(77 days)
No
The description focuses on the mechanical operation of a peristaltic pump and does not mention any AI or ML components or functionalities.
No
The device, an "Infiltration Pump," is indicated for "lipoplasty general tumescent infiltration to include body contouring." While it performs a function in a medical procedure, its primary role is to pump fluid, not to treat or cure a disease or condition itself. Therapeutic devices typically directly provide a medical benefit or treatment.
No
The device, an Infiltration Pump, is described as being used for "lipoplasty general tumescent infiltration to include body contouring" to move fluid. There is no mention of it being used to collect or analyze data for diagnosis.
No
The device description explicitly details mechanical components like a multiple roller pump and a mechanical tubing clamp, 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 is "lipoplasty general tumescent infiltration to include body contouring." This describes a procedure performed directly on a patient's body for therapeutic or cosmetic purposes.
- Device Description: The device description details a pump that moves fluid from an IV bag to an infiltration site. This is consistent with delivering fluids into the body, not analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver fluid into the body, which is not the purpose of an IVD.
N/A
Intended Use / Indications for Use
The Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The Infiltration Pump is not intended for intravenous use.
Product codes
FRM, FRN
Device Description
The principles of operation and technology incorporated in the Infiltration Pump are equivalent to peristaltic infiltration/irrigation devices, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller.
The Infiltration Pump uses a multiple roller pump and a mechanical tubing clamp to squeeze and hold tubing and assist in moving fluid from an IV fluid bag to the infiltration site. As with all peristaltic pumps, the Infiltration Pump contacts only the tubing and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
PSI-TEC Peristaltic Infiltration Pump, Klein Surgical Infiltration Pump, Model KIP-II
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
APR 2 7 2005
510(k) Summary of Safety and Effectiveness
| Submitted by: | B. Leon Wilson
Quality Manager
Carolina Medical, Inc.
157 Industrial Drive
King, NC 27021 USA |
|----------------------|-----------------------------------------------------------------------------------------------------------|
| | Telephone #: (336) 983-5132
Facsimile #: (336) 983-8992 |
| Date Prepared: | January 28, 2005 |
| Trade Name: | Infiltration Pump |
| Common Name: | Infiltration Pump |
| Classification Name: | Infusion Pump
21 CFR 880.5725 (2004), Product Code FRM |
Establishment Registration Number:
Carolina Medical, Inc. is located at 157 Industrial Drive. We are registered with the Food and Drug Administration as Establishment Number 1017913.
Indications for Use:
The Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The Infiltration Pump is not intended for intravenous use.
Device Description:
The principles of operation and technology incorporated in the Infiltration Pump are equivalent to peristaltic infiltration/irrigation devices, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller.
The Infiltration Pump uses a multiple roller pump and a mechanical tubing clamp to squeeze and hold tubing and assist in moving fluid from an IV fluid bag to the infiltration site. As with all peristaltic pumps, the Infiltration Pump contacts only the tubing and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.
1
Substantial Equivalence Claim:
Substantial Equivaloroo Claimic and technology incorporated in the Carolina The principles of operation and technology infiltration/irrigation devices with Medical innitration i amp ad with a roller, which the FDA has found to be substantially equivalent to devices as listed below:
| Product: | PSI-TEC Peristaltic |
|---|---|
| Infiltration Pump | |
| Manufacturer: | Byron Medical, Inc. |
| 510(k) Number: | K040149 |
| Substantial Equivalence Date: | June 3, 2004 |
| Substantial Equivalence Letter: | See Appendix A |
Product:
Manufacturer: 510(k) Number: Substantial Equivalence Date: Substantial Equivalence Letter: Klein Surgical Infiltration Pump, Model KIP-II HK Surgical, Inc. K031432 August 7, 2003 See Appendix A
-end of summary-
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2005
Mr. Leon Wilson Quality Manager California Medical, Incorporated 157 Industrial Drive P.O. Box 307 King, North Carolina 27021-0307
Re: K050324
Trade/Device Name: Infiltration Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: February 7, 2005 Received: February 9, 2005
Dear Mr. Wilson:
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 mureations for ass barror to May 28, 1976, the enactment date of the Medical Device micrate conmiseres press that have been reclassified in accordance with the provisions of Amendinens, or to do roug, and Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 000; Drug, and one may, therefore, market the device, subject to the general approvin application (the Act. The general controls provisions of the Act include confirements 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 If your device is olasbirou (soo as additional controls. Existing major regulations affecting (1 MA), it may of subject to tack and of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be fourther announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Wilson
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 moan that I Dr mas made statutes and regulations administered by other Federal agencies. of the Act of uny 1 oderal bands and survey and submitted to: registration r ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice alle nisting (21 et rears of ); equality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in als quadis ion 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) This letter whil anon yourse organ.
The Forest notification. The FDA finding of substantial equivalence of your device to a premarket notification. - I sults 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), rf you deente spleeting af Compliance at (240) 276-0115. 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 may obtain 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/industry/support/index.html.
Sincerely vours,
Smitte Michiend ms.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):K050324
Device Name:
Infiltration Pump
Indications for Use:
The Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The Infiltration Pump is not intended for intravenous use.
2 Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
N/A Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Antin Vm
( Division Sign-Off) of vision of Anesthesiology, General Hospital, Intection Control, Dental Devices
Page 1 of 1
510(k) Number: k$\phi$$\Psi$0324