The InfuSite Needleless Access Device is a closed system needleless accessory, which permits blood sampling, intermittent injection or infusion of fluids or medications when connected exclusively to luer systems.

Device Description

The InfuSite Needleless Access Device is a closed system needleless multi-purpose catheter accessory, permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer systems. The InfuSite Needleless Access Device has a polycarbonate male/female luer housing with a swabable silicone membrane, which opens automatically upon connection with a male luer and closes automatically when the male luer is disconnected. Disinfection must be carried out before and after use. The InfuSite contains no metallic components.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the InfuSite Needleless Access Device:

Important Note: The provided document is a 510(k) summary for a medical device (Needleless Access Device), not a diagnostic algorithm or AI software. Therefore, many of the requested categories like "multi reader multi case (MRMC) comparative effectiveness study," "standalone algorithm performance," "number of experts for ground truth," and "training set details" are not applicable to this type of device submission. The focus of this submission is on demonstrating substantial equivalence to predicate devices through performance testing and biocompatibility, not on diagnostic accuracy of an AI.

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria (if stated)	Reported Device Performance
Biocompatibility	Non-irritant, non-toxic	"Biocompatibility data demonstrates that the materials used are non-irritant and non-toxic."
Performance Testing	Substantial equivalence to predicate devices (SmartSite K960280, Swabsite K002689)	"Performance testing demonstrates that the device is substantially equivalent to the predicate devices."
Risk Assessment	Compliance with ISO 14971	"Risk Assessment was conducted in compliance with ISO 14971."
Material Equivalence	Equivalent to predicate devices, no new safety/efficacy issues	"The materials and technology of the InfuSite Needleless Access Device are equivalent to the predicate devices and no new issues of safety and efficacy have been introduced with this device."
Indications for Use	Identical to predicate devices	"The indications for use are identical to the predicate devices."

Study Details (Applicable to this device type)

Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for the performance testing. This information would typically be detailed in the full 510(k) submission, not the summary.
- Data Provenance: Not specified. It's likely that the testing was conducted in a laboratory setting by the manufacturer or contracted labs, rather than involving patient data from specific countries. The testing would be prospective in the sense that the device was specifically tested to meet certain criteria.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of device (needleless access device). Ground truth for diagnostic accuracy (which requires experts) is not relevant here. The "truth" for this device's performance would be objective measurements (e.g., fluid flow rates, leak testing, material integrity, microbiological barrier testing) against established engineering and regulatory standards.
Adjudication method for the test set:
- Not applicable. As the "ground truth" is based on objective, measurable performance characteristics rather than expert interpretation, adjudication methods used for diagnostic studies (like 2+1) are not relevant here.
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 a physical medical device, not an AI or diagnostic algorithm that interacts with human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm.
The type of ground truth used:
- The "ground truth" for this device's performance is based on objective engineering and regulatory standards, including:
  - Biocompatibility test results (e.g., cytotoxicity, sensitization, irritation indices).
  - Physical performance metrics (e.g., flow rates, pressure resistance, leakage, connection integrity, seal integrity after disconnections, microbial barrier performance).
  - Compliance with recognized standards (e.g., ISO, specifically ISO 14971 for risk assessment, and likely other ISO fluid connector standards).
  - Comparison to the performance characteristics of predicate devices.
The sample size for the training set:
- Not applicable. This device is a physical product, not an AI model that requires a training set.
How the ground truth for the training set was established:
- Not applicable. No training set for an AI model.

Summary

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K112073

APR 1 1 2012

PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.93)

Date of Preparation: July 6, 2011

Applicant:

Rx Devices LLC 2030 Oakes Blvd. Naples, FL 34119

Contact Individual: Charles Hokanson, CEO (610 715-3263) hokanson@earthlink.net

Trade Name: InfuSite Needleless Access Device

Common Name: Needleless Access Device

Regulation Number: 880.5440

FPA Product Code:

Classification Name: Set, Administration, Intravascular

Classification: Class II

Predicate Device Name: Smartsite K960280, Swabsite K002689

Device Description:

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Intended Use:

Technology Characteristics:

The InfuSite Needleless Access Device is substantially equivalent to the predicate devices. No new materials or new issues of safety and efficacy have been introduced with this device.

Summary of Design Control Activities:

The Infusite was designed and developed in accordance ISO and FDA design control guidelines. Biocompatibility data demonstrates that the materials used are non-irritant and non-toxic. Performance testing demonstrates that the device is substantially equivalent to the predicate devices (SmartSite, K960280, Swabsite K002689). Risk Assessment was conducted in compliance with ISO 14971.

Conclusion:

The indications for use are identical to the predicate devices. The materials and technology of the InfuSite Needleless Access Device are equivalent to the predicate devices and no new issues of safety and efficacy have been introduced with this device. Biocompatibility testing, performance testing and risk assessment demonstrate that the InfuSite Needleless Access Device is substantially equivalent to the predicate devices, and safe and effective, when used in accordance with the supplied instructions for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Charles Hokanson CEO Rx Devices LLC 2030 Oakes Blvd. Naples, Florida 34119

ARR. 1 1 2012

Re: K112073

Trade/Device Name: InfuSite Needleless Access Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 12, 2012 Received: March 14, 2012

Dear Mr. Hokanson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Hokanson

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony. D. Awuta

Anthony D. Watson, B.S., M.S., M.B.A. 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):

InfuSite Needleless Access Device Device Name:

Indications For Use:

Prescription Use X (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)
(Division Sign-Off)	4/12/12

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112073

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.