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:
a. Blood Pressure Cuff
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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for an Aneroid Sphygmomanometer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria through a clinical or algorithmic performance study in the way one would for an AI/ML medical device.

Therefore, many of the requested points regarding acceptance criteria, study design, ground truth establishment, and expert involvement are not applicable to this type of submission, which relies primarily on bench testing and comparison to an existing predicate device's specifications and performance.

However, I can extract the relevant information regarding acceptance criteria as defined by the device's specifications and compliance with standards.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document states compliance with EN ISO 81060-1:2012 Non-Invasive Sphygmomanometers – Part 1: Requirements and Test Methods for Non-Automated Measurement Type and includes specific accuracy figures.

Acceptance Criterion	Reported Device Performance
Measuring Range	Pressure: 0 - 300 mmHg
Accuracy	Pressure: +/- 3 mmHg
Cytotoxicity	Not cytotoxic (based on ISO 10993-5)
Irritation	Not an irritant (based on ISO 10993-10)
Sensitization	Not a sensitizer (based on ISO 10993-10)

2. Sample size used for the test set and the data provenance:

The document states: "No clinical study is included in this submission."
The "tests" referred to are "Non-Clinical Tests" which include bench testing for performance and biological evaluation (cytotoxicity, irritation, sensitization).
The sample size for these non-clinical tests is not specified in the provided text.
Data provenance (country of origin, retrospective/prospective) is not applicable or specified as there's no clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There was no clinical study involving experts establishing ground truth for performance comparison. Performance was assessed via bench testing against established standards (e.g., ISO for accuracy and biocompatibility).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical data requiring expert adjudication was submitted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an Aneroid Sphygmomanometer, a mechanical blood pressure monitor, not an AI/ML-driven diagnostic or assistive device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a mechanical device, not an algorithm. Its performance is inherent to its physical design and manufacturing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For accuracy: The ground truth is the reference standard measurement obtained during bench testing, often against a calibrated master device or a known pressure standard, as outlined in EN ISO 81060-1.
For biocompatibility: The ground truth is determined by the results of in vitro and in vivo tests conducted according to ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization), which define acceptance criteria for these biological responses.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set for an AI/ML model was involved.

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

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.

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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)

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.

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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: +86-573-83133191 Fax:+86-573-83133190 Email: maoxiaoh@126.com

1. Designated Submission Correspondent
  Mr. Ray Wang

Beijing Believe Tech. Service Co., Ltd

Tel: +86-21-50313932, Fax: +86-21-68093116 Email: Ray.Wang@believe-med.com

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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:

Device Description

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;

Identification of Predicate Device(s) ર.

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Page 3 of 5

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

1. 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;
1. Clinical Test Conclusion

No clinical study is included in this submission.

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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 anon-automated, mechanical blood pressuremonitor that is used for the indirectmeasurement (non-invasive) and display ofarterial blood pressure. It can be used byprofessionals as well as trained individualusers over age 18 at hospitals or at home tomonitor both systolic and diastolic pressure.	The Aneroid Sphygmomanometer is anon-automated, mechanical blood pressuremonitor that is used for the indirectmeasurement (non-invasive) and display ofarterial blood pressure. It can be used byprofessionals as well as trained individualusers over age 18 at hospitals or at home tomonitor both systolic and diastolic pressure.The device is for use in OTC.	SE
OperatingPrinciple	The Aneroid Sphygmomanometer withStethoscope is a non-invasive bloodpressure measurement system formonitoring blood pressure levels. Thisnon-automated sphygmomanometer uses anoccluding cuff, an aneroidsphygmomanometer to measure pressureand a stethoscope for detecting Korotkoffsounds.	The Aneroid Sphygmomanometer withStethoscope is a non-invasive bloodpressure measurement system formonitoring blood pressure levels. Thisnon-automated sphygmomanometer uses anoccluding cuff, an aneroidsphygmomanometer to measure pressureand a stethoscope for detecting Korotkoffsounds.	SE
Basic Design	The principle of sphygmomanometer isbase on hooke's law, the flexible sensitivecomponent (mirco-pressure file box) will beflexible deformation under the influence ofpressure and use the mechanical group(gear set) to amplify the pressure value andindicate the value in the gauge.	The principle of sphygmomanometer isbase on hooke's law, the flexible sensitivecomponent (mirco-pressure file box) will beflexible deformation under the influence ofpressure and use the mechanical group(gear set) to amplify the pressure value andindicate the value in the gauge.	SE
MeasuringMethod	Aneroid / Auscultatory	Aneroid / Auscultatory	SE
Inflationsystem:	Manual inflation with air pump bulb	Manual inflation with air pump bulb	SE
Deflationsystem:	Manual deflation	Manual deflation	SE
Components	Blood Pressure Cuff (Audit)/Stethoscope/Rotary Pin, 300 mmHg gauge/Air pump bulb	Adjustable D-ring Cuff (Audit Size)/Stethoscope/ Non-stop rotary pin, 300mmHg gauge	SE
Measuringrange:	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, notcyteotoxicity effect	Comply with ISO 10993-5	SE
Irritation	Under the conditions of the study, not anirritant	Comply with ISO 10993-10	SE
Sensitization	Under conditions of the study, not asensitizer.		SE

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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.

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).