K Number

Device Name

SONADA ULTRASOUND SYSTEM

Manufacturer

SONOVISION CORP.

Date Cleared

2000-04-14

(211 days)

Product Code

OXO

Regulation Number

892.1650

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Small Organ, Transrectal, Transvaginal, Peripheral Vascular. CLI 4900 6.5MHz Trans-vaginal (endocavity) probe: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transvaginal. CLI 5000 6.5MHz Trans-rectal (endocavity) probe: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transrectal. CLI 6000 12.5MHz Peripheral Vascular probe: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ, Peripheral Vascular. CLI 7900 3.5MHz General Abdominal probe: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal.

Device Description

Not Found

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text describes a standard ultrasound device and its probes, focusing on intended use and anatomical sites. There is no mention of AI, ML, or related concepts in the document.

Therapeutic

No
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis," indicating its purpose is for diagnosis rather than treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body".

SaMD (Software as a Medical Device)

The intended use and device description clearly indicate the use of physical ultrasound probes (CLI 4900, CLI 5000, CLI 6000, CLI 7900) which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device function: The description clearly states the device is for "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This is an in vivo diagnostic method, meaning it is performed directly on the living body, not on a sample taken from the body.
Anatomical sites: The listed anatomical sites (Abdominal, Small Organ, Transrectal, Transvaginal, Peripheral Vascular) are all locations within the human body where ultrasound is applied externally or internally, not where samples are collected for testing.

Therefore, this device falls under the category of medical imaging devices rather than in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

For SONADA Ultrasound System:
Clinical Application: Abdominal (P), Small Organ (P) (Small organ=Breast, Thyroid, Testes), Transrectal (P), Transvaginal (P), Peripheral Vascular (P)

For CLI 4900 6.5MHz Trans-vaginal (endocavity) probe:
Clinical Application: Transvaginal (P)

For CLI 5000 6.5MHz Trans-rectal (endocavity) probe:
Clinical Application: Transrectal (P)

For CLI 6000 12.5MHz Peripheral Vascular probe:
Clinical Application: Small Organ (P) (Small organ = Breast, Thyroid, Testes), Peripheral Vascular (P)

For CLI 7900 3.5MHz General Abdominal probe:
Clinical Application: Abdominal (P)

Product codes (comma separated list FDA assigned to the subject device)

90 IYO, 90 IYN

Device Description

SONADA Ultrasound System. This product includes the following probe model numbers: CLI 4900 6.5MHz Trans-vaginal (endocavity) probe, CLI 5000 6.5MHZ Trans-rectal (endocavity) probe, CLI 6000 12.5MHz Peripheral Vascular probe, CLI 7900 3.5MHz General Abdominal probe.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Human body, Trans-vaginal (endocavity), Trans-rectal (endocavity), Peripheral Vascular, General Abdominal, Breast, Thyroid, Testes

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.

Not Found

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

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/14 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Public Health Service

APR 1 4 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Paul Schneider, Ph.D. Requlatory Affairs Consultant SonoVision Corporation 377 Route 17 South Suite 204 Hasbrouck Heights, NJ 07604

Re : K993092 SONADA Ultrasound System Regulatory Class: II/21 CFR 892.1560/21 CFR 892.1550 Product Code: 90 IYO/90 IYN Dated: March 10, 2000 Received: March 13, 2000

Dear Dr. Schneider:

We have reviewed your Section 510(k) 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 SONADA Ultrasound System, as described in your premarket notification:

Probe Model Numbers

CLI 4900 6.5MHz Trans-vaginal (endocavity) probe CLI 5000 6.5MHZ Trans-rectal (endocavity) probe CLI 6000 12.5MHz Peripheral Vascular probe CLI 7900 3.5MHz General Abdominal probe

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. ನ್ನ substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Page 2 - Paul Schneider, Ph.D.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Daniel A. Szyman
Daniel G. Schulte, M.D.

aniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

Device name: SONADA ULTRASOUND SYSTEM

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		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P
Transvaginal		P
Transurethral
Intravascular
Peripheral Vascular		P		P
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)

N= new indication: P= previously cleared by FDA: E= added under Appendix E Small organ=Breast, Thyroid, Testes Additional Comments:

image =>

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)

Jarich A. Sypm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 42 510(k) Number

3-4

Device Name: CLI 4900 6.5MHz Trans-vaginal (endocavity) probe

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

İntended Use: Diagnostic utrasound imaging or thuid 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)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal		P
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:__________________

PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE WEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Seymour
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number

Device name: CLI 5000 6.5MHz Trans-rectal (endocavity) probe

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)
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

Additional Comments:__________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGEIF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Syym
Division Sign-Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Device name: CLI 6000 12.5MHz Peripheral Vascular probe

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;

Clinical Application	Mode of Operation
	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)		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P		P
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, Thyroid, Testes

PLEASE DO NOT VIRATE 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 Ligon
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT. and Radiological Devic

510(k) Number K993042

Device name: CLI 7900 3.5MHz General Abdominal probe

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

litended 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		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
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:

(PLEASE DO NOT VIRITE 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. Symm

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number