(368 days)
Not Found
No
The description focuses on pressure sensing and image generation based on tactile data, with no mention of AI/ML algorithms for analysis or interpretation.
No.
The device is intended to produce a surface pressure map as an aid in documenting palpable breast lesions. It does not treat or cure any condition, which is a characteristic of therapeutic devices.
Yes
The device is described as an aid in documenting palpable breast lesions identified during a clinical breast examination, which helps in the diagnostic process. It collects tactile data to generate images and provide information on a lesion's size, shape, and hardness, all of which contribute to characterization of a potential abnormality.
No
The device description explicitly states it includes a "rechargeable, battery-powered hand-held wand (sensor unit)" which is a hardware component used to collect data. It also mentions a "calibration and training phantom," a "scale," and a "holder for the wand," all of which are hardware.
Based on the provided information, the SureTouch Mobile Pressure Mapping System 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.
- SureTouch's function: The SureTouch system works by applying pressure to the surface of the breast and creating a pressure map. It is a physical examination aid, not a test performed on a biological sample taken from the body.
The device is used in conjunction with a clinical breast examination, which is a physical examination technique. It provides additional information about palpable lesions but does not analyze biological material.
N/A
Intended Use / Indications for Use
The SureTouch Mobile Pressure Mapping System is intended to produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breast examination. The SureTouch Mobile Pressure Mapping System is intended for use by a qualified healthcare professional trained in its use and is not for home use.
Product codes (comma separated list FDA assigned to the subject device)
NKA
Device Description
The SureTouch Mobile Pressure Mapping System ("SureTouch") is a computer-based device that produces a pressure map, called a tactile image, of specific areas of the breast as an aid to document lesions detected during a clinical breast exam. SureTouch utilizes a rechargeable, battery-powered hand-held wand (sensor unit) that incorporates a 30 x 40 mm array of pressure sensing elements to collect tactile data as the device is moved across the breast. Data collected using the wand are wirelessly transferred to the tablet display where they are used to generate tactile images and provide information on a lesion's size, shape and hardness. The final report includes a tactile image of each lesion along with its user inputted location. The SureTouch System also includes a calibration and training phantom, a scale to ensure correct force applied during calibration procedures, and a holder for the wand.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Tactile pressure mapping
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified healthcare professional trained in its use / Not for home use.
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)
- Software information that met the recommendations for a minor level of concern software per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Cybersecurity information that met the recommendations in the FDA guidance document, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
- Electrical safety testing per ANSI/AAMI EN60601-1:2006+A11:2013+A12:2014.
- Electromagnetic compatibility testing per IEC 60601-1-2:2007 (3rd edition).
- Wireless technology information that met the recommendations in the FDA guidance document "Radio Frequency Wireless Technology in Medical Device."
- Intra and inter-observer, and inter-system accuracy and reproducibility testing as described in the FDA "Class II Special Controls Guidance Document: Breast Lesion Documentation System." Testing met all acceptance criteria.
- Force gauge validation: Testing to assess the accuracy and reproducibility of the force gauge shown on the device display that is used for device calibration and to assess force applied during an exam. Testing met all acceptance criteria.
- Algorithm output sensitivity: Testing to assess sensitivity of the device algorithms to calibration errors. Testing met all acceptance criteria.
- Phantom testing:
- Testing to assess accuracy of sensor measurement when placed under a uniform calibration force as compared to calibration force applied using the phantom and scale. Testing met all acceptance criteria.
- Testing to demonstrate that aging of the calibration and training pad did not impact device calibration results. Testing met all acceptance criteria.
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.
BreastView Visual Mapping System (DEN020001)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it.
June 28, 2019
Sure, Inc. Laurence Harvey Senior Quality Engineer Certified Compliance Solutions 11665 Avena Place, Suite 203 San Diego, CA 92128
Re: K181672
Trade/Device Name: SureTouch Mobile Pressure Mapping System Regulation Number: 21 CFR§ 884.2990 Regulation Name: Breast Lesion Documentation System Regulatory Class: II Product Code: NKA Dated: May 17, 2019 Received: May 28, 2019
Dear Laurence Harvey:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181672
Device Name SureTouch Mobile Pressure Mapping System
Indications for Use (Describe)
The SureTouch Mobile Pressure Mapping System is intended to produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breast examination. The SureTouch Mobile Pressure Mapping System is intended for use by a qualified healthcare professional trained in its use and is not for home use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K181672 - SureTouch Mobile Pressure Mapping System
| Submitter: | Sure, Inc |
|---|---|
| Address: | 1404 Granvia Altamira |
| Palos Verdes Estates, CA. 90274 | |
| Phone number: | (833) 787-3642 |
| Contact person: | David Ables, CTO |
| Phone number: | (833) 787-3642 x 701 |
| Date prepared: | June 25, 2019 |
| Trade name: | SureTouch Mobile Pressure Mapping System |
| Common Name: | Documentation System for Breast Lesions |
| Regulation Number: | 21 CFR 884.2990 |
| Regulation Name: | Breast Lesion Documentation System |
| Product Code: | NKA (System, Documentation, Breast Lesion) |
| Regulatory Class: | Class II |
Predicate Device: BreastView Visual Mapping System (DEN020001). This predicate device has not been subject to any design related recalls.
