(96 days)
No
The summary describes a standard B-mode ultrasound system for breast imaging and does not mention any AI or ML components or capabilities.
No.
The device is described as an ultrasonic imaging system for diagnostic purposes (imaging of a patient's breast), not for treating a condition.
Yes
The "Intended Use / Indications for Use" states the device is for "imaging of a patient's breast", and the "Predicate Device(s)" are explicitly named as "Diagnostic Ultrasound System".
No
The device description explicitly lists hardware components such as an exam table, motor drive assembly, fluidics system, power supply, and an ultrasound probe. While it includes an ultrasound system that acquires and stores data, the overall device is a physical system with integrated hardware.
Based on the provided information, the Sofia™ (ATUS) device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "B-mode ultrasonic imaging system for imaging of a patient's breast". This is an in vivo (within a living organism) imaging procedure, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description details components for acquiring ultrasound images from a patient's breast, which aligns with in vivo imaging.
- Input Imaging Modality: B-mode ultrasonic imaging is an in vivo imaging technique.
- Anatomical Site: The breast is an anatomical site within the body.
IVD devices are typically used to examine specimens (like blood, urine, tissue) taken from the body to provide diagnostic information. The Sofia™ (ATUS) device directly images the breast within the patient.
N/A
Intended Use / Indications for Use
The Sofia™ (ATUS) device is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application: Small Organ (Breast), Mode of Operation: B.
Additional Comments: The iVu Imaging Sofia™ Automated Tomographic Ultrasound (ATUS) device is intended for ultrasonic breast examinations.
Product codes
ITX, IYO
Device Description
The Sofia™ (ATUS) device consists of three (3) major components 1) an exam table which houses the examination pyramid, motor drive assembly, fluidics evacuation and storage system, and the power supply assembly 2) an ultrasound probe which is embedded into the exam pyramid on one end and connected to the ultrasound system on the other end, 3) an ultrasound system that acquires and stores the ultrasound data from the patient's breast exam.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
B-mode ultrasonic imaging
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
The function and performance of the Sofia™ (ATUS) system have been evaluated through non-clinical design verification and validation tests. Testing included mechanical performance evaluations and simulated use tests. The results of the Sofia™ (ATUS) systems performance evaluations demonstrate that the Sofia™ (ATUS) device design is well suited for its intended use.
iVu Imaging completed mechanical performance evaluations to verify that the Sofia™ (ATUS) system meets predetermined specifications, conforms to product performance requirements, and supports the compatibility of internal components. Test results, as documented in Section 7, support that the Sofia™ (ATUS) system meets the predetermined specifications and performance requirements for its intended use.
Additional testing of The Sofia™ (ATUS) device will be performed by an independent testing laboratory (Intertek Testing Services NA, Inc) and must demonstrate conformance with the IEC 60601 series of electrical and electromagnetic safety standards before commercial distribution begins. In Section 7 of this document, under "ELECTRICAL SAFETY TESTING" is a signed certification by the President of iVu attesting to the fact that such testing will occur prior to commercialization. The following specific standards will be tested.
IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety; (Amd. 1-1991) (CENELEC EN 60601-1: 1990) (Amd. 2-1995) (Corrigendum-1995)
UL 60601-1 UL Standard for Safety Medical Electrical Equipment, Part 1: General Requirements for Safety Issued: 4/25/2003 Ed: 1
CAN/CSA-C22.2 No. 601.1-M90 Canadian Electrical Code, Part I. Rev. 1999
IEC 60601-1-2 Issued: 2001/09/30 Ed:2 Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Req. and Tests
In Section 7, Bench testing included testing performed in-house, as well as, an opinion from an expert in the field of acoustic sonography who also performed and documented acoustical output testing. In-house testing, the opinion, and acoustic testing demonstrate the safety and effectiveness of the Sofia (ATUS) system.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
JUN - 3, 2008
Section 2 - 510(k) Summary and Certification
[As required by 21 CFR 807.92(c)]
1. Contact Person
Mark L. Stribling President & CEO iVu Imaging Corporation www.ivuimaging.com 4121 Grace Ln, Grapevine, TX 76051-6586 Tel: 817-545-9766 Fax: 817-354-0062 Email: mstribling@ivuimaging.com
2. General Information
| Name: | iVu Imaging Corporation |
|---|---|
| Trade Name: | Sofia™ (ATUS) Imaging Device |
| Classification Name: | Transducer, Ultrasonic, Diagnostic |
| Classification: | This device is classified by the Reproductive, Abdominal |
| and Radiological Devices into Class II, (21 CFR 892.1560 | |
| Ultrasonic pulsed echo imaging system and 892.1570 | |
| Diagnostic ultrasonic transducer) |
3. Device Description
The Sofia™ (ATUS) device consists of three (3) major components 1) an exam table which houses the examination pyramid, motor drive assembly, fluidics evacuation and storage system, and the power supply assembly 2) an ultrasound probe which is embedded into the exam pyramid on one end and connected to the ultrasound system on the other end, 3) an ultrasound system that acquires and stores the ultrasound data from the patient's breast exam.
