(104 days)
No
The document describes a physical medical device (a hemodialysis catheter) and its performance characteristics. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are in vitro tests of the physical properties and function of the catheter.
No
The device is a hemodialysis catheter, which is used for vascular access but does not directly provide therapeutic treatment itself. Instead, it facilitates the connection to an external dialysis machine or blood cleansing device, which performs the therapeutic function.
No
The device description clearly states its purpose is for "attaining short-term vascular access in pediatric, adolescent and adult patients for hemodialysis, hemoperfusion or apheresis," which are therapeutic procedures, not diagnostic ones. It connects to an "external dialysis machine or blood cleansing device."
No
The device description clearly describes a physical catheter with lumens, a bifurcation, extension legs, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, the GlidePath™ 10F long-term hemodialysis catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "attaining short-term vascular access in pediatric, adolescent and adult patients for hemodialysis, hemoperfusion or apheresis." This is a procedure performed directly on a patient's body to access their bloodstream for treatment.
- Device Description: The description details a catheter designed to be inserted into a vein to connect to an external dialysis machine. This is a medical device used for a therapeutic procedure, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis. IVDs are typically used in laboratories or point-of-care settings to diagnose, monitor, or screen for diseases or conditions.
Therefore, the GlidePath™ 10F long-term hemodialysis catheter is a medical device used for a therapeutic procedure involving direct patient access, not an IVD.
N/A
Intended Use / Indications for Use
The GlidePath™ 10F long-term hemodialysis catheter is indicated for use in attaining short-term vascular access in pediatric, adolescent and adult patients for hemodialysis, hemoperfusion or apheresis as determined by the prescribing physician. Access is attained via the internal jugular vein, or femoral vein, Catheters longer than 22 cm are intended for femoral vein insertion, depending on patient anatomy and size.
Product codes (comma separated list FDA assigned to the subject device)
MSD
Device Description
The Glidepath™ 10F Long-Term Hemodialysis Catheter features a dual-lumen shaft with optimized double-D cross-sectional designs providing separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector connects to the blood intake on the dialysis machine and the venous (blue) luer connector connects to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. Long-term dialysis catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in overthe-guidewire placement. The dialysis catheters are offered in various lengths. This line extension of GlidePath™ has been designed with smaller patients in mind and for physicians that may prefer a smaller diameter catheter, so product offerings include the smaller lumen diameter, 10 F, and shorter lengths, 10 cm to 23 cm. Additionally, Glidepath™ 10F Long-Term Hemodialysis Catheter has been designed to reach adequate flow rate requirements for pediatric patients or smaller adult patients for whom a physician desires a smaller catheter size.
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
pediatric, adolescent and adult
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 and reference devices, their technical characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed on the subject device:
- . Catheter Tip (Damage After Flexure)
- Tip Tensile .
- . Tunneler (Shaft to Tunneler Tensile)
- Catheter Tip Stiffness .
- Surface Inspection .
- Catheter Insertion Over Split Sheath Introducer ●
- Assembly Leak Resistance ●
- Flow Rates .
- Catheter Collapse .
- Catheter Tensile (Shaft to Bifurcation) ●
- Catheter Tensile (Extension Leg to Bifurcation)
- . Catheter Tensile (Extension Leq to Connector)
- Cuff Securement .
- Burst ●
- Recirculation .
- Mechanical Hemolysis ●
- Catheter Shaft Stiffness ●
- Catheter Radiopacity .
- . Thumb Clamps
- . Extension Legs (Knitting, Flow)
The results from these tests performed in accordance with the same standards and FDA guidance were used for the subjects, references, and predicate the designs.
The comparative results for pediatric specific characteristics of flow rates, recirculation, and hemolysis also demonstrate that the technical characteristics and performance criteria of the GlidePath™ 10F Long-Term Dialysis Catheter is substantially equivalent to the pediatric reference device Medcomp Pediatric Ash Split Cath™ XL 10F. The testing results show that the minor differences in device characteristics between the subject device, reference device and predicate device do not raise any new questions of safety or effectiveness and that they can perform in a manner equivalent to devices currently on the market for the same intended use and indicated for a similar patient population.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
June 22, 2020
C R Bard, Inc Joan Bergstrom Regulatory Affairs Specialist 1625 West Third Street Tempe, AZ 85281
Re: K200627
Trade/Device Name: GlidePath 10F Long-Term Hemodialysis Catheter Regulation Number: 21 CFR 876.5540 Regulation Name: Blood Access Device and Accessories Regulatory Class: II Product Code: MSD Dated: May 21, 2020 Received: May 22, 2020
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 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, 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
2
Indications for Use
510(k) Number (if known) K200627
Device Name
GlidePath™ 10F Long-Term Hemodialysis Catheter
Indications for Use (Describe)
The GlidePath™ 10F long-term hemodialysis catheter is indicated for use in attaining short-term vascular access in pediatric, adolescent and adult patients for hemodialysis, hemoperfusion or apheresis as determined by the prescribing physician. Access is attained via the internal jugular vein, or femoral vein, Catheters longer than 22 cm are intended for femoral vein insertion, depending on patient anatomy and size.
