(245 days)
Not Found
No
The document describes a mechanical device (aneurysm clips and appliers) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the "occlusion of cerebral aneurysms," which directly treats a medical condition.
No
The Yasargil Aneurysm Clips are intended for occlusion of cerebral aneurysms, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details physical components (clips and appliers made of titanium alloy, phynox, and stainless steel) and performance studies focus on biomechanical and material properties, not software functionality.
Based on the provided information, the Yasargil Aneurysm Clips are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "occlusion of cerebral aneurysms in either a temporary or permanent manner." This is a surgical intervention performed directly on the patient's body.
- Device Description: The device is a physical clip designed to be implanted or used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. The Yasargil Aneurysm Clips are used inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
HCH, HCI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
K043041, K003519, K002871, K984109, K983758, K970050, K922272, K913765, K833652, K833651, K833650
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
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. Racosky
610-984-9291 (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, Aneurysm
882.4175- 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.
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.
INDICATIONS FOR USE
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.
1
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 and | ||
| Clip Appliers | Aneruysm Clips and Clip | |
| Appliers | ||
| K043041nc003519/K002871 | ||
| K984109/K983758nc970050 | ||
| K940970/K922272nc913765 | ||
| K833652/K833651nc833650 | ||
| Indications | 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. | 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. | ||
| Aneurysm Clip: | ||
| Material | Titanium Alloy (Ti6Al6V) or | |
| Phynox (CoCr) | Titanium Alloy (Ti6Al6V) or | |
| Phynox (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) or | |
| Phynox (CoCr) | Titanium Alloy (Ti6Al6V) or | |
| Phynox (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 |
2
Page 3 of 3
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.
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
4
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
5
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 -
6
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
1