(90 days)
The device is intended for use in the irrigation of the ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures.
The I.V. Piggyback Irrigating System is designed with a releasably mounted modular endoscope valve assembly. It is designed for controlled irrigation through an endoscope during urological and/or endoscopic procedures. The design of the valve allows the irrigation to be controlled between the finger and the thumb of the hand holding the endoscope, leaving the other hand completely froe for stone extraction, lithotripsy, or biopsy.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Kosin Technologies, LLC Piggyback Irrigating System:
Acceptance Criteria and Device Performance
The provided document describes a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than establishing novel safety and effectiveness criteria. Therefore, the "acceptance criteria" are primarily based on demonstrating comparable performance and characteristics to the predicate device, the C.R. Bard Syringe Assist Irrigation System.
The table below summarizes the key comparative performance aspects mentioned in the document:
| Acceptance Criteria (inferred from predicate comparison) | Kosin Piggyback Irrigating System (Reported Device Performance) | C.R. Bard Syringe Assist Irrigation System (Predicate Performance) |
|---|---|---|
| Intended Use | Irrigation of ureter and renal pelvis during therapeutic and diagnostic ureteroscopy/ureteropyescopy. Manual control of irrigation flow. | Irrigation of ureter and renal pelvis during therapeutic and diagnostic ureteroscopy/ureteropyescopy. Connects to endoscope with standard luer adapters. |
| Users | Hospitals, clinics, laboratories | Hospitals, clinics, laboratories |
| Materials | Polycarbonate, nylon, PVC, thermoplastic elastomer, silicone rubber, stainless steel | Natural Rubber Latex, polycarbonate, PVC, lubricant |
| Lubricant Composition | Medical grade silicone | Medical grade silicone |
| Sterility Assurance Level (SAL) | 10^-6 SAL | 10^-6 SAL |
| Packaging Material | Tyvek pouch | Tyvek pouch |
| Modes of Irrigation | 1. Continuous by gravity |
- Intermittent by depressing plunger | 1. Continuous by gravity
- Intermittent by depressing plunger |
| Flow Rate (4-foot head height) | 9.8 L/hr | 14.7 L/hr |
| Flow Rate (6-foot head height) | 12.0 L/hr | 17.8 L/hr |
| Flow Rate (6-foot head height with pressure cuff) | 14.4 L/hr | 22.9 L/hr |
| Plunger Activation Force | 0.76 lbf | 3.99 lbf |
| Single Use Only | Single Use | Single Use |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation, Systemic Toxicity | Same (Implies similar satisfactory results) |
| Sterilization Method | Gamma | EtO |
Note on "Acceptance Criteria": In a 510(k) for substantial equivalence, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as the predicate device by having similar technological characteristics and performance, or that any differences do not raise new questions of safety or effectiveness. The document highlights the differences in flow rate and plunger activation force, implying that these differences were deemed acceptable by the FDA for the device to be substantially equivalent.
Study Details
The provided document describes a comparative performance testing study.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not explicitly state the sample size (e.g., number of devices tested, number of measurements taken for flow rate or plunger activation).
- Data Provenance: The data is generated from "comparative performance testing" between the proposed and predicate devices. No information is provided regarding the country of origin or whether it was retrospective or prospective, but it implies a prospective lab-based testing scenario.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of performance testing (flow rate, plunger force, biocompatibility) typically does not involve human experts establishing "ground truth" in the way a clinical study or diagnostic imaging study would. The ground truth for characteristics like flow rate and activation force is established by objective physical measurements using calibrated equipment.
- For biocompatibility, the tests are performed according to established standards, and the results are interpreted against those standards, which are based on expert consensus in toxicology and materials science, but individual experts are not adjudicating cases.
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Adjudication method for the test set:
- Not applicable. The study involves objective measurements and standard biocompatibility tests, not subjective interpretations requiring adjudication.
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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 is a physical performance comparison between two medical devices, not an AI-assisted diagnostic study. Therefore, an MRMC comparative effectiveness study is not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
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The type of ground truth used:
- For physical characteristics (flow rate, plunger activation), the ground truth is derived from objective, quantitative physical measurements using scientific instruments.
- For biocompatibility, the ground truth is established through standardized in vitro and in vivo testing that assesses cellular responses, sensitization, irritation, and systemic toxicity against accepted safety profiles for medical device materials.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.