(197 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on a surface pressure map and software for documentation, not analysis using AI/ML.
No
The device is intended to aid in documentation and mapping of palpable breast lesions, not to treat or directly manage a condition.
No
The device is intended to aid in documenting palpable breast lesions, not in identifying or diagnosing them. It produces a surface pressure map to record existing findings, rather than performing an analysis to determine the presence or nature of a condition.
No
The device description explicitly states that the iBreastExam system consists of both hardware and software components, listing specific hardware components like the Scanhead and Computer System.
Based on the provided information, the iBreastExam™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The iBreastExam™ device produces a surface pressure map of the breast, which is a physical measurement taken directly from the patient's body, not a specimen.
- The intended use describes a physical examination aid. The device is intended to aid in documenting palpable breast lesions identified during a clinical breast exam, which is a physical examination.
- The input modality is a surface pressure map. This is a physical measurement, not a test performed on a biological sample.
Therefore, the iBreastExam™ device falls under the category of a medical device used for physical examination and documentation, not an IVD.
N/A
Intended Use / Indications for Use
iBreastExam™ 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™ device 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 iBreastExam system consists of a group of hardware and software components. The hardware component(s) consist of:
- iBreastExam Scanhead
- Computer System
- USB Wall Charger and Charging Cables .
The software component(s) consist of:
- iBEConnect Software Program ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified healthcare professional trained in its use and is 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)
Performance tests were conducted per Class II Special Controls Guidance Document: Breast Lesion Documentation System, including electrical safety tests, electromagnetic compatibility tests as well as biocompatibility test. In addition, a side-by-side performance test was conducted between iBreastExam™ and the predicate device (BreastView).
Complete validation and verification was performed on all software and hardware subsystems. In summary, all test results were satisfactory and did not raise any additional safety or effectiveness concerns.
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2015
UE LifeSciences, Inc. Mihir Shah CEO 3711 Market Street, Suite 800 Philadelphia, PA 19104
Re: K142926 Trade/Device Name: iBreastExam Regulation Number: 21 CFR 884.2990 Regulation Name: Breast lesion documentation system Regulatory Class: II Product Code: NKA Dated: March 16, 2015 Received: March 20, 2015
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. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142926
Device Name
iBreastExam
Indications for Use (Describe)
iBreastExam™ 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™ 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for UE LifeSciences. The logo consists of a circular design with overlapping rings in shades of blue, gray, and pink. Below the circular design, the text "UE LifeSciences" is written in a simple, sans-serif font.
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
Applicant and Official Correspondent:
UE LifeSciences. Inc. C/o Mihir B. Shah 3711 Market St, Suite 800 Philadelphia, PA 19104
| Contact Person: | Mihir Shah |
|---|---|
| Tel: | 631-980-8340 |
| Email: | mihir@uelifesciences.com |
April 23, 2015 Date Prepared:
Name of Device:
iBreastExam Classification Name: Breast Lesion Documentation System (12 CFR 884.2990) Regulation Class: Class II Product Code: NKA
Predicate Device:
BREASTVIEW® VISUAL MAPPING SYSTEM (K010514 granted through de novo process)
Intended Use:
The device is intended to produce a surface 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 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.
4
Image /page/4/Picture/0 description: The image shows the logo for UE LifeSciences. The logo consists of a circular design with overlapping rings in blue, pink, and gray. Below the circular design, the text "UE LifeSciences" is written in a simple, sans-serif font.
Indications for Use:
iBreastExam™ (iBreastExam) 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™ device is intended for use by a qualified healthcare professional trained in its use and is not for home use.
Technological Characteristics:
The iBreastExam system consists of a group of hardware and software components. The hardware component(s) consist of:
- iBreastExam Scanhead
- Computer System
- USB Wall Charger and Charging Cables .
The software component(s) consist of:
- iBEConnect Software Program ●
Performance Testing:
Performance tests were conducted per Class II Special Controls Guidance Document: Breast Lesion Documentation System, including electrical safety tests, electromagnetic compatibility tests as well as biocompatibility test. In addition, a side-by-side performance test was conducted between iBreastExam™ and the predicate device (BreastView).
Complete validation and verification was performed on all software and hardware subsystems. In summary, all test results were satisfactory and did not raise any additional safety or effectiveness concerns.
Substantial Equivalence:
| Parameter | Subject device | Predicate device – BreastView Visual Mapping System |
|---|---|---|
| Intended use | Same as the predicate | is intended to produce a surface pressure map of |
| the breast as an aid to document palpable breast | ||
| lesions identified during a clinical breast exam. | ||
| Processing unit | Same as the predicate | Computer with software, Windows based |
| operating system | ||
| Data acquisition method | Same as the predicate | Array of pressure sensors mounted on hand- |
| held scanhead | ||
| Lesion documentation | Same as the predicate | Lesion size, location, stiffness, shape |
| Detectable lesion size | ≥5mm | 5-40mm |
| Number of sensors in imaging | 16 | 416 |
| Pressure sensor array size | 28mm × 28mm | 40mm×25mm |
5
| Image display | Same as the predicate | Yes |
|---|---|---|
| Image storage | Same as the predicate | Yes |
| Comparison to previous images | Same as the predicate | No |
| Final report | Same as the predicate | Color tactile maps |
| Patient contacting component | Reusable scanhead made of | |
| acrylonitrile butadiene styrene | Disposable, single use cover (made of | |
| polyurethane) attached to the scanhead | ||
| Use with lotion | Not needed | Needed |
Substantial Equivalence Discussion
- Intended use The subject and predicate devices have the same intended use. .
- Technological characteristics Similarities between the subject and predicate devices ●
- ★ They use computer with software. Windows based operating system.
-
- They used the same data acquisition method - Array of pressure sensors mounted on handheld scanhead.
-
- They provide the same lesion documentation lesion size, location, stiffness, and shape.
- ★ They detect the similar lesion sizes.
- ★ They have the same features regarding image display, image storage, image comparison, and format of final report.
- Technological characteristics Differences between the subject and predicate devices ●
- ★ The subject imaging component contains 16 sensors whereas the predicate imaging component has 416 sensors. Also, the subject device has a smaller pressure sensor array size. The differences raise an effectiveness concern, but there is no new type of question. Bench testing data showed that the subject device is effective.
-
- The subject device uses different material (ABS vs. polyurethane used in the predicate device), raising a safety concern. However, safety related to material is not a new type of question and can be assessed by accepted biocompatibility testing. Biocompatibility data demonstrated that the subject device is safe.
In conclusion, the subject device is substantial equivalent in terms of safety and effectiveness.