(174 days)
The PleurX Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the PleurX Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The PleurX Peritoneal Catheter is indicated for adults only.
The PleurX Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.
The PleurX Peritoneal Catheter System provides patients with a convenient method to relieve ascites symptoms. The primary components of the PleurX Peritoneal Catheter System are the PleurX Peritoneal Catheter and the PleurX Drainage Kits.
The provided text primarily details a 510(k) premarket notification for the "PleurX Peritoneal Catheter System" and clarifies its indications for use, rather than presenting a study with specific acceptance criteria and performance data in a quantitative manner. The document asserts that the device is substantially equivalent to a legally marketed predicate device (CareFusion PleurX Peritoneal Catheter System: K160437).
However, I can extract the following information related to performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of quantitative acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device and states that "Bench-level testing was carried out... to demonstrate substantial equivalence."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Substantial Equivalence | Stated to be substantially equivalent to the predicate device K160437. |
| Leak Testing | Performed to evaluate performance of the catheter valve. (Results not quantified in this document) |
| Safety and Efficacy (Non-clinical) | Results of non-clinical tests show the device is "as safe, as effective, and performs as well as the legally marketed predicate device." |
| Safety and Efficacy (Clinical Literature Review) | Demonstrates a history of safety and efficacy in non-malignant refractory ascites and indicates that complication incidence is more related to patient-specific health status than the underlying cause of ascites. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified for any bench-level or clinical literature review.
- Data Provenance:
- Bench-level testing: Conducted by the manufacturer (CareFusion).
- Clinical information: Derived from a "clinical literature review." Details on the scope (e.g., country of origin, retrospective/prospective nature of the studies reviewed) are not provided in this excerpt.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided. The document primarily refers to bench testing and a literature review, not a test set requiring expert ground truth establishment in the typical sense of a diagnostic or AI study.
4. Adjudication Method for the Test Set:
Not applicable, as no described test set with expert ground truth establishment is present in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study is not mentioned as having been conducted. The submission relies on non-clinical testing and a clinical literature review to support substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device is a physical medical device (catheter system), not an algorithm or AI system.
7. The Type of Ground Truth Used:
- For non-clinical testing: Performance against established engineering and design specifications for medical devices, inferred from "predicate devices and leak testing."
- For clinical information: The "clinical literature review" served as the basis for understanding safety and efficacy, implying published clinical data from existing studies constituted the "ground truth" for the claims made regarding the device's performance in managing ascites.
8. The Sample Size for the Training Set:
Not applicable, as this is not an AI/algorithm-based device requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 21, 2020
CareFusion Nazeer Khan Manager, Regulatory Affairs 75 North Fairway Drive Vernon Hills, Illinois 60061
Re: K201155
Trade/Device Name: PleurX Peritoneal Catheter System Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal Dialysis System and Accessories Regulatory Class: Class II Product Code: PNG Dated: September 18, 2020 Received: September 21, 2020
Dear Nazeer Khan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the kits have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kits. 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
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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. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal. Gastrointestinal. Obesity and Transplant Devices OHT3: Office of GastroRenal. ObGyn. General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201155
Device Name PleurX Peritoneal Catheter System
Indications for Use (Describe)
The PleurX Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the PleurX Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (L VP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The PleurX Peritoneal Catheter is indicated for adults only.
The PleurX Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the BD logo. On the left is an orange circle with a white starburst-like design inside. To the right of the circle are the letters "BD" in blue. The letters are large and bold.
510(k) SUMMARY – K
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| SUBMITTER INFORMATION | |
|---|---|
| Name | CareFusion |
| Address | 75 North Fairway Drive, Vernon Hills, IL 60061 |
| Phone number | (847) 362-8067 |
| Establishment Registration Number | 1423507 |
| Name of contact person | Nazeer Khan |
| Date prepared | April 29, 2020 |
| DEVICE INFORMATION | |
| Trade or proprietary name | PleurX Peritoneal Catheter System |
| Common or usual name | Peritoneal Catheter, peritoneal, long-term, indwelling |
| Classification name | Peritoneal dialysis system and accessories |
| Classification panel | Gastroenterology / Urology |
| Regulation | Class II per 21CFR 876.5630 |
| Product Code(s) | PNG |
| Legally marketed device(s) to which equivalence is claimed | CareFusion PleurX Peritoneal Catheter System: K160437 |
| Reason for 510(k) submission | This 510(k) submission is for a PleurX Peritoneal Catheter System for ascites management in patients with non-malignant as well as malignant causes. |
| Device description | The PleurX Peritoneal Catheter System provides patients with a convenient method to relieve ascites symptoms. The primary components of the PleurX Peritoneal Catheter System are the PleurX Peritoneal Catheter and the PleurX Drainage Kits. |
| Intended use of the device | The intended use of an indwelling peritoneal drainage catheter is for drainage of refractory ascites with long-term occurrence from the peritoneal cavity. |
| Indications for use | The PleurX Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the PleurX Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The PleurX Peritoneal Catheter is indicated for adults only. |
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Image /page/4/Picture/1 description: The image shows the BD logo. The logo consists of an orange circle with a white star-like design inside, followed by the letters "BD" in blue. The letters are bold and sans-serif.
The PleurX Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristic | New Device | Predicate |
|---|---|---|
| CatheterDescription | Same | CareFusion PleurX Peritoneal Catheter System: K160437Internal: Fenestrations, radiopaque markings & cuffExternal: Valve |
| Method | Same | CareFusion PleurX Peritoneal Catheter System: K160437Percutaneously tunneled indwelling |
| Means ofDrainage | Same | Wall suction, water seal drainage system, portable suction,vacuum bottles or other appropriate method |
CONCLUSION OF DEVICE COMPARISON
The technological characteristics of the proposed device are substantially equivalent to the predicate.
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Bench-level testing was carried out on the PleurX Peritoneal Catheter System to demonstrate substantial equivalence. The performance testing requirements were determined by the predicate devices and leak testing was performed to evaluate performance of the catheter valve.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical tests were conducted for this submission. The modified indications for use statement was supported using a clinical literature review. The literature review demonstrates that the device has a history of safety and efficacy in non-malignant refractory ascites and that the incidence of devicerelated complications is more closely related to patient specific health status and preferences than the underlying cause (malignant vs non-malignant) of ascites.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The results of the non-clinical tests show that the CareFusion PleurX Peritoneal Catheter System is as safe, as effective, and performs as well as the legally marketed predicate 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.