The 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 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 disposable blood pressure cuff. All the disposable blood pressure cuff has same structure, which contains Cuff and single tube. The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics (Cuff) and PVC (Air tube), thereinto, the non-woven fabrics (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 6 models with different population with different circumference size.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information needed to fully answer your request regarding the acceptance criteria, study details, and sample sizes for the medical device described. The document is a 510(k) summary for a Disposable NIBP Cuff, which primarily focuses on establishing substantial equivalence to a predicate device.

Here's a breakdown of what is and is not in the text, relative to your request:

What is present in the document:

Acceptance Criteria (Indirectly): The document states that "Non-clinical tests were conducted to verify that the subject device met all design specifications" and that it complies with "ISO 81060-1, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007." This standard would implicitly define the performance acceptance criteria for blood pressure cuffs. However, the specific numerical acceptance criteria (e.g., maximum allowable error in mmHg) are not explicitly listed in the provided text. The "Max. Leakage" of "< 4mm Hg/ min." is mentioned as a comparison point to the predicate, implying it's an acceptance criterion.
Study Proving Acceptance Criteria (Indirectly): The document mentions that "Non-clinical tests were conducted" and specifically references "Performance testing accordance with ISO 81060-1 has been conducted and provided with this submission." This indicates that a study was performed to demonstrate compliance with the standard.
Biocompatibility Testing: It explicitly states that "Biocompatibility testing accordance with ISO 10993-1 has been conducted" and lists the types of tests: Cytotoxicity, Sensitization, and Irritation. These are acceptance criteria for biocompatibility.
Device Performance (Indirectly): The document states that "The test results demonstrated that the subject device complies with the following standards," suggesting that the device met the performance requirements of ISO 81060-1 and the biocompatibility tests.

What is not present in the document, and therefore cannot be provided in the requested table/description:

A table of acceptance criteria and reported device performance with specific values. While ISO 81060-1 is referenced, the specific numerical acceptance criteria from that standard are not detailed in this summary, nor are the reported results of the specific device (e.g., "Device A achieved X mmHg accuracy").
Sample size used for the test set. The text mentions "non-clinical tests" and "performance testing" but does not specify the number of devices or measurements included in these tests.
Data provenance (e.g., country of origin of the data, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and their qualifications. This type of detail is usually for studies involving human interpretation (e.g., imaging devices) and is not applicable here as this is a physical blood pressure cuff.
Adjudication method. (Not applicable for this type of device testing).
Multi-reader multi-case (MRMC) comparative effectiveness study. (Not applicable for this type of device testing).
Standalone (algorithm only) performance. (Not applicable, as this is a physical device, not an algorithm).
Type of ground truth used. For a blood pressure cuff, the "ground truth" would be established by validated reference measurement devices or methods within the ISO 81060-1 standard, but this is not explicitly detailed.
Sample size for the training set. (Not applicable, as this is not an AI/ML device that requires a training set).
How the ground truth for the training set was established. (Not applicable).

Based on the available information, here is what can be inferred and presented:

The provided text describes the acceptance criteria and related studies for the Disposable NIBP Cuff (K193629).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (as inferred/stated)	Reported Device Performance (as inferred/stated)
Performance (Functional)	Compliance with ISO 81060-1: Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type	The subject device complies with ISO 81060-1.
Maximum Leakage	< 4mm Hg/ min.	Met (implied by comparison to predicate)
Biocompatibility - Cytotoxicity	No potential cytotoxicity	No potential cytotoxicity observed
Biocompatibility - Sensitization	No sensitization observed	No sensitization observed
Biocompatibility - Irritation	Negligible (no observed primary irritation)	Negligible (no observed primary irritation)
Design Specifications	Met all design specifications	Met all design specifications

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

Test Set Sample Size: Not specified in the document.
Data Provenance: The studies are "non-clinical tests" and "performance testing" conducted for the submission for an FDA 510(k) by Shenzhen Changke Connect Electronics Co., Ltd. and Chonconn Medical Device Consulting Co., Ltd. (both based in China). The specific country where the physical testing took place is not explicitly stated, but it's likely associated with the manufacturer's location. The studies are prospective in nature, designed to demonstrate compliance.

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

This information is not applicable for the type of device (blood pressure cuff). The ground truth for such devices is established through validated measurement methods and reference instruments as per standards like ISO 81060-1, rather than expert human interpretation.

4. Adjudication method for the test set

Not applicable for this type of device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not done. This type of study is typically for diagnostic imaging devices where human readers interpret medical images, which is not relevant for a blood pressure cuff.

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

This is not an algorithm-only device. The reference to "non-clinical data" and "performance testing" implies a standalone device performance evaluation against established standards.

