The MRI Neuro Surgical Drape is intended to provide a sterile, disposable covering of the MRI instrumentation during surgical procedures conducted under MRI imaging. The Device Number is 100. Accessories: Grommet, grommet tool and trackball cover.

Device Description

The MRI Procedure Drape is composed of urethane film, polyethylene EVA copolymer film and polypropylene nonwoven material, creating a sterile barrier for a surgical procedure. The construction includes a suspension system that allows the clear film area to move with the patient as they are moved in and out of the MRI scanner bore.

AI/ML Overview

The provided text describes a 510(k) submission for the "SurgiVision MRI Neuro Surgical Drape and accessories." This submission focuses on establishing substantial equivalence to a predicate device for a medical drape, not an AI/ML-driven diagnostic or assistive device. Therefore, many of the requested categories related to AI performance, ground truth, expert opinions, and comparative effectiveness studies are not applicable to this document.

However, I can extract the information that is relevant to the device's acceptance criteria and the study that proves it meets those criteria based on the provided text.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied from testing)	Reported Device Performance
Sterilization	Positive outcomes
Shelf Life	Positive outcomes
Tensile Strength	Positive outcomes
Tear Resistance	Positive outcomes
Slow Rate Penetration	Positive outcomes
Flammability	Positive outcomes
MRI Safe	Yes
Sterile Barrier Function	Yes

Explanation: The document states, "Testing to applicable Standards has been completed with positive outcomes." The listed "Top level of testing performed" defines the performance characteristics that were evaluated and met. The "Description of Device" and "Intended Use Statement" also imply the requirement for a sterile barrier and MRI safety, both of which are addressed.

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for the performance tests (tensile, tear, flammability, etc.) or provide details on the data provenance (e.g., country of origin, retrospective/prospective). These are typically contained within the full test reports, which are not included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a surgical drape, not a diagnostic imaging device requiring expert interpretation for ground truth establishment. Performance testing for drapes typically involves laboratory measurements against established standards.

4. Adjudication method for the test set

Not applicable. As noted above, this involves laboratory performance testing, not subjective interpretation requiring adjudication.

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

Not applicable. This device is a surgical drape, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a surgical drape, not an algorithm.

7. The type of ground truth used

For the performance characteristics (sterilization, shelf life, tensile, tear, penetration, flammability), the "ground truth" would be the objective measurements against established performance standards for surgical drapes and materials. For "MRI Safe," the ground truth would be testing confirming compatibility with MRI environments.

8. The sample size for the training set

Not applicable. This device is a physical product, not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This device is a physical product, not a machine learning algorithm.

Summary

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09) 34 3

510(k) (Traditional) Submission Section 5, 510(k) Summary

Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the SurgiVision MRI Neuro Surgical Drape and accessories.

1. Company making the submission:

Name of Owner:	SurgiVision, Inc.
Address:	5 MusickIrvine, CA 92618
Telephone:	949-900-6833
Fax:	949-900-6834
Contact:	Edward Waddell
E-mail:	Ewaddell@surgivision.com
Correspondent:	J. Harvey Knauss
Address:	11984 South Evelyn CircleHouston, Texas 77071-3404
Telephone:	713-723-4080
Fax:	713-723-0786
E-mail:	harvey.knauss@gmail.com

Device Name: 2.

Common Name:	Surgical Drape andaccessories
Proprietary Name:	MRI Neuro SurgicalDrape and accessories
Regulation Number:	878.4370
Product Code:	KKX

Predicate Device: 3.

Surgical Concept Designs Surgical Drape, K081476

4. Intended Use Statement:

The MRI Procedure drape is intended to provide a sterile, disposable covering of the MRI instrumentation during surgical procedures conducted under MR imaging. The Device Number is 100. Accessories: Grommet, grommet tool and trackball cover.

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Description of Device: 5.

1. Summary of the technological characteristics of the device compared to the predicate device.

Characteristic	MRI Neuro Drape
Classification	21CFR 878.4370	21CFR 878.4370
Regulation
Product Code	KKX	KKX
PrescriptionDevice	Yes	Yes
Composition	PE and PP	PE
Sold Sterile	Yes	Yes
Sold Single Use	Yes	Yes
MRI Safe	Yes	Unknown

7. Testing:

Testing to applicable Standards has been completed with positive outcomes.

Top level of testing performed:

Sterilization and Shelf Life .
Performance Testing Bench, including tensile, tear resistance, slow . rate penetration and flammability

8. Rx or OTC:

The MRI Procedure Drape is an Rx prescription device per 21 CFR Subpart D.

9. Conclusions:

The MRI Procedure Drape is equivalent to the predicate device in the scope of practical application, effectiveness at this application, and ensuring the safety of its subject.

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K091343

The MRI procedure drape does not raise any new safety or effectiveness issues.

SurgiVision, Inc.

Edward Waddell

Edward Waddell Director of Quality and Regulatory

Date: 9/2/9

Section 5 510(k) Submission Page #

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.

SFP 2 2 2009

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

SurgiVision, Incorporated C/O Mr. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071

Re: K091343

Trade/Device Name: MRI Neuro Drape Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: September 2, 2009 Received: September 3, 2009

Dear Mr. Knauss:

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 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- Mr. Knauss

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/ucm1115809.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,

Anthony V. Martin

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K091343

Device Name: MRI Neuro Drape

Indications for Use: The MRI Neuro Surgical Drape is intended to provide a sterile, disposable covering of the MRI instrumentation during surgical procedures conducted under MRI imaging. The Device Number is 100. Accessories: Grommet, grommet tool and trackball cover.

/Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula M. Murphy, R.Q.

Olylgion Sian=Off) Division of Anesthestology, General Hospital Riadlion Control. Dental Devices

510(k) Number: K091343

Page 1 of 1

Section 4 510(k) Submission Page #

Indcations for use form.doc Delphi Consulting Group Houston, TX 77071

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.