AWARE PAD

K991469 · Aac Consulting Group, Inc. · IYO · Jul 20, 1999 · Radiology

Device Facts

• Record ID: K991469
• Device Name: AWARE PAD
• Applicant: Aac Consulting Group, Inc.
• Product Code: IYO · Radiology
• Decision Date: Jul 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Aware™ Pad is indicated as an aid for performing breast self-examination.

Device Story

Aware™ Pad is a manual aid for breast self-examination. Device consists of a 9.5-inch diameter thin polyester polyurethane bladder containing silicone fluid. Used by patient during self-examination; pad is placed between fingers and breast tissue. Silicone fluid and flexible bladder design reduce friction between skin surfaces, facilitating tactile sensitivity during palpation. Device is non-electronic, non-powered, and mechanical in nature. No clinical data or automated processing involved.

Clinical Evidence

No clinical data.

Technological Characteristics

Thin polyester polyurethane bladder (9.5-inch diameter) containing silicone fluid. Mechanical device; no energy source, connectivity, or software. Designed for manual use to reduce friction during tactile breast examination.

Indications for Use

Indicated for individuals performing breast self-examination as an aid to the process.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Sensor Pad® (K973450)

Submission Summary (Full Text)

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## 510(k) SUMMARY

- This Summary was prepared in accordance with the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

| GENERAL INFORMATION: | | |
|----------------------|-----------------------------------------------------|-------------------|
| Establishment - | AAC Consulting Group, Inc. | |
| | 7475 Wisconsin Ave., Suite 850 | |
| | Bethesda, MD 20814 | |
| Contact Person: | Eduardo March, Senior Consultant | |
| | Teleph.- 301-986-4440 | Fax- 301-986-4448 |
| Device Name - | Aware ™ Pad | |
| Classification Name- | Mammographic X-ray Systems (CFR 892.1710), Class II | |

- ============================================================================================================================================================================== PERFORMANCE STANDARD: No mandatory performance or voluntary standards are applicable.
- ||| SUBSTANTIAL EQUIVALENCE: The Aware TM pad is substantially equivalent to a currently marketed device, the Sensor Pad® (K973450).

### 111 INDICATIONS FOR USE: The Aware™ Pad is indicated as an aid for performing breast self-examination.

#### TECHNOLOGICAL CHARACTERISTICS: IV

Aware TM Pad is a thin polyurethane bladder, 9.5 inches in diameter containing a small quantity of silicone fluid. The very thin nature of the polyester polyurethane allows the pad 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 bladder, provides easy sliding between the upper and lower surfaces of the bladder. Therefore, when properly used between the finger and the soft breast tissues of the patient, a reduction of friction is observed.

Prepared: 19 April 1999

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Image /page/1/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three faces in profile, one behind the other, with a stylized design below them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 20 1999

Mr. Eduardo March, RAC Senior Consultant AAC Consulting Group, Inc. 7575 Wisconsin Avenue, Suite 850 Bethesda, MD 20814

Re: K991469 Aware™ Pad Dated: April 26, 1999 Received: April 28, 1999 Regulatory Class: II 21 CFR §892.1560/Procode: 90 IYO

Dear Mr. March:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, 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 III (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, blease note the requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known): K 991469

Aware™ Pad Device Name:

## Indications for Use:

The Aware™ Pad is indicated as an aid for performing breast selfexamination.

vision Sign-Off)
vision of Reproductive, Abdominal, ENT,
nd Radiological Devices
510(k) Number K991469

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

Prescription Use: (Per 21 CFR 80.109)

OR

Over-the-Counter Use: