K Number

Device Name

Aneroid Sphygmomanometer

Manufacturer

Wenzhou Kangshun Medical Devices Co.,Ltd

Date Cleared

2023-06-28

(91 days)

Product Code

DXQ LDE

Regulation Number

870.1120

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K212416

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states it is a "manual non-invasive aneroid sphygmomanometer" and relies on a "manual method for detecting Korotkoff sounds." There is no mention of automated analysis or algorithms that would suggest AI/ML.

Therapeutic

No
This device is an aneroid sphygmomanometer, used for measuring blood pressure. Measurement devices are diagnostic rather than therapeutic, as they do not treat or alleviate a medical condition.

Diagnostic

Yes
The device is used for the measurement of systolic and diastolic pressure, which are diagnostic indicators of a patient's health status.

SaMD (Software as a Medical Device)

The device description explicitly details physical components such as an inflation cuff, manual inflation bulb, manometer (Aneroid gauge), and optional stethoscopes, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that the aneroid sphygmomanometer is used for the measurement of systolic and diastolic pressure on a patient's upper arm (or leg for a child). This is a direct measurement of a physiological parameter on the living body, not a test performed on a sample taken from the body.
Method of Operation: The device uses a cuff, inflation bulb, and a manometer in conjunction with a stethoscope to detect Korotkoff sounds. This is a physical, non-invasive method of measuring blood pressure.
Lack of Sample Analysis: There is no mention of collecting or analyzing any biological samples.

Therefore, the device described is a non-invasive medical device used for measuring blood pressure, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DXQ,LDE

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper Arm (leg for child)

Indicated Patient Age Range

Children or adults

Intended User / Care Setting

medical professionals or in the home

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
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

Key results: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K212416

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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.

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

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.

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 of

Comparison	Subject Device	Predicate Device	Comment
Product Name	Non-Automated Blood
Pressure Meter	WX non-Automated Blood Pressure
Meter	--
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 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	WX non-Automated Blood Pressure
Meter 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	Same
Elements of
Comparison	Subject Device	Predicate Device	Comment
	manual method for detecting
Korotkoff sounds.
There are a variety of
stethoscopes can be an
optioned accessory,depending
on the model.	manual method for detecting
Korotkoff sounds.
There are a variety of stethoscopes
can be an optioned accessory,
depending on the model.
The device is applicable to all
patients 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, heathcare
facility, ambulance etc.	Home, Hospital, heathcare facility,
ambulance etc.	Same
Target population	Children or adults	Infants, children, young adults, and
adults	Different 1
Anatomical sites	Upper Arm (leg for child)	Upper Arm (leg for child)	Same
Measurement Method	Auscultatory Korotkoff sounds
Method	Auscultatory Korotkoff sounds
Method	Same
Inflation	Manual	Manual	Same
Deflation	Manual	Manual	Same
Display	Aneroid Manometer	Aneroid Manometer	Same
The monitor scale	0 to 300 mmHg with a
minimum interval of 2 mmHg	From 0 to 300 mmHg with a
minimum interval of 2 mmHg	Same
Design of blood
pressure meter	The device comprises tubing
attached to a soft inelastic cuff
with an integrated inflatable
bladder that is wrapped	The device comprises tubing
attached to a soft inelastic cuff with
an integrated inflatable bladder that
is wrapped around the patient's limb	Same
Elements of
Comparison	Subject Device	Predicate Device	Comment
	around the patient's limb and
secured by hook and loop
closure.	and secured by hook and loop
closure.
Design
of Stethoscope	Three types of option:
Single head
Dual head
Sprague Rappaport	Three types of option:
Single head
Dual head
Sprague Rappaport	Same
Materials	The manometer:
Zinc Alloy or Aluminum
materials.
The tubing, inflation bulb:
PVC.
Cuff:Nylon cloth.	The manometer:
Zinc Alloy or Aluminum materials.
The tubing,inflation bulb:
PVC or nature latex
Cuff:
Nylon cloth or cotton cloth for
outside layer.
Cuff bladder:
PVC or nature latex	Same
Accuracy	Pressure:
+/- 3 mmHg of reading	Pressure:
+/- 3 mmHg of reading	Same
Compatibility
with
environment	It can be used from 50°F to
104°F (10°C to 40°C) and 15%
~ 85%RH humidity	It can be used from 50°F to
104°F(10°C to 40°C) and 15% ~
85%RH humidity	Same
Cuff Size	Ks-1222:500mm*140mm
Ks-1621:520mm*140mm
Ks-2201:630mm*175mm
Ks-2203:720mm*210mm
Ks-3201:380mm*110mm	20"x 5.5" (510mm*140mm)
21.7"x 6.3" (550mm*160mm)
24.4"x 6.9" (620mm*175mm)
28.3"x 8.3" (720mm*210mm)
13.4"x 4.15" (340mm*105mm)	Different 2
Cuff Circumference	Fits arm circumferences	Fits arm circumferences 220mm to	Same
Elements of
Comparison	Subject Device	Predicate Device	Comment
	220mm to 440 mm. The
standard cuff should be
available for use in measuring
a child's leg blood pressure
and for children with larger
arms	440 mm. The standard cuff should
be available for use in measuring a
child's leg blood pressure and for
children with larger arms
Cuff Color	Blue	Blue, Pink, Black	Same
Contents
(with
accessories)	Aneroid gauge, Arm Cuff, Inflation Bulb, Vinyl storage
pouch and Instruction Manual,
Stethoscope (option)	Aneroid gauge, Arm Cuff, Inflation
Bulb, Vinyl storage pouch and
Instruction Manual, Stethoscope
(option)	Same
Biocompatibility	Conforms to the requirements
of ISO 10993 series
standards.	Biocompatible as requirement of
ISO 10993-1 ISO 10993-5 ISO
10993-10	Same
Performance	compatible as requirement of
ISO 81060-1	compatible as requirement of ISO
81060-1	Same

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

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.

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