ANDON BLOOD PRESSURE CUFF

K133117 · Andon Health Co, Ltd. · DXQ · Mar 4, 2014 · Cardiovascular

Device Facts

• Record ID: K133117
• Device Name: ANDON BLOOD PRESSURE CUFF
• Applicant: Andon Health Co, Ltd.
• Product Code: DXQ · Cardiovascular
• Decision Date: Mar 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2

Intended Use

Blood Pressure Cuffs are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to complete the measurement of blood parameters on adults.

Device Story

Andon Blood Pressure Cuff is a reusable, rectangle, soft inelastic sleeve with an internal bladder and single-tube connector. Designed for use on the upper arm, it connects to a non-invasive blood pressure monitor to facilitate inflation and deflation during measurement. Available in multiple sizes (15cm-48cm arm range) to accommodate different patient anatomies. The device functions as a mechanical interface for blood pressure monitoring in clinical or home settings. It does not contain electronic components or software; it relies on the host monitor for signal processing and data output. By providing a stable, occlusive pressure, it enables the monitor to detect blood pressure parameters, assisting healthcare providers or patients in monitoring cardiovascular health.

Clinical Evidence

No clinical data provided. Compliance with IEC 80601-2-30 (particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers) was demonstrated via bench testing.

Technological Characteristics

Inelastic sleeve with internal bladder; single-tube pneumatic connection. Materials evaluated for biocompatibility per ISO 10993-5 and ISO 10993-10. Dimensions vary by model (15cm to 48cm arm circumference). Mechanical device; no energy source or software.

Indications for Use

Indicated for adult patients requiring non-invasive blood pressure measurement via an upper arm cuff used in conjunction with a compatible blood pressure monitor.

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

• Blood Pressure Cuff (K102825)

Submission Summary (Full Text)

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# 510(k) Summary

K133117 page 1 of 3

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.

## 1.0 submitter's information

| Name: | Andon Health Co., Ltd. |
|---------------------------------|------------------------------------------------------------|
| Address: | No 3, Jinping Street Ya An Road, Nankai District, Tianjin, |
| | P.R. China |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: 09/25/2013 | |
| | |

# 2.0 Device information

Trade name: Andon Blood Pressure Cuff Blood Pressure Cuff Device name: Classification name: Blood pressure Cuff

# 3.0 Classification

Production code: DXQ Regulation number: 870.1120 Classification: II Panel: Cardiovascular

# 4.0 Predicate device information

| 1 | Manufacturer: | APK Technology Co, Ltd |
|---|----------------|------------------------|
| | Device: | Blood Pressure Cuff |
| | 510(k) number: | K102825 |

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#### 5.0 Intended use

Blood Pressure Cuffs are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to complete the measurement of blood parameters on adults.

#### 6.0 Device description

The proposed device, Blood Pressure Cuff, is a rectangle soft inelastic sleeve reusable with a bladder. There is a single-tube connected to the bladder and the Non Invasive Blood Pressure Monitor for inflating and deflating. The device should connected to a Non Invasive Blood Pressure Monitor to complete the function. There is various sizes for different arm range as follows:

| Model | Arm range |
|-------------|-----------|
| KD-525-P31 | 20cm-34cm |
| KD-525-P32 | 30cm-44cm |
| KD-525-P33 | 40cm-48cm |
| KD-525-P34 | 15cm-24cm |
| KD-5917-P42 | 22cm-42cm |

## 7.0 Summary comparing technological characteristics with predicate device

| Technological Characteristics | Comparison result |
|-------------------------------|-------------------|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Similar |
| Biocompatibility | Identical |
| Function | Identical |

# 8.0 Discussion of non-clinical and clinical test performed

#### Non-clinical Tests have been done as follows:

a. Safety and performance characteristics of the test according to IEC 80601-2-30

b. Biocompatibility test has been performed according to ISO 10993-5 and ISO 10993-10

None of the test demonstrates that the Blood Pressure Cuffs bring new questions of safety and effectiveness.

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#### Clinical Test Concerning the Compliance of ANSI/AAMI SP10

Clinical test has been done in accordance with IEC 80601-2-30-Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers, and the test result shows, the device met all applicable requirements of the standard.

#### 9.0 Performance summary

The new cuffs conform to the following standards:

- · IEC 80601-2-30: Particular requirements for the basic safety and performance of of of automated non-invasive essential sphygmomanometers
- · ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk manangement process
- · ISO 10993-5: Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytoto xicity.
- · ISO 10993-10: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization

#### 10.0 Comparison to the predicate device and the conclusion

Compared to the predicate device, the new cuffs are very similar in the intended use, the design principle, the material, the performance and the applicable standards.

However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.

So we claims the proposed cuffs to be Substantially Equivalent (SE) to the predicate devices Blood Pressure Cuff(K102825).

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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

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

[Image of the Department of Health and Human Services logo]

March 4, 2014

Andon Health Co., Ltd Liu Yi No. 3 Jinping Street, Ya An Road, Nankai District Tianjin, 300190 CN

Re: K133117

> Trade/Device Name: Andon Blood Pressure Cuff (Model: KD-525-P31, KD-525-P32, KD-525-P33, KD-525-P34, KD-5917-P42) Regulation Number: 21 CFR 870.1120 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXQ Dated: January 2, 2014 Received: January 6, 2014

Dear Liu Yi,

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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems

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Page 2 - Liu Yi

(OS) 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 Small Manufacturers, International and Consumer Assistance 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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Andon Blood Pressure Cuff FDA 510(k) Files

# Statement of Indications for Use

K133117 510(k) Number :

Andon Blood Pressure Cuff (Model: KD-525-P31, Device name: KD-525-P33, KD-525-P34, KD-525-P32, KD-5917-P42)

#### Indications for use:

Blood Pressure Cuffs are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to complete the measurement of blood parameters on adults.

AND/OR Over-The-Counter Use YES Prescription use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Date:
FDA 2024.03.04
14:44:16 -05'00'
for Bram Zuckerman

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