(17 days)
Not Found
No
The summary describes a standard audio Doppler device for detecting fetal heartbeats and does not mention any AI or ML capabilities.
No
The device is described as an audio Doppler used for detecting fetal heartbeats, not for treating any condition.
Yes
The device is used for "detecting fetal heart beats", which is a form of gathering information about the patient's physiological state to assist in a medical assessment.
No
The device description explicitly states it is a "hand-held, battery powered audio Doppler device integrated with 3MHz probe," indicating it is a hardware device with a physical probe and power source, not software only.
Based on the provided information, the JPD-100S Fetal Doppler is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- JPD-100S Function: The JPD-100S Fetal Doppler is a device that uses Doppler ultrasound to detect fetal heart beats directly from the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "detecting fetal heart beats," which is a direct measurement from the patient, not an analysis of a biological sample.
Therefore, the JPD-100S Fetal Doppler falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Fetal Doppler JPD-100S is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.
Product codes (comma separated list FDA assigned to the subject device)
KNG
Device Description
JPD-100S Fetal Doppler is a prescription from licensed physician in hospitals, clinics and private offices. It is a hand-held, battery powered audio Doppler device integrated with 3MHz probe, used for detecting fetal heart beats. An the device is normally applied to pregnancy for more than twelve weeks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler/Ultrasound
Anatomical Site
Fetal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription from licensed physician in hospitals, clinics and private offices.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications, including electrical safety, EMC, specification per following standards.
IEC60601-1(1988; Amendment 1, 1991-11, Amendment 2, 1995): Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
IEC60601-1-2 (2001): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - 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 devices -- Part 5: Tests for In Vitro cytotoxicity
ISO 10993-10 (2002; Amd. 1:2006): Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
Results of these tests demonstrate compliance to the requirements of all consensus standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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: +86-755-2669 6279 | ||
| Fax: +86-755-2685 2678 | ||
| Email: rd@jumper-medical.com | ||
| Submission | ||
| Correspondent | Ms. Diana Hong / Mr. Lee Fu | |
| Shanghai Mid-Link Business Consulting Co., Ltd | ||
| P.O. BOX 237-023 | ||
| Shanghai, 200237, China | ||
| Tel: +86-21-64264467 | ||
| Fax: 240-238-7587 | ||
| Email: diana.hong@mid-link.net | ||
| 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 | |
| hospitals, clinics and private offices. It is a hand-held, battery powered | ||
| audio Doppler device integrated with 3MHz probe, used for detecting | ||
| fetal heart beats. And the device is normally applied to pregnancy for | ||
| more than twelve weeks. | ||
| Test Conclusion | Laboratory testing was conducted to validate and verify that the | |
| proposed devices met all design specifications, including electrical | ||
| safety, EMC, specification per following standards. | ||
| IEC60601-1(1988; Amendment 1, 1991-11, Amendment 2, 1995): | ||
| Medical electrical equipment -Part 1: General requirements for basic | ||
| safety and essential performance | ||
| IEC60601-1-2 (2001): Medical electrical equipment - Part 1-2: | ||
| General requirements for basic safety and essential performance - | ||
| 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 devices -- Part | ||
| 5: Tests for In Vitro cytotoxicity | ||
| ISO 10993-10 (2002; Amd. 1:2006): Biological evaluation of medical | ||
| devices - Part 10: Tests for irritation and delayed-type hypersensitivity | ||
| Results of these tests demonstrate compliance to the requirements of | ||
| all consensus standards. | ||
| Comparison Summary | The proposed device shares same classification, intended use, similar | |
| technical specifications, same safety specifications and skin-contact | ||
| material with the predicate device. The main difference includes | ||
| battery, operation and storage conditions, transducer frequency and | ||
| Isata, but the difference is considered to have no effect on | ||
| effectiveness and safe. The SE analysis of the difference is provided as | ||
| following. | ||
| The batteries of proposed and predicate device are different. But both | ||
| of them comply with the requirements of electrical safety and EMC of | ||
| 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 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)
(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 | |||||||||
| (Track 1 only) | Specific (Track 1&3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||||
| (Specify) | Other* | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & 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 | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| 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