(25 days)
- The Paragon Infusion System with Bolus is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, subcutaneous, intramuscular and epidural.
- The Paragon Infusion System with Bolus is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Paragon Infusion System with Bolus. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market prior to May 28, 1976, or reclassified. This substantial equivalence determination is based on a review of the company's premarket notification, which would have included data and information to support this claim. However, the details of that data and the specific performance criteria used for testing are not included in this FDA clearance letter.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: This information is not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method for the test set: This information is not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an infusion system, not an AI-assisted diagnostic tool, so an MRMC study is not applicable and is not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This device is an infusion system, not an algorithm.
- The type of ground truth used: This information is not present.
- The sample size for the training set: This information is not present.
- How the ground truth for the training set was established: This information is not present.
The document primarily focuses on the regulatory clearance process, outlining the device's classification, product code, and indications for use. It also provides contact information for further inquiries regarding FDA regulations.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle's head is facing left, and its beak is slightly open. The text "DEPARTMENT OF HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2002
Mr. Shane Noehre Director, Regulatory Affairs I-Flow Corporation 20202 Windrow Drive Lake Forest, California 92630
Re: K023827
Trade/Device Name: Paragon Infusion System with Bolus Regulation Number: 880.5725 . Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: November 14, 2002 Received: November 18, 2002
Dear Mr. Noehre:
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 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 vour 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.
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Page 2 - Mr. Noehre
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.
This letter will allow you to begin 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 Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Verl 3 - 4/24/96
Applicant:
Flow Corporation
510(k) Number (if known):
Device Name:
Paragon Infusion System with Bolus
Indications For Use:
-
- The Paragon Infusion System with Bolus is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, subcutaneous, intramuscular and epidural.
-
- The Paragon Infusion System with Bolus is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.
Patricia Ciuente
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K023827
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 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).