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 neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

Device Description

The subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes. The subject device includes reusable blood pressure cuff. All the reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube. The reusable blood pressure cuff is reusable device, Model CK-XT-78211-XXX series are made of PU synthetic leather (Cuff) and TPU (Air Hose), and the PU synthetic leather (Cuff) is the material used to contacting with the patient's intact skin. Model CK-XT-78243-XXX series are made of Nylon (Cuff) and silica gel (Air Hose), and the Nylon (Cuff) is the material used to contacting with the patient's intact skin.

AI/ML Overview

The provided text describes a 510(k) submission for a Reusable NIBP Cuff, demonstrating its substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

The document focuses on non-clinical data and biocompatibility testing, primarily to show compliance with international standards and substantial equivalence, rather than a direct comparison against specific performance acceptance criteria for the blood pressure measurement accuracy itself (which is typically addressed by standards like ISO 81060-2).

Therefore, it is not possible to fully answer the request based on the provided text. I will extract the available information and explicitly state what is missing.

Missing Information from the Provided Document:

A table of specific acceptance criteria for blood pressure measurement accuracy and corresponding device performance data against these criteria. The document mentions compliance with ISO 81060-1 but does not provide the specific performance results or acceptance limits for accuracy from this standard.
The exact sample size used for any performance testing related to blood pressure measurement accuracy.
Data provenance (country of origin, retrospective/prospective) for any detailed performance study.
Number and qualifications of experts for ground truth establishment.
Adjudication method for a test set.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
Whether a standalone (algorithm only) performance study was done.
The specific type of ground truth used for performance validation (e.g., direct arterial measurement, oscillometric reference).
Sample size for the training set (no training set mentioned as this is a physical medical device, not an AI/software device).
How ground truth for the training set was established (not applicable).

Based on the provided text, here is the information available:

1. A table of acceptance criteria and the reported device performance

The document states that non-clinical tests were conducted to verify that the subject device met all design specifications and complied with specific standards, implying these standards define the acceptance criteria. However, explicit numerical acceptance criteria and the device's reported performance against them are not provided in a detailed table as requested.

The relevant standards mentioned are:

ISO 81060-1: Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.
ISO 10993-5: Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity.
ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.

For biocompatibility testing, the acceptance criteria are generally "no sensitization observed" and "Negligible (no observed primary irritation)" and passing cytotoxicity tests, which the device reportedly met. These are general statements rather than specific numerical criteria.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified for any performance testing related to NIBP accuracy. For biocompatibility, "the battery of testing" was mentioned, but specific sample sizes of biological material or animals are not detailed.
Data Provenance: Not specified. The submission sponsor and correspondent are based in China (Shenzhen, P.R. China).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided as the device is a physical NIBP cuff, not an AI/software device usually requiring expert ground truth in this context. The performance verification likely involved physical laboratory testing and possibly clinical studies, not expert review of images or data.

4. Adjudication method for the test set

Not applicable/Not provided. This usually pertains to studies involving expert review for AI/image analysis.

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

Not applicable/Not provided. This pertains to AI-assisted diagnostic devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. This pertains to AI/software performance. The device is a physical medical accessory.

7. The type of ground truth used

For NIBP cuff performance (ISO 81060-1): The standard typically describes methods for validating the accuracy of non-invasive blood pressure measurements, often against a reference method (e.g., intra-arterial pressure measurement) or a validated simulator. The exact ground truth method used in their specific tests is not detailed in this summary.
For Biocompatibility (ISO 10993-5, -10): The ground truth is established through standardized laboratory assays for cytotoxicity, sensitization, and irritation using accepted biological models (e.g., cell cultures, animal models, or human patch tests).

8. The sample size for the training set

Not applicable. This device is a physical NIBP cuff, not a software or AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, no training set is relevant for this type of device.

Summary

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September 17, 2019

Shenzhen Changke Connect Electronics Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A. NanShan Medical devices Industrial Park Nanshan District Shenzhen, 518067 CHINA

Re: K191253

Trade/Device Name: Reusable NIBP Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: August 29, 2019 Received: August 29, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191253

Device Name Reusable NIBP Cuff

Indications for Use (Describe)

The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child 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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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2019/04/08

1. Submission sponsor

Name: Shenzhen Changke Connect Electronics Co., Ltd. Address: A2-4th floor of Xiang dali Technology Park, No.87 of HengPing Road, Henggang, Longgang District, Shenzhen, P.R. China Contact person: Yahui Zhou Title: General manager E-mail: zhouyahui(@szcklt.com

Tel: +86 136 1301 2560

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	Reusable NIBP Cuff
Model	CK-XT-78211-001, CK-XT-78211-003, CK-XT-78211-005, CK-XT-78211-006,CK-XT-78211-007, CK-XT-78211-008, CK-XT-78243-000, CK-XT-78243-001,CK-XT-78243-003, CK-XT-78243-005, CK-XT-78243-007, CK-XT-78243-008
Common Name	Non-invasive Blood pressure cuff
Regulatory Class	Class II
Classification	21CFR 870.1120 / Blood pressure cuff / DXQ
Submission type	Traditional 510(K)

Subject Device Information 3.

4. Predicate Device

By submission of the Traditional 510(k), Shenzhen Changke Connect Electronics Co., Ltd. is requesting clearance for Reusable NIBP Cuff. It is comparable to the following legally marketed system:

Shenzhen Caremed Medical Technology Co., Ltd. Reusable Blood Pressure Cuff under 1. K182433.
The subject device has same intended use, same target patient population, same performance effectiveness, performance safety as the predicate devices and no question is raised regarding to effectiveness and safety.

