(9 days)
The Transvaginal Doppler Probe is intended for bilateral detection of uterine blood vessels.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transvaginal
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.
This document describes a 510(k) premarket notification for a Vascular Control Systems, Inc. Transvaginal Doppler Probe (K031358). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data for new claims. Therefore, the information regarding acceptance criteria and detailed study performance as typically found for novel devices with specific performance claims is limited.
However, based on the provided text, here's an analysis:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | Designed and tested to comply with IEC 60601-1 |
| Thermal Safety | Compliance with IEC 60601-1 | Designed and tested to comply with IEC 60601-1 |
| Acoustic Output | Measurements in accordance with FDA Guidance (Appendix G) | Acoustic output measurements performed; detailed results not explicitly stated in summary but implies compliance for "reliable performance" |
| Performance Reliability | Reliable performance during testing | Test results indicate reliable performance when used as instructed. |
| Substantial Equivalence | Comparison to predicate device (K023024) | Demonstrated substantial equivalence in intended use, technological characteristics (8 MHz pulsed-wave Doppler sensor, distal crystal location, stainless steel construction). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific clinical "test set" in the context of efficacy or diagnostic performance. The testing mentioned (electrical, thermal, acoustic output) are non-clinical engineering and safety tests. Thus, this information is not applicable or provided for a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document does not describe a clinical study requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable as the document does not describe a clinical study requiring adjudication for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission is a 510(k) demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device, not a comparative clinical trial.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is not an algorithm, but rather a physical probe (transducer) that connects to a transceiver box. Therefore, the concept of "standalone algorithm performance" is not applicable. The device's performance is inherently linked to its use by a human operator with the transceiver.
7. The Type of Ground Truth Used
For the non-clinical tests (electrical, thermal, acoustic output), the "ground truth" would be established by physical measurements and adherence to international standards (IEC 60601-1) and FDA guidance documents for acoustic output.
For the substantial equivalence claim, the "ground truth" is the established characteristics and performance of the predicate device (K023024).
8. The Sample Size for the Training Set
This information is not applicable as this device does not involve a machine learning algorithm that requires a training set. The "training" here refers to manufacturing and design to meet specified engineering and safety standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above. The "ground truth" for manufacturing and design would be engineering specifications and regulatory standards.
Summary of Device and Evidence:
The Vascular Control Systems, Inc. Transvaginal Doppler Probe is an 8 MHz pulsed-wave Doppler sensor intended for bilateral detection of uterine blood vessels. Its 510(k) clearance was based on demonstrating substantial equivalence to its own previously cleared device (K023024).
The primary evidence presented for meeting "acceptance criteria" (though not explicitly framed as such with specific numerical targets in the summary) is:
- Compliance with IEC 60601-1 for electrical and thermal safety.
- Acoustic output measurements performed in accordance with FDA guidance, which implicitly met acceptable levels to ensure "reliable performance" and no "new issues of safety, effectiveness, or performance."
- Technological similarity to the predicate device, including the 8 MHz pulsed-wave Doppler sensor, distal crystal location, and stainless steel construction, which supports the claim of similar performance for the stated intended use.
The submission is a regulatory pathway for devices considered substantially equivalent, and therefore, it does not typically involve detailed clinical studies with specific performance metrics against clinical ground truth, expert adjudication, or MRMC studies for human reader improvement. The focus is on demonstrating that the new device is as safe and effective as a legally marketed one.
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Vascular Control Systems, Inc. Transvaginal Doppler Probe
Confidential Premarket Notification (510(k))
SUMMARY OF SAFETY AND EFFECTIVENESS
MAY - 9 2003
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 Paseo Adelanto, Ste. ESan Juan Capistrano, CA 92675(949) 488-8700 |
|---|---|---|
| b. | Contact Person: | Kathleen RobertsSenior Regulatory Affairs SpecialistTelephone: (949) 488-8700 ext. 115Fax: (949) 488-8708 |
- April 18, 2003 Date Summary Prepared: C.
Name of device, including trade name and classification name: 2.
| a. | Trade/Proprietary Name: | Transvaginal Doppler Probe |
|---|---|---|
| b. | Classification name: | Diagnostic Ultrasonic Transducer(21 CFR §892.1570) |
-
- Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
| Company: | Vascular Control Systems, Inc. |
|---|---|
| Device: | Transvaginal Doppler Probe |
| 510(k): | K023024 |
| Date Cleared: | September 26, 2002 |
-
- 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.
- 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):
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ડ. Statement of intended use:
The Transvaginal Doppler Probe is intended for bilateral detection of uterine blood vessels.
Statement of how the technological characteristics of the device compare to 6. those of the predicate or legally marketed device.
The Transvaginal Doppler Probe and the predicate device are both intended to detect 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.
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stripes representing health, human services, and prevention. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2003
Vascular Control Systems, Inc. % Mr. Heinz Joerg Steneberg Responsible Third Party TUV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K031358 Trade Name: Transvaginal Doppler Probe,
Models # 09-0012-01, 09-0012-02, and 09-0012-03 Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 ITX Dated: April 28, 2003 Received: April 30, 2003
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 Vascular Technologies Doppler Transceiver (8 MHz selectable channel, P/N 108900) as described in your premarket notification:
Transducer Model Number
| 09-0012-01 |
|---|
| 09-0012-02 |
| 09-0012-03 |
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
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Page 2 - Mr. Steneberg
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 (QS) 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 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 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 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 Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David A. Lynam
Nancy C. Prender
Nancy C. Brogdo Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
| 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 | P | |||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments: Model # 09-0012-01, 09-0012-02, 09-0012-03
The transducer is specified for use with the Vascular Technology, Inc. Doppler Transceiver,
8 MHz Selectable Channel, VTI P/N 108900
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
Concurrence of CDRH, Office of Device Evaluation (
Prescription Use (Per 21 CFR 801.109)
David A. Bergman
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§ 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.