The SabreSource™ Drape is intended to help prevent contamination of the SabreSource™ device when used in the operating room or other surgical environments.
The SabreSource™ Drape is to be used in an operating room environment to cover the SabreSource™ device when it is mounted on an x-ray machine for procedures wherein it is deemed desirable to protect the SabreSource™ device from contamination with patient fluids or liquids.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SabreSource™ Drape. This is a medical device accessory and the submission focuses on its substantial equivalence to predicate devices, rather than establishing its performance through a study with acceptance criteria in the typical sense of a diagnostic or therapeutic device.

Therefore, the requested information for acceptance criteria and a study proving performance cannot be fully provided in the format requested, as that type of study was not conducted or required for this device. The information provided outlines the technological characteristics and intended use that form the basis for its substantial equivalence, which is the primary "proof" for this type of device.

Here's how to address the request based on the provided document:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for this device revolves around its ability to function as a sterile barrier and allow laser transmission, thereby being substantially equivalent to existing devices.

Acceptance Criterion (Implicit from description)	Reported Device Performance
1. Ability to prevent contamination of the SabreSource™ device.	Described as "a sterile plastic bag to cover the SabreSource™ Targeting System." The intended use explicitly states, "The SabreSource™ Drape is intended to help prevent contamination of the SabreSource™ device." This is inherent in its design as a sterile drape.
2. Allowing undistorted transmission of the laser beam.	"The drape contains an optically clear window shaped like a section of a hemisphere with a 30 cm radius that will allow undistorted transmission of the laser beam from the SabreSource™ to the patient."
3. Substantial equivalence to predicate devices (regarding safety and effectiveness).	"Any dimensional or design differences between the SabreSource™ Drape and the predicate devices are minor and raise no new issues of safety or effectiveness." The FDA's 510(k) clearance explicitly states the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

Study Details (Not applicable for this type of submission)

The provided document describes a 510(k) submission for a medical device accessory (a drape). For such devices, the primary "proof" is demonstrating substantial equivalence to existing legally marketed predicate devices, rather than conducting a controlled clinical study with specific acceptance criteria, sample sizes, and ground truth in the way one would for a diagnostic algorithm or a novel therapeutic device.

Therefore, the following information is not available or applicable from the provided text:

Sample size used for the test set and the data provenance: No test set or clinical study was mentioned or required for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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, as this is not an AI diagnostic device or one involving human reader performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-based device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context is established by the functional characteristics of the drape (sterility, optical clarity) and its equivalence to predicates.
The sample size for the training set: Not applicable, as this is not a machine learning/AI device.
How the ground truth for the training set was established: Not applicable.

In summary: The K041846 submission for the SabreSource™ Drape is a 510(k) premarket notification that relies on demonstrating substantial equivalence to predicate devices. The "proof" is in showing that its technological characteristics and intended use are similar to already approved drapes, and any differences raise "no new issues of safety or effectiveness." This type of submission does not typically involve the detailed performance studies, ground truth establishment, and expert reviews that would be required for a novel diagnostic or AI-powered device.

Summary

{0}------------------------------------------------

UG 2 6 2004

K041846 510(k) SUMMARY MINRAD INC. SabreSource™ Drape

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Contact Person

John McNeirney MINRAD INC. 847 Main Street Buffalo, NY 14203 Phone: (716) 855-1068 Facsimile: (716) 855-1078 Date Prepared December 19, 2003

Name of Device and Name/Address of Sponsor

SabreSource™ Drape

MINRAD INC. 847 Main Street Buffalo, NY 14203

Device Name

Trade Name:	SabreSource™ Drape
Common Names:	Equipment Cover, Equipment Drape
Classification Name:	Light Beam Patient Position Indicator AccessorySurgical Drape and Drape Accessories

Predicate Devices

Microtek Medical, Inc. - Large C-Arm Drape Product Number 4982 2) Contour Fabricators Number CFI-600, equipment drape 3) MINRAD INC. - DRTSTM Drape

Intended Use

The SabreSource™ Drape is intended to help prevent contamination of the SabreSource™ device when used in the operating room or other surgical environments.

Technological Characteristics and Substantial Equivalence

The SabreSource™ Drape is a sterile plastic bag to cover the SabreSource™ Targeting System. The drape contains an optically clear window shaped like a section of a hemisphere with a 30 cm radius that will allow undistorted transmission of the laser beam from the SabreSource™ to the patient. Any dimensional or design differences between the SabreSource™ Drape and the predicate devices are minor and raise no new issues of safety or effectiveness.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with three stylized lines representing its wings. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2004

Mr. John McNeirney Vice President and CTO MINRAD, Inc. 847 Main Street BUFFALO NY 14203

Re: K041846 Trade/Device Name: SabreSource™ Drape Model 301900 Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical drape and drape accessories

Regulatory Class: II Product Code: 79 KKX Dated: July 28, 2004 Received: July 30, 2004

Dear Mr. McNeirney:

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.

1f 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.

{2}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter watification. The FDA finding of substantial equivalence of your device to a legally promaticated 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 11 you deem office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other or other world to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

SabreSource™ Drape Indications for Use Statement

K041846

510(k) Number (if known):

This is an initial submission; no 510(k) number has been issued.

Device Name:

SabreSource™ Drape

Indications for Use:

The SabreSource™ Drape is to be used in an operating room environment to cover the SabreSource™ device when it is mounted on an x-ray machine for procedures wherein it is deemed desirable to protect the SabreSource™ device from contamination with patient fluids or liquids.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 C.F.R. 801.109)

(Division Sign-Off

Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.