(108 days)
Used to obtain endometrial cytological and histological samples.
The Tao Brush™ I.U.M.C. Endometrial Sampler is a brush assembly fitted inside a shaft. A coaxial sheath promotes sample protection and there are positioning marks on the end of the shaft. The brush head procures and adequate representative sample of the endometrial and the tip protects the patient from abrasion. The devices are provided sterile and are intended for one time use.
The provided text describes the 510(k) submission for the Tao Brush™ I.U.M.C. Endometrial Sampler. However, it does not contain specific details about acceptance criteria, a dedicated study proving device performance against such criteria, sample sizes for test or training sets, data provenance, expert qualifications for ground truth, adjudication methods, or MRMC comparative effectiveness studies. The submission states that "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards. Testing data and information is included in this submission," but the actual data and methodology are not included in the provided snippets.
Therefore, the following information is based only on what is explicitly stated or can be inferred from the provided text. Many fields will be marked as "Not provided in the text."
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided text does not explicitly define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present a table of reported device performance against such criteria for the Tao Brush™ I.U.M.C. Endometrial Sampler. It generally states that "performance testing" was conducted.
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not explicitly stated (implied: compliance with FDA guidance and international standards) | Performed (details not provided) |
| Sterility | Not explicitly stated (implied: compliance with FDA guidance and international standards) | Performed (details not provided) |
| Performance (general sampling efficacy) | Not explicitly stated (implied: adequate representative sample retrieval) | "procures an adequate representative sample of the endometrial" (from device description); Performance testing performed (details not provided) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not provided.
- Data Provenance: Not provided. The text only states that testing was performed, but doesn't mention the country of origin of data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication method for the test set
- Adjudication Method: Not provided.
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
- MRMC Study: No. This device is an endometrial sampler, a physical medical device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: Not applicable. This is a physical sampling device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated for performance testing. Given the device's purpose ("used to obtain endometrial cytological and histological samples"), the ground truth for evaluating sampling efficacy would typically involve laboratory analysis (e.g., pathology reports) of the procured samples, but this is an inference, not directly stated.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable. This is a physical device, not an AI algorithm.
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Tao Brush™ I.U.M.C. Endometrial Sampler STED 510(k) submission Cook Urological, Incorporated July 31, 2008
NOV - 7 2008
510(k) SUMMARY
| Submitted by: | Cindy FooteRegulatory Affairs SpecialistCook Urological, Incorporated1100 West Morgan StreetSpencer, IN 47460July 31, 2008 |
|---|---|
| Device: | |
| Trade Name: | Tao Brush™ I.U.M.C. Endometrial Sampler |
| Proposed Classification Name: | Brush, Endometrial21 CFR Part 884.1100Class II, HFE |
Predicate Devices:
The Tao Brush™ I.U.M.C. Endometrial Sampler is identical to the Tao Brush™ I.U.M.C. Endometrial Sampler (version 1, K941298) in design, materials of construction, and cytological sampling. The Tao Brush™ I.U.M.C. Endometrial Sampler is similar to the Pipelle™ by CooperSurgical (K881456), in regards to histological sampling.
Device Description:
The Tao Brush™ I.U.M.C. Endometrial Sampler is a brush assembly fitted inside a shaft. A coaxial sheath promotes sample protection and there are positioning marks on the end of the shaft. The brush head procures and adequate representative sample of the endometrial and the tip protects the patient from abrasion. The devices are provided sterile and are intended for one time use.
Substantial Equivalence:
The Cook® Cervical Ripening Balloon is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.
Test Data:
Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards. Testing data and information is included in this submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of the usual one.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2008
Ms. Cindy Footc Regulatory Affairs Specialist COOK® Urological 1100 W. Morgan Street SPENCER IN 47460
Re: K082066
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: September 30, 2008 Received: October 1, 2008
Dear Ms. Foote:
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 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.
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Page 2
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jorgu Mzhang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Tao Brush™ I.U.M.C. Endometrial Sampler STED 510(k) submission Cook Urological, Incorporated July 31, 2008
Indications for Use
510(k) Number (if known):_ KO82066 __
Name of Device:
Tao Brush™ I.U.M.C. Endometrial Sampler
Indications for Use:
Used to obtain endometrial cytological and histological samples.
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)
Hels Remer
Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number
Company Confidential Cook Urological
§ 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.