Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and bench testing of a microcatheter, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

No.
The device is a microcatheter intended for infusion of substances (contrast, drug, embolic materials) and does not inherently provide therapy itself. The therapy comes from the infused substance.

Diagnostic

No

The device is intended for the infusion of substances (contrast media, drugs, embolic materials), which are therapeutic or facilitate imaging, rather than for the direct acquisition or analysis of diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components such as a catheter shaft, inner and outer liners, a stainless steel coil, a hub, and a radiopaque marker band, indicating it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
Device Function: The IntraNovo Microcatheter is an infusion catheter intended for intravascular use. It is used to deliver substances (contrast media, drugs, embolic materials) directly into blood vessels within the body.
Lack of Specimen Examination: The device does not examine any specimens derived from the human body outside of the body. Its function is to deliver substances into the body.

Therefore, based on the provided information, the IntraNovo Microcatheter is a medical device used for therapeutic and diagnostic procedures performed in vivo (within the living body), not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The IntraNovo Microcatheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremittes, and all coronary vessels. The Microcatheter is also intended for drug infusion in intra-arterial therapy and infusion of embolic materials for hemostasis. The Microcatheter should not be used in cerebral vessels.

Product codes

DQO

Device Description

The IntraNovo Microcatheter (the "IntraNovo 21" or the "Microcatheter") is an infusion catheter intended for intravascular use. The Microcatheter consists of a single lumen. The shaft consists of a lubricous inner liner made from polytetrafluoroethylene (PTFE) with a stainless steel coil over the inner liner. The outer liner consists of different lengths of colored polyether block amide with varying durometers hardness. A lubricious hydrophilic coating covers the distal end of the IntraNovo Microcatheter. One radiopaque marker band is placed at the distal end of the Microcatheter and above the stainless steel coil. A polycarbonate hub is attached to the proximal end of the Microcatheter with a strain relief placed over the distal end of the hub.
The device shaft has an outer diameter of 2.9 French size on the proximal end and 2.4 French size on the distal end with an inner diameter of 0.021" throughout the shaft. The device is available in lengths of 110 cm and 130 cm.
The following accessories are included with the Microcatheter: a stainless steel steam shaping mandrel to allow for manual shaping of the distal tip and a 3.0 mL syringe.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Peripheral, coronary; Peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremittes, and all coronary vessels. The Microcatheter should not be used in cerebral vessels.

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

The following bench tests were performed to evaluate the design elements and performance characteristics of the IntraNovo Microcatheter and to demonstrate substantial equivalence to the predicate device. The IntraNovo Microcatheter met the predetermined acceptance criteria. Testing was performed on non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2). Tests results show that the IntraNovo Microcatheter is substantially equivalent to the predicate device.
Study Type: Bench Tests
Sample Size: Not specified, but tests were performed on non-aged devices (T=0) and devices subject to 2 years of accelerated aging (T=2).
Key Results: All tests passed for both T=0 and T=2 conditions, demonstrating substantial equivalence to the predicate device.

Key Metrics

Not Found

Predicate Device(s)

K142817

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 13, 2016

Texas Medical Technologies, Inc. % E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K153125

Trade/Device Name: IntraNovo Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: December 10, 2015 Received: December 14, 2015

Dear E.J. Smith:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

Device Name IntraNovo Microcatheter

Indications for Use (Describe)

The IntraNovo Microcatheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremittes, and all coronary vessels. The Microcatheter is also intended for drug infusion in intra-arterial therapy and infusion of embolic materials for hemostasis. The Microcatheter should not be used in cerebral vessels.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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:

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510(k) Summary

1. Company Information & Contact Person

| Company Name:
Company Address | Texas Medical Technologies, Inc
9005 Montana Ave. Ste. A
El Paso, Texas 79925 |
|----------------------------------|-------------------------------------------------------------------------------------|
| Telephone:
Fax: | (915) 774-4321
(915) 774-4323 |
| Date Prepared: | 10/20/2015 |

1. Device Name & Classification

Proprietary Name:	IntraNovo Microcatheter
Common Name:	Microcatheter
Classification Name:	Diagnostic Intravascular Catheter
Regulation Number:	21 CFR 870.1200
Product Code:	DQO
Device Class:	Class II

1. Predicate Device

Proprietary Name:	IntraNovo 25 Microcatheter
Company Name:	Texas Medical Technologies, Inc.
Common Name:	Microcatheter
Classification Name:	Diagnostic Intravascular Catheter
Regulation Number:	21 CFR 870.1200
Product Code:	DQO
Device Class:	Class II
510(k) Number:	K142817

