(84 days)
Not Found
No
The device description and lack of mentions of AI/ML, image processing, training/test sets, or performance metrics strongly suggest it is a simple mechanical aid.
No.
The device is indicated as an aid for performing breast self-examinations, which is a screening or diagnostic tool, not a therapeutic intervention.
No
The device is described as an aid for performing breast self-examinations, which helps reduce friction to make lumps more palpable. It does not independently diagnose conditions.
No
The device description clearly states it is a physical glove containing fluid, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SensaTouch™ Function: The SensaTouch™ is a physical aid used externally on the breast to reduce friction during a self-examination. It does not analyze any biological samples taken from the body.
The device description and intended use clearly indicate it's a physical tool for tactile examination, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The SensaTouch™ - Breast Self-Exam Glove is indicated as an aid for performing breast selfexaminations.
SensaTouch™ is indicated as an aid for performing breast self-examinations.
Product codes
90 IYO
Device Description
The SensaTouch™ - Breast Self-Exam Glove is a very thin double wall polyurethane glove, 8 inches in diameter containing a small quantity of colored lubricating fluid. The very thin nature of the polyester polyurethane allows the glove to conform to the shape of the tissues underlying it. The very low coefficient of friction property of the silicone fluid in combination with the very thin and flexible glove, provides easy sliding between the upper and lower surfaces of the glove. Therefore, when properly used between the fingers and the soft breast tissues of the patient, a reduction of friction is observed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Premarket Notification Santé Féminine Limited- SensaTouch™ August 13, 2004
Section IX K042250 510 (k) Summary
This Summary was prepared in accordance with the Safe Medical Devices Act of 1990 and 21 CFR 807.92
1. General Information
NOV : 2 2004
- . Device Name and Classification
SensaTouch™ - Breast Self-Exam Glove
21 CFR 892.1710 "Mammographic x-ray System (accessory)"
Class II
- . Contact Name and Address
Charity Martin Santé Féminine Limited 4859 Martin Court - Suite #5 Smyrna, GA 30082
2. Performance Standard
No mandatory or voluntary standards are applicable.
3. Substantial Equivalence
The SensaTouch™ - Breast Self-Exam Glove is substantially equivalent to the currently marketed OTC devices, Sensor Pad (K973450), My Breast Friend (K023390), and Aware Pad (K991469).
4. Indications for Use
The SensaTouch™ - Breast Self-Exam Glove is indicated as an aid for performing breast selfexaminations.
5. Technological Characteristics
The SensaTouch™ - Breast Self-Exam Glove is a very thin double wall polyurethane glove, 8 inches in diameter containing a small quantity of colored lubricating fluid. The very thin nature of the polyester polyurethane allows the glove to conform to the shape of the tissues underlying it. The very low coefficient of friction property of the silicone fluid in combination with the very thin and flexible glove, provides easy sliding between the upper and lower surfaces of the glove. Therefore, when properly used between the fingers and the soft breast tissues of the patient, a reduction of friction is observed.
Date Prepared 13 August 2004
1
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines extending from its body, representing the department's mission to protect and promote the health and well-being of Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 2004
Aluna Management Co., LLC • % Ms. Charity Martin Operations Engineer Santé Féminine Limited . 4859 Martin Ct., Suite #5 SMYRNA GA 30082
Re: K042250
Trade/Device Name: SensaTouch™ Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system
Regulatory Class: II Product Code: 90 IYO Dated: August 13, 2004 Received: August 20, 2004
. Dear Ms. Martin:
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 (Premarket Approval), 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.
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.
2
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Premarket Notification Santé Féminine Limited- SensaTouch™ August 13, 2004
SECTION VII. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): 042250
Device Name: _ SensaTouch™
Indications for Use:
SensaTouch™ is indicated as an aid for performing breast self-examinations.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Hogdon
(Division Sign-Off)
(Division Sign-C Division of Reproductive, Abdominal, and Radiological Device
510(k) Number