Aneroid Sphygmomanometer

K151246 · Jiaxing Zhongfa Medical Products Co., Ltd. · DXQ · Jun 30, 2015 · Cardiovascular

Device Facts

• Record ID: K151246
• Device Name: Aneroid Sphygmomanometer
• Applicant: Jiaxing Zhongfa Medical Products 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

Intended Use

The Aneroid Sphygmomanometer is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users over age 18 at hospitals or at home to monitor both systolic and diastolic pressure.

Device Story

Non-automated, mechanical blood pressure monitor; uses occluding cuff, air pump bulb, and stethoscope. Operates via auscultatory method; user manually inflates cuff and listens for Korotkoff sounds via stethoscope while observing pressure gauge. Gauge utilizes Hooke's law; flexible pressure-sensitive component deforms under pressure; mechanical gear set amplifies movement to indicate value on 300 mmHg dial. Used by professionals or trained individuals (age 18+) in hospitals or homes. Provides systolic and diastolic pressure readings; aids clinical decision-making by enabling blood pressure monitoring.

Clinical Evidence

No clinical data. Bench testing only, including performance accuracy testing and biocompatibility assessments (cytotoxicity, irritation, and sensitization).

Technological Characteristics

Mechanical aneroid sphygmomanometer. Materials: cuff, stethoscope, air pump bulb, rotary pin gauge. Principle: Hooke's law/mechanical gear amplification. Measuring range: 0-300 mmHg. Accuracy: +/- 3 mmHg. Standards: ISO 10993-5, ISO 10993-10, EN ISO 81060-1. No software or electronic components.

Indications for Use

Indicated for non-invasive, indirect measurement and display of arterial blood pressure in individuals over age 18. Suitable for use by healthcare professionals or trained lay users in clinical or home settings.

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

• Aneroid Sphygmomanometer with Stethoscope, Model LD-100 (K092245)

Submission Summary (Full Text)

{0}------------------------------------------------

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2015

Jiaxing Zhongfa Medical Products Co., Ltd. % 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: K151246 Trade/Device Name: Aneroid Sphygmomanometer, Models ZF-113, ZF-114, and ZF-115 Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: May 6. 2015 Received: May 11, 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.

{1}------------------------------------------------

Page 2 - Mr. Ray Wang

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 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.

sincerely yours,

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) K151246

Device Name

Aneroid Sphygmomanometer, Models ZF-113, ZF-114, and ZF-115

## Indications for Use (Describe)

The Aneroid Sphygmomanometer is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users over age 18 at hospitals or at home to monitor both systolic and diastolic pressure.

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) |

_ | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 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:2015/5/6
- Sponsor Identification 2.

## Jiaxing ZhongFa Medical Products Co.,Ltd.

No.38 Building 1, Zhong Fa Group, Zhuang Shi Village, Feng Qiao Town, Nanhu District, Jiaxing City, Zhejiang Province, China 314008

Establishment Registration Number: Pending

Contact Person: Mao XiaoHua 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]

{4}------------------------------------------------

#### Page 2 of 5

#### 4. Identification of Proposed Device

Trade Name: Aneroid Sphygmomanometer Common Name: Aneroid Sphygmomanometer Model(s): ZF113, ZF114, ZF115

#### Regulatory Information

Classification Name: Blood Pressure Cuff Classification: 2 Product Code: DXQ Regulation Number: 870.1120 Review Panel: Cardiovascular

## Intended Use Statement:

The Aneroid Sphygmomanometer is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users over age 18 at hospitals or at home to monitor both systolic and diastolic pressure.

#### Device Description

The Aneroid Sphygmomanometer with stethoscope is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This non-automated sphygmomanometer uses an occluding cuff, an sphygmomanometer to measure pressure and a stethoscope for detecting Korotkoff sounds.

