Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm

K152202 · Tni Manufacturing, Inc. · DQY · Dec 14, 2015 · Cardiovascular

Device Facts

• Record ID: K152202
• Device Name: Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm
• Applicant: Tni Manufacturing, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Intermediate Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Device Story

Intermediate Catheter is a variable stiffness, single-use, sterile, non-pyrogenic device; functions as a reinforcing conduit for other intravascular devices. Input: manual insertion through guide catheter or vascular sheath by physician. Operation: provides access to target site in peripheral and neuro vasculature. Construction: PTFE-lined lumen; stainless steel braid, stainless steel coil, and Nitinol coil reinforcement; hydrophilic coating; radiopaque Platinum/Iridium marker band. Output: physical access path for interventional devices. Clinical benefit: facilitates delivery of interventional tools to target vascular sites. Accessories include Tuohy-Borst hemostasis valve and split introducer sheath.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via biocompatibility (ISO 10993-1), sterilization (ISO 11135), radiographic detectability, visual inspection, working length, hub compatibility, dimensional analysis, leak testing (air/liquid), particulate testing (USP 788), catheter burst, tensile strength, corrosion resistance, and packaging integrity (ASTM F1929-12, ASTM F88-09). All samples met acceptance criteria.

Technological Characteristics

Variable stiffness catheter; PTFE-lined lumen; stainless steel braid, stainless steel coil, and Nitinol coil reinforcement; hydrophilic coating; Platinum/Iridium marker band. Dimensions: 105/115/125 cm lengths; 0.060" ID; 0.072" distal/0.078" proximal OD. Sterilization: Ethylene Oxide. Standards: ISO 10993-1, ISO 11135, ISO 10555-1, ISO 594-1/2, USP 788, ASTM F1929-12, ASTM F88-09.

Indications for Use

Indicated for the introduction of interventional devices into the peripheral and neuro vasculature in patients requiring such access.

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

• 5MAXTM DDC Distal Delivery Catheters (K122772)

Submission Summary (Full Text)

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

Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

December 14, 2015

TNI Manufacturing, Inc. % Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K152202

Trade/Device Name: Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, DYB, DTL Dated: November 19, 2015 Received: November 23, 2015

Dear Mr. Job:

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

{1}------------------------------------------------

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.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Carlos L. Pena -S/^

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K152202

Device Name Intermediate Catheter

Indications for Use (Describe)

The Intermediate Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

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 [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

#### Submitter's Name and Address

TNI Manufacturing, Inc. 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: [phone] Facsimile: 1-954-742-5989

#### Contact Information

Daniel Sablyak President 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: [phone] Facsimile: 1-954-742-5989 E-Mail: [e-mail]

### Date Prepared

November 16, 2015

### Device Trade or Proprietary Name

Intermediate Catheter Hemostasis Valve Split Sheath Introducer

### Device Common or Classification Name:

Catheter, Percutaneous, 21CFR870.1250, Class II Hemostasis Valve, 21CFR870.4290, Class II Catheter Introducer, 21CFR870.1340, Class II

#### Product Code:

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

DQY (Catheter)

DTL (Hemostasis Valve)

DYB (Catheter Dilator)

## Identification of the Legally Marketed Devices to which Equivalence is Being Claimed

| Name of Predicate Device | Name of Manufacturer | 510(k) Number |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| 5MAXTM DDC<br>Distal Delivery Catheters | Penumbra, Inc.<br>Alameda, California | K122772 |
| | Predicate Device<br>Penumbra 5MAXTM<br>DDC | Intermediate Catheter |
| 510(k) Number | K122772 | K152202 |
| Classification | 21CFR870.1250, Class II | Same |
| Product Code | DQY | Same |
| Indication For Use | The DDC Catheters are<br>indicated for the<br>introduction of<br>interventional devices into<br>the peripheral and neuro<br>vasculature. | The Intermediate Catheter is<br>indicated for the<br>introduction of<br>interventional devices into<br>the peripheral and neuro<br>vasculature. |
| Inner Lumen | PTFE | PTFE |
| Catheter Shaft<br>Material | Nylon, PTFE,<br>polyurethane,<br>hydrophilic coating | Nylon, PTFE, polyimide,<br>polyether block amide, PET,<br>polycarbonate/urethane<br>hydrophilic coating |
| Hub Material | Polycarbonate | Same |
| Catheter Shaft<br>Reinforcement | Stainless Steel/Nitinol | Same |
| Marker Band | Platinum/Iridium | Same |
| Packaging | Tyvek Pouch,<br>polyethylene support<br>hoop, packaging card,<br>SBS Carton | Same |
| Sterilization | Ethylene Oxide | Same |
| Pyrogenicity | Nonpyrogenic | Same |
| Inside Diameter (ID) | 0.062" | Same |
| Outside Diameter<br>(OD) | 6 Fr | Same |
| Working Lengths (cm) | 115 and 125 cm | 105, 115, and 125 cm |
| | Predicate Device<br>Penumbra 5MAX™<br>DDC | Intermediate Catheter |
| Compatible Guidewire | 0.038" | Same |

