(316 days)
No
The device description and performance studies focus on the physical properties and functionality of a catheter system, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a catheter system used for the introduction of interventional devices, not for providing therapy itself.
No
The device is a catheter system indicated for the introduction of interventional devices, primarily for therapeutic or procedural purposes, not for diagnosing conditions.
No
The device description explicitly details physical components like a catheter, introducer tool, and packaging hoop, indicating it is a hardware device, not software-only.
Based on the provided information, 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 peripheral and neurovasculature." This describes a device used within the body for a procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a catheter system designed for insertion into blood vessels. This aligns with an interventional device, not an IVD.
- 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.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Minjie Catheter System's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
The Minjie Catheter System is indicated for the introduction of interventional devices into the peripheral and neruovasculature.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQY
Device Description
The Minjie Catheter System consists of the Minjie Catheter, Introducer Peel Away Tool and packaging hoop with Elbow Flush Luer. The Minjie Catheter is a single lumen. flexible, variable stiffness composite catheter with a Nitinol structure. A radiopaque marker band on the distal tip of the catheter is used for visualization under fluoroscopy. The distal section of the catheter is coated with a hydrophilic coating, to reduce friction during intravascular use. The Minjie Catheter System dimensions are included in the individual device label. The devices are supplied sterile and are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Minjie Catheter is used for visualization under fluoroscopy.
Anatomical Site
Peripheral and neurovasculature
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)
Performance Data (Non-Clinical Testing):
Sterilization and Shelf-Life: Validated EO sterilization cycle to ensure a sterility assurance level (SAL) of 10-6. Endotoxin testing conducted. Aging studies established product functionality and packaging sterility for up to twenty-four months. All acceptance criteria met.
Biocompatibility Testing: Performed in accordance with FDA guidance "Use of International Standard ISO 10993-1" for a limited exposure (
§ 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 2, 2022
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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Kai Medtech, LLC Ricardo Olivo Senior Director, Quality and Reguatory Affairs 22651 Lambert Street, Suite 107 Lake Forest, California 92630
Re: K212288
Trade/Device Name: Minjie Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: April 29, 2022 Received: May 3, 2022
Dear Ricardo Olivo:
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) K212288
Device Name Minjie Catheter System
Indications for Use (Describe)
The Minjie Catheter System is indicated for the introduction of interventional devices into the peripheral and neruovasculature.
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)
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
510(k) Summary K212288
This 510(k) Summary for the Minjie Catheter System is submitted in accordance with the requirements of 21 CFR Part 807.92 and following the recommendations outlined in FDA guidance, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]," issued on July 28, 2014.
Submitter
| Submitter: | Kai Medtech, LLC
22651 Lambert Street, Suite 107
Lake Forest, CA 92630 USA |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ricardo Olivo
Senior Director, Quality and Regulatory Affairs
+1 (949) 767-8960, Extension 109
ricardo.olivo@kaimtgroup.com |
| Date Prepared: | June 01, 2022 |
Device Name and Details
| Trade Name of Device: | Minjie Catheter System |
|---|---|
| Common Name of | |
| Device: | Distal Access Catheter |
| Device Classification: | Class II |
| Device Classification | |
| Name: | Percutaneous Catheter |
| Regulation Number/ | |
| Description: | 21 CFR 870.1250, Percutaneous Catheter |
| Classification | |
| Product Code: | Primary Product Code: QJP |
| Secondary Product Code: DQY | |
| Review Panel: | Neurology |
4
| 510(k)
Number | Product
Code | Trade Name of Device | Device Manufacturer |
|--------------------------|-----------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------|
| Predicate Device | | | |
| K150107 | DQY | Arc™ Intracranial Support
Catheter and Arc™ Mini
Intracranial Support
Catheter | Micro Therapeutics, Inc.
d/b/a ev3 Neurovascular |
| Reference Devices | | | |
| K161152 | DQY | Navien Intracranial Support
Catheter | Micro Therapeutics, Inc.
d/b/a ev3 Neurovascular |
| K140080 | DQY | ENVOY® Distal Access (DA)
Guiding Catheter | Codman & Shurtleff, Inc. |
Table 1: Legally Marketed Predicate and Reference Devices
Device Description
The Minjie Catheter System consists of the Minjie Catheter, Introducer Peel Away Tool and packaging hoop with Elbow Flush Luer. The Minjie Catheter is a single lumen. flexible, variable stiffness composite catheter with a Nitinol structure. A radiopaque marker band on the distal tip of the catheter is used for visualization under fluoroscopy. The distal section of the catheter is coated with a hydrophilic coating, to reduce friction during intravascular use. The Minjie Catheter System dimensions are included in the individual device label. The devices are supplied sterile and are intended for single use only.
