Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML capabilities.

Therapeutic

No
The device is described as a micro catheter intended for delivery of therapeutic devices, not as a therapeutic device itself.

Diagnostic

No

The device description and intended use state that the micro catheter is for the delivery of therapeutic devices and infusion of contrast media. It is not described as a device used to identify, monitor, or predict disease.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical catheter with a lumen, Luer adapter, lubricious coating, and radiopaque marker. It is intended for physical introduction into the vasculature.

IVD (In Vitro Diagnostic)

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 delivery of therapeutic devices and contrast media into the body (peripheral and neuro vasculature). This is an in vivo (within the living body) application.
Device Description: The description details a catheter designed for insertion into blood vessels. This is a medical device used for direct intervention within the body.
Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens outside the body.

Therefore, the Micro Catheter described is a medical device used for therapeutic and diagnostic procedures performed within the patient's body, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Micro Catheter is intended for selective delivery of therapeutic devices and infusion of contrast media into the peripheral and neuro vasculature.

Product codes

QJP, DQY

Device Description

The proposed device Micro Catheter is a single-lumen catheter designed to be introduced over a steerable guidewire into the peripheral and neuro vasculature. The proximal end of the catheter incorporates standard Luer adapter to facilitate the attachment of accessories. The outer surface of the catheter has a lubricious coating at the distal end of the Micro Catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The device is intended for single use and is provided sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral 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

Non clinical tests were conducted to verify that the proposed device met all design specifications and was substantially equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ISO 10993-3: 2014, ISO 10993-4: 2017, ISO 10993-5: 2009, ISO 10993-7: 2008, ISO 10993-10: 2010, ISO 10993-11: 2017, USP , ASTM F1929-15, ASTM F88/88M-15, ISO 594-1: 1986, ISO 594-2: 1998, ISO 10555-1: 2013, ISO 80369-7: 2106. No clinical studies were necessary to demonstrate substantial equivalence.

Key Metrics

Not Found

Predicate Device(s)

K192122

Reference Device(s)

K993672, K001966

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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February 10, 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Shanghai Heartcare Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 China

Re: K202926

Trade/Device Name: Micro Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: January 8, 2022 Received: January 11, 2022

Dear Diana Hong:

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

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K202926

Device Name Micro Catheter

Indications for Use (Describe)

The Micro Catheter is intended for selective delivery of therapeutic devices and infusion of contrast media into the peripheral 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)

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of 21 CFR 807.92.

510(k) Number: __ K202926

Date of Preparation: 02/10/2022

1. Sponsor Identification

Shanghai Heartcare Medical Technology Co., Ltd.

590 Ruiqing Rd, Building 4, Suite 201, East Zhangjing High-Tech Park, Shanghai, P.R. China

Establishment Registration Number: Not registered

Contact Person: Zongyu Xue Position: RA Director Tel: +86-18621683501 Fax: +86-21-68798512 Email: zyxue@strokemedical.com

2. Designated Submission Correspondent

Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

3. Identification of Proposed Device

Trade Name: Micro Catheter Common Name: Intravascular Catheter

Regulatory Information

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Primary Product Code Classification Name: Catheter, Percutaneous, Neurovasculature Classification: II Product Code: QJP Regulation Number: 21CFR 870.1250 Review Panel: Neurology

Secondary Product Code Classification Name: Catheter, Percutaneous Classification: II Product Code: DQY Regulation Number: 21CFR 870.1250 Review Panel: Cardiovascular

Identification of Predicate Device and Reference Devices 4.

Predicate Device 510(k) Number: K192122 Product Name: Trevo Trak 21 Microcatheter

Reference Device 1 510(k) Number: K993672 Product Name: Rebar Micro Catheter

Reference Device 2 510(k) Number: K001966 Product Name: Rebar Micro Catheter

રં. Device Description

The proposed device Micro Catheter is a single-lumen catheter designed to be introduced over a steerable guidewire into the peripheral and neuro vasculature. The proximal end of the catheter incorporates standard Luer adapter to facilitate the attachment of accessories. The outer surface of the catheter has a lubricious coating at the distal end of the Micro Catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The device is intended for single use and is provided sterile.

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6. Indications for Use

The Micro Catheter is intended for selective delivery of therapeutic devices and into the peripheral and neuro vasulature.

