(27 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 treat a medical condition directly.
No
This device is described as a guide catheter used to introduce interventional devices, not to diagnose a condition. While it has a radiopaque marker for visualization, its primary function is delivery, not diagnosis.
No
The device description clearly details a physical catheter with various material components (metal coils/braids, medical grade polymers, hydrophilic coating, radiopaque marker) and accessories (rotating hemostasis valve). This indicates a hardware-based medical device, not a software-only one.
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, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: 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.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its purpose is to facilitate the delivery of other devices within the body.
Therefore, based on the provided information, this device is a medical device used for interventional procedures within the body, not an In Vitro Diagnostic device.
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 (comma separated list FDA assigned to the subject device)
QJP, 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. LDP Catheter 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
Fluoroscopy
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 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 test attributes (Delivery, Compatibility, and Retraction (Trackability); Flexibility and Kink Resistance; Compatibility with other Devices (external); Guidewire Compatibility; Interventional Device Compatibility (internal); Luer Compatibility; Accessory Compatibility; Catheter Bond Strength; Dimensional (Distal ID, Proximal ID, Distal OD, Proximal OD); Catheter Torque Strength; Coating - Particulate and Integrity; Coating – Lubricity and Durability) passed their respective specifications.
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
May 22, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Imperative Care, Inc. Shivani Patel Principal Regulatory Affairs Specialist 1359 Dell Avenue, Campbell, California 95008
Re: K231168
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: QJP, DQY Dated: April 24, 2023 Received: April 25, 2023
Dear Shivani Patel:
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 -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
Enclosure
2
Indications for Use
510(k) Number (if known) K231168
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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ 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(s)
Proprietary Name:
Common/Usual Name: Classification Name: Product Code:
Regulation: Manufacturer: 510(k):
Imperative Care, Inc. 1359 Dell Avenue Campbell, CA 95008 Shivani Patel 510-468-8862 spatel(@imperativecare.com May 19, 2023
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 Guide Catheter Catheter, Percutaneous, Neurovasculature QJP DOY 21 CFR. 870.1250 Imperative Care Inc. K212224
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 angled distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker
4
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 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 LDP Catheters cleared under K212224. 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. Modifications to the predicate include minor dimensional modifications for a line extension and manufacturing process improvements.
5
| Device Attribute | Predicate device | Subject device |
|---|---|---|
| FDA Product | ||
| Classification | Class II, QJP and | |
| DQY, 21 CFR 870.1250 | Class II, QJP and | |
| DQY, 21 CFR 870.1250 | ||
| Product Name | TracStar LDP Large Distal | |
| • Platform | ||
| Zoom 88 Large Distal | ||
| • Platform | TracStar LDP Large Distal | |
| • Platform | ||
| Zoom 88 Large Distal | ||
| • Platform | ||
| Zoom 88 Large Distal | ||
| • Platform Support | ||
| 510(k) Number | K212224 | K231168 |
| Indications for Use | TracStar LDP Large Distal | |
| Platform: | ||
| The TracStar LDP Large Distal | ||
| Platform is indicated for the | ||
| introduction of interventional | ||
| devices into the peripheral, | ||
| coronary, and neuro vasculature. | ||
| Zoom 88 Large Distal Platform: | ||
| The Zoom 88 Large Distal | ||
| Platform is indicated for the | ||
| introduction of interventional | ||
| devices into the peripheral, | ||
| coronary, and neuro vasculature. | TracStar LDP Large Distal | |
| Platform: | ||
| Same | ||
| Zoom 88 Large Distal Platform | ||
| and Zoom 88 Large Distal | ||
| Platform Support: | ||
| 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. | ||
| Condition Supplied | Sterile and Single Use | Same |
| Sterilization Method | Ethylene Oxide (EtO), SAL 10-6 | Same |
| Inner Diameter | ||
| (ID, Distal) | 0.088" | Same |
| Outer Diameter | ||
| (OD, Distal) | 0.106" | Same |
| Inner Diameter | ||
| (ID, Proximal) | 0.088" | Same |
| Outer Diameter | ||
| (OD, Proximal) | 0.110" | Same |
| Effective Length | TracStar LDP: 80, 90, 95, 105 cm | |
| Zoom 88 LDP: 100 cm, 110 cm | TracStar LDP: Same | |
| • Zoom 88 LDP: Same | ||
| • Zoom 88 LDP Support: | ||
| • 100 cm | ||
| Device Attribute | Predicate device | Subject device |
| Tip Design | Beveled distal edge, soft, flexible, atraumatic tip | Same |
| Distal Catheter Shaft | Reinforced with metals and polymers | ● TracStar LDP: Same |
| ● Zoom 88 LDP: Same | ||
| ● Zoom 88 LDP Support: | ||
| Same metal reinforcement, | ||
| modified polymer | ||
| reinforcement | ||
| 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 |
Table 1: Comparison of Subject and Predicate Device
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.
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 | |
| Dimensional (Distal ID, | ||
| Proximal ID, Distal OD, | ||
| Proximal OD) | All defined catheter dimensions are within | |
| the specified tolerances | 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 | |
| Coating - Particulate | ||
| and Integrity | The amount of particulate matter generated | |
| during simulated use testing shall be | ||
| determined and compared to competitive | ||
| products and techniques. There were no | ||
| coating anomalies or significant wear | ||
| observed post simulated use. | Pass |
8
| Test Attribute | Specification | Results |
|---|---|---|
| Coating – Lubricity and | ||
| Durability | Coating must be lubricious with a specified average pull force. | Pass |
I. Biocompatibility Testing:
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 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".
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 sterilization processing as the predicate LDP Catheters. The new Zoom 88 Large Distal Platform Support Catheter has the same general design, the same raw materials, manufacturing processes and manufacturing aids as the predicate LDP Catheters. Verification testing of the subject LDP Catheters followed the same test methods as the predicate LDP Catheters. Therefore, aging data from the predicate LDP Catheters is applicable for the subject LDP Catheters and additional shelf-life testing was not required.
There are no changes to the packaging compared to the predicate LDP Catheters. Therefore, the original testing on the predicate LDP Catheters applies to the subject LDP Catheters 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 effectiveness concerns. As appropriate, previous bench and laboratory testing was
9
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 device share the same intended use, basic technological characteristics, and performance characteristics.