(70 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guide catheter, with no mention of AI or ML capabilities.
No
The device is a guide catheter used to introduce other interventional devices, not to provide therapy itself.
No
The device is a guide catheter designed to introduce other interventional devices into the vasculature, not to diagnose medical conditions. Its function is to provide access, not to obtain diagnostic information.
No
The device description clearly details a physical catheter with specific material components (metal coils/braids, medical grade polymers), a hydrophilic coating, an angled soft tip, and a radiopaque marker. It also mentions being packaged with a rotating hemostasis valve. These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "introduction of interventional devices into the peripheral, coronary, and neuro vasculature." This describes a device used within the body for a procedural purpose, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a catheter, a physical tube inserted into blood vessels. This is consistent with an interventional device, not an IVD which typically involves reagents, test strips, or analytical instruments.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
The device is clearly an interventional medical device used for accessing and navigating within the vascular system to facilitate other procedures.
N/A
Intended Use / Indications for Use
The TracStar Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The ZOOM 88 and ZOOM 88-T Large Distal Platform are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQY
Device Description
The Imperative Care Large Distal Platform (LDP) Catheters include the TracStar™ LDP, Zoom™ 88 LDP and Zoom™ 88-T LDP. The LDP Catheters are 0.038" 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.
Accessory devices required, but not supplied include:
- Guidewires
- Support/diagnostic catheters
- Introducer sheaths
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary, and neuro vasculature
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)
Bench and Laboratory (in-vitro) testing evaluated the similarities and differences between the subject and predicate Imperative Care Inc., Large Distal Platform (LDP) Catheters. The test results were reviewed and found to demonstrate that any differences between the subject and predicate devices do not significantly impact any catheter performance parameters that would affect safety or efficacy. These tests were performed per company approved protocols, test methods, and performance standards.
Tests and Performance Specifications:
- 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. Results: Pass
- Flexibility and Kink Resistance: There shall be no kinking of shaft (permanent deformation) after simulated use. Results: 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. Results: Pass
- Guidewire Compatibility: The catheters shall be able to be delivered over the maximum size guidewire indicated in the product labeling. Results: 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. Results: Pass
- Luer Compatibility: Devices and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7. Results: Pass
- Accessory Compatibility: Devices shall be compatible with an RHV. Results: Pass
- Catheter Bond Strength: The catheter shall have sufficient bond strengths to remain intact throughout a procedure. Results: Pass
- Freedom from Leakage – positive pressure: No liquid leakage from the hub or catheter shaft at 46psi for 30 seconds. Results: Pass
- Freedom from Leakage – negative pressure: No air leakage into a 20cc syringe when vacuum pulled for 15 seconds. Results: Pass
- Kink Resistance: There shall be no kinking of the catheter shaft (permanent deformation) after wrapping around anatomically relevant bend radii. Results: 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. Results: Pass
- Access Force: Catheters shall not require excessive force to safely navigate and track to the target anatomy. Results: Pass
Biocompatibility Testing: There are no changes to 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.
Sterilization: The LDP Catheters are sterilized using a validated EtO process with a sterility assurance level of 1x10-6 validated per the overkill method in accordance with ISO 11135.
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.
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.
Not Found
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
§ 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).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 3, 2021
Imperative Care, Inc. Kristin Ellis Regulatory Affairs Manager 1359 Dell Avenue Campbell, California 95008
Re: K203764
Trade/Device Name: TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: December 21, 2020 Received: December 23, 2020
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
1
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 (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 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
2
Indications for Use
510(k) Number (if known) K203764
Device Name TracStar™ Large Distal Platform ZOOM™ 88 Large Distal Platform ZOOM™ 88-T Large Distal Platform
Indications for Use (Describe)
The TracStar Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The ZOOM 88 and ZOOM 88-T Large Distal Platform are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
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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3
510(k) Summary, K203764
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
Proprietary Name:
Common/Usual Name: Classification Name: Product Code: Regulation: Manufacturer: 510(k) #'s:
Imperative Care, Inc. 1359 Dell Avenue Campbell, CA 95008 Kristin Ellis 408-857-0934 kellis@imperativecare.com December 21, 2020
TracStar™ Large Distal Platform ZOOM™ 88 Large Distal Platform ZOOM™ 88-T Large Distal Platform Guide Catheter Catheter, Percutaneous, Neurovasculature OJP DOY 21 CFR 870.1250
- EagleRay Long Sheath EagleRay Access Catheter Guide Catheter Catheter, Percutaneous DOY 21 CFR. 870.1250 Imperative Care Inc. K180169
D. Device Description:
The Imperative Care Large Distal Platform (LDP) Catheters include the TracStar™ LDP, Zoom™ 88 LDP and Zoom™ 88-T LDP. The LDP Catheters are 0.038" 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
4
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 Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The ZOOM 88 and ZOOM 88-T Large Distal Platform are 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 device is the Imperative Care EagleRay Access Catheters cleared under K180169. The predicate and subject devices share the same intended use, basic technology characteristics, and the same performance characteristics, demonstrated through bench and laboratory testing as shown in Table 1.
