Disposable Blood Pressure Cuff Guard

• K Number: K150227
• Device Name: Disposable Blood Pressure Cuff Guard
• Manufacturer: PINHU SAMA MEDICAL PACKING CO., LTD.
• Date Cleared: 2015-04-02 ( 59 days)
• Product Code: DXQ
• Regulation Number: 870.1120

Intended Use

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.

Predicate Devices

K141998

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical barrier (a cover) for blood pressure cuffs and the description focuses on its material properties and physical design. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

No.
The device's intended use is to prevent cross-contamination by providing a barrier between a patient and a blood pressure cuff, not to treat or diagnose a medical condition.

Diagnostic

No

This device is a cover for blood pressure cuffs designed to prevent cross-contamination, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical barrier made of polyethylene and Tyvek, designed to cover blood pressure cuffs. It is a tangible product and not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
• Device Function: The described device is a physical barrier (a cover) for a blood pressure cuff. Its purpose is to prevent cross-contamination between patients and the cuff. It does not analyze any biological specimens or provide diagnostic information.
• Intended Use: The intended use clearly states its function is to "reduce or prevent patient cross contamination which can occur during blood pressure measurement procedures." This is a barrier function, not a diagnostic one.
• Performance Studies: The performance studies focus on biological evaluation (cytotoxicity, irritation) and bench testing for physical properties (dimensions, adhesive, compatibility). There are no studies related to analyzing biological samples or diagnostic accuracy.

Therefore, based on the description and intended use, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DXQ

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 blood 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K141998

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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

1

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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

(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)

OR

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
• 2. 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: [phone] Fax:[phone] Email: [e-mail]

• 3. Designated Submission Correspondent
     Mr. Ray Wang

Beijing Believe Tech. Service Co., Ltd

Tel: [phone], Fax: [phone] Email: [e-mail]

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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:

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 blood pressure cuff and patient.

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

5

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.

• 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.

• 6. 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.

• 7. 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 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.	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.	SE
Basic Design	Around the arm pack the blood cuff	Around the arm under the blood cuff	Analysis 1
Materials	Tyvck/Polyethylene	Polyethylene /Medical grade
paper	Analysis 2
Closuse
Method	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, 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

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
---------------	--------------------------------------------------	----

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.