7. Comparison of Technological Characteristics

Item	Subject Device	Predicate Device K192122	Reference Device 1 K993672	Reference Device 2 K001966
Classification	II	II	II	II
Product Code	QJP, DQY	DQO, DQY	KRA	KRA
Regulation Number	21 CFR 870.1250	21 CFR 870.1200
21 CFR 870.1250	21 CFR 870.1210	21 CFR 870.1210
Indication for Use	The Micro Catheter is
intended for selective
delivery of therapeutic
devices and infusion of
contrast media into the
peripheral and neuro
vasculature.	The Microcatheter is indicated
for use in the selective
placement of devices and/or
fluids, such as contrast media,
into the peripheral, coronary,
and neuro vasculature during
diagnostic and/or therapeutic
procedures.	The Rebar Micro Catheter is
intended for the controlled
selective infusion of physician-
specified therapeutic agents or
contrast media into the
vasculature of the peripheral
and neuro anatomy.	The Rebar Micro Catheter is
intended for the controlled
selective infusion of physician-
specified therapeutic agents or
contrast media into the
vasculature of the peripheral
and neuro anatomy.
Component	Ruhr Handle
Outer Stress Tube
Inner Stress Tube
Coil Tube	Outer Jacket
Shaft Braid
Strain Relief
Inner Layer
Catheter Hub	Ruhr Handle
Outer Stress Tube
Inner Stress Tube
Coil Tube	Ruhr Handle
Outer Stress Tube
Inner Stress Tube
Coil Tube
Inner Diameter	0.021, 0.027 inch	0.021 inch	0.027 inch	0.021 inch
Proximal Outer
Diameter	2.85 Fr (0.95 mm)	2.85 Fr (0.95 mm)	2.8 Fr (0.93 mm)	2.8 Fr (0.93 mm)
Distal Outer Diameter	2.55 Fr (0.85 mm),
2.85 Fr (0.95 mm)	2.4 Fr (0.80 mm),
2.0 Fr (0.67 mm)	2.8 Fr (0.93 mm)	2.3 Fr (0.76 mm)
Effective length	110, 130, 145, 153 cm	162 cm	110, 130, 145 cm	110, 130, 153 cm

Maximum Guidewire	0.010 inch	0.018 inch	0.021 inch	0.018 inch
Radiopaque Marker	Yes	Yes	Yes	Yes
Single Use	Yes	Yes	Yes	Yes
Materials
Inner Layer of Coil
Tube	Polytetrafluoroethylene	PTFE	Polytetrafluoroethylene	Polytetrafluoroethylene
Outer Layer of Coil
Tube	Pebax	Polyolefin	Pebax	Pebax
Coating	Polyvinylpyrrolidone (PVP)	Hydrophilic Coating	Hyaluronic Acid	Hyaluronic Acid
Radiopaque Marker	Platinum-iridium alloy	Platinum/iridium	Platinum-iridium alloy	Platinum-iridium alloy
Ruhr Handle	Polycarbonate (PC)	Polyurethane	unknown	unknown
Adhesive	Dymax 204-CTH-F	Acrylic (Acrylated Urethane)	unknown	unknown

Table 1 Comparison of Technological Characteristics

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8. Non-Clinical Performance Testing

Non clinical tests were conducted to verify that the proposed device met all design specifications and was substantially equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-3: 2014 Biological evaluation of medical devices-Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4: 2017 Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood
ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: Tests for in vitrocytotoxicity
ISO 10993-7: 2008 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
ISO 10993-11: 2017 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity
USP Bacterial Endotoxins Test
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F88/88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
ISO 594-1: 1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
ISO 594-2: 1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
ISO 10555-1: 2013 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements
ISO 80369-7: 2106 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

The results of verification and validation testing conducted on the Micro Catheter demonstrate that it performs as designed and is suitable for its intended use. A summary of the tests performed is provided in the table below:

