(277 days)
Med-link Disposable Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
The proposed device, Med-link Disposable Blood Pressure Cuff is rectangle soft inelastic sleeve. There is a single-tube or twin-tube connected to a sealed gas chamber. It is wrapped around the patient's limb/thigh and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in various sizes for different limb range. It is provided non-sterile.
This document is a 510(k) premarket notification for the Med-link Disposable Blood Pressure Cuff. It aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on the FDA recognized consensus standard ISO 81060-1:2007/ AAMI/ANSI/ISO81060-1:2007/(R)2013 Non-Invasive Sphygmomanometers -Part 1: Requirements And Test Methods For Non-Automated Measurement Type, and ISO 10993 (Biological evaluation of medical devices) series for biocompatibility.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard Reference) | Reported Device Performance (Summary) |
|---|---|---|
| Performance | Compliance with ISO 81060-1:2007/ AAMI/ANSI/ISO81060-1:2007/(R)2013, Part 1: Requirements And Test Methods For Non-Automated Measurement Type | "Performance testing was performed on the subject device and results were compared with predicate device. Tests were conducted following applicable procedures outlined in the FDA recognized consensus standard of AAMI/ANSI/ISO81060-1:2007/(R)2013, and results met all relevant requirements in the test standard." |
| Biocompatibility | ISO 10993-1: Biological evaluation of medical devices-Part 1: Evaluation and testing | "A series of safety, essential performance and in vitro biocompatibility tests were performed... The tests listed below were conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10." |
| ISO 10993-5: Test for in vitro cytotoxicity | "Cytotoxicity Test" performed. Data not explicitly detailed in summary but implied to meet criteria. | |
| ISO 10993-10: Tests for Irritation And Skin Sensitization | "Skin irritation Test" and "Skin Sensitization Test (the Guinea Pig maximization test)" performed. Data not explicitly detailed in summary but implied to meet criteria. | |
| Pressure Limit | 0-300mmHg matching predicate devices | Proposed device has a pressure limit of "0-300mmHg," which is identical to the primary and secondary predicate devices. |
| Sterility | Non-sterile matching predicate devices | Proposed device is "Non-sterile," which is identical to the primary and secondary predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance testing. It mentions "Performance testing was performed on the subject device," but does not specify the number of devices or measurements.
The data provenance is not specified regarding country of origin or specific study design (retrospective or prospective). The tests are described as "non-clinical testing," which suggests laboratory-based evaluations rather than human subject trials for the core performance and biocompatibility aspects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document describes the testing of a basic medical accessory (blood pressure cuff). The "ground truth" for its performance is established by objective measurements against a recognized standard (ISO 81060-1). There is no mention of experts establishing a "ground truth" in the way one might for diagnostic imaging or a subjective clinical assessment. The ground truth for biocompatibility is established through standardized laboratory tests.
4. Adjudication Method for the Test Set
Not applicable. The performance and biocompatibility tests are objective measurements against established standards, not subjective assessments requiring adjudication by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a 510(k) submission for a blood pressure cuff, which is a physical accessory, not an AI or imaging-based diagnostic device. Therefore, an MRMC comparative effectiveness study, which typically evaluates human readers' performance with and without AI assistance, is not relevant or applicable here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a passive accessory and does not involve an algorithm. Its function is to interface with a blood pressure measurement system.
7. Type of Ground Truth Used
The ground truth used for performance testing (accuracy and reliability of pressure transmission, cuff inflation/deflation, etc.) is the adherence to the ISO 81060-1 standard's objective requirements and test methods.
For biocompatibility testing, the ground truth is established by the results of standardized laboratory tests (Cytotoxicity, Skin Irritation, Skin Sensitization) as defined by the ISO 10993 series.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning algorithm and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The logo also includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the caduceus symbol.