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So, the conclusion is that the subject device is substantial equivalent to the predicate.

5. Device Description

The subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes.

The subject device includes reusable blood pressure cuff. All the reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube.

The reusable blood pressure cuff is reusable device, Model CK-XT-78211-XXX series are made of PU synthetic leather (Cuff) and TPU (Air Hose), and the PU synthetic leather (Cuff) is the material used to contacting with the patient's intact skin. Model CK-XT-78243-XXX series are made of Nylon (Cuff) and silica gel (Air Hose), and the Nylon (Cuff) is the material used to contacting with the patient's intact skin.

6. Intended use & Indication for use

	7. Comparison to the Predicate Device
Features	Subject DeviceReusable NIBP Cuff	Predicate Device K182433Reusable Blood Pressure Cuff	Remark
Applicant	Shenzhen Changke ConnectElectronics Co., Ltd.	Shenzhen Caremed MedicalTechnology Co., Ltd.	/
ClassificationRegulation	21CRF 870.1120	21CRF 870.1120	Same
Classificationand Code	Class II,DXQ	Class II,DXQ	Same
Commonname	Non-invasive Blood PressureCuff	Non-invasive Blood PressureCuff	Same
Intended use	The reusable blood pressure cuff isan accessory used in conjunctionwith noninvasive blood pressuremeasurement systems. The cuff isnon-sterile and may be reused. It isavailable in neonate, infant, childand adult sizes. The cuff is notdesigned, sold, or intended for useexcept as indicated.	The reusable blood pressure cuff isan accessory used in conjunctionwith noninvasive blood pressuremeasurement systems. The cuff isnon-sterile and may be reused. It isavailable in neonate, infant, childand adult sizes. The cuff is notdesigned, sold, or intended for useexcept as indicated.	Same
PatientPopulations	Adults/Pediatrics	Adults/Pediatrics	Same
Tube Number	One	One or two	Different
			(1)
Principles ofOperation	Bladder is wrapped around thepatient's limb and secured by hookand loop closure Air hose isconnected to the noninvasive bloodpressure measurement systems	Bladder is wrapped around thepatient's limb and secured by hookand loop closure Air hose isconnected to the noninvasive bloodpressure measurement systems	Same
LimbCircumference(Range in cm)	Conform to AHA bladder sizesrecommendationsCK-XT-78211-XXX Series:Infant (10-15cm)Child (14-21.5cm)Small Adult (20.5-28cm)Adult (27-35cm)Large Adult (34-43cm)Adult Thigh (42-54cm)CK-XT-78243-XXX Series:Neonatal (6-11cm)Infant (10-19cm)Child (18-26cm)Adult (25-35cm)Large Adult (33-47cm)Adult Thigh (44-66cm)	Conform to AHA bladder sizesrecommendationsNeonatal (6-11cm)Infant (10-19cm)Child (18-26cm)Small Adult (20-28cm)Adult (25-35cm)Adult Long (25-35cm)Large Adult (33-47cm)Adult Thigh (44-66cm)	Different(2)
Pressure Range	0-300 mmHg	0-300 mmHg	Same
Sterility	Non-sterile	Non-sterile	Same
Max. Leakage	< 4mm Hg/ min.	< 4mm Hg/ min.	Same
Material	CK-XT-78211-XXX Series:Cuff (Patient contacted): PUSynthetic LeatherBladder: TPUTubing: TPUHook: NylonLoop: NylonCK-XT-78243-XXX Series:Cuff (Patient contacted): NylonBladder: TPUTubing: Silica gelHook: NylonLoop: Nylon	Cuff (Patient contacted): PUSynthetic LeatherBladder: Transparent Polyurethane(TPU Film)Tubing: PVCHook: Molded NylonLoop: Nylon	Different(3)
y	No sensitization observed;Negligible (no observed primaryirritation)	No sensitization observed;Negligible (no observed primaryirritation)

Comparison to the Predicate Device 7

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Justification of differences:

Justifications for differences between subject device and the predicate device are shown as below:

Different (1): The predicate device includes single tube configuration. All models of subject device use single tube. This difference does not raise any safety or effectiveness issue. Different (2): The limb circumference of subject device is included in the range of the predicate device. And it is disclosed in user manual clearly for selection. Therefore, this difference does not raise any safety or effectiveness issue.

Different (3): The material of subject device and predicate device is different, but both of them comply with ISO 10993-5 and ISO 10993-10. Therefore, this difference does not result in any safety and effectiveness issue.

Conclusion:

The subject devices share the same indications for use, device operation, overall technical and functional capabilities, meet the same standards and requirements and therefore, are substantially equivalent to the predicate device(s).

8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Biocompatibility guidance, 2016 (Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process") and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

. Cytotoxicity
Sensitization .
Irritation .

The subject devices are considered surface contacting for a duration of exceed 24 hours but not 30 days.

Non-clinical data

Non-clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:

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. ISO 81060-1, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.
ISO 10993-5: 2009 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro . Cytotoxicity.
. ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization

The test was selected to show substantial equivalence between the subject device and the predicate.

9. Conclusion

It has been shown in this 510(k) submission that the difference between the proposed devices and the predicate devices do not raise any questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.

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).