(100 days)
Pristine™ Hemodialysis Catheter (K182443, cleared May 31, 2019)
GlidePath™ Long-Term Hemodialysis Catheter (K190527, cleared March 05, 2020)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a hemodialysis catheter, with no mention of AI or ML.
No.
The device is a catheter used for vascular access for hemodialysis, apheresis, and infusion, which are procedures rather than treatments for a disease/condition.
No
This device is a hemodialysis catheter used for vascular access, and its description and intended use do not mention any diagnostic capabilities.
No
The device description clearly outlines a physical, implantable catheter made of materials like a radiopaque shaft, luer adapters, extension tubes, and a cuff. The performance studies also detail physical testing of these components (tensile strength, leak decay, etc.), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "attaining short-term vascular access for hemodialysis, apheresis and infusion." This describes a procedure performed on the patient, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into a blood vessel. This is a medical device used for treatment and access, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic tests.
Therefore, the Pristine™ Long-Term Hemodialysis Catheter is a medical device used for vascular access, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pristine™ Long-Term Hemodialysis Catheters are indicated for use in attaining short-term vascular access for hemodialysis, apheresis and infusion. Access is attained via the internal jugular vein, or femoral vein. Catheters longer than 40 cm implant length are indicated for femoral vein insertion. Catheters may be inserted percutaneously.
The Pristine™ Long-Term Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access for hemodialysis, apheresis and infusion. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40 cm implant length are indicated for femoral vein insertion. Catheters may be inserted percutaneously.
Product codes (comma separated list FDA assigned to the subject device)
MSD
Device Description
The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis, apheresis, and infusion. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter bifurcation and suture wings (hub). The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical split tip. The design of the catheter's distal tip includes a split, symmetric Y-Tip™ with notches and without side-holes or slots. The symmetric Y-Tip™ design allows a spatial separation between the distal ends of the two lumens. The Pristine™ Long-Term Hemodialysis Catheter is provided as a sterile, single use device, and is sterilized using a validated ethylene oxide process. The dialysis catheters are offered in various implant lengths, varying from 19 cm to 55 cm as depicted below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal jugular vein, or femoral vein, subclavian vein
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)
The subject device, Pristine™ Long-Term Hemodialysis Catheter, met all of the design verification and validation requirements previously reported for the predicate device. Pristine™ Hemodialysis Catheter (K182443, cleared May 31, 2019). All samples used for final testing of each product attribute were representative of finished products.
For the various design changes, which includes the modified luer geometry change, extension legs process aid material change, and the bifurcation design change, verification testing was performed to the exact same acceptance criteria as K182443 and outlined below:
- . Dimensional and Workmanship Analysis: Luers
- . Luer Occlusion
- . Luer Assembly Tensile
- . Leak Decay
For the additional BPV design changes, such as modified packaging change and modified tunneler design, additional verification and validation testing was performed based on Bard's acceptance criteria. It should be noted that the additional verification tests that were completed based on the modifications made for the subject device are outlined below:
- Tunneler (Shaft to Tunneler Tensile) .
- . Tunneler (Damage after Removal)
- . Sterile Barrier Visual Inspection
- . Sterile Barrier Integrity (Bubble Leak, Dye Leak)
- Minimum Seal Width .
- . External Literature Pouch Damage
- Label Legibility .
- . Tray Cracking
- . Component Movement and Damage
- . Peel Force Test (Poly to Poly, Poly to Tyvek)
All other original verification and validation testing previously completed for the predicate device remains the same and is unchanged as it relates to the subject Pristine™ Long-Term Hemodialysis Catheter. The original testing from the predicate Pristine™ Hemodialysis Catheter was previously provided in K182443, which was cleared on May 31, 2019.
Conclusion: The subject device, the Pristine™ Long-Term Hemodialysis Catheter, meets all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Pristine™ Long-Term Hemodialysis Catheter is therefore substantially equivalent to the legally marketed predicate device, Pristine™ Hemodialysis Catheter.
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.
Pristine™ Hemodialysis Catheter (K182443, cleared May 31, 2019)
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.
GlidePath™ Long-Term Hemodialysis Catheter (K190527, cleared March 05, 2020)
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
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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April 2, 2021
C. R. Bard, Inc. Arieona Boyle Regulatory Affairs Specialist 1625 West Third Street Tempe. AZ 85281
Re: K203767
Trade/Device Name: Pristine™ Long-Term Hemodialysis Catheter Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood Access Device and Accessories Regulatory Class: II Product Code: MSD Dated: February 26, 2021 Received: March 1, 2021
Dear Arieona Boyle:
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 Mav 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 kit 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 kit'tray. 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.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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 -S
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) K203767
Device Name PristineTM Long-Term Hemodialysis Catheter
Indications for Use (Describe)
The Pristine™ Long-Term Hemodialysis Catheters are indicated for use in attaining short-term vascular access for hemodialysis, apheresis and infusion. Access is attained via the internal jugular vein, or femoral vein. Catheters longer than 40 cm implant length are indicated for femoral vein insertion. Catheters may be inserted percutaneously.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Pristine™ Long-Term Hemodialysis Catheter 510(k) Summary 21 CFR 807.92
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 510(k) summary upon which substantial equivalence determination is based is as follows:
Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc
1625 West 3rd Street
Tempe, Arizona 85281 |
|------------|-------------------------------------------------------------------------------|
| Phone: | 480-597-8260 |
| Fax: | 312-949-0436 |
| Contact: | Arieona Boyle, Regulatory Affairs Specialist |
| Date: | December 22, 2020 |
Subject Device Name:
| Device Trade Name: | Pristine™ Long-Term Hemodialysis Catheter |
|---|---|
| Common or Usual Name: | Catheter, Hemodialysis, Implanted |
| Device Classification: | Class II |
| Classification Name: | Blood Access Device and Accessories |
| Product Code: | MSD |
| Regulation Number: | 21 CFR 876.5540 |
| Classification Panel: | Gastroenterology/Urology |
Predicate Device:
Pristine™ Hemodialysis Catheter (K182443, cleared May 31, 2019)
Reference Device:
GlidePath™ Long-Term Hemodialysis Catheter (K190527, cleared March 05, 2020)
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Device Description:
The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis, apheresis, and infusion. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter bifurcation and suture wings (hub). The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical split tip. The design of the catheter's distal tip includes a split, symmetric Y-Tip™ with notches and without side-holes or slots. The symmetric Y-Tip™ design allows a spatial separation between the distal ends of the two lumens. The Pristine™ Long-Term Hemodialysis Catheter is provided as a sterile, single use device, and is sterilized using a validated ethylene oxide process. The dialysis catheters are offered in various implant lengths, varying from 19 cm to 55 cm as depicted below.
