(452 days)
The VECTEC Disposable Pneumoperitoneum Needle is a single-use, sterile device intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish a pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
The VECTEC Disposable Pneumoperitoneum Needle is a disposable, single-use, sterile surgical tool used in laparoscopy for insufflation of the abdominal cavity prior to use of a trocar during abdominal surgery. The device is sterilized using a traditional, validated ethylene oxide procedure per ISO 11135-1: 2007 to a SAL of 10t and with acceptable residual EO levels per ISO 10993-7: 2008.
The provided text describes a 510(k) submission for the VECTEC Disposable Pneumoperitoneum Needle, focusing on its substantial equivalence to predicate devices. The performance testing section details the types of tests conducted but does not specify numerical acceptance criteria or detailed performance metrics in the format you requested for AI/software devices. This document is for a physical medical device, not a software or AI device, which explains the absence of some of the requested information.
Here's an attempt to structure the available information according to your request, with an understanding that many fields will be "Not Applicable" or "Not Provided" due to the nature of the device and the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility (Cytotoxicity, Irritation, Sensitization) | Compliant with ISO 10993-1, -5, -10, -12 | "show acceptable results" and "composed of biocompatible materials" |
| Sterilization Validation | Compliant with ISO 11135-1: 2007, SAL of 10-6 | "traditional, validated ethylene oxide procedure" |
| Ethylene Oxide Residuals | Compliant with ISO 10993-7: 2008 | "acceptable residual EO levels" |
| Luer Lock operation | Functional (implicit, compared to predicate) | "acceptable results" (in comparison with predicate) |
| Spring assembly resistance | Functional (implicit, compared to predicate) | "acceptable results" (in comparison with predicate) |
| Disassembly test | Functional (implicit, compared to predicate) | "acceptable results" (in comparison with predicate) |
| Indicator tests | Functional (implicit, compared to predicate) | "acceptable results" (in comparison with predicate) |
| Needle puncture tests (in vivo) | Functional (implicit) | "acceptable results" |
| Gas flow tests of insufflation (in vivo) | Functional (implicit) | "acceptable results" |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated for each test. For mechanical bench testing, it's implied that "the predicate" (Ethicon Endopath Veress Needle) was used for comparison. For in vivo testing, the text mentions "a full-sized porcine model," but the number of models or tests performed is not specified.
- Data Provenance:
- Biocompatibility, Sterilization, EO Residuals: Laboratory testing.
- Mechanical Bench Testing: Benchtop testing, likely in a lab setting, comparing to a predicate device.
- In Vivo Testing: "full-sized porcine model," indicating animal testing. No country of origin is mentioned for the in vivo data.
- Retrospective or Prospective: These tests would be considered prospective for the purpose of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: For the in vivo testing, it states "conducted by a general surgeon." This implies at least one expert.
- Qualifications of Experts: "a general surgeon with experience in laparoscopy."
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not provided. The tests described are primarily objective performance tests or animal studies, not requiring human consensus for ground truth on a test set in the way a clinical image analysis study would.
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
- MRMC Study: No, this is not an AI or software device. This section is not applicable.
- Effect Size of AI assistance: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, this is not an AI or software device. This section is not applicable.
7. The type of ground truth used
- Ground Truth:
- For biocompatibility, sterilization, and EO residuals: Established standards and validated laboratory methods (e.g., ISO standards).
- For mechanical bench testing: Comparison against the established performance of a legally marketed predicate device (Ethicon Endopath Veress Needle).
- For in vivo testing (needle puncture, gas flow): Direct observation and assessment by a qualified surgeon in a porcine model. This would be considered 'expert observation' or 'functional demonstration'.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a physical device submission; there isn't a "training set" in the context of an AI/ML algorithm. The "training" here would refer to the design and refinement of the physical device based on engineering principles and prior knowledge of medical devices, which isn't described in terms of a data set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set in the AI/ML sense. The "ground truth" for the device's design and engineering would be based on established medical device requirements, engineering standards, and the performance characteristics of predicate devices, which the VECTEC device was designed to emulate or be equivalent to.
Summary of Device Type:
It's crucial to reiterate that the VECTEC Disposable Pneumoperitoneum Needle is a physical medical device, not an AI/software device. Therefore, many of the questions related to AI/ML specific concepts (such as test sets for algorithms, human readers, AI assistance, training sets, etc.) are not applicable to this submission. The "study" referenced refers to standard medical device performance testing (biocompatibility, sterilization, mechanical, and in vivo animal testing) to demonstrate substantial equivalence to legally marketed predicate devices.
§ 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.