(77 days)
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Not Found
No
The description explicitly states a "manual method for detecting Korotkoff sounds" and references a predicate device that is a traditional sphygmomanometer, indicating a non-AI/ML approach.
No
The device is described as a sphygmomanometer, which is used for measurement and diagnosis, not for treatment. Its intended use is "for the measurement of systolic and diastolic blood pressure values."
Yes
The device is described as measuring systolic and diastolic blood pressure values, which is a diagnostic measurement.
No
The device description explicitly states "Accoson Greenlight 300 Sphygmomanometer," which is a physical medical device (a type of blood pressure monitor) and not software only. The description also mentions blood pressure cuffs and a manual method for detecting Korotkoff sounds, further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the measurement of systolic and diastolic blood pressure values. This is a physiological measurement taken directly from the patient's body.
- Method: The method described involves manually attaching a cuff, manual inflation, and manual detection of Korotkoff sounds. This is a physical measurement technique.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The device described is a sphygmomanometer, which is a medical device used for measuring blood pressure in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
N/A
Intended Use / Indications for Use
The device is intended to be used by medical professionals only for the measurement of systolic and diastolic blood pressure values. The device is intended to be used with blood pressure cuffs supplied for use with the device, which are manually attached to a patient's limb. The device provides a manual method for detecting Korotkoff sounds in adult, pediatric and neonate patient groups. The device cuffs are available in a range of adult, pediatric and neonate sizes for sale in the United States.
Product codes
DXN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
patient's limb
Indicated Patient Age Range
adult, pediatric and neonate patient groups
Intended User / Care Setting
medical professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2004
- Beller Bron
A. C. Cossor & Son (Surgical) Ltd. c/o Mr. A. J. Cossor Director Accoson Works Vale Road London N4 1PS UNITED KINGDOM
Re: K040410
Trade Name: Accoson Greenlight 300 Sphygmomanometer Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurcment System Regulatory Class: II (two) Product Code: DXN Dated: February 16, 2004 Received: March 10, 2004
Dear Mr. Cossor:
Wc have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosed of to stgasy the Medical Device Amendments, or to connineres phor to may 20, 1978, as econdance with the provisions of the Federal Food, Drug, uevices that have been require approval of a premarket approval application (PMA). and Cosmetic Ace (11et) that de novice, subject to the general controls provisions of the Act. The 1 ou may, therefore, thanks the act include requirements for annual registration, listing of general econtrols proving practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may be subject to back acceral Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. A. J. Cossor
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri a location or our device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any it call 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 CIN I at 807), adomig (21 OFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation only of probegin marketing your device as described in your Section 510(k) This icuer with anow you to begin maxioning of substantial equivalence of your device to a legally prematication: "The PDF intemsgssification 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 If you desire spoonte aarros 70- 9 1) 594-4648. Also, please note the regulation entifled, Connect the Office of Court to premarket notification" (21CFR Part 807.97). You may obtain of Small other general 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,
Arlene B. Boane
Bra
Di
Di
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): Ko40410
Device Name:_Accoson_greenlight 300 sphygmomanometer
Indications For Use:
The device is intended to be used by medical professionals only for the measurement of The device is intended to be used by moules. The device is intended to be used with attesped to a systolic and diastolic blood pressure valuer related which are manually attached to a
blood pressure cuffs supplied for use with the device Kerefleff overde biood pressure curis Supplied for ass with a manual method for detecting Koroticoline in exactly patient and inalidally innated, with a range of adult, pediatric and neonate sizes in exactly The device currs are available in a range of a and, or sale in the United States. the Same Way and Substantally oqurvation the Accoson greenlight 300 sphygmomanometer under 370(it) humr adult, pediatric and neonate patient groups.
Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ashley B. Brown
(Division Sign Off Division of Cardiovascular Devices
510(k) Number_
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