(261 days)
Not Found
No
The 510(k) summary describes a mechanical injection port system with antimicrobial properties. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The device is an injection port system intended to inhibit microorganism growth on its surfaces and eliminate needle-stick injuries, not to treat existing conditions or administer therapy.
No
The device is an injection port system designed to eliminate needle-stick injuries and inhibit microbial growth on its surfaces, which are functions related to intravenous administration and infection prevention, not diagnosis. The "Intended Use / Indications for Use" section explicitly states "The subject device is not intended to treat existing infections" and its primary function is for "intravenous and blood administration sets."
No
The device description clearly outlines physical components such as injection ports, septums, and administration sets, and discusses material composition and mechanical features. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is an injection port system for intravenous and blood administration sets. Its purpose is to facilitate the delivery of fluids and blood into a patient's bloodstream, not to analyze samples taken from the patient.
- The device's function is mechanical and antimicrobial. The primary functions described are providing a needle-free access point, maintaining a sterile fluid pathway, and inhibiting microbial growth on the device surfaces. These are not diagnostic functions.
- The "in vitro antibacterial activity" mentioned refers to testing of the device itself. The text explicitly states "Correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested." This indicates that the in vitro testing was done on the device to demonstrate its antimicrobial properties, not to diagnose a condition in a patient.
Therefore, the RyMed Technologies InVision-Plus CS™ with Neutral Advantage™ Technology Injection Port Systems are medical devices used for patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FPA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K991653, K081289, K993691, K090134
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
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 �
1
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)]
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.
2
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 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® 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.
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.
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.
3
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.
4
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
5
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 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.
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