The Aesculap Slim Clip Appliers are manufactured from stainless steel (body & jaw). The previously cleared appliers are available in lengths ranging from 50 mm to 110 mm in 10 mm increments. In addition to the straight jaw configuration (0%), the Clip Appliers are available with jaws angled up & down (5° to 15°), left & right (5° to 15°), in increments of 5° in all lengths. This submission intends to add additional lengths of 120 mm and 130 mm in these configurations. This submission intends to add additional jaw angulations of 20° to 45° up and down and 20° to 30° left and right in 5° increments and lengths ranging from 50-130 mm in 10 mm increments. In addition to these configurations, clip appliers with latches will be available in lengths ranging from 70 mm to 110 mm increments with jaw angulations ranging from straight, 5° to 45° up and down and 5° to 30° left and right in 5° increments. Each Clip Applier is individually laser marked with the type of clip designated for use. In addition, at least one identification plug is located within one of the handles to aid in identifying the aneurysm clip designation.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Aesculap Slim Clip Applier, a device used for opening, closing, and applying Aesculap YASARGIL aneurysm clips. The submission aims to add new lengths and jaw angulations, as well as an optional latch feature, to existing cleared appliers.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test	Acceptance Criteria (Methodology)	Reported Device Performance (Results)	Conclusion
Benchmark Functional Test	(1) Meet required interface and opening width of the aneurysm clip. (2) Successful release of designated aneurysm clip in the craniotomy. (3) Latch functionality.	Pass	The devices interfaced successfully with the aneurysm clips while providing the correct opening width. In addition, the devices successfully released the aneurysm clips within the craniotomy.
Predicate/Subject Device Comparison Test	Comparison between predicate and subject device ensuring: (1) Required interface and opening width of designated aneurysm clip. (2) Successful performance of the clip applier with the aneurysm clip. (3) Latch functionality.	Pass	The performance testing demonstrated that the subject devices are substantially equivalent to the predicate devices.
Usability Test	(1) Ensuring identification of designated clip type for the specific clip applier. (2) Legibility of additional Clip Applier identification features, i.e., company name, article number, and UDI information. (3) Ensuring visualization of surgical site. (4) Ability to grasp, hold, and apply YASARGIL Aneurysm Clip. (5) Latch usability test.	Pass	The usability test demonstrated that the subject devices were properly identified and met the usability requirements.

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

The document does not explicitly state the specific sample sizes used for each test (e.g., number of appliers, number of clips, number of simulated craniotomies). It generally refers to "all required testing" being completed. The tests are bench tests, meaning they were conducted in a laboratory setting, not with human subjects. Thus, data provenance in terms of country of origin or retrospective/prospective medical data is not applicable here as the test data is generated in a controlled environment.

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

This information is not provided in the document. The tests performed are primarily functional and mechanical, suggesting that the "ground truth" is defined by engineering specifications and performance standards rather than expert clinical consensus.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the bench testing (Pass/Fail results against predefined criteria), formal adjudication by multiple parties for each test outcome is unlikely to have been a primary method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device is a surgical instrument (aneurysm clip applier), and the studies described are bench tests to confirm its mechanical and functional equivalence to predicate devices, not studies involving human readers interpreting imaging data or clinical outcomes. Therefore, an effect size of human readers improving with or without AI assistance is not applicable.

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

This question is not applicable to the Aesculap Slim Clip Applier. This device is a manual surgical instrument, not an algorithm or AI-powered system.

7. The Type of Ground Truth Used

The ground truth for the acceptance criteria and testing appears to be based on:

Engineering Specifications: The required interface and opening width of the aneurysm clip, and the ability to release the clip successfully.
Functional Performance Standards: The successful performance of the clip applier with the aneurysm clip, and latch functionality.
Usability Requirements: Ensuring proper identification features, legibility, visualization of the surgical site, and the ability to grasp, hold, and apply the clip.

These are primarily objective, measurable criteria related to the device's design and intended function.

8. The Sample Size for the Training Set

This is not applicable. The Aesculap Slim Clip Applier is a mechanical medical device, not a machine learning or AI algorithm that requires training data.

9. How the Ground Truth for the Training Set was Established

This is not applicable, as there is no training set for a mechanical device.

Summary

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April 17, 2018

Aesculap, Inc. Paul Amudala Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K180914

Trade/Device Name: Aesculap Slim Clip Applier Regulation Number: 21 CFR 882.4175 Regulation Name: Aneurysm Clip Applier Regulatory Class: Class II Product Code: HCI Dated: April 6, 2018 Received: April 9, 2018

Dear Paul Amudala:

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 complies 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image contains the text "Carlos L. Pena - S". The text is in a simple, sans-serif font and is left-aligned. The letters are dark, contrasting with the white background. There is a faint logo of the FDA in the background.

Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180914

Device Name Aesculap Slim Clip Applier

Indications for Use (Describe)

The Aesculap Slip Clip Applier forceps are used for opening, closing, and applying Aesculap Y ASARGIL aneurysm clips.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY - K180914

Aesculap Slim Clip Applier April 06, 2018

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Paul Amudala610-984-9303 (phone)610-791-6882 (fax)paul.amudala@aesculapimplants.com
TRADE NAME:	Aesculap Slim Clip Applier
COMMON NAME:	Aneurysm Clip Applier
REGULATION NUMBER:	21CFR882.4175 – Applier, Aneurysm Clip
PRODUCT CODE:	HCI
REVIEW PANEL:	Neurology

SUBSTANTIAL EQUIVALENCE

Aesculap. Inc. believes that the Aesculap Slim Clip Applier forceps are substantially equivalent to Clip Appliers cleared in Primary Predicate K173271 and Reference Predicate K131500 (including K043041, K003519, K002871, K984109, K983758, K970050, K922272, K913765, K833652, K833651, K833650, and K772200).

DEVICE DESCRIPTION

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Each Clip Applier is individually laser marked with the type of clip designated for use. In addition, at least one identification plug is located within one of the handles to aid in identifying the aneurysm clip designation.

INDICATIONS FOR USE

The Aesculap Slim Clip Applier forceps are used for opening, closing, and applying Aesculap YASARGIL aneurysm clips.

TECHNOLOGICAL CHARACTERISTICS (Compared to the Primary Predicate)

The Aesculap Slim Clip Applier forceps are substantially equivalent to the predicate Aesculap Slim Clip Applier forceps and YASARGIL Aneurysm Clip Applier forceps. The intended use, fundamental scientific principles, and base materials of the Clip Appliers (body and jaw) remain unchanged since last clearance. The additional Aesculap Slim Clip Applier forceps are offered with optional latches and additional sizes and angulations but function the same as the Primary and Reference predicates.

	Principle Device	Primary PredicateK173271	Reference PredicateK131500(including K043041, K003519,K002871, K984109, K983758,K970050, K940970, K922272,K913765, K833652, K833651,K833650 and K772200)YASARGIL Aneurysm Clipsand Clip Appliers (ClipAppliers only)
Indications	The Aesculap SlimClip Applier forcepsare used for opening,closing, and applyingAesculap YASARGILaneurysm clips.	The Aesculap Slim ClipApplier forceps are usedfor opening, closing, andapplying AesculapYASARGIL aneurysmclips.	The YASARGIL AneurysmClips are intended forocclusion of cerebralaneurysms in either atemporary or permanentmanner. They are applied withAesculap Clip Appliers, whichcontain titanium alloy orphynox jaws.
Clip Applier:
Body Material(Jaw & Body)	Stainless Steel	Stainless Steel	Titanium Alloy (Ti6AI6V) orStainless Steel
Length	50mm to 110mm,120mm and 130mm	50mm to 110mm	50mm, 90mm, 70mm, and110mm
Jaw Angulation	Straight, up & down,left & right	Straight, up & down, left& right	Straight, angled, bayonet
Optional Latch	Yes	No	Yes
Non-Sterile	Yes	Same	Same
Clip DesignationFeature	Yes	Same	Same

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TESTING

All required testing was completed for the Aesculap Slim Clip Applier forceps. Bench testing results demonstrate that the Aesculap Slim Clip Applier forceps are substantially equivalent when compared to the Aesculap Clip Appliers currently on the market. Bench testing was performed to demonstrate that the Aesculap Slim Clip Applier forceps perform as intended and are safe, as effective, and perform as well as the predicate devices.

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Performance Testcompleted	Methodology	Results	Conclusions
Benchmark FunctionalTest	(1) Meet required interfaceand opening width of theaneurysm clip.(2) Successful release ofdesignated aneurysm clip inthe craniotomy.(3) Latch functionality	Pass	The devices interfaced successfullywith the aneurysm clips whileproviding the correct opening width.In addition the devices successfullyreleased the aneurysm clips withinthe craniotomy.
Predicate/SubjectDevice ComparisonTest	Comparison betweenpredicate and subject deviceensuring:(1) Required interface andopening width of designatedaneurysm clip.(2) Successful performance ofthe clip applier with theaneurysm clip.(3) Latch functionality	Pass	The performance testingdemonstrated that the subjectdevices are substantially equivalentto the predicate devices.
Usability Test	(1) Ensuring identification ofdesignated clip type for thespecific clip applier.(2) Legibility of additionalClip Applier identificationfeatures, i.e. company name,article number, and UDIinformation.(3) Ensuring visualization ofsurgical site.(4) Ability to grasp, hold, andapply YASARGIL AneurysmClip.(5) Latch usability test	Pass	The usability test demonstrated thatthe subject devices were properlyidentified and met the usabilityrequirements.

STERILIZATION: The Aesculap Slim Clip Applier forceps will continue to be provided nonsterile similar to the predicate devices. They are intended to be sterilized prior to use.

BIOCOMPATIBILITY: There is no change to the patient contacting material of the Aesculap Slim Clip Applier forceps since they are manufactured from the same Stainless Steel as the predicate devices.

CONCLUSION

Aesculap believes that the Aesculap Slim Clip Applier forceps presented in this submission are substantially equivalent in design, materials, intended use, and perform as safe and effective as Aesculap's currently marketed devices.

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).