INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)

K962495 · Advanced Cardiovascular Systems, Inc. · MAV · Sep 12, 1996 · Cardiovascular

Device Facts

• Record ID: K962495
• Device Name: INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)
• Applicant: Advanced Cardiovascular Systems, Inc.
• Product Code: MAV · Cardiovascular
• Decision Date: Sep 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 PACK™: INDEFLATOR PLUS 30™ 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, arthrectomy devices, stent delivery systems, intravascular ultrasound devices.)

Device Story

Manually operated inflation device; pressurizes/depressurizes balloon catheters; monitors pressure via integrated gauge. PLUS 30 PRIORITY PACK includes inflation device plus accessories: torque device, guide wire introducer, rotating hemostatic valve. Used in vascular procedures by clinicians (physicians/technicians) to facilitate balloon dilatation, stent delivery, or diagnostic imaging. Output is controlled pressure applied to interventional devices; enables precise balloon inflation for vessel treatment. Benefits include controlled, monitored pressure delivery during interventional procedures.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence based on design and functional similarity to predicate devices.

Technological Characteristics

Mechanical inflation device; manual operation; integrated pressure gauge. Includes accessory kit (torque device, guide wire introducer, rotating hemostatic valve). No software or electronic components.

Indications for Use

Indicated for patients undergoing vascular procedures requiring inflation/deflation of interventional or diagnostic devices (e.g., balloon catheters, atherectomy devices, stent delivery systems, IVUS). No specific age or gender contraindications stated.

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 PLUS 20™ (K872981)
• ACS 20/30 INDEFLATOR™ (K961471)

Submission Summary (Full Text)

{0}

K962495
SEP 12 1996

# 510(k) Summary
## INDEFLATOR PLUS 30™ Inflation Device and PLUS 30 PRIORITY PACK™

**Device Name:** INDEFLATOR PLUS 30™ Inflation Device PLUS 30 PRIORITY PACK™

**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 PACK™:

INDEFLATOR PLUS 30™ 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, arthrectomy 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.

C. 14

{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 inflation 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 20™ 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 PACK™ are substantially equivalent to the currently marketed ACS INDEFLATOR PLUS 20™ Inflation Device and the INDEFLATOR PLUS 30™ mechanical inflation devices.