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.

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.

AI/ML Overview

This submission (K040149) is a 510(k) premarket notification for a medical device called "The PSI TEC III Peristaltic Infiltration Pump." A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics for the new device as would be seen for novel technologies or higher-risk devices.

Based on the provided document, there is no information available about acceptance criteria, a specific study proving the device meets those criteria, or most of the requested details about such a study.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device...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..." This confirms that the approval was based on substantial equivalence, not on a standalone performance study with defined acceptance criteria for the new device K040149 itself.

Here's an attempt to answer the questions based on the available text, highlighting what is not present:

Table of acceptance criteria and the reported device performance
- Not provided. The document does not specify performance acceptance criteria for the new device (PSI TEC III Peristaltic Infiltration Pump) or report specific performance metrics against such criteria. The submission is framed around substantial equivalence to existing devices.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary. The approval is based on substantial equivalence to predicate devices, not on a performance study of the PSI TEC III itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an irrigation/infusion pump, not an AI-assisted diagnostic tool. No MRMC study would be relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a pump, not an algorithm. Standalone performance for a physical device would refer to its functional specifications (e.g., flow rate accuracy, pressure), but these are not detailed as specific performance study results in this summary. The substantial equivalence argument implicitly assumes its performance is comparable to predicates.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary.
The sample size for the training set
- Not applicable/Not provided. This information pertains to a type of performance study (often for AI/ML) that is not described for this device.
How the ground truth for the training set was established
- Not applicable/Not provided. This information pertains to a type of performance study (often for AI/ML) that is not described for this device.

Summary of available information related to equivalence:

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Predicate Devices for Substantial Equivalence Claim:

Product: Bi-Phasic Infiltrator
- Manufacturer: Reliance Medical
- 510(k) Number: K012044
- Substantial Equivalence Date: August 28th, 2001
Product: Autofuse V Infiltration Pump
- Manufacturer: Randolph-Austin
- 510(k) Number: K980394
- Substantial Equivalence Date: March 25th, 1998
Product: Wells-Johnson Infusion System
- Manufacturer: Wells-Johnson
- 510(k) Number: K991437
- Substantial Equivalence Date: August 30th, 1999

The substantial equivalence claim is based on the "principles of operation and technology incorporated" being similar to these predicates, specifically mentioning that the PT-PINF III uses a single-cam roller and a grooved channel to squeeze and hold tubing, similar to other peristaltic irrigation systems. It also mentions that, like all peristaltic pumps, it contacts only the tubing and not the fluid, thus maintaining sterility.

In conclusion, for this specific 510(k) submission, the device did not undergo a study to meet defined acceptance criteria in the way a novel diagnostic or therapeutic device might. Its approval was based on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices.

Summary

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K040149

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 Syringe21 CFR § 880.6960 (1997)
	Infusion Pump21 CFR § 880.5725 (1997)
	Jet Lavage21 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 andbody 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.

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510(k) SUMMARY (cont.)

Device Description:

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.

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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.

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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

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Indications for Use

510(k) Number (if known):

K040149

Device Name:

The PSI TEC III Peristaltic Infiltration Pump

Indications For 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

Regulation Number and Section

§ 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).