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510(k) Data Aggregation
(262 days)
The devices, Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar, have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.
The proposed devices, Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar, are basic equipment used during laparoscopic surgical, which consist of Puncture Needle, Puncture Sleeve, Injection Valve, Cap and Safety lock. They are available in multiple configurations, including bladed type, bladeless type and optical type. In order to obtain access to the surgical site during laparoscopic surgery, the Puncture Needle is introduced into Puncture Sleeve to accomplish cannula penetration of the abdominal wall. The sleeve is connected to the Injection Valve at its proximal end and once the abdominal/thoracic wall is punctured, the puncture needle is removed. The sleeve acts as a channel for the introduction of the endoscopes and instruments. Generically, puncture needle and sleeve are available in a range of lengths and diameters to accommodate different sizes surgical instrument
Here's an analysis of the provided text regarding the acceptance criteria and study that proves the device meets them, structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes performance tests and states that the proposed devices performed comparably to predicate devices, concluding "no adverse indications or results." The "performance" column below summarizes the tests performed and the general findings.
| Test Category | Specific Test / Requirement | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Performance (Bench) | Instrument Insertion and Removal Force Test | Performance comparable to predicate devices | Met, results demonstrated substantial equivalence |
| Leak Resistance Test | Performance comparable to predicate devices | Met, results demonstrated substantial equivalence | |
| Snap Feature Retention Force Test | Performance comparable to predicate devices | Met, results demonstrated substantial equivalence | |
| Performance (In Vivo) | Penetration force (porcine model) | Performance comparable to predicate devices | Met, results demonstrated substantial equivalence |
| Fixation force (porcine model) | Performance comparable to predicate devices | Met, results demonstrated substantial equivalence | |
| Visualization performance (optical type, porcine model) | Performance comparable to predicate devices | Met, results demonstrated substantial equivalence | |
| Tip integrity after insertion (porcine model) | Performance comparable to predicate devices (no adverse findings) | Met, results demonstrated substantial equivalence | |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | No cytotoxicity | No cytotoxicity |
| Irritation and Sensitization (ISO 10993-10) | No irritation, no sensitization | No irritation, no sensitization | |
| Pyrogen Study (ISO 10993-11) | No pyrogen | No pyrogen | |
| Sterility & Packaging | Ethylene Oxide Sterilization Residuals (ISO 10993-7) | Compliant | Compliant (implied by meeting specification/requirements) |
| Seal Strength (ASTM F88/F88M-15) | Compliant | Met specifications and requirements (implied) | |
| Seal Leak Detection (ASTM F1929-15) | Compliant | Met specifications and requirements (implied) | |
| Endotoxin Limit (USP <85>) | 20 EU per device | 20 EU per device (for proposed and predicate) | |
| Other | SAL (Sterility Assurance Level) | 10^-6 | 10^-6 (for proposed and predicate) |
| Shelf life | 2 years (for proposed) | 2 years | |
| Packaging method | Sealing method | Sealing method | |
| Label/Labeling | Comply with 21, CFR Section 801 | Comply with 21, CFR Section 801 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for any of the performance or biocompatibility tests. The document only mentions "an in vivo study was conducted on porcine model" without specifying the number of animals or trials.
- Data Provenance: The tests were conducted by the manufacturer, Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. The in vivo study was done on a porcine model, indicating animal testing. The specific country where these tests took place is not stated, but the manufacturer is based in China. The data is prospective for the tests conducted to support this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The statement "results demonstrated that the performances of the proposed device are substantial equivalent to those of the predicate device" implies internal evaluation of test results, but no details on experts or their qualifications for establishing a "ground truth" are given for these types of tests (e.g., force measurements, leak resistance, biocompatibility).
4. Adjudication Method for the Test Set
- This information is not provided as these are objective performance and biocompatibility tests, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study was done."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable to this device. This is a physical medical device (trocar), not an AI algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
- The "ground truth" in this context refers to the objective measurements and established standards for physical device performance (e.g., force values, leak rates, biological response to materials, sterility assurance levels) as defined by international standards (ISO, ASTM, USP) and general safety/performance requirements for medical devices. The comparison is also made against the performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
- This question is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.
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