(87 days)
No
The description focuses on mechanical components and pressure monitoring, with no mention of AI/ML terms or functionalities.
No
The device is described as an "Inflation Device" intended for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon. It does not directly provide a therapeutic effect but rather supports the function of a therapeutic device (balloon dilatation catheter).
No
The device is described as creating and monitoring pressure in a balloon and deflating it, which is an interventional function, not a diagnostic one. It is used with balloon dilatation catheters, which are therapeutic devices.
No
The device description explicitly details physical components like a pressure gauge, syringe, plunger, tubing, and outer housing, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as being for use with balloon dilatation catheters to create and monitor pressure, and to deflate the balloon. This is a mechanical function used during a medical procedure, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details mechanical components like a syringe, pressure gauge, and tubing. These are tools for manipulating pressure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
The device is an accessory used in intravascular procedures, which are performed directly on the patient's circulatory system.
N/A
Intended Use / Indications for Use
The Encore 26 and Encore 30 Inflation Devices are intended for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
The Encore 26 and Encore 30 Advantage Kits are accessories used for general intravascular procedures.
Product codes
MAV
Device Description
The Encore 26 and Encore 30 Inflation Devices consist of a pressure gauge, a 20cc syringe, a plunger with a thread lock mechanism, a finger-actuated button for lock release and tubing with a male rotating luer for connection to a balloon dilatation catheter and an outer housing.
The Encore 26 and Encore 30 Advantage Kits consist of SCIMED's Avenue Insertion Tool (K922410), TD2 Torque Device (K922706), GateWay PLUS Y-Adapter (K951089), and the Encore 26 or Encore 30 Inflation Device.
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
Testing and evaluation of the Encore 26 was encompassed in the device leak testing of the Encore 30 Inflation Device. The alternate manufacturing process of insert molding was also evaluated for leak. Gauge accuracy testing was conducted on 26 and 30 atmosphere gauges. Test results verified that the inflation devices' design meet the minimum requirements and are adequate for their intended use. The SCIMED Encore 26 and Encore 30 Inflation Devices are considered substantially equivalent to inflation devices currently marketed by SCIMED, Merit Medical Systems, Inc., and Cordis Corporation based on a comparison of intended use, the design and the results of in-vitro testing and evaluation.
All components within the Encore 26 and Encore 30 Advantage Kits are currently marketed devices and labeled consistent with their premarket notifications; therefore, no testing of the individual devices was conducted.
Key Metrics
Not Found
Predicate Device(s)
SCIMED Encore™ Inflation Device, Merit® Monarch™ Inflation Device, Cordis® Reusable Inflation Devices, SCIMED Encore™ Advantage Kits, ACS® 20/20 Priority Pack
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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SECTION TWO--SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990) Prepared December 21, 1995
| I. | General Provisions: | |
|---|---|---|
| Submitter's Name and Address: | SCIMED Life Systems, Inc. | |
| One SCIMED Place | ||
| Maple Grove, Minnesota 55311 | ||
| Contact Person: | Diane M. Lowe | |
| (612) 494-2454 | ||
| Classification Name: | Class II, Balloon Inflation Syringe (74 MAV) | |
| Common or Usual Name: | Balloon Dilatation Pressure Gauge | |
| Proprietary Name: | SCIMED® Encore™ 26 Inflation Device | |
| SCIMED Encore™ 30 Inflation Device | ||
| SCIMED Encore™ 26 Advantage Kit | ||
| SCIMED Encore™ 30 Advantage Kit | ||
| II. | Name of Predicate Devices: | |
| SCIMED Encore™ Inflation Device | ||
| Merit® Monarch™ Inflation Device | ||
| Cordis® Reusable Inflation Devices | ||
| SCIMED Encore™ Advantage Kits | ||
| ACS® 20/20 Priority Pack |
III. Device Description:
The Encore 26 and Encore 30 Inflation Devices consist of a pressure gauge, a 20cc syringe, a plunger with a thread lock mechanism, a finger-actuated button for lock release and tubing with a male rotating luer for connection to a balloon dilatation catheter and an outer housing.
The Encore 26 and Encore 30 Advantage Kits consist of SCIMED's Avenue Insertion Tool (K922410), TD2 Torque Device (K922706), GateWay PLUS Y-Adapter (K951089), and the Encore 26 or Encore 30 Inflation Device.
1
IV. Intended Use:
The Encore 26 and Encore 30 Inflation Devices are intended for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
The Encore 26 and Encore 30 Advantage Kits are accessories used for general intravascular procedures.
V. Summary of Technological Characteristics:
The Encore 26 and Encore 30 Inflation Devices are similar to SCIMED's currently marketed Encore Inflation Device, except that the devices create and monitor higher pressures. The Encore 26 and Encore 30 syringe with integral y-connector is polycarbonate, the plunger tip is nylon with two polypropylene o-rings. The devices will use a solvent bond or an alternative method of insert molding to attach the polyurethane tubing to the male rotating luer and the y-connector. The Encore 26 and Encore 30 Inflation Devices are considered substantially equivalent to inflation devices currently marketed by SCIMED, Merit Medical Systems, Inc, and Cordis Corporation.
The components in the Encore 26 and Encore 30 Advantage Kits are identical to currently marketed components. The Encore Advantage Kits are considered substantially equivalent to kits currently marketed by SCIMED and ACS®.
VI. Non-clinical Test Summary:
Testing and evaluation of the Encore 26 was encompassed in the device leak testing of the Encore 30 Inflation Device. The alternate manufacturing process of insert molding was also evaluated for leak. Gauge accuracy testing was conducted on 26 and 30 atmosphere gauges. Test results verified that the inflation devices' design meet the minimum requirements and are adequate for their intended use. The SCIMED Encore 26 and Encore 30 Inflation Devices are considered substantially equivalent to inflation devices currently marketed by SCIMED, Merit Medical Systems, Inc., and Cordis Corporation based on a comparison of intended use, the design and the results of in-vitro testing and evaluation.
All components within the Encore 26 and Encore 30 Advantage Kits are currently marketed devices and labeled consistent with their premarket notifications; therefore, no testing of the individual devices was conducted.