The Beeline system is intended for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management. The Beeline system is indicated for intravenous, intra-arterial, enteral, subcutaneous, percutaneous and epidural infusion of medications or fluids requiring continuous and/or intermittent delivery at controlled infusion rates. The Beeline system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment, and alternative care sites.
The Beeline system is intended to provide 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. The Beeline system is also intended for patientcontrolled infusion using the integrated bolus device.
The Beeline system is intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

Device Description

The Beeline device consists of a spring-pressurized medication reservoir with a flowratecontrolling administration set. A spring applies force against a piston, pressurizing the medication. The administration set includes a flow restrictor component with controlled internal diameter and length. The flow rate at which medication is dispensed from the system is a function of the pressure applied to the medication and the dimensions of the flow restrictor component. The medication may be dispensed from the system continuously and/or intermittently.

The size of the reservoir and the amount of flow restriction are determined to yield a variety of product codes with differing infusion volumes and flow rates. The physician prescribes for a patient a flow rate and reservoir size based on the individual patient needs.

Administration sets may incorporate a bolus feature, which may be used alone or in conjunction with basal (continuous) or KVO (very low) flow. The bolus device consists of a dosage reservoir that is filled when activated manually. After the bolus device has been activated, the bolus volume is infused at a controlled flow rate. The bolus device is integrated into the administration set and allows patient-controlled administration of medication as needed.

A procedure kit option provides various components that facilitate setup and use of the Beeline system.

The Beeline system is intended for single patient use.

AI/ML Overview

The provided document is a 510(k) Summary for modifications to the McKinley Beeline System, an infusion pump. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics typically found for novel device approvals.

Therefore, the document does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria, as it's not a study report. It describes modifications to an existing device and argues for its substantial equivalence to previously cleared devices.

Here's a breakdown of why the requested information is not available in the provided text, and what is present:

Information NOT available in the document:

A table of acceptance criteria and the reported device performance: This document doesn't define explicit acceptance criteria for this specific submission. Instead, it relies on the predicate devices having already met such criteria. The "reported device performance" is not quantified in the way a clinical study report would present it (e.g., sensitivity, specificity, accuracy, etc., for a diagnostic device, or specific functional benchmarks for a therapeutic device).
Sample size used for the test set and the data provenance: No clinical testing or formal "test set" is described for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no test set or ground truth described in this submission.
Adjudication method for the test set: Not applicable.
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 infusion pump, not an AI-assisted diagnostic or therapeutic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable, as there is no mention of a "training set" in the context of device development or machine learning.
How the ground truth for the training set was established: Not applicable.

What the document does provide, related to its purpose:

Device Description: It describes the Beeline system as a "spring-pressurized medication reservoir with a flow-rate controlling administration set" that dispenses medication continuously and/or intermittently. It also mentions variations in reservoir size, flow rates, and the addition of a bolus feature.
Modifications: The submission is for modifications to an existing device, including "extension of the flow rate range, addition of medication reservoir volumes, addition of an indication for use, addition of bolus capability, and addition of intermittent flow capability."
Predicate Devices: It lists several predicate devices (McKinley Beeline system K032642, McKinley's Accufuser K033039, I-Flow Elastomeric Pump K040337, Baxter Colleague Volumetric Pump K010566, and SIMS Deltec CADD-Prizm Model 6101 K000842) to establish substantial equivalence.
Conclusion: The central argument is that "The modified Beeline system does not raise any new safety and efficacy concerns when compared to the original device that is already legally marketed. The Beeline system is substantially equivalent to the named predicate devices." This is the "proof" required for a 510(k) clearance – not a clinical trial proving specific performance against acceptance criteria, but a demonstration of equivalence to devices already proven safe and effective.
Indications for Use: These are detailed, outlining the intended applications for continuous and/or intermittent infusion of medications (antibiotics, chemotherapy, pain management, local anesthetics) in various settings and routes (IV, IA, enteral, subcutaneous, percutaneous, epidural), including patient-controlled bolus.

