Predicate Devices

Reference Devices

K131500, K043041, K003519, K002871, K984109, K983758, K970050, K922272, K913765, K833652, K833651, K833650, K772200

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical properties and substantial equivalence to predicate devices, with no mention of AI or ML.

Therapeutic

No.
A therapeutic device is one that treats or prevents a disease or condition. This device is an applier used for aneurysm clips, which are the therapeutic components. The applier itself is an instrument for applying the clip rather than directly providing therapy.

Diagnostic

No.
The "Intended Use" states that the device is "used for opening, closing, and applying Aesculap Y ASARGIL aneurysm clips," indicating it is a surgical tool, not a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states the device is manufactured from stainless steel and describes various physical configurations (lengths, jaw angles, latches), indicating it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "opening, closing, and applying Aesculap Y ASARGIL aneurysm clips." This describes a surgical instrument used in vivo (within the body) during a procedure.
Device Description: The description details a physical tool made of stainless steel with different lengths and jaw configurations. This is consistent with a surgical instrument.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are specifically designed to perform tests on samples taken from the body, not to be used within the body during a surgical procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

HCI

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. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Benchmark Functional Test:
- Methodology: (1) Meet required interface and opening width of the aneurysm clip. (2) Successful release of designated aneurysm clip in the craniotomy. (3) Latch functionality
- Results: 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:
- Methodology: 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
- Results: Pass. The performance testing demonstrated that the subject devices are substantially equivalent to the predicate devices.
Usability Test:
- Methodology: (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
- Results: Pass. The usability test demonstrated that the subject devices were properly identified and met the usability requirements.

Key Metrics

Not Found

Predicate Device(s)

K173271

Reference Device(s)

K131500, K043041, K003519, K002871, K984109, K983758, K970050, K922272, K913765, K833652, K833651, K833650, K772200

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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.

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 Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|--------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Paul Amudala
610-984-9303 (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

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
K173271 | Reference Predicate
K131500
(including K043041, K003519,
K002871, K984109, K983758,
K970050, K940970, K922272,
K913765, K833652, K833651,
K833650 and K772200)
YASARGIL Aneurysm Clips
and Clip Appliers (Clip
Appliers only) |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The Aesculap Slim
Clip Applier forceps
are used for opening,
closing, and applying
Aesculap YASARGIL
aneurysm clips. | The Aesculap Slim Clip
Applier forceps are used
for opening, closing, and
applying Aesculap
YASARGIL aneurysm
clips. | The YASARGIL Aneurysm
Clips are intended for
occlusion of cerebral
aneurysms in either a
temporary or permanent
manner. They are applied with
Aesculap Clip Appliers, which
contain titanium alloy or
phynox jaws. |
| Clip Applier: | | | |
| Body Material
(Jaw & Body) | Stainless Steel | Stainless Steel | Titanium Alloy (Ti6AI6V) or
Stainless Steel |
| Length | 50mm to 110mm,
120mm and 130mm | 50mm to 110mm | 50mm, 90mm, 70mm, and
110mm |
| 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 Designation
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

completed	Methodology	Results
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.

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.