1
The Sofia™ (ATUS) device, as well as, the two predicate devices (Trade Name: FFBU Diagnostic Ultrasound System manufactured by U-Systems, Inc (K032640), Trade Name: ABUS Diagnostic Ultrasound System manufactured by U-Systems, Inc (K052355) utilize standard B-Mode grayscale ultrasound to achieve their intended use. Both the Sofia™ (ATUS) device and the U-Systems FFBU and ABUS systems use automated linear ultrasound transducers to evaluate breast tissue. The Sofia™ (ATUS) device, as well as, the U-Systems FFBU and ABUS systems all use automated linear transducers to acquire serial 2D grayscale images of the entire breast. These 2D images can then be reviewed by a radiologist to determine if any abnormal anatomical features are present in the patient's breast. The Sofia™ (ATUS) system utilizes the same mode of operations, general operating principals, as well as, general and specific indications for use as the predicate devices described above.
4. Intended Use
The Sofia™ (ATUS) device is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.
5. Substantial Equivalence Comparison
The iVu Sofia™ (ATUS) device is substantially equivalent to the following devices with respect to intended use, design, materials and construction:
- The FFBU Diagnostic Ultrasound System manufactured by U-. Systems, Inc (K032640)
- . The ABUS Diagnostic Ultrasound System manufactured by U-Systems, Inc (K052355).
Section 4 of this 510K shows much more detail relative to specific similarities and differences between the Sofia™ (ATUS) system and the predicate devices; also a table is provided for clarity. The Sofia™ (ATUS) device and the predicate devices are substantially equivalent in their intended uses and / or device design. In addition to the similar intended use, all of the predicate devices utilize B-Mode Grayscale Ultrasound to achieve their intended use. Both the Sofia™ (ATUS) and the predicate devices use automated linear ultrasound transducers to image breast tissue. Both the Sofia™ (ATUS) device and the predicate devices use commercially available FDA 510K approved ultrasound systems to acquire ultrasound images.
2
The Sofia™ (ATUS) system uses the GE LOGIQ e (K050126). The U-Systems ABUS and FFBU systems use the Siemens Antares DUS (K023720). Refer to Attachment I for a copy of the GE Medical Systems 510K (K050126).
A brief discussion of the similarities and differences between the Sofia™ (ATUS) device and its predicate devices is provided below.
Similarities
- Similar to the Sofia™ (ATUS), the U-Systems FFBU system uses an automated . linear transducer to acquire serial 2D images of the patient's breast. The FFBU system uses a commercially available FDA 510K approved ultrasound system to acquire and process B-Mode grayscale images of a patient's breast.
- Similar to the Sofia™ (ATUS), the U-Systems ABUS system uses an automated . linear transducer to acquire serial 2D images of the entire patient's breast. The ABUS system uses a commercially available FDA 510K approved ultrasound system to acquire and process B-Mode grayscale images of a patient's breast.
Differences
- . The Sofia™ (ATUS) system uses an FDA 510K approved linear transducer manufactured by GE Medical Systems. The U-Systems ABUS device uses a custom automated linear transducer. The transducers listed above are all broad band transducers with frequency ranges between 7MHZ and 11MHZ.
- t The Sofia™ (ATUS) system positions the patient in a prone position lying on its examination table with the breast in a pendulous position within the pyramid shaped dome. The U-Systems ABUS and FFBU devices position the patient in a supine position and use the transducer housing of its devise to compress the breast tissue between the transducer face and the thoracic wall.
- . iVu's pendulous position of the breast in a fluid environment eliminates the need for breast compression. No new issues of safety or efficacy are created.
