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

Intended 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.

Predicate Devices

• ACS INDEFLATOR 20/20™ (K872981)
• Baxter Inflation Pro™ II (K895836)

Submission Summary (Full Text)

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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 [phone]
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 [phone]
19112943