AESCULAP AXIAL CLIP APPLIER

K984109 · Aesculap, Inc. · HCI · Feb 12, 1999 · Neurology

Device Facts

• Record ID: K984109
• Device Name: AESCULAP AXIAL CLIP APPLIER
• Applicant: Aesculap, Inc.
• Product Code: HCI · Neurology
• Decision Date: Feb 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4175
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aesculap Axial Clip Appliers are used for holding and applying intracranial aneurysm clips.

Device Story

Manual surgical instrument used by neurosurgeons to hold and apply intracranial aneurysm clips. Device consists of a shaft and jaw mechanism available in various lengths (70mm, 90mm, 110mm) and jaw sizes (mini, standard). Materials include titanium and phynox. Operates as a mechanical forceps; no electronic or software components. Used in clinical neurosurgical settings to facilitate clip placement on aneurysms.

Clinical Evidence

No clinical data provided. Bench testing only; device conforms to ASTM F700-93 and proposed ASTM Standard 1B.

Technological Characteristics

Manual surgical instrument. Materials: titanium and phynox. Dimensions: 70mm, 90mm, 110mm lengths; mini and standard jaw sizes. Mechanical actuation. Conforms to ASTM F700-93 and proposed ASTM Standard 1B.

Indications for Use

Indicated for holding and applying intracranial aneurysm clips in patients requiring neurosurgical intervention.

Regulatory Classification

Identification

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

Predicate Devices

• Yasargil Clip Applying Forceps by Aesculap, Inc. (K833651)
• Aneurysm Clip Appliers by Aesculap, Inc. (K940970)
• Elekta Clip Appliers by Elekta (K955064)

Submission Summary (Full Text)

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2/12/99

510(k) Premarket Notification

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Aesculap Axial Clip Appliers

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

in Accordance with SMDA of 1990

# AESCULAP AXIAL CLIP APPLIERS

November 13, 1998

#### Company

Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080

#### Contact

Lia S. Jones, Regulatory Associate Phone: [phone] Fax: E-Mail: [e-mail]

Trade Name Axial Clip Applier

Common Name(s) Aneurysm Clip Applier Applying Forceps

# Product Code and Classification Name

84HCI; Aneurysm Clip Applier

Product Classification Class II

#### Requiatory Classification

21 CFR § 882.4175

#### Intended Use

The Aesculap Axial Clip Appliers are used for holding and applying intracranial aneurysm clips.

#### Device Description

There are twelve Axial clip appliers; each with complete material and design compatibility with Aesculap's existing Yasargil titanium and phynox aneurysm clip patterns. The new Axial clip appliers are available in three lengths (70mm, 90mm, 110mm), two jaw sizes (mini and standard), and two jaw materials (phynox and titanium).

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Aesculap Axial Clip Appliers

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#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

in Accordance with SMDA of 1990

#### AESCULAP AXIAL CLIP APPLIERS

November 13, 1998

#### Summary of Technological Characteristics

The new Axial clip appliers do not impart any new technological features or characteristics from Aesculap's current aneurysm clip appliers (Yasarqil, Caspar and Vario) other than the slightly modified jaw design and the take-apart shaft. These minor modifications, however, do not affect the safety and effectiveness of the new Axial clip appliers, as demonstrated by the information submitted in this premarket notification.

#### Performance Data

No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.

However, the Axial clip appliers presented in this submission do conform to the following ASTM Standards:

F700-93: Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments

Proposed ASTM Standard 1B: Specifications for the Requirements and Disclosure of Aneurysm Self-Closing Appliers

#### Substantial Equivalence

Aesculap believes that its new Axial Clip Appliers are substantially equivalent in design, material composition, function and intended use as the following clip appliers currently in commercial distribution and cleared by the FDA:

- · Yasargil Clip Applying Forceps by Aesculap, Inc. (K833651)
- · Aneurysm Clip Appliers by Aesculap. Inc. (K940970)
- · Elekta Clip Appliers by Elekta (K955064)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 1999

Ms. Lia S. Jones Regulatory Associate Aesculap 1000 Gateway Boulevard South San Francisco, California 94080-7030

Re: K984109 Trade Name: Aesculap Axial Clip Appliers Regulatory Class: II Product Code: HCI Dated: November 16, 1998 Received: November 17, 1998

Dear Ms. Jones:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Lia S. Jones

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Aesculap Axial Clip Appliers

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

Aesculap Axial Clip Appliers

### Indications for Use:

The Aesculap Axial Clip Appliers are used for holding and applying intracranial aneurysm clips.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

(Division Sign-Off)
Division of General Restorative Devices K984109
510(k) Number

Prescription Use *_ or Over-the-Counter Use _*
(per 21 CFR 801.109)