4. Device Description

The IntraNovo Microcatheter (the "IntraNovo 21" or the "Microcatheter") is an infusion catheter intended for intravascular use. The Microcatheter consists of a single lumen. The shaft consists of a lubricous inner liner made from polytetrafluoroethylene (PTFE) with a stainless steel coil over the inner liner. The outer liner consists of different lengths of colored polyether block amide with varying durometers hardness. A lubricious hydrophilic coating covers the distal end of the IntraNovo Microcatheter. One radiopaque marker band is placed at the distal end of the Microcatheter and above the stainless steel coil. A polycarbonate hub is attached to the proximal end of the Microcatheter with a strain relief placed over the distal end of the hub.

4

The device shaft has an outer diameter of 2.9 French size on the proximal end and 2.4 French size on the distal end with an inner diameter of 0.021" throughout the shaft. The device is available in lengths of 110 cm and 130 cm.

The following accessories are included with the Microcatheter: a stainless steel steam shaping mandrel to allow for manual shaping of the distal tip and a 3.0 mL syringe.

| Design &
Development
Model
Number | Commercial
Model
Number | Shaft
Length
(cm) | Outer Diameter | | Inner
Diameter | Marker Band
Configuration | Tip Shape |
|--------------------------------------------|-------------------------------|-------------------------|----------------|---------|-------------------|------------------------------|-------------------------|
| SMC-21110-1S | MC-2411-1SN | 110 | 2.7 Fr. | 2.9 Fr. | 0.025" | 1 Marker Band | Straight
(shapeable) |
| SMC-21130-1S | MC-2413-1SN | 130 | 2.7 Fr. | 2.9 Fr. | 0.025" | 1 Marker Band | Straight
(shapeable) |

Table 4.1 IntraNovo Microcatheter Models and Sizes

1. Indications for Use
  The IntraNovo Microcatheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, and all coronary vessels. The Microcatheter is also intended for drug infusion in intra-arterial therapy and infusion of embolic materials for hemostasis. The Microcatheter should not be used in cerebral vessels.
Predicate Product Comparison Table 6.

| Technical
Characteristics /
Principle of
Operation | IntraNovo
Microcatheter | IntraNovo 25
Microcatheter
(Predicate) | Comments |
|-------------------------------------------------------------|----------------------------------------|----------------------------------------------|--------------------------|
| 510(k) Number | | K142817 | |
| Length | 100cm - 130cm | 100cm -130 cm-
150cm | Same |
| Outer Diameter | Distal: 2.4 Fr.
Proximal 2.9 Fr. | Distal: 2.7 Fr.
Proximal 2.9 Fr. | Different 1
Identical |
| Inner Diameter | 0.021" | 0.025" | Different 2 |
| Maximum Pressure | 5,171 kPa (750 psi) | 5,171 kPa (750 psi) | Identical |
| Distal Curve | Straight (shapeable) | Straight
(shapeable) | Identical |
| Inner Liner
Material | Polytetraflouroethyl
ene
(PTFE)* | Polytetraflouroethy
lene
(PTFE)* | Identical |
| Coil Reinforcement
Material | Stainless Steel* | Stainless Steel* | Identical |

5

Radiopaque Marker	Platinum/Iridium*	Platinum/Iridium*	Identical
Outer Shaft
Material	Polyether Block
Amide*	Polyether Block
Amide*	Identical
Luer Material	Polycarbonate*	Polycarbonate*	Identical
Luer Connector	Female Luer
Connector*	Female Luer
Connector*	Identical
Hydrophilic Coated	Yes*	Yes*	Identical
Anatomical Site
Use	Peripheral,
Coronary	Peripheral,
Coronary	Identical
Supplied
Accessories	Shaping Mandrel,
Injection Syringe	Shaping Mandrel,
Injection Syringe	Identical
Delivery to Site	Over-the-wire	Over-the-wire	Identical
Guidewire
Compatibility	Maximum 0.018"	Maximum 0.021"	Different 3
Packaging	Polyethylene Hoop
and Tyvek Pouch	Polyethylene Hoop
and Tyvek Pouch	Identical
Sterilization	EtO Gas	EtO Gas	Identical

7. Discussion of Technological Characteristics

Both devices are equivalent with respect to their indications for use, fundamental design, technology and principles of operation, materials, performance, sterilization, and packaging.

