(76 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical properties of a drainage system, with no mention of AI or ML.
Yes
The device is indicated for the intermittent, long-term drainage of symptomatic, recurrent, malignant ascites for the palliation of symptoms, which is a therapeutic purpose.
No
The device is intended for drainage and symptom relief, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components like catheters, drainage bottles, drainage line sets, drainage bag kits, dressing kits, catheter access kits, catheter insertion stylets, and valved peelable introducers. These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the drainage of symptomatic, recurrent, malignant ascites. This is a therapeutic and palliative function, not a diagnostic one.
- Device Description: The description focuses on the components used for drainage (catheter and drainage kits).
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like ascites fluid) to diagnose a condition, determine a patient's state of health, or monitor a treatment.
- Performance Studies: The performance studies focus on the physical properties and safety of the device for drainage, not on the accuracy or reliability of any diagnostic measurements.
IVD devices are used to perform tests on samples taken from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This device's function is to remove fluid from the body for symptom relief, which is a medical procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Pleurx 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 Pleurx 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.
Product codes (comma separated list FDA assigned to the subject device)
PNG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Results: 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.
N/A - No clinical tests were conducted for this submission
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K113854, K110396, K090394, K040150
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
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.
1
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
2
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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Image /page/3/Picture/0 description: The image shows the logo for CareFusion. The logo consists of a circular icon to the left of the company name. The icon contains a shield-like shape within the circle. The text "CareFusion" is written in a bold, sans-serif font.
:
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 | ||
| Establishment | |||
| Registration Number | 1423507 | ||
| Name of contact person | Joy Greidanus | ||
| Date prepared | October 10, 2012 | ||
| NAME OF DEVICE | |||
| Trade or proprietary | |||
| name | 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 marketed | |||
| device(s) to which | |||
| equivalence is claimed | CareFusion Pleurx Catheter Systems: K113854 | ||
| Bard Aspira Pleural Drainage System: K110396 | |||
| Martech (MEDCOMP) Valved Tearaway Introducer: K090394 | |||
| Greatbatch (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 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. | |||
| Intended use of the | |||
| device | The Pleurx 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 Pleurx 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. | | |
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED
TO THE PREDICATE DEVICE | | | |
| Characteristic | New Device | | Predicates:
CareFusion Pleurx Catheter System: K113854
Bard Aspira Pleural Catheter System K110396
Martech (MEDCOMP) Valved Tearaway
Introducer: K090394
Greatbatch (MedAmicus) Incorporated
FlowGuard Peelable Introducer: K040150 |
| Catheter
Description | Internal: fenestrations, radiopaque
markings & cuff
External: valve | | Same |
| Method | Percutaneously tunneled - indwelling | | Same |
| Means of
Drainage | Wall suction, water seal drainage
system, portable suction, vacuum
bottles or other appropriate method | | Same |
| Valved
Peelable
Introducers | Peelable sheath, dilator, hub, valve | | Same |
| Access Kit | Provides access for sample
aspirations 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 and
Testing | | |
| Residuals | ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: Ethylene Oxide
Sterilization 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 for
Common 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 Part
1 & 2 | | |
| Performance | ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene Oxide
Sterilization | | |
| Performance | AAMI TIR28:2009 Product Adoption and Process Equivalency for Ethylene Oxide
Sterilization | | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL
EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | | |
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Image /page/5/Picture/0 description: The image contains the logo for CareFusion. The logo consists of a circular emblem on the left and the word "CareFusion" on the right. The emblem appears to be a stylized representation of a shield or protective symbol. The text "CareFusion" is written in a bold, sans-serif font.
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.