MATRIXBRUSH ENDOMETRIAL SAMPLER

K112763 · Post Oak Innovations, Inc. · HFE · Jun 18, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K112763
• Device Name: MATRIXBRUSH ENDOMETRIAL SAMPLER
• Applicant: Post Oak Innovations, Inc.
• Product Code: HFE · Obstetrics/Gynecology
• Decision Date: Jun 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1100
• Device Class: Class 2

Intended Use

The MatrixBrush Endometrial Sampler is used to obtain endometrial cells for microscopic examination and/or for microbiology cultures.

Device Story

MatrixBrush Endometrial Sampler is a sterile, single-use device for collecting endometrial tissue samples. It features a spirally twisted stainless steel core covered by plastic with marked gradations, a nylon brush head at the distal end, and an atraumatic plastic bulb to prevent penetration. A moveable plastic sheath covers the brush head and shaft. The device is operated by a clinician to collect cells for microscopic examination or microbiology cultures. The design facilitates safe tissue retrieval, with the atraumatic bulb protecting the patient during insertion and sampling.

Clinical Evidence

Bench testing only. In vitro testing was conducted to evaluate the adherence of the bristles and brush head to ensure safety and effectiveness.

Technological Characteristics

Sterile, single-use endometrial brush. Materials: stainless steel core, plastic covering, nylon brush head. Features: spirally twisted shaft with gradations, atraumatic plastic bulb, moveable plastic sheath. Mechanical device; no energy source or software.

Indications for Use

Indicated for obtaining endometrial cells for microscopic examination and/or microbiology cultures in patients requiring endometrial sampling.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Tao Brush™ I.U.M.C. Endometrial Sampler Cook Urological, Inc. (K082066)

Submission Summary (Full Text)

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JUN 1 8 2012

K112763

#### POST OAK 1 2 × N 0 V A T 1 0 N S

# Section 5. 510(k) Summary for MatrixBrush™ Endometrial Sampler

This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92(c).

Submission Post Oak Innovations, Inc. Sponsor: 909 Post Oak Street Austin, TX 78704

> Contact: Alexandra J. Gillespie, M.D., President Phone: [phone] Fax: [phone] Email: [e-mail]

Submission Correspondent: QA Consulting, Inc. 9433 Bee Caves Road Building 1, Suite 140 Austin, TX 78733

Contact: Heather Crawford, Consultant Cell: [phone] Office: [phone] Fax: [phone] [e-mail] Email:

Date Summary September 19, 2011 Prepared:

Device:

Common/Classification Name:

R

Regulation Number:

Classification:

Trade Name:

MatrixBrush™ Endometrial Sampler

Endometrial brush Product Code HFE

21 CFR § 884.1100

Class II

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#### POST OAK 1 N H G V A T I Q G & S

Predicate Device:

Tao Brush™ I.U.M.C. Endometrial Sampler Cook Urological, Inc. K082066

Device The MatrixBrush Endometrial Sampler is a sterile, single-use endometrial Description: tissue sampling device. The MatrixBrush shaft is comprised of a spirally twisted stainless steel core covered by plastic with marked gradations. A nylon brush head at the distal end of the device collects a tissue sample and an atraumatic plastic bulb located on the extreme distal end protects the patient from penetration. A moveable plastic sheath overlies the brush head and device shaft.

Intended Use: The MatrixBrush Endometrial Sampler is used to obtain endometrial cells for microscopic examination and/or for microbiology cultures.

As an element of demonstrating safety and effectiveness of the MatrixBrush Summary of Endometrial Sampler and substantial equivalence to the predicate device, in Non-Clinical Data Submitted: vitro testing to evaluate adherence of the bristles and brush head was completed.

Safety and Effectiveness: This premarket notification has demonstrated the differences between the MatrixBrush Endometrial Sampler and predicate device do not raise any questions regarding its safety and effectiveness. The subject and predicate device are substantially equivalent in terms of intended use and technological characteristics. Non-clinical mechanical test results demonstrate the MatrixBrush performance is satisfactory and suitable for its intended use. The MatrixBrush Endometrial Sampler is therefore determined to be substantially equivalent to the referenced predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

JUN 1 8 2012

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

Post Oak Innovations, Inc. % Ms. Heather Crawford, RAC Consultant QA Consulting, Inc. 9433 Bee Caves Road, Building 1, Suite 140 AUSTIN TX 78733

Re: K112763

> Trade/Device Name: MatrixBrush™ Endometrial Sampler Regulation Number: 21 CFR& 884.1100 Regulation Name: Endometrial brush Regulatory Class: II Product Code: HFE Dated: June 8, 2012 Received: June 11, 2012

#### Dear Ms. Crawford:

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. 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

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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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Evanko

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

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## Indications for Use

510(k) Number (if known):

Device Name:

K112763

MatrixBrush™ Endometrial Sampler

Indications for Use:

The MatrixBrush Endometrial Sampler is used to obtain endometrial cells for microscopic examination and/or for microbiology cultures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112763