(36 days)
Not Found
No
The description details a manual sphygmomanometer and explicitly states "manual method for detecting Korotkoff sounds," with no mention of AI or ML terms or functionalities.
No
The device is described as a sphygmomanometer used for measuring blood pressure, which is a diagnostic function, not a therapeutic one. Therapeutic devices are typically used to treat or cure a disease or condition.
Yes
The device is described as intended for the "measurement of systolic and diastolic pressure on adults," which is a diagnostic function for monitoring health conditions like hypertension.
No
The device description explicitly details physical components like tubing, a sleeve, an inflatable bladder, and a non-invasive sphygmomanometer, indicating it is a hardware device, not software-only.
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 systolic and diastolic blood pressure on adults. This is a physiological measurement taken directly from the patient's body.
- Device Description: The device is a sphygmomanometer, which is a non-invasive medical device used to measure blood pressure. It involves a cuff, tubing, and a method for detecting Korotkoff sounds.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
Therefore, this device falls under the category of a non-invasive medical device used for physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manua attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
Product codes (comma separated list FDA assigned to the subject device)
DXQ
Device Description
The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure . The device tubing is connected to a non-invasive sphygmomanometer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's limb
Indicated Patient Age Range
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 JJ METER's Sphygmomanometer(model: JHT-1110, JHT-1500, JHT-1611) have been tested conform to the ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type, and ISO 10993-5 and ISO 10993-10.
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.
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
§ 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
K141392; page 1 of 3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Date: May 27, 2014
- Submitter:
Name: SUZHOU JJ METER CO., LTD.
Add: No.156 Xuqing Rd, Xushuguan Town, Suzhou New District, P.R. China
Tel: 0086-512-66168979
Fax: 0086-512-66168979
- Contact Person:
Long Yang (COO.)
Shenzhen Hlongmed Biotech Co., Ltd.
R1508, East Building, Yihai Plaza, Chuangye Road, Nanshan District,Shenzhen, P.R. China
Tel: 0086-755-86664986
Fax: 0086-755-86664933
E-mail: yanglong@hlongmed.com
1
K141392
l
3. Device Information:
| Trade name: | Sphygmomanometer |
|---|---|
| Model: | JHT-1110, JHT-1500, JHT-16 |
| Common name: | Blood Pressure Cuff |
| Classification name: | Blood Pressure Cuff |
| Review Panel: | Cardiovascular |
| Product Code: | DXQ |
| Regulation Class: | II |
| Regulation Number: | 870.1120 |
4. Predicate Device Information:
Company Name: Wenzhou Bokang instruments Co., Ltd.
Device Name: Aneroid Sphygmomanometer BK2002
510(k) number: K043286.
5. Device Description:
The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure . The device tubing is connected to a non-invasive sphygmomanometer.
6. Indication For Use:
The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be
2
Page 3 of 3
manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
7. Technological Characteristics:
The JJ METER's Sphygmomanometer(model: JHT-1110, JHT-1500, JHT-1611) are virtually the same as Bokang's Aneroid Sphygmomanometer BK2002.
8. Safety and Performance Data:
The JJ METER's Sphygmomanometer(model: JHT-1110, JHT-1500, JHT-1611) have been tested conform to the ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type, and ISO 10993-5 and ISO 10993-10.
9. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this pre-market notification. SUZHOU JJ METER CO., LTD concludes that the Sphygmomanometer( models JHT-1110, JHT-1500, JHT-1611) are safe and effective, and substantially equivalent to the predicate device described herein.
3
Image /page/3/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 or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G Silver Spring, MD 20993-0002
July 2, 2014
Suzhou Jj Meter Co., Ltd. c/o Ms. Long Yang Official Correspondent R1508, East Bldg, Yihai Plaza Chuangye Rd. Nanshan District Shenzhen, Guangdong, 518054 CH
K141392 Re:
Trade/Device Name: Sphygmomanometer (Models JHT-1110, JHT-1500, JHT-1611) Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: May 20, 2014 Received: May 27, 2014
Dear Ms. Yang:
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, 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 IVD and Part 809); medical device reporting (reporting of
4
Page 2 - Ms. Long Yang
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 IVD and Part 809), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/dcfault.htm.
Sincerely yours,
Image /page/4/Picture/6 description: The image shows a logo with the letters FDA in a stylized font. The letters are interconnected and have a textured appearance. There is a signature or some other form of writing across the letters.
forbram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K141392
Device Name: __ Sphygmomanometer (Model: JHT-1110, JHT-1500, JHT-1611) _______________________________________________________________________________________________________
Indications For Use:
í
The device is intended to be used by medical professionals
or in the home for the measurement of systolic and diastolic
pressure on adults. The device is intended to be manua attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
(BLEASE DO NOT WRITE BETON THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Image /page/5/Picture/7 description: The image shows a document with the title "Concurrence of CDRH, Office of Device Evaluation (ODE)". There is a signature and the date "2014.07.02 14:34:45-04'00'". The document indicates "Over-The-Counter Use" with an "X" marked, and also mentions "Prescription Use (Per 21 CFR 801.109)" along with an "OR" separator.