7. The type of ground truth used

For functional performance (ISO 81060-1): The ground truth would be established through a comparison to a validated reference method or device as per the requirements of the ISO 81060-1 standard. This standard specifies test methods for accuracy and other performance aspects of sphygmomanometers.
For biocompatibility (ISO 10993-1): The ground truth is established by standardized biological assays and tests (cytotoxicity, sensitization, irritation) using defined cell lines, animal models, or human volunteers (for irritation patch tests) according to the ISO 10993-1 standard.

8. The sample size for the training set

Not applicable as this is a physical medical device and not an artificial intelligence/machine learning algorithm requiring a training set.

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

Not applicable as there is no training set for this type of device.

Summary

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March 25, 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: K193629

Trade/Device Name: Disposable NIBP Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: December 24, 2019 Received: December 26, 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.

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

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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,

LT 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) K193629

Device Name Disposable NIBP Cuff

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17)	Page 1 of 1
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FORM FDA 3881 (7/17)

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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2019/12/24

Submission sponsor 1.

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	Disposable NIBP Cuff
Model	CK-XT-88062-001, CK-XT-88062-003, CK-XT-88062-005, CK-XT-88062-007, CK-XT-88062-008, CK-XT-88062-010
Common Name	Non-invasive Blood pressure cuff
Regulatory Class	Class II
Classification	21CFR 870.1120 / Blood pressure cuff / DXQ
Submission type	Traditional 510(K)

3. Subject Device Information

4. Predicate Device

Manufacturer: Shenzhen Caremed Medical Technology Co., Ltd.

Device: Caremed Disposable Blood Pressure Cuff

510(k) No.: K182433.

Device Description 5.

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 disposable blood pressure cuff. All the disposable blood pressure cuff has same structure, which contains Cuff and single tube.

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The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics (Cuff) and PVC (Air tube), thereinto, the non-woven fabrics (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 6 models with different population with different circumference size.

6. Intended use & Indication for use

Features	Subject DeviceDisposable NIBP Cuff	Predicate Device K182433Disposable 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 disposable blood pressure cuffis an accessory used in conjunctionwith noninvasive blood pressuremeasurement systems. The cuff isnon-sterile and for single-patientuse. It is available in neonate,infant, child and adult sizes. Thecuff is not designed, sold, orintended for use except asindicated.	The disposable blood pressure cuffis an accessory used in conjunctionwith noninvasive blood pressuremeasurement systems. The cuff isnon-sterile and for single-patientuse. It is available in neonate,infant, child and adult sizes. Thecuff is not designed, sold, orintended for use except asindicated.	Same
PatientPopulations	Adults/Pediatrics	Adults/Pediatrics	Same
Tube Number	One	One	Same
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
Limb	Conform to AHA bladder sizes	Conform to AHA bladder sizes	Different

Comparison to the Predicate Device 7.

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Circumference	recommendations	recommendations	(1)
(Range in cm)	Neonatal (7-13 cm)	Neonatal 1 (3-6 cm)
	Infant (9-14.8 cm)	Neonatal 2 (4-8 cm)
	Child (13.8-21.5 cm)	Neonatal 3 (6-11 cm)
	Adult (27.5-36.5 cm)	Neonatal 4 (7-13 cm)
	Large Adult (35.5-46 cm)	Neonatal 5 (8-15 cm)
	Adult Thigh (45-56.5 cm)	Infant (9-14.8 cm)
		Child (13.8-21.5 cm)
		Small Adult (20.5-28.5 cm)
		Adult (27.5-36.5 cm)
		Adult Long (27.5-36.5/46.5 cm)
		Large Adult (35.5-46 cm)
		Large Adult Long (35.5-46 cm)
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	Non-woven (Patient contacted);	Non-woven (Patient contacted);	Different
	PVC;	nylon;	(2)
	ABS.	PVC.
Biocompatibilit	No potential cytotoxicity;	No potential cytotoxicity;	Same
y	No sensitization observed;	No sensitization observed;
	Negligible (no observed primary	Negligible (no observed primary
	irritation)	irritation)

Justification of differences:

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

Different (1): The difference in the limb circumference. Performance testing accordance with ISO 81060-1 has been conducted and provided with this submission. Therefore, this difference does not raise any safety or effectiveness issue.

Different (2): The difference in the material. Biocompatibility testing accordance with ISO 10993-1 has been conducted and provided with this submission. Therefore, this difference does not raise any safety or effectiveness issue.

Performance Data 8.

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

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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:

. ISO 81060-1, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.
The test was selected to show substantial equivalence between the subject device and the predicate.

9. Conclusion

Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject Disposable NIBP Cuff has been shown to be substantially equivalent to legally marketed predicate device.

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).