SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM

K960771 · Rymed Technologies, Inc. · FPA · Dec 10, 1996 · General Hospital

Device Facts

• Record ID: K960771
• Device Name: SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM
• Applicant: Rymed Technologies, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Dec 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

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

Device Story

SLAV™ Injection Port Systems consist of Heparin Lock Injection Ports or Y-Injection Site Ports featuring a two-piece valve mechanism. Designed for needleless intravenous and blood administration to comply with OSHA safety standards regarding needle stick injuries. Device operates by allowing fluid access through a silicone valve; supports minimum 100 activations without leakage. Used in clinical settings for IV therapy; provides high flow rates and low priming volumes to minimize dead space. Healthcare providers use the port to facilitate fluid delivery; benefits include reduced risk of accidental needle sticks and improved fluid management efficiency.

Clinical Evidence

Bench testing only. Comparative performance testing against Braun SafSite® and Medex Nu-Site™ evaluated fluid flow rate (≥150 cc/min), priming volume (<0.1 mls), and durability (100 activations). SLAV™ passed all tests; predicates failed priming volume requirements.

Technological Characteristics

Materials: ABS, Silicone, PVC, Polyethylene, Polypropylene. Sensing/Actuation: Mechanical two-piece silicone valve. Connectivity: None. Sterilization: ETO. Form factor: Heparin lock or Y-injection site ports, including J-loop and T-connector extensions.

Indications for Use

Indicated for single patient use in intravenous and blood administration.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Braun SafSite®
• Medex Nu-Site™

Submission Summary (Full Text)

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SLAV™ Injection Port Connector Systems Pre-Market Notification (510 k)
K 960111
Page 23 of 27

DEC 10 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 Silicone 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 |

RyMed Technologies, Inc.

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SLAV™ Injection Port Connector Systems Pre-Market Notification (510 k) Page 24 of 27

Summary of Technological Characteristics continuation...

| 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
≥ 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.

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SLAV™ Injection Port Connector Systems Pre-Market Notification (510 k) Page 25 of 27

# 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.


RyMed Technologies, Inc.