(109 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is indicated for delivering radiopaque media for diagnostic procedures, not for treatment.
No
The device is indicated for delivering radiopaque media in conjunction with diagnostic procedures, meaning it facilitates diagnostic procedures rather than performing the diagnosis itself.
No
The device description clearly details a physical catheter with specific dimensions, materials (braid reinforced), and features (luer hub, radiopaque distal shaft, tapered distal tip). This is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a catheter used to deliver radiopaque media into the peripheral vascular system for diagnostic imaging (fluoroscopy). It is used in vivo (within the living body), not in vitro (in a test tube or lab setting).
- Intended Use: The intended use is to deliver contrast for imaging, which is a procedure performed directly on the patient.
- Device Description: The physical description of the catheter and its components aligns with a medical device used for insertion into the body.
- Performance Studies: The performance studies mentioned are bench and laboratory testing based on a catheter performance standard (ISO 10555-1), not studies evaluating the diagnostic accuracy of analyzing biological samples.
Therefore, based on the provided information, the Zoom 6F Insert Catheter is a medical device used for a diagnostic procedure performed on a patient, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Zoom 6F Insert Catheters are indicated for use in delivering radiopaque media to selected sites in the peripheral vascular system in conjunction with routine diagnostic procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The Imperative Care Zoom™ 6F Insert Catheters are single lumen, braid reinforced, variable stiffness catheters. The catheters feature a standard luer hub on the proximal end, a radiopaque distal shaft and tip, and a tapered distal tip provided pre-shaped with various curve configurations. The curve configurations are designed to selectively engage arteries from the access sites such as the femoral, radial, and brachial arteries. The Zoom 6F Insert Catheter outer diameter is 0.082" (2.08 mm), the inner diameter is 0.041" (1.04 mm), and the tapered distal tip outer diameter is 0.061" (1.55 mm). The catheters are offered in working lengths of 137 cm, 139 cm, 140 cm, and 143 cm and come in three different tip configurations: VRT, SIM and VTK. The Zoom 6F Insert Catheters are compatible with standard luer lock devices (e.g., syringes), ≤ 0.038" diameter guidewires, ≥ 180 cm length guidewires, ≥ 6F introducer sheaths and ≥ 0.088" inner diameter guide catheters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician trained in endovascular techniques and experienced in endovascular procedures
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 subject device, Zoom 6F Insert Catheter. 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 Zoom 6F Insert Catheter and predicate Impress Angiographic Catheters do not significantly impact any performance parameters that would adversely affect the safety or effectiveness of the subject Zoom 6F Insert Catheter.
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
April 2, 2024
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 & 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" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
Imperative Care, Inc. Nguyen Teri Lead Regulatory Affairs Specialist 1359 Dell Avenue Campbell, California 95008
Re: K233975
Trade/Device Name: Zoom 6F Insert Catheters Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: February 20, 2024 Received: February 21, 2024
Dear Nguyen Teri:
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,
Samuel G. Raben -S
for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Zoom 6F Insert Catheter (Zoom SIM);
Zoom 6F Insert Catheter (Zoom VTK);
Zoom 6F Insert Catheter (Zoom VRT)
Indications for Use (Describe)
The Zoom 6F Insert Catheters are indicated for use in delivering radiopaque media to selected sites in the peripheral vascular system in conjunction with routine diagnostic procedures.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
March 26, 2024
Zoom™ 6F Insert Catheter Diagnostic Intravascular Catheter Catheter, Intravascular, Diagnostic DQO 21 CFR 870.1200
Impress Angiographic Catheter Diagnostic Intravascular Catheter Catheter, Intravascular, Diagnostic DQO 21 CFR. 870.1200 Merit Medical Systems, Inc. K191608
D. Device Description:
The Imperative Care Zoom™ 6F Insert Catheters are single lumen, braid reinforced, variable stiffness catheters. The catheters feature a standard luer hub on the proximal end, a radiopaque distal shaft and tip, and a tapered distal tip provided pre-shaped with various curve configurations. The curve configurations are designed to selectively engage arteries from the access sites such as the femoral, radial, and brachial arteries. The Zoom 6F Insert Catheter outer diameter is 0.082" (2.08 mm), the inner diameter is 0.041" (1.04 mm), and the tapered distal tip outer diameter is 0.061" (1.55 mm). The catheters are offered in working lengths of 137 cm, 139 cm, 140 cm, and 143 cm and come in three different tip configurations: VRT, SIM and VTK. The Zoom 6F Insert Catheters are compatible with standard luer lock devices (e.g., syringes), ≤ 0.038" diameter guidewires, ≥ 180 cm length guidewires, ≥ 6F introducer sheaths and ≥ 0.088" inner diameter guide catheters.
