(28 days)
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.
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.
The provided text describes a 510(k) submission for the Medtronic Clip Gun Kit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the input document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
Instead, the submission states:
- 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 (K896723)."
- Substantial Equivalence: "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."
The FDA's letter confirms: "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent... to legally marketed predicate devices."
In summary, there is no clinical study data with specific acceptance criteria or performance metrics provided in this 510(k) submission. The device was cleared based on its substantial equivalence in design, materials, intended use, and performance characteristics to a previously cleared predicate device.
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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 Neurosurgery125 Cremona DriveGoleta CA, 93117(805) 968-1546 ext. 1773Fax: (805) 968-9336 |
| Contact Person: | Jeffrey Henderson |
| Date: | January 6, 2005 |
| Trade or Proprietary Name: | Medtronic Clip Gun Kit |
| Common usual or Classification Name: | Dispensing Gun; Raney TypeScalp 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 (240) 276-0115. 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 (800) 633-2011 or (301) 443-6597 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 |
|---|---|
| -------------- | -------------------------------------------------------- |
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
§ 882.4150 Scalp clip.
(a)
Identification. A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp.(b)
Classification. Class II (performance standards).