INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)
K961471 · Advanced Cardiovascular Systems, Inc. · MAV · May 8, 1996 · Cardiovascular
Device Facts
Record ID
K961471
Device Name
INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)
Applicant
Advanced Cardiovascular Systems, Inc.
Product Code
MAV · Cardiovascular
Decision Date
May 8, 1996
Decision
SESK
Submission Type
Traditional
Regulation
21 CFR 870.1650
Device Class
Class 2
Attributes
Therapeutic
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 catheters, artherectomy devices, stent delivery systems, intravascular ultrasound devices.)
Device Story
Manually operated inflation device; creates and monitors pressure in balloon catheters during cardiovascular procedures. Includes pressure gauge for monitoring. 20/30 PRIORITY PACK™ includes inflation device plus accessories: torque device, guide wire introducer, rotating hemostatic valve. Used by clinicians in cardiovascular settings to facilitate interventional/diagnostic device deployment. Output is controlled pressure for balloon inflation; enables physician to perform angioplasty or stent delivery. Benefits patient by allowing precise control of interventional device expansion.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Manually operated mechanical inflation device. Includes pressure gauge, torque device, guide wire introducer, and rotating hemostatic valve. Non-powered. No software or electronic components.
Indications for Use
Indicated for use during cardiovascular procedures requiring inflation/monitoring of interventional devices (e.g., balloon catheters, stent delivery systems, atherectomy devices, IVUS). No specific patient population or contraindications defined.
Regulatory Classification
Special Controls
*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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GUIDANT
K961471
# 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 catheters, artherectomy 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
P0 128 43
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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 similar 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
19112943
