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 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.

AI/ML Overview

The Karl Storz Scalp Dura Retractor is a medical device for neurosurgery. The provided document is a 510(k) summary for this device, seeking substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria with performance metrics.

However, based on the information provided, we can infer the "acceptance criteria" relate to mechanical equivalence and
reprocessing validation, and the "study" is the mechanical testing and reprocessing validation.

Here is an analysis based on the provided text:

1. Table of "Acceptance Criteria" and the Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Mechanical Equivalence	Device's load deflection properties should be substantially equivalent to predicate devices.	"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 Validation	Device must have validated cleaning instructions and sterilization methods for reprocessing in healthcare facilities, adhering to FDA and AAMI guidelines.	"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' and AAMI TIR 12:2004."
Intended Use	The device should be validated for its specific intended use of elevating dura and scalp layers away from cranial bone during endoscopic-assisted strip craniectomies.	"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." (Details of this testing are not provided in the summary).
Safety and Effectiveness	The device should not raise new issues of safety and effectiveness compared to predicate devices.	"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."

2. Sample Size Used for the Test Set and the Data Provenance:

Mechanical Testing (Load Deflection Test):
- Sample Size: Not explicitly stated in the summary how many units of the Karl Storz Scalp Dura Retractor were tested or how many units of the predicate devices were used for comparison.
- Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer. It is prospective testing of new device models.
Reprocessing Validation:
- Sample Size: Not explicitly stated, however, reprocessing validation typically involves multiple cycles of cleaning and sterilization
  on a representative number of devices to demonstrate efficacy and device integrity.
- Data Provenance: Not specified, but validation studies are generally conducted in a controlled laboratory environment by the manufacturer or a contracted third-party lab. It is prospective testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not provided in the 510(k) summary. Given the nature of the "studies" (mechanical testing and reprocessing validation), expert consensus in the traditional sense of clinical evaluation with human readers for ground truth would not be applicable. Mechanical and reprocessing tests rely on objective measurements against established standards.

4. Adjudication Method for the Test Set:

This information is not applicable as the "studies" described are not human reader-based evaluations requiring adjudication. Mechanical testing and reprocessing validation follow predefined protocols and measurement criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This document describes a medical device (a surgical retractor), not an AI-assisted diagnostic tool or system that would involve human readers and AI assistance for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, this is not applicable. The device is a manual surgical instrument, not an algorithm.

7. The Type of Ground Truth Used:

Mechanical Testing: The "ground truth" for mechanical equivalence was based on objective physical measurements (load deflection) and comparison to the performance characteristics of predicate devices, adhering to engineering principles and potentially relevant industry standards not detailed in this summary.
Reprocessing Validation: The "ground truth" was based on successful demonstration of cleaning efficacy (e.g., removal of biological soil to predefined levels) and sterility assurance (e.g., sterilization leading to a sterility assurance level of 10^-6), according to established regulatory guidance (FDA) and industry standards (AAMI TIR 12:2004).

8. The Sample Size for the Training Set:

Not applicable. This device is a manual surgical instrument, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As above, there is no "training set" for this type of device.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device. The "studies" focus on engineering and reprocessing validation rather than clinical performance that would involve human readers, AI, or traditional clinical endpoints for establishing ground truth from patient data.

Summary

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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 800 321 1304

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.2151 E. Grand AvenueEl Segundo, CA 90245-5017Phone: (424) 218-8381Fax: (424) 218-8519
Contact Person:	Crystal DizolRegulatory Affairs SpecialistEmail: cdizol@ksea.com
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:

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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: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:Grossman Self-Retaining LowProfile Brain Retractor(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/SpinalRetractor Model A 1090(K960807)Budde®-Halo Retractor(K830332)	To retract soft tissue during neurosurgical procedures.
Ohio Medical Instrument Co.:Tew Cranial/Spinal RetractorModel A 1090(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 SpinalRetractor Set (K882071)Apfelbaum CerebellarRetractorBudde®-Halo Retractor(K830332)	For posterior fossa or intraspinal microsurgery where retraction is required.
Ohio Medical Instrument Co.:Budde®-Halo Retractor(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 (800) 638-2041 or (301) 796-7100 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

JEFFREY TOY __________________________________________________________________________________________________________________________________________________________________

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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number K093054

Regulation Number and Section

§ 882.4800 Self-retaining retractor for neurosurgery.

(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).