6. Summary of Studies
The function and performance of the Sofia™ (ATUS) system have been evaluated through non-clinical design verification and validation tests. Testing included mechanical performance evaluations and simulated use tests. The results of the Sofia™ (ATUS) systems performance evaluations demonstrate that the Sofia™ (ATUS) device design is well suited for its intended use.
iVu Imaging completed mechanical performance evaluations to verify that the Sofia™ (ATUS) system meets predetermined specifications, conforms to product performance requirements, and supports the compatibility of internal components. Test results, as documented in Section 7, support that the Sofia™ (ATUS) system meets the predetermined specifications and performance requirements for its intended use.
3
Additional testing of The Sofia™ (ATUS) device will be performed by an independent testing laboratory (Intertek Testing Services NA, Inc) and must demonstrate conformance with the IEC 60601 series of electrical and electromagnetic safety standards before commercial distribution begins. In Section 7 of this document, under "ELECTRICAL SAFETY TESTING" is a signed certification by the President of iVu attesting to the fact that such testing will occur prior to commercialization. The following specific standards will be tested.
| Document
| Number | Description |
|---|---|
| IEC 60601-1 | IEC 60601-1 Issue 1988/12/01 Ed:2 Medical Electrical Equipment |
| Part 1: General Requirements for Safety; (Amd. 1-1991) | |
| (CENELEC EN 60601-1: 1990) (Amd. 2-1995) (Corrigendum-1995) | |
| UL 60601-1 | UL 60601-1 UL Standard for Safety Medical Electrical Equipment, |
| Part 1: General Requirements for Safety Issued: 4/25/2003 Ed: 1 | |
| CAN/CSA-C22.2 No. | |
| 601.1-M90 | CAN/CSA-C22.2 No. 601.1-M90 Canadian Electrical Code, Part I. |
| Rev. 1999 | |
| IEC 60601-1-2 | IEC 60601-1-2 Issued: 2001/09/30 Ed:2 Medical Electrical |
| Equipment Part 1-2: General Requirements for Safety - | |
| Collateral Standard: Electromagnetic Compatibility - Req. and | |
| Tests |
In Section 7, Bench testing included testing performed in-house, as well as, an opinion from an expert in the field of acoustic sonography who also performed and documented acoustical output testing. In-house testing, the opinion, and acoustic testing demonstrate the safety and effectiveness of the Sofia (ATUS) system.
7. Conclusion (statement of equivalence)
The data and information provided in this submission supports a substantial equivalence determination, and, therefore, 510(k) premarket notification clearance of the Sofia™ (ATUS) Device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three stripes on its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 2008
iVu Imaging Corportaion % Mr. Daniel W. Lehtonen Sr. Staff Engineer - Medical Devices Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OF 44087
Rc: K080555
Trade/Device Name: Sofia™ Automated Tomographic Ultrasound (ATUS) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: ITX and IYO Dated: May 16, 2008 Received: May 19, 2008
Dear Mr. Lehtonen:
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 following transducers intended for use with the Sofia™ Automated Tomographic Ultrasound (ATUS), as described in your premarket notification:
Transducer Model Number
12L-RS
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 CFR Part 801); good manufacturing practice requirements as set forth in the quality
5
Page 2 - Mr. Lehtonen
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.
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 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 your responsibilities under the Act from 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 Paul Hardy at (240) 276-3666.
Sincerely yours,
Vogue McHanz
Sm Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
6
Indications for Use Statement
Page 1 of 1
510(k) Number: K080255
Sofia™ Automated Tomographic Ultrasound (ATUS) Device Name:
Indications for use:
The Sofia™ (ATUS) device is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aomi M Whang
(Division Sign-Off)
D sion of Reproductive, Abdominal a F -diological Devices ! (U(k) Number
7
Diagnostic Ultrasound Indications for Use Form
510(K) Number: K080555
Device Name: Sofia ™ Automated Tomographic Ultrasound (ATUS) device Ultrasound probe - GE 12L-RS
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) | P | ||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculoskeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N=New indication: P=Previously Cleared by FDA; E= Added Under Appendix E
Additional Comments: The iVu Imaging Sofia™ Automated Tomographic Ultrasound (ATUS) device is intended for ultrasonic breast examinations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
lone In Whay
(Division Sign-Off) Division of Reproductive, Abdominal ar Radiological Dev 510(k) Number