(28 days)
The Aquamantys single-use disposable Malleable Bipolar Sealer with Light is a sterile, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The Aquamantys Malleable Bipolar Sealer is similar to the Aquamantys 6.0 Bipolar Sealer, cleared via K#052859, in that they are comprised of a pencil-grip handle which houses an electrode terminating at the distal tip. The Aquamantys Malleable Bipolar Sealer is constructed of the same medical device grade materials as the Aquamantys 6.0 except for the LED light circuit and over molded shaft. All biocompatibility data is on file at TissueLink Medical, Inc. A summary is included in Section 5 of this submission. The manufacture of both devices is similar, consisting of an electrode tip/shaft assembly extending out of an ergonomically designed clamshell body. Both devices have two parallel (along the axis of symmetry) electrodes stemming from the handle that are approximately 4-6 millimeters apart. Both devices are electrically insulated, leaving only the tip of each shaft electrically active. Like the Aquamantys 6.0 Bipolar Sealer, each tip of the Aquamantys Malleable is a smooth stainle cylinder with a hemispherical end. Each tip is set at a downward angle between 0° - 45° along the long axis of the device. The Aquamantys 6.0 device has a slot located on each tip oriented lateral to the handle towards the outside of the device, allowing saline to flow from the inner lumen of the hypotube to the electrode. The Aquamantys Malleable device incorporates a hole instead of a slot, similarly oriented lateral to the handle towards the outside of the device. The saline wets the outer surface of the stainless steel electrode tip in a manner identical to the Aquamantys 6.0 Bipolar Sealer. The device is not intended for use without saline. Ten (10) feet of saline tubing and electrical cord are routed distally from the handle. The distal end of the disposable electrical cord contains a standard three (3) prong paddle plug for connection to the Aquamantys Pump Generator System. The saline tubing is connected to an I.V. pump segment. The L.V. pump segment contains a 6" pump tubing portion for loading into the Aquamantys Pump portion of the Aquamantys Pump Generator System and a Drip Chamber/spike set for connection to the saline delivery source. The simultaneous application of saline irrigation and radio-frequency energy allows coagulation of bleeding tissue at much lower temperatures than conventional dry radiofrequency coagulation. This prevents the formation of surface eschar. Most conventional electrosurgical devices create a surface eschar that is hard and scab-like. The Aquamantys Malleable Bipolar Sealer has an optional illumination provided by a LED light positioned between the electrodes at the distal end of the device. It can be switched on or off with a button located on the handpiece and is used to illuminate the surgical site if needed. The Aquamantys Malleable Bipolar Sealer also incorporates a malleable shaft that can be bent by the user into various positions, while maintaining the functionality as identified in the product specifications.
The provided text describes a Special 510(k) submission for the Aquamantys Malleable Bipolar Sealer with Light. This type of submission is used when a modification is made to an existing device that has already received 510(k) clearance, and the modification does not raise new questions of safety or effectiveness. As such, the study conducted is focused on demonstrating substantial equivalence to the predicate device, rather than establishing de novo performance metrics or diagnostic accuracies typically seen in AI/reader studies.
Therefore, many of the typical acceptance criteria and study details related to diagnostic accuracy, such as AUC, sensitivity, specificity, sample size for test sets with ground truth established by experts, MRMC studies, or standalone algorithm performance, are not applicable to this type of device and submission.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (How the new device performed) |
|---|---|
| Technological Characteristics Equivalence | Shares the same fundamental technology as the predicate device (Aquamantys 6.0 Bipolar Sealer). Technology is based on simultaneous saline irrigation and RF power delivery, operating with the Aquamantys Pump Generator. No modifications to the Pump Generator software required. |
| Materials Equivalence | Constructed of the same medical device grade materials as the predicate, except for the LED light circuit and over molded shaft. All biocompatibility data is on file. |
| Design Equivalence (Electrode & Saline Delivery) | Similar design to predicate device. The Malleable device incorporates a hole instead of a slot for saline delivery, but is "similarly oriented lateral to the handle towards the outside of the device" and "wets the outer surface of the stainless steel electrode tip in a manner identical to the Aquamantys 6.0 Bipolar Sealer." |
| Functionality (Malleable Shaft) | The malleable shaft can be bent by the user into various positions while maintaining functionality as identified in product specifications. |
| Functionality (Optional Illumination) | Optional illumination provided by an LED light, switchable on/off via a button on the handpiece, used to illuminate the surgical site. |
| Biocompatibility | All biocompatibility data is on file (for the materials used, which are mostly the same as the predicate). |
| Overall Performance Equivalence to Predicate | "The performance of this device is substantially equivalent to the predicate device and performs as intended." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The "test set" in this context refers to the modifications and features of the new device that were evaluated against the predicate device's established performance and specifications. This is not a clinical test set from patient data.
- Sample Size: Not applicable in the traditional sense of a clinical trial. The evaluation involved comparing the design, materials, and functional aspects of the new device to the predicate device and internal specifications.
- Data Provenance: Not applicable in terms of patient data origin. The data provenance would be from internal engineering and material testing within TissueLink Medical, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. Ground truth, in the sense of expert consensus on diagnostic findings, is not relevant for this engineering and equivalence testing. The "ground truth" here is the established function and safety of the predicate device and the design specifications of the new device.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring expert adjudication of findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not performed on these devices." This type of study focuses on device modifications and their impact on human interpretation or intervention, which isn't typically required for a Special 510(k) where substantial equivalence is demonstrated through engineering and performance testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/algorithm-based device. "Standalone performance" in this context would refer to the device's functional performance according to its specifications, which was implicitly done through nonclinical testing.
7. The Type of Ground Truth Used
- Engineering Specifications and Predicate Device Performance: The "ground truth" against which the new device was evaluated consisted of the established performance characteristics and safety profile of the predicate device (Aquamantys 6.0 Bipolar Sealer, K#052859) and internal engineering and quality specifications of TissueLink Medical, Inc.
- The goal was to demonstrate that the changes (malleable shaft, LED light, saline delivery hole instead of slot) did not alter the fundamental safety and effectiveness or introduce new risks, thus maintaining substantial equivalence to the predicate.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.