SCALP DURA RETRACTOR, MODEL KS00474

K093054 · KARL STORZ Endoscopy-America, Inc. · GZT · Nov 15, 2010 · Neurology

Device Facts

• Record ID: K093054
• Device Name: SCALP DURA RETRACTOR, MODEL KS00474
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: GZT · Neurology
• Decision Date: Nov 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Karl Storz Scalp Dura Retractor is intended for use to elevate dura and scalp layers away from cranial bone during endoscopic-assisted strip craniectomies.

Device Story

Karl Storz Scalp Dura Retractor is a non-powered, manual, self-retaining neurosurgical retractor. Device assembly includes handle, stationary blade, telescope sheath/cannula, and adjustable/movable blade. Two knobs control device function: one for telescoping stationary blade, one for angular opening of adjustable blade. Telescope cannula allows endoscope insertion for direct visualization of surgical site. Used in OR by neurosurgeons to retract soft tissue. Provides retraction in single plane. Benefits patient by facilitating endoscopic-assisted strip craniectomies through improved visualization and tissue elevation.

Clinical Evidence

Bench testing only. Mechanical equivalence demonstrated via load deflection test comparing lateral deflection displacements against Tew Cranial/Spinal Retractor Model A and Budde-Halo Retractor.

Technological Characteristics

Non-powered, manual, self-retaining retractor. Material: stainless steel. Features handle-mounted blades with telescoping and angular adjustment knobs. Includes telescope cannula for endoscope integration. Reusable and sterilizable via steam (pre-vacuum).

Indications for Use

Indicated for elevating dura and scalp layers away from cranial bone during endoscopic-assisted strip craniectomies in patients undergoing neurosurgical procedures.

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

• Grossman Self-retaining Low Profile Brain Retractor (K060097)
• TEW Cranial/Spinal Retractor Model A 1090 (K960807)
• BUDDE Halo Retractor (K830332)

Reference Devices

• Karlin Crank Frame Spinal Retractor Set (K882071)
• Apfelbaum Cerebellar Retractor

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo features the word "STORZ" in large, bold letters, with a black circle in the middle of the "O". Below the word "STORZ" is the text "KARL STORZ ENDOSKOPE" in a smaller font. The background of the image is a textured pattern.

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KARL STORZ Endoscopy-America, Inc.

2151 E. Grand Avenue El Segundo, California 90245

Toll Free 800 421 0837 Fax [phone]

K093054

NOV 1 5 2010

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.

| Submitter: | Karl Storz Endoscopy-America, Inc.<br>2151 E. Grand Avenue<br>El Segundo, CA 90245-5017<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Crystal Dizol<br>Regulatory Affairs Specialist<br>Email: [e-mail] |
| Date Prepared: | April 29, 2010 |
| Device Trade Name: | Karl Storz Scalp Dura Retractor |
| Common Name: | Retractor, Self-retaining |
| Classification Name: | Self-retaining retractor for neurosurgery. |
| Regulation Number: | 21 CFR 882.4800 |
| Product Code | GZT |

#### Predicate Device(s):

KLS-Martin, LP: Grossman Self-retaining Low Profile Brain Retractor (K060097) Ohio Medical Instrument Co.: TEW Cranial/Spinal Retractor Model A 1090 (K960807) Ohio Medical Instrument Co .: BUDDE Halo Retractor (K830332)

#### Device Description:

The Karl Storz Scalp Dura Retractor is a non-powered, manual, adjustable, self-retaining retractor for neurosurgery. The assembly comprises a retractor handle, a stationary blade, a telescope sheath/cannula, and an adjustable/movable blade. One knob controls the telescoping of the stationary blade and a second knob controls the angular opening of the adjustable blade. The telescope cannula allows for the introduction of an endoscope for direct visualization of the surgical site.

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Image /page/1/Picture/0 description: The image shows the word "STORZ" in a bold, sans-serif font, with a circle in the middle of the "O". Below the word "STORZ" is the phrase "KARL STORZ-ENDOSKOPE" in a smaller font. The text is black and white, and the image appears to be a logo or branding for a company named "STORZ" that specializes in endoscopes.

#### Intended Use:

The Karl Storz Scalp Dura Retractor is intended for use to elevate dura and scalp layers away from cranial bone during endoscopic-assisted strip craniectomies.

#### Technological Characteristics:

The primary difference between the Karl Storz Scalp Dura Retractor and the predicate devices is the design of the mechanism that allows for adjustability of the retractor blades. The retractor blades of the predicate devices are mounted on segmented flexible arms that allow the user to position the arms over a range of configurations in three dimensions. The retractor blades of the Karl Storz Scalp Dura Retractor are mounted to provide retraction configurations in a single plane. Differences in design exist to support the specific indication for use and do not raise any new issues of safety and effectiveness. For a summary of technological characteristics of the Karl Storz Scalp Dura Retractor as compared to the predicate devices, please refer to the attached substantial equivalence table.

