(458 days)
Med-link Wrist Digital Blood Pressure Monitor is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm.
Med-link Upper Arm Digital Blood Pressure Monitor is non-invasive measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the upper arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-32cm.
The proposed devices are battery driven automatic non-invasive blood pressure Monitor. It is used for automatically conduct the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist or upper arm within its claimed range and accuracy by oscillometry technique. Devices are consisted of three main parts: external hardwares (such as cuff), analog circuit, and MCU. The devices have the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time.
The proposed devices are intended to be used in medical facilities or at home and provided non-sterile. The proposed devices have 2 models:
Med-link Wrist Digital Blood Pressure Monitor Model:ESM101
Med-link Upper Arm Digital Blood Pressure Monitor Model:ESM201
Here's an analysis of the provided text regarding the acceptance criteria and study for the Med-link Wrist Digital Blood Pressure Monitor Model: ESM101 and Med-link Upper Arm Digital Blood Pressure Monitor Model: ESM201.
1. Table of Acceptance Criteria & Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Pressure Accuracy | ±3 mmHg (AAMI SP10) | ±3 mmHg (ISO 80601-2-30 and ISO 81060-2) |
| Pulse Accuracy | ±5% (AAMI SP10) | ±5% (ISO 80601-2-30 and ISO 81060-2) |
| Measurement Range (Pressure) | 0~280 mmHg | 0~280 mmHg |
| Measurement Range (Pulse) | 40~199 beats/minute | 40~199 beats/minute |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-1-11 | Comply with IEC 60601-1 |
| EMC (Electromagnetic Compatibility) | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Biocompatibility | All patient contacting materials evaluated by ISO 10993-1, -5, -10 | All patient contacting materials evaluated by ISO 10993-1, -5, -10 |
Study That Proves the Device Meets Acceptance Criteria:
The document states that a series of tests were performed in accordance with several standards to assess the safety and effectiveness of the Med-link Digital Blood Pressure Monitor. Specifically for performance, the standard cited is ISO 81060-2 Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type. This standard outlines the requirements for clinical validation of automated non-invasive sphygmomanometers.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the clinical validation described by ISO 81060-2. However, the ISO 81060-2 standard itself mandates a minimum number of subjects for clinical validation. This information would typically be found in the full clinical study report, which is not included in this 510(k) summary.
The document does not explicitly state the country of origin of the data nor whether the study was retrospective or prospective. It just mentions "a series of safety, essential performance and biocompatibility tests were performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts or their qualifications for establishing the ground truth during the clinical validation tests (ISO 81060-2). Clinical validation per ISO 81060-2 typically involves simultaneous auscultatory measurements by trained observers (experts) that serve as the reference standard against which the automated device's measurements are compared.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method used. In the context of ISO 81060-2, the reference standard for blood pressure measurements is typically established by two trained observers performing auscultatory measurements. Discrepancies between these observers would then usually be handled by a predefined adjudication process (e.g., a third observer). However, this specific detail is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The evaluation focuses on the standalone performance of the device against a reference standard.
6. Standalone Performance Study
Yes, a standalone performance study was done. The document states that "a series of safety, essential performance and biocompatibility tests were performed" and explicitly mentions ISO 81060-2, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers and ISO 81060-2 Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type. These standards are used to establish the standalone performance of the device (algorithm only, as applied in an automated device like this blood pressure monitor).
7. Type of Ground Truth Used
Based on the reference to ISO 81060-2, the ground truth for the test set would be expert auscultatory measurements (the "reference sphygmomanometer"). This involves trained human observers using mercury or aneroid sphygmomanometers to manually measure blood pressure, which is then compared to the automated device's readings.
8. Sample Size for the Training Set
The document does not provide any information regarding a "training set" or its sample size. This type of device (a deterministic blood pressure monitor based on oscillometry) typically does not involve machine learning models that require a separate "training set" in the same way an AI/ML-based diagnostic device would. The internal algorithms are typically calibrated and validated, but not "trained" on a large dataset in the sense of deep learning.
