(97 days)
Not Found
No
The device description explicitly states it is a "non-automated, mechanical blood pressure monitor" and relies on manual detection of Korotkoff sounds. There is no mention of AI or ML in the provided text.
No
The device is used for monitoring blood pressure, not for treating any condition. Its purpose is measurement and display of physiological data.
Yes
The device measures and displays arterial blood pressure, which is a physiological parameter used in diagnosis.
No
The device description explicitly details physical components like a cuff, inflatable bladder, aneroid manometer, stethoscope, end valve, air release valve, and bulb, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure arterial blood pressure by detecting Korotkoff sounds. This is a physiological measurement taken directly from the patient's body.
- Device Description: The device is a mechanical blood pressure monitor that uses a cuff, manometer, and stethoscope. These components are used for external measurement and sound detection.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. This device does not process or analyze any bodily specimens.
Therefore, the Caremate Sphygmomanometer with Stethoscope is a non-invasive medical device for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / 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 and diastolic pressure by detecting Korotkoff sound. This product is only for adult use.
Product codes
DXQ, LDE
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.
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.
This product is provided non-sterile and only for adult use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arterial
Indicated Patient Age Range
adult
Intended User / Care Setting
professionals as well as trained individual users at hospitals or at 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
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.
No Clinical Information is required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
090014
510(k) Submission Report – Section IV 510(k) Summary Report SN: A2008-041-064
Caremate
1/2
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 |
| Building 4, No. 281, Hong An Road, Xinnong | |
| Jinshan District, Shanghai, China | |
| Contact Person: Mark Chu | |
| Tel: +(1)86-21-57341588 | |
| Fax: +(1)86-21-37284210 | |
| Email: mark@carematemed.com | |
| Submission Correspondent | Ms. Xiaoming Hong / Mr. Li Fu |
| Shanghai Mid-Link Consulting Co., Ltd | |
| Suite 8D, No.19, Lane 999 | |
| Zhongshan No.2 Road(S), Shanghai, 200030, China | |
| Proposed Device | Device Trade Name: Caremate Sphygmomanometer with Stethoscope; |
| Models: CM-BPM and CM-PBPM; | |
| Classification Name: blood pressure cuff; | |
| Product Code of Sphygmomanometer: DXQ; | |
| Regulation Number of Sphygmomanometer: 870.1120; | |
| Device Class of Sphygmomanometer: II (510(k)); | |
| Review Panel: Cardiovascular; | |
| Classification Name: stethoscope, manual; | |
| Product Code of Stethoscope: LDE; | |
| Regulation Number of Stethoscope: 870.1875; | |
| Device Class of Stethoscope: I (510(k) Exempt) | |
| 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) |
i
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health and Human Services.
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.
3
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
4
090014
510(k) Submission Report - Section III Indication for Use Statement Report SN: A2008-041-064
11
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