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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.

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."

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The VECTEC Disposable Trocar and Laparoscopic Accessories are single-use, sterile devices intended to provide access to and visualization of body cavities, organs, and canals and to cut, dissect, manipulate, and/or cauterize various tissues during endoscopic/laparoscopic, general, vascular, gynecological and thoracic surgical procedures. Accessories include scissors, forceps, dissectors and a hook.

The VECTEC Disposable Trocars and Laparoscopic Accessories can be used in a variety of procedures (general, vascular, gynecological and thoracic surgical procedures) to cut, dissect, manipulate, and/or cauterize various tissues. Trocars are sterile, single-use devices that allow visualization of body cavities and use of the laparoscopic accessories. The accessory devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors, forceps, and dissectors have a handle attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. All devices are sterilized using a traditional, validated ethylene oxide procedure per EN 550:1994 to a SAL of 106 and with acceptable residual EO levels per ISO 0993-7:1995.

Here's a breakdown of the acceptance criteria and the study details for the VECTEC Disposable Trocars and Laparoscopic Accessories, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VECTEC device were based on demonstrating substantial equivalence to predicate devices, particularly regarding safety and performance. The primary performance criteria centered on the dielectric withstand testing requirements for electrosurgical devices.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a "test set" in the context of clinical data or patient samples. The performance testing described is bench electrosurgical device performance testing. Therefore, there is no information on sample sizes related to human or animal subjects, nor on data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be laboratory-based on the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to this submission. The "ground truth" for the performance testing was adherence to the ANSI/AAMI HF-18:2001 standard for dielectric withstand testing and comparison to the characteristics of predicate devices. This is a technical standard rather than a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable. Since there's no clinical test set requiring human interpretation or consensus, there's no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission relies on substantial equivalence to predicate devices and bench testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is not an algorithm or AI system. It is a physical medical device (trocars and laparoscopic accessories) designed for direct surgical use.

7. The Type of Ground Truth Used

The ground truth used for demonstrating the device's acceptable performance was primarily:

• Engineering Standards: Meeting the dielectric withstand testing requirements of ANSI/AAMI HF-18:2001.
• Predicate Device Equivalence: Direct comparison of technological characteristics, intended use, materials, and energy source compatibility with already legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this type of device.

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Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures where instruments are introduced into the body through a cannula.

The Microline ACCUSHEAR Laparoscopic Surgical Instruments are a line of nonsterile, reusable 5 mm diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula. The device is used with monopolar electrosurgical generators.

This is a 510(k) premarket notification for a medical device (ACCUSHEAR Laparoscopic Surgical Instruments), not an AI/ML medical device. Therefore, the concept of "acceptance criteria" and "study proving device meets acceptance criteria" as it applies to AI/ML performance metrics and studies is not directly applicable in the same way.

However, based on the provided text, I can infer the "acceptance criteria" for this device from the perspective of substantial equivalence to a predicate device, and the "study" is the information provided in the 510(k) submission itself that demonstrates this equivalence.

Here's how I can interpret and answer your request in the context of this specific regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device 510(k), the "acceptance criteria" is typically demonstrating substantial equivalence to a legally marketed predicate device. The "performance" is that the new device performs as safely and effectively as the predicate, with no new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance

This is not applicable for this type of device and submission. There is no "test set" in the context of an AI/ML device relying on data. The submission relies on a comparison of the device's design and intended use to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. There is no ground truth, test set, or expert review in this sense for a traditional surgical instrument 510(k). The "ground truth" is established by the existing regulatory clearance and safe market history of the predicate devices.

4. Adjudication method for the test set

This is not applicable. There is no test set or adjudication method for this type of submission.

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

This is not applicable. This is not an AI/ML device, and no MRMC study would be performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is not an AI/ML device.

7. The type of ground truth used

For a traditional 510(k) like this, the "ground truth" (if you can call it that) is the demonstration of substantial equivalence to a legally marketed device that has already established its safety and effectiveness. This is based on:

• Predicate Device History: The predicate devices ("Re-New" K962119 and "Selec-Tip" K980758) have already been cleared by the FDA, implying their safety and effectiveness have been appropriately assessed.
• Design Rationale: The manufacturer's rationale that the minor modification to the shaft and handpiece connection does not affect safety or effectiveness.

8. The sample size for the training set

This is not applicable. This is not an AI/ML device, and there is no training set.

9. How the ground truth for the training set was established

This is not applicable. There is no training set for this type of device.

In Summary for this Specific Device:

The "study" proving the device meets "acceptance criteria" for a 510(k) is the submission itself, which articulates:

• The device's description and intended use.
• The identification of predicate devices with established safety and effectiveness.
• A detailed comparison demonstrating that the new device is substantially equivalent to the predicate, particularly highlighting that any modifications are minor and do not introduce new safety or effectiveness concerns.

The FDA's review of this submission and subsequent clearance (K982984) serves as the "proof" that the device meets the regulatory acceptance criteria for market entry via the 510(k) pathway.

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