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.

AI/ML Overview

This document is an FDA 510(k) clearance letter for a diagnostic ultrasound system. It primarily addresses the regulatory approval process rather than specific performance metrics or clinical study details. Therefore, direct answers to many of your questions, especially those regarding acceptance criteria and study results, are not present in the provided text.

However, based on the information provided, here's what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The clearance letter confirms substantial equivalence but does not detail specific acceptance criteria for performance or the results against those criteria. The main "acceptance criteria" discussed are regulatory compliance and the condition of submitting a post-clearance special report on acoustic output measurements.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided. The document does not describe any specific test set or data provenance for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. The document does not describe any test set for which ground truth was established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. No test set or adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. This document pertains to a diagnostic ultrasound system and its "Contrast Harmonic Imaging" mode, not an AI-assisted device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is an ultrasound system, not an algorithm, so a standalone algorithm performance test is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided. No specific "ground truth" related to performance evaluation is mentioned. The clearance is based on substantial equivalence to predicate devices, which implies that the new device performs similarly and is safe and effective for its intended uses.

8. The sample size for the training set

This information is not provided. As this is a traditional diagnostic device, not an AI/ML device, a "training set" in the context of machine learning model development is not applicable.

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

Summary of what is present:

Device: Model 1.0 Diagnostic Ultrasound System with Contrast Harmonic Imaging and Transducer Model Number 214U.
Clearance Type: 510(k) clearance, indicating substantial equivalence to legally marketed predicate devices.
Intended Use: Diagnostic Ultrasound for various clinical applications (Fetal, Abdominal, Pediatric, Small Organ - Testes, adult female breast, thyroid, Cardiac, Peripheral Vascular) using various modes (B, M, PWD, Color Doppler, Amplitude Doppler, Combined).
New Feature: Addition of Contrast Harmonics mode to optimize images when using contrast media, utilizing second harmonics.
Post-Clearance Condition: The manufacturer must submit a post-clearance special report containing acoustic output measurements based on production line devices. This is a condition for the substantial equivalence determination to apply to production units.
Predicate Devices: Model 1.0 was previously cleared under K963863, K952551, and K982498.

This document focuses on the regulatory process of clearance for a new feature (Contrast Harmonic mode) on an existing device, confirming its safety and effectiveness through substantial equivalence to previously cleared devices. It does not contain detailed performance study data, as might be found in a clinical trial report.

Summary

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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.

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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)

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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	ColorDoppler	AmplitudeDoppler	ColorVelocity	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		(1)	N
Abdominal		P	P	P		P	P		(1)	N
Intraoperative(specify)
IntraoperativeNeurological
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
PeripheralVascular		P	P	P		P	P		(1)	N
Laparoscope
Musculo-skeletelConventional
Musculo-skeletelSuperficial
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

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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	ColorDoppler	AmplitudeDoppler	ColorVelocity	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		(1)	N
Abdominal		P	P	P		P	P		(1)	N
Intraoperative(specify)
IntraoperativeNeurological
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
PeripheralVascular		P	P	P		P	P		(1)	N
1 aparoscope
Musculo-skeletelConventional
Musculo-skeletelSuperficial
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

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.