The Yasargil Titanium Alloy aneurysm clips is to occlude cerebral aneurysms in either a temporary or permanent manner. They are applied by Aesculap clip appliers with titanium alloy jaws.

Device Description

These titanium alloy aneurysm clips will be available in mini and standard sizes, and as temporary or permanent devices.

AI/ML Overview

The provided text describes a 510(k) summary for Yasargil Titanium Aneurysm Clips, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria as might be found in a performance study for a diagnostic AI.

However, I can extract information related to the device's characteristics and the studies performed to support its safety and effectiveness, interpreting them as a form of "acceptance criteria" and "study results" within the context of a medical device submission focused on material and mechanical properties, and biocompatibility.

Here's an attempt to structure the information according to your request, acknowledging that it's not a typical AI performance study.

Device Name: Yasargil Titanium Aneurysm Clips

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material Composition	Conforms to ISO Standard 5832/3 and ASTM standard F136 for titanium alloy (Ti6AL4V).	Material composition and properties conform to ISO Standard 5832/3 and ASTM standard F136.
Biocompatibility	No significant neurotoxicity or adverse clinical observations after implantation in cerebrum and subarachnoid space.	Neurological implantation study (albino rabbits) showed no significant clinical observations, neurobehavioral findings, or weight changes over 180 days. Consistent with predicate device (Spetzler TI 100 Aneurysm Clips).
Mechanical & Metallurgical Integrity (Production Process)	Production process does not affect mechanical/metallurgical integrity; no surface/subsurface cracks after grinding, bending, adjustment; good mechanical properties at laser welding site; no significant changes in heat-affected zone; adequate removal of thin oxide layers.	Scanning electron microscopy, metallography, and energy dispersive x-ray analysis show production process does not affect integrity. No cracks observed. Laser welding site has good mechanical properties. Metallographic studies show no significant changes. Surface studies indicate adequate oxide layer removal.
Closing Force	Comparable to currently marketed predicate (Yasargil Phynox aneurysm clips).	Closing force tested and found comparable to Yasargil Phynox aneurysm clips.
MRI Compatibility	Non-ferromagnetic; weaker paramagnetic properties than predicate (Phynox) or stainless steel; no detectable deflections/torsions at magnetic field strengths up to 4.7T; reduced artifacts in nuclear spin resonance and CT scans; no measurable heating effect.	All materials non-ferromagnetic; titanium alloy had detectable weaker paramagnetic properties than Phynox or non-martensitic stainless steel. No detectable deflections/torsions at 4.7T. Artifacts substantially reduced in nuclear spin resonance and CT scans. No measurable heating effect.
Design Comparison	Similar or identical to current Yasargil Phynox clip patterns; expanded to include additional temporary clip patterns. Similar features, dimensions, and styles to other legally marketed predicate devices.	Yasargil titanium aneurysm clips are very similar or identical to current Yasargil Phynox clip patterns. Product line expanded for temporary clips. Shares similar features, dimensions, and styles with other listed predicate devices (Spetzler Ti 100, Codman, Sugita Aneurysm clips).

2. Sample Size for the Test Set and Data Provenance

Biocompatibility Study: Albino rabbits were used. The exact number of animals is not specified, but it refers to "test or control implanted animals." The study was conducted in animals, not humans.
Mechanical, Metallurgical & MRI Testing: The sample size for these tests (e.g., number of clips tested) is not specified. The provenance would be internal laboratory testing of the manufactured devices.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This is not a study requiring expert readers to establish ground truth for clinical cases. The ground truth for biocompatibility was established through histological and clinical observations in animal models, and for mechanical/material properties through various engineering and material science analyses.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving expert adjudication of clinical findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This submission focuses on material properties, biocompatibility, and mechanical performance of the device itself, not on human reader performance with or without AI assistance.

6. Standalone Performance (Algorithm only without human-in-the-loop performance)

No, this is not an AI/algorithm. This refers to the intrinsic performance of the physical aneurysm clip in terms of its material, mechanical, and biological properties. The studies described are essentially "standalone" performance evaluations of the device's physical characteristics.

7. Type of Ground Truth Used

Material Composition: Conformance to established ISO and ASTM standards, verified through analytical chemistry and material science techniques.
Biocompatibility: Histological analysis and clinical observations of animal tissues and behavior (lack of neurotoxicity, lack of adverse clinical findings).
Mechanical/Metallurgical: Results from scanning electron microscopy, metallography, energy dispersive x-ray analysis, and direct mechanical force testing (closing force).
MRI Compatibility: Direct measurements of magnetic properties, deflection, artifact generation, and heating effects in various magnetic field strengths.

8. Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in the context of this traditional medical device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/14 description: The image shows the AESCULAP logo, which includes a symbol of a snake wrapped around a staff inside a circle, followed by the word "AESCULAP." to the right. Above the logo, there is a handwritten number "K970050". The logo and number are in black and white.

