(21 days)
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.)
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.
This device submission, K961471, for the INDEFLATOR 20/30™ Inflation Device and 20/30 PRIORITY PACK™ does not contain information typically found in studies designed to establish acceptance criteria for AI/ML-based medical devices.
The document is a 510(k) Summary for a medical device that appears to be a manually operated mechanical inflation device for use in cardiovascular procedures. The submission focuses on demonstrating substantial equivalence to predicate devices (ACS INDEFLATOR 20/20™ and Baxter Inflation Pro™ II) based on similar indications, methods of use, design, and manufacturing processes.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria because the provided text describes a traditional medical device, not an AI/ML system. The concepts of "acceptance criteria" and "study" in the context of AI/ML performance (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training sets) are not relevant to this type of device submission.
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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.
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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
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§ 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.