The Lockbox is intended to hold a Medfusion™ 3000 Series Syringe Pump and provide reasonably secure access to the medication syringe contained within.

Device Description

The Lockbox is an accessory to the Medfusion™ 3000 Series Syringe Pump. It is a lockable, plastic enclosure for the pump when the pump is loaded with a commercially available syringe containing medication. The Lockbox may be attached to an IV pole with the Pole Mount Bracket or with modification to a horizontal square rail.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called "Lockbox for Medfusion™ 3000 Series Pumps". This device is a lockable plastic enclosure for an infusion pump and is primarily evaluated based on its physical properties and biocompatibility, not on AI or diagnostic performance metrics. Therefore, many of the requested categories for AI-based device evaluation are not applicable.

Here's an analysis of the available information:

Acceptance Criteria and Study Details for "Lockbox for Medfusion™ 3000 Series Pumps"

Given the nature of the device (a physical lockbox accessory for an infusion pump), the acceptance criteria and study methods differ significantly from those typically used for AI/diagnostic devices. The focus is on physical suitability, safety (biocompatibility), and achieving its stated intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Physical Suitability	Ability to securely hold the Medfusion™ 3000 Series Syringe Pump.	Confirmed through bench testing.
	Ability to provide reasonably secure access to the medication syringe.	Confirmed through bench testing.
	Compatibility with various mounting options (IV pole, horizontal square rail).	Demonstrated (implicitly through design description and intended use).
Biocompatibility	Materials of construction are biocompatible; no adverse biological reactions expected.	Assessed. Device is biocompatible based on similarity to other marketed devices from Smiths Medical MD, Inc.
Usability	Ergonomics and ease of use in its intended environment.	Evaluated through Usability Studies.
Structural Integrity	Durability and robustness under normal conditions of use.	Evaluated through Bench Testing.
Dimensional Conformance	Correct fit with the Medfusion™ 3000 Series Syringe Pump.	Evaluated through Bench Testing.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated in terms of a specific number of units for bench testing or usability studies.
Data Provenance: The testing was "non-clinical" and involved "Bench Testing" and "Usability Studies." This suggests in-house testing performed by Smiths Medical MD, Inc. No information regarding country of origin for data or whether it was retrospective/prospective is provided, as it's not relevant for this type of device testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable in the context of this device. The "ground truth" for a physical lockbox relates to its mechanical function, security, and material science, which are typically assessed by engineers and materials scientists rather than medical experts in a diagnostic "ground truth" sense.

4. Adjudication Method for the Test Set

Not applicable. The evaluation of physical properties and usability does not involve an adjudication method like those used for diagnostic decisions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers interpret medical images or data. The Lockbox is a physical accessory, not a diagnostic tool or something that directly influences human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. There is no algorithm or AI component in the Lockbox device. Its "performance" is entirely physical and mechanical.

7. The Type of Ground Truth Used

The "ground truth" was established based on engineering specifications, material science principles, and functional requirements for a secure enclosure. For biocompatibility, it was based on similarity to established biocompatible materials used in other Smiths Medical products.

8. The Sample Size for the Training Set

Not applicable. There is no AI model or algorithm that required a "training set" for this device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary

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510(k) Summary (As required by 21 CFR 807.92(c))

K091181 510(k) Number: Page 1 of 2

Date Prepared 20 April 2009, Updated 11 June, 2009

Submitter Information

JUN 1 2 2009

Submitter's Name:	Smiths Medical MD, Inc.
Address:	1265 Grey Fox Road
	St. Paul, MN 55112

Establishment Registration: 2183502

Contact Person: James Chapman Sr. Regulatory Affairs Associate Phone: (651) 628-7611 Fax: (651) 628-7457

Device Information

Trade Name:	Lockbox
Common Name:	Lockbox for use with Medfusion™ 3000 Series Pumps
Classification Name:
Product Code:	MRZ
Regulation:	21 CFR §880.5725

Predicate Device(s)

The predicate devices are the currently marketed LockBox for use with the CADD®-Solis Ambulatory Infusion Pump (K080743) and LockBox with Syringe Holder (K942161).

Device Description

Intended Use/Indications for Use

The Lockbox is intended to hold a Medfusion™ 3000 Series Syringe Pump and provide reasonably secure access to the medication syringe contained within.

Lockbox for use with Medfusion™ 3000 Series Pumps Smiths Medical MD, Inc.

Smiths Medical MD, Inc. Submission Page 15

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510(k) Summary Page 2 of 2

Summary of Non-Clinical Testing

The non-clinical testing included assessment of the physical properties of the Lockbox and its ability to achieve its intended use. Bench testing of the Lockbox confirmed the suitability of the device for its intended use. The following physical tests were performed:

Bench Testing Usability Studies

A biocompatibility assessment of the device was also performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. The device is biocompatible based on the similarity of the materials of construction to other devices currently marketed by Smiths Medical MD, Inc.

Summary of Clinical Testing

Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the Lockbox.

Statement of Equivalence

The Lockbox for Medfusion™ 3000 Series Pumps is substantially equivalent to the currently marketed LockBox for use with the CADD® -Solis Ambulatory Infusion Pump and LockBox with Syringe Holder based on a comparison of the indications for use and the technological characteristics of the device.

Conclusion

The Lockbox for use with Medfusion™ 3000 Series Pumps is substantially equivalent to the currently marketed LockBox for use with the CADD -Solis Ambulatory Infusion Pump and LockBox with Syringe Holder based on the technological characteristics of the devices. Bench tests confirmed the suitability of the device for its intended use.

Lockbox for use with Medfusion™ 3000 Series Pumps Smiths Medical MD, Inc.

Smiths Medical MD, Inc. Submission Page 16

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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 consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

JUN 1 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James Chapman Senior Regulatory Affairs Associate Smiths Medical MD, Incorporated 1265 Grey Fox Road Sait Paul, Minnesota 55112

Re: K091181

Trade/Device Name: Lockbox for Medfusion™ 3000 Series Pumps Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: April 20, 2009 Received: April 23, 2009

Dear Mr. Chapman:

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 may, 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 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. Chapman

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers Offices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runner

Susan Runner, D.D.S., M.A. Acting 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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SMITHS MEDICAL MD, INC. 510(k) Premarket Notification

Indications for Use Statement

Koqußi 510(k) Number: __

Device Name: Lockbox for Medfusion™ 3000 Series Pumps

Indications for Use:

"The Lockbox is intended to hold a Medfusion™ 3000 Series Pump and provide reasonably secure access to the medication syringe contained within."

Prescription Use ਮ (Per 21 CFR 801 . 109)

AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sef. R.R.

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

510(k) Number: K091181

Lockbox for use with Medfusion™ 3000 Series Pumps Submission Page 14

Tab 5 - 1

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).