(225 days)
Not Found
No
The device description and performance studies focus on the physical properties and standard testing of a blood pressure cuff, with no mention of AI or ML.
No
The device is described as an "accessory used in conjunction with noninvasive blood pressure measurement systems" and is a "cuff." It is used to measure blood pressure, not to treat a condition or restore a function, which are characteristics of therapeutic devices.
No
A blood pressure cuff is an accessory that helps measure blood pressure, but it does not directly diagnose a condition from the measurement. It facilitates the diagnostic process by being part of a larger measurement system.
No
The device description clearly states it is a "rectangle soft inelastic sleeve with bladder, to which a single-tube or twin-tube is connected," which are physical hardware components. The performance studies also focus on hardware-related standards like ISO 81060-1 and IEC 80601-2-30.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the Med-link Reusable Blood Pressure Cuff clearly states its intended use is as an accessory for noninvasive blood pressure measurement systems. It is applied externally to the patient's limb to facilitate the measurement of blood pressure.
- There is no mention of analyzing any biological specimens.
The device is a medical device, but specifically a non-invasive accessory for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Med-link Reusable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
Product codes (comma separated list FDA assigned to the subject device)
DXQ
Device Description
The proposed device, Med-link Reusable Blood Pressure Cuffs is rectangle soft inelastic sleeve with bladder, to which a single-tube or twin-tube is connected. It is wrapped around the patient's limb 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's limb (arm or thigh)
Indicated Patient Age Range
neonatal, infant, pediatric and adult
Intended User / Care Setting
Not Found
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)
A series of safety, essential performance and biocompatibility tests were performed to assess the safety and effectiveness of Med-link Reusable Blood Pressure Cuff. The tests listed below were conducted in accordance with
ISO 81060-1, non-invasive sphygmomanometers - part 1: requirements and test methods for non-automated measurement type.
IEC 80601-2-30 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
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
- Cytotoxicity Test
- Skin irritation Test
- Skin Sensitization Test
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
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shenzhen Med-link Electronics Tech Co., Ltd. Baihan Feng Regulatory Affairs Specialist 4th Floor, Building A Yingtailong Industrial Park Dalang South Road, Longhua District Shenzhen, China 518109
Re: K173869
Trade/Device Name: Med-link Reusable Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: June 25, 2018 Received: June 25, 2018
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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
M.A. Hillemann
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Med-link Reusable Blood Pressure Cuff
Indications for Use (Describe)
Med-link Reusable Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. 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) |
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Image /page/3/Picture/1 description: The image shows the logo for MEDLINKET. The logo has the word "MED" in red, with a blue arc above it. There is a red circle to the right of the word "MED", and the word "LINKET" in blue to the right of the circle. The letters "TM" are in small black font above the letters "KET".
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: 0086-755-61120299 Fax:0086-755-61120055 Establishment Registration Number: 3006636961
2. Contact Person
Baihan Feng (Regulatory Affairs Specialist) E-mail: mdl001@medlinket.com
3. Data of Submission
15th, Dec. 2017
Identification of the Device 4.
Trade Name: Med-link Reusable Blood Pressure Cuff
| Table 1 Device Model | ||
|---|---|---|
| Device Name/Type | Device Model |
|---|---|
| Reusable Blood | |
| Pressure Cuff | Y000N1, Y000N2, Y000I1, Y000I2, Y000C1, Y000C2, Y000S1, Y000S2, Y000A1, Y000A2, Y000L1, Y000L2, Y000T1, Y000T2, Y000RC1, Y000RC2, Y000RSA1, Y000RSA2, Y000RA1, Y000RA2, Y000RAL1, Y000RAL2, Y000RLA1, Y000RLA2, Y000RT1, Y000RT2 |
Common Name: Non-invasive Blood Pressure Cuff
Classification Name: Blood Pressure Cuff
Classification Regulation: 21 CFR 870.1120
Product Code: DXQ
- న. Identification of the Predicate Device
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Image /page/4/Picture/1 description: The image contains a logo for MedLinket. The logo has the word "MED" in red, with a blue arc underneath it. There is a red circle to the right of "MED", and the word "LINKET" in blue to the right of the circle. There is a "TM" symbol in the upper right corner of the word "LINKET".
| No. | Device Name | Common Name | Manufacture | Classification and Code | Classification regulation | 510(k) number |
|---|---|---|---|---|---|---|
| Primary Predicate | Disposable/Reusable Blood Pressure Cuff | Non-invasive Blood pressure cuff | XUZHOU MAICUFF | |||
| TECHNOLOGY | ||||||
| CO.,LTD. | Class II, DXQ | 21 CFR 870.1120 | K151290 | |||
| Secondary Predicate | Unimed Blood Pressure Cuff | Non-invasive Blood pressure cuff | Unimed Medical supplies Inc. | Class II, DXQ | 21 CFR 870.1120 | K112544 |
Table 2 Predicate Device Information
6. Intended Use and Indications for Use of the Subject device
Med-link Reusable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonatal, infant, 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 Reusable Blood Pressure Cuffs is rectangle soft inelastic sleeve with bladder, to which a single-tube or twin-tube is connected. It is wrapped around the patient's limb 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 | Y000N1 | 6-11 |
| 2 | Y000N2 | 6-11 |
| 3 | Y000I1 | 10-15 |
| 4 | Y000I2 | 10-15 |
| 5 | Y000C1 | 14-21 |
| 6 | Y000C2 | 14-21 |
| 7 | Y000S1 | 20.5-28 |
| 8 | Y000S2 | 20.5-28 |
Table 3 Intended Limb Range for Each Model
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Image /page/5/Picture/1 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 word "MED" is a red circle, followed by the word "LINKET" in blue. The letters "TM" are in superscript to the right of the word "LINKET".
