Aesculap Slim Clip Applier

K180914 · Aesculap, Inc. · HCI · Apr 17, 2018 · Neurology

Device Facts

• Record ID: K180914
• Device Name: Aesculap Slim Clip Applier
• Applicant: Aesculap, Inc.
• Product Code: HCI · Neurology
• Decision Date: Apr 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4175
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Manual surgical instrument; stainless steel forceps; used by neurosurgeons in OR. Function: opening, closing, and applying YASARGIL aneurysm clips. Input: manual force applied by surgeon to handles. Transformation: mechanical leverage transfers force to jaws to manipulate clip. Output: controlled placement/release of aneurysm clip. Features: various lengths (50-130mm), jaw angulations (straight, 5-45° up/down, 5-30° left/right), and optional latches. Identification: laser marking and identification plug in handle to match applier to specific clip type. Benefit: enables precise occlusion of cerebral aneurysms.

Clinical Evidence

Bench testing only. No clinical data. Testing included functional benchmarks (interface, opening width, clip release, latch functionality), predicate comparison, and usability testing (identification, legibility, visualization, handling). All tests passed.

Technological Characteristics

Materials: Stainless steel (body and jaw). Form factor: Manual forceps, 50-130mm lengths, various jaw angulations (straight, up/down, left/right). Features: Optional latch, laser-marked clip designation, identification plug. Sterilization: Non-sterile, intended for user sterilization. Connectivity: None.

Indications for Use

Indicated for use in the opening, closing, and application of Aesculap YASARGIL aneurysm clips during neurosurgical procedures.

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 (K173271)
• YASARGIL Aneurysm Clips and Clip Appliers (K131500)
• K043041
• K003519
• K002871
• K984109
• K983758
• K970050
• K922272
• K913765
• K833652
• K833651
• K833650
• K772200

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|------------------------------------------------------------------------------------------------|--|
| <span style="text-decoration: overline;">X</span> 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.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|--------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Paul Amudala<br>610-984-9303 (phone)<br>610-791-6882 (fax)<br>[e-mail] |
| 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

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.

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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 Predicate<br>K173271 | Reference Predicate<br>K131500<br>(including K043041, K003519,<br>K002871, K984109, K983758,<br>K970050, K940970, K922272,<br>K913765, K833652, K833651,<br>K833650 and K772200)<br>YASARGIL Aneurysm Clips<br>and Clip Appliers (Clip<br>Appliers only) |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The Aesculap Slim<br>Clip Applier forceps<br>are used for opening,<br>closing, and applying<br>Aesculap YASARGIL<br>aneurysm clips. | The Aesculap Slim Clip<br>Applier forceps are used<br>for opening, closing, and<br>applying Aesculap<br>YASARGIL aneurysm<br>clips. | The YASARGIL Aneurysm<br>Clips are intended for<br>occlusion of cerebral<br>aneurysms in either a<br>temporary or permanent<br>manner. They are applied with<br>Aesculap Clip Appliers, which<br>contain titanium alloy or<br>phynox jaws. |
| Clip Applier: | | | |
| Body Material<br>(Jaw & Body) | Stainless Steel | Stainless Steel | Titanium Alloy (Ti6AI6V) or<br>Stainless Steel |
| Length | 50mm to 110mm,<br>120mm and 130mm | 50mm to 110mm | 50mm, 90mm, 70mm, and<br>110mm |
| Jaw Angulation | Straight, up & down,<br>left & right | Straight, up & down, left<br>& right | Straight, angled, bayonet |
| Optional Latch | Yes | No | Yes |
| Non-Sterile | Yes | Same | Same |
| Clip Designation<br>Feature | 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 Test<br>completed | Methodology | Results | Conclusions |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Benchmark Functional<br>Test | (1) Meet required interface<br>and opening width of the<br>aneurysm clip.<br>(2) Successful release of<br>designated aneurysm clip in<br>the craniotomy.<br>(3) Latch functionality | Pass | The devices interfaced successfully<br>with the aneurysm clips while<br>providing the correct opening width.<br>In addition the devices successfully<br>released the aneurysm clips within<br>the craniotomy. |
| Predicate/Subject<br>Device Comparison<br>Test | Comparison between<br>predicate and subject device<br>ensuring:<br>(1) Required interface and<br>opening width of designated<br>aneurysm clip.<br>(2) Successful performance of<br>the clip applier with the<br>aneurysm clip.<br>(3) Latch functionality | Pass | The performance testing<br>demonstrated that the subject<br>devices are substantially equivalent<br>to the predicate devices. |
| Usability Test | (1) Ensuring identification of<br>designated clip type for the<br>specific clip applier.<br>(2) Legibility of additional<br>Clip Applier identification<br>features, i.e. company name,<br>article number, and UDI<br>information.<br>(3) Ensuring visualization of<br>surgical site.<br>(4) Ability to grasp, hold, and<br>apply YASARGIL Aneurysm<br>Clip.<br>(5) Latch usability test | Pass | The usability test demonstrated that<br>the subject devices were properly<br>identified and met the usability<br>requirements. |

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.