Aneroid Sphygmomanometer

K230859 · Wenzhou Kangshun Medical Devices Co.,Ltd · DXQ · Jun 28, 2023 · Cardiovascular

Device Facts

• Record ID: K230859
• Device Name: Aneroid Sphygmomanometer
• Applicant: Wenzhou Kangshun Medical Devices Co.,Ltd
• Product Code: DXQ · Cardiovascular
• Decision Date: Jun 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

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

Device Story

Manual non-invasive aneroid sphygmomanometer; consists of inflation cuff, manual inflation bulb, and aneroid manometer gauge. Used in home, hospital, or clinical settings by medical professionals or patients. Operator wraps cuff around patient's upper arm (or leg for children); manually inflates cuff using bulb; listens for Korotkoff sounds via stethoscope (optional accessory). Manometer displays pressure readings (0-300 mmHg). Device provides manual blood pressure measurement; aids clinicians in patient assessment and monitoring.

Clinical Evidence

No clinical data. Bench testing only. Performance validated per ISO 81060-1:2007. Biocompatibility validated per ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, and ISO 10993-23:2021 (cytotoxicity, skin sensitization, and irritation tests).

Technological Characteristics

Manual aneroid sphygmomanometer. Materials: Zinc alloy/aluminum (manometer), PVC (tubing/bulb), Nylon (cuff). Measurement range: 0-300 mmHg; 2 mmHg interval. Accuracy: +/- 3 mmHg. Non-electronic/mechanical operation. Biocompatible per ISO 10993. Performance per ISO 81060-1.

Indications for Use

Indicated for measurement of systolic and diastolic blood pressure in children and adults. Intended for use by medical professionals or in home settings. Requires manual inflation and manual detection of Korotkoff sounds.

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

• WX non-Automated Blood Pressure Meter (K212416)

Submission Summary (Full Text)

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

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.

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

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K230859

Device Name Non-Automated Blood Pressure Meter

#### Indications for Use (Describe)

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.

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

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

| <span> <span style="text-decoration:overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="text-decoration:overline;">X</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|

#### 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."

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

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:[phone] Contact Person (including title):Eric Shi (QA&QC Manager) E-mail:[e-mail] 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.

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

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<br>Comparison | Subject Device | Predicate Device | Comment |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Product Name | Non-Automated Blood<br>Pressure Meter | WX non-Automated Blood Pressure<br>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<br>used by medical professionals<br>or in the home for the<br>measurement of systolic and<br>diastolic pressure on children<br>or adults.The device is<br>intended to be manually<br>attached to a patient and<br>manually inflated along with a | WX non-Automated Blood Pressure<br>Meter is intended to be used by<br>medical professionals or in the<br>home for the measurement of<br>systolic and diastolic pressure on<br>children or adults.<br>The device is intended to be<br>manually attached to a patient and<br>manually inflated along with a | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device | Comment |
| | manual method for detecting<br>Korotkoff sounds.<br>There are a variety of<br>stethoscopes can be an<br>optioned accessory,depending<br>on the model. | manual method for detecting<br>Korotkoff sounds.<br>There are a variety of stethoscopes<br>can be an optioned accessory,<br>depending on the model.<br>The device is applicable to all<br>patients at least 2 years of age. | |
| Model | Ks-1222,Ks-1621,Ks-3201,<br>Ks-2201,Ks-2203 | WX02,WX0201, WX0202,<br>WX0203 | |
| Over-TheCounter Use | Yes | Yes | |
| Where used | Home, Hospital, heathcare<br>facility, ambulance etc. | Home, Hospital, heathcare facility,<br>ambulance etc. | Same |
| Target population | Children or adults | Infants, children, young adults, and<br>adults | Different 1 |
| Anatomical sites | Upper Arm (leg for child) | Upper Arm (leg for child) | Same |
| Measurement Method | Auscultatory Korotkoff sounds<br>Method | Auscultatory Korotkoff sounds<br>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<br>minimum interval of 2 mmHg | From 0 to 300 mmHg with a<br>minimum interval of 2 mmHg | Same |
| Design of blood<br>pressure meter | The device comprises tubing<br>attached to a soft inelastic cuff<br>with an integrated inflatable<br>bladder that is wrapped | The device comprises tubing<br>attached to a soft inelastic cuff with<br>an integrated inflatable bladder that<br>is wrapped around the patient's limb | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device | Comment |
| | around the patient's limb and<br>secured by hook and loop<br>closure. | and secured by hook and loop<br>closure. | |
| Design<br>of Stethoscope | Three types of option:<br>Single head<br>Dual head<br>Sprague Rappaport | Three types of option:<br>Single head<br>Dual head<br>Sprague Rappaport | Same |
| Materials | The manometer:<br>Zinc Alloy or Aluminum<br>materials.<br>The tubing, inflation bulb:<br>PVC.<br>Cuff:Nylon cloth. | The manometer:<br>Zinc Alloy or Aluminum materials.<br>The tubing,inflation bulb:<br>PVC or nature latex<br>Cuff:<br>Nylon cloth or cotton cloth for<br>outside layer.<br>Cuff bladder:<br>PVC or nature latex | Same |
| Accuracy | Pressure:<br>+/- 3 mmHg of reading | Pressure:<br>+/- 3 mmHg of reading | Same |
| Compatibility<br>with<br>environment | It can be used from 50°F to<br>104°F (10°C to 40°C) and 15%<br>~ 85%RH humidity | It can be used from 50°F to<br>104°F(10°C to 40°C) and 15% ~<br>85%RH humidity | Same |
| Cuff Size | Ks-1222:500mm*140mm<br>Ks-1621:520mm*140mm<br>Ks-2201:630mm*175mm<br>Ks-2203:720mm*210mm<br>Ks-3201:380mm*110mm | 20"x 5.5" (510mm*140mm)<br>21.7"x 6.3" (550mm*160mm)<br>24.4"x 6.9" (620mm*175mm)<br>28.3"x 8.3" (720mm*210mm)<br>13.4"x 4.15" (340mm*105mm) | Different 2 |
| Cuff Circumference | Fits arm circumferences | Fits arm circumferences 220mm to | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device | Comment |
| | 220mm to 440 mm. The<br>standard cuff should be<br>available for use in measuring<br>a child's leg blood pressure<br>and for children with larger<br>arms | 440 mm. The standard cuff should<br>be available for use in measuring a<br>child's leg blood pressure and for<br>children with larger arms | |
| Cuff Color | Blue | Blue, Pink, Black | Same |
| Contents<br>(with<br>accessories) | Aneroid gauge, Arm Cuff, Inflation Bulb, Vinyl storage<br>pouch and Instruction Manual,<br>Stethoscope (option) | Aneroid gauge, Arm Cuff, Inflation<br>Bulb, Vinyl storage pouch and<br>Instruction Manual, Stethoscope<br>(option) | Same |
| Biocompatibility | Conforms to the requirements<br>of ISO 10993 series<br>standards. | Biocompatible as requirement of<br>ISO 10993-1 ISO 10993-5 ISO<br>10993-10 | Same |
| Performance | compatible as requirement of<br>ISO 81060-1 | compatible as requirement of ISO<br>81060-1 | Same |

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

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

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

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

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

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.

{8}------------------------------------------------

| 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