(24 days)
The Fetal Doppler is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.
The Fetal Doppler is a hand-held, battery powered audio Doppler device integrated with 2MHz probe for detecting fetal heart beat. The device is normally applied to pregnancy as early as 12 weeks through the principle of ultrasound shift in hospital or homecare environment. The Fetal Doppler includes the following components: Power supply module, User interface, Signal collection and process module and Control module
The provided text describes a 510(k) submission for a Fetal Doppler device (K112911). However, the information regarding acceptance criteria and the study that proves the device meets the acceptance criteria is extremely limited. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench tests and compliance with recognized standards.
Here's an analysis based on the provided text, highlighting what is present and what is missing based on your questions:
1. Table of acceptance criteria and reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety & Electrical Performance | Compliance with IEC 60601-1 (General Requirements for Safety) | Bench tests demonstrated compliance. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (Collateral standard: Electromagnetic Compatibility) | Bench tests demonstrated compliance. |
| Doppler Performance | Compliance with IEC 61266 (Ultrasonic Hand-held probe Doppler fetal heartbeat detectors - Performance requirements and methods of measurement and reporting) | Bench tests demonstrated compliance. |
| Biocompatibility (Cytotoxicity) | Compliance with ISO 10993-5 (Tests for Vitro cytotoxicity) | Bench tests demonstrated compliance. |
| Biocompatibility (Irritation & Delayed Hypersensitivity) | Compliance with ISO 10993-10 (Test for irritation and delay-type hypersensitivity) | Bench tests demonstrated compliance. |
| Intended Use Achievement | "detecting fetal heart beats" (as per the intended use statement) | The non-clinical tests collectively aimed to verify the device's ability to perform its intended function safely and effectively, implying it can detect fetal heartbeats. |
Missing Information:
- Specific quantitative performance metrics: The document mentions compliance with standards but doesn't provide specific numerical thresholds or the device's measured performance against those thresholds (e.g., specific accuracy levels for heart rate detection, signal-to-noise ratios, etc.). It only states that the device "met all design specifications" and "complies with the following standards."
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The submission refers to "Bench tests," which implies testing of devices in a lab setting, but doesn't quantify the number of devices or measurements taken.
- Data Provenance: The tests are described as "Bench tests," which means they were conducted in a controlled environment, likely by the manufacturer (Beijing Choice Electronic Technology Co., Ltd.) given the context of a 510(k) submission. No information on country of origin for specific test data is provided beyond the manufacturer's location (Beijing, China), and the tests are inherently "retrospective" as they are performed on the manufactured device models for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission focuses on non-clinical engineering and biocompatibility tests. There is no mention of a clinical study, human observers, or experts establishing ground truth for fetal heartbeat detection in a direct patient setting for this 510(k). The "ground truth" for these non-clinical tests would be the established scientific and engineering principles outlined in the referenced standards.
4. Adjudication method for the test set
- Not applicable. As there's no mention of a human-involved "test set" and ground truth establishment, there is no adjudication method described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study or AI assistance is not mentioned or relevant for this submission of a basic Fetal Doppler device. This device is a direct measurement tool, not an AI-assisted diagnostic system requiring human interpretation comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly stated in these terms, but conceptually, yes in its most basic form. The device itself is "standalone" in that it detects fetal heartbeats directly. There is no "algorithm only" performance reported in the context of advanced signal processing or AI. The performance of the device in detecting heartbeats without human interpretation of raw signals is what the IEC 61266 standard compliance would address.
7. The type of ground truth used
- For the non-clinical tests, the "ground truth" is defined by:
- Engineering specifications and recognized international standards: IEC 60601-1, IEC 60601-1-2, IEC 61266, ISO 10993-5, ISO 10993-10. These standards establish the acceptable performance thresholds and methodologies.
- Comparison to a predicate device: The submission states that the proposed device was verified to be "Substantially Equivalent (SE) to the predicate device" through bench tests, implying the predicate device's performance (which was already cleared by the FDA) served as a benchmark for equivalence.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in the conventional sense. The "training" for such a device would be its design and manufacturing process according to engineering principles.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth establishment for it.
{0}------------------------------------------------
Project #:M0242011Bc Premarket Notification 510(k) Submission Section 111 510(k) Summary
Section III 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: _
-
- Date of Submission: Sep 26, 2011
-
- Sponsor
Beijing Choice Electronic Technology Co., Ltd No.9 Shuangyuan Road, Badachu Hi-Tich Zone, Shijingshan District, Beijing, China, 100041 Establishment Registration Number: 3005569927 Contact Person: Lei Chen Position: Quality Director Tel: +86-010-88204630 Fax: +86-010-88204632 Email: cc@choicemmed.com
-
- Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
- Proposed Device Identification 4.
Proposed Device Name: Fetal Doppler Proposed Device Model: MD800 Classification: II Product Code: KNG Regulation Number: 21 CFR 884.2660 Review Panel: Obstetrics/ Gynecology Intended Use Statement:
{1}------------------------------------------------
The Fetal Doppler is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.
-
ર Predicate Device Identification
510(k) Number: K100626 Product Name: Doppler Fetal Heart Rate Detector Manufacturer: Shenzhen Biocare Electronics Co., Ltd -
- Device Description
The Fetal Doppler is a hand-held, battery powered audio Doppler device integrated with 2MHz probe for detecting fetal heart beat. The device is normally applied to pregnancy as early as 12 weeks through the principle of ultrasound shift in hospital or homecare environment.
- Device Description
The Fetal Doppler includes the following components: Power supply module, User interface, Signal collection and process module and Control module
-
- Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
IEC 60601-1 2005+ CORR.1 (2006) + CORR.2 (2007), Medical Electrical Equipment – Part 1: General Requirements for Safety.
IEC 60601-1-2:2007, Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests
IEC 61266:1994 Ultrasonic~ Hand-held probe Doppler fetal heartbeat detectors- Performance requirements and methods of measurement and reporting.
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity,
ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivitv
-
- Substantially Equivalent Conclusion
The proposed device, Fetal Doppler, is determined to be Substantially Equivalent (SE) to the predicate device, Doppler Fetal Heart Rate Detector, K100626, in respect of safety and effectiveness.
- Substantially Equivalent Conclusion
III-2
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. A horizontal line is placed under the text.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Beijing Choice Electronic Technology Co., Ltd. Ms. Diana Hong General Manager MID-Link Consulting Co., Ltd. P.O. Box 237-023 Shanghai, 200237 CHINA .
OCT 2 7 2011
Re: K112911
Trade/Device Name: Fetal Doppler Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG Dated: September 30, 2011 Received: October 3, 2011
Dear Ms. Hong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
{3}------------------------------------------------
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Project #: M0242011Bc
Section II Indications for Use
510(k) Number: Device Name: Fetal Doppler
Indications for Use:
The Fetal Doppler is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.
�PRESCRIPTION USE (Part 21 CFR 801 Subpart D) ■OVER-THE-COUNTER USE (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mary Pastel
Divis of Radiologics Office of In Vitro Diagnostic ice Evaluation and Safety
510K K112911
§ 884.2660 Fetal ultrasonic monitor and accessories.
(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).