The Accufuser and Accufuser Plus systems are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into the intra-operative (soft tissue / body cavity) site. The Accufuser Plus is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include pain management for preoperative and postoperative and postoperative surgery.

The Accufuser and Accufuser Plus systems are also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.

The Accufuser/Accufuser Plus system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

Device Description

The Accufuser/Accufuser Plus system consists of a pump and an integrated administration set. The pump is a continuous silicone balloon type. The pump provides continuous fluid delivery with an attached, fixed rate administration set. The pumps are supplied as fixed flow rates. A silicone balloon is used as both the fluid reservoir of the device and the pressure (energy) source.

The Accufuser/Accufuser Plus pump and administration set are intended for single patient use.

The Accufuser Plus is the Accufuser with the addition of a Patient Medication Control Module (PCM). The PCM allows the patient to administer a bolus of a fixed volume with a fixed lockout (re-fill) time. The PCM in integrated into the administration set with a bolus button that allows the patient controlled administration of medication as needed.

The Standard Procedure Kit is substantially equivalent to the predicate devices. The kit includes various kit components such as catheter, needle, syringe, y adapter, dressing, tape, gauze and carry case.

AI/ML Overview

This is a 510(k) premarket notification for an elastomeric infusion pump. There is no information in this document about a study that used a test set, human readers or ground truth as this is not applicable for this kind of device. The document mostly focuses on the substantial equivalence to predicate devices and the device's specifications.

Here's the relevant information extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Parameter	Acceptance Criteria (from device specifications)	Reported Device Performance (from device specifications)
Accuracy
60 ml Reservoir	+/- 10% of nominal flow rate at 95% confidence interval	+/- 10% of nominal flow rate at 95% confidence interval
100 ml Reservoir	+/- 10% of nominal flow rate at 95% confidence interval	+/- 10% of nominal flow rate at 95% confidence interval
275 ml Reservoir	+/- 15% of nominal flow rate at 95% confidence interval	+/- 15% of nominal flow rate at 95% confidence interval
550 ml Reservoir	+/- 15% of nominal flow rate at 95% confidence interval	+/- 15% of nominal flow rate at 95% confidence interval
Operating Pressure	Not explicitly stated as acceptance criteria, but a characteristic of the device.	5 to 6 psi
System Residual Volume	< an explicitly stated value (implied "as low as possible")	< 3 ml (includes tubing and reservoir)
Operating Temperature	Calibrated to deliver at 32°C / 89.6°F. (Effect: Flow rate increases approximately 1% per 1°F / 0.56°C increase in temperature.)	The Accufuser and Accufuser Plus systems are calibrated to deliver solution at the labeled nominal flow rate when the temperature of the infusate in the flow restrictor (distal end) is 32° C / 89.6°F (normal skin temperature). Flow rate increases approximately 1% per 1°F / 0.56°C increase in temperature.
Fluid Viscosity	Calibrated using 5% Dextrose in Water (D5W). (Effect: Flow rate increases as fluid viscosity decreases.)	The Accufuser and Accufuser Plus systems are calibrated using 5% Dextrose in Water (D5W) as the infusate. Flow rate increases as fluid viscosity decreases. (E.g., Using sterile water as diluent will increase the flow rate by approximately 10%.)
Head Height	Calibrated with zero head height. (Effect: Increased head height will cause increased flow rate.)	The Accufuser and Accufuser Plus systems are calibrated with zero head height. Increased head height will cause increased flow rate. (E.g., +43 cm / +17" of head height will increase flow rate by approximately 12%.)
Material Conformance	Conformance with ISO 10993 Part 1 for fluid path materials.	All fluid path materials of the Accufuser/Accufuser Plus system are in conformance with ISO 10993 Part 1.
Sterilization	ETO sterilization (packaging suitable for it, and it's a validated method).	Packaging is suitable for ETO sterilization. ETO is the validated sterilization method.
Reservoir Volume Range	Not explicitly stated as acceptance criteria, but a characteristic of the device.	60 ml to 550 ml
Flow Rate Range	Not explicitly stated as acceptance criteria, but a characteristic of the device.	0.5 ml/hr to 10.0 ml/hr
Bolus Levels	Not explicitly stated as acceptance criteria, but a characteristic of the device.	0.5 ml, 1.0 ml and 2.0 ml
Lockout Times	Not explicitly stated as acceptance criteria, but a characteristic of the device.	6 minutes to 60 minutes and include increments of 6, 8, 15, 30 and 60 minutes.

