(121 days)
Not Found
Not Found
No
The device description and intended use clearly state that the device is a radiolucent foam cushion for patient comfort and positioning during x-ray imaging. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device's intended use is to provide patient comfort and aid in positioning during breast imaging, not to treat or diagnose a disease or condition.
No
The device, emBRACE, is described as a foam cushion intended for patient comfort and positioning during breast visualization using x-ray technology, not for diagnosing medical conditions.
No
The device description explicitly states that emBRACE is a "radiolucent foam cushion," which is a physical hardware component, not software.
Based on the provided information, the device "emBRACE" is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- emBRACE's Intended Use: The intended use of emBRACE is to provide padding and aid in positioning during radiologic visualization of the breast using x-ray technology. It is a physical cushion used externally on the patient.
- No Sample Testing: emBRACE does not involve the testing of any biological samples from the patient.
Therefore, emBRACE falls under the category of a medical device used for patient comfort and positioning during an imaging procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
emBRACE is intended to provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray technology.
embrace is intended to provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray technology.
Product codes (comma separated list FDA assigned to the subject device)
IZH, IYX
Device Description
emBRACE is a radiolucent foam cushion used during radiologic visualization of the breast. emBRACE is non-sterile and is a single use device.
emBRACE will be offered in the following configurations for ease of use dependent o the radiological system used:
- Product Number 00283-001 for use on an 18x24cm bucky. .
- Product Number 00283-100 for use on a 25x29cm bucky. .
- Product Number 00283-200 for use on a 29x30cm bucky. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray technology
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
MammoPad® Radiolucent Cushion
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
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows two abstract shapes that are mirror images of each other. Each shape is composed of curved and straight lines, creating a geometric design. The shapes are black and white, with the black areas forming the main structure and the white areas creating negative space within the design.
IZI MEDICAL PRODUCTS
K101373 SEP 1 5 2010
hnology. Defining value. Leading
| 510(k) | Summary |
|---|---|
| Device Name: | emBRACE |
| Classification Name: | Accessory to X-Ray Mammographic System (IZH) |
| 21 CFR 892.1710 | |
| Accessory to Scintillation (Gamma) Camera (IYX) | |
| 21 CFR 892.1100 | |
| Device Classification: | Class II (IZH) |
| Class I (IYX) | |
| Predicate Device: | MammoPad® Radiolucent Cushion |
| Manufacturer: | IZI Medical LLC |
| 7020 Tudsbury Road | |
| Baltimore, MD 21244 | |
| Establishment Registration Number: | 1123169 |
| Submitter/Official Contact: | Ronald T. Horton |
| IZI Medical Products LLC | |
| 7020 Tudsbury Road | |
| Baltimore, MD 21244 | |
| Phone: (410) 594-9403 (ext 248) | |
| Intended Use: |
emBRACE is intended to provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray technology.
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Image /page/1/Picture/0 description: The image shows a logo that is split into two parts. The left part of the logo has a shape that resembles the letter 'H' with curved edges. The right part of the logo has a shape that resembles the letter 'A' with curved edges. The logo is black and white.
Refining technology. Defining value. Leading the way.
Page 2
Summary
Device Description:
emBRACE is a radiolucent foam cushion used during radiologic visualization of the breast. emBRACE is non-sterile and is a single use device.
emBRACE will be offered in the following configurations for ease of use dependent o the radiological system used:
- Product Number 00283-001 for use on an 18x24cm bucky. .
- Product Number 00283-100 for use on a 25x29cm bucky. .
- Product Number 00283-200 for use on a 29x30cm bucky. .
Technological Characteristics/Performance Data Summary:
emBRACE is equivalent to the predicate device, with the same principles of operation and overall technological characteristics.
IZI Medical Products LLC will provide safety and effectiveness information supporting the FDA finding of Substantial Equivalence to any person within 30 days of a written request.
Conclusion:
Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, emBRACE is determined to be substantially equivalent to an existing legally marketed device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Helen Zinreich Shafer CEO IZI Medical Products 7020 Tudsbury Dr. BALTIMORE MD 21244
SEP 1 5 2010
Re: K101373
Trade/Device Name: Embrace Mammography Cushion Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IZH Dated: August 11, 2010 Received: August 12, 2010
Dear Ms. Shafer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket . notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
K101373 SEP 1 5 2010
510(k) Number (if known): __K101373
embrace Mammography Cushion Device Name:
Indications for Use:
embrace is intended to provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray technology.
Prescription Use
AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
:
oncurrençe of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Concurrence of SDRH, Office
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101373
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