The Aneroid Syphygmomanometer contains:

- Blood Pressure Cuff a.
- b. Stethoscope, which is use to detect the Korotkoff sounds;
- c. Rotary Pin, 300 mmHg gauge, which is use to indicate the measurement result;
- d. Air pump bulb, which is use to inflate the blood pressure cuff;
- e. User Manual, which is use to instruct the user;

The Aneroid Sphygmomanometer with Stethoscope enables the user to monitor the pressure of flowing blood that is exerted against the arteries at highest (systolic or contraction) and lowest (diastolic or relaxation) pressure.

The proposed device has three models, ZF-113/ZF-114/ZF-115, in this submission, the three models has same intended use, same design and measuring principle, same accessories and same measuring range. The only difference between the models is appearance of gauge.

- Identification of Predicate Device(s) ર.

{5}------------------------------------------------

Page 3 of 5

Predicate Device K092245 Aneroid Sphygmomanometer with Stethoscope, Model LD-100 HONSUN(NANTONG) 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:

- A 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;
- > EN ISO 81060-1:2012 Non-Invasive Sphygmomanometers – Part 1: Requirements and Test Methods for Non-Automated Measurement Type;
- A Bench Testing for the performance of Accuracy;
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

{6}------------------------------------------------

Page 4 of 5

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

# Table 1 General Comparison

| ITEM | Proposed Device | Predicate Device | Remark |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Intended Use | The Aneroid Sphygmomanometer is a<br>non-automated, mechanical blood pressure<br>monitor that is used for the indirect<br>measurement (non-invasive) and display of<br>arterial blood pressure. It can be used by<br>professionals as well as trained individual<br>users over age 18 at hospitals or at home to<br>monitor both systolic and diastolic pressure. | The Aneroid Sphygmomanometer is a<br>non-automated, mechanical blood pressure<br>monitor that is used for the indirect<br>measurement (non-invasive) and display of<br>arterial blood pressure. It can be used by<br>professionals as well as trained individual<br>users over age 18 at hospitals or at home to<br>monitor both systolic and diastolic pressure.<br>The device is for use in OTC. | SE |
| Operating<br>Principle | The Aneroid Sphygmomanometer with<br>Stethoscope is a non-invasive blood<br>pressure measurement system for<br>monitoring blood pressure levels. This<br>non-automated sphygmomanometer uses an<br>occluding cuff, an aneroid<br>sphygmomanometer to measure pressure<br>and a stethoscope for detecting Korotkoff<br>sounds. | The Aneroid Sphygmomanometer with<br>Stethoscope is a non-invasive blood<br>pressure measurement system for<br>monitoring blood pressure levels. This<br>non-automated sphygmomanometer uses an<br>occluding cuff, an aneroid<br>sphygmomanometer to measure pressure<br>and a stethoscope for detecting Korotkoff<br>sounds. | SE |
| Basic Design | The principle of sphygmomanometer is<br>base on hooke's law, the flexible sensitive<br>component (mirco-pressure file box) will be<br>flexible deformation under the influence of<br>pressure and use the mechanical group<br>(gear set) to amplify the pressure value and<br>indicate the value in the gauge. | The principle of sphygmomanometer is<br>base on hooke's law, the flexible sensitive<br>component (mirco-pressure file box) will be<br>flexible deformation under the influence of<br>pressure and use the mechanical group<br>(gear set) to amplify the pressure value and<br>indicate the value in the gauge. | SE |
| Measuring<br>Method | Aneroid / Auscultatory | Aneroid / Auscultatory | SE |
| Inflation<br>system: | Manual inflation with air pump bulb | Manual inflation with air pump bulb | SE |
| Deflation<br>system: | Manual deflation | Manual deflation | SE |
| Components | Blood Pressure Cuff (Audit)/<br>Stethoscope/Rotary Pin, 300 mmHg gauge/<br>Air pump bulb | Adjustable D-ring Cuff (Audit Size)/<br>Stethoscope/ Non-stop rotary pin, 300<br>mmHg gauge | SE |
| Measuring<br>range: | Pressure: 0 - 300 mmHg | Pressure: 0 - 300 mmHg | SE |
| Accuracy: | Pressure: +3 mmHg | Pressure: +3 mmHg | SE |
| 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 |

{7}------------------------------------------------

Table 2 Biocompatibility Comparison

#### 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.