(128 days)
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.
Habley Medical Technology Corporation S.A.R.S. II™ (Semi-Automatic-The 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 This consists of inwardly extending lugs positioned in the vial adapter mechanism. 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.
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.
The provided text describes a medical device, the Habley Medical Technology Corporation S.A.R.S. II™ (Semi-Automatic-Reconstituting-System), but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The document is a 510(k) summary, which typically focuses on describing the device, its intended use, and substantial equivalence to predicate devices, rather than detailed performance study results with acceptance criteria.
Therefore, I cannot populate the requested table or answer the specific questions based on the provided input. The input primarily details:
- Submitted By/Contact Person/Date Prepared: Administrative information.
- Device Name & Classification: Identification and regulatory status.
- Predicate Devices: Other similar devices on the market.
- Intended Use: What the device is designed for.
- Device Description: A detailed explanation of the device's components and how they work.
- Configurations: How the device will be packaged and sold.
To answer your questions, data from a separate performance study report or clinical trial would be required.
{0}------------------------------------------------
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 (714) 472-8080
2. Contact Person
Mr. Terry M. Haber Habley Medical Technology Corporation 22982 Alcalde Drive Laguna Hills, CA 92653 Telephone (714) 472-8080
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.
{1}------------------------------------------------
ഗ Predicate Devices
Vetter Lyo-Ject System, the Abbott ADD-Vantage System (K941545), and the UpJohn Mix-O-Vial.
Q. 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
Habley Medical Technology Corporation S.A.R.S. II™ (Semi-Automatic-The 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 This consists of inwardly extending lugs positioned in the vial adapter mechanism. 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.
{2}------------------------------------------------
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)
I I lalde
§ 880.5860 Piston syringe.
(a)
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.(b)
Classification. Class II (performance standards).