(206 days)
No
The summary describes a physical medical device (catheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is used for hemodialysis, hemoperfusion, or apheresis therapy, which are treatments for medical conditions.
No
The device description and intended use clearly state that it is for achieving vascular access for therapies like hemodialysis, hemoperfusion, or apheresis, and connects to an external dialysis machine. It does not mention any function for diagnosing conditions or diseases.
No
The device description clearly outlines a physical catheter with various hardware components (shaft, hub, extension legs, luer connectors, clamps, tip). The performance studies also focus on physical and mechanical properties of the device.
Based on the provided information, the GlidePath™ Retro Long-Term Hemodialysis Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for attaining vascular access for hemodialysis, hemoperfusion, or apheresis therapy. These are procedures performed directly on the patient's body to treat a medical condition.
- Device Description: The device is a catheter designed to be inserted into a vein to facilitate the flow of blood to and from an external machine. It is a physical device used for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to testing or analyzing biological samples (like blood, urine, etc.) outside of the body. IVDs are typically used in laboratories or point-of-care settings to diagnose, monitor, or screen for diseases or conditions by examining these samples.
Therefore, the GlidePath™ Retro Long-Term Hemodialysis Catheter is a therapeutic medical device used for direct patient treatment, not an IVD.
N/A
Intended Use / Indications for Use
The GlidePath™ Retro Long-Term Hemodialysis Catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40 cm are intended for femoral vein insertion.
Product codes (comma separated list FDA assigned to the subject device)
MSD
Device Description
The GlidePath™ Retro Long-Term Hemodialysis Catheter features a dual-lumen polyurethane catheter shaft with optimized double-D cross-sectional design providing separate arterial and venous lumens, an external bifurcation hub with SwiftClick connector assembled by physician upon placement, and arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector secures to the blood intake on the dialysis machine and the venous (blue) luer connector secures to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in over-the-guidewire placement. The dialysis catheter is offered in various lengths. GlidePath™ Retro Long-Term Hemodialysis Catheters diameter and tip to cuff lengths are listed below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal jugular vein, subclavian vein, or femoral 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)
To demonstrate substantial equivalence of the subject device to the predicate device, both technical characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, tests for the following characteristics and performance criteria were performed on the subject device:
- Extension Leq to Bifurcation Tensile
- Bifurcation to Catheter Shaft while assembled with Swiftclick Tensile
- Flow Rate
- Recirculation
- Mechanical Hemolysis
- Catheter Assembly Leak
- Catheter Burst
- Surface Inspection
- Stylet to Luer Tensile
- Stylet Assembly Leak
- Priming Luer Interface
- Catheter Cap to Tunneler Rod Tensile
- Tunneler Rod Malleability
- Package Performance
- Sterility and Endotoxin
- Biocompatibility per ISO 10993
- Human Factors Evaluation
The results of these comparisons and tests performed in accordance with standards and FDA guidance, demonstrate that the technical characteristics and performance criteria of the GlidePath™ Retro Long-Term Hemodialysis Catheter is substantially equivalent to the predicate, comparable in technology to the reference, and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
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.
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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Image /page/0/Picture/0 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 1, 2021
C.R. Bard, Inc. Joan Bergstrom Regulatory Affairs Specialist 1625 W. Third Street Tempe, Arizona 85281
Re: K203575
Trade/Device Name: GlidePath™ Retro Long-Term Hemodialysis Catheter Regulation Number: 21 CFR 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: Class II Product Code: MSD Dated: May 27, 2021 Received: May 28, 2021
Dear Joan Bergstrom:
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. 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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 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.
