(33 days)
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Not Found
No
The device description and intended use describe a purely mechanical device (a clip) used to enhance the force of another mechanical device (an aneurysm clip). There is no mention of software, data processing, or any technology that would involve AI or ML.
Yes
The device is intended to occlude cerebral aneurysms, which involves treating a disease condition. This fits the definition of a therapeutic device.
No
The device is described as a "Booster Clip" intended to increase the closing force of existing aneurysm clips to occlude cerebral aneurysms. Its function is to provide additional mechanical pressure for treatment, not to diagnose or detect a medical condition.
No
The device description clearly states it is a physical clip made from a cobalt alloy, intended to be used with other physical aneurysm clips. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Aesculap Yasargil Aneurysm Clip Booster Clip is a surgical implant designed to physically increase the closing force of another surgical implant (an aneurysm clip) to occlude a cerebral aneurysm. It is used during a surgical procedure on the patient's body, not on a sample taken from the body.
- Intended Use: The intended use clearly states it's for "increasing the closing force of standard permanent aneurysm clips to occlude cerebral aneurysms," which is a surgical intervention, not a diagnostic test.
The information provided describes a surgical device used directly on the patient during a neurosurgical procedure.
N/A
Intended Use / Indications for Use
The Aesculap Yasargil Aneurysm Clip Booster Clip is intended to be used for increasing the closing force of standard permanent aneurysm clips to occlude cerebral aneurysms.
Product codes (comma separated list FDA assigned to the subject device)
84 HCH
Device Description
The Aesculap Yasarqil Aneurysm Clip Booster Clip is designed to provide additional pressure for occlusion of cerebral aneurysms when used with a standard aneurysm clip during neurosurgical procedures. They are made from Phynox (cobalt alloy) per ISO 5832/7 and are for use with Phynox aneurysm clips only.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
cerebral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s)" for the Aesculap Yasargil Aneurysm Clip Booster Clip was completed. Biomechanical testing results demonstrate the Aesculap Yasarqil Aneurysm Clip Phynox Booster Clip provides effective clip force enhancement and is substantially equivalent to Yasargil Aneurysm Clip Titanium Booster Clip currently on the market.
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.
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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
AUG 2 0 2003esculap Yasargil Aneurysm Clip Phynox Booster Clip
$\phi$32198
Page 1 of 1
C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (in Accordance with SMDA of 1990)
AESCULAP YASARGIL ANEURYSM CLIP BOOSTER CLIP
July 17, 2003
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|-----------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull
800-258-1946 x 5072 (phone)
610-791-6882 (fax) |
| TRADE NAME: | Aesculap Yasargil Aneurysm Clip Phynox Booster Clip |
| COMMON NAME: | Aneurysm Clip Booster or Reinforcement Clip |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 84 HCH |
| CLASSIFICATION: | 882.5200 - Clip, Aneurysm |
| REVIEW PANEL: | Neurology |
INDICATIONS FOR USE
The Aesculap Yasargil Aneurysm Clip Booster Clip is intended to be used for increasing the closing force of standard permanent aneurysm clips to occlude cerebral aneurysms.
DEVICE DESCRIPTION
The Aesculap Yasarqil Aneurysm Clip Booster Clip is designed to provide additional pressure for occlusion of cerebral aneurysms when used with a standard aneurysm clip during neurosurgical procedures. They are made from Phynox (cobalt alloy) per ISO 5832/7 and are for use with Phynox aneurysm clips only.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s)" for the Aesculap Yasargil Aneurysm Clip Booster Clip was completed. Biomechanical testing results demonstrate the Aesculap Yasarqil Aneurysm Clip Phynox Booster Clip provides effective clip force enhancement and is substantially equivalent to Yasargil Aneurysm Clip Titanium Booster Clip currently on the market.
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Aesculap Yasarqil Aneurysm Clip Booster Clip are substantially equivalent to our currently marketed Yasargil Aneurysm Clip Titanium Booster Clip.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is 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.
AUG 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Matthew M. Hull Senior Regulatory Affairs Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K032198
Trade/Device Name: Aesculap Yasargil Aneurysm Clip Phynox Booster Clip Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm Clip Regulatory Class: II Product Code: HCH Dated: July 17, 2003 Received: July 24, 2003
Dear Mr. Hull:
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. Iisting 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 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.
2
Page 2 - Mr. Matthew M. Hull
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
for Mark A. Milhens
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
INDICATIONS FOR USE STATEMENT B.
510(k) Number: K432198
Device Name: Aesculap Yasargil Aneurysm Clip Phynox Booster Clip
Indication for Use:
The Aesculap Yasargil Aneurysm Clip Booster Clip is intended to be used for increasing the rne hosodiap Tradard permanent aneurysm clips to occlude cerebral aneurysms.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K032198 |
| Prescription Use | or Over-the-Counter Use | ||
|---|---|---|---|
| (per 21 CFR 801.109) |