Z FLEX-270TM STEERABLE SHEATH

K112541 · Great Batch Medical · DRA · Feb 7, 2012 · Cardiovascular

Device Facts

• Record ID: K112541
• Device Name: Z FLEX-270TM STEERABLE SHEATH
• Applicant: Great Batch Medical
• Product Code: DRA · Cardiovascular
• Decision Date: Feb 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1280
• Device Class: Class 2

Intended Use

The Z°Flex-270™ Steerable Sheath is intended to facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature, and into the chambers of the heart.

Device Story

The Z°Flex-270™ Steerable Sheath is a 12 Fr percutaneous device designed for vascular and cardiac access. It consists of a shaft and a handle with a rotating mechanism for uni-directional tip deflection. The kit includes a dilator and guidewire. Used by clinicians in a clinical setting, the device facilitates the placement of diagnostic or therapeutic catheters. The operator manually controls the sheath's deflection via the handle to navigate the vasculature. By providing a steerable pathway, the device assists in the precise positioning of catheters, potentially improving procedural efficiency and patient outcomes during cardiac or vascular interventions.

Clinical Evidence

Bench testing only. Testing included sterilization (ISO 11135-1), shelf life, packaging, and mechanical performance (hemostasis valve leak per ISO 11070, deflection, air aspiration, fatigue, tip robustness, kink resistance, torque, tensile, dilator-to-sheath retention, and guidewire testing per ISO 11070). Biocompatibility testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemolysis, PTT, platelet/leukocyte counts, complement activation, and 4-hour in-vivo thrombosis. Results confirmed the device met all functional and performance specifications.

Technological Characteristics

12 Fr percutaneous steerable sheath; uni-directional adjustable tip geometry; rotating handle deflection mechanism. Includes dilator and guidewire. Mechanical construction; non-powered. Biocompatibility testing per ISO 10993 standards. Sterilization per ISO 11135-1.

Indications for Use

Indicated for transvenous introduction of diagnostic or therapeutic catheters into the vasculature and heart chambers.

Regulatory Classification

Identification

A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

Predicate Devices

• Medtronic FlexCath Steerable Sheath and Dilator (K102176)

Submission Summary (Full Text)

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# <112541

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FEB - 7 2012

## 510(k) Summary

#### Applicant Information 1.0

Applicant:

Facility Establishment Registration Number:

Submitter:

Contact Person: Date Prepared:

Greatbatch Medical 2183787

Greatbatch Medical · 2300 Berkshire Lane North Minneapolis, MN 55441 [phone] (Phone) [phone] (Fax)

Sara Bakker August 31, 2011

#### 2.0 Device Information

Trade Name: Common Name: Classification Name: Product Code: Regulation: Classification Panel:

Z°Flex-270™ Steerable Sheath Steerable Catheter Catheter, Steerable DRA Class II 21 CFR 870.1280 Cardiovascular

#### 3.0 Predicate Device

The subject device is equivalent to the following device:

- K102176 Medtronic FlexCath Steerable Sheath and Dilator .

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#### 4.0 Description of Device

The Z°Flex-270™ Steerable Sheath is a 12 Fr percutaneous steerable sheath with a flexible tip designed for gaining access to the vasculature including the coronary systems. It is comprised of two (2) main sections: the shaft and the handle. The Z°Flex-270 Steerable Sheath has uni-directional adjustable tip geometry with a rotating mechanism on the handle used to control sheath deflection. A dilator and guidewire are included with each kit.

#### 5.0 Indications for Use

The Z°Flex-270™ Steerable Sheath is indicated for use to facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature and into the chambers of the heart.

#### 6.0 Predicate Device Comparison / Technological Characteristics

The Z°Flex-270™ Steerable Sheath has similar indications for use, technological characteristics and identical principles of operation compared to the predicate Medtronic FlexCath Steerable Sheath (K102176). ZºFlex-270 indications for use differ from FlexCath in that Z°Flex-270 is intended for venous access only. Z°Flex-270 also differs slightly in the design of the deflection mechanisms and includes a guidewire, provided for convenience in the steerable sheath kit for convenience. Performance (bench) testing and biocompatibility testing were performed to demonstrate that the proposed device performs as intended and does not raise new questions of safety or efficacy compared to the predicate device.

#### 7.0 Description of Safety and Substantial Equivalence

To verify that the Z°Flex-270™ Steerable Sheath design met its functional and performance requirements, representative finished, sterilized samples of the subject device underwent the following testing, biocompatibility, sterilization, packaging, mechanical testing and shelf-life testing in accordance with applicable industry standards and FDA guidance.

Testing included:

- Sterilization testing per ISO 11135-1 .
- Shelf Life .
- Packaging .
- Performance (Bench) testing: .
- Visual
- Dimensional
- · Functional
- . Hemostasis valve leak testing (per ISO 11070)
- Deflection testing .
- . Air aspiration and hemostasis
- . Fatigue testing (deflection)

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- Sheath tip robustness testing after multiple catheter . deployment/retractions
- Kink resistance .
- Torque .
- Tensile testing .
- Dilator to sheath retention .
- Guidewire testing per ISO 11070 ●

Biocompatibility testing for the subject device included:

- Cytotoxicity .
- � Sensitization
- Irritation/Intracutaneous Reactivity .
- Acute Systemic Toxicity .
- Materials Mediated Rabbit Pvrogen .
- . Hemolysis
- Partial Thromboplastin Time
- . Platelet and Leukocyte Counts
- . Complement Activation
- Thrombosis (In-vivo) 4 hour contact .
- Testing for Latex, DEHP, and Bisphenol A .

Conclusion: Test results demonstrate that the Z°Flex-270 Steerable Sheath met all specifications per functional and performance requirements. The device performs as intended and does not raise any new questions of safety or efficacy.

#### 8.0 Statement of Equivalence

The Z°Flex-270 Steerable Sheath has similar indications for use, technological characteristics and identical principles of operation compared to the predicate Medtronic FlexCath Steerable Sheath. Based on these similarities, in addition to the results from safety and performance testing, ZºFlex-270 Steerable Sheath is considered substantially equivalent to the Medtronic FlexCath Steerable Sheath (K102176).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

FEB - 7 2012

Greatbatch Medical c/o Ms. Sara Bakker Senior Regulatory Affairs Specialist 2300 Berkshire Lane N Minneapolis, MN 55441

Re: K112541

> Trade Name: ZºFlex-270TM Steerable Sheath Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: II (two) Product Code: DRA Dated: November 30, 2011 Received: December 1, 2011

Dear Ms. Bakker:

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.

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Page 2 - Ms. Sara Bakker

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance: 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

וכר

Sincerely yours,

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

Enclosures

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## Indications for Use Statement

510(k) Number (if known):_K|| 254 l

Device Name: Z°Flex-2707M Steerable Sheath

Indications for Use:

The Z°Flex-270TM Steerable Sheath is intended to facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature, and into the chambers of the heart.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Division Sign Off

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K112541