(41 days)
Not Found
No
The description focuses on automated image acquisition and a software for manual review. There is no mention of AI/ML for image analysis, interpretation, or decision support.
No
The device is indicated for imaging and is not described as providing any therapeutic effect or treatment.
Yes
The device is indicated for "B-mode ultrasonic imaging of the patient's breast," which is a method used to visualize internal structures for medical assessment, directly implying a diagnostic purpose.
No
The device description explicitly states that the system includes a "SonoCiné Image Acquisition Station Model 100" which is described as a "probe guiding adjunct to ultrasound systems" that uses a "servo motor guided arm" and contains a "computer". This indicates the presence of hardware components beyond just software.
Based on the provided information, the SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- SonoCiné Function: The SonoCiné system is described as an adjunct to mammography for B-mode ultrasonic imaging of the patient's breast. It uses an ultrasound transducer to create images of the breast tissue in vivo (within the living body). It does not involve the analysis of specimens taken from the body.
- Device Description: The description clearly outlines the system's components and their functions, all of which relate to acquiring and reviewing ultrasound images directly from the patient's breast.
Therefore, the SonoCiné system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the patient's breast when used with an automatic scanning linear array transducer. This device is not intended to be used as a replacement for screening mammography.
Product codes
IYO
Device Description
SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 consisting of SonoCiné Image Acquisition Station Model 100 and SonoCiné Image Reading Station Model 100.
The SonoCiné Image Acquisition Station Model 100 is a probe guiding adjunct to ultrasound systems which have been previously cleared by FDA. The SonoCiné Image Acquisition Station Model 100 uses a servo motor guided arm to control the speed and direction of the ultrasound transducer during breast scanning examinations. In addition, the SonoCiné Image Acquisition Station Model 100 contains a computer which interfaces to the video output of ultrasound system to record and store, electronically, the ultrasound images at regular time intervals.
The SonoCiné Image Reading Station Model 100 is a software product intended to operate on a personal computer with minimum performance configurations. The SonoCiné Image Reading Station Model 100 is a software product intended to allow after-the-fact review of the images obtained and stored by the SonoCiné Image Acquisition Station Model 100.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
B-mode ultrasonic imaging
Anatomical Site
patient's 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
System Validation Testing was performed on a breast phantom with 10 (ten) masses randomly positioned.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
DESIGN VALIDATION TESTS: NON-CLINICAL TESTING: System Validation Testing was performed on a breast phantom with 10 (ten) masses randomly positioned. All 10 of the masses were successfully identified. The results indicate that the SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 is substantially equivalent to the listed predicate devices.
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.
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
§ 892.1560 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 5.
OCT 1 4 2008
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: August 10, 2008
510(k) number:
Applicant Information: SonoCiné, Inc.
5475 Reno Corporate Drive Reno, NV 89511
Contact Person
Robert J. Chin, Ph.D. Requlatory Consultant (650) 593-5225
Device Information:
| Trade Name: | SonoCiné Adjunctive Breast Ultrasound System (ABU) Model |
|---|---|
| 100 | |
| Classification: | Class II |
| Classification Name: | System, imaging, pulsed echo, ultrasonic |
Physical Description:
SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 consisting of SonoCiné Image Acquisition Station Model 100 and SonoCiné Image Reading Station Model 100.
The SonoCiné Image Acquisition Station Model 100 is a probe guiding adjunct to ultrasound systems which have been previously cleared by FDA. The SonoCiné Image Acquisition Station Model 100 uses a servo motor guided arm to control the speed and direction of the ultrasound transducer during breast scanning examinations. In addition, the SonoCiné Image Acquisition Station Model 100 contains a computer which interfaces to the video output of ultrasound system to record and store, electronically, the ultrasound images at reqular time intervals.
The SonoCiné Image Reading Station Model 100 is a software product intended to operate on a personal computer with minimum performance configurations. The SonoCiné Image Reading Station Model 100 is a software product intended to allow after-the-fact review of the images obtained and stored by the SonoCiné Image Acquisition Station Model 100.
Intended Use: The SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 is indicated for use as an adiunct to mammography for B-mode ultrasonic imaging of the patient's breast when used with an automatic scanning linear array transducer. This device is not intended to be used as a replacement for screening mammography.
Equivalent Device: The subject device is substantially equivalent in intended use and/or method of operation to the following devices which were previously cleared by FDA
1
The Orison Embrace System (Orison, Corp; Johnson City, TN) (K070477) and
The ABUS Diagnostic Ultrasound System (U-Systems, Inc; San Jose, CA) (K052355)
SonoCiné, Inc. claims that the SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 is substantially equivalent to the devices previously cleared by FDA in K070477 and K052355. SonoCiné, Inc. claims this equivalence because the proposed device has an equivalent intended use, manufacturing materials, operating principles, and physical and operational specifications compared to the predicate devices.
Test Results: DESIGN VERIFICATION TEST: The design specifications of the SonoCiné Adiunctive Breast Ultrasound System (ABU) Station Model 100 were tested and verified to confirm that the product performance fulfilled those specification requirements.
DESIGN VALIDATION TESTS:
NON-CLINICAL TESTING: System Validation Testing was performed on a breast phantom with 10 (ten) masses randomly positioned. All 10 of the masses were successfully identified.)
The results indicate that the SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 is substantially equivalent to the listed predicate devices.
Summary:
Based on the intended use, product, performance and software information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows a logo with a circular border containing text, and a symbol in the center. The text around the border is not clearly legible, but it appears to be in all capital letters. The central symbol consists of three curved lines that resemble stylized bird wings or flowing lines. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 2008
SonoCinc, Inc. % Mr. Morten S. Christensen Staff Engineer & FDA Office Coordinator Underwriters Laboratories, Inc. 455 E. Trimble Rd. SAN JOSE CA 35131
Re: K082543
Tradc/Device Name: SonoCiné Adjunctive Breast Ultrasound System (AUB) Model 100 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed imaging system Regulatory Class; II Product Code: IYO Dated: September 26, 2008 Received: September 29, 2008
Dear Mr. Christensen:
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 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.
3
Page 2
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 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 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/odrh/industry/support/index.html.
Sincerely yours,
loque M. Whang
Joyce M. Whang, Ph.D Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT 4.
510(k) Number (if known):
Device Name:
Indications for Use: The SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the patient's breast when used with an automatic scanning linear array transducer. This device is not intended to be used as a replacement for screening mammography.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE).
| (Divisi | |
|---|---|
| Divisi | |
| Radio | Abdominal and |
| 510(k | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K082543 |
5475 Reno Corporate Dr. Suite 200 Reno NV 89511 Phone (775) 851-7474 Fax (775) 256-1845 www.SonoCine.com
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5
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
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 (specify) | N | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) | ||||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||||
| Additional Comments: Small Organ - Breast, B-Mode | ||||||||||
| The SonoCine Adjunctive Breast Ultrasound 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)
F-3
Jules Renen
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082543