Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope

K211084 · Shanghai Caremate Medical Device Co., Ltd. · DXQ · Oct 19, 2021 · Cardiovascular

Device Facts

• Record ID: K211084
• Device Name: Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
• Applicant: Shanghai Caremate Medical Device Co., Ltd.
• Product Code: DXQ · Cardiovascular
• Decision Date: Oct 19, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Non-invasive, non-automated, reusable aneroid sphygmomanometer; used by medical professionals or patients at home/hospital/clinic. Device consists of manometer, inflatable cuff with bladder, inflation bulb, and optional stethoscope. Operator manually wraps cuff around patient limb, inflates via bulb, and uses auscultatory Korotkoff sound method to determine blood pressure. Manometer displays pressure (0-300 mmHg). Output is visual pressure reading used by clinician/user for blood pressure monitoring. Benefits include manual, portable, non-electric blood pressure assessment.

Clinical Evidence

No clinical data included. Bench testing only. Compliance with ISO 81060-1 (non-automated sphygmomanometer performance) and ISO 10993 (biocompatibility: cytotoxicity, sensitization, irritation) verified.

Technological Characteristics

Aneroid manometer (aluminum or ABS); cuff bladder/tubing/bulb (neoprene, silicone rubber, natural latex, or PVC); nylon cuff. Manual inflation/deflation. Pressure range 0-300 mmHg, 2 mmHg intervals. Accuracy +/- 3 mmHg. Non-sterile, reusable. Biocompatibility per ISO 10993-1, -5, -10. Performance per ISO 81060-1.

Indications for Use

Indicated for measurement of systolic and diastolic blood pressure in newborns, infants, children, young adults, and adults. Used by medical professionals or in home settings. No specific contraindications listed.

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

• Aneroid sphygmomanometer, Model HS-20A, HS-20D, HS-201W, HS-201Y, HS-201C1, HS-201Q3 Aneroid sphygmomanometer with stethoscope, Model HS-50C, HS-50B, HS-50D (K192500)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 19, 2021

Shanghai Caremate Medical Device Co. Ltd Mark Chu General Manager Building 4, No. 281, Hong An Road, Jinshan District, Shanghai. 201503 China

Re: K211084

Trade/Device Name: Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ, LDE Dated: August 28, 2021 Received: September 16, 2021

Dear Mark Chu:

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

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

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,

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

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

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K211084

Device Name

Aneroid sphygmomanometer, Aneroid sphygmomanometer with stethoscope

Indications for Use (Describe)

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.

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)

#### 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}------------------------------------------------

# 510(k) Summary

## Sponsor Identification and Designated Submission Correspondent

| Company name | Shanghai Caremate Medical Device Co. Ltd |
|-----------------------------------|-----------------------------------------------------------------------------------------------|
| Address | Building 4, No. 281, Hong An Road, Zhujing Town, Jinshan<br>District, Shanghai, 201503, China |
| Establishment Registration Number | 3007699082 |
| Contact name | Mark Chu |
| Contact title | General Manager |
| Phone | [phone] |
| Fax | [phone] |
| Email | [e-mail] |

## Date of Preparation: 9/8/2021

.

| Predicate Device Information | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K192500 |
| Trade Name | Aneroid sphygmomanometer, Model HS-20A, HS-20D, HS-201W, HS-201Y, HS-201C1, HS-201Q3<br>Aneroid sphygmomanometer with stethoscope, Model HS-50C, HS-50B, HS-50D |

| Proposed Device Information | |
|-----------------------------|------------------------------------------------------------------------|
| Trade Name | Aneroid sphygmomanometer,<br>Aneroid sphygmomanometer with stethoscope |
| Classification Name | Blood pressure cuff |
| Regulatory Information | |
| Classification Product code | DXQ |
| Subsequent Product Code | LDE |
| Regulation Number | CFR 870.1120,<br>CFR 870.1875 |
| ReviewPanel | Cardiovascular |

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

#### Indications for Use of Propose Device

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 of Propose Device

The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. The proposed device is non-invasive, non-automated, non-sterile, reusable device.

