance Imaging (MRI) systems according to ASTM F 2503 and is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 24, 2014

"Aesculap", Inc. c/o Ms. Kathy A. Racosky 3773 Corporate Parkway Center Valley, PA 18034

Re: K131500

Aesculap Yasargil Aneurysm Clips and Clip Appliers Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm Clip Regulatory Class: II Product Code: HCH, HCI Dated: December 12, 2013 Received: December 13, 2013

Dear Ms. Racosky:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 complics 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

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Page 2 - Ms. Kathy A. Racosky

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/or You/Industrv/default.htm. 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/MedicalDevices/Safety/ReportalProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/Medica}Devices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Carlos L. Pena -S

Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K131500

Device Name

Yasargil Aneurysm Clips and Clip Appliers

Indications for Use (Describe)

The Yasargil Aneurysm Clips are intended for occlusion of cercbral aneurysms in either a temporary or permanent manner. They are applied with Acsculap clip appliers, which contain titanium alloy or phynox jaws.

Type of Use (Select one or both, as applicable)

🇿 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Carlos L. Pena -

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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).