iBreastExam
Device Facts
| Record ID | K190575 |
|---|---|
| Device Name | iBreastExam |
| Applicant | Ue Lifesciences, Inc. |
| Product Code | NKA · Obstetrics/Gynecology |
| Decision Date | Jul 16, 2019 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 884.2990 |
| Device Class | Class 2 |
Indications for Use
iBreastExam Gen II device is intended to produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breast exam. iBreastExam Gen II device is intended for use by a qualified healthcare professional trained in its use and is not for home use.
Device Story
iBreastExam Gen II is a visual mapping system for documenting palpable breast lesions. The device consists of a handheld scanhead with an array of 648 capacitive pressure sensors and a computer system running iBEConnect software. During a clinical breast exam, the operator moves the scanhead over the breast; the sensors measure tissue elasticity via micro-palpations. Resistance offered by tissue is converted to voltage, which the software translates into a surface pressure map. Stiff areas (potential lesions) are displayed in red, while fatty/glandular tissue is displayed in green. The system provides software-based positioning guidance. The output is a tactile map used by the clinician to document lesion size, shape, and location. The device is a documentation tool, not a diagnostic device; clinical decisions must rely on standard diagnostic exams like ultrasound or mammography. It benefits patients by providing a standardized record of palpable findings.
Clinical Evidence
No clinical data. Evidence consists of bench testing using silicone phantoms to evaluate inter-observer, intra-observer, and inter-system accuracy and reproducibility for measuring lesion size, shape, and stiffness. Testing demonstrated that the device produces accurate and reproducible results. Electrical and mechanical safety and electromagnetic compatibility were verified against IEC 60601-1 and IEC 60601-1-2 standards.
Technological Characteristics
Handheld scanhead with 648 capacitive pressure sensors; 40mm x 35mm array size. Battery-powered during use. Patient-contacting material: ABS. Non-sterile. Connectivity: Bluetooth wireless to computer. Software: iBEConnect for data acquisition, visualization, and reporting. Cleaning: 70% isopropyl alcohol wipes.
Indications for Use
Indicated for use by trained healthcare professionals to document palpable breast lesions identified during clinical breast exams. Not for home use.
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
- iBreastExam (K142926)
Submission Summary (Full Text)
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July 16, 2019
UE LifeSciences Inc. Mihir Shah CEO 3401 Market St. Suite 200 Philadelphia, PA 19104
Re: K190575/S001 Trade/Device Name: iBreastExam Gen II Regulation Number: 21 CFR 884.2990 Regulation Name: Breast Lesion Documentation System Regulatory Class: II Product Code: NKA Dated: June 11, 2019 Received: June 12, 2019
Dear Mihir Shah:
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.
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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); 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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 medical devices and radiation-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 Andrews Assistant Division 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
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# Indications for Use
510(k) Number (if known) K190575
Device Name iBreastExam Gen II
Indications for Use (Describe)
iBreastExam Gen II device is intended to produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breastExam Gen II device 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) | |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------|
| <div> <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
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# 510(k) SUMMARY iBreastExam Gen II (K190575)
| Submitter's Name: | UE LifeSciences Inc. |
|-------------------|----------------------------------------------------|
| Address: | 3401 Market St, Suite 200<br>Philadelphia PA 19104 |
| Contact Person: | Mihir Shah |
Tel: 631.980.8340 Email: info@uelifesciences.com Date Prepared: July 16, 2019
| Product Trade Name | iBreastExam Gen II |
|-----------------------|------------------------------------------------------------------------------------------------------|
| Classification Number | 21 CFR 884.2990 |
| Classification Name | Breast Lesion Documentation System |
| Product Code | NKA |
| Regulatory Class | Class II |
| Predicate Device(s) | iBreastExam (K142926)<br>The predicate device has not been subject to any design related<br>recalls. |
## Description of the Device
iBreastExam Gen II is a visual mapping system, intended to produce a surface pressure map of the breast as an aid in documenting breast lesions identified during a clinical breast exam. The use of iBreastExam Gen II does not involve the use of any ionizing radiation.
## Technological Characteristics:
The iBreastExam Gen II system consists of a group of hardware and software components. The hardware component(s) consist of:
- iBreastExam Gen II Scanhead
- . Computer System
- USB Wall Charger and Charging Cables
The software component(s) consist of:
- iBEConnect Software Program .
