PRIMI SUPPORT CATHETER

K132701 · Thermopeutix, Inc. · DQY · Sep 26, 2013 · Cardiovascular

Device Facts

• Record ID: K132701
• Device Name: PRIMI SUPPORT CATHETER
• Applicant: Thermopeutix, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 26, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Indications for Use

The Primi™ Support Catheter is intended to be used in conjunction with guidewires in order to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The support catheter also may be used to selectively infuse/deliver physician specified diagnostic and/or therapeutic agents, such as sterile saline, contrast agents, vaso-dilators, anti-blastics, lytics, and anti-thrombotics, with or without a guidewire in position.

Device Story

Single-lumen support catheter; used in peripheral vasculature; facilitates guidewire placement/exchange; enables selective infusion of diagnostic/therapeutic agents via luer hub. Features tapered tip for crossing; radiopaque marker for positioning; integral spine wire for support. Available in various diameters (0.014", 0.018", 0.035") and lengths (90-170 cm). Distal portion includes advanced hydrophilic coating for lubricity. Operated by physicians in clinical settings. Benefits include improved access to discreet vascular regions and reduced friction during insertion.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993), dimensional analysis, wire movement/compatibility, torque, kink resistance, hub leakage, peripheral model passage, coating durability/particulate analysis, radiopacity, injection pressure, flow rate, and tensile strength. All tests met specifications.

Technological Characteristics

Single-lumen catheter; Pebax hub/outer/distal shaft; HDPE inner shaft; stainless steel tapered core wire; platinum/iridium marker band. Advanced hydrophilic coating on distal portion. 5 Fr and 6 Fr sheath compatibility. Max injection pressure 300 psi. Sterilized for single use.

Indications for Use

Indicated for patients requiring access to peripheral vasculature for guidewire placement/exchange or selective infusion of diagnostic/therapeutic agents.

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

• ThermopeutiX Primi™ Support Catheter (K130850)

Submission Summary (Full Text)

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#### 510 (k) SUMMARY ·

#### Applicant

ThermopeutiX, Inc. 9951B Businesspark Avenue San Diego, California 92131 Phone: [phone] Fax: [phone]

#### Manufacturer

ThermopeutiX, Inc. 9951B Businesspark Avenue San Diego, California 92131 Phone: [phone] Fax: [phone]

2 6 2013

Contact Person

Jason Ford, Quality Assurance

Common Names: Support Catheter

Classification Name: Devices of this type are classified as Class II under 21 CFR Part CFR Part 870.1250, Percutaneous Catheter (Product Code DQY).

Proprietary Name: Primi™ Support Catheter

Predicate Devices

The ThermopeutiX Primi™ Support Catheter with the advanced hydrophilic coating is substantially equivalent in indications, design, construction and features to the ThermopeutiX Primi™ Support Catheter cleared under 510(k) K130850 with the exception of the hydrophilic coating.

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#### Indications for Use

There is no change in the indications for use for the Primi™ Support Catheter with the advanced hydrophilic coating. The existing Primi™ Support Catheter indications statement remains unchanged. The indications for use are as follows:

The Primi™ Support Catheter is intended to be used in conjunction with guidewires in order to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The support catheter also may be used to selectively infuse/deliver physician specified diagnostic and/or therapeutic agents, such as sterile saline, contrast agents, vaso-dilators, anti-blastics, lytics, and anti-thrombotics, with or without a guidewire in position.

#### Device Description

The ThermopeutiX Support Catheter that is the submission is a single lumen catheter with a radiopaque marker that aids in positioning the catheter and a tapered tip to facilitate entry. The catheter utilizes an integral spine wire. The catheter is available in several diameters and lengths which are 0.014", 0.018", or 0.035" guidewire compatible. The working lengths are 90 cm thru 170 cm. Reference Table 1 for model number availability. The distal portion of the catheter shaft has a hydrophilic coating to facilitate insertion. The device has a luer hub connector to allow infusion of diagnostic and/or therapeutic agents. The device is supplied sterile and is intended for single use only. Reference Table 2 below for physical and performance characteristics.

