(90 days)
The intended use of the New Device is the establishment of pneumonperitoneum.
The ENDOPATH® Ultra Veress Insufflation Needle has applications in gynecologic laparoscopy and other minimally invasive abdominal procedures for establishment of pneumonperitoneum.
The ENDOPATH® Ultra Veress Insufflation Needle is a spring-loaded, blunt stylet safety mechanism similar in function to a Veress needle. It is used to establish pneumoperitoneum prior to abdominal endoscopy. The 14 gauge stainless steel needle is attached at its proximal end to a plastic handle. The handle is shaped for comfort in the hand and contains a stopcock and a luer lock connector for insufflating the abdominal cavity. Inside the needle sleeve and extending beyond the needle tip is a spring-loaded, blunt stylet. The stylet retracts as the needle is pushed through the abdominal tissue and automatically advances forward once the peritoneum is established.
The provided text describes a 510(k) summary for the ENDOPATH® Ultra Veress Insufflation Needle. This submission is for a medical device that establishes pneumoperitoneum, and as such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to a predicate device, rather than proving diagnostic performance in the way an AI algorithm or diagnostic test would be evaluated.
Here's the breakdown based on your request, adapted for this type of medical device submission:
Acceptance Criteria and Study for ENDOPATH® Ultra Veress Insufflation Needle
The acceptance criteria for the ENDOPATH® Ultra Veress Insufflation Needle are established by demonstrating that its performance is equivalent to a legally marketed predicate device. This is a common approach for 510(k) submissions, where the new device is shown to be substantially equivalent in terms of safety and effectiveness to an already approved device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Criteria (Acceptance Criteria) | Reported Device Performance |
|---|---|
| Flow Rate | Equivalent to Predicate Device |
| Spring Force to Deflect Stylet | Equivalent to Predicate Device |
| Audible Rate | Equivalent to Predicate Device |
| Needle Penetration | Equivalent to Predicate Device |
Note: The document explicitly states "From the data generated, it can be concluded that the New Device performed equivalent to the Predicate Device." This "equivalence" is the core of meeting the acceptance criteria for a 510(k) pathway.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes used for the bench tests. It broadly states "Bench data was used to evaluate the performance."
- Data Provenance: The studies were bench studies conducted by the manufacturer, Ethicon Endo-Surgery, Inc. The exact country of origin is not explicitly stated for the data generation, but the manufacturer is based in Cincinnati, Ohio, USA. The studies are prospective in the sense that they were designed and executed to evaluate the new device's performance against the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This question is not applicable to this type of device submission. The "ground truth" here is the established performance characteristics of the predicate device, not expert consensus on medical images or diagnoses. The FDA evaluates the submission based on engineering and performance data compared to the predicate, and does not involve experts establishing ground truth in the diagnostic sense for these comparisons.
4. Adjudication Method for the Test Set:
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or subjective interpretations. For objective bench performance tests comparing device characteristics, an adjudication method is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of a diagnostic aid (often AI) on human reader performance, usually in interpreting medical images or data. The ENDOPATH® Ultra Veress Insufflation Needle is a surgical instrument, and its evaluation focuses on physical performance characteristics rather than diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a form of "standalone" evaluation was done. The performance data presented (flow rate, spring force, audible rate, needle penetration) represent the intrinsic, standalone performance of the device itself, without a "human-in-the-loop" directly influencing these physical metrics during the test. The human element would be in using the device, but the tests evaluate its inherent mechanical and functional characteristics.
7. The Type of Ground Truth Used:
- The "ground truth" for this comparative evaluation is the established and legally marketed performance of the predicate device. The new device's performance metrics were compared to those of the predicate device to establish substantial equivalence.
8. The Sample Size for the Training Set:
This question is not applicable. The device is a mechanical surgical instrument, not an AI algorithm or a statistical model that requires a "training set" in the computational sense. The "training" for such a device would be the engineering design and manufacturing processes, not data-driven learning.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reasons as #8. There is no "training set" or corresponding ground truth establishment in the context of an AI or statistical model.
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.