### Key Components and Functions:
| Component | Function |
|-----------------------------|------------------------------------------------------------------------------|
| iBreastExam Gen II Scanhead | To collect size, location, shape and stiffness data from the breast surface. |
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| Computer System | To receive, store, display and print lesion documentation data. |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| USB Wall Charger and<br>Charging Cables | To recharge the iBreastExam Gen II Scanhead and the Computer<br>System. |
| iBEConnect<br>Software Program | To provide a user with the ability to create tactile map of the breasts.<br>The software also provides an interface with the database in the<br>system and the ability to add, modify, retrieve and delete patient<br>and exam data including the tactile maps. The software can also be<br>used to generate reports. |
#### Table 1: Key components and functions
Device Characteristics:
| • | Use Type: | Repeat Use |
|---|------------------------------|----------------------------|
| • | Sterilization: | Non-sterile |
| • | Software: | Yes |
| • | Coatings/Additives: | No |
| • | Power Sources: | Battery Powered during use |
| • | Patient Contacting Material: | ABS |
| • | Type of Contact: | Skin surface (breast) |
| • | Duration of contact: | 5-10minutes |
- Physician's Office, Hospital, Primary Care ● Environment of use:
The device is intended to produce a surface pressure map of the breast as an aid in documenting size, shape, and location of breast lesions identified during a clinical breast exam. It is a documentation tool. It is not intended for diagnosis. The device should only be used to document a lesion already palpated on clinical breast exam. Clinical management decisions should only be made on the basis of the clinical and diagnostic examinations (e.g. ultrasound or mammography). If there is a disagreement between the examination and the record produced by the device, decisions should be made on the basis of the clinical examination.
### Sterilization and Shelf Life:
The iBreastExam Gen II device does not have any sterilization requirements. The scanhead should be cleaned and disinfected by wiping twice with medical grade alcohol wipes (70% Isopropyl Alcohol) before and after each use. The iBreastExam Gen II system does not require any special storage conditions for the device. The storage conditions do not affect the device safety or effectiveness. The device does not have any specific shelf-life.
## Principle and Theory of Operation:
iBreastExam Gen II system consists of a Scanhead which houses an array of capacitive pressure sensors. These pressure sensors measure tissue elasticity by making micro-palpations on the surface of the breasts and by differentiations in tissue stiffness. In that, the hard or
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stiff areas will produce a response (depicted by red color on computer screen) as compared to fatty, glandular breast tissue (depicted by green color on computer screen). The amount of resistance offered by the breast tissues will be directly converted to voltage as measured by the sensing portion of the capacitive pressure sensors.
The breast lesion documentation procedure can only be performed after the Scanhead has an established Bluetooth wireless connection with the Computer, which is indicated on the Computer screen. The iBEConnect Software Program provides software-based positioning guidance to the user in order to perform the procedure. Tactile maps generated from the pressure data during the procedure can be displayed, stored, reviewed and printed using the iBEConnect Software Program.
| Hardware Controls & Indicators | Description |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer on/off button | The on/off button of the computer system switches on the<br>Computer system |
| Scanhead On/Off button | The On/Off button applies power to the scan head. When the<br>control is in the On position, the physician can place the<br>scan head on the breast and capture images. If it is in the Off<br>position then the device cannot be used. |
| Blue LED | The Blue LED is located between the mini-USB charging port<br>and the ON/OFF button on the Scanhead. It indicates whether<br>the Scanhead is charging or not. When, the Scanhead is<br>plugged in and the blue LED is ON, it indicates that the<br>Scanhead is charging. The blue LED is turned off while not<br>charging. |
Functional Performance Characteristics & Requirements:
Table 1: Hardware controls and indicators
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| Software Controls and Indicators | Description |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Graphical User Interface | The iBEConnect Software Program provides the graphical<br>user interface to operate the iBreastExam Gen II System. |
| Calibrate | iBreastExam Gen II Scanhead must be calibrated before each<br>use. The calibration establishes that, a baseline reading is<br>obtained from the breast tissue by selecting a lesion-free breast<br>area and that the pressure sensors are performing within the<br>acceptable range of factory calibration. |
| Normal Scan Mode | In this mode, the user follows the software guided positioning<br>routine to perform the procedure. |
| Quick Scan Mode | In this mode, the software guided positioning routine is<br>disabled, allowing the operator to select specific locations of<br>interest. |
iBreastExam Gen II System software controls and indicators as described in the table below:
Table 2: Software controls and indicators
### Indications for Use
iBreastExam Gen II device is intended to produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breast exam. iBreastExam Gen II device is intended for use by a qualified healthcare professional trained in its use and is not for home use.
