(60 days)
Not Found
Not Found
No
The device description and performance studies indicate a simple physical film with a grid, with no mention of computational or learning capabilities.
No.
The device is intended as an aid in relocating points of interest, not for treating a condition or disease.
No
The intended use states that the device is an aide in relocating points of interest once found, not for the initial detection or diagnosis.
No
The device description explicitly states it is a "Thin plastic film with a preprinted numbered grid and orientation markings," indicating it is a physical, hardware-based device, not software.
Based on the provided information, the SafeTouch 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. They are used to provide information for diagnosis, monitoring, or screening.
- SafeTouch Function: The description of SafeTouch clearly states its intended use is as an "aide in relocating points of interest discovered upon the human body." It's a physical tool (a thin plastic film with a grid) used externally on the body to mark locations.
- No Sample Analysis: There is no mention of SafeTouch analyzing any biological samples from the patient. It doesn't perform any tests on bodily fluids or tissues.
Therefore, SafeTouch falls outside the scope of an In Vitro Diagnostic device. It's a physical marking tool used for anatomical localization.
N/A
Intended Use / Indications for Use
The device is intended to assist medical examiners in reproducibly representing the location of discovered breast lumps.
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.
Product codes
85 NHM
Device Description
Thin plastic film with a preprinted numbered grid and orientation markings
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast / Human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical examiners
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)
Not Found
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.
Not Found
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
§ 884.2990 Breast lesion documentation system.
(a)
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.(b)
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.
0
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# 763-712-8706 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.
1
K014300
Page 2 of 2
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.
2
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.
3
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
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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