(367 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the catheters, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for use in hemodialysis, hemoperfusion, or apheresis therapy, which are medical treatments designed to treat or prevent disease.
No
Explanation: The provided text describes the device as a catheter used for hemodialysis, hemoperfusion, or apheresis therapy. Its function is to provide vascular access for treatment, not to diagnose a condition or disease.
No
The device description clearly describes physical catheters and associated hardware components for vascular access. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the catheters are for "attaining short-term vascular access for hemodialysis, hemoperfusion or apheresis therapy." These are procedures performed directly on the patient's body to access their bloodstream for treatment.
- Device Description: The description details a physical device (catheter) inserted into a vein to connect to an external machine for blood processing.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples. It is a tool for accessing the vascular system for therapeutic purposes.
The device is a therapeutic device used for accessing the vascular system for treatment, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The GlidePath™ Long-Term Hemodialysis Catheters are indicated for use in attaining short-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 40cm are intended for femoral vein insertion.
The HemoStar™ and HemoStar™ XK 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 greater 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™, HemoStar™, and HemoStar™ XK Long-Term Hemodialysis Catheters feature a dual-lumen shaft with 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. Both the staggered and symmetrical catheter tips contain holes that aid in the distribution of blood flow or aid in over-the-quidewire placement. The dialysis catheters are offered in various lengths in straight or Alphacurve™ configurations. Alphacurve™ configurations feature a pre-formed, ~225 ° curve. Long-term dialysis catheters are tunneled to provide greater distance between the skin and entry site into the vein and provide a physical barrier to the migration of skin organisms.
The HemoStar™ and HemoStar™ XK Long-Term Dialysis Catheters feature a fixed, staggered distal tip. This tip design is identical to that of the predicate devices, HemoGlide™ Star Series and HemoGlide™ Star Series XK Long-Term Dialysis Catheters, cleared August 12, 2005 under K051748.
The GlidePath™ Long-Term Dialysis Catheters, launched in February 2013, are a modification of the HemoStar™ Long-Term Dialysis Catheters. GlidePath™ catheters feature an optimized catheter shaft extrusion profile and a modified tip which is fixed and symmetrical, allowing for reduced luminal pressure during use. The GlidePath™ catheters also include a preloaded stylet for ease of placement. This accessory was previously cleared under K090101. The changes to the catheter were documented via internal note to file prior to launch in 2013.
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 devices to the predicate devices, their technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following bench tests were performed on the subject devices:
HemoStar™ and HemoStar XK™ Alphacurve™:
- · Guidewire Removal
- Priming Volume
- Shaft Bifurcation Tensile
- Flow Rate
- Shaft Tensile
- Burst Testing
- · Kink Testing
GlidePath™ Modifications (including Alphacurve™):
- Shaft Stiffness With and Without Stylet
- Catheter-to-Tunneler Detachment
- Tunneler Tip Bend
- · Stylet Removal
- · Guidewire removal and Visual Inspection
- · Kink Testing
- Catheter Tip Tensile
- Occlusion Simulation against vessel wall Initial Placement
- · Occlusion Simulation against vessel wall Flow Method
- · Tip Stiffness
- Flow and Collapse
- · Recirculation Glass Heart Model
- Radiopacity
- · Assembly Tensile
- · Assembly Leak Resistance
- Burst
- Cuff Tensile
- Priming Volume
- · Introducer Sheath Passage
Conclusions:
The subject devices, the GlidePath™, HemoStar™, and HemoStar™ XK Long-Term Hemodialysis Catheters, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Bard GlidePath™, HemoStar™, and HemoStar™ XK Long-Term Hemodialysis Catheters are substantially equivalent to the legally marketed predicate devices HemoGlide™ Star Series, and HemoGlide™ Star Series XK Long-Term Hemodialysis Catheters.
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.
0
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.
