(42 days)
Not Found
No
The summary describes a mechanical injection port system and focuses on physical properties and performance metrics like flow rate and resealing. There is no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is an injection port system intended for intravenous and blood administration sets, designed to eliminate needle-stick injuries. It facilitates the administration of substances but does not directly treat or prevent a disease or condition itself.
No
The device description and intended use indicate that the device is an injection port system for fluid administration, not for diagnosing medical conditions.
No
The device description explicitly details physical components made of medical-grade plastics and silicone, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "single patient use in intravenous and blood administration sets without need for needles". This describes a device used for administering fluids or blood directly into a patient's bloodstream.
- Device Description: The description details components like injection ports, valves, and luer housings, all consistent with a device used for intravenous access and fluid delivery.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, etc.) to provide diagnostic information about a patient's health. IVDs are designed to perform tests on biological samples outside the body.
- Performance Metrics: The performance metrics listed (fluid reflux, flow rate, priming volume, reseal) are all related to the physical function and performance of a device used for fluid administration, not diagnostic testing.
Therefore, the RyMed Technologies InVision-Plus™ Injection Port Systems are a medical device used for patient care (specifically intravenous access and fluid delivery), but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RyMed Technologies InVision-Plus™ 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.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The RyMed Technologies INVISION-PLUS™ Injection Port Systems are composed of either a Heparin Lock Injection Port, or a Y - Injection Port that contain a specialized two part valve made from medical grade Silicone material. The female luer housing, guide washer, and heparin lock are made from medical grade plastics. The valve provides excellent fluid Flow Rates, low Priming Volumes, and reseals after extended use.
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)
Extensive bench testing of both devices has demonstrated this. The recirculating blood contact materials of the device have been carefully selected for their long history of biocompatibility and have been tested to assure that they meet the requirements of ISO 10993-1.
Performance Data:
- Fluid reflux: 0.012 mL (Met criteria:
§ 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
Summary of Safety and Effectiveness for the RyMed Technologies INVISION-PLUS™ Injection Ports
JUN 2 4 1999
submitted by:
RyMed Technologies, Inc. 3110 Blue Sage Drive Woodward, OK 73801
Identification of a Legally Marketed Predicate Device
The RyMed Technologies INVISION-PLUS™ Injection Port Systems are substantially equivalent to Injection Port Systems manufactured by:
ICU Medical, San Clemente, CA .
The RyMed Technologies INVISION-PLUS™ Injection Port Systems are composed of either a Heparin Lock Injection Port, or a Y - Injection Port that contain a specialized two part valve made from medical grade Silicone material. The female luer housing, guide washer, and heparin lock are made from medical grade plastics. The valve provides excellent fluid Flow Rates, low Priming Volumes, and reseals after extended use.
See appendix 1 for diagram and fluid flow path through valve.
Intended Use
The RyMed Technologies InVision-Plus™ 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.
| Test | Acceptance Criteria | RyMed InVision-
Plus™ |
|-------------------------------------------------------|--------------------------------|--------------------------|
| Fluid reflux |