### Device Description

The Intermediate Catheter is a variable stiffness catheter and has a catheter shaft reinforced with a stainless steel braid, a stainless steel coil, a Nitinol coil, and has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a nominal distal outer diameter of 0.072" and a nominal proximal outer diameter of 0.078". It is available with a nominal inner diameter of 0.060". They are available in three working lengths, 105 cm, 115 cm. and 125 cm. The Intermediate Catheters have a PTFE-lined lumen, which is braid and coil reinforced, flexible, and has a hydrophilic coating. The Intermediate Catheters are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve and a split introducer sheath. The Intermediate Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

### Indications For Use

The Intermediate Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

### Comparison to Predicate Device

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

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

### Summary of Non Clinical Data

Biocompatibility tests conducted with the Intermediate Catheters and accessories were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for limited duration (<24 hours), external communicating devices, contacting circulating blood. Studies were conducted pursuant to 21CFR58, Good Laboratory Practices. Biocompatibility testing found the Intermediate Catheters to be biocompatible non-pyrogenic. and

The conclusions drawn from the physical, mechanical, and performance testing of the subject Intermediate Catheter and accessories demonstrates that the product is as safe and as effective for its labeled indications and is Substantially Equivalent to the legally marketed predicate device.

| Test | Test Method<br>Summary | Results |
|-------------------------------|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Biocompatibility | Testing completed<br>per ISO 10993-1 | All units tested must meet the acceptance<br>criteria. All samples met the acceptance<br>criteria. |
| Sterilization<br>Validation | Testing completed<br>per ISO 11135 | All units tested must meet the acceptance<br>criteria. All samples met the acceptance<br>criteria. |
| Radiographic<br>Detectability | Testing completed<br>per ISO 10555-1 | All units tested must meet the acceptance<br>criteria. All samples met the acceptance<br>criteria. |
| Visual Inspection | Testing completed<br>per ISO 10555-1 | All units tested must meet the acceptance<br>criteria. All samples met the acceptance<br>criteria. |
| Test | Test Method<br>Summary | Results |
| Working Length | Testing completed<br>per ISO 10555-1 | All units tested must meet the acceptance<br>criteria. All samples met the acceptance<br>criteria. |
| Hub compatibility | Testing completed<br>per ISO 594-1 and<br>ISO 594-2 | All units tested must meet the acceptance<br>criteria. All samples met the acceptance<br>criteria. |
| Outside diameter | Testing completed<br>per ISO 10555-1 | All units tested must meet the acceptance<br>criteria. All samples met the acceptance<br>criteria. |
| Leak — Air | Testing completed<br>per ISO 10555-1 | All units tested must meet the acceptance<br>criteria. All samples met the acceptance<br>criteria. |
| Leak — Liquid | Testing completed<br>per ISO 10555-1 | All units tested must meet the acceptance<br>criteria. All samples met the acceptance<br>criteria. |
| Particulates | Testing completed<br>per USP 788 | All units tested must meet the acceptance<br>criteria. All samples met the acceptance<br>criteria. |
| Catheter Burst | Testing completed<br>per ISO 10555-1 | All units tested must meet the acceptance<br>criteria. All samples met the acceptance<br>criteria. |
| Tensile | Testing completed<br>per ISO 10555-1 | All units tested must meet the acceptance<br>criteria. All samples met the acceptance<br>criteria. |
| Corrosion | Testing completed<br>per ISO 10555-1 | All units tested must meet the acceptance<br>criteria. All samples met the acceptance<br>criteria. |
| Packaging - Dye<br>Leak | Testing completed<br>per ASTM F1929-<br>12 | All units tested must meet the acceptance<br>criteria. All samples met the acceptance<br>criteria. |
| Packaging - Peel | Testing completed<br>per ASTM F88-09 | All units tested must meet the acceptance<br>criteria. All samples met the acceptance<br>criteria. |

Intermediate Catheter Performance Testing

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