The indications for use statement of the subject device is unchanged from the predicate device; accordingly, the subject and predicate device have the same intended use.
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# Comparison of Technological Characteristics
A substantial equivalence table below compares iBreastExam Gen II and the predicate devices, iBreastExam (K142926) and outlines the similarities and the differences.
| FDA K# | iBreastExam Gen II (K190575) | iBreastExam (K142926) |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation # | 21 CFR Section 884.2990 | 21 CFR Section 884.2990 |
| Device Class | Class II | Class II |
| Product Code | NKA | NKA |
| Classification<br>Name (Reg #) | Breast Lesion Documentation<br>System | Breast Lesion Documentation<br>System |
| Intended Use | To produce a surface pressure map<br>of the breast as an aid to document<br>palpable breast lesions identified<br>and/ or monitored during a clinical<br>breast exam. | To produce a surface pressure map<br>of the breast as an aid to document<br>palpable breast lesions identified<br>and/ or monitored during a clinical<br>breast exam. |
| Processing unit | Computer with software, Windows<br>based operating system | Computer with software, Windows<br>based operating system |
| Data Acquisition<br>Method | Array of pressure sensors mounted<br>on hand-held scanhead | Array of pressure sensors mounted<br>on hand-held scanhead |
| Lesion<br>characterization | Lesion size, Lesion location, Lesion<br>stiffness, Lesion shape | Lesion size, Lesion location, Lesion<br>stiffness, Lesion shape |
| Number of sensors<br>in imaging<br>component | 648 | 16 |
| Lesion<br>Documentation | Yes | Yes |
| Detectable lesion<br>size | 5mm and above | 5mm and above |
| Pressure Sensor<br>Array Size | 40mm x 35mm | 28mm x 28mm |
| Imaging<br>component cover | Yes | Yes |
| Position<br>orientation<br>Reference | Software based positioning system | Software based positioning system |
| Monitor | Color monitor | Color monitor |
| Printer | Optional, can be connected to any<br>inkjet printer if required | Optional, can be connected to any<br>inkjet printer if required |
| Lotion | No | No |
| Keyboard and<br>mouse | Keyboard/touch | Keyboard/touch |
| Display images | Yes | Yes |
| Storage of images | Yes | Yes |
| Printed Hardcopy<br>of images | Yes | Yes |
| Comparison to<br>previous images | No | No |
| Final report | Color Tactile Maps | Color Tactile Maps |
| Prescription or<br>OTC | Prescription | Prescription |
| Intended users | Healthcare professionals | Healthcare professionals |
| Intended<br>Environment | Physician's office or clinic | Physician's office or clinic |
| Sterile<br>components | None | None |
| Method of<br>sterilization | None | None |
| Cleaning method | Commercially available medical<br>grade alcohol (70% isopropyl<br>alcohol) wipes | Commercially available medical<br>grade alcohol (70% isopropyl<br>alcohol) wipes |
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Table 4: Substantial Equivalence Table
### Differences in Technological Characteristics:
| Differences in Technological Characteristics | Explanation |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Number of sensors in imaging component:<br>648 pressure sensors in iBreastExam Gen II vs.<br>16 pressure sensors in predicate iBreastExam (K142926) | While the iBreastExam Gen II system consists of more sensors compared to predicate iBreastExam (K142926), the output of iBreastExam Gen II system is identical to that of predicate iBreastExam (K142926). |
| Pressure Sensor Array Size:<br>40mm x 35mm in iBreastExam Gen II vs.<br>28mm x 28mm in iBreastExam (K142926) | This is a minor design difference and the difference in pressure sensor array size does not raise any further concern related to safety or effectiveness for the iBreastExam Gen II system. |
Table 5: Difference in technological characteristics
The differences in technological characteristics do not raise different questions of safety and effectiveness.
## Performance Testing
Performance tests were conducted per Class II Special Controls Guidance Document: Breast Lesion Documentation System - Guidance for Industry and FDA Staff. The testing procedures include bench tests, electrical and mechanical safety tests and electromagnetic compatibility tests. In addition, a side-by-side performance test was conducted between subject device (K190575) and the predicate device, iBreastExam (K142926).
