(49 days)
The family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope is intended for physician use to examine the anal sphincter, anus, rectum, and to perform various diagnostic and therapeutic procedures by using additional accessories.
The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope are disposable, sterile rectoscopes, proctoscope and anoscopes with a light source which can be external or integrated on the handle. The devices are designed for the examination and treatment of anus (anoscopes) and the examination of rectum (proctoscopes and rectoscopes). The devices consist of plastic anoscopes, proctoscopes for diagnostic or therapeutic use. The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope is made by two categories of devices: Diagnostic Anoscopes, Proctoscopes and Rectoscopes and Surgical Proctoscopes. The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope includes both models which require the external light source and models which not require the external light source. In the latter case the light source is integrated on the handle. The external light source is provided as an accessory of the device family and it can be the THD Shining Light and the THD pen light.
The manufacturer, THD S.p.A., submitted a 510(k) premarket notification for a "Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope". This submission is for device modifications to an already approved product family (K103647). The modifications include the availability of THD Light-scope devices in sterile condition and changes to the handle materials (ABS Terluran and ABS Novodur replacing ABS Lustran).
The document does not describe a study involving AI, human readers, or a test set in the traditional sense of diagnostic or clinical performance studies. Instead, the provided text details design verification tests to ensure the updated device's safety and effectiveness due to manufacturing material and sterilization changes.
Here's an analysis based on the provided text, focusing on the acceptance criteria and the "study" (design verification tests) that proves the device meets them, as much as possible given the context of a medical device modification submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Modification | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterility of the products | Validation and effectiveness test | Safety and effectiveness of sterilization method | The design verification tests were performed as a result of the risk analysis assessment (Annex 4.2). A declaration of conformity with design controls is included in annex 1.1. (Implies satisfactory performance meeting criteria). |
| Packaging | Design verification | Product shelf life maintenance | The design verification tests were performed as a result of the risk analysis assessment (Annex 4.2). A declaration of conformity with design controls is included in annex 1.1. (Implies satisfactory performance meeting criteria). |
| Handle materials | Design verification | Safety and effectiveness of the materials | The design verification tests were performed as a result of the risk analysis assessment (Annex 4.2). A declaration of conformity with design controls is included in annex 1.1. (Implies satisfactory performance meeting criteria). |
2. Sample Size for the Test Set and Data Provenance
The document does not detail specific sample sizes for these design verification tests. The tests are related to material changes and sterilization processes, so "test set" here refers to the samples of the modified devices subjected to validation. The data provenance is internal to THD S.p.A., an Italian company, performing design verification tests for a 510(k) submission to the FDA. These would be prospective tests performed on the modified devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For these types of engineering and sterilization validation tests, "experts" typically refers to qualified engineers, microbiologists, and materials scientists involved in the testing and evaluation process. The document does not specify the number or qualifications of these experts. The "ground truth" for these tests is established by industry standards, regulatory requirements, and validated test methodologies for sterilization efficacy and material biocompatibility/durability.
4. Adjudication Method for the Test Set
Not applicable in the context of these design verification tests. Adjudication methods like 2+1 or 3+1 are used for clinical trial endpoints or image interpretation by multiple readers. Here, the outcome of the tests (e.g., successful sterilization, material integrity) is determined by objective measurements against established criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for device modifications concerning materials and sterilization, not a diagnostic AI device requiring clinical performance or human reader studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical instrument (anoscope, proctoscope, rectoscope, light-scope), not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for these design verification tests is based on:
- Sterilization Validation Standards: Demonstrating that the sterilization process achieves a specified sterility assurance level (SAL), typically accepted industry standards (e.g., ANSI/AAMI/ISO 11135 for ethylene oxide, or similar for other methods).
- Material Safety Standards: Demonstrating the biocompatibility and physical properties of the new handle materials meet safety and performance requirements, often referencing ISO standards (e.g., ISO 10993 for biocompatibility) and relevant engineering specifications.
- Packaging Integrity Tests: Ensuring the packaging maintains sterility and product integrity over the claimed shelf life, according to ISO and ASTM standards.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no training set in that context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm. The "ground truth" for the device's technical validation (as described above in point 7) is established through adherence to recognized international and national standards for medical device manufacturing, sterilization, and materials.
§ 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.