MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL by MEDEGEN MEDICAL MANUFACTURING SERVICES

The MaxGuard Advanced Luer Activated Device with Antimicrobial Technology is a sterile single use positive displacement connector for needleless access to the IV line and/or IV catheter during IV therapy. The MaxGuard Connector can be used for direct injection, intermittent infusion, continuous infusion or aspiration.

The MaxGuard with Antimicrobial Technology may inhibit the growth of microorganisms on the surfaces of the MaxGuard device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially contaminated. The antimicrobial agent is not intended to be used as a treatment for existing infections.

The MaxGuard with Antimicrobial Technology has been shown to provide a 4+ log reduction of the following organisms:

Staphylococcus aureus, ATCC 6558 Staphylococcus epidermidis. ATCC 12228 Escherichia coli, ATCC 8739 Enterococcus faecalis, ATCC 51299 Pseudomonas aeruginosa, ATCC 9027 Klebsiella pneumonia. ATCC 4352 Candida albicans, ATCC 10231

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "MaxGuard Advanced Luer Activated Device with Antimicrobial Technology." It's an FDA clearance letter, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study design, or performance metrics in the context of an AI/ML device.

This document describes a medical device designed to reduce microbial contamination in IV lines. The "acceptance criteria" presented are related to its antimicrobial efficacy, specifically its ability to achieve a "4+ log reduction" of certain microorganisms. This is not a study about an AI/ML device, so most of the questions are not applicable.

Here's the information that can be extracted from the provided text, re-interpreting "acceptance criteria" as the claimed performance standard for its antimicrobial properties:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Antimicrobial Efficacy Claim)	Reported Device Performance (Antimicrobial Efficacy)
Device inhibits the growth of microorganisms on its surfaces.	Device provides a 4+ log reduction of specific organisms.

Specific organisms for which a 4+ log reduction was demonstrated:

Staphylococcus aureus, ATCC 6558
Staphylococcus epidermidis, ATCC 12228
Escherichia coli, ATCC 8739
Enterococcus faecalis, ATCC 51299
Pseudomonas aeruginosa, ATCC 9027
Klebsiella pneumonia, ATCC 4352
Candida albicans, ATCC 10231

The following information cannot be found in the provided document, as it pertains to an AI/ML device study, which is not the subject of this 510(k) clearance:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The sample size for the training set
How the ground truth for the training set was established

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

DEC 3 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medegen Medical Manufacturing System C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Service L.L.C. 1394 25th Street, N.W. Buffalo, Minnesota 55313

Re: K083765

Trade/Device Name: MaxGuard Advanced Luer Activated Device with Antimicrobial Technology Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class; II Product Code: FPA Dated: December 17, 2008 Received: December 18, 2008

Dear Mr. Job:

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. Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mcan 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Chiu S. Lin, Ph.D.

Chiu S. Lin. Ph. D Division 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): 《¢83765

Device Name: MaxGuard Advanced Luer Activated Device with Antimicrobial Technology

Indications for Use:

The MaxGuard with Antimicrobial Technology has been shown to provide a 4+ log reduction of the following organisms:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number:

Section 4-1

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.