MEDTRONIC CLIP GUN KIT

K050044 · Medtronic Neurosurgery · HBO · Feb 7, 2005 · Neurology

Device Facts

• Record ID: K050044
• Device Name: MEDTRONIC CLIP GUN KIT
• Applicant: Medtronic Neurosurgery
• Product Code: HBO · Neurology
• Decision Date: Feb 7, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Medtronic Neurosurgery Clip Gun Raney-type clips provide hemostasis during cranial surgery by preventing arterial bleeding from small vessels of the skin and deeper vessels under the scalp.

Device Story

The Medtronic Clip Gun Kit is a manual surgical instrument used to apply Raney-type scalp clips. The device is used by surgeons during craniotomy procedures to provide hemostasis by clamping small vessels of the skin and scalp. The kit consists of a dispensing gun and clips. It is a non-implantable, transient-use device. The surgeon operates the gun to place clips on the scalp edges, which mechanically compresses the vessels to prevent bleeding. This facilitates a clear surgical field and reduces blood loss during cranial access.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual dispensing gun and Raney-type scalp clips. Non-implantable, transient-use device. Materials of fabrication are identical to the predicate device.

Indications for Use

Indicated for patients undergoing cranial surgery requiring hemostasis of small vessels of the skin and deeper vessels under the scalp.

Regulatory Classification

Identification

A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp.

Predicate Devices

• Clip Gun with Raney Type Scalp Clips (K896723)

Submission Summary (Full Text)

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## K050044

## 4. 510k Summary

FEB - 7 2005

This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87.

| Establishment Registration Number: | 2021898 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Address of Manufacturer: | Medtronic Neurosurgery<br>125 Cremona Drive<br>Goleta CA, 93117<br>[phone] ext. 1773<br>Fax: [phone] |
| Contact Person: | Jeffrey Henderson |
| Date: | January 6, 2005 |
| Trade or Proprietary Name: | Medtronic Clip Gun Kit |
| Common usual or Classification Name: | Dispensing Gun; Raney Type<br>Scalp Clips ( 882.4150) |

Predicate Device Identification:

Clip Gun with Raney Type Scalp Clips (K896723)

Description: The Clip Gun Kit contains Raney-type clips intended to provide hemostasis during cranial surgery by preventing arterial bleeding from vessels under the scalp. The Clips are a non-implantable transient use device.

Intended Use: The Medtronic Neurosurgery Clip Gun Raney-type clips provide hemostasis during cranial surgery by preventing arterial bleeding from small vessels of the skin and deeper vessels under the scalp.

Intended Use of predicate device(s): The Clip Gun utilizes standard Raney-type scalp clips to provide hemostasis for craniotomy.

Technological comparison: Medtronic Neurosurgery submits that the materials of fabrication, intended use, performance characteristics and design specifications of the Clip Gun Kit are the same as the previously reviewed and cleared Clip Gun with Raney Type Scalp Clips. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Clip Gun Kit products based upon the predicate and currently marketed devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 7 2005

Mr. Jeffrey Henderson Vice President, Quality and Regulatory Affairs Medtronic Neurosurgery 125 Cremona Drive Goleta, California 93117

Re: K050044

Trade/Device Name: Clip Gun Kit Regulation Number: 21 CFR 882.4150 Regulation Name: Scalp Clip Regulatory Class: II Product Code: HBO Dated: January 6, 2005 Received: January 19, 2005

Dear Mr. Henderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications ferenced above and have sure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to connineres phor to may 20, 2017 11:53 in accordance with the provisions of the Federal Food, Drug, de necs mat have boon recident at require approval of a premarket approval application (PMA). and Cosmetic rice (11ct) market the device, subject to the general controls provisions of the Act. The r ou may, merelore, manel and as act include requirements for annual registration, listing of general controlly proficions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a00 rols. Existing major regulations affecting your device can thay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be round in ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least of advised that 1971 0188aartes over device complies with other requirements of the Act that I DA has made a acterimalations administered by other Federal agencies. You must of any I catal statutes and regarations and limited to: registration and listing (21 Compry with an the Not 810 cart 801); good manufacturing practice requirements as set CFR I at 6077, adoling (21 OFF Part 820); and if applicable, the electronic fordin in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Jeffrey Henderson

This letter will allow you to begin marketing your device as described in your Section 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 clevice to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Sovall Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Millkerson

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

Enclosure

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| Device Name: | Clip Gun Kit Special 510(k) Number (if known): K050044 |
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Indications for Use:

The Medtronic Neurosurgery Clip Gun Raney-type clips provide hemostasis during cranial surgery by preventing atterial bleeding from small vessels of the skin and deeper vessels
under the scell under the scalp.

Over the Counter Use: or Prescription Use: (Per 21 CFR 801.109)

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Mark N Milken

KOSDOYY

(Division Sign-Division of General, Restorative, and Neurological Devices

510(e) Number