Public Health Service
November 28, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Shenzhen Med-link Electronics Tech Co., Ltd. Mina Cheng Regulatory Affairs Specialist 4th Fl, Bldg A, Yingtailong Industrial Prk, Dalang South Road, Longhua District Shenzhen, 518109 CN
Re: K160530
Trade/Device Name: Med-link Disposable Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: December 22, 2015 Received: February 25, 2016
Dear Mina Cheng:
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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mude Jellm
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K160530
Device Name Med-link Disposable Blood Pressure Cuff
Indications for Use (Describe)
Med-link Disposable Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for MedLinket. The logo has the word "MED" in red, with a blue swoosh underneath. To the right of "MED" is a red circle, followed by the word "LINKET" in blue, with a "TM" symbol in the upper right corner.
Shenzhen Med-link Electronics Tech Co., Ltd.
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:K160530
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: 0086-755-61120299 Fax: 0086-755-61120055 Establishment Registration Number: 3006636961
2. Contact Person
Mina Cheng (Regulatory Affairs Specialist) E-mail: user22@med-linket.com
3. Date of preparation
Nov. 19, 2016
4. I Identification of the Device
Trade Name: Med-link Disposable Blood Pressure Cuff
Models as listed below:
| Device Name/Type | Device Model |
|---|---|
| Disposable BloodPressure Cuff | Y000DSN1-1#, Y000DSN2-1#, Y000DSN1-2#, Y000DSN2-2#,Y000DSN1-3#, Y000DSN2-3#, Y000DSN1-4#, Y000DSN2-4#,Y000DSN1-5#, Y000DSN2-5#, Y000DC1, Y000DC2, Y000DSA1,Y000DSA2, Y000DA1, Y000DA2, Y000DAL1, Y000DAL2,Y000DLA1, Y000DLA2, Y000DT1, Y000DT2 |
Common Name: Non-invasive Blood Pressure Cuff
II
Classification Name: Blood Pressure Cuff
Device Classification:
Classification Regulation: 21 CFR 870.1120
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for MedLinket. The logo has the word "MED" in red, with the letters stacked on top of each other. There is a blue swoosh underneath the word "MED", and a red circle to the right of the swoosh. The word "LINKET" is in blue, and is to the right of the red circle, with the letters in a bold font. There is a trademark symbol to the right of the word "LINKET".
Product Code: DXQ
5. I Identification of the Predicate Device
| No. | Device Name | CommonName | Manufacture | Classificationand Code | Classificiationregulation | 510(k)number |
|---|---|---|---|---|---|---|
| PrimaryPredicate | Disposable/ReusableBlood Pressure Cuff | Non-invasiveBloodpressure cuff | XUZHOUMAICUFFTECHNOLOGYCO.,LTD. | Class II,DXQ | 21 CRF870.1120 | K151290 |
| SecondaryPredicate | Unimed DisposableBlood Pressure Cuff | Non-invasiveBloodpressure cuff | Unimed Medicalsupplies Inc. | Class II,DXQ | 21 CRF870.1120 | K120364 |
Table 2 Predicate Devices Information
Intended Use and Indications for Use of the Subject device 6.
Med-link Disposable Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
7. Device Description
The proposed device, Med-link Disposable Blood Pressure Cuff is rectangle soft inelastic sleeve. There is a single-tube or twin-tube connected to a sealed gas chamber. It is wrapped around the patient's limb/thigh and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in various sizes for different limb range. It is provided non-sterile.
| No. | Model | Intended Limb Range(Unit: cm) |
|---|---|---|
| 1 | Y000DSN1-1# | 3 - 6 |
| 2 | Y000DSN2-1# | 3 - 6 |
| 3 | Y000DSN1-2# | 4 - 8 |
| 4 | Y000DSN2-2# | 4 - 8 |
| 5 | Y000DSN1-3# | 6 - 11 |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Medlinket. The logo is red and blue, with the word "MED" in red and the word "LINKET" in blue. There is a red circle in the middle of the logo. The logo also has the trademark symbol.