4
Accessory devices required, but not supplied, include:
- . Guidewires
- Introducer Sheaths
- Guide Catheters ●
- RHV/Standard Luer Lock Devices ●
E. Indications for Use:
The Zoom 6F Insert Catheters are indicated for use in delivering radiopaque media to selected sites in the peripheral vascular system in conjunction with routine diagnostic procedures.
F. Principles of Operation:
The subject Zoom 6F Insert Catheters are advanced into the vasculature by a physician trained in endovascular techniques and experienced in endovascular procedures. Use of the Zoom 6F Insert Catheters relies on standard angiographic techniques.
G. Predicate Comparison:
The predicate devices are the Medical Impress Angiographic Catheters (K191608). The predicate and subject devices share the same intended use, basic technological characteristics, and similar performance characteristics, demonstrated through bench and laboratory testing. As shown in Table 1, all fundamental technological characteristics of the subject device are substantially equivalent to the predicate device Merit Medical Impress Angiographic Catheter FDA-cleared under K191608.
5
| Description | Predicate Device
Merit Medical Impress
Angiographic Catheter
(K191608) | Subject Device
Zoom 6F Insert Catheter |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Device Classification | Class II | Same |
| Regulation Number | 21 CFR 870.1200 | Same |
| FDA Device Code | DQO | Same |
| Indications for Use | Angiographic catheters are
designed to be used for
delivering radiopaque media to
selected sites in the vascular
system in conjunction with
routine diagnostic procedures.
Angiographic catheters with
marker bands may also be used
for anatomical measurements. | The Zoom 6F Insert Catheter is
indicated for use in delivering
radiopaque media to selected
sites in the peripheral vascular
system in conjunction with
routine diagnostic procedures. |
| Contraindications | None known | Same |
| Materials | Commonly used medical grade
plastics & metals. | Same |
| Inner Diameter | 0.046" | 0.041" |
| Outer Diameter | 5F (0.066") | 6F (0.082") |
| Effective Length | 40cm to 125cm | 137cm, 139cm, 140cm, 143cm |
| Guide Wire Compatibility | Compatible with 0.035"
(VERT) and 0.038" (SIM and
VTK) diameter guidewires or
smaller. | Compatible with 0.038"
diameter guidewires or smaller
and ≥ 180 cm length |
| Introducer Sheath/Guide
Catheter Compatibility | Compatible with 5F (0.066")
Introducer Sheath | Compatible with 0.088" Inner
Diameter guide catheter or
larger |
| Luer Compatibility | Compatible with standard luer
lock devices | Same |
6
| Description | Predicate Device
Merit Medical Impress
Angiographic Catheter
(K191608) | Subject Device
Zoom 6F Insert Catheter |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Tip Shape | Provided in a variety of tip
shapes, including:
- VTK
- VERT
- SIM2 | Same |
| Shaft Lumen Construction | Braided configurations | Same |
| Packaged Accessories | None | Same |
| Condition Supplied | Sterile and Single Use | Same |
| Sterilization Method | Ethylene Oxide | Same |
| Sterility Assurance Level
(SAL) | 10-6 | Same |
| Packaging Configuration | Pouch
Backing Card
Shelf Carton
Shipper Box | Same |
| Radiopacity | With and without radiopaque
marker band, distal shaft is
radiopaque | No radiopaque marker band,
distal shaft is radiopaque |
| Hydrophilic Coating | With and without hydrophilic
coating | Without hydrophilic coating |
| Maximum Dynamic Burst
Pressure | 1200 psi | Same |
| Flow Rate | 5F SIM 2, 100cm length: 814 $psi$ (57 kg/cm2) at 15 mL/sec
5F VERT, 100cm length: 888 $psi$ (62 kg/cm2) at 15 mL/sec
5F VTK, 125cm length: 1030 $psi$ (72 kg/cm2) at 14 mL/sec | 1065 $psi$ (75 kg/cm2) at 10
mL/sec |
7
510(k) Summary
H. Performance Data Supporting Substantial Equivalence:
Bench and Laboratory (In-vitro) testing was completed to evaluate the subject device, Zoom 6F Insert Catheter. Performance specifications and test methods were based primarily on catheter performance standard ISO 10555-1. 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 Zoom 6F Insert Catheter and predicate Impress Angiographic Catheters do not significantly impact any performance parameters that would adversely affect the safety or effectiveness of the subject Zoom 6F Insert Catheter.
