(76 days)
The Pleux Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, for the palliation of symptoms related to recurrent malignant ascites and for peritoneal placement only.
The Pleurx Drainage Bottle Kits and Drainage Line Set are indicated for use either with the Pleurx Peritoneal Catheter or Pleural Catheter for intermittent drainage. The Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.
The Pleurx Drainage Bag Kit is indicated for use only with the Pleurx Peritoneal Catheter for intermittent drainage.
The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site.
The Pleurx Catheter Access Kit is intended to provide access to the Pleurx Catheter for aspiration and catheter maintenance.
The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the peritoneal space.
The Valved Peelable Introducers are intended for use in the percutaneous insertion of a catheter into the peritoneal space.
The Pleurx Peritoneal Catheter System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the Pleurx Catheter System are the Pleurx Periloneal Catheter and the Pleurx Drainage Kits.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Pleurx Peritoneal Catheter System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific acceptance criteria with quantitative thresholds alongside reported device performance results in the way commonly seen for AI/ML devices or diagnostic tools. Instead, it lists the types of non-clinical tests performed and states that the device "meets or exceeds all performance requirements."
However, we can infer the "acceptance criteria" were implied by the referenced standards, and the "reported device performance" is a general statement of compliance.
| Acceptance Criterion (Implied by Standard/Test Type) | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1:2009) | Meets/Exceeds performance requirements |
| Residuals (Ethylene Oxide Sterilization) (ISO 10993-7:2008) | Meets/Exceeds performance requirements |
| Sterile Drainage Catheters (EN 1617:1997) | Meets/Exceeds performance requirements |
| Catheters Other Than Intravascular Catheters - Test Methods for Common Properties (EN 1618:1997) | Meets/Exceeds performance requirements |
| Sterile, Single-use Intravascular Catheters (ISO 11070) | Meets/Exceeds performance requirements |
| Packaging for Terminally Sterilized Medical Devices (ANSI/AAMI/ISO 11607-1,2:2006) | Meets/Exceeds performance requirements |
| Accelerated Aging of Sterile Barrier Systems (ASTM F1980-07) | Meets/Exceeds performance requirements |
| Sterilization of healthcare products - Biological Indicators (ISO 11138-1,2:2006) | Meets/Exceeds performance requirements |
| Sterilization of Medical Devices - Microbiological Methods (ISO 11737-1,2:2006) | Meets/Exceeds performance requirements |
| Medical Device, Validation and Routine Control of Ethylene Oxide Sterilization (ISO 11135:2007) | Meets/Exceeds performance requirements |
| Product Adoption and Process Equivalency for Ethylene Oxide Sterilization (AAMI TIR28:2009) | Meets/Exceeds performance requirements |
| Tensile Strength (Bench-level testing) | Meets/Exceeds performance requirements |
| Leakage (Bench-level testing) | Meets/Exceeds performance requirements |
| Bond Strength (Bench-level testing) | Meets/Exceeds performance requirements |
| Deformation (Bench-level testing) | Meets/Exceeds performance requirements |
| Security of Connections (Bench-level testing) | Meets/Exceeds performance requirements |
2. Sample Size and Data Provenance
The document explicitly states: "N/A - No clinical tests were conducted for this submission".
Therefore, there is no information on:
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Sample size for the training set.
3. Number of Experts and Qualifications
Since no clinical studies were performed, there is no mention of experts used to establish ground truth. The device's performance was evaluated through non-clinical, bench-level testing against established standards.
4. Adjudication Method
Not applicable, as no clinical studies with expert review were conducted.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. No clinical studies were performed, and this device is a physical medical device (catheter system), not an AI/ML diagnostic tool typically assessed with MRMC studies.
6. Standalone Performance
The device's performance was evaluated in a standalone manner through "bench-level testing" and compliance with referenced standards. The statement "The results of the non-clinical tests show that the CareFusion Pleurx Peritoneal Catheter System meets or exceed all performance requirements" indicates standalone assessment against predefined engineering and material standards. This is not a "standalone algorithm performance" in the context of AI, but rather standalone physical device performance.
