(132 days)
No
The description focuses on the mechanical operation of a peristaltic pump and does not mention any AI or ML components.
No
Explanation: The device is an infiltration pump used for moving fluid to a site for lipoplasty and body contouring, which are medical procedures. However, the device itself is not providing a direct therapeutic effect on a disease or condition; it is a tool used within a procedure. Therapeutic devices are typically defined as those that treat, mitigate, or prevent a disease or condition. This device's function is to facilitate the delivery of fluid during a procedure, not to be a therapy in itself.
No
The device, "PSI TEC III Peristaltic Infiltration Pump," is explicitly described as a pump for "lipoplasty general tumescent infiltration." Its function is to move fluid to an infiltration site, which is a therapeutic or procedural action, not a diagnostic one. There is no mention of it being used to gather information about a patient's health status or condition.
No
The device description clearly describes a physical pump with mechanical components (single-cam roller, grooved channel) that interacts with tubing to move fluid. This is a hardware device, not software-only.
Based on the provided information, the PSI TEC III Peristaltic Infiltration Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "lipoplasty general tumescent infiltration to include body contouring." This describes a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The device description explains how the pump moves fluid into the patient's body for infiltration. It does not describe any analysis or testing of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The PSI TEC III Peristaltic Infiltration Pump is a medical device used for delivering fluid into the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The PSI TEC III Peristaltic Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The PSI TEC III Peristaltic Infiltration Pump is not intended for intravenous use.
Product codes
FRN
Device Description
The principles of operation and technology incorporated in the PT-PINF III pump are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller.
The PT-PINF III uses a single-cam roller and a grooved channel to squeeze and hold tubing and assist in moving fluid from an I.V. fluid bag to the infiltration site. As with all peristaltic pumps, the PT-PINF III contacts only the tubing/tractor 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)
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
Byron Medical Confidential - TRADE SECRET
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92
Submitted by:
Regina S. Harris Quality & Regulatory Affairs Manager Byron Medical, Inc. 602 W. Rillito St Tucson, AZ 85705
Telephone #: (520) 573-0857 Facsimile #: (520) 746-1757
Date Prepared:
December 05, 2003
Establishment Registration Number:
Byron Medical is located at 602 W Rillito St. We are registered with the Food and Drug Administration as Establishment Number 2025576.
| Classification Name: | Irrigating Syringe
21 CFR § 880.6960 (1997) |
|----------------------|-----------------------------------------------------------------------------|
| | Infusion Pump
21 CFR § 880.5725 (1997) |
| | Jet Lavage
21 CFR § 880.5475 (1997) |
| Common/Usual Name: | Syringe Irrigation/Infiltration Pump |
| Proprietary Name: | Psi-Tec Syringe Infusion Pump |
| Indication for Use: | Lipoplasty general tumescent to include liposuction and
body contouring. |
PROPRIETARY & CONFIDENTIAL
This document is the property of Byron Medical, Inc. in Tucson, AZ. This document may not without witten consent of executive or designated management representative.
1
510(k) SUMMARY (cont.)
Device Description:
The principles of operation and technology incorporated in the PT-PINF III pump are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller
The PT-PINF III uses a single-cam roller and a grooved channel to squeeze and hold tubing and assist in moving fluid from an I.V. fluid bag to the infiltration site. As with all peristaltic pumps, the PT-PINF III contacts only the tubing/tractor and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.
Substantial Equivalence Claim:
The principles of operation and technology incorporated in the Byron Medical PT-PINF III Pump and accessories are similar to other irrigation devices with the function to deliver fluid with a roller, which the FDA has founded to be substantially equivalent to pre-amendment devices as outlined below:
| Product: | Bi-Phasic Infiltrator |
|---|---|
| Manufacturer: | Reliance Medical |
| 510(k) Number: | K012044 |
| Substantial Equivalence Date: | August 28th, 2001 |
| Substantial Equivalence Letter: | Exhibit O.I |
| Product: | Autofuse V Infiltration Pump |
| Manufacturer: | Randolph- Austin |
| 510(k) Number: | K980394 |
| Substantial Equivalence Date: | March 25th, 1998 |
| Substantial Equivalence Letter: | Exhibit O.II |
| Product: | Wells-Johnson Infusion System |
| Manufacturer: | Wells-Johnson |
| 510(k) Number: | K991437 |
| Substantial Equivalence Date: | August 30th, 1999 |
| Substantial Equivalence Letter: | Exhibit O.III |
-end of summary-
PROPRIETARY & CONFIDENTIAL
This document is the property of Byron Medical, Inc. in Tucson, AZ. This document may rot be oppied in whole or part without written consent of executive or designated management representative.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three stripes extending from its wing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
UN - 3 2004
Ms. Regina S. Harris Regulatory Affairs Manager Byron Medical, Incorporated 602 W. Rillito St. Tucson, Arizona 85705
Re: K040149
Ro40117
Trade/Device Name: The PSI TEC III Peristaltic Infiltration Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: May 3, 2004 Received: May 5, 2004
Dear Ms. Harris:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your becatermined 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to do roug, and Cosmetic Act (Act) that do not require approval of a premarket the roderal 1 004, Drag, and Coommay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the Fist - Insting 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 II your device is classified (000 a001 additional controls. Existing major regulations affecting (FMA), it may be subject to tass ade of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in firsher announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Harris
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled of a basetan and many of the with other requirements mean that IDA has made a decembers and regulations administered by other Federal agencies. of the Act of ally rederal states and regarments, including, but not limited to: registration You must comply with an the Fee s required to reart 801); good manufacturing practice and listing (21 CFR Part 807), labeling (21 cm (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); a requirements as set form in the quality Systems (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 will anow you to obgin mained of your device of your device to a premits in the results in the PDF millions 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), IT you desire specific at 7.0 2019 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Carl
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):
Device Name:
The PSI TEC III Peristaltic Infiltration Pump
Indications For Use:
The PSI TEC III Peristaltic Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The PSI TEC III Peristaltic Infiltration Pump is not intended for intravenous use.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
N/A Over-The-Counter Use _ (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cathy Turner
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page 1 of 1
510(k) Number Legu al 49