(25 days)
Not Found
No
The document describes a standard ultrasound system with image processing, but there is no mention of AI, ML, or related concepts in the intended use, device description, or other sections. The lack of information on training/test sets and performance metrics also suggests the absence of AI/ML.
No
The device is clearly indicated for "diagnostic ultrasound imaging" and produces "2D images", not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system and transducers are "intended for diagnostic ultrasound imaging of the human body."
No
The device description explicitly lists multiple hardware components including a system console, keyboard, ultrasound probe, monitor, and printer, indicating it is a hardware-based system with associated software.
Based on the provided information, the SONALIS® system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The SONALIS® system uses ultrasound waves to image within the human body.
- The intended use is diagnostic ultrasound imaging. This is a form of medical imaging, not laboratory testing of biological samples.
- The device description focuses on imaging components. It describes a system console, probes, monitor, etc., which are typical for imaging devices.
- There is no mention of analyzing biological samples or performing tests on them.
Therefore, the SONALIS® system falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SONALIS® system and transducers are intended for diagnostic ultrasound imaging of the human body. The clinical application is trans-rectal imaging. Typical examination using the SONALIS® Platform system: Prostate and Rectal wall studies.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The SONALIS® is a real time, two-dimensional, diagnostic system that produces high quality images. The system currently supports imaging applications for trans-aectorl ultrasound imaging. The system consists of:
- system console,
- keyboard.
- ultrasound probe,
- ultrasound probe connector,
- power cord,
- high resolution LCD monitor to display the image,
- System Operating Manual
- B&W graphic printer.
Mentions image processing
Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as a 2D images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Human body, trans-rectal imaging, Prostate, Rectal wall
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 892.1570 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
Kloozoy
510(k) Summary 807.92(c)
FEB 1 9 2010
SPONSOR Company Name:
Company Address
ﺎ ﮨﮯ
Best NOMOS
One Best Drive Pittsburg, PA 15202
Telephone:
(800) 70-NOMOS
Contact Person:
Andrew Chi Palko
Summary Preparation Date: November 24, 2009
DEVICE NAME
Trade Name: Common/Usual Name: Classification Name:
Regulation Number: Product Code: Device Class:
PREDICATE DEVICE
Legally Marketed Equivalent Device Company 3G Ultrasound Inc. Sonalis Ultrasound System
807.92(a)(2)
807.92(a)(1)
Sonalis® Ultrasound System Diagnostic Ultrasound System Ultrasonic pulsed echo imaging system, Diagnostic ultrasonic transducer 892.1560, 892.1570 IYO, ITX Class II
510(k) # K043189
Product
DEVICE DESCRIPTION
The SONALIS® is a real time, two-dimensional, diagnostic system that produces high quality images. The system currently supports imaging applications for trans-aectorl ultrasound imaging. The system consists of:
- . system console,
- . keyboard.
- . ultrasound probe,
- . ultrasound probe connector,
- . power cord,
- high resolution LCD monitor to display the image, �
- System Operating Manual ●
- B&W graphic printer .
2023-24
807.92(a)(3)
807.92(a)(4)
1
DEVICE INTENDED USE
807.92(a)(5)
The SONALIS® system and transducers are intended for diagnostic ultrasound imaging of the human body. The clinical application is trans-rectal imaging. Typical examination using the SONALIS® Platform system: Prostate and Rectal wall studies.
COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)
This device operates identically to the predicate device in that the piezoelectrical material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as a 2D images.
NONCLINICAL AND CLINICAL TEST
807.92(b)
SAFETY and EFFECTIVENESS
.. - - - ---------------------------------------------------------------------------------------------------------------------------------------------------------------------
The SONALIS® is compliant to the safety standards.
UL60601-1 (2003), 181 Edition Medical Electrical Equipment, Part 1, General Requirements for Safety
IEC 60601-1 (1988), 2nd Edition, Medical Electrical Equipment, Part 1: General Requirements for Safety +A1(91) + A2(95)
IEC 60601-2 (2001), 2nd Edition Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic compatibility IEC 60601-2-37 (2001), 1st Edition Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment +A1(2004)
BIOCOMPATIBILITY
SONALIS® was tested in accordance with the testing requirements of the ISO 10993 Recognized Standards and found to be safe for its intended use.
CONCLUSION
807.92(b)(3)
The SONALIS® Ultrasound System is the same device as the predicate except for updated components that do not affect safety and efficacy. The SONALIS@ Ultressound System is the same device
- Intended Use
- . Design
- Technological Characteristics 0
The Sonalis Ultrasound System introduces no new questions concerning the safety or effectiveness and is thus substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped with three horizontal bars. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
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
Best NOMOS % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062
FEB 1 9 2010
Re: K100204
Trade/Device Name: SONALIS Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: January 15, 2010 Received: January 22, 2010
Dear Mr. Devine:
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 iddions 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 In Include in Including of 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, isting 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 frither 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 manon coss not incan 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 freporting 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 vours.
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
510(k) Number (if known): K100204
Device Name: SONALIS
Indications for Use:
The SONALIS® system and transducers are intended for diagnostic ultrasound imaging of the human body. The clinical application is trans-rectal imaging.
Typical examination using the SONALIS® Platform system: Prostate and Rectal wall studies.
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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Hh
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number_
Page 1 of 1
5
TRACK 1
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 | Color | ||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic . | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | |||||||||
| 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
. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1
Additional Comments: Sonalis TRT TRIVIEW -467 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
M
Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K100204