The proposed device is consisting of manometer, cuff, cuff bladder, inflation bulb and with/without stethoscope. There are eight models including CM-BPM, CM-BPM-S, CM-BPM-D, CM-BPM-R, CM-PBPM-1, CM-PBPM-2, CM-PBPM-3 and CM-PBPM-C. The differences of eight models are on the size and material of manometer, material of cuff bladder, material of inflation bulb and stethoscope type if the device has stethoscope.

#### 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:

ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type [FDA recognition No .: 3-96].

ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity[FDA recognition No.: 2-245];

ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization[FDA recognition No .: 2-174];

#### Biocompatibility testing:

The biocompatibility evaluation for the cuff and stethoscope was conducted in accordance with the FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing with a risk management process ." September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The testing items included:

- · Cytotoxicity
- · Sensitization
- · Irritation

#### Performance testing:

Non-invasive sphygmomanometers performance testing per ISO 81060-1:2007;

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

## Clinical Test Conclusion

No clinical study is included in this submission.

## Comparison of Technology Characteristics

| ITEM | Proposed Device<br>Aneroid Sphygmomanometer | Predicate Device<br>K192500 | Rema<br>rk |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Product<br>name | Aneroid sphygmomanometer,<br>Aneroid sphygmomanometer with<br>stethoscope | Aneroid sphygmomanometer,<br>Model HS-20A, HS-20D,<br>HS-201W, HS-201Y, HS-201C1,<br>HS-201Q3<br>Aneroid sphygmomanometer with<br>stethoscope, Model HS-50C,<br>HS-50B, HS-50D | |
| Product<br>Code | DXQ, LDE | DXQ, LDE | Same |
| Regulation<br>No. | 21 CFR 870.1120<br>21 CFR 870.1875 | 21 CFR 870.1120<br>21 CFR 870.1875 | Same |
| Class | II | II | Same |
| Indication<br>for Use | The device is intended to be used by<br>medical professionals or in the home<br>for the measurement of systolic and<br>diastolic pressure on new borns,<br>infants, children, young adults and<br>adults. The device is intended to be<br>manually attached to a patient and<br>manually inflated along with a<br>manual method for detecting<br>Korotkoff sounds. | The device is intended to be used by<br>medical professionals or in the<br>home for the measurement of<br>systolic and diastolic pressure. The<br>device is intended to be manually<br>attached to a patient and manually<br>inflated along with a manual<br>method for detecting Korotkoff<br>sounds. | Different 1 |
| Over-The<br>Counter<br>Use | Yes | Yes | Same |
| Where<br>used | Home, Hospital, healthcare facility,<br>ambulance etc. | Home, Hospital, healthcare facility,<br>ambulance etc. | Same |
| Target<br>population | New borns, infants, children, young<br>adults and adults | New borns, infants, children, young<br>adults and adults | Same |
| Anatomical<br>sites | Upper Arm (leg for child) | Upper Arm (leg for child) | Same |
| Measurement<br>Method | Auscultatory Korotkoff sounds<br>Method | Auscultatory Korotkoff sounds<br>Method | Same |
| Method | | | |
| 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 |
| The<br>monitor<br>scale | From 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<br>the device | The device comprises tubing attached<br>to a soft inelastic cuff with an<br>integrated inflatable bladder that is<br>wrapped around the patient's limb and<br>secured by hook and loop closure. | 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<br>and secured by hook and loop<br>closure. | SE |
| Design of<br>Stethoscope | Three types option:<br>Single head<br>Dual head<br>Sprague Rappaport | Three types option:<br>Single head<br>Dual head<br>Sprague Rappaport | Same |
| Materials | The manometer: aluminum or ABS<br>The tubing, inflation bulb and cuff<br>bladder: Neoprene or Silicon rubber<br>or Nature latex or PVC | The manometer: aluminum and<br>stainless steel materials.<br>The tubing, inflation bulb and cuff<br>bladder: PVC or nature latex. | Differ<br>ent 2 |
| | Cuff: Nylon cloth for outside layer. | Cuff: Nylon cloth for outside layer. | |
| Accuracy | Pressure: +/- 3 mmHg of reading. | Pressure: +/- 3 mmHg of reading. | Same |
| Cuff sizes | 31.49" × 8.66" (800mm*220mm)<br>24.41" × 6.89" (620mm*175mm)<br>20.47" × 5.51" (520mm*140mm)<br>13.4" × 4.33" (340mm*110mm)<br>9.84"×3.15" (250mm*80mm)<br>8.27" × 2.36" (210mm*60mm) | 780mm*220mm<br>615mm*175mm<br>540mm*145mm<br>500mm*140mm<br>345mm*110mm<br>255mm*75mm<br>185mm*55mm | Differ<br>ent 3 |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| Cuff<br>circumference | Fits arm circumferences<br>100mm-620mm, the standard cuff<br>should be available for use in<br>measuring a New born, infant, child's<br>leg blood pressure and for child, young<br>adult, and adult with larger arms | Fits arm circumferences<br>100mm-660mm, the standard cuff<br>should be available for use in<br>measuring a New born, infant,<br>child's leg blood pressure and for<br>child, young adult, and adult with<br>larger arms | Differ<br>ent 4 |
| | | | |
| | | | |
| | | | |
| | | | |
| Cuff<br>bladder<br>size | 13.39" × 6.69" (340mm*170mm)<br>12.2"×5.51" (310mm*140mm)<br>8.66"×4.72' (220mm*120mm)<br>6.69"×3.15" (170mm*80mm)<br>4.33" × 2.36" (110mm*60mm) | 180mm*370mm<br>145mm*315mm<br>120mm*220mm<br>80mm*150mm<br>60mm*120mm | Differ<br>ent 5 |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| Configurat<br>ion | Manometer, cuff, cuff bladder,<br>inflation bulb and with/without<br>stethoscope. | Manometer, cuff, cuff bladder,<br>inflation bulb and with/without<br>stethoscope. | Same |
| Biocompat<br>ibility | biocompatible as requirement of ISO<br>10993-1, ISO 10993-5, ISO 10993-10 | biocompatible as requirement of<br>ISO 10993-1, ISO 10993-5, ISO<br>10993-10 | Same |
| Performan<br>ce | compatible as requirement of ISO<br>81060-1 | compatible as requirement of ISO<br>81060-1 | Same |