| Attribute | Pristine™ Hemodialysis Catheter Product
Offerings |
|-----------------------------------------|------------------------------------------------------|
| Catheter Outer Diameter (F) | 15.5 |
| Catheter Shaft Length, Tip to Cuff (cm) | 19, 23, 28, 33, 55 |
| Catheter Shaft Length, Tip to Hub (cm) | 24, 28, 33, 38, 60 |
| Overall Catheter Length (cm) | 35, 39, 44, 49, 71 |
Indications for Use of Device:
The Pristine™ Long-Term Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access for hemodialysis, apheresis and infusion. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40 cm implant length are indicated for femoral vein insertion. Catheters may be inserted percutaneously.
Comparison to Predicate Device and Reference Device:
The subject Pristine™ Long-Term Hemodialysis Catheter has the following similarities to the predicate Pristine™ Hemodialysis Catheter (K182443, cleared May 31, 2019):
- . Same intended use
- o Same indications for use
- . Same target population
- . Same operating principle
5
- . Same fundamental scientific technology
- . Same sterility assurance level and method of sterilization
The subject Pristine™ Long-Term Hemodialysis Catheter has the following similarities to the reference GlidePath™ 14.5F Long-Term Hemodialysis Catheter (K190527, cleared March 05, 2020):
- . Similar intended use
- . Similar indications for use
- Same target population .
- Similar operating principle .
- Same fundamental scientific technology .
- . Same sterility assurance level, method of sterilization, and same sterilization facility
- . Similar packaging configuration
The subject Pristine™ Long-Term Hemodialysis Catheter has the following differences to the Predicate, Pristine™ Hemodialysis Catheter (K182443, cleared May 31, 2019):
- Modified Luer geometry removal of excessive material (wings) from the external . surface of the Luer
- . Removal/elimination of the quantity of two process aid materials used in the extension legs extrusion process
- . Reducing the external thickness on the center of the bifurcation by 0.2 mm
- . Modified packaging configuration with addition of catheter tip holder for packaging purposes
- . Different sterilization facilities and manufacturing plant as a result of acquisition by Bard
- Expanded standard components .
- . Modified tunneler design
- . Addition of ID tags to device clamps, removal of printing on the device luers, and modified printing on the bifurcation
The subject device incorporates the same intended use, indications for use, target population, operating principle, fundamental scientific technology and a similar design and materials as the predicate Pristine™ Hemodialysis catheter. The GlidePath™ Long-Term Hemodialysis Catheter reference device is included for sterilization, shelf-life, packaging, printing of the bifurcation and
6
ID clamps of the catheter, and kit componentry and associated equivalent material comparisons onlv.
Performance Data:
The subject device, Pristine™ Long-Term Hemodialysis Catheter, met all of the design verification and validation requirements previously reported for the predicate device. Pristine™ Hemodialysis Catheter (K182443, cleared May 31, 2019). All samples used for final testing of each product attribute were representative of finished products.
For the various design changes, which includes the modified luer geometry change, extension legs process aid material change, and the bifurcation design change, verification testing was performed to the exact same acceptance criteria as K182443 and outlined below:
- . Dimensional and Workmanship Analysis: Luers
- . Luer Occlusion
- . Luer Assembly Tensile
- . Leak Decay
For the additional BPV design changes, such as modified packaging change and modified tunneler design, additional verification and validation testing was performed based on Bard's acceptance criteria. It should be noted that the additional verification tests that were completed based on the modifications made for the subject device are outlined below:
- Tunneler (Shaft to Tunneler Tensile) .
- . Tunneler (Damage after Removal)
- . Sterile Barrier Visual Inspection
- . Sterile Barrier Integrity (Bubble Leak, Dye Leak)
- Minimum Seal Width .
- . External Literature Pouch Damage
- Label Legibility .
- . Tray Cracking
- . Component Movement and Damage
- . Peel Force Test (Poly to Poly, Poly to Tyvek)
All other original verification and validation testing previously completed for the predicate device remains the same and is unchanged as it relates to the subject Pristine™ Long-Term
7
Hemodialysis Catheter. The original testing from the predicate Pristine™ Hemodialysis Catheter was previously provided in K182443, which was cleared on May 31, 2019.
Conclusion:
The subject device, the Pristine™ Long-Term Hemodialysis Catheter, meets all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Pristine™ Long-Term Hemodialysis Catheter is therefore substantially equivalent to the legally marketed predicate device, Pristine™ Hemodialysis Catheter.