(156 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of a drainage system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used for the palliation of symptoms related to recurrent ascites and pleural effusion, and for providing pleurodesis (resolution of the pleural effusion), which are all therapeutic functions.
No
The device is designed for intermittent drainage of ascites and pleural effusion, and for palliation of symptoms, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components, including catheters, valves, drainage lines, bags, and insertion kits. There is no mention of software as a component of the device.
Based on the provided text, 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 PeritX™ Peritoneal Catheter System and its accessories are designed for the drainage of fluid from the peritoneal cavity or pleural space. This is a therapeutic or palliative procedure to relieve symptoms, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states the purpose is for "intermittent, long-term drainage" and "palliation of symptoms." It does not mention any analysis or testing of the drained fluid for diagnostic purposes.
The device is a medical device used for managing a condition, not for diagnosing it.
N/A
Intended Use / Indications for Use
The PeritX™ Drainage Kits are indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.
The PeritX™ Peritoneal Catheter System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and nonmalignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms relate to recurrent ascites. The use of the PeritX™ 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 intra hepatic portosystemic shunt or LVP. The PeritX™ Peritoneal Catheter is indicated for adults only.
The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.
For Pleural Use: The PleurX™ LP Catheter Mini Kit is indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for the palliation of dyspnea due to pleural effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX™ Low Profile Catheter is indicated for adults only.
For Peritoneal Use: The PleurX™ LP Catheter Mini Kit 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™ Low Profile 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™ Low Profile Catheter is indicated for adults only.
The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.
The PeritX™ Valve Kit is indicated for use in adults only. The PeritX™ Valve Kit is designed for health care facility use only. There is no change to the PeritX™ Valve Kit within this submission.
For Pleural Use: The Catheter Access Kit is intended to provide access to the PleurX™ Catheter to inject and withdraw fluids.
For Peritoneal Use: The Catheter Access Kit is intended to provide access to the PeritX™ Catheter for aspiration and catheter maintenance.
The Lockable Drainage Line is indicated for use only with the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter for intermittent drainage.
The Lockable Drainage Line Kit is indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage. The Lockable Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, or other appropriate method (portable suction).
The PleurX™ Supplemental Insertion Kit intended to aid in the percutaneous insertion of a PleurX™ Catheter into the pleural space and PeritX™ Catheter into the peritoneal space.
The Procedure Pack is indicated for dressing of the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter and exit site.
The PleurX™ Drainage Kits are indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage.
The PeritX™ Drainage Bag is indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.
Product codes (comma separated list FDA assigned to the subject device)
PNG
Device Description
The subject device, the PeritX™ Peritoneal Catheter System, includes the PeritX™ Peritoneal Catheter and PleurX™ Low Profile Catheter, sterile, single use indwelling peritoneal catheters, the PeritX™ Valve Kit, Catheter Access Kit, Lockable Drainage Line, Lockable Drainage Line Kit, PleurX™ Supplemental Insertion Kit, Procedure Pack, PleurX™ Drainage Kits, and the PeritX™ Drainage Bag that allow for the management of ascites at home.
The PeritX™ Drainage Kit (for vacuum-initiated drainage) is a sterile, single use fluid collection device used with the Peritoneal Catheter to drain fluid from the peritoneal cavity to relieve symptoms associated with malignant and non-malignant ascites. The PeritX™ Drainage Kit includes the PeritX™ Drainage Bag and Procedure Pack. The PeritX™ Drainage Kit is offered in two sizes (1L and 2L).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peritoneal cavity, pleural space
Indicated Patient Age Range
Adults only
Intended User / Care Setting
Home management (for the PeritX™ Peritoneal Catheter System); health care facility use only (for the PeritX™ Valve Kit)
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)
To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated. Using internal risk assessment procedures based on ISO 14971:2019, "Medical Devices - Application of Risk Management to Medical Devices," the following non-clinical tests were performed:
- Visual Inspection of Reference Marking Integrity ●
- Access Tip to Catheter Valve Tensile
- Corner Hole Tensile Strength .
- Tubular Junctions Tensile Strength
- Snapper to Housing Tensile Strength
- Access Tip to Access Tip Protector Tensile Strength
- Volume Capacity .
- Drop Test ●
- Resistance to Leakage During Aspiration or Vacuum
- Visual Inspection of Deformation
- Backflow Volume .
- Flow Control Slider Use
- Access Tip to Catheter Valve Connection
- Tear Tab Use
- Packaging Validation
- Sterilization Testing
The results demonstrate that the technological characteristics and performance criteria of the PeritX™ Peritoneal Catheter System when used with the new accessory, the PeritX™ Drainage Kit are comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device.
