The Transvaginal Doppler Probe is a ring-handled instrument with integrated Doppler sensors, which allow for bilateral blood flow sensing of the uterine blood vessels by connecting to a commercially available portable transceiver box. The Transvaginal Doppler Probe is manufactured from stainless steel.

AI/ML Overview

The provided document for K023024, "Vascular Control Systems, Inc. Transvaginal Doppler Probe," is a 510(k) premarket notification. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical studies.

Therefore, the document does not contain information on:

Acceptance criteria and reported device performance in a table. No specific quantitative performance metrics or acceptance thresholds are provided.
A study proving the device meets acceptance criteria. The document references nonclinical tests for electrical, thermal, and acoustic safety, but not a study demonstrating clinical performance or meeting specific acceptance criteria.
Sample size used for the test set or data provenance. No test set for clinical performance is described.
Number of experts used to establish ground truth or their qualifications. Ground truth for clinical performance is not discussed.
Adjudication method for the test set. No test set or adjudication process is mentioned.
Multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is not mentioned.
Standalone (algorithm only) performance. This device is a probe, not an algorithm.
Type of ground truth used. No ground truth for clinical performance is mentioned.
Sample size for the training set. No training set for an algorithm is applicable.
How the ground truth for the training set was established. Not applicable.

What the document does include regarding performance:

The document states under "Brief summary of nonclinical tests and results" (Section 7 from {1}) that:

The Transvaginal Doppler Probe was "designed and tested to comply with the requirements of IEC 60601-1 for electrical and thermal safety."
"Acoustic output power measurements were performed in accordance with the FDA Guidance document 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers'."
"Test results indicate reliable performance when the device is used in accordance with the Instructions for Use."
"The Transvaginal Doppler Probe does not raise new issues of safety, effectiveness, or performance of the product."

In the FDA's clearance letter ( {3} and {4}), there's a condition for clearance:

"This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a post clearance 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."

This indicates that while initial acoustic output measurements were submitted, further confirmation from production units was required post-clearance. The "unacceptable values" here refer to regulatory limits for acoustic output, not clinical performance acceptance criteria in the sense of a diagnostic accuracy study.

In summary, the 510(k) submission for the Vascular Control Systems, Inc. Transvaginal Doppler Probe relies on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and nonclinical safety testing, rather than presenting a clinical study with specific acceptance criteria and performance metrics.

Summary

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K023024

Vascular Control Systems, Inc. Transvaginal Doppler Probe

SEP 2 6 2002

Confidential Premarket Notification (510(k))

SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA and 21 CFR 807.92.

1. Submitter's name, address, telephone number, contact person, and date summary prepared:

a.	Submitter:	Vascular Control Systems, Inc.32236-E Paseo AdelantoSan Juan Capistrano, CA 92675(949) 488-8700
b.	Contact Person:	Al MemmoloVice President, Regulatory Affairs/Quality Assurance(949) 488-8700 ext. 108

Date Summary Prepared: August 14, 2002 C.

Name of device, including trade name and classification name:

a.	Trade/Proprietary Name:	Transvaginal Doppler Probe
b.	Classification name:	Diagnostic Ultrasonic Transducer(21 CFR §892.1570)

1. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

Company:	Koven Technology, Inc.
Device:	PW Doppler Vascular Probes
510(k):	K935994
Date Cleared:	May 11, 1995

1. A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
  The Transvaginal Doppler Probe is a ring-handled instrument with integrated Doppler sensors, which allow for bilateral blood flow sensing of the uterine blood vessels by connecting to a commercially available portable transceiver box. The Transvaginal Doppler Probe is manufactured from stainless steel.

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ડ. Statement of intended use:

The Transvaginal Doppler Probe is intended for bilateral detection of uterine blood vessels.

6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.

The Transvaginal Doppler Probe and the predicate device are both intended for detecting blood flow of blood vessels using an 8 MHz pulsed-wave Doppler sensor. The Doppler crystals in both devices are located at the distal end to allow for forward detection of blood flow. Both devices are constructed of stainless steel and are provided non-sterile, and are reusable.

7. Brief summary of nonclinical tests and results:

The Transvaginal Doppler Probe has been designed and tested to comply with the requirements of IEC 60601-1 for electrical and thermal safety. Acoustic output power measurements were performed in accordance with the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers". Test results indicate reliable performance when the device is used in accordance with the Instructions for Use. The Transvaginal Doppler Probe does not raise new issues of safety, effectiveness, or performance of the product.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 26 2002

Vascular Control Systems c/o Mr. Heinz Joerg Steneberg Division Manager Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K023024

Trade Name: Transvaginal Doppler Probe, Model 09-0006-02 Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: Class II Product Code: 90 ITX Dated: August 19, 2002 Received: September 11, 2002

Dear Mr. Steneberg:

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 Transvaginal Doppler Probe, as described in your premarket notification:

Transducer Model Number

Model 09-0006-02 1.5x15mm 8MHz

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Page 2 - Mr. Heinz Joerg Steneberg -

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 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 that FDA has made a determination that your device complies with other requirements of the Act 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a post clearance 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 Secking 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 regulation (21 CFR Part 801, 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 Part 807.97). Other general information on your

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Page 3 – Mr. Heinz Joerg Steneberg

responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free 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 Mr. Rodrigo Perez at (301) 594-1212.

Sincerely yours,

David A. Bergman

for

llor Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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l ransvaginal

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 he human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(specify)
IntraoperativeNeurological
Pediatric
Small Organ(specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal				N
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments: Model 09-0006-02

The transducer is specified for use with the Vascular Technology, Inc. Doppler Transceiver, 8 MHz Selectable Channel, VTI P/N 108900

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

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

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K023024

Indications for Use Statement

510(k) Number (if known):

K013024

Page 1 of 1

Device Name:

Transvaginal Doppler Probe

Indications for Use:

The Transvaginal Doppler Probe is intended for bilateral detection of uterine blood vessels.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_ Prescription Use OR Over-The-Counter-Use (Per 21 CFR 801.109)

Regulation Number and Section

§ 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.