(59 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
This device is described as a guide catheter for introducing other interventional devices, rather than directly providing a therapeutic effect itself.
No
Explanation: The device is described as a guide catheter used for introducing interventional devices into the vasculature. Its function is to facilitate the delivery of other tools, not to diagnose conditions.
No
The device description clearly details physical components such as a hollow cylindrical tube, metal coils/braids, medical grade polymers, a hydrophilic coating, an angled distal soft tip, a radiopaque marker, and a rotating hemostasis valve. These are all hardware components, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The description clearly states that this device is a guide catheter used for introducing interventional devices into the peripheral, coronary, and neuro vasculature. This is an invasive procedure performed inside the body.
- Intended Use: The intended use is to facilitate the introduction of other devices into the body's blood vessels. This is a procedural tool, not a diagnostic test performed on a sample.
- Input Imaging Modality: The use of fluoroscopy indicates real-time imaging during a procedure within the body, not the analysis of a collected sample.
The device is a medical device used for interventional procedures, but it does not fit the definition of an In Vitro Diagnostic.
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 and Zoom 88 Large Distal Platform Support are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Product codes
OJP, DQY
Device Description
The Imperative Care Large Distal Platform™ (LDP) Catheters include the Zoom™ 88 Large Distal Platform™, Zoom™ 88 Large Distal Platform™ Support, and TracStar™ LDP 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. The LDP Catheters have an inner diameter (ID) of 0.088" (6F compatible), and a maximum outer diameter (OD) 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.
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
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.
Tests Performed:
- 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. (Result: Pass)
- Tip Flexibility: The catheter distal tip flexibility shall be comparable to the predicate. (Result: Pass)
- Visual Inspection: The catheter shall meet visual inspection criteria. The printing on the strain relief must be legible. (Result: Pass)
- Dimensional (Distal ID, Proximal ID, Distal OD, Proximal OD): All defined catheter dimensions are within the specified tolerances. (Result: Pass)
- Catheter Bond Strength: The catheter shall have sufficient bond strengths to remain intact throughout a procedure. (Result: Pass)
- Freedom from Leakage - Positive Pressure: The catheter must remain leak free under specified test conditions. (Result: Pass)
- Freedom from Leakage - Negative Pressure: The catheter must remain leak free under specified test conditions. (Result: Pass)
- Burst Pressure: The catheter must withstand pressure testing under dynamic flow conditions. (Result: Pass)
- Static Burst: The catheter shall meet criteria for static burst pressure testing. (Result: Pass)
- Catheter Torque Strength: With the catheter tip constrained from movement, the proximal end was rotated until failure. The catheter shall not be damaged when rotated at least two (2) full rotations (720 degrees). (Result: Pass)
- Kink Resistance: There shall be no kinking of the catheter shaft around respective clinically relevant minimum bend radii in distal tip, medial and proximal locations. (Result: Pass)
- Flexibility: The catheters need to have acceptable flexure values for tracking in the vasculature. (Result: Pass)
- Proximal Shaft Stiffness: The stiffness of the proximal shaft was evaluated to ensure comparable stiffness to the predicate. (Result: Pass)
- Delivery Force: The catheters shall not be too stiff or require excessive force to safely navigate and track to the target neurovasculature. (Result: 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. (Result: Pass)
- Guidewire Compatibility: The catheters shall be able to be delivered over the maximum size guidewire indicated in the product labeling. (Result: 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. (Result: Pass)
- Luer Compatibility: Devices and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7. (Result: Pass)
- Accessory Compatibility: Devices shall be compatible with an RHV. (Result: Pass)
- Coating - Particulate: The amount of particulate matter generated during simulated use testing shall be determined and compared to competitive products and techniques. (Result: Pass)
- Coating - Lubricity, Durability and Integrity: Coating must be lubricious with a specified average pull force. There were no coating anomalies or significant wear observed post simulated use. (Result: Pass)
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
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
June 6, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Imperative Care, Inc. Kristin Ellis Director, Regulatory Affairs 1359 Dell Avenue, Campbell, California 95008
Re: K240948
Trade/Device Name: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: OJP, DQY Dated: April 5, 2024 Received: April 8, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S
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
2
Indications for Use
510(k) Number (if known) K240948
Device Name TracStar™ LDP Large Distal Platform™ Zoom™ 88 Large Distal Platform™ Zoom™ 88 Large Distal Platform™ Support
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 and Zoom 88 Large Distal Platform Support 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
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 June 4, 2024
TracStar™ LDP Large Distal Platform™ Zoom™ 88 Large Distal Platform™ Zoom™ 88 Large Distal Platform™ Support Guide Catheter Catheter, Percutaneous, Neurovasculature OJP DQY 21 CFR 870.1250
TracStar™ LDP Large Distal Platform™ Zoom™ 88 Large Distal Platform™ Zoom™ 88 Large Distal Platform™ Support Guide Catheter Catheter, Percutaneous, Neurovasculature OJP DQY 21 CFR. 870.1250 Imperative Care, Inc. K231168
D. Device Description:
The Imperative Care Large Distal Platform™ (LDP) Catheters include the Zoom™ 88 Large Distal Platform™, Zoom™ 88 Large Distal Platform™ Support, and TracStar™ LDP 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
4
angled distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. The LDP Catheters have an inner diameter (ID) of 0.088" (6F compatible), and a maximum outer diameter (OD) 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 and Zoom 88 Large Distal Platform Support 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 devices are the Imperative Care 0.088" ID Large Distal Platform (LDP) Catheters cleared under K231168. The predicate and subject devices share the same intended use, basic technological characteristics, and the same performance characteristics, demonstrated through bench and laboratory testing as shown in Table 1.
