The RyMed Technologies InVision-Plus CS™ with Neutral Advantage™ Technology Injection Port Systems are intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use.

The RyMed Technologies InVision-Plus" CS™ with Neutral Advantage™ Technology Injection Port contains silver ions and chlorhexidine, which are intended to inhibit the growth of microorganisms on the treated surfaces of the device, which include the septum and the fluid path.

The RyMed Technologies InVision-Plus® CSTM with Neutral Advantage™ Technology Injection Port has been shown to be effective for 7 days against the following microorganisms: Acinetobacter baumamnii, Methicillinresistant Staphylococcus aureus, Staphylococcus aureus, Escherichia coli, Candida albicans, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus epidermidis.

The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions.

Correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested.

The InVision-Plus® CSTM with Neutral Advantage™ Technology Injection Port Systems may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 ml/sec.

Device Description

RyMed's InVision-Plus® CS™ with Neutral Advantage™ Technology features pronounced intraluminal catheter fluid pathway protection using a combination of ten mechanical design features incorporated specifically for patient protection. The Neutral Advantage™ Technology features include a smooth swabbable septum surface, septum seal integrity with no gaps or openings, a double microbial barrier, straightthrough fluid pathway, zero dead space, zero fluid displacement, low priming volume, 100% effective blood clearing, saline-only flush option and no clamping sequence or positive pressure syringe technique required.

The RyMed Technologies InVision-Plus® CS™ with Neutral Advantage™ Technology Injection Port Systems are intended for single patient use in intravenous and blood administration sets without needles, thus eliminating the potential for needle-stick injuries during use.

The RyMed Technologies InVision-Plus® CS™ with Neutral Advantage™ Technology Injection Port contains silver ions and chlorhexidine, which are intended to inhibit the growth of microorganisms on the treated surfaces of the device, which include the septum and the fluid path.

The RyMed Technologies InVision-Plus® CSTM with Neutral Advantage™ Technology Injection Port has been shown to be effective for 7 days against the following microorganisms: Acinetobacter baumannii, Methicillinresistant Staphylococcus aureus, Staphylococcus aureus, Escherichia coli, Candida albicans, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus epidermidis.

The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions.

Correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested.

The InVision-Plus® CS™ with Neutral Advantage™ Technology Injection Port Systems may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec.

The device is offered in the following configurations:

o Stand alone connector
0 Administration Sets
o Stopcocks

The subject device is composed of materials that have been successfully and safely used in medical devices including the predicate devices. The materials used in the subject device have been subjected to and passed biocompatibility testing.

The subject device may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. When used with a low pressure power injector, the subject device must be secured with other devices rated for pressures up to 325 psi with a luer lock connection.

The subject devices are sterile single-use devices.

AI/ML Overview

The acceptance criteria for the RyMed Technologies InVision-Plus® CS™ with Neutral Advantage™ Technology Injection Port System, as well as the study details, are derived from the provided 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Biocompatibility	Successfully passed a standard battery of biocompatibility assays per ISO 10993.
Septum Seal Integrity	Assured through various physical and mechanical tests.
Microbial Ingress Prevention	Demonstrated through microbial ingress testing.
Antimicrobial Effectiveness (Septum & Fluid Path)	Shown to be effective for 7 days against: Acinetobacter baumannii, Methicillin-resistant Staphylococcus aureus, Staphylococcus aureus, Escherichia coli, Candida albicans, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus epidermidis.
Pressure Rating for Power Injectors	Rated for a maximum pressure of 325 psi.
Flow Rate for Power Injectors	Rated for a maximum flow rate of 10 mL/sec.

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

The document does not explicitly state a sample size for the test set in terms of a specific number of devices. However, the performance data cited appears to be from in vitro studies. The provenance is not explicitly mentioned as a country of origin, but the testing would have been conducted by or for RyMed Technologies, Inc., which is a US-based company. The nature of these tests (biocompatibility, microbial ingress, physical/mechanical) indicates they are prospective in nature, performed specifically to evaluate the device.

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

This information is not provided in the document. The studies performed (biocompatibility, microbial, physical/mechanical) rely on standardized testing methodologies and objective measurements rather than expert consensus on a 'ground truth' in the way clinical studies often do.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The testing described (biocompatibility, microbial, physical/mechanical) does not involve adjudication by experts as there are objective pass/fail criteria for these types of in vitro tests.

5. 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

No, an MRMC comparative effectiveness study was not done. This device is an intravascular administration set with antimicrobial properties, not an AI-assisted diagnostic or imaging device that would typically undergo such a study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance data described reflects standalone algorithm/device performance. The device's antimicrobial effectiveness, biocompatibility, and physical properties were tested directly, independent of a human operator's performance or interpretation.

7. The Type of Ground Truth Used

The ground truth for the performance criteria is based on objective measurements and standardized laboratory testing protocols.

Biocompatibility: Established by adherence to ISO 10993 standards and measuring biological responses.
Antimicrobial Effectiveness: Established by quantifying the inhibition of microbial growth on treated surfaces through laboratory incubation and enumeration methods.
Physical/Mechanical Properties (Seal Integrity, Pressure, Flow Rate): Established by direct measurement against predefined specifications using appropriate engineering and fluid dynamics testing.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is not an AI/machine learning model, so there is no "training set" in the conventional sense. The device itself is the product being tested.