| PU14 -20-90 | PU14-40-90 | PU14 -60-90 | PU14 -80-90 | PU14 -100-90 | PU14 -120-90 |
|----------------|----------------|----------------|----------------|-----------------|-----------------|
| PU14 -20-90HF | PU14 -40-90HF | PU14 -60-90HF | PU14 -80-90HF | PU14 -100-90HF | PU14 -120-90HF |
| PU18-20-90 | PU18-40-90 | PU18-60-90 | PU18-80-90 | PU18-100-90 | PU18-120-90 |
| PU35-20-90 | PU35-40-90 | PU35-60-90 | PU35-80-90 | PU35-100-90 | PU35-120-90 |
| PU14 -20-130 | PU14 -40-130 | PU14 -60-130 | PU14 -80-130 | PU14 -100-130 | PU14 -120-130 |
| PU14 -20-130HF | PU14-40-130HF | PU14 -60-130HF | PU14 -80-130HF | PU14 -100-130HF | PU14 -120-130HF |
| PU18-20-130 | PU18-40-130 | PU18-60-130 | PU18-80-130 | PU18-100-130 | PU18-120-130 |
| PU35-20-130 | PU35-40-130 | PU35-60-130 | PU35-80-130 | PU35-100-130 | PU35-120-130 |
| PU14 -20-150 | PU14 -40-150 | PU14 -60-150 | PU14 -80-150 | PU14 -100-150 | PU14 -120-150 |
| PU14 -20-150HF | PU14 -40-150HF | PU14 -60-150HF | PU14 -80-150HF | PU14 -100-150HF | PU14 -120-150HF |
| PU18-20-150 | PU18-40-150 | PU18-60-150 | PU18-80-150 | PU18-100-150 | PU18-120-150 |
| PU35-20-150 | PU35-40-150 | PU35-60-150 | PU35-80-150 | PU35-100-150 | PU35-120-150 |
| PU14 -20-170 | PU14 -40-170 | PU14 -60-170 | PU14 -80-170 | PU14 -100-170 | PU14 -120-170 |
| PU14 -20-170HF | PU14 -40-170HF | PU14 -60-170HF | PU14 -80-170HF | PU14 -100-170HF | PU14 -120-170HF |
| PU18-20-170 | PU18-40-170 | PU18-60-170 | PU18-80-170 | PU18-100-170 | PU18-120-170 |
| PU35-20-170 | PU35-40-170 | PU35-60-170 | PU35-80-170 | PU35-100-170 | PU35-120-170 |

#### Table 1- Model Numbers for the Primi™ Support Catheter with the advanced hydrophilic coating

* The HF suffix indicates the high flow version

PUxx-yy-zzz, xx=guide wire size (0.014", 0.018", or 0.035")

yy=distal shaft length (20mm, 40mm, 60mm, 100mm, or 120mm) zzz=Overall catheter length (150cm or 170cm)

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| Element/Feature | ThermopeutiX Primi Support Catheters |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Working Length (s) | 90 cm - 170 cm; polymer shaft with integral spine wire |
| Distal Shaft Length (mm) | 20, 40, 60, 80, 100, 120 |
| Outside Diameter (s) | Distal:0.045" - 0.064"<br>Proximal: 0.060" - 0.080" |
| Lumen | One |
| Guide wire Compatibility | 0.014" - 0.035" |
| Distal End Configuration | Tapered tip for ease of crossing |
| Fluid connection | Luer hub connector |
| Flow rate @ 150 psi | 0.014" wire models > 0.80 cc/sec, Saline<br>0.035" wire models > 0.50 cc/sec, Saline<br>0.014" wire models > 0.30 cc/sec, Contrast<br>0.035 wire models > 0.15 cc/sec, Contrast |
| Maximum Injection Pressure | 300 psi |
| Hydrophilic Coating | Yes; distal portion, for lubricity |
| Radiopaque Markers | One |
| Sheath Compatibility | 5 Fr and 6 Fr |
| Catheter Materials | Hub-Pebax<br>Outer Shaft-Pebax<br>Inner Shaft-HDPE<br>Distal Shaft-Pebax w/radiopaque filler<br>Core Wire-Stainless Steel tapered wire<br>Coating-Hydrophilic proprietary coating |

## Table 2-Physical and Performance Characteristics

#### Technological Characteristics Comparison

The Primi™ Support Catheter with the advanced hydrophilic coating is identical in design and construction to the currently marketed Primi™ Support Catheter with the exception of the hydrophilic coating. The advanced hydrophilic coating provides comparable lubricity with a reduction in particulates. The coating is applied to the same portion of the candidate device as the predicate device. The coating thickness is considered equivalent between the candidate and predicate device.

