(141 days)
50–8000, 50–7500, 50–7510
50-8000, 50-7500, 50-7510
No
The device description and intended use focus on a physical catheter and drainage system, with no mention of AI/ML capabilities or data processing beyond fluid removal.
Yes
The device is used for "intermittent drainage of symptomatic, recurrent, malignant ascites" and "palliation of symptoms related to recurrent malignant ascites," which are therapeutic interventions aimed at alleviating medical conditions and their associated symptoms.
No
This device is a drainage catheter system used for therapeutic purposes (draining fluid and palliating symptoms), not for diagnosing conditions.
No
The device description clearly outlines physical components like a silicone catheter, valve, vacuum bottle, drainage line, and procedure pack, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Denver® Pleurx Peritoneal Catheter Kit and Drainage Kits are used for the physical drainage of fluid (ascites) from the peritoneal cavity. They are a medical device used for a therapeutic procedure, not for analyzing a sample to provide diagnostic information.
- Intended Use: The intended use clearly states "Intermittent drainage of symptomatic, recurrent, malignant ascites" and "Palliation of symptoms related to recurrent malignant ascites." This describes a treatment or symptom management function, not a diagnostic one.
Therefore, the device is a therapeutic medical device used for fluid drainage, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Denver® Pleurx Peritoneal Catheter Kit (50-8000) is indicated for:
- Intermittent drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease
- Palliation of symptoms related to recurrent malignant ascites
- Peritoneal placement only
The Denver® Pleurx Drainage Kits (50-7500 and 50-7510) are indicated for use with either the Pleurx Peritoneal Catheter Kit or the Pleural Catheter Kit.
The Denver Pleurx Peritoneal Catheter Kit and the Denver Pleurx Drainage Kits are indicated for
- Intermittent drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease.
- Palliation of symptoms related to recurrent malignant ascites.
- For peritoneal placement only.
Product codes
PNG
Device Description
The Pleurx Catheter is silicone catheter that can be thought of as containing three zones: the fenestrated zone which is implanted in the body cavity and used to collect fluid; the cuffed zone, which is placed inside a subcutaneous tunnel; and the externalized zone. which includes a valve that remains closed, except when purposefully accessed for a drainage procedure. The Pleurx Drainage Kit includes a vacuum bottle with drainage line that connects to the Pleurx catheter for removing fluid. It also includes a procedure pack. that includes all the supplies needed to perform the drainage procedure and to replace the dressing over the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal
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)
- Gathering clinical data to show that the catheter is effective for removing ascites and relieving symptoms until death or ascites resolution in the majority of patients.
- Gathering clinical data to show that for most patients the duration of catheter function is at least twice as long as the interval between paracentesis procedures before catheter placement.
- Gathering clinical data to show that the complication rates associated with the use of the device for malignant ascites are similar to those for other similar devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2017
Denver Biomedical, Inc. % Nancy Sauer Evergreen Research, Inc. 433 Park Point Drive, Suite 140 Golden, CO 80401
Re: K051711
Trade/Device Name: Pleurx Peritoneal Catheter Kit and Drainage Kits Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: PNG Dated: November 2, 2005 Received: November 7, 2005
Dear Nancy Sauer:
This letter corrects our substantially equivalent letter of November 15, 2005.
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 - Nancy Sauer
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
Indications for Use
510(k) Number (if known): K051711
Device Name: Pleurx Peritoneal Catheter Kit and Drainage Kits
Indications for Use:
.
The Denver® Pleurx Peritoncal Catheter Kit (50-8000) is indicated for:
- Intermittent drainage of symptomatic, recurrent, malignant ascites that does not ● respond to medical management of the underlying disease
- Palliation of symptoms related to recurrent malignant ascites ●
- Peritoneal placement only ●
The Denver® Pleurx Drainage Kits (50-7500 and 50-7510) are indicated for use with either the Pleurx Peritoneal Catheter Kit or the Pleural Catheter Kit.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
. . . . . . .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ylancyc Broxton
Division Sign-Off
ion of Reproductive, Abdominal. and Radiological De 510(k) Number
Page _ 1_ of __ 1_
(Posted November 13, 2003)
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KOS1711
Page 1 of 2
NOV 1 5 2005
510(k) Summary
Sponsor Information
Denver Biomedical, Inc. 14998 W. 6th Ave., Bldg. E700 Golden. CO 80401 303-279-7500
Contact Person: Jeff Hill, RA/QA Coordinator
This 510(k) summary was prepared on June 23, 2005 and updated November 10, 2005.
Device Identification
This special 510(k) is for a modification to the intended use of the Pleurx Catheter and Pleurx Drainage Kits.
Intended Use
The Denver Pleurx Peritoneal Catheter Kit and the Denver Pleurx Drainage Kits are indicated for
Intermittent drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease.
Palliation of symptoms related to recurrent malignant ascites.
For peritoneal placement only.
Device Description
The Pleurx Catheter is silicone catheter that can be thought of as containing three zones: the fenestrated zone which is implanted in the body cavity and used to collect fluid; the cuffed zone, which is placed inside a subcutaneous tunnel; and the externalized zone. which includes a valve that remains closed, except when purposefully accessed for a drainage procedure. The Pleurx Drainage Kit includes a vacuum bottle with drainage line that connects to the Pleurx catheter for removing fluid. It also includes a procedure pack. that includes all the supplies needed to perform the drainage procedure and to replace the dressing over the catheter.
Substantial Equivalence to Currently Marketed Device
The sponsor used the following techniques to determine that the modified design is substantially equivalent to that of currently marketed products.
- Verifying that the design and materials are the same or similar to those of legally ● marketed medical devices, including the existing Pleurx Catheter and other catheters for long-term implantation in the peritoneal cavity.
- Comparing the proposed intended use to the intended use of other legally . marketed devices.
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K05174 Page 2 of 2
- Gathering clinical data to show that the catheter is effective for removing ascites . and relieving symptoms until death or ascites resolution in the majority of patients.
- Gathering clinical data to show that for most patients the duration of catheter . function is at least twice as long as the interval between paracentesis procedures before catheter placement.
- . Gathering clinical data to show that the complication rates associated with the use of the device for malignant ascites are similar to those for other similar devices.
- Applying risk management techniques to assess the potential impact of the change . in intended use on device safety, and adopting appropriate risk control measures.