This device has the potential to reduce or prevent patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. It covers a blood pressure cuff to provide a barrier between patient and cuff.

Device Description

This device is a cover for blood pressure cuffs. It is made of polyethylene coated on Tyvck. Blood pressure cuffs are used throughout the healthcare industry as a means of monitoring patient blood pressure. Because blood pressure cuffs are used on multiple patients there is a concern about cross contamination.

When the blood pressure cuffs become contaminated they should be cleaned. A blood pressure cuff Guard can reduce the need to clean blood pressure cuffs.

In order to address the cross contamination issue for blood pressure cuffs a blood pressure cuff Guard has been designed. The product is a non-sterile, clean, ready to use sleeve that is applied between the patient arm and the blood pressure cuff. The cuff Guard has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient.

The blood pressure cuff Guard is a single patient product designed to survive average use during an average hospital stay. If the blood pressure cuff Guard becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff Guard.

The blood cuff Guard has a two layer structure. The inner layer is made of Tyvck. The outer layer is made of cast film of polyethylene.

The polyethylene is a fluid repellent, and is resistant to microbial penetration, thus provides a barrier between the pressure cuff and patient.

The whole guard is approximately 20 um thick and is available in various different length and width.

The guard is designed as pouchlike with one open, the blood pressure cuff can be packed into it and sealed with adhesive tape, and which can be secured around the patient arm by two velcro. The adhesive tapes are located at the edge of open and the Velcro located at the two ends of outer guard, both of them are not contact with the patient skin.

AI/ML Overview

This document is a 510(k) summary for a Disposable Blood Pressure Cuff Guard (K150227). It describes the device's intention to reduce cross-contamination during blood pressure measurement and claims substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative performance metric sense (e.g., a specific percentage reduction in microbial count). Instead, the acceptance criteria are implicitly linked to demonstrating substantial equivalence to a predicate device by showing that the proposed device meets design specifications and passes certain non-clinical tests.

Acceptance Criteria (Implicit)	Reported Device Performance
Intended Use Equivalence	Proposed Device: "This device has the potential to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. It covers a blood pressure cuff to provide a barrier between patient and cuff." Predicate Device: (Identical Indication)
Biocompatibility (Cytotoxicity)	Proposed Device: "Under the conditions of the study, not cytotoxicity effect." Predicate Device: "Comply with ISO 10993-5"
Biocompatibility (Irritation)	Proposed Device: "Under the conditions of the study, not an irritant." Predicate Device: "Comply with ISO 10993-10"
Biocompatibility (Sensitization)	Proposed Device: "Under conditions of the study, not a sensitizer." Predicate Device: "Comply with ISO 10993-10"
Design Specifications (Dimensions, Adhesive Tape, Velcro)	Proposed Device: Bench testing for "performance of Dimensions, Adhesive Tape, Compatibility with BP Cuff and Velcro" was conducted. (Specific performance details are not provided, only that tests were done and "met all design specifications").
Basic Design (Packaging the cuff vs. under the cuff)	Analysis 1 states: "The proposed device has different Design to the predicate device, the current design we used is pack the blood cuff, this way could fix the blood cuff around the arm more steadily during measurement process, so we consider this as the proposed device is SE with the predicate device." (This is an explanation for difference, not a performance metric per se).
Materials (Tyvek/Polyethylene vs. Polyethylene/Paper)	Analysis 2 states: "The proposed device has different materials to the predicate device, this different may causes potential biocompatibility risk, for this risk we conducted the biocompatibility test according to the ISO 10993-5 and ISO 10993-10, the test results showed that the proposed devices did not induce any risk relating to the cytotoxicity, irritation or sensitization." (This points to the biocompatibility results).
Closure Method (Velcro/Adhesive Tape vs. Adhesive Tape)	Analysis 3 states: "The proposed device has different closure method to the predicate device, but the Velcro has the effect to fix the guard and cuff, so we consider this as the proposed device is SE with the predicate device." (Similar to basic design, an explanation of difference leading to SE conclusion).

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

Test Set Sample Size: Not explicitly stated. The non-clinical tests (biocompatibility, bench testing) would have involved a certain number of samples or specimens, but the exact count is not provided in this summary.
Data Provenance: The tests were conducted by Pinghu Sama Medical Packing Co., Ltd. (China). The document does not specify if the data is retrospective or prospective, but as it's for a new device, it would implicitly be prospective testing of the manufactured product.

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

Number of Experts: Not applicable/not stated. The ground truth for biocompatibility studies is typically established by laboratory testing against ISO standards and interpreted by qualified toxicologists or biologists, not through expert consensus in the way a medical image might be. For bench testing, the "ground truth" would be the design specifications and established engineering principles.
Qualifications of Experts: Not applicable/not stated in this document.