#### Mechanical Testing:

The Karl Storz Scalp Dura Retractor demonstrated mechanical equivalence by a load deflection test, in which the device was loaded and the lateral deflection was measured. The deflection displacements were found to be substantially equivalent to the predicate Tew Cranial Spinal Retractor Model A as well as the Budde-Halo Retractor.

#### Reprocessing Instructions for Health Care Facilities:

The labeling for the Karl Storz Scalp Dura Retractor includes validated cleaning instructions and device sterilization by steam (pre-vacuum) for reprocessing in health care facilities in accordance with "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance (available at http://www.fda.gov/cdrh/ode/198.pdf) and AAMI TIR 12:2004, "Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers."

#### Determination of Substantlal Equivalence:

The Karl Storz Scalp Dura Retractor is substantially equivalent to the predicate devices. Where differences in performance or technology exist, it has been demonstrated that they do not adversely impact safety or effectiveness. In addition, the Karl Storz Scalp Dura Retractor has been tested to validate its use for the specific intended use of elevating dura and scalp layers away from cranial bone during endoscopic-assisted strip craniectomies. The Karl Storz Scalp Dura Retractor and its predicate devices are reusable and sterilizable non-powered, manual, adjustable, self-retaining retractors for use during neurosurgical procedures.

#### Conclusions:

The Karl Storz Scalp Dura Retractor is substantially equivalent to the identified predicate devices and does not raise any new issues of safety and efficacy.

Att: Substantial Equivalence Table for Karl Storz Scalp Dura Retractor

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SUBSTANTIAL EQUIVALENCE TABLE FOR KARL STORZ SCALP DURA RETRACTOR

| Manufacturer | Description | Material | Usability | Predicates | Intended Use |
|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Karl Storz:<br>Scalp Dura Retractor | Non-powered, manual, self-retaining retractor with handle-mounted retraction blades for retraction configurations in a single plane. | Stainless steel | Reusable, Sterilizable | See below | To elevate dura and scalp layers away from cranial bone during endoscopic-assisted strip craniectomies. |
| KLS-Martin, LP:<br>Grossman Self-Retaining Low<br>Profile Brain Retractor<br>(K060097) | Non-powered, manual, self-retaining retractor with retraction blades mounted on flexible segmented arms for retraction in any three-dimensional configuration. | Same | Same | Tew Cranial/Spinal<br>Retractor Model A 1090<br>(K960807)<br>Budde®-Halo Retractor<br>(K830332) | To retract soft tissue during neurosurgical procedures. |
| Ohio Medical Instrument Co.:<br>Tew Cranial/Spinal Retractor<br>Model A 1090<br>(K960807) | Non-powered, manual, self-retaining retractor with frame retractor for planar skin or muscle retraction and flexible micro-retractor arms for retraction in any three-dimensional configuration. | Same | Same | Karlin Crank Frame Spinal<br>Retractor Set (K882071)<br>Apfelbaum Cerebellar<br>Retractor<br>Budde®-Halo Retractor<br>(K830332) | For posterior fossa or intraspinal microsurgery where retraction is required. |
| Ohio Medical Instrument Co.:<br>Budde®-Halo Retractor<br>(K830332) | Non-powered, manual, self-retaining retractor with frame retractor to support flexible segmented retractor arms for retraction in any three-dimensional configuration | Same | Same | Unknown | For mounting and positioning flexible arms for retracting membranes, particularly of the brain, during surgical operations. |

STORZ

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of an eagle or bird with three wing-like strokes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Karl Storz Endoscopy-America, Inc. c/o Ms. Crystal (Dizol) Hagan Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245

### Re: K093054

Trade/Device Name: Scalp Dura Retractor, Model KS00474 Regulation Number: 21 CFR 882.4800 Regulation Name: Self-Retaining Retractor For Neurosurgery Regulatory Class: Class II Product Code: GZT Dated: November 5, 2010 Received: November 8, 2010

1 5 2010 NOV

Dear Ms. Hagan:

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. Iisting 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.

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Page 2 - Ms. Crystal (Dizol) Hagan

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Earle H. Knott

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

Enclosure

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Koy 3054

# INDICATIONS FOR USE

NOV 1 5 2010

## 510(k) Number (if known): Not yet assigned

Device Name: Karl Storz Scalp Dura Retractor

The Karl Storz Scalp Dura Retractor is intended for use to Indications for Use: elevate dura and scalp layers away from cranial bone during endoscopic-assisted strip craniectomies.

X Prescription Use: (21 CFR 801 Subpart C) (21 CFR 801 Subpart D)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

JEFFREY TOY __________________________________________________________________________________________________________________________________________________________________

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

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510(k) Number K093054