(60 days)
The Diversatek Healthcare PureFlo™ System (tubing and accessories to accommodate various gastrointestinal endoscopes and irrigation pumps) is intended to provide irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction pump or electrosurgical unit.
The Diversatek Healthcare PureFlo™ Auxiliary Water Jet Connector is used in conjunction with the PureFlo™ Irrigation Tubing and is intended to provide irrigation fluids such as sterile water supplied during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
The Diversatek Healthcare PureFlo™ Water Bottle Tubing is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
The Diversatek Healthcare PureFlo™ Water Bottle Tubing CO2 is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
This submission includes the Diversatek Healthcare PureFlo™ Irrigation System and Water Bottle Tubing. All devices within this submission are provided sterile.
The Diversatek Healthcare PureFlo™ Irrigation System (tubing and accessories to accommodate various gastrointestinal endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
The Diversatek Healthcare PureFlo™ Auxiliary Water Jet Connector is used in conjunction with the PureFlo™ Irrigation Tubing and is intended to provide irrigation via irrigation fluids such as sterile water supplied during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
The irrigation system consists of irrigation tubing and a single-use auxiliary water jet connector. The tubing is inserted into a water bottle and the cap is screwed on the water bottle. The roller pump tubing of the irrigation tubing is then positioned within one of the specified pumps. The tubing is then connected to the auxiliary water jet connector. The auxiliary water jet connector is then connected to the auxiliary water port of the endoscope. To activate the flow of water, the foot pedal of the pump is pressed. The tubing should be primed prior to insertion of the endoscope in the patient.
The auxiliary water jet connector is replaced after each patient. The irrigation tubing can be used for up to 24 hours on multiple patients.
The Diversatek Healthcare PureFlo™ Water Bottle Tubing is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
With the pinch clip open, the water bottle tubing is inserted into a water bottle and the cap is screwed on the water bottle. The endoscope connector is then connected to the air/water port on the Gl endoscope. The tubing is then primed prior to insertion of the endoscope in the patient.
The water bottle tubing can be used for up to 24 hours on multiple patients.
The Diversatek Healthcare PureFlo™ Water Bottle Tubing CO2 is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
The PureFlo™ Water Bottle Tubing CO2 is used with either air or CO2.
If using with air: With both blue and white pinch clips open, the water bottle tubing is inserted into a water bottle and the cap is screwed on the water bottle. The endoscope connector is then connected to the air/water port on the GI endoscope. The white pinch clamp is then closed. The tubing is then primed prior to insertion of the endoscope in the patient.
If using with CO2: With both blue and white pinch clips open, the water bottle tubing is inserted into a water bottle and the cap is screwed on the water bottle. The endoscope connector is then connected to the air/water port on the GI endoscope. The CO2 Connector / Luer Lock is then connected to the luer lock connection on the CO2 insufflator. The CO2 source and insufflator is then turned on. Then turn on the light source of the processor. The tubing is then primed prior to insertion of the endoscope in the patient.
The water bottle tubing CO2 can be used for up to 24 hours on multiple patients.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical performance testing for the Diversatek Healthcare PureFlo™ Irrigation System / Water Bottle Tubing units. While explicit "acceptance criteria" are not listed with numerical thresholds, the document states: "All test results passed, demonstrating that the device is as safe, as effective, and performs as well as or better than the predicate device." This implies that the acceptance criteria were defined by achieving outcomes comparable to or superior to the predicate devices and demonstrating safety and effectiveness.
| Test Performed | Implied Acceptance Criteria (Based on "passed" statement) | Reported Device Performance |
|---|---|---|
| 1. Device Specification Conformation | Device specifications met | Passed |
| 2. Leakage Test | No detectable leaks | Passed |
| 3. Irrigation Tubing Simulated Use Test | Functioned as intended during simulated use | Passed |
| 4. Pinch Clip Test | Pinch clip operated correctly and maintained integrity | Passed |
| 5. Water Bottle Tubing Simulated Use Test | Functioned as intended during simulated use | Passed |
| 6. Backflow Test | No backflow observed | Passed |
| 7. 24-Hour Simulated Use Test | Maintained performance and integrity over 24 hours of simulated use | Passed |
| 8. Tensile Test | Components maintained strength and integrity under tensile forces | Passed |
| Sterilization (EO Gas) | Sterility Assurance Level (SAL) of 10⁻⁶ achieved and maintained for 3 years shelf life | Passed (validated EO cycle, aging validation passed) |
| Biocompatibility (Cytotoxicity) | No cytotoxic effects | Passed |
| Biocompatibility (Sensitization) | No sensitization reactions | Passed |
| Biocompatibility (Intracutaneous Reactivity) | No adverse intracutaneous reactions | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact number of units used for each non-clinical test. It states "Diversatek Healthcare performed bench testing to support substantial equivalence. The following testing was performed on Diversatek Healthcare samples from final, finished devices that were subjected to all manufacturing processes for the 'to be marketed' device (including sterilization, environmental conditioning, and transportation)."
- Data Provenance: The data is from non-clinical bench testing performed by Diversatek Healthcare. It is prospective in the sense that fresh, "to be marketed" devices were used for testing. The country of origin of the data is not explicitly stated, but the submission is to the U.S. FDA, suggesting the testing was conducted to meet U.S. regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable as the described study is a non-clinical bench testing study, not a clinical study involving human experts or ground truth in that sense. The "ground truth" for these tests would be the established engineering and biological specifications and performance standards.
4. Adjudication Method for the Test Set:
This section is not applicable for the same reason as point 3. No human experts were involved in adjudicating outcomes for these bench tests. The results were likely assessed against predetermined engineering and biological standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical bench testing, not a clinical study comparing human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, this is not applicable. The device described (irrigation system/water bottle tubing) is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests was based on established engineering specifications, performance standards, and biological safety criteria (e.g., ISO 10993-1 for biocompatibility). The claim is for "substantial equivalence" to predicate devices, inferring that the performance benchmarks of the predicate devices also serve as a form of reference.
8. The Sample Size for the Training Set:
This section is not applicable. The device is not an AI/machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the same reason as point 8.
§ 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.