| 9 | Y000A1 | 27-35 |
|---|---|---|
| 10 | Y000A2 | 27-35 |
| 11 | Y000L1 | 34-43 |
| 12 | Y000L2 | 34-43 |
| 13 | Y000T1 | 42-54 |
| 14 | Y000T2 | 42-54 |
| 15 | Y000RC1 | 15-22 |
| 16 | Y000RC2 | 15-22 |
| 17 | Y000RSA1 | 17-25 |
| 18 | Y000RSA2 | 17-25 |
| 19 | Y000RA1 | 24-32 |
| 20 | Y000RA2 | 24-32 |
| 21 | Y000RAL1 | 28-37 |
| 22 | Y000RAL2 | 28-37 |
| 23 | Y000RLA1 | 32-42 |
| 24 | Y000RLA2 | 32-42 |
| 25 | Y000RT1 | 42-50 |
| 26 | Y000RT2 | 42-50 |
8. Non-clinical Testing
A series of safety, essential performance and biocompatibility tests were performed to assess the safety and effectiveness of Med-link Reusable Blood Pressure Cuff. The tests listed below were conducted in accordance with
ISO 81060-1, non-invasive sphygmomanometers - part 1: requirements and test methods for non-automated measurement type.
IEC 80601-2-30 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
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
- Cytotoxicity Test
- Skin irritation Test
- Skin Sensitization Test
Substantial Equivalence Determination 9.
Table 4 Comparison to Predicate Devices
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Image /page/6/Picture/1 description: The image shows the logo for MED LINKET. The logo has the word "MED" in red, with the letters stacked on top of each other. A blue swoosh starts below the word "MED" and curves to the right, ending at a red circle. To the right of the red circle is the word "LINKET" in blue, with the letters in a straight line. The letters "TM" are in superscript to the right of the word "LINKET".
| Item | Proposed Device | Predicate Device | Secondary Predicate
Device | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Trade name | Med-link Reusable Blood
Pressure Cuff | Reusable Blood Pressure
Cuff | Unimed Disposable Blood
Pressure Cuff | |
| 510(K)
Submitter | Shenzhen Med-link
Electronics Tech Co.,
Ltd. | XUZHOU MAICUFF
TECHNOLOGY
CO.,LTD. | Unimed Medical supplies
Inc. | |
| 510(K) Number | - | K151290 | K112544 | |
| Classification
Regulation | 21CRF 870.1120 | 21CRF 870.1120 | 21CRF 870.1120 | |
| Classification
and Code | Class II,
DXQ | Class II,
DXQ | Class II,
DXQ | |
| Common name | Non-invasive Blood
Pressure Cuff | Non-invasive Blood
Pressure Cuff | Non-invasive Blood
Pressure Cuff | |
| Intended use | Med-link Reusable Blood
Pressure
Cuff is an
accessory used in
conjunction with
non-invasive blood
pressure measurement
systems. The cuff is
non-sterile. It is available
in neonatal, infant,
pediatric and adult sizes.
The cuff is not designed,
sold, or intended for use
except as indicated. | The reusable blood
pressure cuff is an
accessory used in
conjunction with
noninvasive blood
pressure measurement
systems. The cuff is
non-sterile and may be
reused. It is available in
infant, pediatric and adult
sizes. | The Unimed disposable
blood pressure cuff is an
accessory used in
conjunction with
noninvasive blood pressure
measurement systems. The
cuff is non-sterile and may
be reused. It is available in
pediatric and adult sizes.
The cuff is not designed,
sold, or intended for use
except as indicated. | |
| Patient
populations | Adults/Pediatrics | Adults/Pediatrics | Adults/Pediatrics | |
| Material
Contacting
patient | Cuff: Nonwoven Polyester
with TPU laminate
Air hose: PVC tap and
Silicone tube | Cuff: nylon TPU
Air hose: PVC | Cuff: Pu Synthetic Leather
Air Tubing: PVC | |
| Tube
configuration | One or two tube | One or two tube | One or two tube | |
| Item | Proposed Device | Predicate Device | Secondary Predicate
Device | |
| Size | Conform to AHA bladder
sizes recommendations
Neonatal (6-11cm)
Infant (10-15cm)
Pediatric (14-22cm)
Small Adult (17-28cm)
Adult (24-37cm)
Large Adult (32-43cm)
Adult Thigh (42-54cm) | Conform to AHA bladder
sizes recommendations
Infant (9-14.5cm)
Pediatric (13-21.5cm)
Small Adult (21-27cm)
Adult (26-35.5cm)
Large Adult (35-45cm) | Conform to AHA bladder
sizes recommendations
Neonatal (6-11cm)
Infant (10-19cm)
Pediatric (18-26cm)
Small Adult (20-28 cm)
Adult (25-35 cm)
Large Adult (33-47cm)
Large Adult Long
(33-47cm)
Thigh (46-66cm) | |
| | Pressure limit | 0-300mmHg | 0-300mmHg | 0-300mmHg |
| | Sterile | No | No | No |
| | Biocompatibility | Comply with ISO 10993-5
and ISO 10993-10
biocompatibility
evaluation | Comply with ISO 10993-5
and ISO 10993-10
biocompatibility
evaluation | Comply with ISO 10993-5
and ISO 10993-10
biocompatibility
evaluation |
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Image /page/7/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, followed by the word "LINKET" in blue. The letters "TM" are in the upper right corner of the word "LINKET".
Med-link Reusable 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, overweight. 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. Conclusion
Based on the comparison and analysis above, it can be concluded that: Med-link Reusable Blood Pressure Cuff are as safe and effective as the predicate devices.