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

Device Description

The product is a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories of MODEL Ks-1222,Ks-1621,Ks-3201,Ks-2203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. It is conjunction with Stethoscope when use.

AI/ML Overview

The provided document is a 510(k) summary for an Aneroid Sphygmomanometer. It details the device's characteristics and its comparison to a predicate device to establish substantial equivalence. However, this document does not describe a study involving an AI-powered device or a multi-reader multi-case (MRMC) comparative effectiveness study.

The device in question, an "Aneroid Sphygmomanometer," is a manual, non-automated blood pressure meter. The performance testing cited is against ISO 81060-1:2007 "Non-invasive sphygmomanometersPart 1: Requirements and test methods for non-automated measurement type." This standard governs the accuracy of manual blood pressure devices, not AI performance.

Therefore, many of the requested details, such as acceptance criteria for AI performance, sample sizes for test/training sets for AI, ground truth establishment for AI, expert involvement for AI, MRMC studies, and standalone AI performance, are not applicable to this submission.

The document focuses on demonstrating that the new manual device performs similarly to a legally marketed predicate manual device and meets relevant performance and biocompatibility standards for non-automated devices.

However, I can extract the general "acceptance criteria" for the accuracy of the blood pressure measurement as stated in the comparison table and the performance test standard:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Blood Pressure Measurement Accuracy)	Reported Device Performance (Subject Device)
Pressure: +/- 3 mmHg of reading (per ISO 81060-1)	Pressure: +/- 3 mmHg of reading
Compatibility with Environment
Can be used from 50°F to 104°F (10°C to 40°C) and 15% ~ 85% RH humidity	Can be used from 50°F to 104°F (10°C to 40°C) and 15% ~ 85% RH humidity
Biocompatibility
Conforms to the requirements of ISO 10993 series standards (specifically ISO 10993-1, -5, -10, -23)	Conforms to the requirements of ISO 10993 series standards

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

Sample Size for performance testing: The document states "full performance testing representing the current devices currently marketed" and mentions compliance with ISO 81060-1. While the specific number of subjects/measurements is not detailed in this summary, ISO 81060-1 typically requires clinical validation with a certain number of subjects (e.g., at least 85 subjects for blood pressure accuracy evaluation). The document does not specify data provenance (country, retrospective/prospective).
Data Provenance: Not explicitly stated.

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

Not applicable for AI-driven performance. For a manual blood pressure device assessed against ISO 81060-1, the "ground truth" for blood pressure typically comes from a reference measurement method (e.g., intra-arterial measurement or a highly accurate clinical standard measurement performed by trained personnel). The document does not specify the number or qualifications of these individuals involved in the ground truth establishment for clinical validation, as it's a standard process dictated by the ISO standard.

4. Adjudication method for the test set:

Not applicable for AI-driven performance. For a manual blood pressure device, adjudication would not be in the typical sense of expert review of AI outputs.

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:

No, an MRMC study was not done. This is a manual, non-AI device.

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

Not applicable. This is a manual device; there is no algorithm in the sense of AI. The performance testing is for the physical device itself.

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

For blood pressure measurement accuracy (referenced by ISO 81060-1), the ground truth is typically established by simultaneous measurements using a highly accurate reference method (e.g., intra-arterial pressure or a validated mercury sphygmomanometer measurement by trained observers). This is a technical ground truth related to physical measurement.

8. The sample size for the training set:

Not applicable. This is a non-AI device; there is no "training set."

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

Not applicable. This is a non-AI device.

In summary, the provided FDA 510(k) summary is for a traditional, non-automated medical device (Aneroid Sphygmomanometer). Therefore, it does not contain information related to AI-specific study designs, acceptance criteria, or performance metrics. The "study" proving the device meets acceptance criteria refers to non-clinical performance testing against established international standards for manual blood pressure devices and biocompatibility.

Summary

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June 28, 2023

Wenzhou Kangshun Medical Devices Co.,Ltd Eric Shi OA&OC Manager No. 706 Yanyun Road,Lingkun Street,Oujiangkou Industrial Cluster District Wenzhou City, Zhejiang 325011 China

Re: K230859

Trade/Device Name: Aneroid Sphygmomanometer Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: March 29, 2023 Received: March 29, 2023

Dear Eric Shi:

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. 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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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.

Hetal B. Patel -S

for

Robert Kazmierski Acting Assistant Director Division of Cardiac Electrophysiology Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230859

Device Name Non-Automated Blood Pressure Meter

Indications for Use (Describe)

There are a variety of stethoscopes can be an optioned accessory,depending on the model.

