Predicate Devices

Not Found

Reference Devices

BRAUN SafSite®, Medex Nu-Site™

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical design and performance characteristics of a valve-based injection port system, with no mention of AI or ML.

Therapeutic

No.
The device description indicates its purpose is for intravenous and blood administration and to prevent needle stick injuries, not to treat any specific medical condition.

Diagnostic

No

The device is an injection port system for intravenous and blood administration, designed to facilitate fluid flow and prevent needle stick injuries. Its intended use and description do not involve diagnosing any medical conditions; rather, it is a tool for drug and fluid delivery.

SaMD (Software as a Medical Device)

No

The device description clearly states it is composed of physical components (plastic and silicone valve) and is intended for intravenous and blood administration, indicating a hardware-based medical device. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "for single patient use in intravenous and blood administration." This describes a device used in vivo (within the body) for delivering fluids and blood, not for testing samples in vitro (outside the body).
Device Description: The description focuses on the physical components and function of an injection port system used for administering fluids, not for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting analytes, or providing diagnostic information.

Therefore, the RyMed Technologies SLAV™ Injection Port Systems are medical devices used for fluid administration, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The RyMed Technologies SLAV™ Injection Port Systems are intended for single patient use in intravenous and blood administration.

Product codes

Not Found

Device Description

The RyMed Technologies SLAV™ Injection Port Systems are composed of either a Heparin Lock Injection Port, or a Y-Injection Site Port that contain a specialized two piece valve made from a medical grade clear plastic and a medical grade Slicone material. This specialized valve completely eliminates the use of Needles forcing compliance with the new OSHA standards of safety avoiding accidental needle stick injuries, the valve also provides excellent fluid Flow Rates, requires very low Priming Volumes, and it eliminates "dead spaces" that could entrap blood. This valve has the ability to activate injection ports a minimum of 100 times without leaking or change in its performance.

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

Test	SLAV™ Injection Port	BRAUN SafSite®	Medex Nu-Site™
Fluid Flow Rate >= 150 cc / min.	Passed	Passed	Passed
Ideal Priming Volume less than 0.1 mls	Passed	Failed	Failed
100 Activation's with no leaking or change in performance capabilities	Passed	Passed	Passed

Key Metrics

Not Found

Predicate Device(s)

BRAUN MEDICAL, MEDEX

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

SLAV ™ Injection Port Connector Systems Pre-Market Notification (510 k)

K460)))/
Page 23of 27

DEC 1 0 1996

Summary of Safety and Effectiveness for the RyMed Technologies SLAV™ Injection Ports submitted by RyMed Technologies, Inc. 3110 Blue Sage Drive Woodward, OK 73801

Identification of a Legally Marketed Predicate Device

The RyMed Technologies SLAV™ Injection Port Systems are substantially equivalent Injection Ports Systems manufactured by:

BRAUN MEDICAL. Bethlehem. Pennsylvania .
. MEDEX, Hilliard, Ohio

Device Description

The RyMed Technologies SLAV™ Injection Port Systems are composed of either a Heparin Lock Injection Port, or a Y-Injection Site Port that contain a specialized two piece valve made from a medical grade clear plastic and a medical grade Slicone material. This specialized valve completely eliminates the use of Needles forcing compliance with the new OSHA standards of safety avoiding accidental needle stick injuries, the valve also provides excellent fluid Flow Rates, requires very low Priming Volumes, and it eliminates "dead spaces" that could entrap blood. This valve has the ability to activate injection ports a minimum of 100 times without leaking or change in its performance.

Intended for Use

The RyMed Technologies SLAV™ Injection Port Systems are intended for single patient use in intravenous and blood administration.

Summary of Technological Characteristics

| Feature | SLAV™ Injection Port | Predicate Device
Braun SafSite® | Predicate Device
Medex Nu-Site™ |
|----------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|
| Intended Use | Intravenous and Blood
Administration. | Intravenous and Blood
Administration. | Intravenous and Blood
Administration. |
| Disposable
Single Patient Use | Yes | Yes | Yes |

1

Summary of Technological Characteristics continuation...

First (for the rest to be a deads, very dal

| Feature | SLAV™ Injection Port | Predicate Device
Braun SafSite® | Predicate Device
Medex Nu-Site™ |
|-----------------------------|--------------------------------------------------|----------------------------------------------|------------------------------------|
| Flow Rate | 310-350 mls / min. | > 250 mls / min. | > 250 mls / min. |
| Priming Vol. Required | 0.028 mls. | 0.30 mls | 0.12 mls. |
| Heparin Lock Injec. Ports | Yes | Yes | Yes |
| J - Loop Tube Extension | Yes | No | Yes |
| T - Connector/ Tube Ext. | Yes | No | Yes |
| IV Administration Sets | Yes | No | No |
| Multiple Access IV Manifold | Yes | Yes | Yes |
| Packaging | Blister Pack | Blister Pack | Blister Pack |
| Sterilization | ETO | Unknown, believed
to be ETO | Unknown, believed
to be ETO |
| Non-Pyrogenic | Yes | Yes | Yes |
| Materials | ABS, Silicone, PVC
Polyethylene/Polypropylene | Polycarbonate, Silicone
PVC, Polyethylene | ABS, Silicone, PVC
Polyethylene |
| Performance Standards | Unknown | Unknown | Unknown |

Summary of Performance Data

Test	SLAV™ Injection Port	BRAUN SafSite®	Medex Nu-Site™
Fluid Flow Rate
$\ge$ 150 cc / min.	Passed	Passed	Passed
Ideal Priming Volume
less than 0.1 mls	Passed	Failed	Failed
100 Activation's with no
leaking or change in
performance capabilities	Passed	Passed	Passed

RyMed Technologies, Inc.

2

Conclusion

The SLAV™ Injection Port Systems meet the requirements to be considered similar in Technological Characteristics and in Performance to the predicate devices, we believe that the SLAV™ Injection Port Systems are safe and effective and perform as well as or better than the predicate devices. The SLAV™ will be manufactured per specifications and under Good Manufacturing Practices by an ISO 9000 Certified manufacturer to ensure the devices are safe and effective for its intended use.

RyMed Technologies, Inc.

Debra Wm. Ryan
Debra Wm. Ryan

Dana Wm. Ryan President/CEO