Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff

• K Number: K151290
• Device Name: Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff
• Manufacturer: XUZHOU MAICUFF TECHNOLOGY CO.,LTD.
• Date Cleared: 2015-06-30 ( 46 days)
• Product Code: DXQ
• Regulation Number: 870.1120

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 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) 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.

Predicate Devices

K120364, K112544

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly define the device as a simple blood pressure cuff accessory, with no mention of any computational or analytical capabilities that would involve AI or ML. The performance studies focus on material safety and basic functionality, not algorithmic performance.

Therapeutic

No
The device is described as an accessory used in conjunction with noninvasive blood pressure measurement systems, indicating it is for diagnostic or monitoring purposes, not for treating a condition.

Diagnostic

No

This device is an accessory (a blood pressure cuff) used in conjunction with noninvasive blood pressure measurement systems. It does not perform the diagnostic function of measuring or interpreting blood pressure itself.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components (cuff with bladder, air hose) made of materials like non-woven fabrics, PVC, and Nylon TPU. It also describes different sizes and configurations (single/double tube), indicating a hardware-based device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to be an accessory for noninvasive blood pressure measurement systems. This is a physiological measurement taken directly from the patient's body.
• Device Description: The device is a blood pressure cuff, which is a mechanical component used to apply pressure to the arm to facilitate blood pressure measurement. It does not involve the examination of specimens derived from the human body.
• Performance Studies: The performance studies focus on biological evaluation (cytotoxicity, irritation, sensitization) and compliance with standards for non-invasive sphygmomanometers. These are typical tests for devices that interact directly with the patient's body, not for IVDs which analyze biological samples.

IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This blood pressure cuff does not perform such analysis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DXQ

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) 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.

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

Neonatal, pediatric and adult sizes for disposable. Infant, pediatric and adult sizes for reusable.

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.
• ISO 81060-1:2012 Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type
  No clinical study is included in this submission.

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

Not Found

Predicate Device(s)

K120364, K112544

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)

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

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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

2

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)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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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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
(Disposable Blood Pressure Cuff) | Predicate Device (K120364) | Remark |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| 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 Unimed 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 cuff
is no designed, sold, or intended for use
except as indicated. | SE |
| Patient
Populations | Adults/Pediatrics | Adults/Pediatrics | |
| Tube
Configuration | One or two tube | One or two tube | |
| Size | Conform to AHA bladder sizes
recommendations
Neonatal 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) | Conform to AHA bladder sizes
recommendations
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 Long(35.5-46 cm)
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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| ITEM | Proposed Device
(Reusable Blood Pressure Cuff) | Predicate Device (K112544) | Remark |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Intended Use | 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. | The Unimed 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 pediatric and adult
sizes. The cuff is no designed, sold, or
intended for use except as indicated. | SE |
| Patient
Populations | Adults/Pediatrics | Adults/Pediatrics | SE |
| Tube
Configuration | One or two tube | One or two tube | SE |
| Size | Conform to AHA bladder sizes
recommendations
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) | Conform to AHA bladder sizes
recommendations
Neonatal (6-11 cm)
Infant (10-19 cm)
Pediatric (18-26 cm)
Small Adult (20-28 cm)
Adult (25-35 cm)
Adult Long(25-35 cm)
Large Adult (33-47 cm)
Large Adult Long(33-47 cm)
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
cyteotoxicity effect	Comply with ISO 10993-5	SE
Irritation	Under the conditions of the study, not an
irritant	Comply with ISO 10993-10	SE
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.