CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE

K090014 · Caremate Medical Device Co., Ltd. · DXQ · Apr 9, 2009 · Cardiovascular

Device Facts

• Record ID: K090014
• Device Name: CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE
• Applicant: Caremate Medical Device Co., Ltd.
• Product Code: DXQ · Cardiovascular
• Decision Date: Apr 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2

Intended Use

Caremate Sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (noninvasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospitals or at home to monitor both systolic and diastolic pressure by detecting Korotkoff sound. This product is only for adult use.

Device Story

Non-automated, mechanical blood pressure monitor; consists of inflatable cuff, aneroid manometer, stethoscope, bulb, and air release valve. Used by professionals or trained individuals in hospitals or homes. Operator inflates cuff, uses stethoscope to detect Korotkoff sounds, and reads pressure from manometer to determine systolic and diastolic blood pressure. Models CM-BPM and CM-PBPM differ only in physical integration of bulb and manometer. Device provides manual blood pressure monitoring to assist clinical decision-making.

Clinical Evidence

No clinical data required.

Technological Characteristics

Non-automated, mechanical sphygmomanometer. Components: inflatable cuff, aneroid manometer, stethoscope, bulb, air release valve. Non-sterile. Adult use only.

Indications for Use

Indicated for adult patients for non-invasive, indirect measurement and monitoring of systolic and diastolic arterial blood pressure via Korotkoff sound detection. Suitable for use by healthcare professionals or trained individuals in clinical or home settings.

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 KT-A01 with Stethoscope (K081951)

Submission Summary (Full Text)

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090014

510(k) Submission Report – Section IV 510(k) Summary Report SN: A2008-041-064

Caremate

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Section IV 510(k) Summary

> Caremate Medical Device Co., Ltd Caremate Sphygmomanometer with Stethoscope (As Required by CFR 807.92)

| Date of Preparation | December 29, 2009 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Sponsor | Caremate Medical Device Co., Ltd<br>Building 4, No. 281, Hong An Road, Xinnong<br>Jinshan District, Shanghai, China<br>Contact Person: Mark Chu<br>Tel: +(1)86-21-57341588<br>Fax: +(1)86-21-37284210<br>Email: [e-mail] |
| Submission Correspondent | Ms. Xiaoming Hong / Mr. Li Fu<br>Shanghai Mid-Link Consulting Co., Ltd<br>Suite 8D, No.19, Lane 999<br>Zhongshan No.2 Road(S), Shanghai, 200030, China |
| Proposed Device | Device Trade Name: Caremate Sphygmomanometer with Stethoscope;<br>Models: CM-BPM and CM-PBPM;<br>Classification Name: blood pressure cuff;<br>Product Code of Sphygmomanometer: DXQ;<br>Regulation Number of Sphygmomanometer: 870.1120;<br>Device Class of Sphygmomanometer: II (510(k));<br>Review Panel: Cardiovascular;<br>Classification Name: stethoscope, manual;<br>Product Code of Stethoscope: LDE;<br>Regulation Number of Stethoscope: 870.1875;<br>Device Class of Stethoscope: I (510(k) Exempt)<br>Review Panel: Cardiovascular |

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## Caremate

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| Intended Use | Caremate Sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (noninvasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospitals or at home to monitor both systolic and diastolic pressure by detecting Korotkoff sound. This product is only for adult use. |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The proposed device, Caremate Sphygmomanometer with Stethoscope, is a non-invasive and non automated device intended to measure the blood pressure. It contains of a cuff with inflatable bladder and an aneroid manometer to measure the pressure, as well as a stethoscope for detecting the Korotkoff sound; In addition, an end valve, an air release valve and a bulb are included to complete its function. |
| Device Description | Caremate Sphygmomanometer with Stethoscope has two models, CM-BPM and CM-PBPM. They are following the same design principle and same components. The only differences are that the bulb and the aneroid manometer are connected together. The operator can held them in one hand. This design feature facilitates the using of this device and will not affect the performance. |
| Device Description | This product is provided non-sterile and only for adult use. |
| Non-Clinical Testing Summary | Laboratory testing was conducted to validate and verify that the proposed device, Caremate Sphygmomanometer with Stethoscope, both CM-BPM and CM-PBPM met all design specifications and was substantially equivalent to the predicate device. |
| Clinical Testing Summary | No Clinical Information is required. |
| Predicate Identification | K081951 cleared in Aug 15, 2008 Aneroid Sphygmomanometer Model KT-A01 with Stethoscope Manufacturer: Wenzhou Kindcare Import & Export Co., Ltd |
| SE Conclusion | The Caremate Sphygmomanometer with Stethoscope (CM-BPM and CM-PBPM) is claimed to be Substantially Equivalent (SE) to Aneroid Sphygmomanometer Model KT-A01 with Stethoscope (K081951 cleared in Aug 15, 2008) |

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Public Health Service

APR 0 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Caremate Medical Device Co., Ltd. c/o Ms. Xiaoming (Diana) Hong Shanghai Midlink Business Consulting Co., Ltd. Suite 8D, No. 19, Lane 999 Zhongshan No. 2 Road (S) Shanghai, China 200030

Re: K090014

Trade/Device Name: Caremate Sphygmomanometer with Stethoscope, Models CM-BPM and CM-PBPM Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (Two) Product Code: DXQ Dated: Undated Received: April 3, 2009

Dear Ms. Hong:

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. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/:

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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090014

510(k) Submission Report - Section III Indication for Use Statement Report SN: A2008-041-064

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## Indication for Use Statement Section III

510(k) Number:

Device Name: Caremate Sphygmomanometer with Stethoscope

Indications for Use:

Caremate Sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (noninvasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospitals or at home to monitor both systolic pressure by detecting Korotkoff sound. This product is only for adult use.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sidn-Off) ardiovascular Devices K090014 Numt