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

This device is an elastomeric infusion pump. The provided document is a 510(k) summary for a submission in 2002. It does not describe a clinical study involving a "test set" of patient data in the context of AI/software performance.
The performance criteria are related to the physical and functional characteristics of the pump (e.g., flow rate accuracy, residual volume). The "study" referenced would involve laboratory testing and engineering verification, not clinical data sets.
Therefore, information on sample size for a "test set" or "data provenance" (country of origin, retrospective/prospective) as it relates to AI/software is not applicable and not present in this document.

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

Not applicable. This is not a study assessing AI performance or diagnostic accuracy based on expert interpretation of data. The ground truth for device performance (e.g., flow rate) would be established by validated measurement equipment and engineering standards.

4. Adjudication method for the test set:

Not applicable, as this is not a study involving human adjudication of results from a test set.

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. This document pertains to an elastomeric infusion pump, not an AI-assisted diagnostic or interpretive device.

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

Not applicable. This device is a physical medical device, an infusion pump, and does not involve standalone algorithm performance in the context of AI.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by validated engineering measurements and testing. For example, flow rate accuracy would be determined by precisely measuring the volume of fluid delivered over a specific time under controlled conditions, comparing it to the nominal (labeled) flow rate. Similarly, residual volume would be measured post-infusion. Calibration standards and metrology provide the "ground truth" for these physical properties.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a "training set." Device design and validation are based on engineering principles and testing.

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

Not applicable, as there is no "training set" for this type of device.

Summary

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K0J309f

Section D

Premarket Notification – 510(k) Summary of Safety and Effectiveness for Accufuser, Accufuser Plus and Standard Procedure Kit

DEC 0 9 2002

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Premarket Notification - 510(k) Summary of Safety and Effectiveness for Accufuser, Accufuser Plus and Standard Procedure Kit

September 17, 2002 Date Prepared:

Trade Name: Accufuser; Accufuser Plus; Standard Procedure Kit

Common Name: Elastomeric Infusion Pump Kit

Classification Name: Pump, Infusion, Elastomeric

Classification Panel: General Hospital and Personal Use Device

Device Classification Regulation Number: 880.5725, Class II

Panel: 80

Procode: MEB

Existing Device Cleared 510(k): K003915, Accufuser and Accufuser Plus

Predicate devices demonstrating substantial equivalence include the following.

K013928, Breg Corporation, Pain Care 3000 and 3200, and accessory Kit. .
K014091, Stryker Pain Pump and Accessory Kit. .
K020862, I-Flow, Infusion Pump and Administration Set. ●

Submitted by:

McKinley Infuser, LLC 631 Howard, #202 San Francisco, CA 94105 USA Phone: 415-543-2196 Contact for questions: John Chappell, RAC Establishment Registration Number: 3003468679 Owner/Operator Number: 9047569

This submission is intended to notify the Food and Drug Administration that McKinley Infuser, LLC intends to market a modification to an existing device (K003915) called the Accufuser/Accufuser Plus and Standard Procedure Kit. Modifications to the existing device include two new indications for use, expansion of the bolus delivery range, addition of two bolus lockout times, addition of one reservoir volume size through combining two reservoirs, addition of flow rates for bolus devices and addition of a standard procedure kit.

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The Accufuser/Accufuser Plus system and its predicate device (K020862) are intended for use as follows.

The Accufuser/Accufuser Plus system is suitable for use as an ambulatory device and is intended for use in the hospital. home environment or alternative care sites.

