(21 days)
The Medical Solutions, Inc.'s Reusable Pressure Infusor is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of fluid.
a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of fluid.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a "MSI Pressure Infusor" device, dated October 29, 1997. It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations.
The document does not include any details about:
- Acceptance criteria for performance.
- A study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Types of ground truth used.
- How ground truth for a training set was established.
This type of information is typically found in a detailed device submission, clinical study report, or a summary of safety and effectiveness, which are not part of this clearance letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 29 1997
Mr. E.J. Smith ·Smith Associates P.O. Box 4343 Crofton, Maryland 21114-4341
Re: K973843 MSI Pressure Infusor Trade Name: Regulatory Class: I Product Code: KZD Dated: October 8, 1997 Received: October 8, 1997 --
Dear Mr. Smith:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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. ಗಳ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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
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through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), 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 requlation 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.qov/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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510(k) Number (if known):K973843
Device Name: MPI Pressure Infusor
Classification Panel: 80KZD General Hospital
Indications for Use:
The Medical Solutions, Inc.'s Reusable Pressure Infusor is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of fluid.
Caution: Federal (U.S.A) law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | or | Over-the-Counter Use |
|---|---|---|---|
| ------------------ | --------------------------------------------------- | ---- | ---------------------- |
(Division Sign-Off) Patricia Crucente
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K973843 |
|---|---|
| --------------- | --------- |
§ 880.5420 Pressure infusor for an I.V. bag.
(a)
Identification. A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.