9. How the Ground Truth for the Training Set Was Established
As no training set is indicated for this type of device, this question is not applicable based on the provided information.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 2, 2019
Shenzhen Med-link Electronics Tech Co, Ltd. Baihan Feng Regulatory Affairs Specialist 4th Fl, Bldg A, Yingtailong Industrial Prk, Dalang South Road, Longhua District Shenzhen. 518109 CHINA
Re: K181154
Trade/Device Name: Med-link Wrist Digital Blood Pressure Monitor Model: ESM101, Med-link Upper Arm Digital Blood Pressure Monitor Model: ESM201 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 28, 2019 Received: July 1, 2019
Dear Baihan Feng:
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) K181154
Device Name
Med-link Wrist Digital Blood Pressure Monitor Model:ESM101 Med-link Upper Arm Digital Blood Pressure Monitor Model:ESM201
Indications for Use (Describe)
Med-link Wrist Digital Blood Pressure Monitor is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm.
Med-link Upper Arm Digital Blood Pressure Monitor is non-invasive measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the upper arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-32cm.
| 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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Image /page/3/Picture/1 description: The image shows the logo for MEDLINKET. The logo consists of the word "MED" in red, with a blue arc extending from the bottom of the "M" to the top of the "D". A red circle is placed to the right of "MED", and the word "LINKET" is written in blue to the right of the circle. The letters "TM" are written in a smaller font size above the "T" in "LINKET".
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. Type of submission: Traditional
The assigned 510(k) number is:
1. Submitter information
Manufacturer Name: Shenzhen Med-link Electronics Tech Co., Ltd. Address: 4th Fl, Bldg A, Yingtailong Industrial Park, Dalang South Road, Longhua District, Shenzhen, Guangdong, CHINA, 518109 Tel: 0086-755-61568825 Fax: 0086-755-61120055 Establishment Registration Number: 3006636961
2. Contact Person
Baihan Feng (Primary Contact) E-mail: MDL001@medlinket.com
Fei Liu E-mail: USER22@med-linket.com
-
- Data of Submission
28th , Jun., 2019
- Data of Submission
4. Identification of the Device
Trade Name: Med-link Wrist Digital Blood Pressure Monitor Model:ESM101
Med-link Upper Arm Digital Blood Pressure Monitor Model:ESM201
Common Name: Non-invasive blood pressure measurement system
Classification Regulation: 21 CFR 870.1130
Product Code: DXN
Identification of the Predicate Device 5.
Table 1 Predicate Device Information
| No. | Device Name | Common | Manufacture | Classifica | Classifi | 510(k) |
|---|---|---|---|---|---|---|
| ----- | ------------- | -------- | ------------- | ------------ | ---------- | -------- |
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Image /page/4/Picture/1 description: The image shows the logo for MEDLINKET. The logo has the word "MED" in red, with a blue arc underneath it. To the right of the arc is a red circle, followed by the word "LINKET" in blue. The letters "TM" are in superscript to the right of the word "LINKET".
| Name | tion andCode | cationregulation | number | ||||
|---|---|---|---|---|---|---|---|
| 1 | FullAutomatic(NIBP)Blood PressureMonitor, ModelHL158LA | BloodPressureMonitor | Health & LifeCo.,Ltd. | Class II,DXN | 21 CFR870.1130 | K130564 | |
| 2 | AGE AutomaticUpper Arm BloodPressure Monitor | Noninvasive bloodpressuremeasurement system | Ageless HealthIndustrial Ltd. | Class II,DXN | 21 CFR870.1130 | K123882 |
6. Indications for Use of the Subject device
Med-link Wrist Digital Blood Pressure Monitor is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm.
Med-link Upper Arm Digital Blood Pressure Monitor is non-invasive measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the upper arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-32cm.
7. Device Description
The proposed devices are battery driven automatic non-invasive blood pressure Monitor. It is used for automatically conduct the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist or upper arm within its claimed range and accuracy by oscillometry technique. Devices are consisted of three main parts: external hardwares (such as cuff), analog circuit, and MCU. The devices have the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time.
The proposed devices are intended to be used in medical facilities or at home and provided non-sterile. The proposed devices have 2 models:
Med-link Wrist Digital Blood Pressure Monitor Model:ESM101
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Image /page/5/Picture/1 description: The image shows the logo for MED LINKET. The logo has the word "MED" in red, with a blue swoosh underneath it. To the right of the word "MED" is a red circle, followed by the word "LINKET" in blue.
