FETAL DOPPLER JPD-100S

K110124 · Shenzhen Jumper Medical Equipment Co., Ltd. · KNG · Feb 4, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K110124
• Device Name: FETAL DOPPLER JPD-100S
• Applicant: Shenzhen Jumper Medical Equipment Co., Ltd.
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: Feb 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The Fetal Doppler JPD-100S is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.

Device Story

JPD-100S is a hand-held, battery-powered audio Doppler device; utilizes 3MHz continuous wave (CW) ultrasound probe to detect fetal heart beats. Operated by licensed physicians in hospitals, clinics, or private offices. Device transforms reflected ultrasonic signals into audible sound; healthcare provider listens to output to confirm fetal heart rate. Provides non-invasive monitoring of fetal status during pregnancy (12+ weeks). Benefits include simple, portable assessment of fetal well-being in clinical settings.

Clinical Evidence

Bench testing only. Validated against IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 61266 (ultrasonic performance), and ISO 10993-5/10 (biocompatibility). Acoustic output testing confirmed compliance with standard criteria for 3MHz transducer and Isata levels.

Technological Characteristics

Hand-held, battery-powered audio Doppler. 3MHz CW transducer. Materials evaluated for biocompatibility per ISO 10993-5 and ISO 10993-10. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 61266. Standalone device.

Indications for Use

Indicated for detection of fetal heart beats in pregnant patients at 12+ weeks gestation. Prescription use only in hospitals, clinics, and private offices.

Regulatory Classification

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.

Predicate Devices

• Contec Pocket Fetal Doppler Baby Sound A (K082480)

Reference Devices

• Contec Pocket Fetal Doppler SONOLINE A (K082480)
• Contec Pocket Fetal Doppler SONOLINE B (K082480)

Submission Summary (Full Text)

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K110124

# Attachment II 510(k) Summary

As Required by CFR 870.92

| Preparing Date | November 23, 2010 | FEB - 4 2011 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Sponsor | Shenzhen Jumper Medical Equipment Co., Ltd | |
| | 5th Floor, Building No.34, Baoyuan Industrial Zone, Xixiang Street, | |
| | Baoan District, Shenzhen, Guangdong 518067, P.R. China | |
| | Boley He Quality Manager | |
| | Tel: [phone] | |
| | Fax: [phone] | |
| | Email: [e-mail] | |
| Submission<br>Correspondent | Ms. Diana Hong / Mr. Lee Fu | |
| | Shanghai Mid-Link Business Consulting Co., Ltd | |
| | P.O. BOX 237-023 | |
| | Shanghai, 200237, China | |
| | Tel: [phone] | |
| | Fax: [phone] | |
| | Email: [e-mail] | |
| Proposed Product | | |
| Trade Name | Fetal Doppler | |
| Model | JPD-100S | |
| Product Code: | KNG | |
| Regulation Number: | 21 CFR 884.2660 | |
| Device Class: | Class II | |
| Submission Purpose: | New Device | |
| Submission Type | Traditional 510(k) | |
| Predicate Device: | | |
| Device Name | Contec Pocket Fetal Doppler Baby Sound A | |
| K Number | K082480 | |
| Manufacturer | Contec Medical Systems Co., LTD | |
| Intended Use | The Fetal Doppler JPD-100S is a hand-held, battery powered audio | |
| | Doppler device used for detecting fetal heart beats. | |
| Device Description | JPD-100S Fetal Doppler is a prescription from licensed physician in<br>hospitals, clinics and private offices. It is a hand-held, battery powered<br>audio Doppler device integrated with 3MHz probe, used for detecting<br>fetal heart beats. And the device is normally applied to pregnancy for<br>more than twelve weeks. | |
| Test Conclusion | Laboratory testing was conducted to validate and verify that the<br>proposed devices met all design specifications, including electrical<br>safety, EMC, specification per following standards. | |
| | IEC60601-1(1988; Amendment 1, 1991-11, Amendment 2, 1995):<br>Medical electrical equipment -Part 1: General requirements for basic<br>safety and essential performance<br>IEC60601-1-2 (2001): Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and essential performance -<br>Collateral standard: Electromagnetic compatibility -Requirements and<br>tests<br>IEC 61266 (1994 ): Ultrasonic - Hand-held probe Doppler fetal<br>heartbeat detectors -Performance requirements and methods of<br>measurement and reporting<br>ISO 10993-5 (2009): Biological evaluation of medical devices -- Part<br>5: Tests for In Vitro cytotoxicity<br>ISO 10993-10 (2002; Amd. 1:2006): Biological evaluation of medical<br>devices - Part 10: Tests for irritation and delayed-type hypersensitivity<br>Results of these tests demonstrate compliance to the requirements of<br>all consensus standards. | |
| Comparison Summary | The proposed device shares same classification, intended use, similar<br>technical specifications, same safety specifications and skin-contact<br>material with the predicate device. The main difference includes<br>battery, operation and storage conditions, transducer frequency and<br>Isata, but the difference is considered to have no effect on<br>effectiveness and safe. The SE analysis of the difference is provided as<br>following.<br>The batteries of proposed and predicate device are different. But both<br>of them comply with the requirements of electrical safety and EMC of<br>IEC 60601-1 and IEC 60601-1-2. Therefore, this difference is | |

