SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)

K090272 · Cardinal Health, Inc. · GZT · Mar 18, 2009 · Neurology

Device Facts

• Record ID: K090272
• Device Name: SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
• Applicant: Cardinal Health, Inc.
• Product Code: GZT · Neurology
• Decision Date: Mar 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4800
• Device Class: Class 2

Intended Use

The Spetzler Snap-On/Slide-On Scalp Retractor Clamps are accessories that are intended to be used to assist in the retraction of the scalp during all supratentorial and infratentorial skull operations.

Device Story

Spetzler Snap-On/Slide-On Scalp Retractor Clamps are surgical accessories used during neurosurgical procedures. Clamps affix to surgical bars surrounding patient's head; interact with elastic scalp retraction hooks to provide self-retaining scalp retraction. Available in two versions (Snap-On, Slide-On) and two sizes (0.5", 20mm) to fit various surgical bars. Used in OR by neurosurgeons to maintain surgical site exposure; facilitates procedure by holding scalp tissue in retracted position, improving surgeon access to operative field.

Clinical Evidence

Bench testing only. Performance testing evaluated design performance and conformance to specifications to demonstrate substantial equivalence.

Technological Characteristics

Mechanical surgical clamps; available in Snap-On and Slide-On configurations; two sizes (0.5" and 20mm). Designed for attachment to standard neurosurgical accessory bars. Non-powered, manual device.

Indications for Use

Indicated for patients undergoing supratentorial and infratentorial skull operations requiring scalp retraction.

Regulatory Classification

Identification

A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.

Predicate Devices

• Rhoton-Merz Self-Retaining Brain Retractor System (K895395)
• Leyla Self-Retaining Brain Retractor System (Preamendment device)

Submission Summary (Full Text)

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K090272

MAR 1 8 2009

Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of three curved lines that converge at one end, resembling a bird in flight or a stylized leaf.

1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6442 FAX: [phone]

## SMDA REQUIREMENTS

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS As required by section 807.92(c) Spetzler Snap-On/Slide-On Scalp Retractor Clamps

| Sponsor: | Cardinal Health<br>1430 Waukegan Road MPKB<br>McGaw Park, IL 60085 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Gina Rajterowski |
| Telephone: | [phone] |
| Fax: | [phone] |
| Date Summary Prepared: | January 2009 |
| Device Name | Spetzler Snap-On/Slide-On Scalp Retractor<br>Clamps |
| Common Name | Clamp accessory used for self-retaining<br>retraction |
| Classification Name | Self-retaining retractor for neurosurgery (21<br>CFR, 882.4800, Product Code GZT) |
| Predicate Device(s) | Rhoton-Merz Self-Retaining Brain Retractor<br>System, K895395<br>Leyla Self-Retaining Brain Retractor System<br>Preamendment device |

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| Description: | The Spetzler Snap-On/Slide-On Scalp Retractor<br>Clamps are surqical accessories that affix to the<br>appropriately sized surgical bars surrounding<br>the patient's head during neurosurgical<br>procedures. The clamps interact with elastic<br>scalp retraction hooks to assist with the self-<br>retaining retraction of the scalp during<br>neurosurgical procedures. The clamps are<br>offered in two versions (Snap-On and Slide-On)<br>and each version is offered in two sizes (0.5"<br>and 20mm) to accommodate most commonly<br>used surgical accessory bars. |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Spetzler Snap-On/Slide-On Scalp Retractor<br>Clamps are accessories that are intended to be<br>used to assist in the retraction of the scalp<br>during all supratentorial and infratentorial skull<br>operations. |
| Summary of Technological<br>Characteristics: | The proposed device and the predicate devices<br>are composed of the same or similar principals<br>of operation, design, materials and<br>manufacturing characteristics. |
| Summary of Testing: | The Spetzler Snap-On/Slide-On Scalp Retractor<br>Clamps were evaluated in non-clinical tests<br>under various conditions to assess the design<br>performance and conformance to design<br>specifications. |
| Non-Clinical Testing | Performance testing demonstrated that the<br>proposed device is substantially equivalent to<br>the currently marketed predicate devices with<br>regard to functional characteristics. |

. .

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

## Public Health Service

MAR 1 8 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardinal Health c/o Gina Rajterowski Regulatory Affairs Manager 1430 Waukegan Road McGaw Park, IL 60085-6787

Re: K090272

Trade/Device Name: Spetzler Snap-On/Slide-On Scalp Retractor Clamps Regulation Number: 21 CFR 882.4800 Regulation Name: Self-retaining retractor for neurosurgery Regulatory Class: Class II Product Code: GZT Dated: March 4, 2009 Received: March 9, 2009

Dear Ms. Rajterowski :

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) 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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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 device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small 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,

M. B. Egelston, m.D.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image contains the logo for Cardinal Health. The logo consists of a stylized graphic element above the text "CardinalHealth". The graphic element appears to be a series of curved lines, possibly representing movement or connectivity. The text is in a simple, sans-serif font.

Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6442 FAX: [phone]

## Indication for Use

510(k) Number (if known):

Device Name:

Spetzler Snap-On/Slide-On Scalp Retractor

Clamps

Indications For Use: The Spetzler Snap-On/Slide-On Scalp Retractor Clamps are accessories that are intended to be used to assist in the retraction of the scalp during supratentorial and infratentorial skull operations.

Prescription Use X

Over-The Counter Use

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

(Division/Sign-Off). Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number