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).

AI/ML Overview

The provided 510(k) summary for the Aesculap Axial Clip Appliers does not include specific acceptance criteria or details of a study that proves the device meets such criteria.

Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices already on the market. Here's a breakdown of the information available and what is missing:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated. The document mentions adherence to ASTM Standards F700-93 and Proposed ASTM Standard 1B. These standards likely contain performance requirements, but the specific metrics and targets considered "acceptance criteria" for this submission are not enumerated.
Reported Device Performance: No specific performance metrics (e.g., clip retention force, applier tip strength, number of application cycles without failure) are reported. The submission states, "The new Axial clip appliers do not impart any new technological features or characteristics from Aesculap's current aneurysm clip appliers... 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." This implies that the performance is considered similar to the predicate devices, but no comparative data is presented.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Test Set Sample Size: Not specified.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable as there is no mention of a study involving expert assessment or ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable; no test set involving expert adjudication is mentioned.

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 (clip applier), not an AI-powered diagnostic tool. MRMC studies are not relevant to its evaluation.

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

Not applicable. This device is a manual surgical instrument; there is no algorithm or AI component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. There is no mention of a ground truth in the context of device performance in this submission. The "ground truth" for substantial equivalence is the safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set."

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

Not applicable.

Summary of the Study (as described in the document):

The document states, "The new Axial clip appliers do not impart any new technological features or characteristics from Aesculap's current aneurysm clip appliers (Yasargil, 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."

This indicates that the "study" or evidence provided is primarily a justification of substantial equivalence based on design similarities and adherence to existing industry standards (ASTM F700-93 and Proposed ASTM Standard 1B), rather than a detailed performance study with explicit acceptance criteria and corresponding results. The submission implies that because the changes are minor and the device conforms to relevant standards, its safety and effectiveness are considered equivalent to the predicate devices. No specific quantitative performance data or clinical study results are presented in this 510(k) summary.

Summary

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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

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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)

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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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Aesculap Axial Clip Appliers

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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)

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).