(96 days)
The OutBound DIP is indicated for intravenous, intra-arterial, subcutaneous, and The OutBound DIP is indicated for inturvenede, may will with the world in the successions of the controlled infusion rates. The OutBound pump is also intended to provide continuous infusion of a local The Outbound pump is also intracperative site for postoperative pain management.
Not Found
I am sorry, but the provided text from the FDA 510(k) letter for the "Outbound Disposable Syringe Infuser" does not contain the specific information you are requesting about acceptance criteria and the study that proves the device meets those criteria.
The 510(k) letter primarily addresses the substantial equivalence determination for regulatory clearance to market the device. It focuses on:
- Device Identification: K982256, Outbound Disposable Syringe Infuser/Outbound II Disposable Infusion Pump.
- General Controls: Acknowledging compliance with general controls like annual registration, good manufacturing practice, labeling, etc.
- Indications for Use: Stating that the device is "indicated for intravenous, intra-arterial, subcutaneous, and epidural infusions at controlled infusion rates" and "for continuous infusion of a local anesthetic at an intraoperative site for postoperative pain management."
The letter does not include details regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for test sets.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of detailed information would typically be found in the 510(k) submission document itself, which is a much larger and more comprehensive document than the clearance letter. The clearance letter confirms that the FDA reviewed those documents and made a determination, but it does not reproduce the detailed study results or acceptance criteria within its content.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1299 MAR
Ms. Suzanne Dennis Director, Regulatory Affairs/Quality Assurance McKinley, Incorporated 4080 Youngfield Street Wheat Ridge, Colorado 80033 USA
Re : K982256 Outbound Disposable Syringe Infuser/ Trade Name: Outbound 2 Disposable Regulatory Class: II Product Code: мев Dated: August 14, 1998 Received: August 17, 1998
Dear Ms. Dennis:
This letter corrects our substantially equivalent letter of August 14, 1998, regarding the Indications for Use (enclosed).
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 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). 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug
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Page 2 - Ms. Dennis
Administration (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 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 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsmamain/html".
Sincerely yours
Timothy A. Ulatowski
Divisibn of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use 510(k) Number (if known): K982256 Device Name: QutBound/OutBound II Disposable_Infusion Pump Indications for Use: The OutBound DIP is indicated for intravenous, intra-arterial, subcutaneous, and The OutBound DIP is indicated for inturvenede, may will with the world in the successions of the controlled infusion rates. The OutBound pump is also intended to provide continuous infusion of a local The Outbound pump is also intracperative site for postoperative pain management.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IE NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices FAANS & LILLE In Car & Car & 2 :
§ 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).