Micro Catheter

K202926 · Shanghai Heartcare Medical Technology Co., Ltd. · QJP · Feb 10, 2022 · Cardiovascular

Device Facts

• Record ID: K202926
• Device Name: Micro Catheter
• Applicant: Shanghai Heartcare Medical Technology Co., Ltd.
• Product Code: QJP · Cardiovascular
• Decision Date: Feb 10, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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

Device Story

Single-lumen intravascular catheter; introduced over steerable guidewire into peripheral and neuro vasculature. Features proximal Luer adapter, lubricious distal coating, and distal radiopaque marker for fluoroscopic visualization. Used in clinical settings by physicians for selective delivery of therapeutic devices and contrast media infusion. Output is visual placement of device/media under fluoroscopy; assists in diagnostic/therapeutic vascular procedures. Benefits patient by enabling targeted access to complex vascular anatomy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including surface evaluation, radiopacity, dimensional verification, liquid/air leakage, burst pressure, tensile force, torque strength/ability, kink resistance, trackability, particulate testing, coating integrity, tip flexibility, corrosion resistance, connector performance, and compatibility testing. Biocompatibility testing performed per ISO 10993 series.

Technological Characteristics

Single-lumen catheter; materials include PTFE (inner layer), Pebax (outer layer), Platinum-iridium (marker), Polycarbonate (handle), and Dymax 204-CTH-F (adhesive). Lubricious PVP coating. Sterilized via Ethylene Oxide (ISO 11135). Dimensions: 0.021/0.027 inch ID; 2.55/2.85 Fr distal OD. Complies with ISO 10555-1, ISO 594-1/2, ISO 80369-7, and ASTM standards for mechanical/packaging performance.

Indications for Use

Indicated for selective delivery of therapeutic devices and infusion of contrast media into the peripheral and neuro vasculature in patients requiring such diagnostic or therapeutic procedures.

Regulatory Classification

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.

Predicate Devices

• Trevo Trak 21 Microcatheter (K192122)

Reference Devices

• Rebar Micro Catheter (K993672)
• Rebar Micro Catheter (K001966)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{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 ([e-mail]) or phone [phone] 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}------------------------------------------------

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) | |
|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">✘</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

**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

[e-mail]

"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

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: [phone] Fax: [phone] Email: [e-mail]

#### 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: [phone], Fax: [phone] Email: [e-mail]

#### 3. Identification of Proposed Device

Trade Name: Micro Catheter Common Name: Intravascular Catheter

Regulatory Information

{4}------------------------------------------------

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.

{5}------------------------------------------------

#### 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<br>21 CFR 870.1250 | 21 CFR 870.1210 | 21 CFR 870.1210 |
| Indication for Use | The Micro Catheter is<br>intended for selective<br>delivery of therapeutic<br>devices and infusion of<br>contrast media into the<br>peripheral and neuro<br>vasculature. | The Microcatheter is indicated<br>for use in the selective<br>placement of devices and/or<br>fluids, such as contrast media,<br>into the peripheral, coronary,<br>and neuro vasculature during<br>diagnostic and/or therapeutic<br>procedures. | The Rebar Micro Catheter is<br>intended for the controlled<br>selective infusion of physician-<br>specified therapeutic agents or<br>contrast media into the<br>vasculature of the peripheral<br>and neuro anatomy. | The Rebar Micro Catheter is<br>intended for the controlled<br>selective infusion of physician-<br>specified therapeutic agents or<br>contrast media into the<br>vasculature of the peripheral<br>and neuro anatomy. |
| Component | Ruhr Handle<br>Outer Stress Tube<br>Inner Stress Tube<br>Coil Tube | Outer Jacket<br>Shaft Braid<br>Strain Relief<br>Inner Layer<br>Catheter Hub | Ruhr Handle<br>Outer Stress Tube<br>Inner Stress Tube<br>Coil Tube | Ruhr Handle<br>Outer Stress Tube<br>Inner Stress Tube<br>Coil Tube |
| Inner Diameter | 0.021, 0.027 inch | 0.021 inch | 0.027 inch | 0.021 inch |
| Proximal Outer<br>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),<br>2.85 Fr (0.95 mm) | 2.4 Fr (0.80 mm),<br>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<br>Tube | Polytetrafluoroethylene | PTFE | Polytetrafluoroethylene | Polytetrafluoroethylene |
| Outer Layer of Coil<br>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

{6}------------------------------------------------

{7}------------------------------------------------

#### 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 <85> 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<br>verification | Verify dimensions using specified<br>measurement tools. Record measurements. | Size verification met acceptance<br>criteria. |
| Liquid leakage | The proposed device was evaluated per ISO<br>10555-1 to demonstrate that the device<br>meets the liquid leakage under pressure<br>requirements. | No liquid leakage. |
| Static burst pressure | Burst pressure tests were performed at<br>pressures greater than the manual syringe<br>injection pressures. | Burst pressure met acceptance<br>criteria. |
| Peak tensile force | Use a tensile test machine to apply a tensile<br>load to the sample and determine whether the<br>maximum tensile force meets the acceptance<br>criteria. | Peak tensile force met acceptance<br>criteria. |
| Torque Strength | Fix the distal end of the catheter and rotate<br>the proximal end until the failure. Record the<br>number of rotation and the failure mode. | Torque strength met acceptance<br>criteria. |
| Torqueability | Rotate the proximal end of the catheter 90<br>degrees to observe the distal end of the<br>catheter and calculate a proximal-to-distal<br>rotational ratio for the device. | Torqueability met acceptance<br>criteria. |
| Kink resistance | The proposed device was evaluated per<br>FDA guidance “Non-Clinical Engineering<br>Tests and Recommended Labeling for<br>Intravascular Stents and Associated<br>Delivery Systems", section IV, C.9. | Kink resistance met acceptance<br>criteria. |
| Trackability | The proposed device was evaluated per FDA<br>guidance "Non-Clinical Engineering Tests<br>and Recommended Labeling for<br>Intravascular Stents and Associated<br>Delivery Systems", section IV, C.2. | Trackability met acceptance<br>criteria. |
| Particulate testing | After simulated use testing with compatible<br>devices, determine the quantity and size of<br>the particles generated. | The number and size of the<br>particles were similar to that of<br>the predicate device. |
| Coating integrity | After simulated use testing with compatible<br>devices, the coating is dyed and checked for<br>coating defects at X 500 magnification. | Coating integrity met<br>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. |

