(66 days)
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 indicated for the "introduction of interventional devices" and provides "access to peripheral, coronary and neuro vasculature." This describes functionality as an access tool for delivering other devices, not a direct therapeutic action itself.
No
Explanation: The device is described as a "guide catheter" intended for the "introduction of interventional devices." Its primary function is to provide access for other devices, not to diagnose a condition itself.
No
The device description clearly details a physical catheter made of medical-grade polymers and metal, with a hydrophilic coating and radiopaque marker. It is a hardware device used for introducing other devices into the vasculature.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states that the TracStar LDP and Zoom 88 LDP are guide catheters used for the introduction of interventional devices into the vasculature. This is a procedure performed inside the body.
- No Specimen Analysis: The device description and intended use do not mention any analysis of biological specimens.
- Imaging Modality: The input imaging modality is Fluoroscopy, which is used for real-time imaging within the body during procedures.
The device is an interventional medical device used to facilitate procedures within the circulatory system, not for diagnostic testing of samples outside the body.
N/A
Intended Use / 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.
Product codes
QJP, DQY
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 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
Bench and Laboratory (in-vitro) testing was completed to evaluate the differences between the subject LDP Catheters and predicate LDP Catheters.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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. All tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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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
1
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
2
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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3
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
4
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
5
laboratory testing as shown in Table 1. Modifications include dimensional updates, additional axial and radial reinforcements, and manufacturing process improvements.
| Device
| Attribute | Subject device | Predicate devices | |
|---|---|---|---|
| FDA Product | |||
| Classification | Class II, QJP and | ||
| DQY, 21 CFR 870.1250 | Class II, QJP and DQY, | ||
| 21 CFR 870.1250 | Class II, DQY, 21 CFR | ||
| 870.1250 | |||
| Product Name | TracStar LDP Large Distal | ||
| Platform | |||
| Zoom 88 Large Distal | |||
| Platform | TracStar Large Distal | ||
| Platform | |||
| ZOOM 88 Large Distal | |||
| Platform | |||
| ZOOM 88-T Large | |||
| Distal Platform | EagleRay Long Sheath | ||
| EagleRay Access Catheter | |||
| 510(k) Number | K212224 | K203764 | K180169 |
| 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. | 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 | Same |
| Sterilization | |||
| Method | Ethylene Oxide (EtO), SAL | ||
| 10-6 | Same | Same | |
| Inner Diameter | |||
| (Distal) | 0.088 | ||
| Device | |||
| Attribute | Subject device | Predicate device(s) | |
| Effective Length | 80 - 110cm | Same | Same |
| Tip Design | Beveled distal edge, soft, | ||
| flexible, atraumatic tip | Same | Same | |
| Distal Catheter | |||
| Shaft | Additional polymer | ||
| reinforcement | Reinforced with metals and | ||
| polymers | Reinforced with metals and | ||
| polymers | |||
| Proximal | |||
| Catheter Shaft | Additional radial | ||
| reinforcement | Reinforced with metals and | ||
| polymers | Reinforced with metals and | ||
| polymers | |||
| Coating | Hydrophilic coating | Same | Same |
| Materials | Commonly used medical | ||
| grade plastics & metals with | |||
| hydrophilic coating | Same | Same | |
| Packaged | |||
| Accessories | Rotating Hemostasis Valve | ||
| (RHV) | Same | Same | |
| 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 | Same |
Table 1: Comparison of Subject and Predicate Devices
6
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.
7
| 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 | |
| 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 |
| Test Attribute | Specification | Results |
| 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 |
Table 2: Tests and Performance Specifications
8
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.
9
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.