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2024
Bard Peripheral Vascular, Inc Gabrielle Wipper Regulatory Affairs Specialist 1625 W 3rd St Tempe, Arizona 85281
Re: K241946
Trade/Device Name: PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritXTM Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurXTM Supplemental Insertion Kit (50-7262); Procedure Pack (50-7290A); PleurXTM Vacuum Bottle, 500 mL (50-7205B); PleurXTM Vacuum Bottle, 1000 mL (50-7210); PleurXTM Drainage Kit, 500 mL (50-7500B); PleurX™ Drainage Kit, 1000 mL (50-7510); PleurX™ Patient Starter Kit, 1000 mL (50-0071); PeritXTM Drainage Bag, 2000 mL (50-9210); PeritXTM Drainage Kit, 2000 mL (50-9510)
Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal Dialysis System And Accessories Regulatory Class: Class II Product Code: PNG Dated: December 6, 2024 Received: December 6, 2024
Dear Gabrielle Wipper:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
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product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
2
803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Image /page/2/Picture/4 description: The image shows the name "Maura Rooney" followed by "-S". The text is in a large, bold font and is centered on a white background. The background has a faint watermark.
Maura Rooney 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272): Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262): Procedure Pack (50-7290A): PleurX™ Vacuum Bottle, 500 mL (50-7205B); PleurX™ Vacuum Bottle, 1000 mL (50-7210); PleurX™ Drainage Kit, 500 mL (50-7500B); PleurX™ Drainage Kit, 1000 mL (50-7510); PleurX™ Patient Starter Kit, 1000 mL (50-0071); PeritX™ Drainage Bag, 2000 mL (50-9210); PeritX™ Drainage Kit, 2000 mL (50-9510)
Indications for Use (Describe)
The PeritX™ Drainage Kits are indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.
The PeritX™ Peritoneal Catheter System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and nonmalignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms relate to recurrent ascites. The use of the PeritX™ 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 intra hepatic portosystemic shunt or LVP. The PeritX™ Peritoneal Catheter is indicated for adults only.
The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.
For Pleural Use: The PleurX™ LP Catheter Mini Kit is indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for the palliation of dyspnea due to pleural effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX™ Low Profile Catheter is indicated for adults only.
For Peritoneal Use: The PleurX™ LP Catheter Mini Kit 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™ Low Profile Catheter for non-malignant ascites is limited
4
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™ Low Profile Catheter is indicated for adults only.
The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.
The PeritX™ Valve Kit is indicated for use in adults only. The PeritX™ Valve Kit is designed for health care facility use only. There is no change to the PeritX™ Valve Kit within this submission.
For Pleural Use: The Catheter Access Kit is intended to provide access to the PleurX™ Catheter to inject and withdraw fluids.
For Peritoneal Use: The Catheter Access Kit is intended to provide access to the PeritX™ Catheter for aspiration and catheter maintenance.
The Lockable Drainage Line is indicated for use only with the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter for intermittent drainage.
The Lockable Drainage Line Kit is indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage. The Lockable Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, or other appropriate method (portable suction).
The PleurX™ Supplemental Insertion Kit intended to aid in the percutaneous insertion of a PleurX™ Catheter into the pleural space and PeritX™ Catheter into the peritoneal space.
The Procedure Pack is indicated for dressing of the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter and exit site.
The PleurX™ Drainage Kits are indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage.
The PeritX™ Drainage Bag is indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
0ver-The-Counter Use (21 CFR 801 Subpart C)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
5
510(k) Summary (21 CFR 878.4300)
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the information upon which substantial equivalence determination is based is as follows:
1. Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc.
1625 West 3rd Street
Tempe, Arizona 85281, USA |
|------------|-------------------------------------------------------------------------------------|
| Phone: | 602-830-5063 |
| Email: | Gabrielle.Wipper@bd.com |
| Contact: | Gabrielle Wipper, Regulatory Affairs Specialist |
| Date: | August 29, 2024 |
2. Subject Device:
| Device Trade Name: | PeritX™ Peritoneal Catheter System |
|---|---|
| Common Name: | Peritoneal Catheter System |
| Classification Name: | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term |
| Indwelling (Product Code: PNG) | |
| Product Classification: | II |
| Review Panel: | Gastroenterology/Urology |
| Regulation | |
| Number/Name: | 21 CFR 876.5630/Peritoneal dialysis system and accessories |
3. Predicate Device:
PeritX™ Peritoneal Catheter System (K201155; Clearance Date October 21, 2020)
4. Device Description
The subject device, the PeritX™ Peritoneal Catheter System, includes the PeritX™ Peritoneal Catheter and PleurX™ Low Profile Catheter, sterile, single use indwelling peritoneal catheters, the PeritX™ Valve Kit, Catheter Access Kit, Lockable Drainage Line, Lockable Drainage Line Kit, PleurX™ Supplemental Insertion Kit, Procedure Pack, PleurX™ Drainage Kits, and the PeritX™ Drainage Bag that allow for the management of ascites at home.
Image /page/5/Picture/14 description: The image shows the logos of two companies, BD and BARD. The BD logo is on the left and consists of an orange sun-like symbol next to the letters BD in blue. The BARD logo is on the right and consists of the word BARD in green, with the text "has joined BD" in a smaller font below it.
