(132 days)
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.
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. 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.
The iBreastExam Gen II device is intended to produce a surface pressure map of the breast to aid in documenting palpable breast lesions identified during a clinical breast exam. It is not for diagnosis, but purely a documentation tool. Clinical management decisions should be based on clinical and diagnostic examinations (e.g., ultrasound or mammography).
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes performance testing related to accuracy and reproducibility, but it does not explicitly state specific pass/fail acceptance criteria (e.g., "accuracy must be greater than X%") for the device's performance characteristics in a numerical form. Instead, the conclusions for each test conducted state that the device "produced accurate and reproducible results." The closest numerical performance characteristic mentioned is "Detectable lesion size: 5mm and above" for both the subject and predicate devices, which can be inferred as a performance expectation.
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|
| Inter-observer accuracy and reproducibility (of location, size, stiffness, and shape) | iBreastExam Gen II produced accurate and reproducible results. |
| Intra-observer accuracy and reproducibility (of location, size, stiffness, and shape) | iBreastExam Gen II produced accurate and reproducible results. |
| Inter-system accuracy and reproducibility (of location, size, stiffness, and shape) | iBreastExam Gen II produced accurate and reproducible results. |
| Detectable lesion size | 5mm and above (same as predicate) |
| Output of the device (compared to predicate) | Output of iBreastExam Gen II system is identical to that of predicate iBreastExam (K142926). |
| Electrical and mechanical safety, and electromagnetic compatibility | All test results were satisfactory and did not raise any additional safety or effectiveness concerns. |
2. Sample Size Used for the Test Set and Data Provenance
For the inter-observer, intra-observer, and inter-system bench tests, the sample size used was 20 subjects.
The tests were performed on silicone phantoms constructed by layering slabs of silicon with lesions placed in between. This indicates that the testing was conducted prospectively in a controlled lab environment using simulated tissue, rather than on human patients or retrospective clinical data. Therefore, there is no country of origin for patient data in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The ground truth for the test set (silicone phantoms) was established by the physical construction of the phantoms themselves, which included lesions of defined location, size, stiffness, and shape. The "experts" in this context were effectively the creators of the phantoms, who embedded the known characteristics.
The testing methodology involved "recruits" (20 subjects) who were "instructed on how to use iBreastExam Gen II and was allowed to perform several practice exams prior to the study." These recruits were the operators performing the measurements, not experts establishing ground truth or interpreting results, as the device's purpose is documentation of palpable lesions. The document does not specify qualifications for these recruits beyond being trained to use the device.
4. Adjudication Method for the Test Set
There was no adjudication method described in the context of establishing ground truth for the test set, as the ground truth was inherently known from the design of the silicone phantoms (known lesion location, size, stiffness, and shape).
For the inter-observer and intra-observer tests, the reproducibility and accuracy were measured against this known phantom ground truth, and for inter-system, it was comparing measurements from different devices against the same phantom.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC comparative effectiveness study mentioned in the provided text. The device, iBreastExam Gen II, is described as a "breast lesion documentation system" that produces a "surface pressure map." Its function is to aid in documenting already palpable lesions and is not intended for diagnosis. The study described focuses on the device's accuracy and reproducibility in measuring known characteristics on phantoms when operated by different individuals or with different devices, not on how it assists human readers in diagnosis or detection. The device itself is not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The provided text describes direct interaction between a human operator ("recruit") and the device. The device collects data based on human operation (placing the scanhead on the phantom) and then presents a tactile map via software. The "iBEConnect Software Program" provides positioning guidance and processes data. However, the performance tests described (inter-observer, intra-observer, inter-system) inherently include a human operator in the loop. The device is explicitly stated to be for use by a "qualified healthcare professional trained in its use." Therefore, a standalone (algorithm only without human-in-the-loop) performance study was not explicitly described or, due to the nature of the device, likely conducted as its intended use requires interaction.
7. The Type of Ground Truth Used
The ground truth used for the performance testing was known physical characteristics of silicone phantoms (defined lesion location, size, stiffness, and shape). This is a form of engineered or simulated ground truth, rather than expert consensus, pathology, or outcomes data from human patients.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI. The tests performed are verification and validation of the device's measurement capabilities. If any internal calibration or parameter setting during device development involved data, it is not mentioned. The user training described for the 20 recruits refers to training them on how to use the device, not training the device's internal algorithms.
9. How the Ground Truth for the Training Set Was Established
Since no specific "training set" for the device's algorithms or software was described (beyond general software validation), the method for establishing its ground truth is not applicable or detailed in the provided information. The device functions by physical principles (capacitive pressure sensors) and software processing, not through a learning algorithm that requires a separate training dataset with established ground truth.