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| | | | | | | | Table 3-Predicate Device Characteristics Comparison |
|--|--|--|--|--|--|--|-----------------------------------------------------|
| | | | | | | | |

| Table 3-Predicate Device Characteristics Comparison | | |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Element/Feature | ThermopeutiX Primi Support Catheter (This 510k) | ThermopeutiX Primi Support Catheter 510(k) K130850 |
| Working Length (s) | 90 cm – 170 cm; polymer shaft with integral spine wire | 90 cm – 170 cm; polymer shaft with integral spine wire |
| Outside Diameter (s) | Distal:0.045" – 0.064"<br>Proximal: 0.060" – 0.080" | Distal:0.045" – 0.064"<br>Proximal: 0.060" – 0.080" |
| Lumen | One | One |
| Guide wire Compatibility | 0.014"-0.035" | 0.014"-0.035" |
| Guide wire Use | Over the Wire | Over the Wire |
| Distal End Configuration | Tapered tip for ease of crossing | Tapered tip for ease of crossing |
| Fluid connection | Luer hub connector | Luer hub connector |
| Flow rate @ 150 psi w/Saline | 0.014" wire models > 0.80 cc/sec<br>0.035" wire models > 0.50 cc/sec | 0.014" wire models > 0.80 cc/sec<br>0.035" wire models > 0.50 cc/sec |
| Flow rate @ 150 psi w/Contrast | 0.014" wire models > 0.30 cc/sec<br>0.035" wire models > 0.15 cc/sec | 0.014" wire models > 0.30 cc/sec<br>0.035" wire models > 0.15 cc/sec |
| Maximum Injection Pressure | Do not exceed 300 psi | Do not exceed 300 psi |
| Coating | Yes; advanced hydrophilic, distal portion | Yes; hydrophilic, distal portion |
| Coating Length | 65 cm, 115 cm or 140 cm<br>(lengths are the same as the predicate across all models) | 65 cm, 115 cm or 140 cm |
| Coating Thickness | Same as predicate | Proprietary |
| Radiopaque Markers | One | One |
| Sheath Compatibility | 5 Fr and 6 Fr | 5 Fr and 6 Fr |
| Materials Used | Hub-Pebax<br>Outer Shaft-Pebax<br>Inner Shaft-HDPE<br>Distal Shaft-Pebax w/radiopaque filler<br>Core Wire-Stainless Steel tapered wire<br>Coating-Advanced hydrophilic proprietary coating<br>Marker Band Platinum/Iridium | Hub-Pebax<br>Outer Shaft-Pebax<br>Inner Shaft-HDPE<br>Distal Shaft-Pebax w/radiopaque filler<br>Core Wire-Stainless Steel tapered wire<br>Coating-Hydrophilic proprietary coating<br>Marker Band Platinum/Iridium |

# Non-Clinical Tests

The non-clinical tests performed on sample devices are listed below. All testing passed internal protocol requirements and met product specifications. All of the requirements in the standards utilized were met.

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-Biocompatibility Testing (ISO10993-1)

-Cytotoxicity (ISO 10993-5)

-Sensitization (Guinea Pig Maximization ISO 10993-10)

-Irritation (ISO 10993-10)

-Systemic Toxicity (ISO 10993-11)

-Complement Activation (C3a and SC5b-9 ISO10993-4)

-Pyrogen (ISO 10993-11)

-Hemocompatibility (Hemolysis, Thromboresistance, Partial Thromboplastin Time (ISO

10993-4 and ASTM F2382)

-Device Functional Testing

-Dimensional

-Wire Movement/Compatibility

-Catheter Torque

-Catheter Kink

-Hub Leakage

-Peripheral Model Passage

-Coating Particulate

-Coating Durability/Integrity

-Radiopacity

-Maximum Injection Pressure

-Flow Rate Testing (wire in/wire out)

-Tensile Test (distal tip, distal tip to wire, distal shaft to proximal shaft, hub to shaft)

-Pouch Seal Integrity

-All performance testing was repeated on samples with a minimum of 10 month aging.

#### Conclusion

Based on the non-clinical testing results, the Primi™ Support Catheters with the advanced hydrophilic coating are substantially equivalent to the legally marketed device identified in this submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

September 26, 2013

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Thermopeutix, Inc. Mr. Jason Ford Quality Engineer 9951B Businesspark Avenue San Diego, CA 92131

Re: K132701

Trade/Device Name: Primi™ Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DOY Dated: July 30, 2013 Received: August 29, 2013

Dear Mr. Ford:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Bram D. Zuckerman -S

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

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ThermopeutiX, Inc. Special 510(k) Premarket Notification July 30, 2013

### INDICATIONS FOR USE STATEMENT

510(k) Number (If Known):

Device Name: Primi™ Support Catheter

Indications For Use:

The Primi™ Support Catheter is intended to be used in conjunction with guidewires in order to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The support catheter also may be used to selectively infuse/deliver physician specified diagnostic and/or therapeutic agents, such as sterile saline, contrast agents, vaso-dilators, anti-blastics, lytics, and anti-thrombotics, with or without a guidewire in position.

Prescription Use: (Part 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use: (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Bram D. Zuckerman -S 2013.09.26 20:13:14 -04