Consistent with FDA's guidance document titled "Use of Standards in Substantial Equivalence Determinations" (March 12, 2000), "Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards" (September 17, 2007), iBreastExam Gen II complies with the following recognized consensus standards:
- . IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012: Medical Electrical Equipment - Part 1: General Requirements for Safety (general electrical safety test)
- IEC 60601-1-2: 2014 (Fourth edition): Medical Electrical Equipment Part 1: General ● Requirements for Safety; Electromagnetic Compatibility -- Requirements and Tests (radiated emission, electrostatic discharge, radiated immunity (including proximity field immunity), and power frequency magnetic field immunity)
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Complete validation and verification were performed on all software and hardware subsystems. In summary, all test results were satisfactory and did not raise any additional safety or effectiveness concerns.
Performance bench tests were conducted for Inter- observer and inter- system accuracy and reproducibility to measure object size, shape and stiffness. Side-by-side testing between the iBreastExam Gen II and its predicate device iBreastExam (K142926) was conducted to determine the accuracy of the results. Tests relating to various conformity standards were also performed to ensure low risk to the patient and user. Each test procedure hypothesis, methods and conclusions are briefly described below:
| Type | Bench Test |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Testing Procedure | Inter-observer accuracy and reproducibility |
| Hypothesis | Different observers obtain reproducible results on the same phantom using the<br>same iBreastExam Gen II device. |
| Method(s) | For this validation, 20 subjects were recruited to perform the iBreastExam Gen<br>II procedure on the silicone phantoms. The silicone phantoms were constructed<br>by layering two individual slabs of silicon, one measuring 20cm x 12.5cm x<br>1cm, and the other measuring 20cm x 12.5cm x 2 cm. The silicone slabs were<br>placed on top of each other, with the lesions placed in between. Depending on<br>which slab was placed on top, the lesion would either be 1cm or 2cm beneath<br>the surface. Each recruit was instructed on how to use iBreastExam Gen II and<br>was allowed to perform several practice exams prior to the study. Each recruit<br>performed iBreastExam Gen II tests using the same device. This test measures<br>the ability of a single iBreastExam Gen II unit to measure the location, size,<br>stiffness, and shape with respect to the defined lesion scenario across all the<br>recruits. |
| Conclusion(s) | iBreastExam Gen II produced accurate and reproducible results. |
Table 6:Inter-Observer Tests
| Type | Bench Test |
|-------------------|---------------------------------------------------------------------------------------------------------------------------|
| Testing Procedure | Intra- observer accuracy and reproducibility |
| Hypothesis | The results obtained from the same iBreastExam Gen II device and a single user<br>are reproducible for the same phantoms. |
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| Method(s) | For this validation, 20 subjects were recruited to perform the iBreastExam Gen II procedure on the silicone phantoms. The silicone phantoms were constructed by layering two individual slabs of silicon, one measuring 20cm x 12.5cm x 1cm, the other measuring 20cm x 12.5cm x 2cm. The silicone slabs were placed on top of each other, with the lesions placed in between. Depending on which slab was placed on top, the lesion would either be 1cm or 2cm beneath the surface. Each recruit was instructed on how to use iBreastExam Gen II and was allowed to perform several practice exams prior to the study. Each recruit performed iBreastExam Gen II tests using the same device. This test measures the ability of a single iBreastExam Gen II unit to measure the location, size, stiffness, and shape with respect to the defined lesion scenario for the same recruit. |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion(s) | iBreastExam Gen II produced accurate and reproducible results. |
Table 7: Intra-Observer Test
| Type | Bench Test |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Testing Procedure | Inter-system accuracy and reproducibility |
| Hypothesis | The results obtained from different iBreastExam Gen II devices and user pairs are reproducible for the same phantoms. |
| Method(s) | For this validation, 20 subjects were recruited to perform the iBreastExam Gen II procedure on the silicone phantoms. The silicone phantoms were constructed by layering two individual slabs of silicon, one measuring 20cm x 12.5cm x 1cm, the other measuring 20cm x 12.5cm x 2cm. The silicone slabs were placed on top of each other, with the lesions placed in between. Depending on which slab was placed on top, the lesion would either be 1cm or 2cm beneath the surface. Each recruit was instructed on how to use iBreastExam Gen II and was allowed to perform several practice exams prior to the study. Each recruit performed iBreastExam Gen II tests using two different devices. This test measures the ability of a multiple iBreastExam Gen II units to measure the location, size, stiffness, and shape with respect to the defined lesion scenario for the same recruit. |
| Conclusion(s) | iBreastExam Gen II produced accurate and reproducible results. |
Table 8: Inter-System Test
## Conclusion
Performance testing provided above support substantial equivalence determination. The tests demonstrate that the subject device (K190575) is as safe, as effective, and performs as well as or better than the legally marketed predicate device, iBreastExam (K142926).
