(66 days)
The TracStar LDP Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Zoom 88 Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Imperative Care Large Distal Platform (LDP) Catheters include the TracStar™ LDP Large Distal Platform and Zoom™ 88 Large Distal Platform. The LDP Catheters are 0.038" diameter or smaller guidewire compatible single lumen guide catheters that provide access to peripheral, coronary and neuro vasculature. The catheters are comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. An angled distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. LDP Catheters have an inner diameter of 0.088" (6F compatible), and a maximum outer diameter of 0.110". The LDP guide catheters are packaged with a rotating hemostasis valve (RHV) that is attached to the proximal luer to help maintain hemostasis.
This document describes the premarket notification for the Imperative Care TracStar LDP Large Distal Platform and Zoom 88 Large Distal Platform, which are guide catheters. The submission is based on substantial equivalence to predicate devices, meaning extensive new studies were not required. The provided text details the acceptance criteria and study findings for this medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Attribute | Acceptance Criteria | Reported Performance |
|---|---|---|
| Delivery, Compatibility, and Retraction (Trackability) | The catheter shall be able to be delivered, deployed, and retracted per the IFU within a simulated neurological model without incurring any damage to the catheter. | Pass |
| Flexibility and Kink Resistance | There shall be no kinking of shaft (permanent deformation) after simulated use. | Pass |
| Compatibility with other Devices (external) | The catheters shall be able to be delivered through the minimum introducer sheath or guide catheter size indicated in the product labeling. | Pass |
| Guidewire Compatibility | The catheters shall be able to be delivered over the maximum size guidewire indicated in the product labeling. | Pass |
| Interventional Device Compatibility (internal) | The catheters shall be able to accommodate other interventional devices (e.g., support catheter, diagnostic catheter) up to the maximum size indicated in the product labeling. | Pass |
| Luer Compatibility | Devices and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7. | Pass |
| Accessory Compatibility | Devices shall be compatible with an RHV. | Pass |
| Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intact throughout a procedure. | Pass |
| Freedom from Leakage – positive pressure | No liquid leakage from the hub or catheter shaft at 46psi for 30 seconds. | Pass |
| Freedom from leakage - negative pressure | No air leakage into a 20cc syringe when vacuum pulled for 15 seconds. | Pass |
| Dynamic Burst Pressure | Catheter does not burst under pressures that could be seen when performing contrast injections with a standard 10cc syringe. | Pass |
| Static Burst Pressure | Catheter does not burst under pressures that could be seen when performing contrast injections with a standard 10cc syringe. | Pass |
| Catheter Torque Strength | With the catheter tip held in a static position, there shall be no separation of any portion of the catheter when rotated at the hub at least two (2) full rotations (720 degrees). | Pass |
| Kink Resistance | There shall be no kinking of the catheter shaft (permanent deformation) after wrapping around anatomically relevant bend radii. | Pass |
| Pushability | The proximal shaft of the catheters shall have sufficient stiffness that the user can easily push the catheter to the target anatomy without buckling. | Pass |
| Access Force | Catheters shall not require excessive force to safely navigate and track to the target anatomy. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (number of units tested) for each individual bench and laboratory test. It generally refers to "bench and laboratory (in-vitro) testing." The data provenance is in-vitro, conducted in a laboratory setting. There is no information regarding country of origin of the data or if it was retrospective or prospective, as these terms typically apply to clinical studies with human participants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. For performance testing of a medical device like a catheter, "ground truth" is typically established by physical measurements, engineering specifications, and adherence to recognized standards (like ISO 10555-1), rather than expert consensus on interpretive data.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data (e.g., imaging) by multiple readers to resolve discrepancies. The performance tests described here are objective, pass/fail engineering tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission is for a medical device (catheter) and relies on bench and laboratory testing for substantial equivalence, not comparative clinical effectiveness with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the device described. The TracStar LDP Large Distal Platform and Zoom 88 Large Distal Platform are physical guide catheters, not algorithms or AI software. Therefore, there is no "algorithm only" or "human-in-the-loop" performance to report.
7. The Type of Ground Truth Used
For the bench and laboratory tests, the "ground truth" is based on pre-defined engineering specifications and performance standards, particularly ISO 10555-1 for catheters. The results are objective measurements against these established criteria, leading to a "Pass" or "Fail" outcome.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical catheter, not an AI/ML algorithm that requires a training set. The substantial equivalence pathway relies on demonstrating that the new device performs similarly to a predicate device through bench testing, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical medical device.
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September 20, 2021
Image /page/0/Picture/1 description: The image shows 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.
Imperative Care, Inc. Kristin Ellis Regulatory Affairs Manager 1359 Dell Avenue Campbell, California 95008
Re: K212224
Trade/Device Name: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: September 1, 2021 Received: September 2, 2021
Dear Kristin Ellis:
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. 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.
