(218 days)
The PuraCath™ Firefly IM Peritoneal Dialysis Connector Disinfecting System is intended for use by PD (peritoneal dialysis) patients as a method of controlling air and touch contamination while performing a solution exchange dialysis patiens as a nethod of connector Disinfecting System is comprised of Firefly™ UV Purification Device, FireflyTM Transfer Catheter, FireflyTM Luer Cover, and FireflyTM 99% IPA bottle.
The effectiveness of the PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System was tested in viro against The enectivelless of the Funceoccus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Streptococus Staphylococcus autous, Staphylococcus aureus, and Candida albicans yielding ≥ 4log reduction in microorganisms.
The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System may be used in the home or a healthicare facility.
The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System provides a way for patients to ensure the cleanliness of the fluid connections associated with ambulatory peritoneal dialysis. The system accomplishes cleaning with a combination of alcohol, flushing with sterile dialysate, and ultraviolet (UV) light. The System consists of the components shown below.
The Firefly UV Purification Device is a multi-year reusable device which helps to clean the connection between the Firefly Transfer Catheter and the dialysate Y-set (Y-set). The UV Purification Device is powered by off-the-shelf, replaceable AA batteries. The UV Purification Device directs ultraviolet (UV) light through the Transfer Catheter connector. UV Purification Device uses lights and an audible alert to indicate device status.
The Firefly Transfer Catheter is a sterile, 6 month use, disposable device providing communication between the indwelling patient catheter and the Y-set. A proprietary, UV transparent control valve on the end of the Transfer Catheter allows for draining and filling the peritoneum. The control valve is actuated manually, adjustable between fully open and fully closed. The Transfer Catheter also has a flush feature. The flush feature allows for flushing of air and potential contaminants from the Y-set prior to fluid exchange.
The Firefly Luer Cover is a 6 month use, disposable, UV transparent component designed to protect the Transfer Catheter connector between uses and to aid in keeping the control valve closed.
The Firefly IPA Dropper Bottle provides a convenient way to apply 99% IPA solution to the inside of the Y-set and Transfer Catheter connectors.
Acceptance Criteria and Study for the Firefly™ Peritoneal Dialysis Connector Disinfecting System
This document describes the acceptance criteria and the study conducted to prove that the Firefly™ Peritoneal Dialysis Connector Disinfecting System meets those criteria, as detailed in the provided FDA 510(k) summary (K151620).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Required Performance) | Reported Device Performance |
|---|---|
| Microbiological Efficacy: Achieve ≥ 4 log reduction in specified microorganisms. | Achieved ≥ 4 log reduction in each tested microorganism: Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Escherichia coli, Streptococcus pneumoniae, Methicillin-resistant Staphylococcus aureus, and Candida albicans. |
| Biocompatibility: Meet ISO 10993 standards for medical devices. | Evaluation conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993. Tests included Cytotoxicity, Sensitization, and Irritation or Intracutaneous Reactivity. (Specific pass/fail results not detailed, but implied by "conducted in accordance" and accepted by FDA). |
| Sterilization: Ensure proper sterilization of components. | Testing conducted to confirm proper sterilization. (Specific acceptance criteria for sterilization, e.g., sterility assurance level (SAL), not explicitly stated, but assumed to meet applicable standards). |
| Electrical Safety and Electromagnetic Interference (EMI): Comply with relevant electrical safety and EMI standards. | Testing conducted to confirm compliance with electrical safety and electromagnetic interference standards. (Specific standards, e.g., IEC 60601-1, are listed as adhered to). |
| Life Cycle Testing: Demonstrate durability and performance over expected lifespan. | Life cycle testing conducted. (Specific performance metrics and duration not explicitly detailed). |
| Light Leak Testing: Ensure no light leakage from the UV Purification Device. | Light leak testing conducted. (Specific acceptance criteria not explicitly detailed). |
| Transit Testing: Withstand transport and shipping conditions. | Transit testing conducted. (Specific acceptance criteria not explicitly detailed). |
| Water Ingress Testing: Ensure protection against water entry. | Water ingress testing conducted. (Specific acceptance criteria not explicitly detailed). |
| Human Factors - Usability: Demonstrate intuitive and safe use by intended users. | Human factors - usability studies conducted. (Specific acceptance criteria not explicitly detailed). |
| Adherence to Performance Standards: Compliance with listed ISO/AAMI/IEC standards. | All applicable requirements of ISO 14971-1:2012, AAMI/ANSI HE75:2009, ISO 62366-1:2015, ISO 15223-1:2012, IEC 60601-1, ISO 10993-1:2009, ISO 10993-7:2008, and ISO 594-2:1998 were met. |
| Substantial Equivalence: Demonstrate substantial equivalence to predicate devices in terms of intended use, design, materials, operation, function, and sterilization method. | Concluded as substantially equivalent to predicate devices based on presented data. |
2. Sample Sizes Used for the Test Set and Data Provenance
The provided document primarily details in vitro studies for microbiological efficacy and various bench tests for physical and electrical performance.
