(109 days)
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.
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.
The provided text describes the submission for a medical device called the "Zoom 6F Insert Catheter." This is a regulatory submission to the FDA, demonstrating "substantial equivalence" to a legally marketed predicate device, the "Impress Angiographic Catheter."
Crucially, this document does not describe an AI/ML device. It describes a physical medical device (a catheter) and its performance through bench and laboratory (in-vitro) testing against physical specifications, not algorithm performance. Therefore, many of the requested items related to AI/ML device testing (e.g., sample size for AI test sets, expert consensus for ground truth, MRMC studies, training set details) are not applicable to this document.
However, I can extract the acceptance criteria and performance data for the physical device as presented.
Description of Acceptance Criteria and Study (for this physical device)
The submission details the design verification and validation testing performed on the Zoom 6F Insert Catheter to demonstrate its substantial equivalence to a predicate device. The "study" here refers to a series of in-vitro bench and laboratory tests, not a clinical trial or an AI/ML model validation.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table (Table 2) summarizing the performance specifications (acceptance criteria) and the results ("Pass") for the Zoom 6F Insert Catheter.
| Test Attribute | Specification | Results ("Performance") |
|---|---|---|
| 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 dimensions 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 (2 specifications) | 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. The device shall be able to bend to a minimum specified radius at all locations without kinking. | Pass |
| 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 (2 specifications) | The device shall not leak liquid when a pressure of 300 kPa minimum is applied and maintained for 30 seconds. 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. (Note: "Compared to competitive products" implies a standard, but the specific numerical acceptance criterion is not explicitly stated as "X < Y" in this summary table). | Pass |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: The document does not specify the exact number of units tested for each attribute. It mentions "Bench and Laboratory (In-vitro) testing." For medical devices, typically this would involve a statistically significant number of samples (e.g., n=3, 5, or more, depending on the test and variation) to ensure reproducibility and reliability, but the exact numbers are not provided in this public summary.
- Data Provenance: The data provenance is "Bench and Laboratory (In-vitro) testing," meaning it was conducted in a controlled lab environment. This is not clinical data, nor attributed to a specific country of origin, retrospective or prospective. It's a physical materials/engineering test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not Applicable. For a physical catheter, "ground truth" is established by direct physical measurements according to specified test methods (e.g., measuring dimensions with calipers, applying pressure, observing flow rates). There are no "experts" in the sense of clinical readers or annotators establishing a ground truth for a test set. Engineering and quality control personnel would perform these tests.
4. Adjudication Method for the Test Set:
- Not Applicable. As the tests are objective physical measurements or observations against predefined specifications, there's no need for an "adjudication method" in the context of human interpretation of data. The results are either "Pass" or "Fail" based on comparison to the specification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is a regulatory submission for a physical diagnostic catheter, not an AI/ML medical device. MRMC studies are relevant for evaluating the impact of AI on human reader performance for diagnostic tasks.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used:
- Physical Specifications and Engineering Standards. The "ground truth" for these tests is the quantitative and qualitative performance specifications derived from medical device standards (e.g., ISO 10555-1, ISO 80369-7) and internal design requirements. For example, "Effective lengths... within specified tolerances" means the measured length must fall within the defined acceptable range.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set.
{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 DeviceMerit Medical ImpressAngiographic Catheter(K191608) | Subject DeviceZoom 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 aredesigned to be used fordelivering radiopaque media toselected sites in the vascularsystem in conjunction withroutine diagnostic procedures.Angiographic catheters withmarker bands may also be usedfor anatomical measurements. | The Zoom 6F Insert Catheter isindicated for use in deliveringradiopaque media to selectedsites in the peripheral vascularsystem in conjunction withroutine diagnostic procedures. |
| Contraindications | None known | Same |
| Materials | Commonly used medical gradeplastics & 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 andVTK) diameter guidewires orsmaller. | Compatible with 0.038"diameter guidewires or smallerand ≥ 180 cm length |
| Introducer Sheath/GuideCatheter Compatibility | Compatible with 5F (0.066")Introducer Sheath | Compatible with 0.088" InnerDiameter guide catheter orlarger |
| Luer Compatibility | Compatible with standard luerlock devices | Same |
{6}------------------------------------------------
| Description | Predicate DeviceMerit Medical ImpressAngiographic Catheter(K191608) | Subject DeviceZoom 6F Insert Catheter |
|---|---|---|
| Tip Shape | Provided in a variety of tipshapes, 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 | PouchBacking CardShelf CartonShipper Box | Same |
| Radiopacity | With and without radiopaquemarker band, distal shaft isradiopaque | No radiopaque marker band,distal shaft is radiopaque |
| Hydrophilic Coating | With and without hydrophiliccoating | Without hydrophilic coating |
| Maximum Dynamic BurstPressure | 1200 psi | Same |
| Flow Rate | 5F SIM 2, 100cm length: 814 $psi$ (57 kg/cm2) at 15 mL/sec5F VERT, 100cm length: 888 $psi$ (62 kg/cm2) at 15 mL/sec5F VTK, 125cm length: 1030 $psi$ (72 kg/cm2) at 14 mL/sec | 1065 $psi$ (75 kg/cm2) at 10mL/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 ofthe device shall be defect free when removedfrom packaging. | Pass |
| Effective Length | Effective lengths of the catheters are within thespecified tolerances. | Pass |
| Guidewirecompatibility | The catheters shall be compatible withguidewire specified in labeling. | Pass |
| Dimensional(Proximal OD,Midsection OD,Maximum OD) | All defined catheter dimension shall be withinspecified tolerances. | Pass |
| Shape/CurveRetention | The device shall be offered with the SIM,VERT, and VTK tip shapes. | Pass |
| Distal Tip | The distal tip shall be a smooth taper andcontain a radiused edge. | Pass |
| Radiopacity | At least the shaped portion of the device shallbe visible under fluoroscopy during use. | Pass |
| Flexibility andKink Resistance | The device must be capable of being insertedinto the access site, selecting the target vessel aminimum and being retracted without damageto the device. | Pass |
| Flexibility andKink Resistance | The device shall be able to bend to a minimumradius specified radius at all locations withoutkinking. | 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.
§ 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).