SONALIS, MODEL 2000
Device Facts
| Record ID | K043189 |
|---|---|
| Device Name | SONALIS, MODEL 2000 |
| Applicant | 3g Ultrasound, Inc. |
| Product Code | IYO · Radiology |
| Decision Date | Feb 9, 2005 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
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 examinations using the Sonalis Platform system Prostate and rectal wall studies.
Device Story
Sonalis Ultrasound System is a mobile, software-controlled diagnostic ultrasound device. It consists of a system console (user interface, display, electronics) and removable transducers (linear and curved linear arrays). The device uses piezoelectric transducers to transmit sound waves into the body; reflected waves are converted into electrical signals, processed, and displayed as 2D images. Operated by healthcare professionals in clinical settings, the system allows for anatomical measurements and analysis to assist in diagnosis. The output is viewed by clinicians on the system display to inform clinical decision-making regarding prostate, rectal, small organ, and peripheral vascular health.
Clinical Evidence
Bench testing only. The device was evaluated against safety standards including UL 2601-1, CSA C22.2 No 601-1, AIUM/NEMA UD 2, AIUM/NEMA UD 3, IEC 1157, IEC 60601-1-2, and IEC 60601-2-37. No clinical data was required for this 510(k) submission.
Technological Characteristics
Mobile diagnostic ultrasound system; piezoelectric transducer technology; supports linear and curved linear arrays; 2D imaging mode; complies with UL 2601-1, CSA C22.2 No 601-1, AIUM/NEMA UD 2/3, IEC 1157, IEC 60601-1-2, and IEC 60601-2-37 standards.
Indications for Use
Indicated for diagnostic ultrasound imaging of the human body, specifically trans-rectal imaging (prostate and rectal wall studies), small organ imaging (thyroid, testes, breast), and peripheral vascular imaging.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Sonada ultrasound System (K993092)
Submission Summary (Full Text)
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KOH-3189
# 510(k) Summary of Safety and Effectiveness
FEB - 9 2005
This summary of safety and effectiveness is provided as part pf the Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions To 21CFR.Part 807, Subpart E, Section 807.92 Content and Format of a 510 (k) Summary.
#### Submitted By: 1)
3G Ultrasound Corporation 200 Williams Drive Ramsey, NJ 07446
Contact Person: Raul Gutierrez
Phone:(201) 280-4419 Fax: (201) 825-1165
Date Prepared: September 03, 2004
- Proprietary Name: 2) Sonalis Ultrasound System
CommonIUsual Name: Diagnostic Ultrasound with Accessories
#### Classification Name: 21 CFR892.1560
# 892.1560 Product Code 90-IYO Ultrasonic Pulsed Echo Imaging System Product Code 90-ITX Diagnostic Ultrasound Transducer# 892.1570
#### Substantially Equivalent Devices 3)
3G Ultrasound Corporation believes that the Sonalis Platform System and transducers are substantially equivalent to the currently marketed Sonada ultrasound System and transducers cleared in K993092.
#### Device Description 4)
The Sonalis System is a general purpose ,mobile ,software controlled ,diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation.
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The device consists of two parts: the system console and the transducer. The console contains the user interface, a display, system electronics and optional peripherals ( printers).
The removable transducers are connected to the system using standard technology. The Sonalis system uses standard transducer technology and supports linear and curved linear arrays.
The Sonalis system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.
The Sonalis Platform system has been designed to meet the following standards:
- UL 2601-1 Safety Requirements for Medical Equipment .
- CSA C22.2 No 601-1, Safety Requirements for Medical Equipment .
- AIUM/NEMA UD 2 Standard for Real-Time Display of Thermal and Mechanical Output . Indices on Diagnostic Ultrasound Equipment.
- AIUM/NEMA UD 3 Standard for Real-Time Display of Thermal and Mechanical Output . Indices on Diagnostic Ultrasound Equipment.
- IEC 1157 Declaration of Acoustic Power .
- 1EC60601-1-2 .
- . 1EC60601-2-37
### 4) Intend Use
The Sonalis system and transducers are intended for diagnostic ultrasound imaging of the human body. The clinical application is trans-rectal imaging.
Typical examinations using the Sonalis Platform system
- Prostate and rectal wall studies. .
### 5} Technical Characteristic
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.
### 6) Conclusion
The Sonalis Platform ultrasound system and transducers are substantially equivalent in safety and effectiveness to the Sonada system and transducers.
- Both systems are intended for diagnostic ultrasound imaging. .
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- Both Systems are essentially the same technologies for imaging and signal processing.
- · Both systems have acoustic output levels below the applicable FDA limits.
- Both systems are manufactured of materials with matcrials that have been evaluated and found to be safe for its application.
End of 510(k) Summary
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a wavy line.
FEB - 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3G Ultrasound, Inc. % Paul Schneider, Ph.D. Official Correspondent Schneider Associates, Inc. 12672 Coral Lakes Drive BOYNTON BEACH FL 33437
Re: K043189
Trade Name: SONALIS Ultrasound 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: 90 IYO and ITX Dated: January 27, 2005 Received: January 28, 2005
Dear Dr. Schneider:
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 SONALIS Ultrasound System, as described in your premarket notification:
#### Transducer Model Number
#### SONO 2001 SONO 2002
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
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Page 2 - Dr. Schneider
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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any I coloral statutes and regaranents, 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 (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping I 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 In Appendix O, (chelood) of the Samostic Ultrasound Systems and Transducers." If the special Seeking Marketing Clearantee of Blaghesable 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 squivalence of your device to a legally marketed notification. THE I D. I 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 your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
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Page 3 – Dr. Schneider
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David A. Lyman
for
N
B
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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Appendix F
# Diagnostic Ultrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 | | N | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Mode of Operation
Additional Comments:
## SONALIS ULTRASOUND SYSTEM_
*_Thyroid, Testes, Breast
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Layman
(Division Sign Division of Reproductive, Abdo and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Section 3-3 F-3
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Appendix F
#### Diagnostic Ultrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 | | | | | | | | | | |
| Pediatnc | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | N | | | | | | | | |
| 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 EMode of Operation
Additional Comments:
SONO 2001 Transducer
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Bergman
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) ്പെടുന്ന of Reproductive, Abdominal tinlegical Devices
Devices
K043189
Section 3-2 F-3
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Appendix F
#### Diagnostic Ultrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 | | N | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
SONO 2002 Transducer Thyroid, Testes, Breast
Mode of Operation
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Heymann
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number
Section 3-3 F-3
