The Tao Brush™ I.U.M.C. Endometrial Sampler has a working length of 26.9 centimeters and a 9.3 French outer sheath measuring 21.5 centimeters in length. The outer sheath slides forward and back to cover or expose the bristles of the brush and thus provides protection from contamination when inserting or removing the brush into/from the uterus for the collection of endometrial cell samples. The 9.5 French acrylonitrile butadiene styrene (ABS) ball tip allows for an atraumatic insertion of the device through the cervix and into the uterus. The nylon brush bristles cover a 3.5 centimeter length of the stainless steel wire shaft, near the distal tip, and form a brush diameter of 6 millimeters. Additionally, there are two indicators to aid physicians in the use of The Tao Brush" I.U.M.C. Endometrial Sampler. The first indicator is a notch on the handle of the device which allows the physician to track rotations of the brush while collecting endometrial cell samples. The second indicator is a black ink mark located on the outer sheath about 7 centimeters from the distal tip of the device. Through visual observation of this marker, the physician can more accurately gauge how far the brush has entered the uterus. The Tao Brush I.U.M.C. Endometrial Sampler is sterilized using ethylene oxide, packaged in a Tyvek® polyethylene peel-open pouch, and has a shelf life of three years. The device is intended for one time use.

AI/ML Overview

The provided text describes a medical device, the Tao Brush™ I.U.M.C. Endometrial Sampler, and its regulatory submission. It details performance testing conducted to demonstrate substantial equivalence to a predicate device, but does not describe a study involving detailed acceptance criteria for diagnostic performance, nor does it involve AI, human readers, or ground truth established by experts/pathology in the context of diagnostic accuracy.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to engineering and biocompatibility tests, not diagnostic performance.

Therefore, the requested information, specifically regarding diagnostic performance criteria, sample sizes for test/training sets, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth types related to diagnostic accuracy, cannot be extracted from this document, as it is not present. The device is a physical sampling tool, not a diagnostic algorithm.

However, I can extract the information that is present regarding the engineering acceptance criteria and the engineering studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance (for engineering/physical properties):

Acceptance Criteria Category	Reported Device Performance (Results)
Tensile Strength	Predetermined acceptance criteria were met (tensile force during proper clinical use should not fracture materials and bonds).
Torque	Predetermined acceptance criteria were met (torque applied during clinical use should not damage the device).
Bristle Retention	Predetermined acceptance criteria were met (bristle adhesion when subjected to forces expected during proper clinical use).
Biocompatibility	Proposed device is non-cytotoxic, non-sensitizing, and non-irritating.
Shelf life and Packaging Integrity	Package system and materials provide an acceptable sterile barrier and a three-year device sterility period.

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

Sample Size for Test Set: Not specified for any of the performance tests. The document mentions "testing" was performed, but does not provide specific numbers of units tested.
Data Provenance: Not specified. The tests were conducted internally or by a contracted lab to support the 510(k) submission.

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

Not applicable as the tests described are for physical device properties and biocompatibility, not for establishing diagnostic ground truth with expert review.

4. Adjudication method for the test set:

Not applicable.

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. This is a physical device, not an AI diagnostic tool.

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

No. This is a physical device.

7. The type of ground truth used:

For the physical tests, the "ground truth" would be the predetermined engineering and material specifications/standards and the pass/fail criteria established for each test (e.g., a certain force causes failure, or a certain level of cytotoxicity is unacceptable).

8. The sample size for the training set:

Not applicable. This is not a machine learning device.

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

Not applicable.

Summary

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

Image /page/0/Picture/2 description: This image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The image is a simple text block with the address information.

May 24, 2017

Cook Incorporated Ian Herman Regulatory Affairs Specialist. China Team 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402

Re: K170603

Trade/Device Name: Tao Brush™ I.U.M.C. Endometrial Sampler Regulation Number: 21 CFR§ 884.1100 Regulation Name: Endometrial Brush Regulatory Class: II Product Code: HFE Dated: February 28, 2017 Received: March 1, 2017

Dear Ian Herman:

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. 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.

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.

Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Image /page/1/Picture/9 description: The image shows the text "Charles Viviano -S" in a large, sans-serif font. The text is black and is set against a white background. The letters are evenly spaced and the text is easy to read. The "-S" is slightly smaller than the rest of the text.

For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K170603 Device Name

Tao Brush™ I.U.M.C. Endometrial Sampler

Indications for Use (Describe)

Indications for Use (Describe)
The Tao Brush™ I.U.M.C. Endometrial Sampler is used to obtain endometrial cytological and histological samples.

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

PSC Publishing Services (101) 443-6700 BF

|| -

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

Tao Brush™ I.U.M.C. Endometrial Sampler 21 CFR §807.92 Date Prepared: May 22, 2017

Submitted By:	Ian Herrman
	Cook Incorporated
	750 Daniels Way
	P.O. Box 489
	Bloomington, IN 47402
	Phone: (812) 339-2235 x104034
	Fax: (812) 332-0281

Device:

Submission:	Traditional 510(k) Premarket Notification
Trade Name:	Tao BrushTM I.U.M.C. Endometrial Sample
Common Name:	Brush, Endometrial
Classification Regulation:	21 CFR §884.1100, Product Code HFE
Device Classification:	Class II
Classification Name:	Endometrial Brush
Classification Panel:	Obstetrics/Gynecology

Predicate Devices:

The predicate device is the Tao Brush™ I.U.M.C. Endometrial Sampler cleared under 510(k) K082066.

Device Description:

{4}------------------------------------------------

which allows the physician to track rotations of the brush while collecting endometrial cell samples. The second indicator is a black ink mark located on the outer sheath about 7 centimeters from the distal tip of the device. Through visual observation of this marker, the physician can more accurately gauge how far the brush has entered the uterus. The Tao Brush I.U.M.C. Endometrial Sampler is sterilized using ethylene oxide, packaged in a Tyvek® polyethylene peel-open pouch, and has a shelf life of three years. The device is intended for one time use.

Indications for Use:

The Tao Brush™ I.U.M.C. Endometrial Sampler is used to obtain endometrial cytological and histological samples.

Comparison to Predicate Devices:

The predicate device is the Tao Brush™ I.U.M.C. Endometrial Sampler (K082066). The predicate device has not been subject to a design-related recall.

The subject and predicate device have the same intended use but different technological characteristics, namely material composition. The technological differences between the predicate and subject device do not raise any different questions of safety and effectiveness.

Performance Testing:

The following testing was performed in order to demonstrate that the Tao Brush" I.U.M.C. Endometrial Sampler met applicable design and performance requirements.

. Tensile Strength - Testing shows the tensile force during proper clinical use should not fracture the Tao Brush™ I.U.M.C. Endometrial Sampler materials and bonds. The results showed that the predetermined acceptance criteria were met.
Torque – Testing shows that torque applied to the device during clinical use should not damage the Tao Brush" I.U.M.C. Endometrial Sampler. The results showed that the predetermined acceptance criteria were met.
. Bristle Retention - As required in Section 3(ii) of 21 CFR 884.1100, testing was performed to assure bristle adhesion when subjected to forces expected during proper clinical use. The results showed that the predetermined acceptance criteria were met.
. Biocompatibility - Testing demonstrated that the proposed device is noncytotoxic, non-sensitizing, and non-irritating.

{5}------------------------------------------------

I Shelf life and Packaging Integrity – Testing demonstrates that the package system and materials provide an acceptable sterile barrier as well as a three year device sterility period.

Conclusion:

In conclusion, the results of these tests support a determination of substantial equivalence of the Tao Brush™ I.U.M.C. Endometrial Sampler to the predicate device.

Regulation Number and Section

§ 884.1100 Endometrial brush.

(a)
Identification. An endometrial brush is a device designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its surface. This device is used to study endometrial cytology (cells).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(2) Labeling:
(i) Indication: Only to evaluate the endometrium, and
(ii) Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and
(3) Design and testing:
(i) The sampling component is covered within the vagina, and
(ii) For adherence of the bristles and brush head.