(146 days)
The PARE Endoscopic Suturing System will allow the surgical physician to suture soft tissue when doing gastroenterological procedures using the operating channel of a flexible endoscope.
The PARÉ Endoscopic Suturing System consists of three concentric tubes and a wire that can fit down the operating channel of a flexible endoscope. Each of the concentric tubes controls a function that is required to do soft tissue suturing at the distal end of the endoscope. These functions include:
- A needle, which is used to puncture through the soft tissue 1.
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- A loop, which is used to capture the free end of the suture.
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- A holder for the suture that is formed into a pre-tied knot.
- A knot pusher, which also performs the function of cutting the suture once the knot is positioned and formed.
The device will be loaded only with sutures that have received FDA approval for human use.
The provided text describes the 510(k) summary for the PARE Endoscopic Suturing System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report as one might find in a peer-reviewed publication or a full PMA.
Here's the breakdown of the information requested based only on the provided text:
Acceptance Criteria and Device Performance Study (PARE Endoscopic Suturing System)
This submission focused on demonstrating substantial equivalence, not on fulfilling specific quantitative acceptance criteria in the same way a new, high-risk device might. The "performance data" section is very brief and qualitative.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Acceptance Criteria (derived from performance data description): | |
| 1. Ability to suture soft tissue in fresh swine esophagus, stomach, and colon. | The materials chosen for the device meet the established specifications necessary for consistent performance of its intended use. The device was able to suture the soft tissue, including the dropping of the pre-tied knot. |
| 2. Compatibility and functionality within existing endoscope operating channels (specifically Olympus Colonoscope type CF-1T140 and Olympus Gastroscope type GIF-PQ20). | (No explicit acceptance metric for this, but implies successful operation) |
Notes on Acceptance Criteria and Performance:
The document does not detail specific, quantitative pass/fail criteria (e.g., "tensile strength of suture line > X N," "suture placement accuracy within Y mm"). Instead, it broadly states that materials meet specifications and the device was able to suture.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The device was "in-vitro tested six times using the operating channel of an Olympus Colonoscope type CF-1T140 and six times using an Olympus Gastroscope type GIF-PQ20." This implies a total of 12 in-vitro tests. The tissue types used were "fresh swine esophagus, stomach and colon soft tissue." The exact number of each tissue type is not specified.
- Data Provenance: The data is from in-vitro bench testing using fresh swine tissue. The country of origin for the data is not specified, but the applicant company is based in Colorado, USA. The study is prospective in the sense that the tests were conducted specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not report on the use of experts to establish ground truth for this bench study. The performance evaluation appears to be based on the direct observation of successful suturing and knot dropping by the testers.
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Adjudication method for the test set:
- Not applicable / Not reported. There is no mention of an adjudication method, as the study appears to be a direct bench test observation rather than an expert-read case review.
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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:
- No. This device is a mechanical endoscopic suturing system, not an AI or diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm. Its operation inherently involves a human physician.
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The type of ground truth used:
- The ground truth for this bench test appears to be the direct observation of the mechanical functionality of the device: "In all experiments the device was able suture the soft tissue including the dropping of the pre-tied knot." This is an objective observation of the successful completion of the intended physical action.
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The sample size for the training set:
- Not applicable / Not reported. This is a mechanical device, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable. As above, no training set was used.
§ 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.