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) |
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GlidePath™ 10F 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: | 480-597-8425 |
| Fax: | 480-449-2546 |
| Contact: | Joan Bergstrom, Regulatory Affairs Specialist |
| Date: | June 15, 2020 |
Subject Device Name:
| Device Trade Name: | GlidePath™ 10F 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:
Bard GlidePath™ Long-Term Hemodialysis Catheter (K190527, cleared March 5, 2020)
Pediatric Reference Device:
Medcomp Pediatric Ash Split Cath™ XL 10F (K020936, cleared October 11, 2002)
4
Device Description:
The Glidepath™ 10F Long-Term Hemodialysis Catheter features a dual-lumen shaft with optimized double-D cross-sectional designs providing separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector connects to the blood intake on the dialysis machine and the venous (blue) luer connector connects to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. Long-term dialysis catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in overthe-guidewire placement. The dialysis catheters are offered in various lengths. This line extension of GlidePath™ has been designed with smaller patients in mind and for physicians that may prefer a smaller diameter catheter, so product offerings include the smaller lumen diameter, 10 F, and shorter lengths, 10 cm to 23 cm. Additionally, Glidepath™ 10F Long-Term Hemodialysis Catheter has been designed to reach adequate flow rate requirements for pediatric patients or smaller adult patients for whom a physician desires a smaller catheter size.
| Attribute | Glidepath™ 10F Long-Term
Hemodialysis Catheter
Product Offerings |
|----------------------------|------------------------------------------------------------------------|
| Catheter Diameter (F) | 10 |
| Catheter Shaft Length (cm) | 10, 12, 15, 19, 23 |
Indications for Use of Device:
GlidePath™ 10F long-term hemodialysis catheter is indicated for use in attaining short-term or long-term vascular access in pediatric, adolescent and adult patients for hemodialysis, hemoperfusion or apheresis as determined by the prescribing physician. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 22 cm are intended for femoral vein insertion, depending on patient anatomy and size.
Comparison to Predicate and Reference Devices:
The Glidepath™ 10F Long-Term Hemodialysis Catheter has the same design, materials, and intended use as the Predicate, Bard GlidePath™ Long-Term Hemodialysis Catheter
5
(K190527, cleared March 5, 2020). Additional Pediatric Reference Device, Medcomp Pediatric Ash Split Cath™ XL 10F (K020936, cleared October 11, 2002) is a performance testing comparator, specifically comparing flow of the subject devices to a pediatric device to demonstrate the substantial equivalence in support of a Pediatric Indication.
Performance Data:
To demonstrate substantial equivalence of the subject device to the predicate and reference devices, their technical characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed on the subject device:
- . Catheter Tip (Damage After Flexure)
- Tip Tensile .
- . Tunneler (Shaft to Tunneler Tensile)
- Catheter Tip Stiffness .
- Surface Inspection .
- Catheter Insertion Over Split Sheath Introducer ●
- Assembly Leak Resistance ●
- Flow Rates .
- Catheter Collapse .
- Catheter Tensile (Shaft to Bifurcation) ●
- Catheter Tensile (Extension Leg to Bifurcation)
- . Catheter Tensile (Extension Leq to Connector)
- Cuff Securement .
- Burst ●
- Recirculation .
- Mechanical Hemolysis ●
- Catheter Shaft Stiffness ●
- Catheter Radiopacity .
- . Thumb Clamps
- . Extension Legs (Knitting, Flow)
The results from these tests performed in accordance with the same standards and FDA guidance were used for the subjects, references, and predicate the designs.
6
The comparative results for pediatric specific characteristics of flow rates, recirculation, and hemolysis also demonstrate that the technical characteristics and performance criteria of the GlidePath™ 10F Long-Term Dialysis Catheter is substantially equivalent to the pediatric reference device Medcomp Pediatric Ash Split Cath™ XL 10F. The testing results show that the minor differences in device characteristics between the subject device, reference device and predicate device do not raise any new questions of safety or effectiveness and that they can perform in a manner equivalent to devices currently on the market for the same intended use and indicated for a similar patient population.
Conclusion:
The subject device, the GlidePath™ 10F Long-Term Dialysis Catheter, meets all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The GlidePath™ 10F Long-Term Dialysis Catheter is therefore substantially equivalent to the legally marketed pediatric reference device Medcomp Pediatric Ash Split Cath™ XL 10F and the legally marketed predicate device, the Bard GlidePath™ Long-Term Hemodialysis Catheter.