{8}------------------------------------------------

{9}------------------------------------------------

## Biocompatibility

The device is categorized as Externally Communicating Device, Circulating Blood, Limited Contact (< 24 hours), per ISO 10993-1, the following testing was conducted:

| Test | Reference Standard | Test Summary | Conclusion |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Cytotoxicity | Tested in accordance with ISO<br>10993-5:2009, Biological<br>Evaluation of Medical Devices –<br>Part 5: Tests for in vitro toxicity. | Verify the viability, if<br>viability is reduced to < 70%<br>of the blank, it has a<br>cytotoxic potential. | Non-cytotoxic |
| Irritation | Tested in accordance with ISO<br>10993-10:2010, Biological<br>Evaluation of Medical Devices –<br>Part 10: Tests for Irritation and<br>Skin Sensitization. | Study animals tested with the<br>subject device were observed<br>for dermal sensitization. | No irritation |
| Sensitization | Tested in accordance with ISO<br>10993-10, Biological Evaluation<br>of Medical Devices – Part 10<br>Tests for Irritation and Skin<br>Sensitization. | Study animals tested with the<br>subject device were observed<br>for dermal sensitization. | No sensitization |
| Systemic Toxicity | Tested in accordance with ISO<br>10993-11:2017,<br>Biological<br>Evaluation of Medical Devices –<br>Part 11: Tests for Systemic<br>Toxicity. | Study animals tested with the<br>subject device were observed<br>for abnormal clinical signs<br>indicative of toxicity during<br>the 72-hour test period. | No systemic toxicity |
| Hemolysis | Tested in accordance with ASTM<br>F756-17, Standard Practice for<br>Assessment of Hemolytic<br>Properties of Materials. | The difference between the<br>hemolytic indexes of the<br>subject device and the<br>negative control was<br>evaluated. | Non-hemolytic |
| Material Mediated<br>Pyrogenicity | Tested in accordance with ISO<br>10993-11:2017,<br>Biological<br>Evaluation of Medical Devices –<br>Part 11: Tests for Systemic<br>Toxicity and USP 42 <151><br>Pyrogen Test. | Study animals were<br>observed for temperature<br>rise. | Nonpyrogenic |
| In<br>Vivo<br>Thromboresistance | Tested in accordance with ISO<br>10993-4:2017,<br>Biological<br>Evaluation of Medical Devices –<br>Part 4: Selection of Tests for<br>Interactions with Blood. | Study animals with subject<br>device were observed for<br>thrombogenic potentials and<br>test results demonstrated<br>similar thromboresistance<br>characteristics with the<br>control device. | Met the<br>predetermined<br>acceptance criteria,<br>the test score is 0,<br>i.e., No thrombosis. |
| Complement<br>Activation | Tested in accordance with ISO<br>10993-4, Biological Evaluation<br>of Medical Devices – Part<br>4:2017: Selection of Tests for<br>Interactions with Blood, SC5b-9<br>Complement Activation. | Comparison of the subject<br>device SC5b-9 value to the<br>predicate device for all<br>exposure times was<br>performed. | No statistical<br>difference from the<br>predicate device |
| Partial<br>Thromboplastin Time | Tested in accordance with ISO 10993-4:2017, Biological<br>Evaluation of Medical Devices –<br>Part 4: Selection of Tests for<br>Interactions with Blood, and<br>ASTM F2382-2018, Standard<br>Test Method for Assessment of<br>Intravascular Medical Device<br>Materials on Partial<br>Thromboplastin Time. | The clotting time was<br>observed for both the subject<br>device and the predicate. | No statistical<br>difference from the<br>predicate device. |
| Bacterial Reverse<br>Mutation | Tested in accordance with ISO<br>10993-3:2014 Biological<br>evaluation of medical devices-<br>Part 3: Tests for genotoxicity,<br>carcinogenicity and reproductive<br>toxicity. | The difference between the<br>number of revertant colonies<br>of the subject device and the<br>negative control was<br>evaluated. | No backward<br>mutation in<br>salmonella<br>typhimurium. |
| In Vitro Mammalian<br>Cell Gene Mutation | Tested in accordance with ISO<br>10993-3:2014 Biological<br>evaluation of medical devices-<br>Part 3: Tests for genotoxicity,<br>carcinogenicity and reproductive<br>toxicity. | The difference between the<br>mutation frequency of the<br>subject device and the<br>negative control was<br>evaluated. | Non-mutagenic to<br>TK+/--3.7.2C<br>Subline of L5178Y<br>cell. |

{10}------------------------------------------------

{11}------------------------------------------------

## 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 <85>. 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.