(96 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is described as "intravenous, intra-arterial, subcutaneous, and controlled infusion rates" and also "intended to provide continuous infusion of a local The Outbound pump is also intracperative site for postoperative pain management," which indicates it is used for medical treatment.
No
The device is described as a pump for controlled infusion rates and continuous infusion for pain management, which are therapeutic functions, not diagnostic ones.
No
The device description is not found, but the intended use clearly describes a "pump" which is a hardware device for controlled infusion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a pump for controlled infusion of substances into the body (intravenous, intra-arterial, subcutaneous, intracperative site). This is a therapeutic or drug delivery function, not a diagnostic function performed in vitro (outside the body).
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays
The device's function is to deliver substances into the body, which is the opposite of an in vitro diagnostic that analyzes substances from the body.
N/A
Intended Use / Indications for Use
The OutBound DIP is indicated for intravenous, intra-arterial, subcutaneous, and intrathecal infusions of medication in a variety of intermittent and continuous flow applications. It is indicated for therapies not requiring an electronic infusion pump for operation. The OutBound DIP will provide controlled infusion rates. The OutBound pump is also intended to provide continuous infusion of a local anesthetic at the intraoperative site for postoperative pain management.
Product codes
MEB
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, resembling a symbol or logo.
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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FAX NO. :
| FROM : | |
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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)
| Prescription Use | ✓ | Over-The-Counter Use |
|---|---|---|
| ------------------ | --- | ---------------------- |
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices FAANS & LILLE In Car & Car & 2 :