7. Type of Ground Truth
The "ground truth" for this device's evaluation was based on:
- Engineering and Material Standards: The various ISO, EN, ANSI/AAMI, and ASTM standards listed (e.g., ISO 10993 for biocompatibility, EN 1617 for drainage catheters, ASTM F1980 for aging).
- Predicate Device Characteristics: The existing predicate devices (e.g., CareFusion Pleurx Catheter Systems: K113854) set the benchmark for technological characteristics.
8. Sample Size for the Training Set
No information is provided, as no clinical studies or machine learning algorithms were involved that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used for this type of device submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2017
CareFusion Joy Greidanus Regulatory Affairs Manager 1500 Waukegan Road McGaw Park, IL 60085
Re: K122422
Trade/Device Name: Pleurx Peritoncal Catheter System Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: PNG Dated: August 8, 2012 Received: August 9, 2012
Dear Joy Greidanus:
This letter corrects our substantially equivalent letter of October 24, 2012.
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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Page 2 - Joy Greidanus
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 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/ResourcesforYou/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,
Benjamin R. Fisher -S
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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K12 2422
CareFusion - August 2012 - Traditional 510(k): Pleurx Peritoneal Catheter System
Image /page/2/Picture/2 description: The image shows the CareFusion logo. The logo consists of a stylized symbol on the left and the word "CareFusion" on the right. The symbol appears to be a shield with a figure inside, possibly representing protection or care. The text "CareFusion" is in a bold, sans-serif font, making it easily readable.
1500 Waukegan Road cGaw Park, Illinois 60085-6787 FAX: 847.473.7790
510(k) Number (if known):
K122422
Unknown at this time
Unknown at this time
Device Name:
Pleurx Peritoneal Catheter System
Indications For Use:
The Pleux Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, for the palliation of symptoms related to recurrent malignant ascites and for peritoneal placement only.
The Pleurx Drainage Bottle Kits and Drainage Line Set are indicated for use either with the Pleurx Peritoneal Catheter or Pleural Catheter for intermittent drainage. The Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.
The Pleurx Drainage Bag Kit is indicated for use only with the Pleurx Peritoneal Catheter for intermittent drainage.
The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site.
The Pleurx Catheter Access Kit is intended to provide access to the Pleurx Catheter for aspiration and catheter maintenance.
The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the peritoneal space.
The Valved Peelable Introducers are intended for use in the percutaneous insertion of a catheter into the peritoneal space.
Prescription Use_X_(Per 21 CFR 801 Subpart D) (Per 21 CFR 807 Subpart C) . And/Or Over-The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K122422
3
00112
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:
OCT 24 2012.
.
510(k) SUMMARY K122422
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| SUBMITTER INFORMATION | |||
|---|---|---|---|
| Name | CareFusion | ||
| Address | 1500 Waukegan Road MPWM, McGaw Park. IL 60085 USA | ||
| Phone number | (847) 473-7404 | ||
| Fax number | (847) 473-7790 | ||
| EstablishmentRegistration Number | 1423507 | ||
| Name of contact person | Joy Greidanus | ||
| Date prepared | October 10, 2012 | ||
| NAME OF DEVICE | |||
| Trade or proprietaryname | Pleurx Peritoneal Catheter System | ||
| Common or usual name | Catheter, peritoneal, long-term, indwelling | ||
| Classification name | Peritoneal Dialysis Systems and Accessories | ||
| Classification panel | Gastroenterology/Urology | ||
| Regulation | Class II per 21CFR §876.5630. Procode PNG | ||
| Product Code(s) | Multiple | ||
| Legally marketeddevice(s) to whichequivalence is claimed | CareFusion Pleurx Catheter Systems: K113854Bard Aspira Pleural Drainage System: K110396Martech (MEDCOMP) Valved Tearaway Introducer: K090394Greatbatch (MedAmicus) Incorporated FlowGuard Peelable Introducer:K040150 | ||
| Reason for 510(k)submission | Expanding the indications for use and adding accessories. | ||
