(124 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard physiological measurement technology.
No
The device is described as a "Non-invasive Hemodynamic Blood Pressure Monitor" intended for "measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW)." It does not mention treating, preventing, or mitigating any disease or condition, which are characteristics of a therapeutic device.
No
Explanation: The device is described as a "Blood Pressure Monitor" intended for "measuring and display of Blood Pressure trending" and "spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW)". It measures these physiological parameters but does not provide a diagnosis of a medical condition.
No
The device description explicitly states it is a "portable non-invasive Hemodynamic Blood Pressure Monitor powered by an internal rechargeable lithium polymer battery" and "contains a pulse wave probe incorporating two LEDs," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the Discovery 1 - Non-invasive Hemodynamic Blood Pressure Monitor device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information about a physiological state, health, or disease.
- The Discovery 1 device measures blood pressure and pulse rate directly from the capillary finger tip tissue. It does not analyze a specimen taken from the body.
- The intended use and device description clearly state it's a non-invasive monitor.
Therefore, the Discovery 1 falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Discovery 1 - Non-invasive Hemodynamic Blood Pressure Monitor device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory. The device is intended for use in the home environment. It is intended to be used by any person aged above 18 years old.
Product codes
DXN
Device Description
Discovery 1 is a portable non-invasive Hemodynamic Blood Pressure Monitor powered by an internal rechargeable lithium polymer battery. It contains a pulse wave probe incorporating two LEDs, which can collect the pulse wave to the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
capillary finger tip tissue (other than the thumb). The ring finger is the recommended site.
Indicated Patient Age Range
above 18 years old
Intended User / Care Setting
home environment / any person aged above 18 years old.
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)
The following performance data were provided in support of the substantial equivalence determination.
- Safety: Ensures the device meet the requirements of IEC 60601-1: 2012 and IEC 60601-1-11: 2015
- EMC: Ensures the temperature probes meet the requirements of IEC 60601-1-2: 2014, IEC 60601-1-11: 2015 clause 12 and ISO 80601-2-61: 2017 clause 201.17 and clause 202
- Clinical accuracy: ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy (Blood Pressure): ±5 mmHg
Accuracy (Pulse rate): ±2% or ±2 bpm, whichever is greater
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
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August 7, 2019
Vita-Course Technologies Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A. NanShan Medical Devices Industrial Park, Nanshan District, Shenzhen, 518067 Cn
Re: K190893
Trade/Device Name: Discovery 1 - Non-invasive Hemodynamic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 9, 2019 Received: May 9, 2019
Dear Kevin Wang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190893
Device Name
Discovery 1 - Non-invasive Hemodynamic Blood Pressure Monitor
Indications for Use (Describe)
The Discovery 1 - Non-invasive Hemodynamic Blood Pressure Monitor device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory. The device is intended for use in the home environment. It is intended to be used by any person aged above 18 years old.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2019/04/01
1. Submission sponsor
Name: Vita-Course Technologies Co., Ltd.
Address: 3F, Block B, Dajiahao Plaza, No.362, Yu'an 2nd Road, Bao'an District, Shenzhen, Guangdong, China
Contact person: Kezheng Ma
Title: Management Representative
E-mail: makezheng@vita-course.com
Tel: +86-755-23188226
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: No. A415, Block A, NanShan Medical devices Industrial Park Nanshan District, Shenzhen,
Guangdong, P.R. China 518067
Contact person: Kevin Wang
E-mail: kevin(@chonconn.com
Tel: +86-755-33941160
| Trade/Device Name | Non-invasive Hemodynamic Blood Pressure Monitor |
|---|---|
| Model | Discovery 1 |
| Common Name | Non-invasive Blood Pressure Monitor |
| Regulatory Class | Class II |
| Classification | 21CFR §870.1130 / System, measurement, blood-pressure, non-invasive / DXN |
| Submission type | Traditional 510(K) |
Subject Device Information 3.
4. Predicate Device
By submission of the Traditional 510(k), Vita-Course Technologies Co., Ltd. is requesting clearance for Discovery 1 Non-invasive Hemodynamic Blood Pressure Monitor. It is comparable to the following legally marketed system:
- Cnoga Medical ACAL, TensorTip ""- Non-invasive Hemodynamic Blood Pressure Monitor 1. under K093981.
