(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 ) | 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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.