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.

Device Description

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

The proposed device is Reusable blood pressure cuff, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.

During the operation process, the integrated inflatable bladder will wrapped around the patient's limb and secured by hook and loop closure, and the air hose will connected to the noninvasive blood pressure measurement systems.

The reusable blood pressure cuff is reusable device, and which is made of 210D Nylon TPU (Cuff) and PVC (Air Hose), thereinto, the 210D Nylon TPU (Cuff) is the material used to contacting with the patient.

The reusable blood pressure cuff has 16 models with different size for different population with different arm size, and the 8 models of 16 are use single tube of air hose and other 8 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.

The Reusable blood pressure cuff is provided as non-sterile.

AI/ML Overview

This document pertains to the 510(k) premarket notification for a Reusable Blood Pressure Cuff (K152468).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" as a separate, quantitative table for the device's main function (blood pressure measurement accuracy). Instead, it focuses on demonstrating substantial equivalence to a predicate device (K151290) through a comparison of various features and compliance with relevant standards for safety and performance.

The "Non-Clinical Test Conclusion" section indicates that the device met design specifications and was substantially equivalent, based on compliance with specific ISO standards.

Acceptance Criteria (related to standards/tests)	Reported Device Performance (Compliance)
Biocompatibility:
ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity	"Under the conditions of the study, not cytotoxicity effect"
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.	"Under the conditions of the study, not an irritant"
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.	"Under conditions of the study, not a sensitizer."
Non-Invasive Sphygmomanometers Performance:
ISO 81060-1:2012 Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type	Complies (implied by "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device")
Physical/Functional Characteristics (compared to predicate):
Intended Use	SE (Substantially Equivalent)
Patient Populations	SE
Tube Configuration	SE
Principles of Operation	SE
Size (Cuff)	Differences noted, but deemed SE due to compliance with ISO 81060-1 and biocompatibility tests (Analysis 1)
Single Use	SE (However, the device name is "Reusable Blood Pressure Cuff", suggesting this might be a typo in the table if "Y" means "yes, single use". Given the device name and description, it's likely "N" for reusable, or the table refers to a single patient use during a visit, not a single lifetime use.) Correction: The "Single Use" row likely means "Single Patient Use", which is "Y", meaning it's used for one patient at a time, but it is reusable across different uses for that same patient. The overall context of "Reusable Blood Pressure Cuff" suggests it's not disposed of after a single measurement.
Sterile	SE ("No")
Pressure Range	SE (0-300 mmHg)
Max. Pressure	SE (400 mmHg vs >350 mmHg)
Tubing Size	SE (OD = 8.0; ID=4.0; L=200;)
Max. Leakage	SE (< 4mm Hg/ min.)
Material	SE (210D Nylon TPU (Cuff) and PVC (Air Hose))

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

The document does not explicitly state the sample size used for the test set for the non-clinical tests (e.g., biocompatibility testing). It mentions compliance with ISO standards, which would imply specific sample size requirements within those standards.

Data Provenance: Not explicitly stated regarding the origin of the test data (e.g., country of origin). The submission is from Shenzhen Vistar Medical Supplies Co., Ltd. in China, implying tests were likely conducted there or by affiliated labs. The studies were non-clinical, so the concept of retrospective or prospective data doesn't directly apply in the same way as clinical trials with human subjects.

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

This information is not provided. The non-clinical tests (biocompatibility, performance against ISO standards) typically rely on standardized laboratory procedures and equipment rather than expert human consensus for "ground truth." For example, cytotoxicity would be measured by laboratory assay, not expert opinion.

4. Adjudication Method for the Test Set

Not applicable in the context of these non-clinical tests. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, not for laboratory testing of device materials or physical performance.

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. This device is a blood pressure cuff, a physical accessory for measurement. It does not involve AI, image interpretation, or human "readers" in the context of diagnostic decision-making. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This is a physical medical device (blood pressure cuff), not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical tests was based on the requirements and methodologies specified in the relevant ISO standards:

Biocompatibility: In vitro cytotoxicity results (ISO 10993-5) and in vivo irritation/sensitization results (ISO 10993-10) using standardized testing protocols.
Performance (Blood Pressure Measurement): Requirements and test methods for non-automated measurement type as defined by ISO 81060-1. This standard would set specific limits for accuracy, leakage, etc., which serve as the "ground truth" for compliance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires 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.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 29, 2015

Shenzhen Vistar Medical Supplies Co., Ltd. Mr. Ray Wang Official Correspondent 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Chaoyang District Beijing, 100024 CN

Re: K152468

Trade/Device Name: Reusable Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: August 25, 2015 Received: August 31, 2015

Dear Mr. Ray 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. 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

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Page 2 - Mr. Ray Wang

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 the quality systems (QS) 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.

