(60 days)
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.
Thin plastic film with a preprinted numbered grid and orientation markings
The provided text describes a 510(k) premarket notification for a device named "SafeTouch," a Breast Exam Recording Sheet. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, the requested information regarding a formal study proving the device meets acceptance criteria is largely not present in the provided text.
Specifically, the document states: "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." This statement is a general claim about the device's characteristics and perceived benefits, not a report of a structured study with quantifiable acceptance criteria.
Below is an attempt to address your request based only on the information available in the provided text, highlighting where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reproducibility of findings (Location of breast lumps) | "The preprinted, numbered grid greatly improves the reproducibility of the findings." (No quantitative data on improvement or a specific acceptance threshold for reproducibility is provided). |
| Patient comfort and acceptance | "a soft, supple film is necessary for the performance of the device and for patient comfort and acceptance." (No specific acceptance criteria or study results on patient comfort/acceptance are provided). |
| Performance of the device (General functionality) | "a soft, supple film is necessary for the performance of the device." (This is a design characteristic, not a performance metric against a specific criterion). |
| Ability to use a new grid sheet with each examination | "allows for the use of a new grid sheet with each examination if desired by the examiner or the patient." (This is a feature description, not a performance outcome against a criterion). |
| Assistance in reproducibly representing location of lumps | The device is intended to "assist medical examiners in reproducibly representing the location of discovered breast lumps." (The document asserts its features contribute to this, but provides no data proving its effectiveness in meeting this goal against a specific threshold or comparison baseline, other than differentiating from the predicate in design features like the grid and orientation marks.) |
| Substantial Equivalence to Predicate Device (Docuform) | The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. This is the overarching "acceptance" criterion for 510(k) clearance, but it is a regulatory finding, not a demonstration of specific clinical performance against predefined metrics. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The text mentions "In our tests," suggesting internal evaluation, but provides no details on the number of cases or subjects involved.
- Data Provenance: Not specified. Given the nature of the claim ("In our tests"), it is likely internal and could be retrospective or prospective, but no details are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- No information provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. The document describes a comparison between SafeTouch and Docuform based on device features (preprinted grid, orientation marks, size, process for transferring marks), not a comparative effectiveness study involving human readers with and without AI assistance. The device itself is a physical recording sheet, not an AI system.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical tool intended to be used by humans, not an algorithm.
7. The Type of Ground Truth Used
- Not specified. Given the intended use, "discovered breast lumps," the ground truth would presumably relate to the actual, confirmed location of such lumps. However, how this was established for any "tests" is not detailed.
8. The Sample Size for the Training Set
- Not applicable/Not specified. This is a physical non-AI device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not specified.
Summary of Missing Information:
The provided 510(k) summary focuses on device description, intended use, and comparison to a predicate device to establish substantial equivalence. It does not provide details of a formal performance study with quantifiable acceptance criteria, sample sizes, expert involvement, or ground truth establishment. The mention of "In our tests" is qualitative and lacks the specific data points requested. This is typical for a Class I or unclassified device seeking 510(k) clearance, where substantial equivalence is often based on design features and intended use rather than extensive clinical performance data.
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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# 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.
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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.
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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 | (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
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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.
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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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§ 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.