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.

Device Description

There are two types of Spetzler™ Round Handle Appliers; Stainless Steel with Titanium Jaws and Pads and completely Titanium. Each type applier has two styles; straight and bayonet.

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification for a medical device called the "Spetzler™ Round Handle Aneurysm Clip Appliers". This type of document is generally about demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific, quantitative acceptance criteria through a formal study with detailed statistical analysis as might be done for a novel device. Therefore, much of the requested information (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not typically found in such a submission because these types of studies are not usually required for a 510(k) clearance based on substantial equivalence.

Based on the provided text, here's an analysis of the acceptance criteria and related information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states, "No applicable performance standards have been promulgated under Section 514 of the FD&C Act for these devices." Instead, the device's "performance" is assessed against its conformity to established material and instrument standards, and its substantial equivalence to predicate devices. The "acceptance criteria" here are qualitative and relate to design, material composition, function, and intended use as compared to existing, cleared devices.

Acceptance Criteria (Demonstrated through Conformance to Standards & Substantial Equivalence)	Reported Device Performance/Compliance
Conformance to Material Standards for Titanium and Titanium Alloys	ASTM B348-97: Standard Specification for Titanium and Titanium Alloy Bars and Billets (Complied) ISO 5832 Part 3, 1978: Implants for Surgery - Metallic materials Part 3: wrought titanium 6-aluminum 4-vanadium alloy (Complied)
Conformance to Handling Standards for Aneurysm Clips and Instruments	ASTM F700-93: Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments (Complied)
Conformance to Material Standards for Stainless Steel (for instruments)	ISO 7153-1:1991: Surgical Instruments - Metallic materials Part 1: Stainless Steel (Complied)
Substantial Equivalence in Design, Material, Function, and Intended Use	The Spetzler™ Round Handle Appliers are deemed substantially equivalent to the following predicate devices: - Elekta Clip Appliers (K955064) - Aesculap Axial Clip Appliers (K984109) - Yasargil, Caspar, Vario Clip Appliers (K940970) - Sundt Slim-Line Aneurysm Clip Applier (K982379)
Device Description & Intended Use	"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 device also states it is designed for use only with Spetzler™ Titanium Aneurysm Clips).
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."

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable in this context. A 510(k) submission generally relies on performance testing (e.g., mechanical, material) to demonstrate compliance with standards and equivalence, rather than a clinical "test set" of patient data. The provided document details compliance with industrial standards (ASTM, ISO) for materials and handling, not clinical data sets. The equivalence is demonstrated through comparison of technical characteristics to already-clezed devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable. The ground truth for this type of submission is typically based on established engineering principles, material science, and the performance history of predicate devices, rather than expert interpretation of clinical data in a test set.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a surgical instrument (aneurysm clip applier), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a manual surgical instrument, not an algorithm.

7. The type of ground truth used:

The "ground truth" in this submission is the established performance and safety profiles of the predicate devices and the compliance with recognized industry standards for materials and surgical instruments. It's built upon:

Engineering specifications and material properties.
Functional design comparisons.
Intended use equivalence to devices already cleared by the FDA.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable for the same reason as point 8.

Summary

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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

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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 TitaniumAlloy Bars and Billets
ASTM F700-93	Standard Practice for Care and Handling ofIntracranial Aneurysm Clips and Instruments
ISO 5832 Part 3, 1978	Implants for Surgery - Metallic materialsPart 3: wrought titanium 6-aluminum 4-vanadiumalloy

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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)

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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.

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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

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Intended Use

Revised February 2, 2000

510(k) Number (if known):

K994191

Device Name:

Spetzler™ Round-Handled Applier Spetzler™ Round-Handled Aneurysm Clip Applier

Indications for Use:

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)

Regulation Number and Section

§ 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).