(17 days)
No
The summary describes standard 3D reconstruction software and does not mention AI, ML, or related concepts.
No
A therapeutic device is used for treating or curing a disease or condition. This device is indicated for imaging and diagnostic purposes (adjunct to mammography for B-mode ultrasonic imaging), not for treatment.
Yes
The device description explicitly states it is an "easy to use diagnostic ultrasound system" and the intended use involves imaging the breast as an adjunct to mammography, which is a diagnostic purpose.
No
The device description explicitly mentions a "diagnostic ultrasound system" and an "automatic scanning concave transducer," which are hardware components. While it includes 3-D visualization software, it is part of a larger system that includes hardware for image acquisition.
Based on the provided information, the Orison Embrace is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the living body (in vitro).
- Orison Embrace Function: The Orison Embrace is an ultrasound system that uses B-mode ultrasonic imaging to visualize the breast within the patient's body. It is a non-invasive imaging device.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples. The device directly images the anatomical site.
Therefore, the Orison Embrace falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ITX, IYO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
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
Testing was done using a phantom breast with a known number of cystic masses (6) randomly positioned. All 12 masses were successfully identified.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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
§ 892.1560 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.
0
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:
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.
Predicate Device:
ABUS U-Systems - K052355
1
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.
2
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
3
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)
4
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
5
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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| (specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| 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
6
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 | Color | ||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined | |||||||||||
| (specify) | Other | |||||||||||
| (specify) | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative | ||||||||||||
| (specify) | ||||||||||||
| Intraoperative | ||||||||||||
| Neurological | ||||||||||||
| 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 ________________________________________________________________________________________________________________________________________________________________