(270 days)
The MatrixBrush™ Endometrial Sampler is used to obtain endometrial cells for microscopic examination and/or for microbiology cultures.
The MatrixBrush Endometrial Sampler is a sterile, single-use endometrial 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.
This document is a 510(k) summary for the MatrixBrush™ Endometrial Sampler. It establishes substantial equivalence to a predicate device based on non-clinical testing. Therefore, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria, specific study designs, or reader-based evaluations.
However, based on the provided text, I can infer and summarize the available information:
1. A table of acceptance criteria and the reported device performance:
The document mentions "in vitro testing to evaluate adherence of the bristles and brush head was completed" and states, "Non-clinical mechanical test results demonstrate the MatrixBrush performance is satisfactory and suitable for its intended use." It also states, "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."
Without access to the full submission or the specific test report, the explicit acceptance criteria are not detailed in this summary. The "reported device performance" is a general statement of satisfaction and suitability rather than specific quantitative metrics.
| Acceptance Criteria (Inferred from "suitability" and "satisfactory performance") | Reported Device Performance (Summary Statement) |
|---|---|
| Bristle adherence (specific quantitative metric not provided) | Evaluated and deemed "satisfactory" |
| Brush head adherence (specific quantitative metric not provided) | Evaluated and deemed "satisfactory" |
| Overall mechanical function for intended use (specific quantitative metric not provided) | Deemed "suitable for its intended use" |
| No new questions regarding safety and effectiveness compared to predicate device | No new safety and effectiveness questions raised |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified in the provided 510(k) summary. The document only mentions "in vitro testing."
- Data provenance: "In vitro testing" implies laboratory-based testing, not human or animal studies. No country of origin is specified for the data, but the submission is to the U.S. FDA by a U.S.-based company. The nature of the testing (in vitro) means it is not directly retrospective or prospective in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the "in vitro testing" described. The testing likely involved mechanical or material engineers evaluating physical properties, not medical experts establishing ground truth for diagnostic outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This type of adjudication method is used for resolving discrepancies in expert interpretations of diagnostic data, which is not what was performed in the "in vitro testing" mentioned.
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. The device is an endometrial sampler, not an AI diagnostic tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used:
For the "in vitro testing" mentioned, the "ground truth" would likely be engineering specifications, material standards, or established mechanical performance criteria for similar devices. It is not expert consensus, pathology, or outcomes data, as those relate to clinical diagnostic performance.
8. The sample size for the training set:
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device type.
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JUN 1 8 2012
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: (888) 943-6057 Fax: (888) 943-6058 Email: agillespie@pathadvantage.com
Submission Correspondent: QA Consulting, Inc. 9433 Bee Caves Road Building 1, Suite 140 Austin, TX 78733
Contact: Heather Crawford, Consultant Cell: (512) 297-6849 Office: (512) 328-9404 Fax: (512) 532-9434 hcrawford@qualityaustin.com 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 (800) 638-2041 or (301) 796-7100 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:
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
§ 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.