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
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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,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K212224
Device Name TracStar LDP Large Distal Platform Zoom 88 Large Distal Platform
Indications for Use (Describe)
The TracStar LDP Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Zoom 88 Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
For activities that do NOT require State Plan Coverage
For activities that DO require State Plan Coverage
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summarv
A. Submitter Information
Submitter's Name: Address:
Contact Person: Telephone: Email: Date of Preparation:
B. Subject Device
Proprietary Names:
Common/Usual Name: Classification Name: Product Code:
Regulation:
C. Predicate Device(s)
Proprietary Name:
Common/Usual Name: Classification Name: Product Code: Regulation: Manufacturer: 510(k):
Proprietary Name:
Common/Usual Name: Classification Name: Product Code: Regulation: Manufacturer: 510(k):
Imperative Care, Inc. 1359 Dell Avenue Campbell, CA 95008 Kristin Ellis 408-857-0934 kellis@imperativecare.com September 1, 2021
TracStar™ LDP Large Distal Platform Zoom™ 88 Large Distal Platform Guide Catheter Catheter, Percutaneous, Neurovasculature OJP DOY 21 CFR 870.1250
TracStar™ Large Distal Platform ZOOM™ 88 Large Distal Platform ZOOM™ 88-T Large Distal Platform Guide Catheter Catheter, Percutaneous, Neurovasculature QJP, DQY 21 CFR. 870.1250 Imperative Care, Inc. K203764
EagleRay Long Sheath EagleRay Access Catheter Guide Catheter Catheter, Percutaneous DQY 21 CFR. 870.1250 Imperative Care Inc. K180169
D. Device Description:
The Imperative Care Large Distal Platform (LDP) Catheters include the TracStar™ LDP Large Distal Platform and Zoom™ 88 Large Distal Platform. The LDP Catheters are 0.038" diameter or smaller guidewire compatible single lumen guide catheters that provide
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access to peripheral, coronary and neuro vasculature. The catheters are comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. An angled distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. LDP Catheters have an inner diameter of 0.088" (6F compatible), and a maximum outer diameter of 0.110". The LDP guide catheters are packaged with a rotating hemostasis valve (RHV) that is attached to the proximal luer to help maintain hemostasis.
Accessory devices required, but not supplied include:
- . Guidewires
- . Support/diagnostic catheters
- . Introducer sheaths
E. Indications for Use:
The TracStar LDP Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Zoom 88 Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
F. Principles of Operation:
The LDP Catheters may be used with support catheters to assist in accessing the target vasculature. During use, the male luer of the RHV is attached to the proximal luer of the LDP Catheter to create a continuous lumen through the catheter and to the RHV ports. The female luer is typically connected to a saline drip line while the LDP Catheter is advanced through the vasculature. Use of the LDP Catheter relies on standard percutaneous interventional techniques, including access site preparation, introducing the catheter portion of the device, advancing the catheter under fluoroscopy, withdrawing the catheter, and closing the access site.
G. Predicate Comparison:
The predicate devices are the Imperative Care LDP Catheters cleared under K203764 and K180169. The predicate and subject devices share intended use, basic technological characteristics, and the same performance characteristics, demonstrated through bench and
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laboratory testing as shown in Table 1. Modifications include dimensional updates, additional axial and radial reinforcements, and manufacturing process improvements.
| DeviceAttribute | Subject device | Predicate devices | |
|---|---|---|---|
| FDA ProductClassification | Class II, QJP andDQY, 21 CFR 870.1250 | Class II, QJP and DQY,21 CFR 870.1250 | Class II, DQY, 21 CFR870.1250 |
| Product Name | TracStar LDP Large DistalPlatformZoom 88 Large DistalPlatform | TracStar Large DistalPlatformZOOM 88 Large DistalPlatformZOOM 88-T LargeDistal Platform | EagleRay Long SheathEagleRay Access Catheter |
| 510(k) Number | K212224 | K203764 | K180169 |
| Indications forUse | The TracStar LDP LargeDistal Platform is indicatedfor the introduction ofinterventional devices intothe peripheral, coronary, andneuro vasculature.The Zoom 88 Large DistalPlatform is indicated for theintroduction ofinterventional devices intothe peripheral, coronary, andneuro vasculature. | The TracStar Large DistalPlatform is indicated for theintroduction of interventionaldevices into the peripheral,coronary, and neurovasculature.The ZOOM 88 and ZOOM 88-T Large Distal Platform areindicated for the introductionof interventional devices intothe peripheral, coronary, andneuro vasculature. | The EagleRay Long Sheathand EagleRay AccessCatheter are indicated forthe introduction ofinterventional devices intothe peripheral, coronary,and neuro vasculature. |
| ConditionSupplied | Sterile and Single Use | Same | Same |
| SterilizationMethod | Ethylene Oxide (EtO), SAL10-6 | Same | Same |
| Inner Diameter(Distal) | 0.088 | ||
| DeviceAttribute | Subject device | Predicate device(s) | |
| Effective Length | 80 - 110cm | Same | Same |
| Tip Design | Beveled distal edge, soft,flexible, atraumatic tip | Same | Same |
| Distal CatheterShaft | Additional polymerreinforcement | Reinforced with metals andpolymers | Reinforced with metals andpolymers |
| ProximalCatheter Shaft | Additional radialreinforcement | Reinforced with metals andpolymers | Reinforced with metals andpolymers |
| Coating | Hydrophilic coating | Same | Same |
| Materials | Commonly used medicalgrade plastics & metals withhydrophilic coating | Same | Same |
| PackagedAccessories | Rotating Hemostasis Valve(RHV) | Same | Same |
| PackagingConfiguration | The catheters are placed in aprotective polyethylene tube,mounted with accessoryRHV onto a polyethylenepackaging card, placed into apouch, sealed and labeled.The sealed pouch and IFUare placed in a labeled shelfcarton box. | Same | Same |
Table 1: Comparison of Subject and Predicate Devices
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H. Performance Data Supporting Substantial Equivalence:
Bench and Laboratory (in-vitro) testing was completed to evaluate the differences between the subject LDP Catheters and predicate LDP Catheters. Performance specifications and test methods were based primarily on catheter performance standard ISO 10555-1 and a summary of the evaluated performance tests and specifications is presented in Table 2.