March 5, 2020
Bard Access Systems, Inc. Joan Bergstrom Regulatory Affairs Specialist 1625 West 3rd Street Tempe, UT 85281
Re: K190527
Trade/Device Name: GlidePath Long-Term Hemodialysis Catheters HemoStar Long-Term Hemodialysis Catheters HemoStar XK Long-Term Hemodialysis Catheters Regulation Number: 21 CFR 876.5540 Regulation Name: Blood Access Device and accessories Regulatory Class: II Product Code: MSD Dated: June 7, 2019 Received: June 10, 2019
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 tray 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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) K190527
Device Name
GlidePath™ Long-Term Hemodialysis Catheter HemoStar™ and HemoStar™ XK Long-Term Hemodialysis Catheters
Indications for Use (Describe)
The GlidePath™ Long-Term Hemodialysis Catheters are indicated for use in attaining short-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 40cm are intended for femoral vein insertion.
The HemoStar™ and HemoStar™ XK 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 greater 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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K190527 Page 1 of 5
Page 1
GlidePath™ / HemoStar™ / HemoStar™ XK / Long-Term Hemodialysis Catheters 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:
Bard Access Systems (C.R. Bard, Inc.) 605 North 5600 West Salt Lake City, Utah 84116
| Contact: | Joan Bergstrom, Regulatory Affairs Specialis |
|---|---|
| Phone: | 480-597-8425 |
| Fax: | 480-449-2546 |
| Date of Submission: | March 3, 2020 |
| Establishment Registration Number: | 3006260740 |
Subject Device:
| Name of Device: | GlidePathTM Long-Term Hemodialysis Catheter
HemoStarTM Long-Term Hemodialysis Catheter
HemoStarTM XK Long-Term Hemodialysis Catheter |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code: | MSD |
| Classification Name: | Blood access device and accessories |
| Common/Usual Name: | Long-term hemodialysis catheters, or chronic hemodialysis catheters |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 876.5540 |
| Predicate Device: | |
| Name of Device: | HemoGlideTM Star Series Long-Term Hemodialysis Catheter
HemoGlideTM Star Series XK Long-Term Dialysis Catheter
(K051748, cleared August 12, 2005) |
| Product Code: | MSD |
Image /page/3/Picture/11 description: The image shows the word "BARD" in a stylized, bold, sans-serif font. Each letter is outlined in black, creating a strong visual impact. The letters are closely spaced, forming a compact and unified design. The overall impression is modern and geometric.
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Page 2
| Classification Name: | Blood access device and accessories |
|---|---|
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 876 5540 |
Device Description:
The GlidePath™, HemoStar™, and HemoStar™ XK Long-Term Hemodialysis Catheters feature a dual-lumen shaft with 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. Both the staggered and symmetrical catheter tips contain holes that aid in the distribution of blood flow or aid in over-the-quidewire placement. The dialysis catheters are offered in various lengths in straight or Alphacurve™ configurations. Alphacurve™ configurations feature a pre-formed, ~225 ° curve. Long-term dialysis catheters are tunneled to provide greater distance between the skin and entry site into the vein and provide a physical barrier to the migration of skin organisms.
The HemoStar™ and HemoStar™ XK Long-Term Dialysis Catheters feature a fixed, staggered distal tip. This tip design is identical to that of the predicate devices, HemoGlide™ Star Series and HemoGlide™ Star Series XK Long-Term Dialysis Catheters, cleared August 12, 2005 under K051748.
The GlidePath™ Long-Term Dialysis Catheters, launched in February 2013, are a modification of the HemoStar™ Long-Term Dialysis Catheters. GlidePath™ catheters feature an optimized catheter shaft extrusion profile and a modified tip which is fixed and symmetrical, allowing for reduced luminal pressure during use. The GlidePath™ catheters also include a preloaded stylet for ease of placement. This accessory was previously cleared under K090101. The changes to the catheter were documented via internal note to file prior to launch in 2013.
Image /page/4/Picture/9 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The "A" in "BARD" is stylized with a triangular shape, and the other letters are more traditional in form. The word is horizontally oriented and appears to be a logo or brand name.
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Intended Use:
HemoStar™ and HemoStar™ XK Long-Term Hemodialysis Catheters are intended for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Catheters greater than 40 cm are intended for femoral vein insertion.
GlidePath™ Long-Term Hemodialysis Catheters are intended for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Catheters greater than 40 cm are intended for femoral vein insertion.
