The Orison Embrace is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the patients breast when used with an automatic scanning linear array transducer.

Device Description

The Embrace™ 3D Ultrasound Tomography System is an easy to use diagnostic ultrasound system to be used as an adjunct to mammography for imaging a patient's breast. Ultrasound images are acquired using a general purpose ultrasound system capable of B-mode imaging in conjunction with an automatic scanning concave transducer. The acquired images are reconstructed using 3-D visualization software at a separate clinical review workstation.

AI/ML Overview

The Orison Embrace System is an ultrasound tomography system intended for use as an adjunct to mammography for B-mode ultrasonic imaging of the patient's breast.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Identification of cystic masses in a phantom breast.	All 12 masses were successfully identified.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: 1 phantom breast with 12 cystic masses.
Data Provenance: The 'test set' was a phantom breast, not human data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable, as a phantom breast was used. The 'known number of cystic masses' and their positions serve as the ground truth.
Qualifications: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The ground truth (number and location of cystic masses) was inherently known due to the nature of the phantom.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done? No. The study described is a technical verification using a phantom, not a clinical study involving human readers.

6. Standalone Performance Study (Algorithm Only)

Standalone Study Done? Yes. The System Verification and Validation Testing seems to be a standalone performance study where the device (Orison Embrace System) was tested on its own to identify known masses in a phantom.

7. Type of Ground Truth Used

Type of Ground Truth: Known physical characteristics in a phantom model (known number and positions of cystic masses).

8. Sample Size for the Training Set

Training Set Sample Size: Not explicitly stated or detailed in the provided summary. The submission focuses on verification testing rather than algorithm training.

9. How Ground Truth for the Training Set Was Established

How Ground Truth Was Established: Not explicitly stated in the provided summary. As this is a 510(k) submission for an ultrasound system, rather than an AI/CADe device, the concept of a separate "training set" with established ground truth in the context of machine learning isn't a primary focus of the non-clinical testing described. The primary "test set" was a phantom.

Summary

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K070477

510(K) SUMMARY (as required by 807.92(c))

January 12, 2007

MAR 0 9 2007

Submitter of 510(k):

Date:

Orison Corporation 121 Boone Ridge Dr. Suite 2004 Johnson City, TN 37615 USA

Transducer, Ultrasonic, Diagnostic

Phone: (423) 282-5919 (423) 282-6320 Fax:

Contact Person:

Al Sandy

Date of Summary:

Date

Orison Embrace System Trade/Proprietary Name:

Classification Name:

Product Code:

ITX IYO

Intended Use:

The Orison Embrace is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the patients breast when used with an automatic scanning linear array transducer.

Device Description:

Predicate Device:

ABUS U-Systems - K052355

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Substantial Equivelance:

Orison Corporation claims the proposed device to be substantially equivalent to the device prevuousley cleared by FDA in K052355. Orison Corporation claims this equivalence because the proposed device has an equivalent intended use, manufacturing materials, operating principles, and physical, operational specifications as compared to the predicate device.

The Orison Embrace System will be used with the Sonix Ultrasound Scanner System manufactured by Ultrasonix Medical Corporation. The Sonix System has already been cleared by the FDA under K061827.

The following non-clinical tests have been completed:

Acoustic output testing-Meets the standard for Global Maximum Output .
System Verification and Validation Testing (Embrace-TPD-0008 Rev A . and Embrace TPR-0006 Rev A) Testing was done using a phantom breast with a known number of cystic masses (6) randomly positioned. All 12 masses were successfully identified.

Results indicate that the Embrace System is substantially equivalent to the listed predicate device.

The similarities and differences between the proposed and predicate devices has been identified and explained in the Cpmparison Matrix which has been included in Section 9 of this submission. Additionally, this matrix is included as an attachment to the 510(k) summary. These differences have no effect on safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an image of three stylized human profiles facing to the right, with flowing lines above them that resemble hair or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 2007

Orison Corporation % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K070477

Trade Name: Orison Embrace System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYO and ITX Dated: February 14, 2007 Received: February 20, 2007

Dear Mr. Lehtonen:

This letter corrects our substantially equivalent letter of March 9, 2007.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the Orison Embrace Probe intended for use with the Orison Embrace System (Sonix Ultrasound Scanner System and Biomedicom Clinical Review Workstation Software), as described in your premarket notification:

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 - Mr. Lehtonen

CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on vour responsibilities under the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Ewa Czerska at (240) 276-3666.

Sincerely vours.

Nancy Brogdon

Nancy C. Brogdon Director. Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Indications for Use

510(k) Number (if known): 07 04 77

Device Name: Orison Embrace System

Indications for Use:

The Orison Embrace is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the patients breast when used with an automatic scanning linear array transducer.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David L. Symm
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Page 1 of 1

10 of 774

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Diagnostic Ultrasound Indications for Use Form Fill out one form for each ultrasound system and each transducer

Orison Embrace System

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(specify)
IntraoperativeNeurological
Pediatric
Small Organ (Breast)		N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Other (specify)

N = new indication; P = previously cleared

Additional Comments: The Orison Embrace System is intended for B-Mode Ultrasonic imaging of a patient's breast.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Segerson
(Division Sign-Off) F-3

(Division Sign-Oil)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 4070/71

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Diagnostic Ultrasound Indications for Use Form Fill out one form for each ultrasound system and each transducer

Orison Embrace Probe

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(specify)
IntraoperativeNeurological
Pediatric
Small Organ (Breast)		N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Other (specify) (*3)

N = new indication; P = previously cleared

Additional Comments: The Orison Embrace Probe is intended for B-Mode Ultrasonic imaging of a patient's breast.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Lynam
F-3

(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.