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The PeritX™ Drainage Kit (for vacuum-initiated drainage) is a sterile, single use fluid collection device used with the Peritoneal Catheter to drain fluid from the peritoneal cavity to relieve symptoms associated with malignant and non-malignant ascites. The PeritX™ Drainage Kit includes the PeritX™ Drainage Bag and Procedure Pack. The PeritX™ Drainage Kit is offered in two sizes (1L and 2L).
5. Indications for Use
The PeritX™ Peritoneal Catheter System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and nonmalignant 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 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 intra hepatic portosystemic shunt or LVP. The PeritX™ Peritoneal Catheter is indicated for adults only.
The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.
For Pleural Use: The PleurX™ LP Catheter Mini Kit is indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for the palliation of dyspnea effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX™ Low Profile Catheter is indicated for adults only.
For Peritoneal Use: The PleurX™ LP Catheter Mini Kit 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™ Low Profile 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™ Low Profile Catheter is indicated for adults only.
The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.
Image /page/6/Picture/10 description: The image shows two company logos. The first logo is for BD, featuring an orange sun-like symbol next to the blue letters 'BD'. The second logo is for BARD, displayed in green, with the text 'has joined BD' underneath in a smaller font size.
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The PeritX™ Valve Kit is indicated for use in adults only. The PeritX™ Valve Kit is designed for health care facility use only. There is no change to the PeritX™ Valve Kit within this submission.
For Pleural Use: The Catheter Access Kit is intended to provide access to the PleurX™ Catheter to inject and withdraw fluids.
For Peritoneal Use: The Catheter Access Kit is intended to provide access to the PeritX™ Catheter for aspiration and catheter maintenance.
The Lockable Drainage Line is indicated for use only with the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter for intermittent drainage.
The Lockable Drainage Line Kit is indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage. The Lockable Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, or other appropriate method (portable suction).
The PleurX™ Supplemental Insertion Kit is intended to aid in the percutaneous insertion of a PleurX™ Catheter into the pleural space and PeritX™ Catheter into the peritoneal space.
The Procedure Pack is indicated for dressing of the Pleural Catheter and PeritX™ Peritoneal Catheter and exit site.
The PleurX™ Drainage Kits are indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage.
The PeritX™ Drainage Bag is indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage. The PeritX™ Drainage Kits are indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.
6. Technological Comparison to Predicate Device
The technological characteristics of the subject device are substantially equivalent to those of the predicate device, in terms of following:
- . Intended Use
- . Patient Population
- Catheter-to-Accessory Interface .
- . Catheter Materials
- Catheter Design .
Bard Peripheral Vascular, Inc.
Image /page/7/Picture/19 description: The image shows two company logos. The first logo is for BD, which includes an orange starburst symbol and the letters "BD" in blue. The second logo is for BARD, with the company name in green. The text "has joined BD" is below the BARD logo.
8
- Mechanism of Action .
- Fundamental Scientific Technology .
- Patient Contact and Duration of Use .
- . Sterility Assurance Level and Method of Sterilization
The subject device and the predicate device are different in the following manner:
- A new accessory vacuum-initiated drainaqe kit, the PeritX™ Drainage Kit .
7. Performance Testing Summary
To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated. Using internal risk assessment procedures based on ISO 14971:2019, "Medical Devices - Application of Risk Management to Medical Devices," the following non-clinical tests were performed:
- Visual Inspection of Reference Marking Integrity ●
- . Access Tip to Catheter Valve Tensile
- Corner Hole Tensile Strength .
- . Tubular Junctions Tensile Strength
- . Snapper to Housing Tensile Strength
- . Access Tip to Access Tip Protector Tensile Strength
- Volume Capacity .
- Drop Test ●
- . Resistance to Leakage During Aspiration or Vacuum
- . Visual Inspection of Deformation
- Backflow Volume .
- . Flow Control Slider Use
- Access Tip to Catheter Valve Connection
- Tear Tab Use
- . Packaging Validation
- . Sterilization Testing
The results demonstrate that the technological characteristics and performance criteria of the PeritX™ Peritoneal Catheter System when used with the new accessory, the PeritX™ Drainage Kit are comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device.
Image /page/8/Picture/28 description: The image shows two company logos. The first logo is for BD, which features an orange sun-like symbol next to the blue letters "BD". The second logo is for BARD, which is written in green, and below it, in a smaller font, it says "has joined BD".
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8. Conclusion
The PeritX™ Peritoneal Catheter System is substantially equivalent to the legally marketed predicate device, the PeritX™ Peritoneal Catheter System (K201155; Clearance Date October 21, 2020).
Image /page/9/Picture/5 description: The image shows two logos. The first logo is for BD, which features an orange sun-like symbol next to the letters "BD" in blue. The second logo is for BARD, with the word "BARD" in green, and the text "has joined BD" in a smaller font below it. The logos are placed side by side.