SAFETOUCH

K014300 · James D Rusin MD, MBA · NHM · Mar 1, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K014300
• Device Name: SAFETOUCH
• Applicant: James D Rusin MD, MBA
• Product Code: NHM · Obstetrics/Gynecology
• Decision Date: Mar 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2990
• Device Class: Class 2

Intended Use

SafeTouch is intended as an aide in relocating points of interest discovered upon the human body, once they are found. A typical application would be to indicate the location of discovered human breast lumps.

Device Story

SafeTouch is a thin, supple plastic film featuring a preprinted numbered grid and orientation markings. During a physical examination, the clinician places the film over the patient's breast or body area containing a suspect lesion. The clinician marks the location of the lesion directly onto the film. The grid and orientation marks provide a reference system to improve the reproducibility of findings compared to freehand marking. The device is intended for use in clinical settings by medical examiners to document findings for patient records. It benefits patients by facilitating accurate tracking and relocation of discovered lumps over time.

Clinical Evidence

Bench testing only. Testing demonstrated that the supple film is necessary for performance and patient comfort, and that the preprinted numbered grid improves the reproducibility of findings.

Technological Characteristics

Thin, supple plastic film; preprinted numbered grid and orientation markings; manual application; non-powered; single-use.

Indications for Use

Indicated for use by medical examiners to assist in reproducibly representing the location of discovered breast lumps or other points of interest on the human body.

Regulatory Classification

Identification

A breast lesion documentation system is a device for use in producing a surface map of the breast as an aid to document palpable breast lesions identified during a clinical breast examination.

Special Controls

*Classification.* Class II (special controls). The device, when it is a breast examination recording sheet, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breast Lesion Documentation System.” See § 884.1(e) for the availability of this guidance document.

Predicate Devices

• Docuform (not 510(k) numbered)

Submission Summary (Full Text)

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K014300
Page 1 of 2

# MAR 1 2002

### 510(k) Summary

## Submitter and Contact Person

Dr. James D. Rusin MD, MBA 3512 Rum River Drive Anoka, MN 55303-1109 Cell# 612-242-8037 Fax# [phone] Submitted 12/15/01

### Device Name

Trade Name: SafeTouch Common Name: Breast Exam Recording Sheet Proprietary Name: SafeTouch Classification: None

### Equivalent Device

Docuform produced by Derma Solutions of Angola, IN

#### Device Description

Thin plastic film with a preprinted numbered grid and orientation markings

#### Intended Use

The device is intended to assist medical examiners in reproducibly representing the location of discovered breast lumps.

#### Device comparisons

Our device, SafeTouch, and the Docuform device have the same intended use. Each device incorporates the use of a supple place film to be place over the breast containing the suspect lesion. A mark is made upon each device over the suspect lesion in the breast.

SafeTouch is preprinted with orientation marks and a numbered grid.

Docuform contains no orientation marks and no grid.

In the case of Docuform, the mark on the supple film is transferred to a permanent firm plastic sheet, which is meant to become part of the patient's permanent record.

# Nonclinical Performance

In our tests, a soft, supple film is necessary for the performance of the device and for patient comfort and acceptance. The preprinted, numbered grid greatly improves the reproducibility of the findings and allows for the use of a new grid sheet with each examination if desired by the examiner or the patient.

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K014300
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i. SafeTouch utilizes preprinted marks for orientation, whereas Docuform relies upon examiners applying orientation marks 'freehand'.

ii. SafeTouch is larger than Docuform.

iii. Docuform incorporates a series of steps whereby the mark upon the supple film is transferred to a hard vinyl film, which becomes part of the permanent record.

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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features a stylized bird with three curved lines representing its wings. The bird is facing to the right. Encircling the bird is text that reads "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2002

Dr. James D. Rusin MD, MBA 3512 Rum River Drive ANOKA MN 55303-1109

Re: K014300

Trade/Device Name: SafeTouch Breast Exam Recording Sheet Regulation Number: None Regulatory Class: Unclassified Product Code: 85 NHM Dated: December 20, 2001 Received: December 31, 2001

Dear Dr. Rusin:

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 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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1_of_1_

610(k) Number: K014300

Device Name:__SafeTouch Breast/Body Recording Sheet

Indications For Use:SafeTouch is intended as an aide in relocating points of interest discovered upon the human body, once they are found. A typical application would be to indicate the location of discovered human breast lumps.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Daniel G. Eyman

dominal

Prescription Use . (Per 21 CFR 801.109) V

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