(76 days)
The reprocessed closure systems are intended to pass sutures through soft tissue during endoscopic/laparoscopic surgery.
The closure system is a set of three components; consisting of one suture passer, one 5mm guide and one 10/12mm guide. The suture passer has a stainless steel shaft with a pointed tip that opens on one side to grasp the suture and a polycarbonate handle with a ring that actuates the tip. The 5mm and 10/12mm guides are made of polycarbonate with a cylindrical head on the proximal end connected to a shaft that tapers to a tip on the distal end. Each guide has two holes in the cylindrical head that pass through to opposite sides of the shaft. The holes allow the suture passer to be passed through the guide.
This document is a 510(k) Premarket Notification submission for a reprocessed medical device, not an AI/ML device. Therefore, the questions regarding acceptance criteria and study specifically for an AI/ML device, such as sample size for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, and standalone algorithm performance, are not applicable.
However, I can provide information based on the device's functional and safety testing as described in the document.
Acceptance Criteria and Device Performance for Reprocessed Closure Systems
This document describes the premarket notification for Reprocessed Closure Systems by Sterilmed, Inc. The core claim is substantial equivalence to the predicate device, the Cooper Surgical Carter-Thomason CloseSure System® (K980123). The "acceptance criteria" here refer to meeting performance standards comparable to the original device and demonstrating that the reprocessing does not compromise safety or effectiveness.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Functional Performance | - Simulated Use: Bench testing through simulated use. |
- Visual Inspection: Visual inspection of the reprocessed devices.
- Fatigue Testing: To assess durability and integrity over repeated use (if applicable to the device's design life).
- Function Testing: Direct testing of the device's ability to perform its intended function. | "Performance testing shows the reprocessed closure systems to perform as originally intended." This implies that the reprocessed devices met the functional specifications of the original device under simulated conditions, passed visual checks, and demonstrated sufficient durability for their intended use. The document explicitly states: "The reprocessed closure systems are identical to the predicate devices in design, materials of construction, and intended use. There are no changes to the clinical applications, patient population, performance specifications, or method of operation." This suggests the performance standards for the reprocessed device are the same as the predicate. |
| Cleaning Validation | Validation of the cleaning procedures to ensure removal of contaminants. | Performed. The implication is successful validation, meeting established standards for cleanliness. |
| Sterilization Validation | ISO 11135: Validation of ethylene oxide sterilization.
USP : Sterility tests. | Performed. The implication is that the sterilization process renders the devices sterile, meeting the requirements of ISO 11135 and USP . |
| Biocompatibility Testing | ISO 10993 Part 18: Chemical characterization of materials to assess potential biological risks. | Performed. This implies that the materials, after reprocessing, remain biocompatible and do not pose unacceptable risks of toxicity or irritation to human tissue. |
| Ethylene Oxide Residuals | ISO 10993-7: Testing for residual ethylene oxide after sterilization. | Performed. This implies that ethylene oxide levels are within safe limits after the sterilization process. |
| Packaging Validation | ASTM D 4169: Performance testing of shipping containers and systems.
ASTM F 88: Seal strength of flexible barrier materials.
ASTM F 2096: Detecting gross leaks in medical packaging by internal pressurization (bubble test). | Performed. This indicates the packaging maintains the sterility of the device until point of use and withstands typical handling and shipping stresses. |
| Shelf Life Validation | ASTM 1980: Accelerated aging to determine shelf life. | Performed. This confirms that the device and its packaging maintain integrity and functionality over its claimed shelf life. |
| Manufacturing Process | Visual and validated functional testing of all products produced. | "The manufacturing process includes visual and validated functional testing of all products produced." This implies ongoing quality assurance ensuring individual reprocessed devices meet specifications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a numerical sample size for the functional and safety testing. It refers to "Representative samples" of reprocessed closure systems being tested. The testing appears to be prospective, carried out as part of the premarket notification process for the reprocessed device. Data provenance is not explicitly mentioned but is assumed to be from Sterilmed, Inc.'s internal testing facilities in the US (Maple Grove, MN).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as this is a submission for a mechanical medical device (reprocessed surgical instruments), not an AI/ML or diagnostic device that requires expert ground truth establishment in the traditional sense. The "ground truth" here is the established performance and safety profile of the original, new device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing consensus among human readers for diagnostic image interpretation or similar tasks, which is not relevant for the functional and safety testing of a reprocessed mechanical surgical instrument.
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
This is not applicable. MRMC studies are used for evaluating diagnostic performance of imaging devices or algorithms with human readers. This submission is for a reprocessed surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this reprocessed device is primarily derived from the design specifications, performance standards, and safety profile of the original, new predicate device (Cooper Surgical Carter-Thomason CloseSure System®). The testing conducted (functional, cleaning, sterilization, biocompatibility, etc.) aimed to demonstrate that the reprocessed device meets these established standards, effectively performing "as originally intended."
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of a reprocessed mechanical device. The "training" for the reprocessing process itself would involve process validation using a certain number of devices, but this is not analogous to an AI/ML training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above. The "ground truth" for process validation would be the successful demonstration of the ability of the reprocessing methods to consistently return the device to its "as new" functional and safety state.
§ 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.