(60 days)
Not Found
No
The device description and performance studies focus on the physical and functional attributes of a catheter and dilator, with no mention of AI, ML, or any software-driven analytical capabilities.
No.
The device is indicated for introducing interventional devices into the vasculature, acting as an access tool rather than providing direct therapeutic treatment.
No
The device is an access system for introducing interventional devices into the vasculature, which is a therapeutic rather than diagnostic function. While it is used with fluoroscopy for placement, its primary role is not to diagnose conditions.
No
The device description explicitly details physical components: a single lumen catheter and a dilator, both constructed from medical grade polymers. It describes physical attributes like dimensions, materials, coatings, and radiopaque markers. The performance studies focus on bench and laboratory testing of these physical components, not software validation.
No, 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 vasculature. This is a procedural device used during a medical intervention, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a catheter and dilator designed for accessing blood vessels. This aligns with a device used for medical procedures, not laboratory testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the device (e.g., flexibility, torque strength, compatibility) and biocompatibility, which are relevant to a medical device used in a procedure, not the analytical performance of a diagnostic test.
In summary, the Imperative Care Radial 088 Access System is a medical device used for accessing the vasculature during interventional procedures, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Imperative Care Radial 088 Access System is 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 Radial 088 Access System (Radial 088 Access System) consists of a single lumen catheter (Radial 088 Access Catheter) and a 6F Dilator intended to provide ease of access to the peripheral, coronary and neuro vasculature using a transradial access (TRA) approach.
The Radial 088 Access Catheter consists of a single lumen, braid and coil reinforced, variable stiffness catheter constructed using medical grade polymers. The catheter features include a standard luer hub on the proximal end and an atraumatic angled tip on the distal end. The distal section is covered in a lubricious hydrophilic coating for ease of tracking through tortuous vasculature to reach the target location. The distal tip has a radiopaque marker to provide the user with visual confirmation of the distal tip location during tracking and placement under fluoroscopy.
The Radial 088 Access Catheter is offered in working lengths of 95 cm, 105 cm, and 110 cm. The catheter has a proximal and distal inner diameter (ID) of 0.088" and is compatible with ≤ 0.038" diameter guidewires and 6F interventional devices having a minimum device length of 120 cm. The catheter has a distal outer diameter (OD) of 0.107" (2.7 mm) and a proximal OD of 0.110" (2.8 mm): the luer hub on the proximal end is compatible with Rotating Hemostasis Valves (RHVs) having a standard luer connector.
The 6F Dilator is a single lumen dilator with a tapered tip constructed of medical grade polymers. The 6F Dilator includes a standard luer hub on the proximal end which is compatible with standard luer lock devices (e.g., syringes). The 6F Dilator has an ID of 0.039" minimum, an OD of 0.083"-0.086" and is offered in a working length of 130 cm (± 2 cm).
Accessories and supplies required, but not supplied, include:
- Rotating Hemostatic Value (RHV)
- . Guidewires
- Support/diagnostic catheters
- . Heparinized saline
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 was completed to evaluate the differences between the subject device, Radial 088 Access System, and the predicate. Performance specifications and test methods were based primarily on catheter performance standard ISO 10555-1.
Results: The test results were reviewed and found to demonstrate that the differences between the subject Radial 088 Access Catheter and predicate TracStar LDP catheters do not significantly impact any performance parameters that would adversely affect the safety or effectiveness of the subject Radial 088 Access System.
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 shows the date May 17, 2022. The month is spelled out, followed by the day and year. The text is in a clear, sans-serif font and is easy to read. The date is likely part of a document or calendar.
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, RAC Associate Director, Regulatory Affairs 1359 Dell Avenue Campbell, California 95008
Re: K220807
Trade/Device Name: Imperative Care Radial 088 Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: March 16. 2022 Received: March 18, 2022
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) K220807
Device Name Imperative Care Radial 088 Access System
Indications for Use (Describe)
The Imperative Care Radial 088 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K220807: 510(k) Summary
A. Submitter Information
Submitter's Name: Address:
Contact Person: Telephone: Email: Date of Preparation:
B. Subject Device
Proprietary Name: Common/Usual Name: Classification Name: Product Code:
Regulation:
C. Predicate Device
Proprietary Name:
Common/Usual Name: Classification Name: Product Code:
Regulation: Manufacturer: 510(k):
Imperative Care, Inc. 1359 Dell Avenue Campbell, CA 95008 Kristin Ellis, RAC (408) 857-0934 kellis@imperativecare.com May 12, 2022
Imperative Care Radial 088 Access System 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 OJP DQY 21 CFR. 870.1250 Imperative Care, Inc. K212224
D. Device Description:
The Imperative Care Radial 088 Access System (Radial 088 Access System) consists of a single lumen catheter (Radial 088 Access Catheter) and a 6F Dilator intended to provide ease of access to the peripheral, coronary and neuro vasculature using a transradial access (TRA) approach.
The Radial 088 Access Catheter consists of a single lumen, braid and coil reinforced, variable stiffness catheter constructed using medical grade polymers. The catheter features include a standard luer hub on the proximal end and an atraumatic angled tip on the distal end. The distal section is covered in a lubricious hydrophilic coating for ease of tracking through tortuous vasculature to reach the target location. The distal tip has a radiopaque marker to provide the user with visual confirmation of the distal tip location during
4
tracking and placement under fluoroscopy.
The Radial 088 Access Catheter is offered in working lengths of 95 cm, 105 cm, and 110 cm. The catheter has a proximal and distal inner diameter (ID) of 0.088" and is compatible with ≤ 0.038" diameter guidewires and 6F interventional devices having a minimum device length of 120 cm. The catheter has a distal outer diameter (OD) of 0.107" (2.7 mm) and a proximal OD of 0.110" (2.8 mm): the luer hub on the proximal end is compatible with Rotating Hemostasis Valves (RHVs) having a standard luer connector.
The 6F Dilator is a single lumen dilator with a tapered tip constructed of medical grade polymers. The 6F Dilator includes a standard luer hub on the proximal end which is compatible with standard luer lock devices (e.g., syringes). The 6F Dilator has an ID of 0.039" minimum, an OD of 0.083"-0.086" and is offered in a working length of 130 cm (± 2 cm).
Accessories and supplies required, but not supplied, include:
- Rotating Hemostatic Value (RHV) ●
- . Guidewires
- Support/diagnostic catheters .
- Heparinized saline ●
E. Indications for Use:
The Imperative Care Radial 088 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
F. Principles of Operation:
Use of the Radial 088 Access System 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.
During use, the male luer of an ancillary RHV is attached to the proximal luer of the Radial 088 Access Catheter to create a continuous lumen through the catheter and to the RHV ports. The female luer of an ancillary RHV is typically connected to a saline drip line while an