ട്. Intended use & Indication for use
The Discovery 1 Non-invasive Hemodynamic Blood Pressure Monitor device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary
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finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory. The device is intended for use in the home environment. It is intended to be used by any person aged above 18 years old.
6. Device Description
Discovery 1 is a portable non-invasive Hemodynamic Blood Pressure Monitor powered by an internal rechargeable lithium polymer battery. It contains a pulse wave probe incorporating two LEDs, which can collect the pulse wave to the device.
7. Principle of Operation
The product is designed to calculate the blood pressure in terms of conduction time of pulse and wave parameters of pulse. This method is proposed based on interdependent characteristics between conduction time of the pulse wave along the arterial as well as characteristic parameters of the pulse wave and arterial pressure. Through the determination of the PPG signal, conduction time of the pulse wave along thee arterial and other correlation variables would be obtained and accordingly the systolic and diastolic pressures of the body are gotten by fitting operation. The pulse rate can be obtained by calculating the pulse wave signal.
Comparison to the Predicate Device 8.
The Discovery 1 non-invasive Hemodynamic Blood Pressure Monitor and TensorTip™ - Non-invasive Hemodynamic Blood Pressure Monitor (K093981), are identical in purpose, function, core technology and method of operation. Only minor differences exist between the Discovery 1 and predicate, which do not affect the safety or effectiveness of the subject device. Table 1 provides a comparison of the subject and predicate devices.
| Features | Subject Device | Predicate Device K093981 | Remark |
|---|---|---|---|
| Discovery 1 non-invasive | |||
| Hemodynamic Blood Pressure | |||
| Monitor | TensorTipTM - Non-invasive | ||
| Hemodynamic Blood Pressure Monitor | |||
| Indication | |||
| for use | The Discovery 1 - Non-invasive | ||
| Hemodynamic Blood Pressure Monitor | |||
| device is a small, lightweight, | |||
| handheld, device intended for | |||
| measuring and display of Blood | |||
| Pressure trending (systolic and | |||
| diastolic) and spot-check of Peripheral | |||
| pulse rate (PPR) and Peripheral pulse | |||
| wave (PPW). Measurement is | |||
| performing on capillary finger tip tissue | |||
| (other than the thumb). The ring finger | |||
| is the recommended site. The results of | The TensorTip - Non-invasive blood | ||
| pressure trending device is a small, | |||
| lightweight, handheld, device intended for | |||
| measuring and display of Blood Pressure | |||
| trending (systolic and diastolic) and spot- | |||
| check of Peripheral pulse rate (PPR) and | |||
| Peripheral pulse wave (PPW). | |||
| Measurement is performing on capillary | |||
| fingertip tissue (other than the thumb). The | |||
| ring finger is the recommended site. The | |||
| results of each measurement are stored in | |||
| the system memory. The device is intended | Same | ||
| Features | Subject Device | ||
| Discovery 1 non-invasive | |||
| Hemodynamic Blood Pressure | |||
| Monitor | |||
| system memory. The device is intended | |||
| for use in the home environment. It is | |||
| intended to be used by any person aged | |||
| above 18 years old. | Predicate Device K093981 | ||
| TensorTipTM- Non-invasive | |||
| Hemodynamic Blood Pressure Monitor | |||
| for use in the home environment. It is | |||
| intended to be used by any person aged | |||
| above 18 years old. | Remark | ||
| Patient | |||
| Population | >18 years old | >18 years old | Same |
| Principle of | |||
| Operation | Hemodynamics | Hemodynamics | Same |
| Power | |||
| source | DC adaptor: 5Vd.c., | ||
| Internal lithium polymer (Li-Pol) | |||
| battery: 3.7Vd.c., 2200 mAh | DC adaptor: 5Vd.c. | ||
| Internal Li-Polymer battery: 3.7Vd.c., | |||
| 740mAh | Different 1) | ||
| Blood | |||
| pressure | Systolic pressure range: 50 mmHg ~200 mmHg | ||
| Diastolic pressure range: 40 mmHg ~160 mmHg | |||
| Accuracy: ±5 mmHg | Systolic pressure range: 90 mmHg ~ 240 mmHg | ||
| Diastolic pressure range: 30 mmHg ~ 130 mmHg | |||
| Accuracy: |