Description of the Accufuser System

The Accufuser/Accufuser Plus pump and administration set are intended for single patient use.

Device Specifications and Safety Functions

The Accufuser/Accufuser Plus system has fill volumes and flow rates substantially equivalent to the pumps of the named predicate devices.

The Accufuser/Accufuser pumps and the identified predicate device use either a glass orifice or PVC tubing to control the flow rate.

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The Accufuser/Accufuser Plus provides a fixed flow and is not subject to fluid runaway conditions similar to that of some electronic pumps.

All fluid path materials of the Accufuser/Accufuser Plus system are in conformance with ISO 10993 Part 1.

There are currently no approved performance standards established for elastomeric infusion pumps under Section 514 of the Food, Drug and Cosmetic Act.

Packaging is suitable for ETO sterilization.

ETO is the validated sterilization method.

Product Configuration:

o Reservoir volume range is from 60 ml to 550 ml.
Flow rate range is 0.5 ml/hr to 10.0 ml/hr. o
Bolus levels are 0.5 ml, 1.0 ml and 2.0 ml. o
o Lockout times range from 6 minutes to 60 minutes and include increments of 6, 8, 15, 30 and 60 minutes.

Materials:	PET-G, ABS, polypropylene, silicone, PVC, polycarbonate,cellulose acetate, PTFE, and acrylic. DEHP-Free.Plasticizer used is TOTM, Tri-Octyl Trimellitate. Latex-Free.
Filter:	1.2 Micron, air-eliminating, in-line filter

System Accuracy	Reservoir Volume	Accuracy
	60 ml	+/- 10% of nominal flow rate at 95% confidence interval
	100 ml	+/- 10% of nominal flow rate at 95% confidence interval
	275 ml	+/- 15% of nominal flow rate at 95% confidence interval
	550 ml	+/- 15% of nominal flow rate at 95% confidence interval
Operating Pressure	5 to 6 psi
System Residual Volume	< 3 ml (includes tubing and reservoir)
Operating Temperature:	The Accufuser and Accufuser Plus systems are calibrated to deliver solution at the labeled nominal

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	flow rate when the temperature of the infusate in theflow restrictor (distal end) is 32° C / 89.6°F (normalskin temperature). Flow rate increasesapproximately 1% per 1°F / 0.56°C increase intemperature.
Fluid Viscosity:	The Accufuser and Accufuser Plus systems are calibratedusing 5% Dextrose in Water (D5W) as the infusate. Flowrate increases as fluid viscosity decreases. (E.g., Usingsterile water as diluent will increase the flow rate byapproximately 10%.)
Head Height:	The Accufuser and Accufuser Plus systems are calibratedwith zero head height. Increased head height will causeincreased flow rate. (E.g., +43 cm / +17" of head heightwill increase flow rate by approximately 12%.)

Conclusion:

The Accufuser/Accufuser Plus and Standard Procedure Kit does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. The Accufuser/Accufuser Plus system and accessory Standard Procedure Kit is substantially equivalent to the named predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol features three stylized human profiles facing right, stacked one behind the other. The profiles are rendered in a thick, curved line, giving a sense of depth and unity.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 9 2002

Mr. John Chappell Regulatory Affairs McKinley Infuser, LLC 631 Howard Street, Suite 202 San Francisco, California 94105

Re: K023098

Trade/Device Name: Accufuser, Accufuser Plus, Standard Procedure Kit Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: September 17, 2002 Received: September 18, 2002

Dear Mr. Chappell:

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 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) that do not require approval of a premarket approval application (PMA). You mav, 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 (PMA), 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Chappell

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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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) 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), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page 1 of 1

Applicant: McKinley Infuser, LLC

510(k) Number (if known): _| (023099

Device Name: Accufuser, Accufuser Plus, Standard Procedure Kit

Indications for Use:

The Accufuser/Accufuser Plus system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Williain

(Optional Format 3-10-98)

Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. K933070

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).