Disposable Blood Pressure Cuff

K152465 · Shenzhen Vistar Medical Supplies Co., Ltd. · DXQ · Oct 29, 2015 · Cardiovascular

Device Facts

• Record ID: K152465
• Device Name: Disposable Blood Pressure Cuff
• Applicant: Shenzhen Vistar Medical Supplies Co., Ltd.
• Product Code: DXQ · Cardiovascular
• Decision Date: Oct 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Disposable blood pressure cuff; accessory for noninvasive blood pressure measurement systems. Consists of inflatable bladder, cuff material (non-woven fabrics/PVC), and air hose (single or double tube). Wrapped around patient limb; secured via hook and loop closure. Air hose connects to external blood pressure monitor. Used in clinical settings to facilitate noninvasive blood pressure measurement. Single-patient use; non-sterile. Provides mechanical interface for pressure transmission from monitor to patient limb.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993-5, ISO 10993-10) and performance testing (ISO 81060-1).

Technological Characteristics

Materials: non-woven fabrics and PVC. Configuration: single or double tube air hose. Pressure range: 0-300 mmHg; max pressure 400 mmHg. Leakage: < 4 mmHg/min. Standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), ISO 81060-1 (sphygmomanometer requirements).

Indications for Use

Indicated for use as an accessory with noninvasive blood pressure measurement systems for neonatal, pediatric, and adult patient populations.

Regulatory Classification

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.

Predicate Devices

• Disposable/Reusable Blood Pressure Cuff (K151290)

Submission Summary (Full Text)

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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 [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 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)

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.

Type of Use (Select one or both, as applicable)

| | <span> × Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--|--------------------------------------------------------------------|
| | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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
- 2. 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: [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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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:

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.

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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
- 7. 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<br>(Disposable Blood Pressure Cuff) | Predicate Device (K151290) | Remark |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | The disposable blood pressure cuff is an<br>accessory used in conjunction with<br>noninvasive blood pressure measurement<br>systems. The cuff is non-sterile and for<br>single-patient use. It is available in<br>neonatal, pediatric and adult sizes. | The disposable blood pressure cuff is an<br>accessory used in conjunction with<br>noninvasive blood pressure measurement<br>systems. The cuff is non-sterile and for<br>single-patient use. It is available in<br>neonatal, pediatric and adult sizes. | SE |
| Patient<br>Populations | Adults/Pediatrics | Adults/Pediatrics | |
| Tube<br>Configuration | One or two tube | One or two tube | SE |
| Principles<br>of<br>Operation | Bladder is wrapped around the patient's<br>limb and secured by hook and loop closure<br>Air hose is connected to the noninvasive<br>blood pressure measurement systems | Bladder is wrapped around the patient's<br>limb and secured by hook and loop closure<br>Air hose is connected to the noninvasive<br>blood pressure measurement systems | SE |
| Size | Conform to AHA bladder sizes<br>recommendations<br>Neonatal 1 (3-6 cm)<br>Neonatal 2 (4-8 cm)<br>Neonatal 3 (6-11 cm)<br>Neonatal 4 (7-13 cm)<br>Neonatal 5 (8-15 cm)<br>Infant (9-14.8 cm)<br>Child (13.8-21.5 cm)<br>Small Adult (20.5-28.5 cm)<br>Adult (27.5-36.5 cm)<br>Adult Long (27.5-36.5 cm)<br>Large Adult(35.5-46 cm)<br>Large Adult (35.5 - 46 cm)<br>Thigh (45 - 56.5 cm) | Conform to AHA bladder sizes<br>recommendations<br>Neonatal 1 (3-5.5 cm)<br>Neonatal 2 (4-8 cm)<br>Neonatal 3 (6-11 cm)<br>Neonatal 4 (7-13 cm)<br>Infant (9-14.5 cm)<br>Pediatric (13-21.5 cm)<br>Small Adult (21-27 cm)<br>Adult (26-35.5 cm)<br>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 |
| Tubing<br>Size (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<br>(Air Hose) | non-woven fabrics & PVC (Cuff) and PVC<br>(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, not<br>cyteotoxicity effect | Comply with ISO 10993-5 | SE |
| Irritation | Under the conditions of the study, not an<br>irritant | Comply with ISO 10993-10 | SE |
| Sensitization | Under conditions of the study, not a<br>sensitizer. | | 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.