The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

Device Description

The ANEROID SPHYGMOMANOMETER and ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE are manual blood pressure monitor used to measure blood presure.It consists of a cuff,a inflation bulb,a pressure gauge, an air valve and a stethoscope(optional).

Cuff: The cuff is made of a durable fabric and is wrapped around the upper arm of the patient. It inflates and deflates during the measurement process. The material of outside layer is nylon cloth.

Inflation Bulb: The inflation bulb is a rubber bulb that connects to the cuff and is used to manually inflate the cuff with air. The material is Neoprene or Silicon rubber or Nature latex or PVC.

Pressure Gauge: The pressure gauge is a circular dial with a needle that indicates the pressure within the cuff. It is calibrated in millimeters of mercury (mmHg) and shows the systolic and diastolic blood pressure readings. The material is Aluminum or ABS.

Air Valve: The valve is a control mechanism that allows for the release of air from the cuff once the measurement is complete.

Stethoscope: Although not a part of the device itself, a stethoscope is typically used in conjunction with an Aneroid Sphygmomanometer to listen for the blood flow sounds, known as Korotkoff sounds, in the brachial artery during the measurement. Three model are single head Stethoscope(Model: TY-S01),Dual Head Stethoscope(Model: TY-S05) and Spraque Rappaport Stethoscope(Model: TY-S04) individually.These stethoscopes are listed in FDA database.

AI/ML Overview

The provided submission describes an Aneroid Sphygmomanometer. Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Reference Standard)
Accuracy	± 3 mmHg (ISO 81060-1:2007)
Biocompatibility	Complies with ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021
Safety & Performance	Complies with ISO 81060-1:2007

The document explicitly states that the "Accuracy" of the device is ± 3 mmHg, which is also the performance reported. For "Biocompatibility" and "Safety & Performance", compliance with the specified ISO standards is the stated performance.

Note: The submission describes an aneroid sphygmomanometer, which is a mechanical device. The concept of an "AI device" with human-in-the-loop performance or standalone performance, sample sizes for test/training sets, adjudication methods, and expert qualifications for ground truth establishment, are not applicable to this type of device. The provided text is a 510(k) summary for a traditional medical device, not an AI/ML-powered device.

Therefore, the following points are answered with "Not Applicable" (N/A) due to the nature of the device.

2. Sample size used for the test set and the data provenance
N/A - This device is a mechanical blood pressure monitor, not an AI/ML-powered device that uses a "test set" in the context of data. The performance testing refers to compliance with a standard (ISO 81060-1), which involves testing the device itself, not an algorithm's performance on a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - See explanation above.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A - See explanation above.

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
N/A - This is a mechanical device, not an AI-assisted one.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is a mechanical device, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
N/A - The ground truth for this device's accuracy would be established by direct comparison to a reference standard, as defined by ISO 81060-1, which likely involves a calibrated pressure standard.

8. The sample size for the training set
N/A - This is a mechanical device, not an AI/ML-powered device that requires a "training set."

9. How the ground truth for the training set was established
N/A - See explanation above.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 20, 2024

Wenzhou Longwan Medical Device Factory Bernard Zeng, Manager Unit 4, Building 27, No. 706 Yanyun Road, Oujiangkou Industrial Cluster District Wenzhou. Zhejiang 325026 China

Re: K240165

Trade/Device Name: Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO, LDE Dated: January 15, 2024 Received: January 22, 2024

Dear Bernard Zeng:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Stephen C. Browning -S

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240165

Device Name

ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE; ANEROID SPHYGMOMANOMETER

Indications for Use (Describe)

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

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 PRAStaff(@fda.hhs.gov

"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."

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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: Dec. 11,2023

1. Submitter's Information

The submitter of this pre-market notification is:

Name:	WENZHOU LONGWAN MEDICAL DEVICE FACTORY
Address:	Unit 4, Building 27, No. 706 Yanyun Road, Oujiangkou IndustrialCluster District, Wenzhou, Zhejiang, 325026 China
Contact person:	Bernard Zeng
Title:	Manager
E-mail:	bernard@taiyumed.com
Tel:	86-13957715667

2. Device Identification

510(K) number:	TBD
Trade/Device Name:	ANEROID SPHYGMOMANOMETER,
	ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE
Common name:	Blood Pressure Cuff
Regulation Number:	870.1120
Regulation Name:	Blood Pressure Cuff
Regulation Class:	Class 2
Panel:	Cardiovascular
Product Code:	DXQ,LDE

3. Predicate Device

510(K) number:	K211084
Trade/Device Name:	Aneroid sphygmomanometer,
	Aneroid sphygmomanometer with stethoscope
Common name:	Blood Pressure Cuff
Regulation Number:	870.1120
Regulation Name:	Blood Pressure Cuff
Regulation Class:	Class 2
Panel:	Cardiovascular
Product Code:	DXQ,LDE

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Traditional 510(k) Submission of ANEROID SPHYGMOMANOMETER

4. Indication for Use

5. Device Description

Cuff: The cuff is made of a durable fabric and is wrapped around the upper arm of the patient. It inflates and deflates during the measurement process. The material of outside layer is nylon cloth.

Inflation Bulb: The inflation bulb is a rubber bulb that connects to the cuff and is used to manually inflate the cuff with air. The material is Neoprene or Silicon rubber or Nature latex or PVC.

Air Valve: The valve is a control mechanism that allows for the release of air from the cuff once the measurement is complete.

