(93 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on manual control by a healthcare professional.
No
The device is used to cause a flow of fluid from an IV bag into a patient, but it explicitly states "The Klein Pump is not intended to be used as an IV infusion pump." An IV infusion pump would typically be considered a therapeutic device because it delivers medication or fluids for treatment. The description for this device, an "Infiltration Pump," and its specific denial of being an "IV infusion pump" suggests it may be for other purposes in a medical setting that are not directly therapeutic in the sense of delivering treatment, such as simply transferring fluids for irrigation or other non-therapeutic procedures, though it does not specify what those uses might be. Without further context, its primary function as described (causing fluid flow) does not inherently qualify it as therapeutic, especially given the exclusion.
No
The device description states it is an "Infiltration Pump" used to "cause a flow of fluid from an IV bag into patient." There is no mention of it being used to diagnose a medical condition.
No
The device is described as an "Infiltration Pump," which is a hardware device used to control fluid flow. The summary does not mention any software component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "cause a flow of fluid from an IV bag into patient". This describes a device that interacts directly with the patient's body for therapeutic or diagnostic purposes in vivo (within the living organism).
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used in vitro (outside the living organism).
The description of the Infiltration Pump's function does not align with the definition of an IVD. It's a device for delivering fluids into the patient, not for testing samples from the patient.
N/A
Intended Use / Indications for Use
This Infiltration Pump is used to cause a flow of fluid from an IV bag into patient in a manner controlled manually by a health care professional. The Klein Pump is not intended to be used as an IV infusion pump.
Product codes
FRN
Device Description
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Mentions image processing
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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
health care professional
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized eagle symbol, which is composed of three curved lines representing the wings and body of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2003
Ms. Sally M. Bowdon General Manager HK Surgical, Incorporated 1271 Puerta Del Sol San Clemente, California 92673
Re: K031432
Trade/Device Name: Klein Surgical Infiltration Pump, Model KIP-II Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: May 5, 2003 Received: May 6, 2003
Dear Ms. Bowdon:
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 your 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.
1
Page 2 -- Ms. Bowdon
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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Ruances
Susan Runner, DDDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510K number:
Device Name: Klein Surgical Infiltration Pump, Model KIP-02
Indications For Use. This Infiltration Pump is used to cause a flow of fluid from an IV bag into patient in a manner controlled manually by a health care professional. The Klein Pump is not intended to be used as an IV infusion pump.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Patrícia Cucente
(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K031432