(78 days)
No
The device description explicitly states it is a "manually operated device" and the function is to "pressurize and depressurize balloon catheters" with pressure monitored via a "pressure gauge." There is no mention of any computational or analytical capabilities that would suggest AI/ML.
No.
The device is used to operate other interventional devices (like balloon catheters) by creating and monitoring pressure; it does not directly provide a therapeutic effect itself.
No
The device is described as an inflation device used to pressurize and depressurize balloon catheters and monitor pressure, primarily in conjunction with interventional or diagnostic devices, but it does not perform diagnostic functions itself. It is a tool used within a procedure.
No
The device description explicitly states it is a "manually operated device" and includes a "pressure gauge," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used "during vascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter." This describes a device used in vivo (within the body) to assist with a medical procedure, not a device used in vitro (outside the body) to examine specimens from the body for diagnostic purposes.
- Device Description: The description reinforces this by stating it's a "manually operated device used to pressurize and depressurize balloon catheters." This is a mechanical function performed during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the INDEFLATOR PLUS 30™ Inflation Device and the PLUS 30 PRIORITY PACK™ are medical devices used in interventional vascular procedures, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The INDEFLATOR PLUS 30™ Inflation Device is recommended for use during vascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter.
The PLUS 30 PRIORITY PACKTM:
INDEFLATOR PLUS 30TM Inflation Device- See description above.
PLUS 30 PRIORITY PACK™ Accessory Kit- The Accessory Kit is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices (e.g., balloon dilatation catheters, artherectomy devices, stent delivery systems, intravascular ultrasound devices.)
Product codes
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Device Description
INDEFLATOR PLUS 30™ Inflation Device is a manually operated device used to pressurize and depressurize balloon catheters. Pressure can be monitored via a pressure gauge.
The PLUS 30 PRIORITY PACK™ is comprised of the INDEFLATOR PLUS 30™ inflation device packaged with accessories used during vascular procedures in conjunction with interventional or diagnostic devices. These accessories include a torque device, a guide wire introducer and a rotating hemostatic valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
vascular procedures
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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
§ 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.
0
510(k) Summary INDEFLATOR PLUS 30™ Inflation Device and PLUS 30 PRIORITY PACKTM
Device Name: INDEFLATOR PLUS 30TM Inflation Device PLUS 30 PRIORITY PACKTM
Devices to which Equivalence is Claimed: ACS INDEFLATOR PLUS 20™ (K872981, October 20, 1987) and the ACS 20/30 INDEFLATOR™ (K961471, May 8, 1996).
Indication for Use: The INDEFLATOR PLUS 30™ Inflation Device is recommended for use during vascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter.
The PLUS 30 PRIORITY PACKTM:
INDEFLATOR PLUS 30TM Inflation Device- See description above.
PLUS 30 PRIORITY PACK™ Accessory Kit- The Accessory Kit is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices (e.g., balloon dilatation catheters, artherectomy devices, stent delivery systems, intravascular ultrasound devices.)
Device Description: INDEFLATOR PLUS 30™ Inflation Device is a manually operated device used to pressurize and depressurize balloon catheters. Pressure can be monitored via a pressure gauge.
The PLUS 30 PRIORITY PACK™ is comprised of the INDEFLATOR PLUS 30™ inflation device packaged with accessories used during vascular procedures in conjunction with interventional or diagnostic devices. These accessories include a torque device, a guide wire introducer and a rotating hemostatic valve.
1
Summary of Substantial Equivalence: The indications, methods and conditions of use, packaging process and location, sterilization process and location are similar to those of the currently marketed ACS INDEFLATOR PLUS 20™ Inflation Device and the ACS 20/30 INDEFLATOR™. The predicate ACS INDEFLATOR PLUS 20™ and the ACS 20/30 INDEFLATOR™, both mechanical infaltion devices, are intended to pressurize and depressurize balloon catheters while allowing pressure monitoring via a pressure gauge. The PLUS 30 PRIORITY PACK™ includes accessories that have been previously cleared and the INDEFLATOR PLUS 30™ Inflation device, which is similar to the ACS INDEFLATOR PLUS 20TM Inflation device.
The INDEFLATOR PLUS 30™ Inflation Device and the PLUS 30 PRIORITY PACK™ are similar in design and indicated use to the predicate devices.
Conclusion: The INDEFLATOR PLUS 30™ Inflation Device and PLUS 30 PRIORITY PACKTM are substantially equivalent to the currently marketed ACS INDEFLATOR PLUS 20™ Inflation Device and the INDEFLATOR PLUS 30™ mechanical inflation devices.