Aesculap Slim Clip Applier

K211572 · Aesculap, Inc. · HCI · Dec 13, 2021 · Neurology

Device Facts

• Record ID: K211572
• Device Name: Aesculap Slim Clip Applier
• Applicant: Aesculap, Inc.
• Product Code: HCI · Neurology
• Decision Date: Dec 13, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4175
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Aesculap Slim Clip Applier is a manual surgical instrument used by neurosurgeons to manipulate and apply titanium aneurysm clips during intracranial procedures. The device consists of stainless steel forceps available in various lengths and jaw angulations, featuring optional latches and identification plugs to ensure compatibility with specific clip types. The current iteration introduces a surface coating to the previously cleared design. The surgeon operates the device manually to open, position, and close the clip on an aneurysm; the device provides the mechanical force necessary to secure the clip, thereby facilitating the occlusion of the aneurysm. The device is provided non-sterile and must be sterilized by the user prior to clinical application.

Clinical Evidence

Bench testing only. Performance testing verified that the minimum opening width of aneurysm clips meets requirements. Biocompatibility testing per ISO 10993-5 and ISO 10993-11 confirmed the device is non-cytotoxic, non-sensitizing, non-pyrogenic, non-irritating, non-toxic, and non-hemolytic.

Technological Characteristics

Stainless steel forceps; various lengths (70mm, 90mm, 110mm) and jaw angulations; optional latch mechanism; identification plugs (POM-C or Propylux); laser marking for clip designation; surface coating added. Manual operation. Provided non-sterile; intended for sterilization prior to use.

Indications for Use

Indicated for opening, closing, and applying permanent or temporary Aesculap YASARGIL titanium aneurysm clips in patients requiring neurosurgical aneurysm repair.

Regulatory Classification

Identification

An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.

Predicate Devices

• Aesculap Slim Clip Applier (K180914)

Reference Devices

• Aesculap Slim Clip Applier (K173271)
• Yasargil, Caspar, Vario Clip Appliers (K940970)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="text-align: left;"> <svg height="15" width="15"> <path d="M2 2 L2 13 L13 13 L13 2 Z M3 3 L12 3 L12 12 L3 12 Z" fill="white" stroke="black"></path> <path d="M4 4 L11 11" stroke="black"></path> <path d="M11 4 L4 11" stroke="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="text-align: left;"> <svg height="15" width="15"> <path d="M2 2 L2 13 L13 13 L13 2 Z M3 3 L12 3 L12 12 L3 12 Z" fill="white" stroke="black"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(K) SUMMARY

[as required by 21 CFR §807.92(c)]

# K211572

| DATE PREPARED: | 13 December 2021 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>[phone] |
| CONTACT: | Paul Amudala<br>Sr. Regulatory Affairs Specialist<br>610-984-9303 (phone)<br>610-417-0839 (mobile)<br>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 PREDICATE<br>DEVICE: | Aesculap Slim Clip Applier (K180914; April 17, 2018) |
| REFERENCE DEVICES: | Aesculap Slim Clip Applier (K173271; November 10, 2017) |
| | Yasargil, Caspar, Vario Clip Appliers (K940970; January<br>24, 1995) |

## DEVICE DESCRIPTION

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.

## 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 Device<br>Aesculap Slim Clip<br>Applier | Predicate<br>Aesculap Slim Clip<br>Applier | Reference Device<br>Aesculap Slim Clip<br>Applier | Reference Device<br>Yasargil, Caspar,<br>Vario Clip Appliers |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| | K211572 | K180914 | K173271 | K940970 (Vario<br>functionality reference<br>only) |
| Indications for<br>Use | The slim clip applier<br>is used to open, close<br>and apply permanent/<br>temporary Aesculap<br>YASARGIL titanium<br>aneurysm clips. | The Aesculap Slim<br>Clip Applier forceps<br>are used for<br>opening, closing,<br>and applying<br>Aesculap<br>YASARGIL<br>aneurysm clips. | The Aesculap Slim<br>Clip Applier forceps<br>are used for<br>opening, closing,<br>and applying<br>Aesculap<br>YASARGIL<br>aneurysm clips. | The Aesculap Titanium<br>Aneurysm clip appliers<br>are used for holding and<br>applying intracranial<br>titanium aneurysm clips. |
| Clip Applier: | | | | |
| Base Material | Stainless Steel | Same | Same | Titanium |
| Type | Standard & Mini &<br>Vario | Standard & Mini | Standard & Mini | Standard & Mini &<br>Vario |
| Length | 70mm, 90mm, 110mm | 50mm to 110mm,<br>120mm and 130mm | 50mm to 110mm | 90mm |
| Jaw Angulation | Vario, straight, up &<br>down, left & right | Straight, up & down, left<br>& right | Straight, up & down, left<br>& right | Vario & various |
| Optional Latch | Yes | Latch or no-latch | No Latch | Latch or no-latch |
| Designated<br>clips | YASARGIL Titanium<br>Clips only<br>(Standard/Mini) | YASARGIL Titanium<br>or Phynox clips<br>(Standard/Mini) | YASARGIL Titanium<br>or Phynox clips<br>(Standard/Mini) | YASARGIL Titanium<br>Clips only<br>(Standard/Mini) |
| Non-Sterile | Yes | Same | Same | Same |
| Clip<br>Designation<br>Feature | Yes (POM-C or<br>Propylux Plug & Laser<br>marking 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 clip<br>opening | To verify the minimum opening<br>width of aneurysm clips meets the<br>requirement. | Pass | The Aesculap Slim<br>Clip Appliers meet<br>the test acceptance<br>criteria. |

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 test<br>articles exhibited a reactivity grade of 0. Positive and negative<br>controls behaved as anticipated. | Non-cytotoxic |
| Sensitization | The test article extracts showed no evidence of causing delayed<br>dermal contact sensitization in the guinea pig. The test article was<br>not considered a sensitizer in the guinea pig maximization test. | Non-sensitive |
| Pyrogenicity | The purpose of this assessment is to determine if a test article<br>extract induces a pyrogenic response following intravenous<br>injection in rabbits (temperature rise below 0.5 °C<br>indicates the absence of pyrogens). Based on the assessment<br>per ISO 10993-11, the materials are non-pyrogenic. | Non-pyrogenic |
| Irritation | All animals appeared normal throughout the study. The test article<br>met the requirements of the test since the difference between each<br>test article extract overall mean score and corresponding control<br>extract overall mean score was 0.0 for both the SC and SO test<br>article extracts. | Normal |
| Systemic Toxicity | There was no mortality or evidence of systemic toxicity from the<br>extracts injected into mice. Each test article extract met the<br>requirements of the study. | Non-Toxic |
| Hemolysis | The test article extract was tested in vitro. The hemolytic index for<br>the test article extract was 0.0% and the test article extract was<br>considered 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.