### Table 1 Comparison of Technology Characteristics

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

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

#### Different 1- Indications for use

The indications for use of proposed device include the target population, while the predicate device doesn't include this information. But they have the same target population, therefore, the proposed device and predicate device have the same indications for use.

#### Different 2- Material

The material of out shell of manometer, material of tubing and inflation bulb of proposed device is different from the predicate device. But these material is not the patient-contact material, therefore the difference on material does not raise new questions on safety and effectiveness of the proposed device.

#### Different 3 - Cuff sizes

The cuff sizes of proposed device are different from predicate device. However, the cuff size of proposed device is similar to the predicate device and the Cuff Circumference of the two devices is the same. The Velcro on cuff is designed to fit varies arm circumference. This difference doesn't raise new problems on the safety and effectiveness of the proposed device. Therefore, this difference on cuff size does not raise new questions on safety and effectiveness of the proposed device.

#### Different 4 - Cuff circumference

The arm circumferences for the proposed cuff is 100mm-620mm, and the arm circumferences for the predicate cuff is 100mm-660mm. The range of arm circumferences for proposed device is covered by that of the predicate device, the difference on cuff circumference does not raise new questions on safety and effectiveness of the proposed device.

#### Different 5 - Cuff bladder size

The cuff bladder size of the proposed device is partly different from predicate device. However, the cuff bladder size of proposed device is similar to the predicate device. It could fit varies requirements of users. This difference doesn't raise new problems on the safety and effectiveness of the proposed device. Therefore, this difference on cuff bladder size does not raise new questions on safety and effectiveness of the proposed device.

#### Conclusion

Based on the comparison and analysis above, the proposed devices are as safe, as effective, and performs as well as the legally marketed predicate device K192500.