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

This information is not applicable. Since there is no training set as per an AI/ML model, there is no ground truth for a training set to be established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for "RyMed TECHNOLOGIES, INC." The logo is black and white and features a stylized image of a three-leaf clover to the left of the company name. The company name is written in a bold, sans-serif font, with the word "RyMed" stacked above "TECHNOLOGIES, INC." The letters in the logo are made up of horizontal lines.

K093489

510 (k) Sumn

JUL 2 9 2010

Date Prepared [21 CFR 807.92(a)(1)]

Revised July 2, 2010

Submitter's Information |21 CFR 807.92(a)(1)|

This 510(k) is being submitted by a Joseph Azary (Regulatory / Quality Consultant) on behalf of RyMed Technologies, Inc. Joseph Azary can be contacted by telephone at (203) 922-0105 or fax at (203) 922-0130. Mailing address: 80 Shelton Technology Center, Shelton, CT 06484.

RyMed Technologies, Inc. is located at 6000 William Cannon Drive Building B, Suite 300, Austin, TX 78749. RyMed Technologies, Inc. is registered with FDA under Establishment Registration# 3005951712.

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade name: InVision-Plus® CSTM with Neutral Advantage™ Technology

Common / Classification Name: Intravascular Administration Set

Classification: This device falls under the responsibility of the Division of General Hospital Devices. Class II, Product Code: FPA, 21 CFR 880.5440

Predicate Device [21 CFR 807.92(a)(3)]

The following predicate devices have been identified:

RyMed Technologies InVision-Plus™ Injection Ports K991653 .
The subject device is similar to the RyMed Technologies In Vision-Plus™ Injection Ports with regard to length, diameter, cross section, intended use, sterility, packaging, and flow rate.

The main difference

is the RyMed Technologies InVision-Plus® CSTM with Neutral Advantage™ Technology Injection Port Systems has a septum containing silver and chlorhexidine, and the spike body contains silver ions. The similarities and differences between the subject device and the untreated predicate device are outlined in Appendix 1.

. Baxter V-Link Antimicrobial Luer Activated Device - K081289
The subject device is similar to the Baxter V-Link Antimicrobial Luer Activated Device except the subject device contains silver and chlorhexidine on the septum as well as silver in the fluid path.
ARROWg*ard Blue Plus™ Multi-Lumen Central Venous Catheter K993691 .
The subject device is similar to the ARROWg ard Blue Plus™ Multi-Lumen Central Venous Catheter in that it contains both silver ions and chlorhexidine acetate.
Bard Intravenous Power Injector Extension Set K090134 �

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The subject device is similar to the Bard Intravenous Power Injector Extension Set in that it is rated for a maximum pressure of 325 psi and flow rate of 10 mL/sec.

Description of the Device [21 CFR 807.92(a)(4)]

The RyMed Technologies InVision-Plus® CSTM with Neutral Advantage™ Technology Injection Port has been shown to be effective for 7 days against the following microorganisms: Acinetobacter baumannii, Methicillinresistant Staphylococcus aureus, Staphylococcus aureus, Escherichia coli, Candida albicans, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus epidermidis.

The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions.

Correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested.

The device is offered in the following configurations:

o Stand alone connector
0 Administration Sets
o Stopcocks

The subject devices are sterile single-use devices.

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Intended Use [21 CFR 807.92(a)(5)]

The RyMed Technologies InVision-Plus® CS™ with Neutral Advantage™ Technology Injection Port Systems are intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use.

The RyMed Technologies InVision-Plus® CS™ with Neutral Advantage™ Technology Injection Port has been shown to be effective for 7 days against the following microorganisms: Acinetobacter baumannii, Methicillinresistant Staphylococcus aureus, Staphylococcus aureus, Escherichia coli, Candida albicans, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus epidermidis.

The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions.

Correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested.

Technological Characteristics [21 CFR 807.92(a)(6)}

The physical and mechanical design of the subject device is identical to the RyMed predicate device (K991653). The only difference in the subject device relative to the RyMed predicate device is that the septum is treated with silver and chlorhexidine, and the fluid path is treated with silver. The predicate devices cleared under K081289 and K993691 contain silver/chlorhexidine, respectively. The predicate device cleared under K090134 is rated for use with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec.

Performance Data [21 CFR 807.92(b)(1)]

The subject device has been subjected to and passed a standard battery of biocompatibility assays per ISO 10993. Additional testing included microbial ingress and various physical and mechanical tests to assure seal integrity of the septum.

Conclusion (21 CFR 807.92(b)(3)]

The differences between the subject devices are minor; it is therefore concluded that the subject device is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH &" is vertically oriented on the left side of the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G6 Silver Spring, MD 20993-0002

RyMed Technologies, Incorporated C/O Mr. Joseph M. Azary Senior Regulatory Consultant / Quality Systems Manager Orchid Design 80 Shelton Technology Center Shelton, Connecticut 06484

JUL 2 9 2010

Re: K093489

Trade/Device Name: InVision-Plus®CSTM with Neutral Advantage™ Technology Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 2, 2010 Received: July 6, 2010

Dear Mr. Azary:

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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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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Susan Ruomer

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

JUL 2 5 2010

510(k) Number (if known):

Device Name: InVision-Plus® CSTM with Neutral Advantage™ Technology

Indications For Use:

The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions.

Correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested.

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)

Richard C. Chapman 7/28/10

Page 1 of 1

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

510(k) Number: K093489

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.