(324 days)
No
The summary describes a mechanical device (aneurysm clips) and its material properties and performance, with no mention of AI or ML.
Yes.
The device is an aneurysm clip intended to occlude cerebral aneurysms, which falls under the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The device is an aneurysm clip, which is used to occlude cerebral aneurysms. Its function is therapeutic, not diagnostic. While its compatibility with imaging modalities is mentioned, this is for assessing its safety during imaging, not for the device itself to perform diagnosis.
No
The device is a physical implant (aneurysm clips made of titanium alloy) and is not software-only. The description focuses on the material properties, mechanical integrity, and biocompatibility of the physical clips.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "occlude cerebral aneurysms in either a temporary or permanent manner." This is a surgical intervention performed in vivo (within the living body).
- Device Description: The device is a physical clip designed to be implanted.
- Anatomical Site: The device is applied to "cerebral aneurysms, cerebrum (brain parenchyma), subarachnoid space," all of which are locations within the body.
- Performance Studies: The performance studies describe implantation studies in animals and testing of the physical properties of the clips. There are no studies related to analyzing biological samples in vitro.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic implant used directly on the patient's anatomy.
N/A
Intended Use / Indications for 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.
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.
Product codes
84 HCH
Device Description
These titanium alloy aneurysm clips will be available in mini and standard sizes, and as temporary or permanent devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance imaging
nuclear spin resonance
CT scans
Anatomical Site
cerebral aneurysms (brain parenchyma)
subarachnoid space
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
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).
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. 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.
Key Metrics
Not Found
Predicate Device(s)
Yasargil Phynox aneurysm clips
K955064, K760771, K782040
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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)
OR
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 _