(87 days)
Not Found
No
The device description and the absence of mentions of AI, DNN, or ML, image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms indicate that this is a mechanical device without AI/ML capabilities.
No
The device is an applier used to hold and apply aneurysm clips during surgical procedures, not to directly treat a disease or condition itself.
No
The device is an applier used for holding and applying intracranial aneurysm clips during surgery, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical medical device (clip appliers) made of materials like titanium and phynox, and available in different lengths and jaw sizes. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "holding and applying intracranial aneurysm clips." This is a surgical procedure performed directly on a patient's body.
- Device Description: The description details a surgical instrument used for manipulating clips during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside of the body, which is the defining characteristic of an in vitro diagnostic device.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used during a procedure on the body.
N/A
Intended Use / Indications for Use
The Aesculap Axial Clip Appliers are used for holding and applying intracranial aneurysm clips.
Product codes (comma separated list FDA assigned to the subject device)
84HCI
Device Description
There are twelve Axial clip appliers; each with complete material and design compatibility with Aesculap's existing Yasargil titanium and phynox aneurysm clip patterns. The new Axial clip appliers are available in three lengths (70mm, 90mm, 110mm), two jaw sizes (mini and standard), and two jaw materials (phynox and titanium).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
However, the Axial clip appliers presented in this submission do conform to the following ASTM Standards:
F700-93: Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments
Proposed ASTM Standard 1B: Specifications for the Requirements and Disclosure of Aneurysm Self-Closing Appliers
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.
Yasargil Clip Applying Forceps by Aesculap, Inc. (K833651), Aneurysm Clip Appliers by Aesculap. Inc. (K940970), Elekta Clip Appliers by Elekta (K955064)
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
§ 882.4175 Aneurysm clip applier.
(a)
Identification. An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.(b)
Classification. Class II (performance standards).
0
2/12/99
510(k) Premarket Notification
Image /page/0/Picture/2 description: The image shows a series of bold, black numbers and letters against a white background. The characters appear to be handwritten or in a font that mimics handwriting, giving them a somewhat irregular and dynamic appearance. The sequence of characters reads 'K9841109'.
Aesculap Axial Clip Appliers
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
in Accordance with SMDA of 1990
AESCULAP AXIAL CLIP APPLIERS
November 13, 1998
Company
Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080
Contact
Lia S. Jones, Regulatory Associate Phone: 650-624-5073 650-589-3007 Fax: E-Mail: lia.jones@aesculap.com
Trade Name Axial Clip Applier
Common Name(s) Aneurysm Clip Applier Applying Forceps
Product Code and Classification Name
84HCI; Aneurysm Clip Applier
Product Classification Class II
Requiatory Classification
21 CFR § 882.4175
Intended Use
The Aesculap Axial Clip Appliers are used for holding and applying intracranial aneurysm clips.
Device Description
There are twelve Axial clip appliers; each with complete material and design compatibility with Aesculap's existing Yasargil titanium and phynox aneurysm clip patterns. The new Axial clip appliers are available in three lengths (70mm, 90mm, 110mm), two jaw sizes (mini and standard), and two jaw materials (phynox and titanium).
1
Aesculap Axial Clip Appliers
Page 2 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
in Accordance with SMDA of 1990
AESCULAP AXIAL CLIP APPLIERS
November 13, 1998
Summary of Technological Characteristics
The new Axial clip appliers do not impart any new technological features or characteristics from Aesculap's current aneurysm clip appliers (Yasarqil, Caspar and Vario) other than the slightly modified jaw design and the take-apart shaft. These minor modifications, however, do not affect the safety and effectiveness of the new Axial clip appliers, as demonstrated by the information submitted in this premarket notification.
Performance Data
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
However, the Axial clip appliers presented in this submission do conform to the following ASTM Standards:
F700-93: Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments
Proposed ASTM Standard 1B: Specifications for the Requirements and Disclosure of Aneurysm Self-Closing Appliers
Substantial Equivalence
Aesculap believes that its new Axial Clip Appliers are substantially equivalent in design, material composition, function and intended use as the following clip appliers currently in commercial distribution and cleared by the FDA:
- · Yasargil Clip Applying Forceps by Aesculap, Inc. (K833651)
- · Aneurysm Clip Appliers by Aesculap. Inc. (K940970)
- · Elekta Clip Appliers by Elekta (K955064)
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird-like figure with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1999
Ms. Lia S. Jones Regulatory Associate Aesculap 1000 Gateway Boulevard South San Francisco, California 94080-7030
Re: K984109 Trade Name: Aesculap Axial Clip Appliers Regulatory Class: II Product Code: HCI Dated: November 16, 1998 Received: November 17, 1998
Dear Ms. Jones:
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 regulations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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.
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Page 2 - Ms. Lia S. Jones
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the text "510(k) Premarket Notification". The text is in a simple, sans-serif font and is left-aligned. The text is likely part of a document or presentation related to medical device regulation.
Image /page/4/Picture/1 description: The image shows a series of bold, black handwritten digits and letters against a white background. The characters appear to be 'K954109'. The style of writing is somewhat stylized and the characters are close together.
Aesculap Axial Clip Appliers
Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Aesculap Axial Clip Appliers
Indications for Use:
The Aesculap Axial Clip Appliers are used for holding and applying intracranial aneurysm clips.
(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 Devices K984109
510(k) Number
Prescription Use _ or Over-the-Counter Use _
(per 21 CFR 801.109)