Mitchell Stein

forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152468

Device Name 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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K152468

Page 1 of 5

510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________

1. Date of Preparation:2015/8/26
1. Sponsor Identification

Shenzhen Vistar Medical Supplies Co., Ltd. 808, Hanhaida Bldg., No. 7 Songgang Blvd. Songgang Town, Shenzhen, China 518105

Establishment Registration Number: Pending

Contact Person: Zhenxun Chen Position: General Manager Tel: +86-0755-85298331 Fax:+86-0755-85298331 Email: chainy.chen@163.com

1. Designated Submission Correspondent
  Mr. Ray Wang

Beijing Believe Tech. Service Co., Ltd

Tel: +86-21-50313932, Fax: +86-21-68093116 Email: Ray.Wang@believe-med.com

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K152468 Page 2 of 5

Identification of Proposed Device 4.

Trade Name: Reusable Blood Pressure Cuff Common Name: Blood Pressure Cuff Model(s): V0111C, V0112C, V0113C, V0114C, V0114C-L, V0115C, V0115C-L, V0116C; V0121C,V0122C,V0123C,V0124C,V0124C,V0125C,V0125C,V0125C-L,V0126C;

Regulatory Information

Classification Name: Blood Pressure Cuff Classification: 2 Product Code: DXQ Regulation Number: 870.1120 Review Panel: Cardiovascular

Indication For Use Statement:

Device Description

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

The proposed device is Reusable blood pressure cuff, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.

The Reusable blood pressure cuff is provided as non-sterile.

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K152468 Page 3 of 5

ર. Identification of Predicate Device(s)
Predicate Device K151290 Reusable/Reusable Blood Pressure Cuff Xuzhou Maicuff Technology Co., Ltd.
1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
A ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ハ ISO 81060-1:2012 Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type
1. Clinical Test Conclusion

No clinical study is included in this submission.

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K152468 Page 4 of 5

8. Substantially Equivalent (SE) Comparison

ITEM	Proposed Device(ReusableBlood Pressure Cuff)	Predicate Device (K151290)	Remark
Intended Use	The reusable blood pressure cuff is anaccessory used in conjunction withnoninvasive blood pressure measurementsystems. The cuff is non-sterile and may bereused. It is available in infant, pediatricand adult sizes.	The reusable blood pressure cuff is anaccessory used in conjunction withnoninvasive blood pressure measurementsystems. The cuff is non-sterile and may bereused. It is available in infant, pediatricand adult sizes.	SE
PatientPopulations	Adults/Pediatrics	Adults/Pediatrics	SE
TubeConfiguration	One or two tube	One or two tube	SE
Principles ofOperation	Bladder is wrapped around the patient'slimb and secured by hook and loop closureAir hose is connected to the noninvasiveblood pressure measurement systems	Bladder is wrapped around the patient'slimb and secured by hook and loop closureAir hose is connected to the noninvasiveblood pressure measurement systems	SE
Size	Conform to AHA bladder sizesrecommendationsInfant (8-13 cm)Child (12-19 cm)Small Adult (17-25 cm)Adult (23-33 cm)Adult Long (23-33 cm)Large Adult(31-40 cm)Large Adult Long (31 - 40 cm)Thigh (38 - 50 cm)	Conform to AHA bladder sizesrecommendationsNeonatal (6-11 cm)Infant (10-19 cm)Pediatric (18-26 cm)Small Adult (20-28 cm)Adult (25-35 cm)Adult Long(25-35 cm)Large Adult (33-47 cm)Large Adult Long(33-47 cm)Adult Thigh (46-66 cm)	Analysis 1
Single Use	Y	Y	SE
Sterile	No	No	SE
Pressure Range	0-300 mmHg	0-300 mmHg	SE
Max. Pressure	400 mmHg	>350 mmHg	SE
TubingSize(mm)	OD = 8.0; ID=4.0; L=200;	OD = 8.0; ID=4.0; L=200;	SE
Max. Leakage	< 4mm Hg/ min.	< 4mm Hg/ min.	SE
Material	210D Nylon TPU (Cuff) and PVC (AirHose)	210D Nylon TPU (Cuff) and PVC (AirHose)	SE
ITEM	Proposed Device	Predicate Device	Remark
Cytotoxicity	Under the conditions of the study, not cyteotoxicity effect	Comply with ISO 10993-5	SE
Irritation	Under the conditions of the study, not an irritant	Comply with ISO 10993-10	SE
Sensitization	Under conditions of the study, not a sensitizer.		SE

Table 1 General Comparison

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Analysis 1:

The proposed device has different size with predicate device for different patient arm circumference, the proposed device are conducted the ISO 81060-1 for the performance and Biocompatibility test as ISO 10993-1 for safety, so we consider that this difference do not affect the SE with the predicate device.

Table 2 Biocompatibility Comparison

Substantially Equivalent (SE) Conclusion 9.

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to 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).