Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff

K151290 · Xuzhou Maicuff Technology Co., Ltd. · DXQ · Jun 30, 2015 · Cardiovascular

Device Facts

• Record ID: K151290
• Device Name: Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff
• Applicant: Xuzhou Maicuff Technology Co., Ltd.
• Product Code: DXQ · Cardiovascular
• Decision Date: Jun 30, 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. 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 Story

Disposable and reusable blood pressure cuffs; accessory to noninvasive blood pressure measurement systems. Disposable version: non-woven fabric and PVC; single-patient use. Reusable version: 210D Nylon TPU and PVC; multi-patient use. Both versions include bladder and air hose (single or double tube). Used in clinical settings to facilitate blood pressure monitoring; cuff inflates to occlude artery; system measures pressure oscillations. Output provided to host monitor for clinical decision-making regarding patient hemodynamic status.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 81060-1 (non-invasive sphygmomanometers) verified.

Technological Characteristics

Materials: Non-woven fabrics/PVC (disposable), 210D Nylon TPU/PVC (reusable). Pressure range: 0-300 mmHg. Configuration: Single or double tube. Sizes: Neonatal, infant, pediatric, adult (AHA compliant). Non-sterile. Mechanical cuff/bladder system; no electronic or software components.

Indications for Use

Indicated for neonatal, infant, pediatric, and adult patient populations requiring noninvasive blood pressure measurement as an accessory to noninvasive blood pressure measurement systems.

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

• Unimed Blood Pressure Cuff (K112544)
• Unimed Blood Pressure Cuff (K120364)

Submission Summary (Full Text)

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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

June 30, 2015

Xuzhou Maicuff Technology Co.,ltd. c/o Mr. Ray Wang Official Correspondent Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Chaoyang District Beijing, 100024 CN

Re: K151290

> Trade/Device Name: Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff -Models: M5541-1#, M5541-2#, M5541-3#, M5514-4#. M5542. M5543. M5544. M5545. M5546: M5301. M5302, M5303, M5304, M5305; M5641-1#, M5641-2#, M5641-3#, M5614-4#, M5642, M5643, M5644, M5645, M5646; and M5401, M5402, M5403, M5404, M5405 Regulation Number: 21 CFR 870.1120 Regulation Name: Blood-Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: April 29, 2015 Received: May 15, 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

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Page 2 - Mr. Ray Wang

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 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.

Sincerelv vours

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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# Indications for Use

510(k) Number (if known) K151290

### Device Name

Disposable/Reusable Blood Pressure Cuff, Models -M5541-1#,M5541-2#,M5541-3#,M5542,M5543,M5544,M5545,M5546;M5301,M5302,M5304,M5305 M5641-1#,M5641-2#,M5641-3#,M5614-4#,M5642,M5643,M5646; and M5401,M5402,M5403,M5404,M5405

Indications for Use (Describe)

The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. 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.

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

| <div> <span> <svg height="16" width="16"> <path d="M2 2 L14 2 L14 14 L2 14 Z M3 3 L13 3 L13 13 L3 13 Z M4 7 L6 9 L12 3 L13 4 L6 11 L3 8 Z" fill="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="16" width="16"> <path d="M2 2 L14 2 L14 14 L2 14 Z M3 3 L13 3 L13 13 L3 13 Z" fill="white"></path> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# K151290

# Page 1 of 6

# 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:2015/5/5
- 2. Sponsor Identification

## XUZHOU MAICUFF TECHNOLOGY CO., LTD.

8#-2-1106 Jinxiujiayuan, Jianguo West Road, Xuzhou City, Jiangsu Province, China

Establishment Registration Number: Pending

Contact Person: Li Zhaoqian 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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K151290 Page 2 of 6

#### Identification of Proposed Device 4.

Trade Name: Disposable/Reusable Blood Pressure Cuff Common Name: Blood Pressure Cuff Model(s): M5541-1#,M5541-2#,M5541-3#,M5514-4#,M5542,M5543,M5544,M5545,M5546; M5641-1#,M5641-2#,M5641-3#,M5614-4#,M5642,M5643,M5644,M5645,M5646; M5301,M5302,M5303,M5304,M5305; M5401,M5402,M5403,M5404,M5405;

### 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.

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 includes disposable blood pressure cuff and reusable blood pressure, both disposable and reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.

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 18 models with different size for different population with different arm size, and the 9 models of 18 are use single tube of air hose and other 9 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.

The reusable blood pressure cuff is reusable device, and which is made of 210D Nylon TPU (Cuff)

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K151290

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 10 models with different size for different population with different arm size, and the 5 models of 10 are use single tube of air hose and other 5 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.

Both disposable and reusable blood pressure cuff are provided as non-sterile.

- Identification of Predicate Device(s) 5.
Predicate Device 510(k) Number: K112544 and K120364

- 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.
- > ISO 81060-1:2012 Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type
- Clinical Test Conclusion 7.

No clinical study is included in this submission.

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K151290 Page 4 of 6

#### Substantially Equivalent (SE) Comparison 8.

| ITEM | Proposed Device<br>(Disposable Blood Pressure Cuff) | Predicate Device (K120364) | 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 Unimed 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 cuff<br>is no designed, sold, or intended for use<br>except as indicated. | SE |
| Patient<br>Populations | Adults/Pediatrics | Adults/Pediatrics | |
| Tube<br>Configuration | One or two tube | One or two tube | |
| Size | 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) | 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 Long(35.5-46 cm)<br>Thigh (45-56 cm) | SE |
| Single Use | Y | Y | |
| Sterile | No | No | |
| Pressure Limits | 0-300 mmHg | 0-300 mmHg | |

# Table 1 General Comparison (Disposable BP Cuff)

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## K151290

| ITEM | Proposed Device<br>(Reusable Blood Pressure Cuff) | Predicate Device (K112544) | Remark |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Intended Use | The reusable blood pressure cuff is an<br>accessory used in conjunction with<br>noninvasive blood pressure measurement<br>systems. The cuff is non-sterile and may be<br>reused. It is available in infant, pediatric<br>and adult sizes. | The Unimed Blood Pressure Cuff is an<br>accessory used in conjunction with<br>noninvasive blood pressure measurement<br>systems. The cuff is non-sterile and may be<br>reused. It is available in pediatric and adult<br>sizes. The cuff is no designed, sold, or<br>intended for use except as indicated. | SE |
| Patient<br>Populations | Adults/Pediatrics | Adults/Pediatrics | SE |
| Tube<br>Configuration | One or two tube | One or two tube | SE |
| Size | Conform to AHA bladder sizes<br>recommendations<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) | Conform to AHA bladder sizes<br>recommendations<br>Neonatal (6-11 cm)<br>Infant (10-19 cm)<br>Pediatric (18-26 cm)<br>Small Adult (20-28 cm)<br>Adult (25-35 cm)<br>Adult Long(25-35 cm)<br>Large Adult (33-47 cm)<br>Large Adult Long(33-47 cm)<br>Adult Thigh (46-66 cm) | SE |
| Single Use | No | No | SE |
| Sterile | No | No | SE |
| Pressure Limits | 0-300 mmHg | 0-300 mmHg | SE |

Table 2 General Comparison (Reusable BP Cuff)

Table 3 Biocompatibility Comparison

| 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 |

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K151290 Page 6 of 6

#### 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.