Med-link Upper Arm Digital Blood Pressure Monitor Model:ESM201
8. Test Summary
A series of safety, essential performance and biocompatibility tests were performed to assess the safety and effectiveness of Med-link Digital Blood Pressure Monitor. The tests listed below were conducted in accordance with
IEC 60601-1 Medical electrical equipment-Part 1:General requirements for basic safety, and essential performance.
IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 80601-2-30, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
ISO 81060-2 Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5 Biological Evaluation of medical devices-Part 5: Test for in vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices- Part 10: Tests For Irritation And Skin Sensitization
- . Cytotoxicity Test
- Skin irritation Test ●
- Skin Sensitization Test .
9. Substantial Equivalence Determination
| Item | Proposed Device | Primary Predicate Device |
|---|---|---|
| Trade name | Med-link Wrist Digital BloodPressure Monitor | Full Automatic(NIBP) BloodPressure Monitor, ModelHL158LA |
| 510(K) Submitter | Shenzhen Med-link ElectronicsTech Co., Ltd. | Health & Life Co.,Ltd. |
| 510(K) Number | — | K130564 |
| ClassificationRegulation | 21CRF 870.1130 | 21CRF 870.1130 |
| Item | Proposed Device | Primary Predicate Device |
| Classificationand Code | Class II,DXN | Class II,DXN |
| Common name | Noninvasive blood pressuremeasurement system | BloodPressureMonitor |
| Type of Use | OTC | OTC |
| Indications forUse | Med-link Wrist Digital BloodPressure Monitor is non-invasiveblood measurement of arterialblood pressure values in adults. Itis intended to measure thediastolic, systolic blood pressuresand pulse rate through aninflatable cuff wrapped around thewrist. It can be used by medicalprofessionals or at home. The cuffcircumference is limited to13.5-19.5 cm. | HL158LA automaticallymeasures human' s Systolic,Diastolic blood pressure andheart rate by using theoscillometric method. Allvalues can be read out in oneLCD panel. Measurementposition is at human being' swrist. The intended use ofthis over-the-counter deviceis for use by people over theage of 18 with wristcircumference ranging fromapprox. 5.3 to 7.7inches(13.5 cm to 19.5 cm)and for home use. |
| Patientpopulations | Adult | Adult |
| Method ofMeasurement | Oscillometric | Oscillometric |
| MeasurementSite | Wrist | Wrist |
| MeasurementRange | Pressure: 0 | Pressure: 0 |
| Accuracy | Pressure: ±3mmHgPulse: ±5% | Pressure: ±3mmHgPulse: ±5% |
| Item | Proposed Device | Primary Predicate Device |
| Inflation andDeflation | Automatic | Automatic |
| Display | LCD | LCD |
| Memory | 2x90 sets | 4x30 sets |
| Cuff Size | 13.5cm~19.5cm | 13.5cm~19.5cm |
| Voice broadcast | Yes | Not-provided |
| Power Supply | DC 3.0V (2xAAA alkalinebattery) | DC 3.0V (2xAAA alkalinebattery) |
| OperationEnvironment | Temperature: +5° C~+40° C;Humidity: 15%~85%RH, | Temperature: +5° C~+40°C;Humidity: 15%~93%RH |
| StorageEnvironment | Temperature: -20° C~+55° CHumidity: ≤95%RH,non-condensing | Temperature: -25° C~+70°CHumidity: ≤95%RH, |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1,IEC 60601-1-11 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Performance | ISO 80601-2-30 and ISO 81060-2 | AAMI SP10 |
| BiocompatibilityEvaluation | All the patient contractingmaterials are evaluated by thebiocompatibility standard ISO10993-1, -5, -10. | All the patient contractingmaterials are evaluated bythebiocompatibility standardISO 10993-1, -5, -10. |
Table 2 Comparison Table for Med-link Wrist Digital Blood Pressure Monitor ESM101
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Image /page/6/Picture/1 description: The image shows the logo for MEDLINKET. The logo features the word "MED" in red, with a blue arc underneath it. To the right of "MED" is a red circle, followed by the word "LINKET" in blue, with the trademark symbol above it.