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

X Prescription Use (Part 21 CFR 801 Subpart D)	X Over-The-Counter Use (21 CFR 801 Subpart C)
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Sponsor: Wenzhou Kangshun Medical Devices Co.,Ltd. Subject Device: Aneroid Sphygmomanometer 510(k) number: K230859 File No.: Chapter 6 510(k) Summary

510(k) Summary

1.Submitter Information

Company Name:Wenzhou Kangshun Medical Devices Co.,Ltd. Address:No.706 Yanyun Road,Lingkun Street,Oujiangkou Industrial Cluster District,Wenzhou City,Zhejiang 325011,China. Phone:+86-13857771939 Contact Person (including title):Eric Shi (QA&QC Manager) E-mail:eric-shi@isosh.com Subject Device Information Traditional Type of 510(k): Common Name: Non-Automated Blood Pressure Meter Trade Name: Aneroid Sphygmomanometer Regulation Name: Blood Pressure Cuff Product Code: DXQ,LDE Regulation Number: 21 CFR 870.1120 Regulation Class: 2 2.Predicate Device Information Common Name: WX non-Automated Blood Pressure Meter Regulation Name: Blood Pressure Cuff 510(k) number: K212416 Product Code: DXQ Regulation Number: 21 CFR 870.1120 Regulation Class: 2

3.Device Description

The product is a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm.

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The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories of MODEL Ks-1222,Ks-1621,Ks-3201,Ks-2203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag.

It is conjunction with Stethoscope when use.

4.Indications for Use

The product is intended to be used by medical professionals or in the home for the measurement of

systolic and diastolic pressure on children or adults. The device is intended to be manually attached

to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

There are a variety of stethoscopes can be an optioned accessory,depending on the model.

5.Summary of Comparison and Technological Characteristics

Table 1 - General Comparison

Elements ofComparison	Subject Device	Predicate Device	Comment
Product Name	Non-Automated BloodPressure Meter	WX non-Automated Blood PressureMeter	--
General Comparison
510(k) Number	K230859	K212416	N/A
Device Classification	Blood Pressure Cuff	Blood Pressure Cuff	Same
Regulation Number	21 CFR 870.1120	21 CFR 870.1120	Same
Product Code	DXQ,LDE	DXQ	Same
Indications for Use	The product is intended to beused by medical professionalsor in the home for themeasurement of systolic anddiastolic pressure on childrenor adults.The device isintended to be manuallyattached to a patient andmanually inflated along with a	WX non-Automated Blood PressureMeter is intended to be used bymedical professionals or in thehome for the measurement ofsystolic and diastolic pressure onchildren or adults.The device is intended to bemanually attached to a patient andmanually inflated along with a	Same
Elements ofComparison	Subject Device	Predicate Device	Comment
	manual method for detectingKorotkoff sounds.There are a variety ofstethoscopes can be anoptioned accessory,dependingon the model.	manual method for detectingKorotkoff sounds.There are a variety of stethoscopescan be an optioned accessory,depending on the model.The device is applicable to allpatients at least 2 years of age.
Model	Ks-1222,Ks-1621,Ks-3201,Ks-2201,Ks-2203	WX02,WX0201, WX0202,WX0203
Over-TheCounter Use	Yes	Yes
Where used	Home, Hospital, heathcarefacility, ambulance etc.	Home, Hospital, heathcare facility,ambulance etc.	Same
Target population	Children or adults	Infants, children, young adults, andadults	Different 1
Anatomical sites	Upper Arm (leg for child)	Upper Arm (leg for child)	Same
Measurement Method	Auscultatory Korotkoff soundsMethod	Auscultatory Korotkoff soundsMethod	Same
Inflation	Manual	Manual	Same
Deflation	Manual	Manual	Same
Display	Aneroid Manometer	Aneroid Manometer	Same
The monitor scale	0 to 300 mmHg with aminimum interval of 2 mmHg	From 0 to 300 mmHg with aminimum interval of 2 mmHg	Same
Design of bloodpressure meter	The device comprises tubingattached to a soft inelastic cuffwith an integrated inflatablebladder that is wrapped	The device comprises tubingattached to a soft inelastic cuff withan integrated inflatable bladder thatis wrapped around the patient's limb	Same
Elements ofComparison	Subject Device	Predicate Device	Comment
	around the patient's limb andsecured by hook and loopclosure.	and secured by hook and loopclosure.
Designof Stethoscope	Three types of option:Single headDual headSprague Rappaport	Three types of option:Single headDual headSprague Rappaport	Same
Materials	The manometer:Zinc Alloy or Aluminummaterials.The tubing, inflation bulb:PVC.Cuff:Nylon cloth.	The manometer:Zinc Alloy or Aluminum materials.The tubing,inflation bulb:PVC or nature latexCuff:Nylon cloth or cotton cloth foroutside layer.Cuff bladder:PVC or nature latex	Same
Accuracy	Pressure:+/- 3 mmHg of reading	Pressure:+/- 3 mmHg of reading	Same
Compatibilitywithenvironment	It can be used from 50°F to104°F (10°C to 40°C) and 15%~ 85%RH humidity	It can be used from 50°F to104°F(10°C to 40°C) and 15% ~85%RH humidity	Same
Cuff Size	Ks-1222:500mm140mmKs-1621:520mm140mmKs-2201:630mm175mmKs-2203:720mm210mmKs-3201:380mm*110mm	20"x 5.5" (510mm140mm)21.7"x 6.3" (550mm160mm)24.4"x 6.9" (620mm175mm)28.3"x 8.3" (720mm210mm)13.4"x 4.15" (340mm*105mm)	Different 2
Cuff Circumference	Fits arm circumferences	Fits arm circumferences 220mm to	Same
Elements ofComparison	Subject Device	Predicate Device	Comment
	220mm to 440 mm. Thestandard cuff should beavailable for use in measuringa child's leg blood pressureand for children with largerarms	440 mm. The standard cuff shouldbe available for use in measuring achild's leg blood pressure and forchildren with larger arms
Cuff Color	Blue	Blue, Pink, Black	Same
Contents(withaccessories)	Aneroid gauge, Arm Cuff, Inflation Bulb, Vinyl storagepouch and Instruction Manual,Stethoscope (option)	Aneroid gauge, Arm Cuff, InflationBulb, Vinyl storage pouch andInstruction Manual, Stethoscope(option)	Same
Biocompatibility	Conforms to the requirementsof ISO 10993 seriesstandards.	Biocompatible as requirement ofISO 10993-1 ISO 10993-5 ISO10993-10	Same
Performance	compatible as requirement ofISO 81060-1	compatible as requirement of ISO81060-1	Same

