S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)

K955164 · Habley Medical Technology Corp. · FMF · Mar 20, 1996 · General Hospital

Device Facts

• Record ID: K955164
• Device Name: S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)
• Applicant: Habley Medical Technology Corp.
• Product Code: FMF · General Hospital
• Decision Date: Mar 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The Habley Medical Technology Corporation S.A.R.S. II™ (Semi-Automatic-Reconstituting-System) is intended for the mixing of an approved two component drug and for delivering the mixed drug (according to the drug labeling) to a receptacle such as an IV Bag for subsequent patient administration.

Device Story

Device facilitates mixing of two-component drugs; consists of syringe adapter assembly, vial adapter assembly, and piston syringe. User couples syringe adapter to piston syringe via Luer lock; vial adapter assembly secures drug vial via spring arms. Interlocking mechanism aligns activation pin; threading components together triggers piercing mechanism. Stainless steel cannula provides fluid pathway between syringe and vial. System allows transfer of diluent to vial for reconstitution and subsequent delivery to IV bag. Used in clinical settings by healthcare professionals. Benefits include standardized, semi-automatic reconstitution process reducing manual handling of drug components.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Mechanical drug reconstitution system. Components: syringe adapter assembly (elastomeric valve, needle cannula, coil compression springs, retaining plate), vial adapter assembly (threaded adapter, safety cup, spring arms, needle cannula, elastomeric seal), and standard piston syringe (21 CFR 880.5860). Fluid pathway: stainless steel cannula. Connectivity: none. Sterilization: provided sterile in blister pack. No software or electronic components.

Indications for Use

Indicated for the reconstitution of two-component drugs and delivery to a receptacle (e.g., IV bag) for patient administration. No specific patient population, age, or gender restrictions stated.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Vetter Lyo-Ject System
• Abbott ADD-Vantage System (K941545)
• UpJohn Mix-O-Vial

Submission Summary (Full Text)

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K955164

# 510(k) SUMMARY FOR THE HABLEY MEDICAL TECHNOLOGY CORPORATION S.A.R.S. II™ (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)

1. Submitted By
MAR 20 1996
Habley Medical Technology Corporation
22982 Alcalde Drive
Laguna Hills, CA 92653
Telephone [phone]

2. Contact Person
Mr. Terry M. Haber
Habley Medical Technology Corporation
22982 Alcalde Drive
Laguna Hills, CA 92653
Telephone [phone]

3. Date Prepared
November 8, 1995

4. Device Name
S.A.R.S. II™ (Semi-Automatic-Reconstituting-System)
Device Common or Usual Name
Drug Reconstitution System
Classification Status and Panel

These devices have not been classified by the Food and Drug Administration as of this date. However, Piston Syringes have been classified by the General and Plastic Surgery Devices Panel as Class II devices under 21 CFR 880.5860.

Habley Medical S.A.R.S. II™ 510(k)
11/9/95
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# 5. Predicate Devices

Vetter Lyo-Ject System, the Abbott ADD-Vantage System (K941545), and the UpJohn Mix-O-Vial.

# 6. Intended Use

## Intended Use

The Habley Medical Technology Corporation S.A.R.S. II™ (Semi-Automatic-Reconstituting-System) is intended for the mixing of an approved two component drug and for delivering the mixed drug (according to the drug labeling) to a receptacle such as an IV Bag for subsequent patient administration.

## Device Description

The Habley Medical Technology Corporation S.A.R.S. II™ (Semi-Automatic-Reconstituting-System) is made up of three components: 1) a syringe adapter assembly, 2) a vial adapter assembly, and 3) a syringe.

The syringe adapter assembly attaches to the piston syringe via a Luer lock connector. The syringe adapter assembly consists of a central cavity which houses an elastomeric valve. The needle cannula is situated within the elastomeric valve and is held in place by a retaining plate. A cannula carrier and coil compression springs are also contained in the syringe adapter assembly and are engaged when the three components are coupled together. When coupled the cannula passes through and is fixed to the cannula carrier. Movement of the cannula and cannula carrier against the coil compression spring causes extension into the interior and opens end of the barrel of the conventional syringe.

The piston syringe that attaches to the syringe adapter assembly is composed of a conventional piston syringe (21 CFR 880.5860). The syringe to be used with the S.A.R.S. II™ will be purchased from a manufacturer of legally marketed syringes. The S.A.R.S. II™ is compatible with any size piston syringe with a standard Luer lock fitting.

The vial adapter assembly attaches to the syringe adapter assembly via an interlocking mechanism. This consists of inwardly extending lugs positioned in the vial adapter assembly that are aligned with outer slots of a retainer ring on the syringe adapter assembly. The interlock of the two components cause an automatic alignment of the activation pin.

Habley Medical S.A.R.S. II™ 510(k)
11/9/95
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The vial adapter assembly includes the threaded vial adapter, safety cup, spring arms to secure the vial, needle cannula, and elastomeric seal. The spring arms activate the piercing mechanism after the components are threaded together. The safety cup size and shape is conformable to conventional drug vials. The syringe adapter assembly includes the elastomeric valves, needle cannula, and latches for attachment to vial adapter assembly or IV Bag. The needle cannula provides a stainless steel fluid pathway between the piston syringe and the vial of an approved drug component or drug.

The Habley Medical Technology Corporation S.A.R.S. II™ (Semi-Automatic-Reconstituting-System) will be commercialized in the following configurations:

- S.A.R.S. II™ including the vial and syringe adapter assemblies. This device will be packaged in a blister pack and provided sterile.
- S.A.R.S. II™ including the vial assembly and syringe adapter assemblies and a piston syringe having a volume of 5, 10, 20 or 30 ml.

Habley Medical S.A.R.S. II™ 510(k)
11/9/95
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