4. Adjudication method for the test set:

Not applicable. This device's evaluation (biocompatibility and bench testing) does not involve a human reader or an adjudication process in the typical sense for diagnostic devices.

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 is a physical medical device (a cuff guard), not an AI-powered diagnostic tool, so MRMC studies are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

Biocompatibility: The ground truth for biocompatibility was established by ISO standards (ISO 10993-5 for cytotoxicity and ISO 10993-10 for irritation and sensitization). The test results were compared against the requirements of these standards.
Bench Testing: The ground truth for bench testing (Dimensions, Adhesive Tape, Compatibility with BP Cuff, Velcro) would be the device's own design specifications and functional requirements.

8. The sample size for the training set:

Not applicable. This device is not an algorithm that requires a training set.

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

Not applicable. This device is not an algorithm that requires a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right.

Public Health Service

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

April 2, 2015

Pinhu Sama Medical Packing Co., Ltd. % Mr. Ray Wang Official Correspondent 1-202, Build 3, Beijing New World No.5 Chaogyang Rd., Chaogyang District Beijing, 100024 CN

Re: K150227

Trade/Device Name: Disposable Blood Pressure Cuff Guard Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: January 30, 2015 Received: February 2, 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 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

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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K150227

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name: Disposable Blood Pressure Cuff Guard_________________________________________________________________________________________________________________________

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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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: K150227

1. Date of Preparation:2015/1/30
1. Sponsor Identification

PINGHU SAMA MEDICAL PACKING CO., LTD. 1 Qunfeng Road, South of Lindai, PingHu, Zhejiang, 314202, China

Establishment Registration Number: 3010521050

Contact Person: Ma JianZhong Position: General Manager Tel: +86-573-85923333 Fax:+86-573-85924444 Email: mjz1966@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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4. Identification of Proposed Device

Trade Name: Disposable Blood Pressure Cuff Guard Common Name: Blood Pressure Cuff Cover Model(s): S. M. L

Regulatory Information

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

Intended Use Statement:

Device Description

When the blood pressure cuffs become contaminated they should be cleaned. A blood pressure cuff Guard can reduce the need to clean blood pressure cuffs.

The blood cuff Guard has a two layer structure. The inner layer is made of Tyvck. The outer layer is made of cast film of polyethylene.

The polyethylene is a fluid repellent, and is resistant to microbial penetration, thus provides a barrier between the blood pressure cuff and patient.

The whole guard is approximately 20 um thick and is available in various different length and

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width.

ર . Identification of Predicate Device(s)
Predicate Device 510(k) Number: K141998 Product Name: SAMA Disposable Blood Pressure Cuff Barriers Model Name: Pinghu Sama Medical Packing 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
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Bench Testing for the performance of Dimensions, Adhesive Tape, Compatibility with BP Cuff and Velcro.
1. Clinical Test Conclusion

No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

	Table 1 General Comparison

ITEM	Proposed Device	Predicate Device	Remark
Intended Use	This device has the potential to reduce orprevent patient to patient crosscontamination which can occur duringblood pressure measurement procedures,for single patient use only. It covers a bloodpressure cuff to provide a barrier betweenpatient and cuff.	This device has the potential to reduce orprevent patient to patient crosscontamination which can occur duringblood pressure measurement procedures,for single patient use only. It covers a bloodpressure cuff to provide a barrier betweenpatient and cuff.	SE
Basic Design	Around the arm pack the blood cuff	Around the arm under the blood cuff	Analysis 1
Materials	Tyvck/Polyethylene	Polyethylene /Medical gradepaper	Analysis 2
ClosuseMethod	Velcro/Adhesive Tape	Adhesive Tape	Analysis 3
Size	S, M, L	S, M, L	SE
Single Use	Yes	Yes	SE
Sterile	No	No	SE

Analysis 1

The proposed device has different Design to the predicate device, the current design we used is pack the blood cuff, this way could fix the blood cuff around the arm more steadily during measurement process, so we consider this as the proposed device is SE with the predicate device.

Analysis 2

The proposed device has different materials to the predicate device, this different may causes potential biocompatibility risk, for this risk we conducted the biocompatibility test according to the ISO 10993-5 and ISO 10993-10, the test results showed that the proposed devices did not induce any risk relating to the cytotoxicity, irritation or sensitization.

So we consider this as the proposed device is SE with the predicate device.

Analysis 3

The proposed device has different closure method to the predicate device, but the Velcro has the effect to fix the guard and cuff, so we consider this as the proposed device is 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

Table 2 Biocompatibility Comparison

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510(k) Summary	K150227
	Page 5 of 5

Sensitization	Under conditions of the study, not a sensitizer.	SE
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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).