(42 days)
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.
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.
The provided document is a 510(k) premarket notification for a medical device (RyMed Technologies INVISION-PLUS™ Injection Ports), not a study report for an AI/ML device. Therefore, the specific information requested in points 2-9 (related to AI/ML study design) is not applicable or cannot be extracted from this document.
However, I can extract and present the acceptance criteria for the device and its reported performance based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Performance (RyMed InVision-Plus™) |
|---|---|---|
| Fluid reflux | <0.015 ml | 0.012 ml (Met criteria) |
| Fluid flow rate w/18 ga catheter | ≥ 1.30 mL/second | 1.47 mL / sec. (Met criteria) |
| Priming volume | < 0.04 mL | 0.0333 mL (Met criteria) |
| Reseal after IV Push (when using normal saline) | Must reseal after 96 hours use | Met criteria |
| Reseal after IV Drip (when using normal saline) | Must reseal after 96 hours use | Met criteria |
| Reseal (when using blood) | Must reseal after 24 hours use | Met criteria |
| Reseal (when using lipids) | Must reseal after 48 hours use | Met criteria |
Explanation of how the device meets acceptance criteria:
The document explicitly states "Met criteria" in the "RyMed InVision-Plus™" column for each of the reseal tests. For fluid reflux, flow rate, and priming volume, specific numerical values are provided that fall within the defined acceptance criteria (e.g., 0.012 mL fluid reflux is less than the <0.015 mL acceptance criteria).
Regarding the AI/ML specific criteria (Points 2-9):
The provided document is a Summary of Safety and Effectiveness for the RyMed Technologies INVISION-PLUS™ Injection Ports, which is a medical device (injection port system). This document describes the device's functional characteristics and its substantial equivalence to a predicate device for market clearance (510(k) submission).
It does not involve Artificial Intelligence (AI) or Machine Learning (ML). Therefore, the questions related to:
- Sample size for test set and data provenance
- Number of experts for ground truth and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How ground truth for the training set was established
are not applicable to this device and cannot be answered from the provided text. The performance data presented are from bench testing of the physical medical device.
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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 | <0.015ml | Met criteria |
| Fluid flow rate w/18 gacatheter | ≥ 1.30 mL/second | Met criteria |
| Priming volume | < 0.04 mL | Met criteria |
| Reseal after IV Push(when using normalsaline) | Must reseal after 96 hours use | Met criteria |
| Reseal after IV Drip(when using normalsaline) | Must reseal after 96 hours use | Met criteria |
| Reseal (when usingblood) | Must reseal after 24 hours use | Met criteria |
| Reseal (when usinglipids) | Must reseal after 48 hours use | Met criteria |
Summary of Performance Data
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| Summary of Technological Characteristics | ||
|---|---|---|
| Feature | Submitted Device | Predicate Device |
|---|---|---|
| Trade Name | INVISION-PLUS™ Injection Port | ICU Medical CLC2000™ |
| Manufacturer | RyMed Technologies | ICU Medical, Inc |
| 510 Number | To be determined | K973167 |
| Intended Use | Intravenous and bloodadministration | Intravenous and bloodadministration |
| Disposable for single patient use | Yes | Yes |
| Fluid Reflux | 0.012 mL | 0.032 mL |
| Flow Rate | 1.47 mL / sec. * | 2.57 mL/ sec. |
| Priming Volume | 0.0333 mL | 0.0735 mL |
| Heparin Lock Injection Ports | Yes | Yes |
| J Loop Tube Extension | Yes | Yes |
| T Connector/ Tube Ext. | Yes | Yes |
| IV Administration Sets | Yes | Yes |
| Packaging | Peel pouch or rigid blister pack | Blister pack |
| Sterilization | Gamma radiation | Unknown, believed to be ETO |
| Non-pyrogenic | Yes | Yes |
| Materials | Polycarbonate; silicone rubber;polyethylene/polypropylene,stainless steel | Polycarbonate, glass filledpolyester, stainless steel, siliconerubber |
- Flow rate acceptance criteria was established at a minimum of 1.30 mL per second. This is the flow rate for an 18 ga. Catheter. 18 ga. Catheters can be used for all I.V. fluid administration (I.V. solutions, lipids, and blood products). Fluid flow rates greater than an 18 ga. Catheter are not required for I.V. Administration.
The INVISION-PLUS™ Injection Port Systems are substantially equivalent to the predicate device. 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.
We believe that the INVISION-PLUS™ Injection Port Systems are safe and effective and perform as well as or better than the predicate device. . The INVISION-PLUS™ has been designed utilizing design control methods in compliance with the GMP. The INVISION-PLUS™ will be manufactured per specifications and under Good Manufacturing Practices by an ISO 9000 certified manufacturer to ensure the device is safe and effective for its intended use.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
JUN 2 4 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Al Weisenborn RyMed Technologies, Incorporated 19526 East Lake Drive Miami, Florida 33015
Re : K991653 InVision-Plus™ Injection Port Connector Trade Name: System Regulatory Class: II Product Code: FPA May 12, 1999 Dated: Received: May 13, 1999
Dear Mr. Weisenborn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.
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Page 2 - Mr. Weisenborn
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact. the Office of Compliance at (301) 594-4639. Also, please cote the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistence at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" a
Sincerely yours,
Timothy A. Ulatowski
V Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 99/653
Page 6 of 27
Indications for Use
Page 1_of_1_
510(k) Number (if known): Not assigned
Device Name InVision-Plus™ Injection Port Connector System
Indications for Use:
The RyMed Technologies InVision-Plus™ Injection Port Systems are
t The RyMed Technologies Invision first researcous and blood intended for single pations use in insedless, thus eliminating administration secs without its a juries during use.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use_
(Per 21 CFR 801.109)
Patricia Ciccutti
(Optional Format 1-2-96)
(Division Sign-Off) Division of Dental, Info and General Hospital 510(k) Number _
RyMed Technologies, Inc
§ 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.