(21 days)
Not Found
No
The device description explicitly states it is "manually operated" and the function is to "pressurize and depressurize balloon catheters" with pressure monitored via a "pressure gauge." There is no mention of AI, ML, or any computational processing beyond basic pressure monitoring.
No
The device is used to operate other interventional or diagnostic devices (e.g., balloon catheters) and is not itself a therapeutic device.
No
The device is described as an "Inflation Device" used to pressurize and depressurize balloon catheters and monitor pressure; its primary function is operational during interventional procedures, not data collection or analysis for diagnosis. While an accessory kit mentions use with "diagnostic devices," the device itself is not presented as having a diagnostic function.
No
The device description explicitly states it is a "manually operated device" with 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/Indications for Use: The device is used during cardiovascular procedures in conjunction with interventional devices like balloon catheters to create and monitor pressure. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description reinforces its function as a manually operated device for pressurizing and depressurizing balloon catheters, again, a direct action during a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely procedural and interventional.
N/A
Intended Use / Indications for Use
INDEFLATOR 20/30™ Inflation Device- The INDEFLATOR 20/30™ Inflation Device is recommended for use during cardiovascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter.
20/30 PRIORITY PACK™ Accessory Kit- The Accessory Kit is recommended for use during cardiovascular procedures in conjunction with interventional and/or diagnostic devices (e.g., balloon dilatation catherectomy devices, stent delivery systems, intravascular ultrasound devices.)
Product codes
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Device Description
The INDEFLATOR 20/30™ Inflation Device is a manually operated device used to pressurize and depressurize balloon catheters. Pressure can be monitored via a pressure gauge.
The 20/30 PRIORITY PACK™ is comprised of the INDEFLATOR 20/30™ 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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
SUMMARY OF SAFETY AND EFFECTIVENESS 510(k) Summary
INDEFLATOR 20/30™ Inflation Device and 20/30 PRIORITY PACK™
Device Name: INDEFLATOR 20/30™ Inflation Device 20/30 PRIORITY PACK™ Accessory Kit
Devices to which Equivalence is Claimed: ACS INDEFLATOR 20/20™ (K872981, October 20, 1987 and Baxter Inflation Pro™ II inflation device (K895836, December 20, 1989).
Indication for Use:
INDEFLATOR 20/30™ Inflation Device- The INDEFLATOR 20/30™ Inflation Device is recommended for use during cardiovascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter.
20/30 PRIORITY PACK™ Accessory Kit- The Accessory Kit is recommended for use during cardiovascular procedures in conjunction with interventional and/or diagnostic devices (e.g., balloon dilatation catherectomy devices, stent delivery systems, intravascular ultrasound devices.)
Device Description:
The INDEFLATOR 20/30™ Inflation Device is a manually operated device used to pressurize and depressurize balloon catheters. Pressure can be monitored via a pressure gauge.
The 20/30 PRIORITY PACK™ is comprised of the INDEFLATOR 20/30™ 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.
GUIDANT CORPORATION ADVANCED CARDIOVASCULAR SYSTEMS 26531 YNEZ ROAD P.O. BOX 9810 TEMECULA, CA 92591-4628 TEL. 909-914-2400
Image /page/0/Picture/13 description: The image shows a combination of handwritten numbers and a symbol. The number '190' is written in a cursive style at the top left. Below it, the number '12' is written, followed by a semicolon and the number '8'. To the right of these numbers, there is a black symbol that resembles a stylized letter or shape.
1
GUIDANT
SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
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 20/20™ Inflation Device. The 20/30 PRIORITY PACK™ includes accessories that have been previously cleared and the INDEFLATOR 20/30™ Inflation device, which is similar to the ACS INDEFLATOR 20/20™ Inflation device. The indications for use are similar to the Baxter Edwards Inflation Pro™ II.
The INDEFLATOR 20/30™ Inflation Device is smilar in design and indicated use to the predicate devices.
Conclusion: The INDEFLATOR 20/30™ Inflation Device is substantially equivalent to the currently marketed ACS INDEFLATOR 20/20™ and the Baxter Edwards Inflation Pro™ II.
GUIDANT CORPORATION ADVANCED CARDIOVASCULAR SYSTEMS 26531 YNEZ ROAD P.O. BOX 9810 TEMECULA, CA 92591-4628 TEL 909-914-2400
$\mathbb{R}_{129}$