The Aesculap Slim Clip Appliers are manufactured from stainless steel and are available in various lengths, jaw angulations, with or without latches. This submission intends to add a coating to the previously cleared clip appliers. 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aesculap Slim Clip Applier, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test	Acceptance Criteria (Implied)	Reported Device Performance	Conclusion
Clip Opening Verification	Minimum opening width of aneurysm clips is met.	Pass	The Aesculap Slim Clip Appliers meet the test acceptance criteria.
Biocompatibility (Cytotoxicity)	Reactivity grade of 0.	Reactivity grade of 0.	Non-cytotoxic
Biocompatibility (Sensitization)	No evidence of delayed dermal contact sensitization.	No evidence of sensitization.	Non-sensitive
Biocompatibility (Pyrogenicity)	Temperature rise below 0.5 °C.	Below 0.5 °C.	Non-pyrogenic
Biocompatibility (Irritation)	Difference between test article extract overall mean score and corresponding control extract overall mean score was 0.0.	Difference of 0.0.	Normal
Biocompatibility (Systemic Toxicity)	No mortality or evidence of systemic toxicity.	No mortality or systemic toxicity.	Non-Toxic
Biocompatibility (Hemolysis)	Hemolytic index of 0.0%.	Hemolytic index of 0.0%.	Non-Hemolytic

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

The document does not explicitly state the sample size used for the mechanical "Verification test for clip opening." It merely states "Pass" for the test.

For biocompatibility testing, the sample sizes are implied by the test descriptions:

Cytotoxicity: "Test articles were extracted for 24 hours per ISO 10993-5." (Specific number of test articles not given).
Sensitization: "in the guinea pig." (Specific number of guinea pigs not given).
Pyrogenicity: "following intravenous injection in rabbits." (Specific number of rabbits not given).
Irritation: "All animals appeared normal throughout the study." (Specific number of animals not given).
Systemic Toxicity: "extracts injected into mice." (Specific number of mice not given).
Hemolysis: "The test article extract was tested in vitro." (Specific number of test articles or replicates not given).

The data provenance is not explicitly stated regarding country of origin or whether it's retrospective/prospective. However, given that these are bench and biocompatibility tests conducted for a 510(k) submission, they are typically conducted prospectively in a controlled laboratory setting by the manufacturer or a contract research organization.

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

Not applicable for this type of device and testing. The ground truth for mechanical performance is based on engineering specifications and physical measurements. The ground truth for biocompatibility is based on established ISO standards and observed biological reactions in animal models or in vitro tests, rather than expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. This document describes bench testing and biocompatibility testing against defined physical and biological parameters, not subjective assessments requiring adjudication by multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is evaluated. The Aesculap Slim Clip Applier is a surgical instrument, and its evaluation focuses on mechanical performance and biocompatibility.

6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)

Yes, the studies described are essentially "standalone" in the sense that they evaluate the device's intrinsic mechanical properties and biocompatibility without a human operator's performance being the primary subject of the test (beyond the execution of the test itself). The "Verification test for clip opening" directly assesses the applier's mechanical function, and the biocompatibility tests evaluate the material's interaction with biological systems. There isn't an "algorithm" per se, but the device's performance is tested independently.

7. Type of Ground Truth Used

For Clip Opening Verification: Engineering specifications and physical measurements of the clip's opening width.
For Biocompatibility Tests: Established biological endpoints and standards (e.g., ISO 10993 series) for cytotoxicity, sensitization, pyrogenicity, irritation, systemic toxicity, and hemolysis.

8. Sample Size for the Training Set

Not applicable. The Aesculap Slim Clip Applier is a mechanical surgical instrument, not an AI/machine learning device that requires a training set of data. The "training" in manufacturing would relate to process validation and quality control, not a data-driven model.

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

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

December 13, 2021

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

Re: K211572

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: November 9, 2021 Received: November 10, 2021

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Naira Muradyan, Ph.D., Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211572

Device Name Aesculap Slim Clip Applier

Indications for Use (Describe)

The slim clip applier is used to open, close and apply permanent/temporary Aesculap Y ASARGIL titanium aneurysm clips.

