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 neonatal, 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 disposable 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 disposable blood pressure cuff is single use device, and which is made of non-woven fabrics & PVC (Cuff) and PVC (Air Hose), thereinto, the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient.

The disposable blood pressure cuff has 26 models with different size for different population with different arm size, and the 13 models of 26 are use single tube of air hose and other 13 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.

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

AI/ML Overview

The provided document describes the 510(k) premarket notification for a Disposable Blood Pressure Cuff (K152465) by Shenzhen Vistar Medical Supplies Co., Ltd. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K151290).

Here's an analysis of the acceptance criteria and the study that proves the device meets these criteria, based on the provided text:

Key Takeaways:

This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness.
The primary means of demonstrating compliance is through non-clinical testing against recognized industry standards and a comparison of specifications with the predicate device.
No clinical study was included in this submission. Therefore, there is no information about human reader performance (MRMC studies) or standalone algorithm performance, as these are typically part of clinical trials for AI/software devices.
The device is a physical medical device (blood pressure cuff), not a software or AI-driven diagnostic tool. Thus, concepts like "ground truth" in the AI sense, expert panels for ground truth establishment, or training sets are not directly applicable in the way they would be for an AI device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from recognized standards and comparison with the predicate device. The performance is reported as compliance with these standards or equivalence to the predicate.

Acceptance Criteria / Specification	Reported Device Performance (Proposed Device)
Intended Use	"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 neonatal, pediatric and adult sizes." (Identical to Predicate)
Patient Populations	Adults/Pediatrics (Identical to Predicate)
Tube Configuration	One or two tube (Identical to Predicate)
Principles of Operation	"Bladder is wrapped around the patient's limb and secured by hook and loop closure Air hose is connected to the noninvasive blood pressure measurement systems" (Identical to Predicate)
Size	Conform to AHA bladder sizes recommendations. Has similar sizes and more size specifications than the predicate for different patient arm circumferences. Neonatal 1 (3-6 cm) Neonatal 2 (4-8 cm) Neonatal 3 (6-11 cm) Neonatal 4 (7-13 cm) Neonatal 5 (8-15 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 cm) Large Adult (35.5-46 cm) Large Adult (35.5 - 46 cm) Thigh (45 - 56.5 cm)
Single Use	Yes (Identical to Predicate)
Sterile	No (Identical to Predicate)
Pressure Range	0-300 mmHg (Identical to Predicate)
Max. Pressure	400 mmHg (Predicate: >350 mmHg)
Tubing Size (mm)	OD = 8.0; ID=4.0; L=200; (Identical to Predicate)
Max. Leakage	< 4mm Hg/ min. (Identical to Predicate)
Material	non-woven fabrics & PVC (Cuff) and PVC (Air Hose) (Identical to Predicate)
Biocompatibility - Cytotoxicity	Under the conditions of the study, not cytotoxicity effect (Complies with ISO 10993-5)
Biocompatibility - Irritation	Under the conditions of the study, not an irritant (Complies with ISO 10993-10)
Biocompatibility - Sensitization	Under conditions of the study, not a sensitizer. (Not explicitly stated for predicate in comparison table, but overall concluded SE)
Performance Standard	Complies with ISO 81060-1:2012 Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type

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

Since this is a non-clinical device and no human clinical trials were conducted for this 510(k) submission, the concept of a "test set" in the context of patient data is not applicable. The testing was performed on the device itself (e.g., individual cuffs, materials).

Sample Size for Test Set: Not specified in terms of number of units tested, but physical units of the device were subjected to laboratory tests.
Data Provenance: Not applicable in the context of patient data. The tests were laboratory-based (e.g., material testing, pressure testing) conducted by the manufacturer. The company is based in China: Shenzhen Vistar Medical Supplies Co., Ltd. (Shenzhen, China). The data is retrospective in the sense that it's generated for the submission but not from a prospective clinical study.

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

This question is not directly applicable to this type of device submission.

"Ground truth" for a physical device is established by meeting engineering specifications and performance standards. These are defined by regulatory bodies and industry standards (e.g., ISO, FDA guidance documents). The "experts" are the engineers and scientists who developed and validated the test methods to ensure compliance with these standards, not external clinicians establishing diagnostic ground truth from patient data.
No specific number or qualifications of experts are mentioned for establishing ground truth, as it's not a diagnostic AI device requiring expert consensus on images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially for evaluating diagnostic performance where disagreements among readers need resolution to establish a reference standard (ground truth). This submission relies on objective laboratory tests and engineering comparisons.