In summary, this document is a regulatory submission for device modification based on substantial equivalence, not a clinical study report. Therefore, the specific details regarding acceptance criteria and performance metrics from a dedicated study are not present.

Summary

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Ko42228

Image /page/0/Picture/1 description: The image shows the logo for McKinley. The logo consists of a stylized mountain shape in black, with a split running down the middle. Below the mountain shape, the word "McKinley" is written in a serif font.

McKinley Medical 4080 Youngfield Street Wheat Ridge, CO 80033 USA 303.420.9569 303.420.4545 Fax

NOV - 8 2004

510(k) Summary of Safety and Effectiveness - Traditional 510(k) for Modifications to the McKinley Beeline System

Date Prepared:	3 August 2004
Contact for questions:	Michelle Pratte
Trade Name:	Beeline Motiv, Propolis. PCA
Common Name:	Infusion Pump System & Kit
Classification Name:	Pump, Infusion
Classification Panel:	80 – General Hospital and Personal Use Devic
Regulation Number:	Class II, 880.5725
Procode:	FRN
Original and previously cleared 510(k)s:	K990461 and K032642

Summary of Safety and Effectiveness for the Beeline System

Modifications to the existing device consist of an extension of the flow rate range, addition of medication reservoir volumes, addition of an indication for use, addition of bolus capability, and addition of intermittent flow capability.

The previously cleared device demonstrating substantial cquivalence is the McKinley Beeline system (K032642).

Supporting predicate devices also demonstrating substantial equivalence is McKinley's Accufuser, Accufuser Plus & standard procedure kit (K033039), the I-Flow Elastomeric Pump (K040337), the Baxter Colleague Volumetric Pump (K010566), and the SIMS Deltec CADD-Prizm® Model 6101 Ambulatory Infusion System (K000842).

The Beeline system is intended for use as follows:

The Beeline system is intended for continuous and/or intermittent infusion of 1. medication for general infusion use, including antibiotic delivery, chemotherapy and pain management. The Beeline system is indicated for intravenous, intraarterial, enteral, subcutaneous, percutaneous and epidural infusion of medications or fluids requiring continuous and/or intermittent delivery at controlled infusion rates. The Beeline system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment, and alternative care sites.
1. The Beeline system is intended to provide continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites

Traditional 510(k) McKinley Beeline System

Summary of Safety and Effectiveness, Page I of 2

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and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. The Beeline system is also intended for patient-controlled infusion using the integrated bolus device.

The Beeline system is intended to significantly decrease narcotic use and pain 3. when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

Summary Description of the Beeline System

A procedure kit option provides various components that facilitate setup and use of the Beeline system.

The Beeline system is intended for single patient use.

Conclusion: The modified Beeline system does not raise any new safety and efficacy concerns when compared to the original device that is already legally marketed. The Beeline system is substantially equivalent to the named predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight. The symbol is composed of three curved lines that converge at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2004

Ms. Michelle Pratte Project Engineer McKinley Medical 4080 Youngfield Street Wheat Ridge, Colorado 80033

Re: K042228

Trade/Device Name: Beeline Motiv, Propolis, PCA Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: August 3, 2004 Received: August 17, 2004

Dear Ms. Pratte:

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 mendments, 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 may, therefore, market the device, subject to the general approvisions 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 (1 wr 1, it na) 0 casyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Pratte

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 (QS) 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), rr you acented the Office of 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 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 vours.

Chyu Lin, Ph.D.

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): K042228

Device Name: Beeline System

Indications For Use:

1. The Beeline system is intended for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management. The Beeline system is indicated for intravenous, intra-arterial, enteral, subcutaneous, percutaneous and epidural infusion of medications or fluids requiring continuous and/or intermittent delivery at controlled infusion rates. The Beeline system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment, and alternative care sites.
1. The Beeline system is intended to provide 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. The Beeline system is also intended for patientcontrolled infusion using the integrated bolus device.
1. The Beeline system is intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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)

Anton Dinn

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

Page 1 of 1

510(k) Number Ko42228

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).