K Number

Device Name

DIAGNOSTIC ULTRASOUND, MODEL 1.0

Manufacturer

VOLUMETRICS MEDICAL IMAGING, INC.

Date Cleared

1999-09-29

(75 days)

Product Code

IYO ITX IYN

Regulation Number

892.1560

Intended Use

Diagnostic Ultrasound Clinical Application: Fetal, Abdominal, Pediatric, Small Organ (Testes, adult female breast, and thyroid), Cardiac, Peripheral Vascular. Mode of Operation: A, B, M, PWD, Color Doppler, Amplitude Doppler, Combined (Single B mode or multi-B mode will operate in single combination with M-Mode, or PWD, or color Doppler, or amplitude Doppler), Other (Contrast Harmonics mode to optimize the image when using contrast media).

Device Description

Model 1.0 Diagnostic Ultrasound System with Contrast Harmonic Imaging. Addition of Contrast Harmonics mode to optimize the image when using contrast media. Contrast Harmonic modes will utilize second harmonics.

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

K963863, K952551, K982498

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound modes and contrast harmonics.

Therapeutic

No
The "Intended Use / Indications for Use" section explicitly states "Diagnostic Ultrasound" and lists various anatomical sites for imaging, which is indicative of a diagnostic, not therapeutic, device. There is no mention of treating, curing, or preventing disease.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic Ultrasound." Additionally, the "Device Description" mentions "Model 1.0 Diagnostic Ultrasound System."

SaMD (Software as a Medical Device)

The device description explicitly states "Model 1.0 Diagnostic Ultrasound System," which indicates a hardware component (the ultrasound system itself) is part of the device, not just software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use/Indications for Use: The intended use clearly states "Diagnostic Ultrasound" and lists various clinical applications related to imaging internal structures of the body. This is characteristic of an in-vivo diagnostic device, not an in-vitro diagnostic device.
Device Description: The description details a "Diagnostic Ultrasound System" and its modes of operation, all of which are used for generating images of the body.
Input Imaging Modality: The input modality is "Diagnostic Ultrasound," which is an imaging technique applied directly to the patient.
Anatomical Site: The listed anatomical sites are all within the human body.

IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body, not to image the body directly.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Model 1.0 Diagnostic Ultrasound System with Contrast Harmonic Imaging is intended for Diagnostic Ultrasound. Clinical applications include Fetal, Abdominal, Pediatric, Small Organ (Testes, adult female breast, and thyroid), Neonatal Cephalic, Cardiac, and Peripheral Vascular. It supports modes of operation such as A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, and Combined (Single B mode or multi-B mode in combination with M-Mode, or PWD, or color Doppler, or amplitude Doppler). The system also includes Contrast Harmonics mode to optimize the image when using contrast media, utilizing second harmonics.

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

90 LYN, 90 IYO, 90 ITX

Device Description

The Model 1.0 Diagnostic Ultrasound System with Contrast Harmonic Imaging is a diagnostic ultrasound system. It includes the Model 214U transducer. It has previously been cleared under 510(k) K963863, K952551, and K982498. The current submission adds Contrast Harmonics mode, which optimizes the image when using contrast media and utilizes second harmonics.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (Testes, adult female breast, thyroid), Neonatal Cephalic, Cardiac, Peripheral Vascular.

Indicated Patient Age Range

Not Found (Implied: Fetal, Pediatric, Neonatal, Adult)

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.

K963863, K952551, K982498

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

§ 892.1560 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.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized bird or eagle with its wings spread.

SEP 2 9 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert W. Titkemeyer Director Quality Assurance and Regulatory Affairs Volumetrics Medical Imaging, Inc. 700 West Main Street Durham, NC 27701

Re: K992378

Model 1.0 Diagnostic Ultrasound System with Contrast Harmonic Imaging Regulatory Class: II 21CFR892.1550/ 90 1YN 21CFR892.1560/ 90 IYO 21CFR892.1570/90 ITX Dated: September 9, 1999 Received: September 10, 1999

Dear Mr. Titkemeyer

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 Model 1.0, as described in your premarket notification:

Transducer Model Number

214U

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. A substantially equivalent determination ussumes 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 - Mr. Robert W. Tikemeyer

.
This determination of substantial equivalence is granted on the condition that prior to shipping the first of This determination of substantial equivalence is granted information, including acoustic output outputi
submit a postelearance special report. This report should contain and submit a postclearance special report should contain comments of the Center is September 30,
measurements based on production ine devices, requested in Apendix O, (carosed) o measurements based on production line devices in Applines of Diagnostic Ultrasound Systems and
1997 "Information for Manufacturers Seeking Marketing Clearanes of Diagnostic 1997 "Information for Manufacturers Seeking Marketing Creater Personality of Preserver of Preserver of Preserver han
Transducers." If the special report is incomplete and sec Transducers." If the special report is incomplete or contains maceptable halse (20).
approved levels), then the 510(k) clearance may not apply to the production units which a considered adulterated or misbranded.

