(108 days)
Not Found
No
The device description and summary of performance studies focus on the mechanical aspects of sample collection and standard testing, with no mention of AI or ML.
No.
The device is used to obtain cytological and histological samples, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is used to obtain cytological and histological samples from the endometrium. These samples are then analyzed to diagnose conditions.
No
The device description clearly describes a physical brush assembly, shaft, and sheath, indicating it is a hardware device for obtaining samples.
Based on the provided information, the Tao Brush™ I.U.M.C. Endometrial Sampler is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain endometrial samples (cytological and histological). It is a tool for sample collection.
- Device Description: The description focuses on the physical components and function of the device for collecting the sample.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis, testing, or interpretation of the collected sample to diagnose a condition. IVDs are designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes.
The Tao Brush is a medical device used for sample collection, which is a step that precedes potential in vitro diagnostic testing of the collected sample.
N/A
Intended Use / Indications for Use
Used to obtain endometrial cytological and histological samples.
Product codes (comma separated list FDA assigned to the subject device)
HFE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
endometrial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Foote
Regulatory Affairs Specialist
Cook Urological, Incorporated
1100 West Morgan Street
Spencer, IN 47460
July 31, 2008 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Device: | |
| Trade Name: | Tao Brush™ I.U.M.C. Endometrial Sampler |
| Proposed Classification Name: | Brush, Endometrial
21 CFR Part 884.1100
Class 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.
1
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.
2
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
3
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