| Test Attribute | Specification | Results |
|---|---|---|
| Visual | The external surface of the effective length of | |
| the device shall be defect free when removed | ||
| from packaging. | Pass | |
| Effective Length | Effective lengths of the catheters are within the | |
| specified tolerances. | Pass | |
| Guidewire | ||
| compatibility | The catheters shall be compatible with | |
| guidewire specified in labeling. | Pass | |
| Dimensional | ||
| (Proximal OD, | ||
| Midsection OD, | ||
| Maximum OD) | All defined catheter dimension shall be within | |
| specified tolerances. | Pass | |
| Shape/Curve | ||
| Retention | The device shall be offered with the SIM, | |
| VERT, and VTK tip shapes. | Pass | |
| Distal Tip | The distal tip shall be a smooth taper and | |
| contain a radiused edge. | Pass | |
| Radiopacity | At least the shaped portion of the device shall | |
| be visible under fluoroscopy during use. | Pass | |
| Flexibility and | ||
| Kink Resistance | The device must be capable of being inserted | |
| into the access site, selecting the target vessel a | ||
| minimum and being retracted without damage | ||
| to the device. | Pass | |
| Flexibility and | ||
| Kink Resistance | The device shall be able to bend to a minimum | |
| radius specified radius at all locations without | ||
| kinking. | Pass |
Table 2: Tests and Performance Specifications
8
| Test Attribute | Specification | Results |
|---|---|---|
| Tensile Strength | Each junction of the device must meet the specified minimum tensile requirement. | Pass |
| Torque Strength | The device shall withstand 720 degree rotation without separation of any portion of the device. | Pass |
| Freedom from Leakage | The device shall not leak liquid when a pressure of 300 kPa minimum is applied and maintained for 30 seconds. | Pass |
| Freedom from Leakage | Air shall not leak into the hub assembly or device shaft during aspiration when vacuum is applied using a 10 mL syringe for 10 seconds. | Pass |
| Proximal Stiffness (Pushability) | The proximal shaft of the catheters shall have sufficient stiffness that the user can easily push the catheter to the target anatomy. | Pass |
| Dynamic Flow | The device shall remain free of leak and rupture, when used with a power injector set to a determined maximum pressure setting and maximum commanded flow rate. | Pass |
| Burst Strength | The device shall exceed the peak pressure present in the catheter at maximum flow conditions as determined per ISO 10555-1. | Pass |
| Flowrate, Positive | The device shall provide a flow rate which complies with ISO 10555-1. | Pass |
| Luer Compatibility | Device shall contain a female hub luer which complies with ISO 80369-7. | Pass |
| Corrosion | The metallic components of the device intended for fluid path contact shall be free of corrosion throughout the use of the device. | Pass |
| Particulate | The amount of particulate matter that comes off the shaft during simulated use testing shall be characterized and compared to competitive products | Pass |
9
510(k) Summary
I. Biocompatibility Testing:
Biocompatibility testing was performed on a representative finished Zoom 6F Insert Catheter to evaluate all direct patient contacting components of the device. This testing was conducted to ensure that the components and raw materials used in the subject Zoom 6F Insert Catheters and the manufacturing processes and sterilization processes result in a biocompatible product. Test results confirmed the subject Zoom 6F Insert Catheters met biological safety requirements per ISO 10993-1 for externally communicating medical devices with circulating blood contact for less than 24 hours.
J. Sterilization:
The Zoom 6F Insert Catheters are sterilized using a validated Ethylene Oxide (EtO) process with a sterility assurance level (SAL) of 10 € 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 1-year expiration dating. Device performance was verified by functional and performance testing.
Packaging and sterile barrier integrity through transportation has been verified. Aging testing has also been performed that supports the sterile barrier integrity following 13 months of accelerated aging.
L. Conclusions:
Imperative Care has completed comprehensive design verification and validation testing to ensure the subject device is biocompatible, performs as intended, meets all necessary performance attributes, and performs consistently throughout its labeled expiration dating. The results of design verification and validation testing did not raise any new issues or different questions of safety and effectiveness.
Based on the results of bench and laboratory testing, the subject device described in this submission is substantially equivalent to the predicate device.