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.

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.

AI/ML Overview

The Med-link Reusable Blood Pressure Cuff underwent non-clinical testing to assess its safety and essential performance. The acceptance criteria and reported device performance are based on compliance with specific ISO and IEC standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (based on standards)	Reported Device Performance
Compliance with ISO 81060-1 (non-invasive sphygmomanometers)	Device tested and found to be in accordance with ISO 81060-1.
Compliance with IEC 80601-2-30 (automated non-invasive sphygmomanometers)	Device tested and found to be in accordance with IEC 80601-2-30.
Compliance with ISO 10993-5 (in vitro cytotoxicity)	Cytotoxicity Test conducted and passed.
Compliance with ISO 10993-10 (irritation and skin sensitization)	Skin Irritation Test and Skin Sensitization Test conducted and passed.
Pressure Limit	0-300mmHg (matches predicate devices).
Sterility	Non-sterile (consistent with intended use and predicate devices).
Conformance to AHA bladder sizes recommendations	The device offers various sizes for neonatal, infant, pediatric, small adult, adult, large adult, and adult thigh, corresponding to recommended limb ranges.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each specific non-clinical test (ISO 81060-1, IEC 80601-2-30, biocompatibility tests). It indicates that "A series of safety, essential performance and biocompatibility tests were performed."
The provenance of the data is not specified in terms of country of origin or whether the tests were retrospective or prospective. It states the tests were "conducted in accordance with" the listed standards, implying a controlled testing environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The non-clinical testing primarily focuses on objective measurements against international standards rather than expert-derived ground truth as might be seen in diagnostic imaging studies.

4. Adjudication Method for the Test Set:

This information is not applicable and is not provided. The testing involves standardized laboratory and performance tests, not a judgmental adjudication process.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This information is not applicable and is not provided. The device is a blood pressure cuff, not an AI-assisted diagnostic tool for which MRMC studies would typically be conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:

This information is not applicable and is not provided. The device is not an algorithm, so standalone algorithm performance is not relevant. The performance of the cuff is evaluated as a physical accessory for blood pressure measurement systems.

7. The Type of Ground Truth Used:

The ground truth for the performance claims relies on:

International Standards: Compliance with ISO 81060-1, IEC 80601-2-30, ISO 10993-5, and ISO 10993-10. These standards establish the acceptable technical performance and safety criteria for such devices.
Biocompatibility Testing: Objective laboratory tests (cytotoxicity, skin irritation, skin sensitization) directly measure the device's interaction with biological systems against established thresholds.
Predicate Device Comparison: The inherent assumption is that if the device performs equivalently to legally marketed predicate devices that have already met regulatory requirements, then it is safe and effective.

8. The Sample Size for the Training Set:

This information is not applicable to this type of medical device. Blood pressure cuffs are mechanical devices, and their performance is established through physical and biological testing, not machine learning models that require training sets.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the reasons stated in item 8.

Summary

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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

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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)

K173869

Device Name

Med-link Reusable Blood Pressure Cuff

Indications for Use (Describe)

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 BloodPressure 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 MAICUFFTECHNOLOGYCO.,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

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 PredicateDevice
Trade name	Med-link Reusable BloodPressure Cuff	Reusable Blood PressureCuff	Unimed Disposable BloodPressure Cuff
510(K)Submitter	Shenzhen Med-linkElectronics Tech Co.,Ltd.	XUZHOU MAICUFFTECHNOLOGYCO.,LTD.	Unimed Medical suppliesInc.
510(K) Number	-	K151290	K112544
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 BloodPressure Cuff	Non-invasive BloodPressure Cuff	Non-invasive BloodPressure Cuff
Intended use	Med-link Reusable BloodPressureCuff is anaccessory used inconjunction withnon-invasive bloodpressure measurementsystems. The cuff isnon-sterile. It is availablein neonatal, infant,pediatric and adult sizes.The cuff is not designed,sold, or intended for useexcept as indicated.	The reusable bloodpressure cuff is anaccessory used inconjunction withnoninvasive bloodpressure measurementsystems. The cuff isnon-sterile and may bereused. It is available ininfant, pediatric and adultsizes.	The Unimed disposableblood pressure cuff is anaccessory used inconjunction withnoninvasive blood pressuremeasurement systems. Thecuff is non-sterile and maybe reused. It is available inpediatric and adult sizes.The cuff is not designed,sold, or intended for useexcept as indicated.
Patientpopulations	Adults/Pediatrics	Adults/Pediatrics	Adults/Pediatrics
MaterialContactingpatient	Cuff: Nonwoven Polyesterwith TPU laminateAir hose: PVC tap andSilicone tube	Cuff: nylon TPUAir hose: PVC	Cuff: Pu Synthetic LeatherAir Tubing: PVC
Tubeconfiguration	One or two tube	One or two tube	One or two tube
Item	Proposed Device	Predicate Device	Secondary PredicateDevice
Size	Conform to AHA bladdersizes recommendationsNeonatal (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 bladdersizes recommendationsInfant (9-14.5cm)Pediatric (13-21.5cm)Small Adult (21-27cm)Adult (26-35.5cm)Large Adult (35-45cm)	Conform to AHA bladdersizes recommendationsNeonatal (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 10993-5and ISO 10993-10biocompatibilityevaluation	Comply with ISO 10993-5and ISO 10993-10biocompatibilityevaluation	Comply with ISO 10993-5and ISO 10993-10biocompatibilityevaluation

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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.

Regulation Number and Section

§ 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).