(128 days)
Not Found
No
The device description focuses on mechanical components and their interaction for drug reconstitution and delivery. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
This device is intended for the mixing and delivery of drugs to a receptacle, not for direct therapeutic treatment of a patient.
No
The device is intended for mixing a two-component drug and delivering it to a receptacle like an IV bag for subsequent patient administration. It does not perform any diagnostic function.
No
The device description explicitly details multiple physical components (syringe adapter assembly, vial adapter assembly, syringe) made of materials like stainless steel and elastomeric valves, indicating it is a hardware device, not software-only.
Based on the provided information, the Habley Medical Technology Corporation S.A.R.S. II™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "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." This describes a device used in the preparation and delivery of medication for direct patient treatment, not for testing samples taken from the human body.
- Device Description: The description details a system for reconstituting and transferring drugs, involving syringes, vial adapters, and fluid pathways. This aligns with a drug delivery or preparation device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
Therefore, the S.A.R.S. II™ falls under the category of a medical device used in the administration of drugs, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
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.
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Vetter Lyo-Ject System, Abbott ADD-Vantage System (K941545), UpJohn Mix-O-Vial.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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