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY iBreastExam Gen II (K190575)
| Submitter's Name: | UE LifeSciences Inc. |
|---|---|
| Address: | 3401 Market St, Suite 200Philadelphia 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)The predicate device has not been subject to any design relatedrecalls. |
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 andCharging Cables | To recharge the iBreastExam Gen II Scanhead and the ComputerSystem. |
| iBEConnectSoftware Program | To provide a user with the ability to create tactile map of the breasts.The software also provides an interface with the database in thesystem and the ability to add, modify, retrieve and delete patientand exam data including the tactile maps. The software can also beused 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 theComputer system |
| Scanhead On/Off button | The On/Off button applies power to the scan head. When thecontrol is in the On position, the physician can place thescan head on the breast and capture images. If it is in the Offposition then the device cannot be used. |
| Blue LED | The Blue LED is located between the mini-USB charging portand the ON/OFF button on the Scanhead. It indicates whetherthe Scanhead is charging or not. When, the Scanhead isplugged in and the blue LED is ON, it indicates that theScanhead is charging. The blue LED is turned off while notcharging. |
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 graphicaluser interface to operate the iBreastExam Gen II System. |
| Calibrate | iBreastExam Gen II Scanhead must be calibrated before eachuse. The calibration establishes that, a baseline reading isobtained from the breast tissue by selecting a lesion-free breastarea and that the pressure sensors are performing within theacceptable range of factory calibration. |
| Normal Scan Mode | In this mode, the user follows the software guided positioningroutine to perform the procedure. |
| Quick Scan Mode | In this mode, the software guided positioning routine isdisabled, allowing the operator to select specific locations ofinterest. |
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 |
| ClassificationName (Reg #) | Breast Lesion DocumentationSystem | Breast Lesion DocumentationSystem |
| Intended Use | To produce a surface pressure mapof the breast as an aid to documentpalpable breast lesions identifiedand/ or monitored during a clinicalbreast exam. | To produce a surface pressure mapof the breast as an aid to documentpalpable breast lesions identifiedand/ or monitored during a clinicalbreast exam. |
| Processing unit | Computer with software, Windowsbased operating system | Computer with software, Windowsbased operating system |
| Data AcquisitionMethod | Array of pressure sensors mountedon hand-held scanhead | Array of pressure sensors mountedon hand-held scanhead |
| Lesioncharacterization | Lesion size, Lesion location, Lesionstiffness, Lesion shape | Lesion size, Lesion location, Lesionstiffness, Lesion shape |
| Number of sensorsin imagingcomponent | 648 | 16 |
| LesionDocumentation | Yes | Yes |
| Detectable lesionsize | 5mm and above | 5mm and above |
| Pressure SensorArray Size | 40mm x 35mm | 28mm x 28mm |
| Imagingcomponent cover | Yes | Yes |
| PositionorientationReference | Software based positioning system | Software based positioning system |
| Monitor | Color monitor | Color monitor |
| Printer | Optional, can be connected to anyinkjet printer if required | Optional, can be connected to anyinkjet printer if required |
| Lotion | No | No |
| Keyboard andmouse | Keyboard/touch | Keyboard/touch |
| Display images | Yes | Yes |
| Storage of images | Yes | Yes |
| Printed Hardcopyof images | Yes | Yes |
| Comparison toprevious images | No | No |
| Final report | Color Tactile Maps | Color Tactile Maps |
| Prescription orOTC | Prescription | Prescription |
| Intended users | Healthcare professionals | Healthcare professionals |
| IntendedEnvironment | Physician's office or clinic | Physician's office or clinic |
| Sterilecomponents | None | None |
| Method ofsterilization | None | None |
| Cleaning method | Commercially available medicalgrade alcohol (70% isopropylalcohol) wipes | Commercially available medicalgrade alcohol (70% isopropylalcohol) 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:648 pressure sensors in iBreastExam Gen II vs.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:40mm x 35mm in iBreastExam Gen II vs.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 thesame iBreastExam Gen II device. |
| Method(s) | For this validation, 20 subjects were recruited to perform the iBreastExam GenII procedure on the silicone phantoms. The silicone phantoms were constructedby layering two individual slabs of silicon, one measuring 20cm x 12.5cm x1cm, and the other measuring 20cm x 12.5cm x 2 cm. The silicone slabs wereplaced on top of each other, with the lesions placed in between. Depending onwhich slab was placed on top, the lesion would either be 1cm or 2cm beneaththe surface. Each recruit was instructed on how to use iBreastExam Gen II andwas allowed to perform several practice exams prior to the study. Each recruitperformed iBreastExam Gen II tests using the same device. This test measuresthe ability of a single iBreastExam Gen II unit to measure the location, size,stiffness, and shape with respect to the defined lesion scenario across all therecruits. |
| 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 userare 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).
§ 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.