The LockBox is an accessory to the CADD® -Solis ambulatory infusion pump. It is a plastic enclosure for the CADD®-Solis ambulatory infusion pump when it is attached to commercially available medication rescrvoir. The reservoir may be a flexible IV bag up to 500 mL in size or a syringe up to 60 mL. The Lockbox may be attached to a CADD-Prizm Polcmount Bracket.

AI/ML Overview

The provided text describes a medical device called "LockBox for CADD®-Solis Ambulatory Infusion Pump," an accessory designed to enclose an infusion pump and its medication reservoir. This submission for 510(k) premarket notification does not include a study proving device performance against specific acceptance criteria in the typical sense of a clinical or analytical study with quantitative metrics.

Instead, the submission states:

"The LockBox was subjected to verification and validation testing as well as human factors usability testing. All tests performed demonstrate the LockBox meets the acceptance criteria for the safety and performance requirements set by the LockBox specifications."

This indicates that the device met internal acceptance criteria defined in its own specifications through a process of verification, validation, and human factors testing. However, the details of these internal acceptance criteria and the results of these tests are not provided in the document.

Therefore, many of the requested details cannot be filled from the given text.

Here's a breakdown of what can be extracted and what cannot:

Information Category	Details from Provided Text
1. Table of Acceptance Criteria & Reported Device Performance
Acceptance Criteria	Not explicitly detailed. The text states: "meets the acceptance criteria for the safety and performance requirements set by the LockBox specifications." These specifications are not provided.
Reported Device Performance	Not explicitly detailed with quantitative metrics. The text states: "All tests performed demonstrate the LockBox meets the acceptance criteria..."
2. Sample size and data provenance for test set	Not specified.
3. Number and qualifications of experts for ground truth	Not applicable, as no external expert-based ground truth was established from clinical studies.
4. Adjudication method for test set	Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study	No. Clinical studies were "deemed not necessary."
6. Standalone (algorithm only without human-in-the-loop) performance study	Not applicable. This is a physical accessory device, not an algorithm.
7. Type of ground truth used	Ground truth for safety and performance was established through verification, validation, and human factors usability testing against internal specifications. No external "clinical" ground truth (e.g., pathology, outcomes data) was used or required.
8. Sample size for the training set	Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
9. How ground truth for the training set was established	Not applicable.

Summary

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Ko80743

510(k) Summary

I. GENERAL INFORMATION

Applicant's Name and Address:	Smiths Medical MD, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	David H. ShortDirector of Regulatory Affairs and Design Assurance
Common/Usual Name:	Lockbox
Proprietary Name:	LockBox for CADD®-Solis Ambulatory Infusion Pump
Equivalence Device Comparison:	LockBox with Syringe Holder

II. DEVICE DESCRIPTION

INTENDED USE OF THE DEVICE III.

The LockBox is intended to hold the CADD®-Solis infusion pump and provide reasonably secure access to the medication reservoir or syringe contained within.

SUMMARY OF STUDIES V.

A. Functional Testing

The LockBox was subjected to verification and validation testing as well as human factors usability testing. All tests performed demonstrate the LockBox meets the acceptance criteria for the safety and performance requirements set by the LockBox specifications.

B. Clinical Studies

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

C. Conclusions Drawn from the Studies

Based upon the information provided, LockBox is safe, effective and performs to established specifications.

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Image /page/1/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 its wings spread, facing left. The eagle is composed of thick, black lines. Surrounding the eagle is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 5 2008

Mr. David H. Short Director of Regulatory Affairs and Design Assurance Smiths Medical MD, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

Re: K080743

Trade/Device Name: LockBox for CADD® -Solis Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ, FRN Dated: April 18, 2008 Received: April 21, 2008

Dear Mr. Short:

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 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. Short

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), please contact 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/industry/support/index.html.

Sincerely yours,

Sutte y. Michin Dns.

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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SMITHS MEDICAL MD, INC. 510(k) Premarket Notification LockBox for CADD®-Solis Infusion Pump

Indications for Use

510(k) Number: K060778

Device Name: LockBox for CADD®-Solis Infusion Pump

Indications for Use:

"The LockBox is a plastic enclosure designed to hold a CADD®-Solis infusion pump and a medication reservoir or syringe."

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The Counter Use

Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Antron D. Nume

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

510(k) Number: K�8�743

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).