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Image /page/7/Picture/1 description: The image shows the logo for MEDLINKET. The logo consists of the word "MED" in red, with a blue arc underneath it. To the right of the arc is a red circle, followed by the word "LINKET" in blue. The letters "TM" are in superscript to the right of the word "LINKET".
Table 3 Comparison Table for Med-link Upper Arm Digital Blood Pressure Monitor ESM201
| Item | Proposed Device | Primary Predicate Device |
|---|---|---|
| Trade name | Med-link Upper Arm DigitalBlood Pressure Monitor | AGE Automatic Upper ArmBlood Pressure Monitor |
| 510(K) Submitter | Shenzhen Med-link ElectronicsTech Co., Ltd. | Ageless Health IndustrialLtd. |
| 510(K) Number | — | K123882 |
| ClassificationRegulation | 21CRF 870.1130 | 21CRF 870.1130 |
| Item | Proposed Device | Primary Predicate Device |
| Classificationand Code | Class II,DXN | Class II,DXN |
| Common name | Noninvasive blood pressuremeasurement system | Noninvasive blood pressuremeasurement system |
| Type of Use | OTC | OTC |
| Indications forUse | Med-link Upper Arm DigitalBlood Pressure Monitor isnon-invasive measurement ofarterial blood pressure values inadults. It is intended to measurethe diastolic, systolic bloodpressures and pulse rate throughan inflatable cuff wrapped aroundthe upper arm. It can be used bymedical professionals or at home.The cuff circumference is limitedto 22-32cm. | AGE Automatic Upper ArmBlood Pressure Monitor isfor use by medicalprofessionals or at home andis a non-invasive bloodpressure measurementsystem intended to measurethe diastolic and systolicblood pressures and pulserate of an adult individual byusing a non-invasivetechnique in which aninflatable cuff is wrappedaround the upper arm. Thecuff circumference is limitedto 24-34cm. |
| Patientpopulations | Adult | Adult |
| Method ofMeasurement | Oscillometric | Oscillometric |
| MeasurementSite | Upper Arm | Upper Arm |
| MeasurementRange | Pressure: 0 | Pressure: 0 |
| Accuracy | Pressure: ±3mmHgPulse: ±5% | Pressure: ±3mmHgPulse: ±5% |
| Inflation andDeflation | Automatic | Automatic |
| Item | Proposed Device | Primary Predicate Device |
| Display | LCD | LCD |
| Memory | 2x90 sets | 2x90 sets |
| Cuff Size | 22cm~32cm | 24cm~34cm |
| Voice broadcast | Yes | Yes |
| Power Supply | DC 6.0V (4xAA alkaline battery) | DC 6.0V (4xAA alkaline battery) |
| OperationEnvironment | Temperature: +5°C~+40°C;Humidity: 15%~85%RH, | Temperature: +5°C~+40°C;Humidity: 10%~95%RH |
| StorageEnvironment | Temperature: -20°C~+55°CHumidity: ≤95%RH | Temperature: -20°C~+65°CHumidity: 10%~95%RH |
| Electrical Safety | Complywith IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Performance | ISO 80601-2-30 and ISO 81060-2 | AAMI SP10 |
| BiocompatibilityEvaluation | All the patient contractingmaterials are evaluated by thebiocompatibility standard ISO10993-1, -5, -10. | All the patient contractingmaterials are evaluated by thebiocompatibility standard ISO10993-1, -5, -10. |
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Image /page/8/Picture/1 description: The image shows the logo for MED LINKET. The logo has the word "MED" in red, with a blue swoosh underneath it. To the right of "MED" is a red circle, and then the word "LINKET" in blue. There is a small "TM" in the upper right corner of the word "LINKET".
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Image /page/9/Picture/1 description: The image shows the logo for MED Linket. The logo has the letters "MED" in red, with a blue swoosh underneath. To the right of the letters is a red circle, and then the word "LINKET" in blue. There is a small "TM" symbol in the upper right corner of the word "LINKET".
The proposed device and its predicate devices have the identical indented use, principle and performance. The differences between the proposed device and the predicate device do not raise any question regarding its safety and effectiveness.
10. Conclusion
Based on the comparison and analysis in this submission, it can be concluded that: Med-link Upper Digital Blood Pressure Monitors are substantially equivalent to the predicate devices in regard to safety and effectiveness.
§ 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).