Test	Test Method Summary	Results and Conclusion
Surface Evaluation	Observe the catheter by eye or under microscope at X 2.5 magnification for any structural or mechanical damage.	Surface met acceptance criteria.
Radiopacity	The radiopaque marker on the catheter tip should be visible under X - ray.	The radiopaque marker on the catheter tip is visible under X-ray.
Dimensional
verification	Verify dimensions using specified
measurement tools. Record measurements.	Size verification met acceptance
criteria.
Liquid leakage	The proposed device was evaluated per ISO
10555-1 to demonstrate that the device
meets the liquid leakage under pressure
requirements.	No liquid leakage.
Static burst pressure	Burst pressure tests were performed at
pressures greater than the manual syringe
injection pressures.	Burst pressure met acceptance
criteria.
Peak tensile force	Use a tensile test machine to apply a tensile
load to the sample and determine whether the
maximum tensile force meets the acceptance
criteria.	Peak tensile force met acceptance
criteria.
Torque Strength	Fix the distal end of the catheter and rotate
the proximal end until the failure. Record the
number of rotation and the failure mode.	Torque strength met acceptance
criteria.
Torqueability	Rotate the proximal end of the catheter 90
degrees to observe the distal end of the
catheter and calculate a proximal-to-distal
rotational ratio for the device.	Torqueability met acceptance
criteria.
Kink resistance	The proposed device was evaluated per
FDA guidance “Non-Clinical Engineering
Tests and Recommended Labeling for
Intravascular Stents and Associated
Delivery Systems", section IV, C.9.	Kink resistance met acceptance
criteria.
Trackability	The proposed device was evaluated per FDA
guidance "Non-Clinical Engineering Tests
and Recommended Labeling for
Intravascular Stents and Associated
Delivery Systems", section IV, C.2.	Trackability met acceptance
criteria.
Particulate testing	After simulated use testing with compatible
devices, determine the quantity and size of
the particles generated.	The number and size of the
particles were similar to that of
the predicate device.
Coating integrity	After simulated use testing with compatible
devices, the coating is dyed and checked for
coating defects at X 500 magnification.	Coating integrity met
acceptance criteria.
Tip flexibility	The proposed device was evaluated per FDA guidance “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling”, section IV, G.15.	Tip flexibility met acceptance criteria.
Air leakage	The proposed device was evaluated per ISO 10555-1 to demonstrate that the device meets the hub aspiration air leakage requirements.	No air leakage.
Corrosion resistance	The proposed device was evaluated per ISO 10555-1 to demonstrate that the device is corrosion resistant.	Corrosion resistance met acceptance criteria.
Connector performance	The proposed device was evaluated per ISO 594-1, 594-2 and 80369-7 to demonstrate that the device meets the requirements for small bore connectors.	Connector performance met acceptance criteria.
Compatibility test	Simulated use testing with compatible devices in a vascular model was performed.	The device can be used as intended.

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9

Biocompatibility

The device is categorized as Externally Communicating Device, Circulating Blood, Limited Contact (
Pyrogen Test. | Study animals were
observed for temperature
rise. | Nonpyrogenic |
| In
Vivo
Thromboresistance | Tested in accordance with ISO
10993-4:2017,
Biological
Evaluation of Medical Devices –
Part 4: Selection of Tests for
Interactions with Blood. | Study animals with subject
device were observed for
thrombogenic potentials and
test results demonstrated
similar thromboresistance
characteristics with the
control device. | Met the
predetermined
acceptance criteria,
the test score is 0,
i.e., No thrombosis. |
| Complement
Activation | Tested in accordance with ISO
10993-4, Biological Evaluation
of Medical Devices – Part
4:2017: Selection of Tests for
Interactions with Blood, SC5b-9
Complement Activation. | Comparison of the subject
device SC5b-9 value to the
predicate device for all
exposure times was
performed. | No statistical
difference from the
predicate device |
| Partial
Thromboplastin Time | Tested in accordance with ISO 10993-4:2017, Biological
Evaluation of Medical Devices –
Part 4: Selection of Tests for
Interactions with Blood, and
ASTM F2382-2018, Standard
Test Method for Assessment of
Intravascular Medical Device
Materials on Partial
Thromboplastin Time. | The clotting time was
observed for both the subject
device and the predicate. | No statistical
difference from the
predicate device. |
| Bacterial Reverse
Mutation | Tested in accordance with ISO
10993-3:2014 Biological
evaluation of medical devices-
Part 3: Tests for genotoxicity,
carcinogenicity and reproductive
toxicity. | The difference between the
number of revertant colonies
of the subject device and the
negative control was
evaluated. | No backward
mutation in
salmonella
typhimurium. |
| In Vitro Mammalian
Cell Gene Mutation | Tested in accordance with ISO
10993-3:2014 Biological
evaluation of medical devices-
Part 3: Tests for genotoxicity,
carcinogenicity and reproductive
toxicity. | The difference between the
mutation frequency of the
subject device and the
negative control was
evaluated. | Non-mutagenic to
TK+/--3.7.2C
Subline of L5178Y
cell. |

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Sterilization and Shelf Life

The Micro Catheter sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10th. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 2.15 EU/device in accordance with USP . Both baseline and accelerated shelf life testing were conducted demonstrating the device will perform as intended to support the proposed 2 year shelf-life.

9. Clinical Performance Testing

No clinical studies were necessary to demonstrate substantial equivalence.

10. Conclusion

The subject device has similar technological characteristics and intended use as the predicate device. The differences do not raise new questions of safety and effectiveness. The biocompatibility, sterility and bench performance testing demonstrate that the Micro Catheter is substantially equivalent to the predicate device.