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

No MRMC study was done. This is a blood pressure cuff, not an AI diagnostic tool that assists human readers.

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

Not applicable. The device is a blood pressure cuff, which is a physical accessory for a non-invasive blood pressure measurement system. It does not contain an algorithm nor is it intended for standalone diagnostic performance in the way an AI software device would be.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on engineering specifications, industry standards, and the performance characteristics of the predicate device.

Engineering Specifications: E.g., pressure range, maximum leakage, tubing dimensions.
Biocompatibility Standards: ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization). Compliance with these standards is considered the "ground truth" for material safety.
Performance Standards: ISO 81060-1:2012 (Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type). Compliance with this standard is the "ground truth" for the cuff's functional performance.
Predicate Device Characteristics: The characteristics of the legally marketed predicate device (K151290) serve as a de facto "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."

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

Not applicable, as there is no training set for a physical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of a human figure, with three faces overlapping each other.

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: K152465

Trade/Device Name: Disposable 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 Stei

for 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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Indications for Use

510(k) Number (if known) K152465

Device Name Disposable 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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K152465

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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K152465 Page 2 of 5

Identification of Proposed Device 4.

Trade Name: Disposable Blood Pressure Cuff Common Name: Blood Pressure Cuff Model(s): V1011N,V1012N,V1013N,V1014N,V1015N,V1011C,V1012C,V1013C,V1014C,V1014C-L,V1015 C. V1015C-L.V1016C: V1021N,V1022N,V1023N,V1024N,V1025N,V1021C,V1023C,V1023C,V1024C,V1024C-L,V102 5C, V1025C-L,V1026C;

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 disposable blood pressure cuff, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.

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

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K152465 Page 3 of 5

ડ. Identification of Predicate Device(s)
Predicate Device K151290 Disposable/Reusable Blood Pressure Cuff Xuzhou Maicuff Technology Co., Ltd.
Non-Clinical Test Conclusion 6.
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:
ハ 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.
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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K152465 Page 4 of 5

8. Substantially Equivalent (SE) Comparison

ITEM	Proposed Device(Disposable Blood Pressure Cuff)	Predicate Device (K151290)	Remark
Intended Use	The disposable blood pressure cuff is anaccessory used in conjunction withnoninvasive blood pressure measurementsystems. The cuff is non-sterile and forsingle-patient use. It is available inneonatal, pediatric and adult sizes.	The disposable blood pressure cuff is anaccessory used in conjunction withnoninvasive blood pressure measurementsystems. The cuff is non-sterile and forsingle-patient use. It is available inneonatal, pediatric and adult sizes.	SE
PatientPopulations	Adults/Pediatrics	Adults/Pediatrics
TubeConfiguration	One or two tube	One or two tube	SE
PrinciplesofOperation	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 sizesrecommendationsNeonatal 1 (3-6 cm)Neonatal 2 (4-8 cm)Neonatal 3 (6-11 cm)Neonatal 4 (7-13 cm)Neonatal 5 (8-15 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 cm)Large Adult(35.5-46 cm)Large Adult (35.5 - 46 cm)Thigh (45 - 56.5 cm)	Conform to AHA bladder sizesrecommendationsNeonatal 1 (3-5.5 cm)Neonatal 2 (4-8 cm)Neonatal 3 (6-11 cm)Neonatal 4 (7-13 cm)Infant (9-14.5 cm)Pediatric (13-21.5 cm)Small Adult (21-27 cm)Adult (26-35.5 cm)Large Adult(35-45 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	non-woven fabrics & PVC (Cuff) and PVC(Air Hose)	non-woven fabrics & PVC (Cuff) and PVC(Air Hose)	SE

Table 1 General Comparison

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Analysis 1:

The proposed device has similar size and more size specifications than predicate device, the more size specifications are intended for more clinical situations with 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.

ITEM	Proposed Device	Predicate Device	Remark
Cytotoxicity	Under the conditions of the study, notcyteotoxicity effect	Comply with ISO 10993-5	SE
Irritation	Under the conditions of the study, not anirritant	Comply with ISO 10993-10	SE
Sensitization	Under conditions of the study, not asensitizer.		SE

Table 2 Biocompatibility Comparison

9. Substantially Equivalent (SE) Conclusion

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).