(83 days)
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No
The provided text describes a fluid infuser and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is intended to treat specific medical conditions (clinical shock, hypotension, and hypoperfusion states) by delivering resuscitative fluids, which fits the definition of a therapeutic device.
No
The device, an ''ID Power Infuser™ Model M100B'', is described as supporting intravenous fluid resuscitation therapy and delivering crystalloid and colloid resuscitative fluids. Its intended use does not involve diagnosing conditions, but rather administering treatment.
No
The intended use describes a device that delivers intravenous fluids, which inherently requires hardware (a pump, tubing, etc.) to perform this function. The lack of a device description doesn't negate the physical nature of fluid delivery.
Based on the provided information, the ID Power Infuser™ Model M100B is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for delivering intravenous fluids to patients to treat shock and related conditions. This is a therapeutic intervention performed on the patient, not a diagnostic test performed on a sample taken from the patient.
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The ID Power Infuser does not perform any such analysis on patient specimens.
Therefore, the ID Power Infuser™ Model M100B is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / Indications for Use
The ID Power Infuser™ Model M100B is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with clinical shock, hypotension, and hypoperfusion states as a result of hemorrhagic blood loss, occult hemorrhage, neurogenic shock, and septic shock.
The device is intended to be used by medical, paramedical, and EMT personnel in the field, and in pre-hospital and hospital environments.
The ID Power Infuser™ Model M100B is intended to deliver crystalloid and colloid resuscitative fluids only. It is NOT intended to support the infusion of blood or blood products, nor is it intended for the delivery of any pharmaceutical or other medications.
Product codes
FRN
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
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Intended User / Care Setting
medical, paramedical, and EMT personnel in the field, and in pre-hospital and hospital environments.
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract human profiles facing to the right, with flowing lines beneath them that could represent water or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP | 8 1999
Infusion Dynamics, Incorporated C/O Mr. Thomas Becze President Princeton Regulatory Associates New Jersey Office 116 Village Boulevard, Suite 200 Princeton, New Jersey 08540-5799
Re: K992044 Infusion Dynamics Power Infuser Model M100B Trade Name: Requlatory Class: II Product Code: FRN Dated: June 10, 1999 Received: June 17, 1999
Dear Mr. Becze:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Becze
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indications For Use Statement
19992044 510(k) Number if known): TO BE ASSIGNED
Device Name: ID Power Infuser™ Model M100B
Indications For Use:
The ID Power Infuser™ Model M100B is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with clinical shock, hypotension, and hypoperfusion states as a result of hemorrhagic blood loss, occult hemorrhage, neurogenic shock, and septic shock.
The device is intended to be used by medical, paramedical, and EMT personnel in the field, and in pre-hospital and hospital environments.
The ID Power Infuser™ Model M100B is intended to deliver crystalloid and colloid resuscitative fluids only. It is NOT intended to support the infusion of blood or blood products, nor is it intended for the delivery of any pharmaceutical or other medications.
Talinza Creciente
ion Sion-Off of Dental, Infection Control, and Ge, cral Hospital Devic
510(k) Number K972044/
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)