| Device description | The Pleurx Peritoneal Catheter System provides patients with a convenientmethod to relieve malignant ascites symptoms at home. The primarycomponents of the Pleurx Catheter System are the Pleurx Periloneal Catheterand the Pleurx Drainage Kits. | ||
| Intended use of thedevice | The Pleurx Peritoneal Catheter System is indicated for intermittent, long termdrainage of symptomatic, recurrent, malignant ascites that does not respond tomedical management of the underlying disease, for the palliation of symptomsrelated to recurrent malignant ascites and for peritoneal placement only.The Pleurx Drainage Bottle Kits and Drainage Line Set are indicated for useeither with the Pleurx Peritoneal Catheter or Pleurx Pleural Catheter forintermittent drainage. The Drainage Line Kit is used to drain fluid usingstandard wall suction, water seal drainage system, vacuum bottle or otherappropriate method.The Pleurx Drainage Bag Kit is indicated for use only with the PleurxPeritoneal Catheter for intermittent drainage.The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site.The Pleurx Catheter Access Kit is intended to provide access to the PleurxCatheter for aspiration and catheter maintenance.The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneousinsertion of the Pleurx Catheter into the peritoneal space.The Valved Peelable Introducers are intended for use in the percutaneousinsertion of a catheter into the peritoneal space. | ||
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPAREDTO THE PREDICATE DEVICE | |||
| Characteristic | New Device | Predicates:CareFusion Pleurx Catheter System: K113854Bard Aspira Pleural Catheter System K110396Martech (MEDCOMP) Valved TearawayIntroducer: K090394Greatbatch (MedAmicus) IncorporatedFlowGuard Peelable Introducer: K040150 | |
| CatheterDescription | Internal: fenestrations, radiopaquemarkings & cuffExternal: valve | Same | |
| Method | Percutaneously tunneled - indwelling | Same | |
| Means ofDrainage | Wall suction, water seal drainagesystem, portable suction, vacuumbottles or other appropriate method | Same | |
| ValvedPeelableIntroducers | Peelable sheath, dilator, hub, valve | Same | |
| Access Kit | Provides access for sampleaspirations and catheter maintenance | Same | |
| Insertion Stylet | Reduces fluid loss, provides stiffening | Same | |
| Characteristic | Standard/Test/FDA Guidance | ||
| Biocompatibility | ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: Evaluation andTesting | ||
| Residuals | ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: Ethylene OxideSterilization Residuals | ||
| Performance | EN 1617:1997 Sterile Drainage Catheters and Accessory Devices for Single Use | ||
| Performance | EN 1618:1997 Catheters Other Than Intravascular Catheters - Test Methods forCommon Properties | ||
| Performance | ISO 11070 Sterile, Single-use Intravascular Catheters | ||
| Performance | ANSI/AAMI/ISO 11607-1,2:2006 Packaging for Terminally Sterilized Medical Devices | ||
| Performance | ASTM F1980-07 Accelerated Aging of Sterile Barrier Systems | ||
| Performance | ISO 11138-1,2:2006 Sterilization of healthcare products - Biological Indicators | ||
| Performance | ISO 11737-1,2:2006 Sterilization of Medical Devices - Microbiological Methods Part1 & 2 | ||
| Performance | ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene OxideSterilization | ||
| Performance | AAMI TIR28:2009 Product Adoption and Process Equivalency for Ethylene OxideSterilization | ||
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE AND/OR OF CLINICAL INFORMATION |
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PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Bench-level testing was carried out on the Pleurx Catheter System to demonstrate substantial equivalence. The performance testing requirements were determined by the predicate devices and further defined by the standards listed below. The testing conducted includes tensile strength, leakage, bond strength, deformation, security of connections, biocompatibility, aging, sterilization and residuals.
N/A - No clinical tests were conducted for this submission
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The results of the non-clinical tests show that the CareFusion Pleurx Peritoneal Catheter System meets or exceed all performance requirements, and are substantially equivalent to the predicate devices.
§ 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.