LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM

K152876 · Tni Manufacturing, Inc. · DQY · Jan 8, 2016 · Cardiovascular

Device Facts

• Record ID: K152876
• Device Name: LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM
• Applicant: Tni Manufacturing, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Device Story

Long Sheath is a variable stiffness, braid-reinforced catheter designed to provide a conduit for interventional devices into peripheral, coronary, and neuro vasculature. Device features a PTFE-lined lumen, hydrophilic coating, and distal radiopaque Platinum/Iridium marker band. Available in 70, 80, and 90 cm lengths with 0.088-inch inner diameter. Supplied with a Tuohy-Borst hemostasis valve and vessel dilator. Used by clinicians to facilitate access to target sites; inserted through a guide catheter or vascular sheath. Provides a stable, reinforcing pathway for secondary intravascular devices. Single-use, sterile, non-pyrogenic device.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included biocompatibility (ISO 10993-1), radiographic detectability, visual inspection, working length, hub compatibility (ISO 594-1/2), dimensional verification, leak testing (air/liquid), particulate matter (USP 788), catheter burst, tensile strength, corrosion resistance, and packaging integrity (ASTM F1929-12, ASTM F88-09). All tests met acceptance criteria.

Technological Characteristics

Variable stiffness catheter; PEBAX shaft with stainless steel braid reinforcement; PTFE-lined lumen; hydrophilic coating; Platinum/Iridium distal marker band; Polycarbonate hub; Polyolefin strain relief. Dimensions: 0.109" OD, 0.088" ID, 70-90 cm lengths. Sterilized via Ethylene Oxide. Complies with ISO 10555-1, ISO 594-1/2, and ISO 10993-1.

Indications for Use

Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature for 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

• NEURON MAX SYSTEM (K111380)

Submission Summary (Full Text)

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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 text "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

January 8, 2016

TNI Manufacturing, Inc. Ms. Marianne Grunwaldt Director, Quality Assurance & Regulatory Affairs 4635 NW 103td Avenue Sunrise. Florida 33351

Re: K152876

Trade/Device Name: Long Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 3, 2015 Received: December 7, 2015

Dear Ms. Grunwaldt:

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

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

Sincerely yours,

Carlos L. Pena AS

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

Enclosure

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# Indications for Use

510(k) Number (if known) K152876

Device Name Long Sheath

Indications for Use (Describe)

The Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasulature.

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)

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# 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

Marianne Grunwaldt Director, Quality Assurance & Regulatory Affairs InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: [phone] Facsimile: 1-954-742-5989 E-Mail: [e-mail]

### Date Prepared

September 25, 2015

#### Device Trade or Proprietary Name

Long Sheath or LS

## Device Common or Classification Name:

Catheter, Percutaneous, 21CFR870.1250, Class II

### Product Code:

DQY

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

| Name of Predicate Device | Name of Manufacturer | 510(k) Number |
|--------------------------|---------------------------------------|---------------|
| NEURON MAX SYSTEM | Penumbra, Inc.<br>Alameda, California | K111380 |

### Device Description

The Long Sheath or LS is a variable stiffness catheter and has a catheter shaft reinforced with a stainless steel braid and has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a nominal outer diameter of 0.109 inches. It is available with a nominal inner diameter of 0.088 inches. They are available in three working lengths: 70 cm, 80 cm, and 90 cm. The Long Sheath has a PTFE-lined lumen, which is braidreinforced, flexible, and has a hydrophilic coating. The LS are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provide a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a dilator. The LS is supplied sterile, non-pyrogenic, and intended for single use only.

### Indications for Use

The Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

| | Predicate Device<br>Penumbra NEURON<br>MAX SYSTEM | TNI Manufacturing, Inc.<br>Long Sheath |
|----------------|---------------------------------------------------|----------------------------------------|
| 510(k) Number | K111380 | K152876 |
| Classification | 21CFR870.1250, Class II | 21CFR870.1250, Class II |
| Product Code | DQY | DQY |

## Comparison to Predicate Device

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| Review Panel | Cardiovascular | Cardiovascular |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication For Use | The Neuron™ MAX<br>System is indicated for the<br>introduction of<br>interventional devices into<br>the peripheral, coronary,<br>and neuro vasculature. | The Long Sheath is<br>indicated for the<br>introduction of<br>interventional devices into<br>the peripheral, coronary,<br>and neuro vasculature. |
| Components Supplied | Sheath, Vessel Dilator,<br>Hemostasis Valve, | Sheath, Vessel Dilator,<br>Hemostasis Valve |
| Catheter Shaft<br>Material | Nylon, Polyurethane | Polyether Block Amide,<br>(PEBAX) |
| Inner Liner | PTFE | PTFE |
| Hub Material | Polycarbonate | Polycarbonate |
| Strain Relief | Polyolefin | Polyolefin |
| Catheter Shaft<br>Reinforcement | Stainless Steel Braid | Stainless Steel Braid |
| Lubricious Coating | Hydrophilic Coating | Hydrophilic Coating |
| Radiopaque Marker<br>Band | Platinum/ Iridium | Platinum/ Iridium |
| Packaging | Tyvek Pouch,<br>polyethylene support tube,<br>packaging card, SBS<br>carton | Tyvek/Nylon Pouch,<br>polyethylene support tube,<br>packaging card, SBS carton |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Pyrogenicity | Nonpyrogenic | Nonpyrogenic |
| Working Lengths | 70, 80, 90, and 100 cm | 70, 80, 90 cm |
| Internal Diameter | 0.088 inches | 0.088 inches |
| Outer Diameter | 0.108 inches | 0.109 inches |
| Shelf Life | 3 years | 3 years |
| Vessel Dilator | Aid in sheath introduction<br>during procedure | Aid in sheath introduction<br>during procedure |
| Hemostasis Valve | Minimizes blood loss | Minimizes blood loss |
| Luer Tapered Hub | Yes | Yes |

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### Summary of Non Clinical Data

Biocompatibility tests conducted with the Long Sheath 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 Long Sheath to be biocompatible and non-pyrogenic.

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

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

Long Sheath Performance Testing

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