emBRACE is intended to provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray technology.

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. .

AI/ML Overview

The provided text describes the regulatory clearance for the "emBRACE" device, a radiolucent foam cushion used for patient comfort and positioning during mammography. However, it does not include the details typically found in a study proving a device meets acceptance criteria related to AI/ML or diagnostic performance.

The document is a 510(k) summary for a Class II medical device (IZH) and Class I (IYX) that received clearance based on substantial equivalence to a predicate device (MammoPad® Radiolucent Cushion). This type of submission generally focuses on demonstrating that the new device has the same intended use, principles of operation, and overall technological characteristics, and raises no new questions of safety and effectiveness compared to the predicate device. It typically does not involve clinical performance studies with specific acceptance criteria as would be expected for a diagnostic or AI-based device's accuracy or efficacy.

Therefore, many of the requested fields cannot be filled from the provided text as the information is not present.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified directly in terms of performance metrics. The general "acceptance criteria" for a 510(k) in this context is demonstrating substantial equivalence to a predicate device in terms of intended use, principles of operation, and technological characteristics, and not raising new questions of safety or effectiveness.	The device was determined to be "substantially equivalent" to the predicate device (MammoPad® Radiolucent Cushion).
Intended Use: provide padding for patient comfort and aid in positioning during radiologic visualization of the breast.	The emBRACE device has the same intended use.
Principles of Operation: Radiolucent foam cushion.	The emBRACE device is a radiolucent foam cushion.
Technological Characteristics: Non-sterile, single use, available in configurations for 18x24cm, 25x29cm, and 29x30cm buckies.	The emBRACE device shares these characteristics.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. This type of information would be relevant for a clinical performance study, which is not described as being conducted for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. No clinical performance study requiring expert ground truth is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not provided. No clinical performance study requiring adjudication is described.

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

No, this was not done. The device is a physical cushion, not an AI or diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this was not done. The device is a physical cushion, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not provided. No ground truth establishment was necessary for this type of device and submission. The "ground truth" for a 510(k) of this nature is typically the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. This is not an AI/ML device requiring a training set.

Summary

{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 892.1710Accessory 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 LLC7020 Tudsbury RoadBaltimore, MD 21244
Establishment Registration Number:	1123169
Submitter/Official Contact:	Ronald T. HortonIZI Medical Products LLC7020 Tudsbury RoadBaltimore, MD 21244Phone: (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.

{1}------------------------------------------------

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.

{2}------------------------------------------------

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

Page 1 of .1.

Regulation Number and Section

§ 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.