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.

Device Description

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.

AI/ML Overview

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 20, 2016

PuraCath Medical, Inc. John Ashley Chief Technology Officer 660 4th Street, #104 San Francisco, CA 94107

Re: K151620

Trade/Device Name: Firefly™ Peritoneal Dialysis Connector Disinfecting System Regulation Number: 21 CFR§ 876.5630 Regulation Name: Periotoneal dialysis system and accessories Regulatory Class: II Product Code: KDJ Dated: December 15, 2015 Received: December 17, 2015

Dear John Ashley,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151620

Device Name FireflyTM Peritoneal Dialysis Connector Disinfecting System

Indications for Use (Describe)

Indications for Use (Descibe)
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 PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System may be used in the home or a healthicare facility.

Type of Use (Select one or both, as applicable)

	Over-The-Counter Use (21 CFR 801 Subpart D)
	Rx - Over-The-Counter Use (21 CFR 801 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801

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510(K) SUMMARY

(21 CFR 807.92)

Applicant:

PuraCath Medical Inc. 185 Berry Street, Suite 330 San Francisco, CA 94107

Manufacturer:

Phoenix DeVentures 18655 Madrone Pkwy, Suite 180 Morgan Hill, CA 95037 (408) 786-5094

Contact Person:

John Ashley Chief Technology Officer E-mail: john@puracath.com Phone: (650) 302-4380 Fax: (415) 520-2373

Date Prepared:

December 14, 2015

Device Information:

Trade Name: Classification: Regulation Number: Product code:

Firefly™ Peritoneal Dialysis Connector Disinfecting System Class II 21 CFR 876.5630 KDJ

Product Description:

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Image /page/4/Picture/0 description: The image shows the text "K151620 page 2/4" at the top, followed by a logo for Puracath Medical. The logo features an abstract orange design above the word "PURACATH" in a blue, sans-serif font. Below "PURACATH", the word "MEDICAL" is written in a smaller, gray, sans-serif font.

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.

Indications for Use:

The PuraCath™ Firefly™ 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.

The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System is comprised of Firefly™ UV Purification Device, Firefly™ Transfer Catheter, Firefly™ Luer Cover, and Firefly™ 99% IPA bottle.

The effectiveness of the PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Streptoccus pneumoniae, Methicillin-resistant Staphylococcus aureus, and Candida albicans yielding ≥ 4log reduction in micro-organisms.

The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System may be used in the home or a healthcare facility.

Predicate Device(s):

1. K883239, Baxter healthcare, CAPD UV Germicidal Exchange Dev System

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Image /page/5/Picture/0 description: The image shows the logo for Puracath Medical. The logo features the company name in a stylized font, with the word "PURACATH" in a larger, teal-colored font and the word "MEDICAL" in a smaller, gray font. Above the company name, there is an abstract graphic consisting of several curved, orange lines that resemble a stylized wing or swoosh. The text "K151620 page 3/4" is at the top of the image.

2) K142806, Catheter Connection, DualCap Disinfectant Cap

The Indications for Use statement for PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System is not identical to the predicate device's Indication for Use statement (K883239); however, the differences do not alter the intended use of the subject device nor do they affect the performance of the device relative to the predicate. Both the subject device and predicate device (K883239) have the same intended use.

Basic Technology Comparison with the Predicate Devices:

Disinfection of catheter connections is the general principle for both the subject and predicate devices. The subject device and the predicate device K883239 both use ultraviolet light as a means of disinfection. Both the subject device and the predicate device K883239 include substantially equivalent catheters and catheter luer caps as well as the ultraviolet light device. The subject device and the predicate device K142806 both use isopropyl alcohol as a means of disinfection. Both the subject device and the predicate device K142806 include substantially equivalent catheter luer caps.

Performance Data:

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995.

The battery of tests included Cytotoxicity, Sensitization, and Irritation or Intracutaneous Reactivity.

Microbiological testing

In vitro antimicrobial efficacy studies were completed and show a ≥ 4 log reduction in each test micro-organism (Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Escherichia coli, Streptoccus pneumoniae, Methicillin-resistant Staphylococcus aureus, and Candida albicans).

Other performance tests

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Image /page/6/Picture/0 description: The image shows the logo for Puracath Medical. The logo is in blue and gray, with the word "PURACATH" in large, bold letters. Below that, the word "MEDICAL" is in smaller, lighter letters. Above the word "PURACATH" is an orange graphic. At the top of the image, the text "K151620 page 4/4" is visible.

Additional testing was conducted to confirm that the PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System preforms as intended. These include sterilization, electrical safety and electromagnetic interference, life cycle, light leak, transit, water ingress, and human factors - usability studies.

Performance Standards:

The following performance standards were adhered to and all applicable requirements were met.

। ISO 14971-1:2012
-AAMI/ANSI HE75:2009
ISO 62366-1:2015 ।
-ISO 15223-1:2012
IEC 60601-1, 300 edition -
ISO 10993-1:2009 -
-ISO 10993-7:2008
। ISO 594-2:1998

Conclusion:

Based on the data provided in this submission, it can be concluded that the PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System is substantially equivalent to the predicate device in terms of intended use, design, materials, operation, function, and sterilization method. The performance bench tests completed in this submission demonstrate that the subject device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.