| Shenzhen Med-link Electronics Tech Co., Ltd. | |||
|---|---|---|---|
| No. | Model | Intended Limb Range(Unit: cm) |
|---|---|---|
| 6 | Y000DSN2-3# | 6 - 11 |
| 7 | Y000DSN1-4# | 7 - 14 |
| 8 | Y000DSN2-4# | 7 - 14 |
| 9 | Y000DSN1-5# | 8 - 15 |
| 10 | Y000DSN2-5# | 8 - 15 |
| 11 | Y000DC1 | 15 - 22 |
| 12 | Y000DC2 | 15 - 22 |
| 13 | Y000DSA1 | 17 - 25 |
| 14 | Y000DSA2 | 17 - 25 |
| 15 | Y000DA1 | 24 - 32 |
| 16 | Y000DA2 | 24 - 32 |
| 17 | Y000DAL1 | 28 - 37 |
| 18 | Y000DAL2 | 28 - 37 |
| 19 | Y000DLA1 | 32 - 42 |
| 20 | Y000DLA2 | 32 - 42 |
| 21 | Y000DT1 | 42 - 50 |
| 22 | Y000DT2 | 42 - 50 |
Table 4 Contact Components and Relevant Materials
| Device Type | Contact Components | Contact Materials |
|---|---|---|
| Med-link Disposable BloodPressure Cuff | Inner face of hose | Nonwoven Polyester with aPVC laminate Backing |
8. Non-clinical Testing
A series of safety, essential performance and in vitro biocompatibility tests were performed to assess the safety and effectiveness of Med-link Disposable Blood Pressure Cuff.
The tests listed below were conducted in accordance with
ISO 10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing
Biological Evaluation of medical devices-Part 5: Test for in vitro cytotoxicity ISO 10993-5
ISO 10993-10 Biological evaluation of medical devices- Part 10: Tests for Irritation And Skin Sensitization
ISO 81060-1:2007/ AAMI/ANSI/ISO81060-1:2007/(R)2013 Non-Invasive Sphygmomanometers -Part 1: Requirements And Test Methods For Non-Automated Measurement Type
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Medlinket. The logo has the word "MED" in red, with a blue swoosh underneath. To the right of the word "MED" is a red circle, followed by the word "LINKET" in blue. The letters "TM" are in the upper right corner of the word "LINKET".
- Cytotoxicity Test .
- Skin irritation Test
- . Skin Sensitization Test (the Guinea Pig maximization test )
9. Technological Comparison with Predicate Device
| Item | Proposed Device | Primary Predicate | Secondary Predicate |
|---|---|---|---|
| Trade name | Med-link Disposable BloodPressure Cuff | Disposable Blood PressureCuff | Unimed Disposable BloodPressure Cuff |
| 510(K)Submitter | Shenzhen Med-linkElectronics Tech Co., Ltd. | XUZHOU MAICUFFTECHNOLOGY CO.,LTD. | Unimed Medical supplies Inc. |
| 510(K) Number | — | K151290 | K120364 |
| ClassificationRegulation | 21CRF 870.1120 | 21CRF 870.1120 | 21CRF 870.1120 |
| Classificationand Code | Class II,DXQ | Class II,DXQ | Class II,DXQ |
| Common name | Non-invasive Blood PressureCuff | Non-invasive Blood PressureCuff | Non-invasive Blood PressureCuff |
| Intended use | Med-link Disposable BloodPressure Cuff is an accessoryused in conjunction withnoninvasive blood pressuremeasurement systems. Thecuff is non-sterile and forsingle-patient use. It isavailable in neonatal,pediatric and adult sizes. Thecuff is not designed, sold, orintended for use except asindicated. | The disposable bloodpressure cuff is an accessoryused in conjunction withnoninvasive blood pressuremeasurement systems. Thecuff is non-sterile and forsingle-patient use. It isavailable in neonatal,pediatric and adult sizes. | The Unimed disposable bloodpressure cuff is an accessoryused in conjunction withnoninvasive blood pressuremeasurement systems. Thecuff is non-sterile and forsingle-patient use. It isavailable in neonatal,pediatric and adult sizes. Thecuff is not designed, sold, orintended for use except asindicated. |
