(104 days)
The NDO Endoscopic Plication System (EPS) is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
The NDO Surgical Endoscopic Plication System (EPS) is a device that deploys a suture-based implant in the stomach near the Gastroesophageal Junction thereby creating a full thickness plication of the gastric cardia for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three procedural components: the Plicator instrument, the Plicator retractor and the Plicator implant cartridge. The implant cartridge and retractor are loaded onto the instrument and the instrument is then passed transorally into the stomach to create the plication. The Plicator instrument's shaft, which comes into contact with the patient, is made of polyurethane. The retractor is made of surgical grade stainless steel, with a polycarbonate sheath. The implant is comprised of two titanium retention bridges, 2.0 polypropylene suture and two ePTFE pledgets. The implant is housed in a disposable cartridge. Once the Plicator instrument has been introduced into the stomach, the retractor is engaged into the gastric cardia and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the implant is deployed, creating a full thickness, serosa-to-serosa plication.
Here's an analysis of the provided text regarding the NDO Surgical Endoscopic Plication System (EPS) and its acceptance criteria and supporting studies:
Acceptance Criteria and Device Performance
The submission focuses on modifications to a previously cleared device (predicate EPS) and demonstrates substantial equivalence. Therefore, the "acceptance criteria" are primarily established by the performance of the predicate device and the new device's ability to meet those same levels of safety and effectiveness, especially for the modified components and new features (like multiple implant deployment).
| Acceptance Criteria Category | Reported Device Performance (Modified EPS) |
|---|---|
| Moisture Ingress Inhibition | The modified leak test port design, cap, and seal reliably inhibit the ingress of moisture into the Plicator instrument during cleaning and high-level disinfection. |
| Instrument/Cartridge Compatibility & Implant Deployment | The modified Plicator instrument and implant cartridge are compatible and reliably deploy Plicator implants. |
| Biocompatibility | Biocompatibility testing confirmed acceptable and equivalent biocompatibility profiles of patient contact materials used in the modified Plicator instrument and implant cartridge as compared to materials present in the predicate instrument and implant cartridge. |
| Feasibility of Multiple Implants | Simulated use testing demonstrated the feasibility of safely deploying multiple, serially placed, Plicator implants. |
| Safety and Effectiveness for Symptoms of GERD (Multiple Implants) | Clinical testing demonstrated that serial placement of multiple, Plicator implants to form multiple, serial, full-thickness plications of the gastric cardia in close proximity to the anterior gastroesophageal junction safely and effectively treats the symptoms of gastroesophageal reflux disease. The submission concludes that "The serial placement of multiple Plicator implants... is equivalent in safety and effectiveness to single Plicator implant placement for the treatment of symptomatic gastroesophageal reflux disease." |
Study Information
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Sample Size used for the test set and the data provenance:
- Bench Testing: Not explicitly stated, but typically involves a specified number of samples for each test (e.g., a certain number of leak tests, implant deployments). The provenance is likely internal lab testing by NDO Surgical, Inc.
- Biocompatibility Testing: Not explicitly stated, but subject to ISO standards for medical device materials. The provenance refers to "patient contact materials" and comparisons to "predicate instrument and implant cartridge."
- Simulated Use Testing: Not explicitly stated regarding sample size. Provenance is likely in-house testing.
- Clinical Testing: Not explicitly stated regarding the number of patients or implants. The data provenance is "clinical experience with the predicate device" which implies a prospective or retrospective analysis of human use data, but the "clinical testing" for the modified device would be prospective. The statement "Clinical testing demonstrated that serial placement of multiple, Plicator implants... safely and effectively treats..." strongly suggests a clinical study was performed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for bench, biocompatibility, and simulated use testing which rely on objective measurements and established protocols.
- For the clinical testing, the "ground truth" would be the patient's GERD symptoms and their response to treatment, assessed by clinicians (likely gastroenterologists) as part of the study. The number of experts or their specific qualifications (e.g., years of experience) are not detailed in this summary.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for the types of tests described (bench, biocompatibility, simulated use).
- For clinical studies, adjudication methods (like independent review panels for adverse events or efficacy endpoints) are common, but this detail is not provided in this 510(k) summary.
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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:
- Not applicable. This device is a surgical instrument, not an imaging or diagnostic AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a manual surgical device with a human operator.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Testing: Objective physical measurements and functional performance tests (e.g., water ingress, implant deployment mechanics).
- Biocompatibility Testing: Compliance with established biocompatibility standards (e.g., ISO 10993).
- Simulated Use Testing: Observational data on successful and safe deployment in a controlled environment.
- Clinical Testing: Patient-reported symptoms of GERD, physician assessment of treatment response, and safety outcomes (adverse events). This falls under outcomes data and clinical assessment.
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The sample size for the training set:
- Not applicable. This is not a machine learning/AI device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. No training set is involved.
§ 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.