(70 days)
Not Found
No
The device description details a traditional aneroid sphygmomanometer using the auscultatory method, which relies on a user detecting Korotkoff sounds with a stethoscope. There is no mention of any computational analysis, algorithms, or learning processes that would indicate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is for monitoring and measurement of blood pressure, not for providing therapy.
Yes
The device is used for the "indirect (noninvasive) measurement of human's Systolic, Diastolic blood pressure," which is a diagnostic measurement.
No
The device description explicitly lists physical components like an aneroid manometer, latex bulb, cuff, valve, and stethoscope set, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. This device measures blood pressure directly on the human body using a cuff and stethoscope.
- The intended use describes a non-invasive measurement of blood pressure. This is a physical measurement, not a diagnostic test performed on a sample.
- The device description details a mechanical process of inflating a cuff and listening for sounds. This is not an in vitro process.
The device described is a standard aneroid sphygmomanometer, which is a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Multiple Brand KTJ-50 is an aneroid sphygmomanometer intended to be used for the indirect (noninvasive) measurement of the arterial blood pressure by trained medical and health care personnel or trained general users.
The Multiple Brand, with model number KTJ-50, aneroid sphygmomanometer is an instrument intended to be used for the indirect (noninvasive) measurement of human's Systolic, Diastolic blood pressure using the auscultatory method by detecting Korotkoff Sound. This device is to be used by trained medical and health care personnel or trained general users.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DXQ
Device Description
The aneroid sphygmomanometer with stethoscope is a non-invasive blood pressure measurement system for monitoring blood pressure levels which can be performed by trained individuals. The sphygmomanometer Model KTJ-50 consists of 5 parts. They are aneroid manometer, latex bulb, cuff, valve and stethoscope set. The aneroid sphygmomanometer with stethoscope enables the user places the attached stethoscope on the inner arm above the bend in the elbow, to detect the Korotkoff sound. After inflation of the user does auditory monitor with the stethoscope to evaluate systolic and diastolic pressure. The two values are recorded as: systolic over diastolic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inner arm above the bend in the elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical and health care personnel or trained general users.
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)
Not Found
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
FEB & 2 2005
K04344
P 1/2
510(K) Summary
Submitter
George Su Crosslinks International 1800 Century Park East, Suite 600 Los Angeles, CA 90067 USA
Tel: 310-229-5748 Fax: 310-388-1067 Email: crosslinks2000@aol.com
Manufacturer:
Golden Horse Medical Equipment (Wuxi) Co., Ltd. 42 Xi Xin Road, Zhang Jing Town, Wuxi City, P. R. China 214194
Tel: +86 510 3791303 Fax: +86 510 3791680 Email: ghmed(@)publicl.wx.js.cn
Device Name:
Proprietary Name: Multiple Common/Usual Name: Aneroid Sphygmomanometer Device Name: Non-invasive Blood-pressure Measurement System Product Code: DXN Classification: Class II
Predicate Device:
Mabis brand and Mabis customers private label brand Establishment: MABIS HEALTHCARE, INC. Regulation Number : 890.5500 Product Code : DXN 510(k) Number: K942072 Registration Number: 1422443 Owner/Operator Number: 9005245
Description of the Multiple Brand KTJ-50:
The aneroid sphygmomanometer with stethoscope is a non-invasive blood pressure measurement system for
1
monitoring blood pressure levels which can be performed by trained individuals. The sphygmomanometer Model KTJ-50 consists of 5 parts. They are aneroid manometer, latex bulb, cuff, valve and stethoscope set. The aneroid sphygmomanometer with stethoscope enables the user places the attached stethoscope on the inner arm above the bend in the elbow, to detect the Korotkoff sound. After inflation of the user does auditory monitor with the stethoscope to evaluate systolic and diastolic pressure. The two values are recorded as: systolic over diastolic.
Intended Use
The Multiple Brand KTJ-50 is an aneroid sphygmomanometer intended to be used for the indirect (noninvasive) measurement of the arterial blood pressure by trained medical and health care personnel or trained general users.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 7 - 2005
Golden Horse Medical Equipment (Wuxi) Co., Ltd. c/o Mr. George Su Crosslinks International, Inc. 1800 Century Park East, Suite 600 Los Angeles, CA 90067
Re: K043444
Trade Name: Multiple, Model KTJ-50 Regulation Number: 21 CFR 870.1120 Regulation Name: Blood-Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: February 09,2005 Received: February 10,2005
Dear Mr. Su:
This letter corrects our substantially equivalent letter of February 22,2005, regarding the regulation number, regulation name, and product code.
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 (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. If your device is classified (see above) into either class 11 (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.
3
Page 2 - Mr. George Su
Please be advised that FDA's issuance of a substantial equivalence determination doks 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Complianceat (240) 276-0293. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
B bimuma for
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number(if known): K043444
Device Name : Non-invasive Blood Pressure Measurement System
Indications for Use:
The Multiple Brand, with model number KTJ-50, aneroid sphygmomanometer is an instrument intended to be used for the indirect (noninvasive) measurement of human's Systolic, Diastolic blood pressure using the auscultatory method by detecting Korotkoff Sound. This device is to be used by trained medical and health care personnel or trained general users.
Prescription Use X (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)
Blumensone
IDWslon Sign-Off) Division of Cordiovascular Deyices 510(k) Numbor_
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(Posted November 13, 2003)