The Pain Control Infusion Pump is a single use device intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative management of pain following surgery. Medication is intended to be delivered percutaneously through a catheter.

The Pain Control Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.

The Pain Control Infusion Pump is not intended for epidural, subcutaneous or vascular drug delivery. It is not intended for the delivery of blood, blood products or TPN.

Device Description

The proposed device, the Sgarlato Laboratories Pain Control Infusion Pump, claims substantial equivalence to a currently marketed device, the Burron Ambulatory Drug Delivery System (K896422). The Pain Control Infusion Pump is identical in design to the Burron device and will be manufactured for Sgarlato Laboratories by Burron, a division of B. Braun, Inc. The Pain Control Infusion Pump is used for the same intended purpose as the Burron Ambulatory Drug Delivery System. There is no change in design, materials, method of manufacture, or intended use and only minor name changes in the labeling from the Burron device.

AI/ML Overview

This document describes a 510(k) submission for the Pain Control Infusion Pump (K990101). Based on the provided text, the device is claiming substantial equivalence to a predicate device, the Burron Ambulatory Drug Delivery System (K896422).

The key aspect of this submission is that the Pain Control Infusion Pump is identical in design to the predicate device and will be manufactured by the same company (Burron, a division of B. Braun, Inc.). There are no changes in design, materials, manufacturing methods, or intended use; only minor name changes in the labeling.

Therefore, the acceptance criteria and proof of meeting those criteria for this specific submission are based on the demonstration of substantial equivalence to the predicate device, rather than a new performance study of the device itself.

Given this context, the request for a table of acceptance criteria and reported device performance through a study is not directly applicable in the way it might be for a novel device or an AI/ML powered device. This submission relies on the established performance and safety of the predicate device.

Here's how to address the questions based on the provided information:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for the Pain Control Infusion Pump (K990101)

This 510(k) submission for the Pain Control Infusion Pump (K990101) relies on the demonstration of substantial equivalence to a legally marketed predicate device, the Burron Ambulatory Drug Delivery System (K896422). The submission explicitly states that the proposed device is identical in design, materials, method of manufacture, and intended use to the predicate device. Therefore, the "acceptance criteria" revolve around proving this substantial equivalence, rather than conducting new performance studies on the Pain Control Infusion Pump itself.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (for Substantial Equivalence)	Reported Device Performance / Evidence
Intended Use: Device performs the same function as the predicate device.	"The Pain Control Infusion Pump is used for the same intended purpose as the Burron Ambulatory Drug Delivery System." (Section 19)
Technological Characteristics: Device has the same design, materials, and manufacturing process as the predicate device.	"The Pain Control Infusion Pump is identical in design to the Burron device and will be manufactured for Sgarlato Laboratories by Burron, a division of B. Braun, Inc." (Section 19) "There is no change in design, materials, method of manufacture..." (Section 19)
Labeling Equivalence: Only minor name changes from predicate device labeling, with no new safety or effectiveness concerns.	"...only minor name changes in the labeling from the Burron device." (Section 19)
Safety and Effectiveness: No new questions of safety or effectiveness are raised.	Implied by the identical nature to a legally marketed predicate and the absence of any design or material changes. (Section 19)

2. Sample size used for the test set and the data provenance

Not Applicable (N/A) for this 510(k) submission.
Since the device is identical to a predicate, no new "test set" or performance data specific to the Pain Control Infusion Pump were required or submitted. The substantial equivalence relies on the established safety and effectiveness of the legally marketed predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable (N/A).
No new clinical studies or "test set" requiring expert ground truth establishment were conducted for this substantial equivalence claim.

4. Adjudication method for the test set

Not Applicable (N/A).
No test set requiring adjudication was used.

5. 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 (N/A).
This device is an infusion pump, not an AI/ML diagnostic or image analysis device. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable (N/A).
This device is an infusion pump, not an algorithm, and does not operate in a standalone algorithmic capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable (N/A), in the context of a new performance study.
The "ground truth" for this submission is the pre-existing regulatory approval and established safety and effectiveness of the identical predicate device, the Burron Ambulatory Drug Delivery System (K896422), which served as the basis for substantial equivalence.

8. The sample size for the training set

Not Applicable (N/A).
This device is an infusion pump and does not involve AI/ML or a "training set" in the context of device performance evaluation.

9. How the ground truth for the training set was established

Not Applicable (N/A).
As there is no training set, this question is not relevant.

Summary

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3/19/99

19. 510(k) Summary

510(k) SUMMARY - Safety and Effectiveness

K990101

Pain Control Infusion Pump

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 1999

Thomas Sgarlato, DPM Sgarlato Laboratories, Incorporated 250 Almendra Avenue Los Gatos, California 95030

Re : K990101 Pain Control Infusion Pump Trade Name: Requlatory Class: II Product Code: FRN February 8, 1999 Dated: January 12, 1999 Received:

Dear Mr. Sgarlato

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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturinq Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq 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 obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Sgarlato

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 requlation (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 requlation entitled, "Misbranding by reference to ene regaration Choroson" (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,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use 20.

INDICATIONS FOR USE

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________ Pain Control Infusion Pump ...................................................................................................................................................

Indications for Use:

The Pain Control Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.

The Pain Control Infusion Pump is not intended for epidural, subcutaneous or vascular drug delivery. It is not intended for the delivery of blood, blood products or TPN.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Paloux Cassente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

2 99101 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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).