5
| Device Attribute | Predicate device | Subject device |
|---|---|---|
| FDA Product | ||
| Classification | Class II, QJP and | |
| DQY, 21 CFR 870.1250 | Same | |
| Product Name | TracStar LDP Large Distal Platform Zoom 88 Large Distal Platform Zoom 88 Large Distal Platform Support | Same |
| 510(k) Number | K231168 | K240948 |
| 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 and Zoom 88 Large
Distal Platform Support are
indicated for the introduction of
interventional devices into the
peripheral, coronary, and neuro
vasculature. | Same |
| Condition Supplied | Sterile and Single Use | Same |
| Sterilization Method | Ethylene Oxide (EtO), SAL 10-6 | Same |
| | Single Cycle | Up to Two (2) Cycles |
| 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 | TracStar LDP: 80 – 105 cm
Zoom 88 LDP: 100 – 110 cm
Zoom 88 LDP Support: 100 cm | TracStar LDP: 80 – 105 cm
Zoom 88 LDP: 110 cm
Zoom 88 LDP Support: 100 cm |
| Tip Design | Beveled distal edge, soft, flexible,
atraumatic tip | Same |
| Device Attribute | Predicate device | Subject device |
| Distal Catheter Shaft | Reinforced with metals and
polymers | Same |
| Proximal Catheter
Shaft | Reinforced with metals and
polymers | Same |
| Coating | Hydrophilic coating | Same |
| Materials | Commonly used medical grade
plastics & metals with hydrophilic
coating | Same |
| Packaged
Accessories | Rotating Hemostasis Valve (RHV) | 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 |
| Shelf life | 12 months | 36 months |
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 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.
| 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 |
| Table 2: Tests and Performance Specifications | |
|---|---|
| ----------------------------------------------- | -- |
7
| Test Attribute | Specification | Results |
|---|---|---|
| Tip Flexibility | The catheter distal tip flexibility shall be | |
| comparable to the predicate. | Pass | |
| Visual Inspection | The catheter shall meet visual inspection | |
| criteria. | ||
| The printing on the strain relief must be | ||
| legible. | Pass | |
| Dimensional (Distal ID, | ||
| Proximal ID, Distal OD, | ||
| Proximal OD) | All defined catheter dimensions are within | |
| the specified tolerances. | Pass | |
| Catheter Bond Strength | The catheter shall have sufficient bond | |
| strengths to remain intact throughout a | ||
| procedure. | Pass | |
| Freedom from Leakage |
- Positive Pressure | The catheter must remain leak free under
specified test conditions. | Pass |
| Freedom from Leakage - Negative Pressure | The catheter must remain leak free under
specified test conditions. | Pass |
| Burst Pressure | The catheter must withstand pressure testing
under dynamic flow conditions. | Pass |
| Static Burst | The catheter shall meet criteria for static
burst pressure testing. | Pass |
| Catheter Torque
Strength | With the catheter tip constrained from
movement, the proximal end was rotated
until failure. The catheter shall not be
damaged when rotated at least two (2) full
rotations (720 degrees). | Pass |
| Kink Resistance | There shall be no kinking of the catheter
shaft around respective clinically relevant
minimum bend radii in distal tip, medial and
proximal locations. | Pass |
| Flexibility | The catheters need to have acceptable
flexure values for tracking in the
vasculature. | Pass |
| Proximal Shaft Stiffness | The stiffness of the proximal shaft was
evaluated to ensure comparable stiffness to
the predicate. | Pass |
| Delivery Force | The catheters shall not be too stiff or require
excessive force to safely navigate and track
to the target neurovasculature. | Pass |
| Test Attribute | Specification | Results |
| 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 |
| Coating - Particulate | The amount of particulate matter generated
during simulated use testing shall be
determined and compared to competitive
products and techniques. | Pass |
| Coating - Lubricity,
Durability and Integrity | Coating must be lubricious with a specified
average pull force. There were no coating
anomalies or significant wear observed post
simulated use. | Pass |
8
I. Biocompatibility Testing:
There are no changes to patient contacting materials, including raw materials, manufacturing processes, and manufacturing aids 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 6 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".
9
K. Shelf Life and Packaging:
Accelerated aging testing based on ASTM F1980 was previously conducted to verify packaged device performance of the predicate LDP Catheters. The subject LDP Catheters undergo the same packaging and similar sterilization processing as the predicate LDP Catheters. The construction of the subject LDP Catheters is the same as the predicate LDP Catheters including raw materials, manufacturing processes, and manufacturing aids. Verification testing of the subject LDP Catheters followed the same test methods as the predicate LDP Catheters. Bench testing of the subject LDP Catheters and packaging supports a three (3) year shelf life.
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 devices and predicate devices share the same intended use, basic technological characteristics, and performance characteristics.