for 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) K203575
Device Name
GlidePath™ Retro Long-Term Hemodialysis Catheter
Indications for Use (Describe)
The GlidePath™ Retro Long-Term Hemodialysis Catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40 cm are intended for femoral vein insertion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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GlidePath™ Retro 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 (1)(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: | 480-597-8425 |
| Fax: | 480-449-2546 |
| Contact: | Joan Bergstrom, Regulatory Affairs Specialist |
| Date | May 27, 2021 |
Subject Device Name:
| Device Trade Name: | GlidePath™ Retro 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 |
| Review Panel: | Gastroenterology/Urology |
Predicate Device:
Bard GlidePath™ Long-Term Dialysis Catheter (K190527, cleared March 5, 2020)
Retrograde Placement Reference Device:
Covidien Palindrome™ Precision RT Chronic Catheter Kit (K111817, cleared August 30, 2011)
4
Device Description:
The GlidePath™ Retro Long-Term Hemodialysis Catheter features a dual-lumen polyurethane catheter shaft with optimized double-D cross-sectional design providing separate arterial and venous lumens, an external bifurcation hub with SwiftClick connector assembled by physician upon placement, and arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector secures to the blood intake on the dialysis machine and the venous (blue) luer connector secures to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in over-the-guidewire placement. The dialysis catheter is offered in various lengths. GlidePath™ Retro Long-Term Hemodialysis Catheters diameter and tip to cuff lengths are listed below.
| Attribute | GlidePath™ Retro Long-Term Hemodialysis Catheter Product Offerings |
|---|---|
| Catheter Diameter (F) | 14.5 |
| Catheter Shaft Length, Tip to Cuff (cm) | 15, 19, 23, 27, 31, 35, 42, 50 |
Indications for Use of Device:
The GlidePath™ Retro Long-Term Hemodialysis Catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40 cm are intended for femoral vein insertion.
Comparison to Predicate and Reference Devices:
The GlidePath™ Retro Long-Term Hemodialysis Catheter has the following similarities to the predicate, GlidePath™ Long-Term Hemodialysis Catheter (K190527, cleared March 5, 2020):
- . Same catheter shaft material
- Same intended use .
- Same indications for use .
- . Same patient target population
- . Same operating principle
- . Same fundamental scientific technology
5
- Same packaging configurations .
- . Same sterility assurance level and method of sterilization
The main difference between the subject device. GlidePath™ Retro Long-Term Hemodialysis Catheter, and the predicate GlidePath™ Long-Term Hemodialysis Catheter is the retrograde placement technique and external bifurcation connector for which the reference device, Covidien Palindrome™ Precision RT Chronic Catheter Kit (K111817, cleared August 30, 2011) and its bifurcation connector serves as technology comparison.
Performance Data:
To demonstrate substantial equivalence of the subject device to the predicate device, both technical characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, tests for the following characteristics and performance criteria were performed on the subject device:
- Extension Leq to Bifurcation Tensile .
- . Bifurcation to Catheter Shaft while assembled with Swiftclick Tensile
- Flow Rate
- . Recirculation
- Mechanical Hemolysis ●
- Catheter Assembly Leak .
- . Catheter Burst
- . Surface Inspection
- Stylet to Luer Tensile .
- . Stylet Assembly Leak
- . Priming Luer Interface
- Catheter Cap to Tunneler Rod Tensile ●
- . Tunneler Rod Malleability
- Package Performance ●
- . Sterility and Endotoxin
- Biocompatibility per ISO 10993 .
- Human Factors Evaluation ●
6
The required retrograde placement technology comparison of specific device characteristics including the external hub connector is made to the reference device, Palindrome™ Precision RT Chronic Catheter Kit (K111817, cleared August 30, 2011). The results of these comparisons and tests performed in accordance with standards and FDA guidance, demonstrate that the technical characteristics and performance criteria of the GlidePath™ Retro Long-Term Hemodialysis Catheter is substantially equivalent to the predicate, comparable in technology to the reference, and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
Conclusion:
The subject device, the GlidePath™ Retro Long-Term Hemodialysis Catheter, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The subject, predicate, and reference devices share the same or similar characteristics: catheter shaft material, intended use, indications for use, target patient population, operating principle, fundamental scientific technology, packaging configurations, and sterility assurance level and method of sterilization. Therefore, Bard Peripheral Vascular, Inc. concludes that the subject device GlidePath™ Retro Long-Term Hemodialysis Catheter is substantially equivalent to the legally marketed predicate device, GlidePath™ Long-Term Hemodialysis Catheter and comparable to the legally marketed reference device Palindrome™ Precision RT Chronic Catheter Kit.