The special report should reference the manufacturer's $10(k) number. It should be clearly and prominently marked
ing the submit of the submit also desdiests to: The special report should relevely in duplicate to:

Food and Drug Administration Pood and Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your premarket notification. The FDA
n a classification in the county in a clearly marketed predicate device results in a class This letter will allow you to begin marketing your device as described in your promoted to the results in a classification for
finding of substantial equivalence of your devi nnumig of substantial equit it your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10
, 10 love and contract and and the Office of Compliance at If you desire specific advice for your device of comminue at (30 ) ( S 99 -459 ). Additionally, for
for in vitro diagnostic devices), please contact the Office of Complianc for in vitro diagnosic devices), please contact the Office of Colfice of Compliance at (301) 594questions on the promotion and advertising of your device, please contact to questions on the promotion and advertising of your develop. An oremarket notification" (21 CFR
4639. Also, please note the regulation entitled, "Misbranding by reference obj 4639. Also, please note the regulation onttitled, "Wishling of the Art may be obtained from the Division of
807.97). Other general information on your responsibilities under 807.97). Other general information on your responsion (800) 638-2041 or at (301) 443-6597 or at its internet
Small Manufacturers Assistance at its toll-free number (800) 638address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Paul M. Gammell, Ph.D. at (301) 594-1212.

Sincerely yours,

Javid C. Sezmm

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

K フブレイア 4

THIS PAGE CONTAINS INFORMATION CONFIDENTIAL TO: VOLUMETRICS Medical Imaging Inc.

Diagnostic Ultrasound Indications for Use Form

Device Name:		Model 1.0
Intended Use:	Diagnostic Ultrasound
Clinical							Mode of Operation
Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal		P	P	P		P	P	(1)	N
Abdominal		P	P	P		P	P	(1)	N
Intraoperative
(specify)
Intraoperative
Neurological
Pediatric		P	P	P		P	P	(1)	N
Small Organ
(specify)		P	P	P		P	P	(1)	N
Neonatal Cephalic		P	P	P		P	P	(1)	N
Adult Cephalic
Cardiac		P	P	P		P	P	(1)	N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral
Vascular		P	P	P		P	P	(1)	N
Laparoscope
Musculo-skeletel
Conventional
Musculo-skeletel
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA; E = Added under Appendix E Additional Comments:

(1) Single B mode or multi-B mode will operate in single combination with M-Mode, or PWD, or color Doppler, or amplitude Doppler (see 4.4.1.1 Transducer Operation table I for a complete listing of combinations).
Small organ (specify) - Testes, adult female breast, and thyroid.

Model 1.0 was previously cleared under 510(k) K963863, K952551, and K982498

Addition of a the following modes:

1 . Contrast Harmonics mode to optimize the image when using contrast media
Contrast Harmonic modes will utilize second harmonics.

David A. Segen
(Division Sta. Off)

.. . Reproductive, Ahdominal, E and Radiological Dev

510(k) Number K992378

Prescription Use (Per 21 CFR 801.109)

Page 4.3-2

K992378

THIS PAGE CONTAINS INFORMATION CONFIDENTIAL TO: VOLUMETRICS Medical Imaging Inc.

Diagnostic Ultrasound Indications for Use Form

Device Name:		Transducer Model 214U
Intended Use:					Diagnostic Ultrasound
Clinical		Mode of Operation
Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal		P	P	P		P	P	(1)	N
Abdominal		P	P	P		P	P	(1)	N
Intraoperative
(specify)
Intraoperative
Neurological
Pediatric		P	P	P		P	P	(1)	N
Small Organ
(specify)		P	P	P		P	P	(1)	N
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P	(1)	N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral
Vascular		P	P	P		P	P	(1)	N
1 aparoscope
Musculo-skeletel
Conventional
Musculo-skeletel
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA; E = Added under Appendix E Additional Comments:

(1) Single B mode or multi-B mode will operate in single combination with M-Mode, or PWD, or color Doppler, or amplitude Doppler (see 4.4.1.1 Table I for a complete listing of combinations).

Small organ (specify) - Testes, adult female breast, thyroid.

The transducer will be operated using Contrast Harmonic mode which operate the transducer at second harmonics.

David A. Shapiro

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

Prescription Use
(Per 21 CFR 801.109)

Page 4.3-3