(91 days)
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Not Found
No
There is no mention of AI, ML, or related technologies in the provided text. The description focuses on the intended use and basic device characteristics.
No
The device is described as an "adjunct to patient assessment in continuous monitoring of respiratory rate" which implies it provides diagnostic or monitoring information, not therapy.
Yes
Androflo™ is intended for use as an "adjunct to patient assessment," which implies it provides information used to diagnose or manage a condition (monitoring respiratory rate). This aligns with the definition of a diagnostic device, which is used to identify or monitor medical conditions.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. Without this information, it's impossible to ascertain if the device includes any hardware components or relies on specific hardware for its function.
Based on the provided information, the Androflo™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Androflo™ is for "continuous monitoring of respiratory rate (breathing frequency)" as an "adjunct to patient assessment." This involves monitoring a physiological parameter directly from the patient, not analyzing a sample (like blood, urine, or tissue) outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information about a disease state, condition, or predisposition based on sample analysis.
IVDs are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. Androflo™'s function of monitoring respiratory rate falls under the category of physiological monitoring devices.
N/A
Intended Use / Indications for Use
"Androflo™ is intended for use as an adjunct to patient assessment in continuous monitoring of respiratory rate (breathing frequency). Androflo™ is indicated for clinical use in adult patients under the supervision of qualified health care professionals trained in the use of the equipment. Androflo™ is not intended for home use or for use as an apnea monitor."
Product codes
BZQ
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
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Indicated Patient Age Range
adult patients
Intended User / Care Setting
qualified health care professionals / clinical use
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.
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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).
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§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing segments, representing health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The logo is presented in black and white.
SEP 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George Papagiannis Andromed, Incorporated 4610 Chemin Du Bois-Franc Saint Laurent, Quebec CANADA H4S 1A7
Re: K051779
Trade/Device Name: ANDROFLOW-RESPIRATORY RATE MONITOR Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing frequency monitor Regulatory Class: II Product Code: BZQ Dated: September 14, 2005 Received: September 15, 2005
Dear Mr. Papagiannis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalcut (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.
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 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.
1
Page 2 - Mr. Papagiannis
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); 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. production will allow you to begin marketing your device as described in your Section 510(k) I mo lotet 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 Compliance at (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Segtie Y. Michuions
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment A
Indications for Use Statement
510(k) Number:
Androflo™ Respiratory Rate Monitor Device Name:
Indications for Use:
"Androflo™ is intended for use as an adjunct to patient assessment in continuous monitoring of respiratory rate (breathing frequency).
Androflo™ is indicated for clinical use in adult patients under the supervision of qualified health care professionals trained in the use of the equipment.
Androflo™ is not intended for home use or for use as an apnea monitor."
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cum Juleon
(Division Sign-Division of Der 20 Hospital Infection Control
510(k) Number:
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________