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

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510(K) SUMMARY

[as required by 21 CFR §807.92(c)]

K211572

DATE PREPARED:	13 December 2021
SUBMITTER:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034+1 800-258-1946
CONTACT:	Paul AmudalaSr. Regulatory Affairs Specialist610-984-9303 (phone)610-417-0839 (mobile)610-791-6882 (fax)
TRADE NAME:	Aesculap Slim Clip Applier
COMMON NAME:	Aneurysm Clip Applier
DEVICE CLASSIFICATION:	Class II
REGULATION NUMBER:	21 CFR 882.4175
PRODUCT CODE:	HCI
REVIEW PANEL:	Neurology
PRIMARY PREDICATEDEVICE:	Aesculap Slim Clip Applier (K180914; April 17, 2018)
REFERENCE DEVICES:	Aesculap Slim Clip Applier (K173271; November 10, 2017)
	Yasargil, Caspar, Vario Clip Appliers (K940970; January24, 1995)

DEVICE DESCRIPTION

INDICATIONS FOR USE

The slim clip applier is used to open, close and apply permanent/temporary Aesculap YASARGIL titanium aneurysm clips.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The Aesculap Slim Clip Applier forceps are substantially equivalent to the predicate Aesculap Slim Clip Applier forceps. The intended use, fundamental scientific principles, and base materials of the clip appliers remain unchanged since last clearance. This submission intends to add a coating to the previously cleared clip appliers.

	Subject DeviceAesculap Slim ClipApplier	PredicateAesculap Slim ClipApplier	Reference DeviceAesculap Slim ClipApplier	Reference DeviceYasargil, Caspar,Vario Clip Appliers
	K211572	K180914	K173271	K940970 (Variofunctionality referenceonly)
Indications forUse	The slim clip applieris used to open, closeand apply permanent/temporary AesculapYASARGIL titaniumaneurysm clips.	The Aesculap SlimClip Applier forcepsare used foropening, closing,and applyingAesculapYASARGILaneurysm clips.	The Aesculap SlimClip Applier forcepsare used foropening, closing,and applyingAesculapYASARGILaneurysm clips.	The Aesculap TitaniumAneurysm clip appliersare used for holding andapplying intracranialtitanium aneurysm clips.
Clip Applier:
Base Material	Stainless Steel	Same	Same	Titanium
Type	Standard & Mini &Vario	Standard & Mini	Standard & Mini	Standard & Mini &Vario
Length	70mm, 90mm, 110mm	50mm to 110mm,120mm and 130mm	50mm to 110mm	90mm
Jaw Angulation	Vario, straight, up &down, left & right	Straight, up & down, left& right	Straight, up & down, left& right	Vario & various
Optional Latch	Yes	Latch or no-latch	No Latch	Latch or no-latch
Designatedclips	YASARGIL TitaniumClips only(Standard/Mini)	YASARGIL Titaniumor Phynox clips(Standard/Mini)	YASARGIL Titaniumor Phynox clips(Standard/Mini)	YASARGIL TitaniumClips only(Standard/Mini)
Non-Sterile	Yes	Same	Same	Same
ClipDesignationFeature	Yes (POM-C orPropylux Plug & Lasermarking on spring)	Same	Same	POM-C
Coating	Yes	No coating	No coating	No coating

TESTING

There is no change to the base design, functionality or intended use of the clip appliers with added coating. Bench testing results demonstrate that the Aesculap Slim Clip Applier is substantially equivalent to the Aesculap Slim Clip Appliers currently on the market. The bench testing of clip appliers demonstrates that the Aesculap Slim Clip Applier forceps perform as intended and are as safe, effective, and perform as well as the predicate devices.

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Performance Test Completed	Test purpose	Results	Conclusion
Verification test for clipopening	To verify the minimum openingwidth of aneurysm clips meets therequirement.	Pass	The Aesculap SlimClip Appliers meetthe test acceptancecriteria.

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: Testing confirmed that the Aesculap Slim Clip Appliers with added coating are biocompatible.

Test	Summary	Conclusion
Cytotoxicity	Test articles were extracted for 24 hours per ISO 10993-5. All testarticles exhibited a reactivity grade of 0. Positive and negativecontrols behaved as anticipated.	Non-cytotoxic
Sensitization	The test article extracts showed no evidence of causing delayeddermal contact sensitization in the guinea pig. The test article wasnot considered a sensitizer in the guinea pig maximization test.	Non-sensitive
Pyrogenicity	The purpose of this assessment is to determine if a test articleextract induces a pyrogenic response following intravenousinjection in rabbits (temperature rise below 0.5 °Cindicates the absence of pyrogens). Based on the assessmentper ISO 10993-11, the materials are non-pyrogenic.	Non-pyrogenic
Irritation	All animals appeared normal throughout the study. The test articlemet the requirements of the test since the difference between eachtest article extract overall mean score and corresponding controlextract overall mean score was 0.0 for both the SC and SO testarticle extracts.	Normal
Systemic Toxicity	There was no mortality or evidence of systemic toxicity from theextracts injected into mice. Each test article extract met therequirements of the study.	Non-Toxic
Hemolysis	The test article extract was tested in vitro. The hemolytic index forthe test article extract was 0.0% and the test article extract wasconsidered non-hemolytic.	Non-Hemolytic

CONCLUSION

Aesculap Slim Clip Applier forceps presented in this submission are substantially equivalent in design, intended use, and performance to the predicate and reference devices. The added coating does not raise new questions of safety and effectiveness.

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).