6. Compared to Predicate Device

Compared to the predicate devices, the subject device has the same intended use, similar product design, similar performance, same safety as the predicate device, the summarized comparison information is listed in the following table

SEComparisons	Subject Device	Predicate Device	Similarities/Differences
510(K) number	TBD	K211084	/
Name	ANEROIDSPHYGMOMANOMETER,ANEROIDSPHYGMOMANOMETERWITH STETHOSCOPE	Aneroid sphygmomanometer,Aneroid sphygmomanometerwith stethoscope	Same
Indication forUse	The device is intended to beused by medical professionals	The device is intended to beused by medical professionals	Same
	or in the home for themeasurement of systolic anddiastolic pressure on newborns, infants, children, youngadults and adults. The deviceis intended to be manuallyattached to a patient andmanually inflated along with a	or in the home for themeasurement of systolic anddiastolic pressure on new borns,infants, children, young adultsand adults. The device isintended to be manuallyattached to a patient andmanually inflated along with a
	manual method for detectingKorotkoff sounds.	manual method for detectingKorotkoff sounds.
Product code	DXQ,LDE	DXQ,LDE	Same
Class	II	II	Same
RegulationNumber	21 CFR 870.1120	21 CFR 870.1120	Same
Common name	Blood Pressure Cuff	Blood Pressure Cuff	Same
Type of Use	Over the Counter	Over the Counter	Same
Environment ofUse	Home, Hospital, healthcarefacility,ambulance etc.	Home, Hospital, healthcarefacility, ambulance etc.	Same
Targetpopulation	New borns, infants, children,young adults and adults	New borns, infants, children,young adults and adults	Same
Site	Upper Arm (leg for child)	Upper Arm (leg for child)	Same
MeasurementMethod	Auscultatory Korotkoff soundsMethod	Auscultatory Korotkoff soundsMethod	Same
Inflation	Manual by inflation bulb	Manual by inflation bulb	Same
Deflation	Manual deflation via valve	Manual deflation via valve	Same
Display	Aneroid Manometer	Aneroid Manometer	Same
Monitor scale	From 0 to 300 mmHg with aminimum interval of 2 mmHg.	From 0 to 300 mmHg with aminimum interval of 2 mmHg.	Same
Design of thedevice	The device comprises tubingattached to a soft inelastic cuffwith an integrated inflatablebladder that is wrapped aroundthe patient's limb and securedby hook and loop closure.	The device comprises tubingattached to a soft inelastic cuffwith an integrated inflatablebladder that is wrapped aroundthe patient's limb and securedby hook and loop closure.	Same
Design ofStethoscope	Three types option:Single headDual headSprague Rappaport	Three types option:Single headDual headSprague Rappaport	Same
Materials	The manometer: aluminum orABSThe tubing, inflation bulb andcuff bladder: Neoprene orSilicon rubber or Nature latexor PVCCuff: Nylon cloth for outsidelayer	The manometer: aluminum orABSThe tubing, inflation bulb andcuff bladder: Neoprene orSilicon rubber or Nature latex orPVCCuff: Nylon cloth for outsidelayer	Same
Accuracy	± 3 mmHg	± 3 mmHg	Same
Cuff sizes	500 ×140mm350 ×100mm600 ×170mm780 × 220mm260 × 80mm200 × 60mm255 × 75mm380 × 110mm560 × 150mm660 × 170mm760 × 210mm	800mm × 220mm620mm × 175mm520mm × 140mm340mm × 110mm250mm × 80mm210mm × 60mm	Different,See Note 1
Cuffcircumference	Fits arm circumferences60mm-660mm, the standardcuff should be available for usein measuring a New born,infant, child's leg bloodpressure and for child, youngadult, and adult with largerarms	Fits arm circumferences100mm-620mm, the standardcuff should be available for usein measuring a New born, infant,child's leg blood pressure andfor child, younq adult, and adultwith larger arms	Different,See Note 1
Cuff bladdersize	220 × 120mm175 × 85mm315 × 145mm375 × 185mm110 × 60mm80 × 40mm115 × 55mm175 × 80mm215 × 120mm310 × 140mm340 × 170mm	340mm × 170mm310mm × 140mm220mm × 120mm170mm × 80mm110mm × 60mm80mm × 40mm	Different.See Note 1
Biocompatibility	ISO 10993-5:2009,ISO 10993-10:2021,ISO 10993-23:2021	ISO 10993-5:2009,ISO 10993-10:2010	Different,See Note 2
Performance	ISO 81060-1:2007	ISO 81060-1:2007	Same

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Traditional 510(k) Submission of ANEROID SPHYGMOMANOMETER

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Traditional 510(k) Submission of ANEROID SPHYGMOMANOMETER

Note 1: All of the cuff were tested alongside aneroid sphygmomanometer according to ISO 81060-1:2007, these differences do not affect safety and effectiveness.

Note 2: The skin irritation testing and skin sensitization testing were conducted in accordance with ISO 10993-23:2021 and ISO 10993-10:2021 due to the version update of the standard, this difference does not affect safety and effectiveness.

The subject device and predicate device are substantially equivalent in the areas of technological characteristics such as basic design, features, method of operation, general function,

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Traditional 510(k) Submission of ANEROID SPHYGMOMANOMETER

application, and intended use. The subject device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.

8. Performance Testing Summary

The subject device comply with:

Clinical test:

Clinical testing is not required.

Non-clinical data

Safety and performance

ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type

Biocompatibility

ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 23: Tests for Irritation

9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject devices ANEROID SPHYGMOMANOMETER,ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE are as safe, as effective, and performs as well as the legally marketed predicated devices Aneroid sphygmomanometer,Aneroid sphygmomanometer with stethoscope(K211084).

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).