The test results were reviewed and found to demonstrate that the differences between the subject LDP Catheters and predicate LDP Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness of the subject LDP Catheters.
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| Test Attribute | Specification | Results |
|---|---|---|
| Delivery, Compatibility,and Retraction(Trackability) | The catheter shall be able to be delivered,deployed, and retracted per the IFU within asimulated neurological model withoutincurring any damage to the catheter. | Pass |
| Flexibility and KinkResistance | There shall be no kinking of shaft(permanent deformation) after simulateduse. | Pass |
| Compatibility with otherDevices (external) | The catheters shall be able to be deliveredthrough the minimum introducer sheath orguide catheter size indicated in the productlabeling. | Pass |
| GuidewireCompatibility | The catheters shall be able to be deliveredover the maximum size guidewire indicatedin the product labeling. | Pass |
| Interventional DeviceCompatibility (internal) | The catheters shall be able to accommodateother interventional devices (e.g., supportcatheter, diagnostic catheter) up to themaximum size indicated in the productlabeling. | Pass |
| Luer Compatibility | Devices and accessories shall be compatiblewith standard syringe luer fittings per ISO80369-7. | Pass |
| Accessory Compatibility | Devices shall be compatible with an RHV. | Pass |
| Catheter Bond Strength | The catheter shall have sufficient bondstrengths to remain intact throughout aprocedure. | Pass |
| Freedom from Leakage– positive pressure | No liquid leakage from the hub or cathetershaft at 46psi for 30 seconds | Pass |
| Freedom from Leakage- negative pressure | No air leakage into a 20cc syringe whenvacuum pulled for 15 seconds. | Pass |
| Dynamic Burst Pressure | Catheter does not burst under pressures thatcould be seen when performing contrastinjections with a standard 10cc syringe. | Pass |
| Static Burst Pressure | Catheter does not burst under pressures thatcould be seen when performing contrastinjections with a standard 10cc syringe. | Pass |
| Test Attribute | Specification | Results |
| Catheter TorqueStrength | With the catheter tip held in a staticposition, there shall be no separation of anyportion of the catheter when rotated at thehub at least two (2) full rotations (720degrees). | Pass |
| Kink Resistance | There shall be no kinking of the cathetershaft (permanent deformation) afterwrapping around anatomically relevantbend radii. | Pass |
| Pushability | The proximal shaft of the catheters shallhave sufficient stiffness that the user caneasily push the catheter to the targetanatomy without buckling. | Pass |
| Access Force | Catheters shall not require excessive forceto safely navigate and track to the targetanatomy. | Pass |
Table 2: Tests and Performance Specifications
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Biocompatibility Testing: L
There are no changes to patient contacting materials compared to the predicate device. Therefore, the original testing on the predicate devices applies to the subject devices and additional biocompatibility testing was not required.
J. Sterilization:
The LDP Catheters are sterilized using a validated EtO process with a sterility assurance level of 1x10 validated per the overkill method in accordance with ISO 11135, "Sterilization Of Health-Care Products - Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices".
K. Shelf Life and Packaging:
Accelerated aging testing based on ASTM F1980 was conducted to verify packaged device performance. A real time aging equivalent of 13 months was used to support a 1-year shelf life claim. Device performance was verified by functional and performance testing.
There are no changes to packaging compared to the predicate device. Therefore, the original testing on the predicate devices applies to the subject devices and additional packaging validation testing was not required.
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L. Conclusions:
Where differences were identified between the subject and predicate devices, a risk assessment was completed to determine if the difference would result in new safety or effectiveness concerns. As appropriate, previous bench and laboratory testing was evaluated for applicability and either the rationale for no impact was documented or verification and validation was repeated as required.
Based on the results of the risk assessments and associated bench and laboratory testing, the subject and predicate devices are substantially equivalent and there are no new safety or effectiveness concerns. The subject device and predicate devices share the same intended use, basic technological characteristics, and performance characteristics.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).