Device Description:
The SureTouch Mobile Pressure Mapping System ("SureTouch") is a computer-based device that produces a pressure map, called a tactile image, of specific areas of the breast as an aid to document lesions detected during a clinical breast exam. SureTouch utilizes a rechargeable, battery-powered hand-held wand (sensor unit) that incorporates a 30 x 40 mm array of pressure sensing elements to collect tactile data as the device is moved across the breast. Data collected using the wand are wirelessly transferred to the tablet display where they are used to generate tactile images and provide information on a lesion's size, shape and hardness. The final report includes a tactile image of each lesion along with its user inputted location. The SureTouch System also includes a calibration and training phantom, a scale to ensure correct force applied during calibration procedures, and a holder for the wand.
Indications for Use:
The SureTouch Mobile Pressure Mapping System is intended to produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breast examination. The SureTouch Mobile Pressure Mapping System is intended for use by a qualified healthcare professional trained in its use and is not for home use.
4
| Parameter | Subject Device
SureTouch System
K181672 | Predicate Device
BreastView Visual
Mapping System
(DEN020001) | Comparison |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The SureTouch
Mobile Pressure
Mapping System is
intended to produce a
surface pressure map
of the breast as an
aid in documenting
palpable breast
lesions identified
during a clinical
breast examination.
The SureTouch
Mobile Pressure
Mapping System is
intended for use by a
qualified healthcare
professional trained
in its use and is not
for home use. | The Breast View
Visual Mapping
System is intended
for use in producing
a surface map of the
breast as an aid to
document palpable
breast lesions
identified during a
clinical breast
examination. | The subject and
predicate devices
have the same
intended use. |
| Sensor | Handheld sensor unit
containing a 30 x 40
mm rectangular array
of 192 sensors. | Handheld sensor unit
containing a 25 x 40
mm array of 416
sensors. | Different – The
predicate device has a
greater number of
sensors than the
subject device.
Differences in sensor
numbers do not raise
different questions of
Safety and
Effectiveness (S&E) |
| Display | Android-based
touchscreen tablet
that controls device
functions and
displays exam
information. | Windows-based PC
that controls device
functions and
displays exam
information. | Different - The
subject and predicate
devices use different
display types. This
difference does not
raise different
questions of S&E. |
| Calibration/Training
Pad and Scale | Yes – pad includes
simulated lesions for
training and is also | No | Different - The
subject device is
provided with a |
| | used for device
calibration in
conjunction with the
provided scale. | | standalone pad and
scale that are used for
calibrating the device.
These differences do
not raise different
questions of S&E. |
| Lesion
Documentation | Lesion size,
hardness, shape and
user-inputted
location | Lesion size, stiffness,
shape, and location. | Different – The
predicate device
includes an automated
lesion location
position system that is
not part of the subject
device that requires
the user to manually
identify the location
of a specific lesion on
the display screen.
This difference does
not raise different
questions of S&E. |
| Detectable Lesion
Size | 5mm to 25x 35 mm | 5-40 mm | Similar |
| Disposable Sheath
and Lotion Use | Device to be used
with a polyurethane
sheath and lotion.
Specifications for
suitable,
commercially-
available sheaths and
lotion provided in
labeling | Device to be used
with a polyurethane
sheath and lotion. | Same |
Comparison of Subject and Predicate Devices:
5
As shown above, the indications for use of the subject and predicate devices are not identical; however, their intended uses are the same (i.e., documenting palpable breast lesions detected during a clinical breast exam).
Regarding technological characteristics, the subject and predicate devices have similarities in their general designs. However, differences do exist as described in the table above (e.g., sensor number, display types, etc.). The differences identified do not raise different questions of safety and effectiveness as compared to the predicate device as stated in the table.
Performance Testing:
The following tests have been conducted to ensure reliable design and performance under the specified testing parameters. These tests include:
6
- . Software information that met the recommendations for a minor level of concern software per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Cybersecurity information that met the recommendations in the FDA guidance document, . "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
- Electrical safety testing per ANSI/AAMI EN60601-1:2006+A11:2013+A12:2014 .
- Electromagnetic compatibility testing per IEC 60601-1-2:2007 (3rd edition) .
- Wireless technology information that met the recommendations in the FDA guidance ● document "Radio Frequency Wireless Technology in Medical Device."
- . Intra and inter-observer, and inter-system accuracy and reproducibility testing as described in the FDA "Class II Special Controls Guidance Document: Breast Lesion Documentation System." Testing met all acceptance criteria.
- Force gauge validation: Testing to assess the accuracy and reproducibility of the force gauge ● shown on the device display that is used for device calibration and to assess force applied during an exam. Testing met all acceptance criteria.
- Algorithm output sensitivity: Testing to assess sensitivity of the device algorithms to ● calibration errors. Testing met all acceptance criteria.
- Phantom testing:
- Testing to assess accuracy of sensor measurement when placed under a uniform O calibration force as compared to calibration force applied using the phantom and scale. Testing met all acceptance criteria.
- Testing to demonstrate that aging of the calibration and training pad did not impact o device calibration results. Testing met all acceptance criteria.
Conclusion:
The results of the performance testing described above demonstrates that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.