- Microbiological Testing: The sample size for the microbiological efficacy testing is not explicitly stated. It is described as "in vitro antimicrobial efficacy studies," suggesting laboratory-based experiments using cultured microorganisms.
- Other Performance Tests (Biocompatibility, Sterilization, Electrical Safety, Life Cycle, Light Leak, Transit, Water Ingress, Human Factors): The sample sizes for these tests are not explicitly stated in the summary. These would typically involve testing a representative number of devices or components.
- Data Provenance: All described studies are pre-market, laboratory-based in vitro and bench testing. No clinical data from human subjects is mentioned for performance evaluation. The data provenance is implied to be from the manufacturer's testing facilities or accredited laboratories. There is no indication of country of origin of the data beyond the manufacturer being US-based, and the submission being to the US FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the given 510(k) summary. For in vitro and bench testing, "ground truth" is typically established by the reference standards and protocols of the tests themselves, conducted by qualified scientists and engineers in a laboratory setting, rather than through expert consensus on observational data.
4. Adjudication Method for the Test Set
This concept is not applicable to the type of studies presented (in vitro microbiological tests and various bench performance tests). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review settings where human interpretation introduces variability requiring a consensus process.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or described. This type of study assesses the impact of a device (often AI) on human reader performance, which is not relevant for this device as it is a physical disinfecting system, not an AI-assisted diagnostic tool.
6. Standalone Performance (Algorithm Only without Human-in-the Loop Performance)
Yes, a form of standalone performance was assessed. The "Microbiological testing" section describes the device's ability to achieve a "≥ 4 log reduction in micro-organisms" in vitro. This demonstrates the device's inherent capability to disinfect independently of human factors (beyond proper operation of the system). Similarly, other bench tests (e.g., electrical safety, life cycle) evaluate the device's inherent performance characteristics as a standalone product. The device itself is not an "algorithm" in the sense of software for interpretation, but rather a physical system.
7. Type of Ground Truth Used
The ground truth for the performance evaluations described in this document is primarily based on:
- In Vitro Microbiological Reference Standards: For the microbiological testing, the ground truth is the known concentration of specified microorganisms and the quantitative measurement of their reduction after exposure to the device. This is a highly controlled, objective, and quantifiable measure.
- Engineering Specifications and Standardized Testing Protocols: For other performance tests (e.g., electrical safety, life cycle, light leak), the ground truth is established by meeting predefined engineering specifications and adhering to recognized industry standards (e.g., ISO, IEC, AAMI/ANSI). These are objective, measurable criteria.
- Physical Measurements and Observations: For tests like transit or water ingress, the ground truth is the observable outcome or measured performance against defined pass/fail criteria.
8. Sample Size for the Training Set
This is not applicable. The Firefly™ Peritoneal Dialysis Connector Disinfecting System is a physical medical device, not a machine learning or AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" for this device.
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.