(219 days)
Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures.
The subject device ReNew V Handpiece Laparoscopic Instruments is a modification to its legally marketed predicate device ReNew Laparoscopic Instruments (K962119). The predicate device ReNew Laparoscopic Instruments (K962119) included the Reusable Hand Piece and the Disposable and Reusable Scissor Tips. The incremental modifications declared in this Traditional 510(k) Submission apply to the subject device ReNew V Handpiece Laparoscopic Instruments which is a Reusable Handpiece (Handle/Shaft) Assembly only. There are no changes to the predicate Disposable and Reusable Scissor Tips (K962119).
The subject device ReNew V Handpiece Laparoscopic Instruments feature a 5mm diameter shaft for use when introduced with 5, 10/11, and 12mm instrument ports of a laparoscope or a cannula. The subject device is made of five (5) primary components, which include: Handle, Contact Pin Assembly, Turning Knob, Shaft Assembly and Flushing Port. The subject device includes variable configurations of 25cm, 34cm, and 42cm lengths; and it will be available in two optional configurations as a non-ratcheted or ratcheted Handpiece.
The subject device ReNew V Handpiece Laparoscopic Instruments can be used to deliver Monopolar High-Frequency (HF) electrical current through the active electrode contacting the patient for cutting or coagulation, dispersing energy through the patient to an inactive patient return electrode and back to the High-Frequency (HF) Generator. The subject device can be used with a U.S. FDA cleared Electrosurgical High-Frequency (HF) Generator which complies with the IEC 60601-1-2 EMC (Electromagnetic Compatibility) testing requirements. The subject device will be marketed with two (2) accessories, which include; Ring Inserts, and Cautery Post. In accordance to 21 CFR § 801.109, Subpart D, the subject device labeling is intended for Prescription use (Rx) only.
The provided text describes a 510(k) submission for the "ReNew V Handpiece Laparoscopic Instruments" and indicates that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device (ReNew Laparoscopic Instruments, K962119).
Crucially, the document does not contain acceptance criteria for specific performance metrics nor does it detail a study that proves the device meets such criteria in terms of clinical effectiveness. Instead, the submission focuses on demonstrating substantial equivalence through engineering and biocompatibility testing, asserting that there were no safety or effectiveness issues raised in these tests, and that the fundamental technology and intended use are identical to the predicate device.
Therefore, many of the requested items (like sample sizes for test and training sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable because the device's substantial equivalence was established through non-clinical performance and biocompatibility testing, not clinical performance studies with specific metrics for diagnostic or therapeutic efficacy.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) summary for a surgical instrument, the "acceptance criteria" are primarily related to safety, functionality, and manufacturing quality, rather than clinical performance metrics. The document states that testing was performed against the device's performance specifications criterion, but doesn't list the specific numerical acceptance criteria.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance | No safety or effectiveness issues raised in bench testing results for: axial pull, impact, thread shear, ball pull, autoclave, electrical handle, insulation tube adhesion, flushing flow, insufflation, stiffness, trocar, tip torque, ratchet strength. |
| Electrical Safety | No safety or effectiveness issues raised in bench testing results for electrical safety. Compatible with US FDA cleared Electrosurgical High-Frequency (HF) Generator complying with IEC 60601-1-2 EMC. |
| Biocompatibility | No safety or effectiveness issues raised in the biocompatibility testing results for: Cytotoxicity, Kligman Maximization Test, Intracutaneous Injection Test, Acute Systemic Injection, Rabbit Pyrogen Test (Material Mediated). |
| Sterilization & Cleaning | Performance demonstrated for automated and manual sterilization and cleaning. |
| Distribution & Packaging | Performance demonstrated for distribution and packaging. |
| Design Control | Assessed in accordance with 21 CFR § 820 (QSR) and internal procedures. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated for each test. The testing was bench-based (laboratory), not clinical data from patients.
- Data Provenance: The testing was conducted by Microline Surgical, Inc. in the USA as part of their internal quality system and product development procedures. It is prospective in the sense that the tests were performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. Ground truth, in the context of expert consensus for clinical data, is not relevant here as the evaluation was based on engineering and laboratory testing of the device itself, not interpretation of clinical outcomes or images by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of clinical data. This was a technical/engineering evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a surgical instrument (handpiece) and not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a manual surgical instrument and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the clinical sense. The "ground truth" for each specific test (e.g., axial pull, electrical safety, biocompatibility) would be defined by the relevant engineering standards, material specifications, and regulatory requirements that the device was tested against. For instance, in biocompatibility, the ground truth is the absence of a cytotoxic or allergenic response as defined by ISO standards.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" described is a series of bench performance tests and biocompatibility tests. The document states:
- "The bench performance testing was performed based upon the subject device Renew V Handpiece Laparoscopic Instruments performance specifications criterion to determine the substantial equivalence with its legally marketed predicate device."
- "A full design verification testing was performed including the following: axial pull, impact, thread shear, ball pull, autoclave, electrical handle, electrical safety, insulation tube adhesion, flushing flow, insufflation, stiffness, trocar, tip torque, ratchet strength, biocompatibility, sterilization and cleaning (automated and manual), distribution and packaging testing."
- "There were no safety or effectiveness issues raised in the bench testing results."
- Biocompatibility testing was conducted pursuant to ISO 10993-1:2009/AC: 2010 and 21 CFR Part 58, covering Cytotoxicity, Kligman Maximization Test, Intracutaneous Injection Test, Acute Systemic Injection, and Rabbit Pyrogen Test.
- "There were no safety or effectiveness issues raised in the biocompatibility testing results."
This body of non-clinical evidence demonstrated that the modified device, the ReNew V Handpiece Laparoscopic Instruments, maintained the safety and performance characteristics of its predicate device, thereby supporting its "Substantial Equivalence" determination by the FDA. No animal or human clinical performance data was deemed necessary for this 510(k) submission, as there was "no change to the fundamental technology and intended use."
§ 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.