(190 days)
Not Found
Not Found
No
The summary describes a peristaltic pump for fluid administration and irrigation, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as an irrigation or infusion pump for administering sterile solutions and is specifically intended for wound irrigation. While it introduces fluids into a wound site, this action in itself does not qualify it as a therapeutic device. It is primarily a delivery system for fluids.
No
The device is described as a pump for administering sterile solutions for wound irrigation, which is a therapeutic rather than a diagnostic function.
No
The device description is not found, but the intended use clearly describes a physical pump ("peristaltic section") for fluid administration, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "administration of sterile solutions" and "rapid introduction of sterile fluids into the wound site for wound irrigation." This describes a device used for delivering fluids into the body or a wound, not for testing samples from the body to diagnose a condition.
- Lack of IVD Characteristics: 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.
Therefore, the K.M.I. Irrigation or Infusion pump "K" Pump is a medical device used for fluid delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The K.M.I. Irrigation or Infusion pump "K" Pump is intended for the administration of sterile solutions drawn from containers using standard sterile administration sets with a 3/8 diameter silicone peristaltic section. The "K" Pump is intended for the rapid introduction of sterile fluids into the wound site for wound irrigation. The "K" pump may also be used with K.M.I.'s DIK Irrigation System.
Product codes
FRN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 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 top half of the circle. Inside the circle is an abstract image of an eagle with three wing-like shapes and two wave-like shapes below.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1999
Mr. Alwin H. Kolster K.M.I. Kolster Methods, Inc. 708 N. Valley Street, Unit N Anaheim, CA 92801
Re : K991203 Trade Name: Irrigation or Infusion Pump "K" Pump Regulatory Class: II Product Code: FRN Dated: August 11, 1999 Received: August 19, 1999
Dear Mr. Kolster:
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, 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 for Medical Devices: a General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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
1
Page 2 - Mr. Kolster
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 regulations.
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. Also, please note the regulation 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Susx Junge
A
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/10 description: The image shows a diagram of a medical instrument. The instrument has a cylindrical body with the letters "K.M.I." printed on it. The instrument has a long, thin tube extending from one end. The other end has a black piece attached to it.
KOLSTER METHODS, II 708 N. VALLEY ST UNI
Anaheim 4-9-99
14991203
Section 4
Intended use
The K.M.I. Irrigation or Infusion pump "K" Pump is intended for the administration of sterile solutions drawn from containers using standard sterile administration sets with a 3/8 diameter silicone peristaltic section. The "K" Pump is intended for the rapid introduction of sterile fluids into the wound site for wound irrigation. The "K" pump may also be used with K.M.I.'s DIK Irrigation System.
$\geq$ Prescription Use
Patricia Cassanete
Division Sign-Off) Onliston of Dental, Infection Control, a >> Ganeral Hospital De State Number .