NOV 26 1997

510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990

Yasargil Titanium Aneurysm Clips

January 3, 1997

Aesculap®, Inc. Submitted by: 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Victoria Mackinnon Phone: (415) 876-7000 x346 FAX: (415) 589-3007 Product: Yasargil Titanium Aneurysm Clips Aneurysm Clips Common Name:

A. Device Description

These titanium alloy aneurysm clips will be available in mini and standard sizes, and as temporary or permanent devices.

B. Intended Use:

The intended use of the Yasargil Titanium Alloy aneurysm clips is to occlude cerebral aneurysms in either a temporary or permanent manner. They are applied by Aesculap clip appliers with titanium alloy jaws

C. -Technological Characteristics:

With exception of device material, the Yasargil Titanium Alloy aneurysm clips do not incorporate any new technological characteristics when compared to Aesculap's Yasargil Phynox aneurysm clips or to other legally marketed devices. The titanium alloy clips share similar tolerances, manufacturing controls, packaging and labeling as the current Phynox clips.

{1}------------------------------------------------

S & E Summary, Yasargil Titanium Clips, page 2.

D. Material Composition / Biocompatibility The material composition is titanium alloy (Ti6AL4V). The alloy composition and properties conforms with ISO Standard 5832/3: "Implants for Surgery Metallic Materials - Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy" and ASTM standard F136: "Specification for Wrought Titanium 6AL-4V Eli Alloy for Surgical Implant Applications".
A neurological implantation study was conducted on Aesculap's titanium allov aneurysm clips to evaluate biocompatibility of these devices. The study evaluated the potential of these clips to induce neurotoxicity after implantation in the cerebrum (brain parenchyma) and within the subarachnoid space of albino rabbits after 90, 140 and 180 days. No significant clinical observations, including any neurobehavioral findings or weight changes, were made in either the test or control implanted animals during the 180-day study. These findings are consistent with the biocompatibility study conducted on the titanium Spetzler TI 100 Aneurysm Clips which have received marketing clearance from the Food and Drug Administration (subject to #K955064).
E. Mechanical. Metallurgical and MRI Testing of the Final Product Studies done on the various stages in the production of the clips using scanning electron microscopy, metallography and energy dispersive x-ray analysis show that the production process does not effect the mechanical and metallurgical integrity of the titanium alloy material. Studies of the device following grinding, bending and adjustment production steps fails to disclose surface or subsurface cracks. Analysis of the laser welding -site shows good mechanical properties without inadmissible gas
- absorption. Metallographic studies show no significant changes in the heat-affected zone, and surface studies indicate adequate removal of thin oxide lavers.

The closing force of each Yasargil Titanium Alloy clips has also been tested and is found to be comparable to the currently marketed Yasargil Phynox aneurysm clips.

The various magnetic resonance imaging tests clearly demonstrated the superiority of the titanium alloy material as compared to stainless steel and cobalt-based allov materials. All materials were non-ferromagnetic: the titanium alloy had detectable weaker paramagnetic properties than the Phynox or non-martenistic stainless steel.

{2}------------------------------------------------

S & E Summary, Yasargil Titanium Clips, page 3.

The titanium alloy clips showed no detectable deflections or torsions at any magnetic field strength, including the 4.7T level. The artifacts caused by titanium implants in both the nuclear spin resonance and CT scans are substantially reduced due to the titanium alloy material. The magnetic field did not induce any measurable heating effect on the clips. All testing indicates the titanium alloy aneurysm clips are safe, effective, and compatible with current diagnostic imaging equipment.

F. Design Comparison

The Yasargil titanium aneurysm clips are very similar or are identical to the current Yasargil Phynox clip patterns. The titanium clip product line has been expanded to include additional temporary clip patterns.

Additionally, the titanium allov aneurysm clips share similar features, dimensions and styles to Spetzler Ti 100 Aneurysm Clips, (subject to #K955064) by Elekta Instruments, Codman occlusion clips (#K760771) such as Sundt-Kees Slim-Line Aneurysm Clips and McFadden Vari-Angle Aneurysm clips as well as to Sugita Aneurysm clips (subject to #K782040) by Downs Surgical, manufactured by Mizuho Medical Co. Ltd.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1997

Ms. Victoria Mackinnon Manager, Regulatory Affairs Aesculap, Inc. 1000 Gateway Boulevard South San Francisco, California 94080-7030

Re: K970050 Yasargil Titanium Aneurysm Clips Trade Name: Regulatory Class: II (two) Product Code: 84 HCH September 4 1997 Dated: September 5, 1997 Received:

Dear Ms. Mackinnon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device equits 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

INDICATION FOR USE STATEMENT

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________ N/A N/A ----------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name:

Yasargil Titanium Aneurysm Clips.

Indication for Use:

ﻟﻤﺴﺘﻌﻤﺎ

The Yasargil Titanium Aneurysm Clips presented in this submission are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner. They are applied by Aesculap clip appliers with titanium alloy jaws.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Barbara hummuman

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K970050 510(k) Number _

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).