Indications for Use of Device:
HemoStar™ and HemoStar™ XK 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 juqular vein or femoral vein. Catheters greater than 40 cm are intended for femoral vein insertion.
GlidePath™ 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 or femoral vein. Catheters greater than 40 cm are intended for femoral vein insertion.
Comparison of Indications for Use to Predicate Device:
The indications for use statement for the subject devices is identical to that of the predicate devices, and therefore does not raise any new issues of safety and effectiveness. Therefore, in this regard the subject devices are substantially equivalent to the predicate devices.
Technological Comparison to Predicate Devices:
The Bard GlidePath™, HemoStar™, and HemoStar™ XK Long-Term Hemodialysis Catheters are substantially equivalent to the predicate devices, the Bard HemoGlide™ Star Series, and HemoGlide™ Star Series XK Long-Term Hemodialysis Catheter (clearance to market via K051748 on August 12, 2005) in the following ways:
- . Same intended use
- . Same indications for use
- Same target population .
- . Same operating principle
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- . Same fundamental scientific technology
- . Same sterility assurance level and method of sterilization
The modifications include the following for HemoStar™, and HemoStar™ XK Long-Term Dialysis Catheters:
- . Rebranding from HemoGlide™ Star Series and HemoGlide™ Star Series XK Long-Term Dialysis Catheters to HemoStar™ and HemoStar™ XK Long-Term Dialysis Catheters
- Alphacurve™ (pre-curved) configurations .
In 2013, Bard launched the GlidePath™ Long-Term Hemodialysis Catheter with modifications to the HemoStar™ Long-Term Hemodialysis Catheter. These modifications only apply to the GlidePath™ Long-Term Hemodialysis Catheter:
- . An optimized extrusion method to improve luminal flow rates was qualified
- . A redesigned symmetrical tip
- . A tapered ingrowth cuff
- An additional 50cm shaft length (within lengths of the cleared Decathlon Long-Term . Hemodialysis Catheter, cleared under K073092)
- . A preloaded stylet (cleared under K090101) was added to the kit
- Alphacurve™ (pre-curved) configurations ●
- . The indications for use statement was slightly modified for clarity
Performance Data:
To demonstrate substantial equivalence of the subject devices to the predicate devices, their technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following bench tests were performed on the subject devices:
HemoStar™ and HemoStar XK™ Alphacurve™:
- · Guidewire Removal
- Priming Volume
- Shaft Bifurcation Tensile
- Flow Rate
Image /page/6/Picture/24 description: The image shows the word "BARD" in a stylized, bold font. The letters are outlined in black, creating a hollow effect. The font is sans-serif and has a geometric appearance.
7
Page 5
- Shaft Tensile
- Burst Testing
- · Kink Testing
GlidePath™ Modifications (including Alphacurve™):
- Shaft Stiffness With and Without Stylet
- Catheter-to-Tunneler Detachment
- Tunneler Tip Bend
- · Stylet Removal
- · Guidewire removal and Visual Inspection
- · Kink Testing
- Catheter Tip Tensile
- Occlusion Simulation against vessel wall Initial Placement
- · Occlusion Simulation against vessel wall Flow Method
- · Tip Stiffness
- Flow and Collapse
- · Recirculation Glass Heart Model
- Radiopacity
- · Assembly Tensile
- · Assembly Leak Resistance
- Burst
- Cuff Tensile
- Priming Volume
- · Introducer Sheath Passage
Conclusions:
The subject devices, the GlidePath™, HemoStar™, and HemoStar™ XK Long-Term Hemodialysis Catheters, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Bard GlidePath™, HemoStar™, and HemoStar™ XK Long-Term Hemodialysis Catheters are substantially equivalent to the legally marketed predicate devices HemoGlide™ Star Series, and HemoGlide™ Star Series XK Long-Term Hemodialysis Catheters.
Image /page/7/Picture/29 description: The image shows the word "BARD" in a stylized, outlined font. Each letter is formed by thick, black lines, creating a bold and modern look. The letters are evenly spaced and aligned horizontally, making the word easily readable. The overall design is clean and minimalist, with a focus on the geometric shapes of the letters.