The IntraNovo Microcatheter does differ from the predicate in outer diameter of 2.4 fr versus predicate's 2.7 fr, inner diameter of 0.021" versus the predicate's 0.025" and guidewire compatibility of a maximum 0.018" versus the predicate's 0.021". The following is a discussion of why no new issues of safety and effectiveness have been raised by these differences:

1. Difference on the distal outer diameter does not impact the product performance or modifies the intended use. The smaller size is intended to reach smaller target vessels in the anatomy. The Microcatheter's instructions for use indicate the minimum sizes of devices compatible with the Microcatheter outer diameter. This difference does not raise any new issues of safety and effectiveness.
1. Difference on the inner diameter does not impact on the product performance or modifies the intended use. The smaller size is intended to reach smaller target vessel in the anatomy. The Microcatheter's instructions for use indicate the maximum sizes of therapeutic agents compatible with the Microcatheter inner diameter. This difference does not raise any new issues of safety and effectiveness.
1. Difference in the guidewire compatibility does not impact on the product performance or modifies the intended use. Device lumen is smaller and therefore the maximum guidewire compatible is smaller. This difference does not raise any new issues of safety and effectiveness.

8. Testing Summary

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The following bench tests were performed to evaluate the design elements and performance characteristics of the IntraNovo Microcatheter and to demonstrate substantial equivalence to the predicate device. The IntraNovo Microcatheter met the predetermined acceptance criteria. Testing was performed on non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2). Tests results show that the IntraNovo Microcatheter is substantially equivalent to the predicate device.

| Test

| Test Name | Applicable

Standard or
Internal Test
Method | Test
Results
(T=0)
and
(T=2) |
|-----------|---------------------------------------------|------------------------------------------------------|------------------------------------------|
| 1 | Guidewire & Guide
Catheter Compatibility | Internal Test
Method | T=0 Pass
T=2 Pass |
| 2 | In-Vitro Track Force | Internal Test
Method | T=0 Pass
T=2 Pass |
| 3 | Durability of Hydrophilic
Coating | Internal Test
Method | T=0 Pass
T=2 Pass |
| 4 | Lubricity of Hydrophilic
Coating | Internal Test
Method | T=0 Pass
T=2 Pass |
| 5 | Tip Shape Retention | Internal Test
Method | T=0 Pass
T=2 Pass |
| 6 | Static Burst Pressure | ISO 10555 | T=0 Pass
T=2 Pass |
| 7 | Dimensional & Physical
Attributes | ISO 10555 | T=0 Pass
T=2 Pass |
| 8 | Corrosion Resistance | ISO 10555 | T=0 Pass
T=2 Pass |
| 9 | Dynamic Burst Pressure | Internal Test
Method | T=0 Pass
T=2 Pass |
| 10 | Air Leak | Internal Test
Method | T=0 Pass
T=2 Pass |
| 11 | Liquid Leakage | Internal Test
Method | T=0 Pass
T=2 Pass |
| 12 | Tensile Strength | ISO 10555 | T=0 Pass
T=2 Pass |
| 13 | Flow Rate | Internal Test
Method | T=0 Pass
T=2 Pass |
| 14 | Kink Resistance | Internal Test
Method | T=0 Pass
T=2 Pass |
| 15 | Radiopacity | ASTM-F640-12 | T=0 Pass
T=2 Pass |
| 16 | Torque to Failure | Internal Test
Method | T=0 Pass
T=2 Pass |
| 17 | Catheter Stiffness | Internal Test
Method | T=0 Pass
T=2 Pass |
| 18 | Packaging Integrity | ASTM F-88-09
ASTM-1929-98 | T=0 Pass
T=2 Pass |
| 19 | Therapeutic Agents | Internal Test
Method | T=0 Pass
T=2 Pass |

9. Bench Testing Table

Table 7.1. Bench Testing Performed on the IntraNovo Microcatheter.
--------------------------------------------------------------------	--

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| 20 | Female Luer Hub
Verification | ISO 594 | T=0 Pass
T=2 Pass |
|----|-------------------------------------------|-------------------------|----------------------|
| 21 | Shipping and Transportation
Simulation | ISTA 3PA | T=0 Pass
T=2 Pass |
| 22 | Coating Integrity | Internal Test
Method | T=0 Pass
T=2 Pass |
| 23 | Torque Response | Internal Test
Method | T=0 Pass
T=2 Pass |
| 24 | Particulate Evaluation | USP | T=0 Pass
T=2 Pass |

10. Biocompatibility

The IntraNovo Microcatheter is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (