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510(k) Data Aggregation
(28 days)
Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing
The Riptide™ Aspiration Pump is intended as a vacuum source for Medtronic aspiration devices or systems for use in hospitals or clinics. Refer to the Instructions for Use included with the accessory aspiration device for indications related to the procedure for which this device will be used.
The Riptide™ Aspiration Pump is an externally powered electromechanical device capable of generating a vacuum designed for drawing fluids and thrombus into the Riptide™ Collection Canister during interventional procedures. It is intended for general suction use in hospitals or clinics and is not intended for transport or field applications. The Riptide™ Aspiration Pump includes a receptacle that holds the Riptide™ Collection Canister with Intermediate Tubing in place. The intermediate tubing is connected to the vacuum inlet port.
The Riptide™ Aspiration Pump package includes the following:
- Riptide™ Aspiration Pump (LMT-RAP)
- Region specific power cord for connection to earthed receptacle.
- Riptide™ Aspiration Pump User's Manual
The following item is required for use with Riptide™ Aspiration Pump (packaged separately):
- Riptide™ Collection Canister with Intermediate Tubing (LMT-RCT)
The Riptide™ Collection Canister is provided non-sterile and is pre-assembled with the Intermediate Tubing. The Riptide™ Collection Canister with Intermediate Tubing is single use. The Riptide™ Collection Canister is the repository for aspirated material. The Riptide™ Canister is placed into the receptacle of the Riptide™ Aspiration Pump as shown in Figure 3. The Intermediate Tubing is then connected to the vacuum inlet port.
Here's an analysis of the Riptide™ Aspiration Pump's acceptance criteria and the study proving it, based on the provided document:
This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive de novo clinical trial data. Therefore, the device's acceptance criteria are framed in terms of meeting established standards and matching the performance of a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Riptide™ Aspiration Pump are primarily based on compliance with international standards for medical electrical equipment and medical suction equipment, as well as demonstrating equivalent performance to the predicate device.
| Acceptance Criteria (Standard / Characteristic) | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601-1, Edition 3.2 2020-08) | Pass |
| Electromagnetic Compatibility (IEC 60601-1-2, Edition 4.1 2020-09) | Pass |
| User Manual Design Validation (FDA Guidance & ISO 14971, ANSI/AAMI HE75) | Pass (evaluated per FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices" and recognized consensus standards ISO 14971 and ANSI/AAMI HE75) |
| Medical Suction Equipment (ISO 10079-1, Fourth Edition 2022-03) | Pass |
| Medical Suction Equipment (ISO 10079-4, First Edition 2021-08) | Pass |
| Vacuum Range | 0-29 inHg (Same as predicate device Penumbra Pump MAX™) |
| Flow Rate (60 Hz US) | 0-0.8 SCFM (0-23 LPM) (Same as predicate device Penumbra Pump MAX™) |
| Voltage | 110-115 Vac (Comparable to predicate device 100-115 Vac) |
| Frequency | 60 Hz (US) (Same as predicate device Penumbra Pump MAX™) |
| Duty Cycle | Non-continuous: 97% (58.2 minutes on, 1.8 minutes off) (Compared to predicate device 97.8% (45 minutes on, 1 minute off) - changed to match reference device Riptide™ Aspiration System) |
| Applied Part Classification | Type CF (Same as predicate device Penumbra Pump MAX™; change from Reference Device Type BF to match predicate) |
| Noise |
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