(143 days)
The KD-322 Semi Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on anyone each time except infants and unconscious people, with the air cuff around the left upper arm according to instruction in the user's guide manual.
The KD-322 Semi Automatic Electronic Blood Pressure Monitor is intended to measure the diastolic and systolic blood pressures and pulse rate of an intended to modules the a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 8.6614 inches to 13.78 inches.
KD-322 Semi Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this device is used to monitor systolic, diastolic blood pressure and pulse rate which will be displayed on a LCD with an electronic interface. After wrapping the air cuff around the left upper arm 1-2cm above elbow joint, automatically inflated or inflated by an internal pump, the device can analyze the signals promptly and display the results.
Here's an analysis of the provided text to extract information about the acceptance criteria and the associated study for the KD-322 Semi Automatic Electronic Blood Pressure Monitor.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance Statement) |
|---|---|
| ANSI/AAMI SP10-1992 Accuracy Requirements | "The results meet or exceed the accuracy requirements of ... ANSI/AAMISP10-1992." |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "...clinical tests were performed and complied the accuracy requirements of ... ANSt/AAMISP10-1992."
3. Number of Experts and Their Qualifications for Ground Truth
The document does not provide information regarding the number of experts used to establish the ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The document does not state the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is an automated blood pressure monitor, so an MRMC study in the context of human reader performance with or without AI assistance is not applicable.
6. Standalone (Algorithm-Only) Performance Study
Yes, a standalone study was done. The clinical tests performed were for the device itself to verify its accuracy against a recognized standard (ANSI/AAMI SP10-1992). The device is an "Automatic Electronic Blood Pressure Monitor," implying its function is standalone in measuring and displaying blood pressure and pulse rate.
7. Type of Ground Truth Used
Based on the reference to "ANSI/AAMI SP10-1992 Accuracy Requirements," the ground truth for the accuracy assessment would typically be established by a reference method or gold standard for blood pressure measurement, as specified within that standard. This often involves a trained observer taking auscultatory measurements using a mercury sphygmomanometer, though the document does not explicitly state this.
8. Sample Size for the Training Set
The document does not provide information regarding the sample size for the training set. This is not surprising as the device described is a semi-automatic electronic blood pressure monitor, not an AI/ML-driven diagnostic device that typically requires a large training set in the conventional sense. Its "training" would be more about calibration and internal algorithm development rather than machine learning from labeled datasets.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any "training set" was established, given the nature of the device as a measurement instrument rather than an AI/ML diagnostic.
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『け(k) Summary
: ! !!!fication of the submitter:
| Emitter: | Kodon (Tianjin) Electron & Electrical ApparatusCo., LTDNo 31, Changjiang Road, Nankai District TianjinP.R. China, 300193 |
|---|---|
| Telephone number: | 86-22-60526082 |
| Fax number: | 86-22-60526162 |
| Contact: | Liu Yi |
| Date of Application: | 23/09/05 |
. : ! fification of the product:
| Device proprietary Name: | KD-322 Semi Automatic Electronic Blood PressureMonitor |
|---|---|
| Common name: | Noninvasive blood pressure measurementsystems |
| Classification name: | Noninvasive blood pressure measurement systemClass II per 21 CFR 870.1130 |
(; rketed Devices to which equivalence is clain () {
| Device | manufacture | 510(k) number |
|---|---|---|
| -622 | Kodon (Tianjin) Electronic and ElectricalApparatus Co., Ltd. | K030353 |
ا : rice description:
. 1822 Semi Automatic Electronic Blood Pressure Monton is a Non-invasive r pressure measurement system for only one perse meach ime. Based ان of mornetric and silicon integrate pressure sensor technology this devise is one to monitor systolic, diastolic blood pressure and purse rate which will be . while on a LCD with an electronic interface most le fiwathing the air bef : und the left upper arm 1-2cm above elbow joint acto natically imlated = 1 : 1 at lased by an internal pump, the device can analyze the signals prompily was : Jay the results.