| Patientpopulations | Adults/Pediatrics | Adults/Pediatrics | Adults/Pediatrics |
| Tubeconfiguration | One or two tube | One or two tube | One or two tube |
| Size | Conform to AHA bladder | Conform to AHA bladder | Conform to AHAbladder |
| Item | Proposed Device | Primary Predicate | Secondary Predicate |
| sizes recommendations | sizes recommendations | sizes recommendations | |
| Neonatal 1# (3-6cm) | Neonatal 1 (3-5.5 cm) | Neonate 1 (3-6 cm) | |
| Neonatal 2# (4-8cm) | Neonatal 2 (4-8 cm) | Neonate 2 (4-8 cm) | |
| Neonatal 3# (6-11cm) | Neonatal 3 (6-11 cm) | Neonate 3 (6-11 cm) | |
| Neonatal 4# (7-14cm) | Neonatal 4 (7-13 cm) | Neonate 4 (7-13 cm) | |
| Infant (8-15cm) | Infant (9-14.5 cm) | Neonate 5 (8-15 cm) | |
| Pediatric (15-22 cm) | Pediatric (13-21.5 cm) | Infant (9-14.8 cm) | |
| Small Adult (17-25 cm) | Small Adult (21-27 cm) | Child (13.8-21 cm) | |
| Adult (24-32cm) | Adult (26-35.5 cm) | Small Adult (20.5-28.5 cm) | |
| Adult long(28-37cm) | Adult (27.5-36.5 cm) | ||
| Large Adult (32-42cm) | Large Adult(35-45 cm) | Large Adult (35.5-46 cm) | |
| Thigh (42-50cm) | Large Adult Long(35.5-46cm) | ||
| Thigh (45-56cm) | |||
| Pressure limit | 0-300mmHg | 0-300mmHg | 0-300mmHg |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| AAMI/ANSI/ISO81060-1:20 | |||
| Non-clinicalRequirement | 07/(R)2013Comply with ISO 10993biocompatibility evaluation | Comply with ISO 10993biocompatibility evaluation | Comply with ISO10993biocompatibility evaluation |
Table 4 Comparison to Primary Predicate Device
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Medlinket. The logo has the word "MED" in red, with a blue swoosh underneath it. To the right of the swoosh is a red circle, followed by the word "LINKET" in blue. There is a small "TM" symbol in the upper right corner of the word "LINKET".
Shenzhen Med-link Electronics Tech Co., Ltd.
Med-link Disposable Blood Pressure Cuff has the same intended use, basic construction and technology specification as the predicate device. They are wrapped around the patient's arm or thigh and secured by a hook and loop fastener commonly called Velcro.
We extend the size to satisfy some special patients such as different neonatal size. Based on the performance testing in this submission, the slight difference on the range of these blood pressure cuffs does not raise any safety or effectiveness issue.
10. Comparison of Performance with Predicate Device
Performance testing was performed on the subject device and results were compared with predicate device. Tests were conducted following applicable procedures outlined in the FDA recognized consensus standard of AAMI/ANSI/ISO81060-1:2007/(R)2013, and results met all relevant requirements in the test standard.
11. Conclusion
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Medlinket. The logo has the word "MED" in red, with a blue swoosh underneath it. To the right of the swoosh is a red circle, and then the word "LINKET" in blue. The letters "TM" are in the upper right corner of the word LINKET.
Shenzhen Med-link Electronics Tech Co., Ltd.
After analyzing safety, essential performance and biocompatibility testing data, it can be concluded that: Med-link Disposable Blood Pressure Cuff are safe and effective as the predicate device.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).