Indications for Use Statement
The Miniie Catheter System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
Comparison of Technological Characteristics with the Predicate Device
A comparison of the technological characteristics of the subject device (Minjie Catheter System) and predicate device (Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter) demonstrates that the technological characteristics of the subject Minjie Catheter System are substantially equivalent to the technological characteristics of the predicate Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter previously cleared under K150107. Refer to Table 2 below for a comparison between the Minjie Catheter System and Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter.
5
| | Predicate Device, ArcTM
Intracranial Support Catheter
and ArcTM Mini Intracranial
Support Catheter (K150107) | Subject Device, Minjie Catheter
System (K212288) | Comparison |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Regulation | DQY (21 CFR 870.1250) | QJP, DQY (21 CFR 870.1250) | Similar |
| Indications for Use
Statement | The ArcTM Intracranial
Support Catheter and ArcTM
Mini Intracranial Support
Catheter are indicated for
the introduction of
interventional
devices into the peripheral
and neurovasculature. | The Minjie Catheter System is
indicated for the introduction of
interventional devices into the
peripheral and neurovasculature. | Same |
| Function /
Principle of Operation | Facilitate introduction and
selective placement of
interventional devices into target
blood vessels in the peripheral
and neuro vasculature. | Facilitate introduction and
selective placement of
interventional devices into
target blood vessels in the
peripheral and neuro
vasculature | Similar |
| Catheter Shaft
Materials | PTFE lined polymeric catheter
with hydrophilic coating | PTFE lined polymeric catheter
with hydrophilic coating | Similar |
| Catheter Shaft
Support | Nitinol | Nitinol | Similar |
| Marker Band | Platinum | Platinum/Iridium | Testing
demonstrated
that the
difference does
not raise new
questions of
safety and
effectiveness. |
| Usable Length | 132cm - 135cm | 115cm - 131cm | Similar |
| Coating Length | 40cm - 45cm | 60cm | Testing
demonstrated
that the
difference does
not raise new
questions of
safety and
effectiveness. |
| Distal Inner Diameter
(ID) | 0.061" | 0.068" (1.73mm) | Testing
demonstrated
that the
difference does
not raise new
questions of
safety and
effectiveness. |
| Distal Outer Diameter
(OD) (Max) | 0.071" | 0.081" (2.06mm) | Testing
demonstrated
that the |
| | | | |
| Proximal ID | 0.069" | 0.068" (1.73mm) | Similar |
| Proximal OD (Max) | 0.082" | 0.083" (2.11mm) | Similar |
| Shaft | Progressively softer from proximal end to distal tip | Progressively softer from proximal end to distal tip | Similar |
| Tip Configuration | Single, straight flexible tip | Single, straight flexible tip | Similar |
| Guidewire
Compatibility | Can be navigated over
guidewire with maximum OD
of 0.038" | Can be navigated over
guidewire with maximum
OD of 0.035" | Testing
demonstrated
that the
difference does
not raise new
questions of
safety and
effectiveness. |
| Packaging | Catheter in polyethylene hoop
attached to packaging card inside
PET / PE / Tyvek pouch inside
SBS carton | Catheter in polyethylene hoop
attached to packaging card
inside PET / PE / Tyvek pouch
inside SBS carton | Similar |
| Accessories | Introducer Tool | Introducer Peel Away Tool | Testing
demonstrated
that the
difference does
not raise new
questions of
safety and
effectiveness. |
| Sterilization Method | Ethylene oxide (EO) gas | EO gas | Similar |
| | | | difference does
not raise new
questions of
safety and
effectiveness. |
Table 2: Comparison between Minjie Catheter System and Arc™ Intracranial Support
Catheter and Arc™ Mini Intracranial Support Catheter.
Page 3 of 8
6
Performance Data (Non-Clinical Testing)
Sterilization and Shelf-Life
The packaged Minjie Catheter System is sterilized using a validated EO sterilization cycle. The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 106 in accordance with ISO 11135:2014, "Sterilization of health care products - Ethylene oxide - Requirements for the development, validation, and routine control Endotoxin testing was conducted in accordance with FDA guidance, "Pyrogen and Endotoxins Testing: Questions and Answers," issued in June 2012.
Aging studies for the Minjie Catheter System have established that the product remains functional, and packaging maintains sterility for up to twenty-four months. Aging studies for packaging integrity and product stability (device functionality) were performed and met all acceptance criteria.
Biocompatibility Testing
Biocompatibility testing was performed in accordance with FDA guidance. "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part Page 4 of 8
7
1: Evaluation and testing within a risk management process"," issued on September 4, 2020, and ISO 10993-1:2018, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," for the Minjie Catheter System categorized as a limited exposure (