The GlidePath™ 13F 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 34 cm are intended for femoral vein insertion.

Device Description

The GlidePath™ 13F Long-Term Hemodialysis Catheter is a vascular access device, intended for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy and features a dual-lumen, optimized double-D cross-sectional catheter shaft with a fixed symmetrical tip design. The catheter has separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial (red) luer and venous (blue) luer and extension legs which connect to an external dialysis machine or blood cleansing device. 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 and aid in overthe-guidewire placement. The GlidePath™ 13F Long-Term Hemodialysis Catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. The device is intended for single patient use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the GlidePath™ 13F Long-Term Hemodialysis Catheter. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the GlidePath™ Long-Term Hemodialysis Catheter (K190527).

The document details various performance tests conducted to support this claim, but it does not describe a study involving an AI/Machine Learning algorithm or human reader improvement with AI assistance. Therefore, many of the requested items related to AI device performance and clinical studies are not applicable or cannot be answered from the provided text.

The acceptance criteria mentioned are general ("met all predetermined acceptance criteria for design verification activities as specified by applicable standards, guidance, test protocols and/or customer inputs") rather than specific quantitative metrics for an AI model's performance.

Here's an analysis based on the provided text, addressing the applicable points:

Acceptance Criteria and Device Performance

The document states that the device "met all predetermined acceptance criteria for design verification activities as specified by applicable standards, guidance, test protocols and/or customer inputs." However, a specific table of quantitative acceptance criteria and reported numerical performance values is not provided in the text. The performance data section lists the types of tests conducted:

Test Characteristic / Performance Criteria	Reported Device Performance
Catheter Tensile	Met acceptance criteria (Implied: results demonstrate substantial equivalence)
Catheter Tip Stiffness	Met acceptance criteria (Implied: results demonstrate substantial equivalence)
Catheter Tip Damage after Flexure	Met acceptance criteria (Implied: results demonstrate substantial equivalence)
Flow Rate	Met acceptance criteria (Implied: results demonstrate substantial equivalence)
Recirculation	Met acceptance criteria (Implied: results demonstrate substantial equivalence)
Mechanical Hemolysis	Met acceptance criteria (Implied: results demonstrate substantial equivalence)
Catheter Assembly Leak	Met acceptance criteria (Implied: results demonstrate substantial equivalence)
Catheter Burst	Met acceptance criteria (Implied: results demonstrate substantial equivalence)
Surface Inspection	Met acceptance criteria (Implied: results demonstrate substantial equivalence)
Stylet to Luer Tensile	Met acceptance criteria (Implied: results demonstrate substantial equivalence)
Stylet Assembly Leak	Met acceptance criteria (Implied: results demonstrate substantial equivalence)
Catheter to Tunneler Rod Tensile	Met acceptance criteria (Implied: results demonstrate substantial equivalence)
Tunneler Rod Malleability	Met acceptance criteria (Implied: results demonstrate substantial equivalence)

Note: The text explicitly states that "The results from these tests performed in accordance with standards and FDA guidance, demonstrate that the technical characteristics and performance criteria of the GlidePath™ 13F Long-Term Hemodialysis Catheter is substantially equivalent to the predicate..."

Study Details (Applicable to Non-AI Device Testing)

This document describes a submission for a traditional medical device (a catheter), not specifically an AI/Machine Learning device. Therefore, many of the questions related to AI study design (like training/test sets, ground truth establishment for AI, expert consensus for AI interpretation, MRMC studies) are not directly applicable to this premarket notification. The "performance data" refers to physical and functional performance testing of the catheter itself, not diagnostic or clinical accuracy.

Sample sizes used for the test set and the data provenance: The document does not specify the number of units tested for each characteristic (e.g., how many catheters were subjected to tensile testing). It also does not discuss "data provenance" in the context of clinical data for an AI model, as this is a physical device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be objective physical measurements or established engineering standards, not expert clinical interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-powered device under review.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI-powered device under review.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance tests listed, the "ground truth" would be the established engineering and medical device standards (e.g., ISO standards, FDA guidance on non-clinical testing) against which the catheter's physical/functional properties were measured.
The sample size for the training set: Not applicable, as this is not an AI device that requires a training set.
How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In summary, the provided document is a 510(k) premarket notification for a physical medical device (a hemodialysis catheter) and details its engineering and physical performance testing to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI/ML algorithm.

Summary

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June 4, 2021

Bard Peripheral Vascular, Inc. Joan Bergstrom Regulatory Affairs Specialist 1625 West 3rd Street Tempe, AZ 85281

Re: K211410

Trade/Device Name: GlidePath™ 13F 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 5, 2021 Received: May 6, 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.

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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, 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211410

Device Name GlidePath™ 13F Long-Term Hemodialysis Catheter

Indications for Use (Describe)

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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510(k) Summary

GlidePath™ 13F 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, Inc1625 West 3rd StreetTempe, Arizona 85281
Phone:	480-597-8425
Fax:	480-449-2546
Contact:	Joan Bergstrom, Regulatory Affairs Specialist
Date	May 5, 2021

Subject Device Name:

Device Trade Name:	GlidePath™ TM 13F 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:

GlidePath™ Long-Term Hemodialysis Catheter (K190527, cleared March 5, 2020)

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Device Description:

Attribute	GlidePath™ 13F Long-Term HemodialysisCatheter Product Offerings
Catheter Diameter (F)	13
Catheter Shaft Length, Tip to Cuff (cm)	15, 19, 23, 27, 31, 35

Indications for Use of Device:

The GlidePath™ 13F Long-Term Hemodialysis Catheter 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 34 cm are intended for femoral vein insertion.

Comparison to Predicate Device:

The GlidePath™ 13F Long-Term Hemodialysis Catheter has the following similarities to the Predicate, Bard 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 .

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. Same fundamental scientific technology
. Same packaging configurations
Same sterility assurance level and method of sterilization .

The differences of the subject device, GlidePath™ 13F Long-Term Hemodialysis Catheter, from the predicate GlidePath™ (14.5F) Long-Term Hemodialysis Catheter are limited to the catheter shaft diameter and catheter lengths offered.

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 evaluated for the subject device:

Catheter Tensile .
Catheter Tip Stiffness
. Catheter Tip Damage after Flexure
. Flow Rate
. Recirculation
Mechanical Hemolysis .
Catheter Assembly Leak
Catheter Burst .
Surface Inspection ●
Stylet to Luer Tensile .
. Stylet Assembly Leak
Catheter to Tunneler Rod Tensile
. Tunneler Rod Malleability

The results from these tests performed in accordance with standards and FDA guidance, demonstrate that the technical characteristics and performance criteria of the GlidePath™ 13F Long-Term Hemodialysis Catheter is substantially equivalent to the predicate and that it can perform in a manner equivalent to devices currently on the market for the same intended use.

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Conclusion:

The subject device, the GlidePath™ 13F Long-Term Hemodialysis Catheter, met all predetermined acceptance criteria for design verification activities as specified by applicable standards, guidance, test protocols and/or customer inputs. The subject device and the predicate device share the same materials, 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™ 13F Long-Term Hemodialysis Catheter is substantially equivalent to the legally marketed predicate device, the GlidePath™ Long-Term Hemodialysis Catheter.

Regulation Number and Section

§ 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.