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Wenzhou Kangshun Medical Devices Co.,Ltd. Sponsor: Subject Device: Aneroid Sphygmomanometer 510(k) number: K230859 File No.: Chapter 6 510(k) Summary

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Wenzhou Kangshun Medical Devices Co.,Ltd. Sponsor: Subject Device: Aneroid Sphygmomanometer 510(k) number: K230859 File No.: Chapter 6 510(k) Summary

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Sponsor: Wenzhou Kangshun Medical Devices Co.,Ltd. Subject Device: Aneroid Sphygmomanometer 510(k) number: K230859 File No.: Chapter 6 510(k) Summary

Different 1: The target population of the product is for children or adults and the target population of the predicate device is for Infants, children, young adults, and adults.

Different 2: The cuff size of Ks-1222,Ks-1621,Ks-2201 is shorter than predicate device.The cuff size of Ks-2203 is equivalent that predicate device.The cuff size of Ks-3201 is more than predicate device

6.Non-clinical Tests Performed on the Proposed Device

The company has performed non-clinical performance testing based on its risk assessment utilizing Failure Mode Effect Analysis (FMEA).

Following Quality System processes,required testing was conducted to validate the cumulative

modifications made to the subject devices.

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Sponsor:	Wenzhou Kangshun Medical Devices Co.,Ltd
Subject Device:	Aneroid Sphygmomanometer
510(k) number:	K230859
File No.:	Chapter 6 510(k) Summary

Substantial Equivalence is being supported with full performance testing representing the current devices currently marketed.

Performance test

• ISO 81060-1:2007 Non-invasive sphygmomanometersPart 1: Requirements and test methods for

non-automated measurement type

Biocompatibility test

Testing was conducted according to relevant sections of ISO 10993:2019 Biological evaluation of

medical devices.

Biocompatibility testing included:

MTT cytotoxicity test
Skin Sensitization Test
Skin Irritation Test
ISO 10993-1:2018 Biological evaluation of medical devices-Part 1: Evaluation and testing within a

risk management process

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

7.Clinical Testing

Not Applicable

8.Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k)

submission K212416,the product is as safe,as effective.

9.Summary Prepared Date

22 June 2023

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).