5
| Device Attribute | Subject device | Predicate device |
|---|---|---|
| FDA Product | ||
| Classification | Class II, QJP and | |
| DQY, 21 CFR 870.1250 | Class II, DQY, 21 CFR 870.1250 | |
| Product Name | TracStar Large Distal Platform | |
| ZOOM 88 Large Distal Platform | ||
| ZOOM 88-T Large Distal Platform | EagleRay Long Sheath and | |
| EagleRay Access Catheter | ||
| 510(k) Number | K203764 | K180169 |
| Indications for Use | The TracStar Large Distal Platform | |
| is indicated for the introduction of | ||
| interventional devices into the | ||
| peripheral, coronary, and neuro | ||
| vasculature. | ||
| The ZOOM 88 and ZOOM 88-T | ||
| Large Distal Platform are indicated | ||
| for the introduction of | ||
| interventional devices into the | ||
| peripheral, coronary, and neuro | ||
| vasculature. | The EagleRay Long Sheath and | |
| EagleRay Access Catheter are | ||
| indicated for the introduction of | ||
| interventional devices into the | ||
| peripheral, coronary, and neuro | ||
| vasculature. | ||
| Condition Supplied | Sterile and Single Use | Same |
| Sterilization Method | Ethylene Oxide (EtO), SAL 10-6 | Same |
| Inner Diameter | ||
| (Distal) | 0.088" | Same |
| Outer Diameter | ||
| (Distal) | 0.106" | Same |
| Inner Diameter | ||
| (Proximal) | 0.088" | Same |
| Outer Diameter | ||
| (Proximal) | 0.110" | Same |
| Effective Length | 80 - 110cm | Same |
| Tip Design | Beveled distal edge, soft, flexible, | |
| atraumatic tip. | Same | |
| Coating | Hydrophilic coating | Same |
| Materials | Commonly used medical grade | |
| plastics & metals with hydrophilic | ||
| coating. | Same | |
| Packaged | ||
| Accessories | Rotating Hemostasis Valve (RHV) | RHV and Catheter Introducer |
| Device Attribute | Subject device | Predicate device |
| Packaging | ||
| Configuration | The catheters are placed in a | |
| protective polyethylene tube, | ||
| mounted with accessory RHV onto | ||
| a polyethylene packaging card, | ||
| placed into a pouch, sealed and | ||
| labeled. The sealed pouch and IFU | ||
| are placed in a labeled shelf carton | ||
| box. | Same |
Table 1: Comparison of Subject and Predicate Device
6
H. Performance Data Supporting Substantial Equivalence:
Bench and Laboratory (in-vitro) testing evaluated the similarities and differences between the subject and predicate Imperative Care Inc., Large Distal Platform (LDP) Catheters. The test results were reviewed and found to demonstrate that any differences between the subject and predicate devices do not significantly impact any catheter performance parameters that would affect safety or efficacy. A summary of the supportive data is presented in Table 2. These tests were performed per company approved protocols, test methods, and performance standards.
| Test Attribute | Specification | Results |
|---|---|---|
| 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 |
Table 2: Tests and Performance Specifications
7
| Test Attribute | Specification | Results |
|---|---|---|
| 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 | |
| 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 |
I. Biocompatibility Testing:
There are no changes to 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 1x106 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".
8
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.
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 efficacy 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 efficacy concerns. As confirmed through the results of bench and lab testing, the subject device and predicate device share the same intended use, basic technological characteristics, and performance characteristics.