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i ! ?nded use:
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4 3-322 Semi Automatic Electronic Blood Pressure: Monton s ntended for use by medical professionals or at home to monitor and cisplay ciastolic, systs is ist od pressure and pulse rate on anyone each time except infants and n xonscious people, with the air cuff around the lef: נוףף arm accordling to ב ב · ruction in the user's guide manual.
i mparison of technological characteristics of new «lavige to joredicate ਼ !
. 1 622 Automatic Electronic Blood Pressure Monitor ceveroped from KD-3322 is mi Autornatic blood pressure monitor. KD-622 has added a bump to ന്യൂട്ടിക an ornatically and we also add some operation programme on software. "" refore KD-622 memory automatic blood pressente rnor itor can nfate on ornatically and store 90 times memory. Comparin ; with KD-622. memory automatic blood pressure monitor, KD-322 has to be infined manually and it nation memory function.
ു വേദമി Tests:
Of hisal tests were performed and complied the acceracy requirements of . . . SI/AAMISP10-1992. The results meet or exceed the appuracy requirements ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
! : n-clinical Tests:
". I non-clinical tests coincide the following standards
-
11901-1 (1988)
Medical electrical equipment----Part 1:Genera - entrents for safety -
11601-1 (1988)
Amendment 2 -
: EU602-2-30: 1995
Medical electrical equipment-part2: Particular recurements for the samily minutomatic cycling indirect blood pressure moniter right uipment. -
: 9706.1-1995
-
· ) · 333-1977
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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 circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring four abstract human figures connected in a flowing, wave-like design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2006
Kondon (Tianjin) Electronic & Electrical Apparatus Co., LTD c/o Mr. Liu Yi No. 31, Changjiang Road, Tianjin P.R. CHINA, 300193
Re: K052676
K052676
Trade Name: KD-322 Semi Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Number: 21 CFR 876.1136
Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: II Product Code: DXN Dated: Undated Received: January 30, 2006
Dear Mr. Liu Yi:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section J IQC) prematic is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predice. Device Amendments. for use stated in the enclosure) to regary indiked production Device Amendments, or to
commerce prior to May 28, 1976, the enactment the capvision of the Federal Food. Drue commerce prior to May 28, 1976, the enactificity of the Federal Food, Drug, devices that have been reclassified in accordance was are approval application (PMA).
and Cosmetic Act (Act) that do not require approval as traisions of the Act. The and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of the You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act merado requirements of the management misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mo entires and regulations affecting your device can
may be subject to such additional controls. Title may be subject to such additions: Laisting may regal to 898 In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 899 be found in the Code of Federal Regalations, in the Federal Register.
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Page 2 - Mr. Liu Yi
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a subscription with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decermination that your as 1988 by other Federal agencies. You must or any Pederal statutes and regulations daminities, but not limited to: registration and listing (21 comply with an the Act 3 requirements, me, good manufacturing practice requirements as setter CFK Part 807); labeling (21 CFR Part 800); good and frapplicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 (21 CFR 1000, 1050 forth in the quanty systems (QD) roganaton (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-10 product radiation connor provisions (Sections of Persons of vice as described in your Section 510(k) i his letter will anow you to oegin hankeling of substantial equivalence of your device to a legally premarket notification. The PDA miding of backanding of 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), phase If you desire specific advice tor your de not on on on one note the regulation entitled, comact the Office of Compullion at (210) 216 - 16 - 16 - 16 - 10 - 10 - 10 - 16 - 16 - 16 - 16 Small Missionaling by reference to premanter to promance the Act from the Division of Small other general information on your responsion.com at its toll-free number (800) 638-204) or and Consumer official webtag Manufacturers, International and Oolisanhi p://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimman for
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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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The KD-322 Semi Automatic Electronic Blood Pressure Monitor is for use by medical rns ND 022 Somminative blood pressure measurement system professionals of at nome and systolic blood pressures and pulse rate of an intended to modules the a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 8.6614 inches to 13.78 inches.
Prescription Use : YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use YES (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).