(57 days)
Not Found
No
The document describes a mechanical surgical instrument (aneurysm clip applier) and makes no mention of AI, ML, image processing, or any software-driven functionality.
No
The device is an aneurysm clip applier, used to hold and apply aneurysm clips during surgery. It is an instrument for a surgical procedure, not a therapeutic device that directly treats a condition.
No
The device is an aneurysm clip applier, which is a surgical tool used to apply aneurysm clips. It is used in the treatment of intracranial aneurysms, not for diagnosis.
No
The device description clearly states it is a physical instrument made of stainless steel and/or titanium, used to hold and apply aneurysm clips. It does not describe any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to hold and apply aneurysm clips during intracranial surgery. This is a surgical instrument used directly on a patient's body.
- Device Description: The description details the physical components of a surgical tool (applier with jaws and pads).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
Indications for and intended use of the aneurysm clip applier is to hold and sufficiently open the aneurysm clip for application during intracranial aneurysm repair surgery. The device is used to deliver the aneurysm clip to the site of the intracranial aneurysm.
The Spetzler™ Round-Handled Applier is designed for use only with the Spetzler™ Titanium Aneurysm Clips.
Product codes (comma separated list FDA assigned to the subject device)
84 HCI
Device Description
There are two types of Spetzler™ Round Handle Appliers; Device Description: Stainless Steel with Titanium Jaws and Pads and completely Titanium. Each type applier has two styles; straight and bayonet.
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 FD&C Act for these devices.
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.
K955064, K984109, K940970, K982379
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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the numbers '994191'. The numbers are written in a clear and legible manner.
Image /page/0/Picture/1 description: The image shows a logo for NMT Neurosciences. The letters "NMT" are in large, bold, white font on a black background. Below the letters, the word "NEUROSCIENCES" is written in a smaller, white font. The logo is simple and modern.
NMT Medical Inc.
FEB
8 2000
Premarket 510(k) Notification
510(k) Summary of Safety and Effectiveness
in Accordance with SMDA of 1990 21 CFR 807.92
Spetzler™ Round Handle Aneurysm Clip Appliers
Sponsor
NMT Medical, Inc. 27 Wormwood Street Boston, MA 02210-1625
Contact
Sherrie Coval Goldsmith, VP Regulatory Affairs Phone: 617-737-0930 Fax: 617-737-0932 email: scg@nmtmedical.com
Submitted Device
Trade Name: Spetzler™ Round Handle Appliers
Common Names: Clip Appliers Applying Forceps Aneurysm Clip Appliers
Classification Name: Applier, Aneurysm Clip
Product Code: 84 HCI
Product Classification:
Regulatory Classification: 21 CFR 882.4175
1
510(k) Summary NMT Medical. Inc. Spetzler™ Round Handle Appliers Page 2 of 3
General Information
- There are two types of Spetzler™ Round Handle Appliers; Device Description: Stainless Steel with Titanium Jaws and Pads and completely Titanium. Each type applier has two styles; straight and bayonet.
- Intended Use: Indications for and intended use of the aneurysm clip applier is to hold and sufficiently open the aneurysm clip for application during aneurysm repair surgery. The device is used to deliver the aneurysm clip to the site of the aneurysm.
The Spetzler™ Round Handle Applier is designed for use only with the Spetzler™ Titanium Aneurysm Clips.
Summary of Technological Characteristics
The new Spetzler™ round Handle Appliers do not impart any new technological feature in design or manufacturing. It is the same as to function and intended use when compared to the predicates. The Spetzler™ Clip Appliers is different in that its spring loaded squeeze mechanism is more compact than the "box" style. Therefore latch engagement and disengagement requires less travel.
Performance Data
No applicable performance standards have been promulgated under Section 514 of the FD&C Act for these devices.
The respective Spetzler™ Round Handle Appliers presented in this submission do conform to the following standards:
| ASTM B348-97 | Standard Specification for Titanium and Titanium
Alloy Bars and Billets |
|-----------------------|------------------------------------------------------------------------------------------------------|
| ASTM F700-93 | Standard Practice for Care and Handling of
Intracranial Aneurysm Clips and Instruments |
| ISO 5832 Part 3, 1978 | Implants for Surgery - Metallic materials
Part 3: wrought titanium 6-aluminum 4-vanadium
alloy |
2
Surgical Instruments - Metallic materials Part 1: ISO 7153-1:1991 Stainless Steel
Substantial Equivalence
NMT Medical, Inc. believes that the Spetzler™ Round Handle 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:
| Elekta Clip Appliers | (Elekta) | (K955064) |
|---|---|---|
| Aesculap Axial Clip Appliers | (Aesculap) | (K984109) |
| Yasargil, Caspar, Vario Clip Appliers | (Aesculap) | (K940970) |
| Sundt Slim-Line Aneurysm Clip Applier | (J & J Prof, Inc.) | (K982379) |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human profiles or a caduceus-like design with three wavy lines.
Public Health Service
FEB 8 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NMT Medical, Inc. c/o Mr. Ronald D. Arkin Arkin & Associates 1733 Canton Lane Marietta. Georgia 30062
Re: K994191
Trade Name: Spetzler™ Round-Handled Applier Spetzler™ Round Handled Aneurysm Clip Applier Regulatory Class: II Product Code: HCI Dated: December 10, 1999 Received: December 13, 1999
Dear Mr. Arkin:
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.
4
Page 2 – Mr. Ronald D. Arkin
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.
Neil RP Ogden
James F. Dillard III
James E. Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Intended Use
Revised February 2, 2000
510(k) Number (if known):
Device Name:
Spetzler™ Round-Handled Applier Spetzler™ Round-Handled Aneurysm Clip Applier
Indications for Use:
Indications for and intended use of the aneurysm clip applier is to hold and sufficiently open the aneurysm clip for application during intracranial aneurysm repair surgery. The device is used to deliver the aneurysm clip to the site of the intracranial aneurysm.
The Spetzler™ Round-Handled Applier is designed for use only with the Spetzler™ Titanium Aneurysm Clips.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nho for J20
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K994/91
(Optional Format 3-10-98)
510(k) Number
YES
Prescription Use (Per 21 CFR 801.109)