DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0
Device Facts
| Record ID | K964987 |
|---|---|
| Device Name | DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 |
| Applicant | Datascope Corp. |
| Product Code | DSP · Cardiovascular |
| Decision Date | Mar 17, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3535 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations: Refractory ventricular failure Cardiogenic shock Unstable refractory angina Impending infarction Mechanical complications due to acute myocardial infarction Ischemic related intractable ventricular arrhythmias Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients Septic shock Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation Support for failed angioplasty and valvuloplasty
Device Story
Intra-aortic balloon (IAB) catheter; placed in descending aorta below subclavian artery; provides mechanical circulatory support. Device functions by inflating/deflating balloon to improve cardiovascular hemodynamics. Used in clinical settings (OR, cath lab) by physicians. Output is hemodynamic support; assists cardiac output; reduces myocardial oxygen demand. Benefits include stabilization of patients in shock or during high-risk cardiac procedures.
Clinical Evidence
No clinical evaluation performed in the U.S. Substantial equivalence supported by in-vitro bench testing comparing functionality and performance to predicate devices.
Technological Characteristics
Intra-aortic balloon catheter. Dimensions and form factor identical to predicate devices. Materials modified in grade and chemical composition compared to predicates; verified via in-vitro testing. No software or electronic components described.
Indications for Use
Indicated for patients requiring cardiovascular support due to refractory ventricular failure, cardiogenic shock, unstable refractory angina, impending infarction, mechanical complications of acute myocardial infarction, ischemic-related intractable ventricular arrhythmias, high-risk surgical/angiography/angioplasty procedures, septic shock, weaning from cardiopulmonary bypass, intraoperative pulsatile flow generation, or failed angioplasty/valvuloplasty.
Regulatory Classification
Identification
An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.
Special Controls
*Classification.* (1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. The special controls for this device are:(i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device; (ii) Software verification, validation, and hazard analysis must be performed; (iii) The device must be demonstrated to be biocompatible; (iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; (v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and (vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device. (2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation. (c) *Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required.* A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 31, 2014, for any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976. Any other intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
Predicate Devices
- Datascope Percor STAT-DL® 9.5Fr. & 10.5Fr. Intra-Aortic Balloons (K940231 & K940178)
- Pediatric IAB (K905663)
- Datascope Type “S” IAB (K790775)
- 30cc/40cc Sensation™ IAB; Model 930/940 IAB’s (Boston Scientific Corp.) (K952221)
- 9.5 Fr. Sensation™ IAB (Boston Scientific Corp.) (K943919)
- 8.0 Fr. 30/40cc, 10.0 Fr. 50cc Sheathless IAB (Arrow International) (K961358)
Related Devices
- K031569 — DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX · Datascope Corp. · Jun 10, 2003
- K980780 — DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES · Datascope Corp. · May 29, 1998
- K980850 — BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS · C.R. Bard, Inc. · Jun 3, 1998
- K020257 — DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S · Datascope Corp. · Apr 24, 2002
- K973962 — BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS · C.R. Bard, Inc. · Feb 19, 1998