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considered has no effect on effectiveness and safety.

The operation and storage conditions of the proposed device have slight differences with those of the predicate device. But these conditions are considered to be able to cover the normal working and storage environment. In addition, these conditions are clearly on the proposed labeling, to remind the user handle and operate with these conditions. Therefore, this difference is considered to have no effect on effectiveness and safe.

The transducer frequency of proposed device and predicate device is different. But the proposed transducer was tested for its acoustic output, and the result demonstrates that it complies with the standard criteria. In addition, 3MHz transducer of fetal doppler is very common in clinical use, such as, 3MHz normal transducer of Contec Pocket Fetal Doppler SONOLINE A and SONOLINE B (k082480). Therefore, this difference is considered to have no effect on effectiveness and safe.

The Isata of proposed device and predicate device is different. But the proposed transducer was tested for its acoustic output, and the result demonstrates that it complies with the standard criteria. In addition, transducer of fetal doppler with Isata <5 mW/cm² is very common in clinical use, such as, CMS-150-T2 and CMS-150-T5 transducer of Contec Pocket Fetal Doppler SONOLINE A and SONOLINE B (k082480). Therefore, this difference is considered to have no effect on effectiveness and safe.

SE Determination

The proposed device, Fetal Doppler JPD-100S, is substantially equivalent (SE) to the predicate device Contec Pocket Fetal Doppler Baby Sound A (K082480).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." is arranged in a circular pattern around the bird-like figure. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Shenzhen Jumper Medical Equipment Co., Ltd % Mr. Marc M. Mouser Engineering Leader/FDA Office Coordinator Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542

FEB - 4 2011

Re: K110124

Trade/Device Name: Fetal Doppler JPD-100s Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasound monitor and accessories Regulatory Class: II Product Code: KNG Dated: December 17, 2010 Received: January 18, 2011

Dear Mr. Mouser:

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 Fetal Doppler JPD-100s, as described in your premarket notification:

#### Transducer Model Number

### 3.0MHz CW

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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

and the country of the county of

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Page 2 - Mr. Mouser

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 (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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

If you have any questions regarding the content of this letter, please contact Lauren Hefner at [phone].

Sincerely Yours,

Amharl. D. O'Rhum for

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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## Section II Indications for Use Statement

510(k) Number: Device Name:

Fetal Doppier JPD-100S

Indications for Use:

The Fetal Doppler JPD-100S is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.

Prescription Use > X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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(Division Sign Off)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K110124

Page 1 of 2

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#### Diagnostic Ultrasound Indications for Use Form

Device Name: Fetal Doppler JPD-100S

Transducer: 3.0MHz CW inherent of the main unit

Intended Use: Detect fetal heart beats as follows:

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|--|
| General<br>(Track 1 only) | Specific (Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | N | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

_Page 2 of 2 II-2

Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110621