HEARTSPAN STEERABLE INTRODUCER KIT

K132164 · Merit Medical Systems, Inc. · DYB · Sep 17, 2013 · Cardiovascular

Device Facts

• Record ID: K132164
• Device Name: HEARTSPAN STEERABLE INTRODUCER KIT
• Applicant: Merit Medical Systems, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 17, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The HeartSpan™ Steerable Introducer Kit is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Device Story

HeartSpan™ Steerable Introducer Kit facilitates catheter introduction into cardiac anatomy. Components include steerable sheath, dilator, and guide wire. Sheath features hemostasis valve to minimize blood loss, sideport for aspiration/infusion/pressure monitoring, and handle with rotating knob for >180° tip deflection (10-56 mm radius). Radiopaque tip marker aids fluoroscopic visualization. Used in hospitals/healthcare facilities by clinicians. Device is sterile, single-use. Sheath wall encapsulates stainless steel braid reinforcement and deflection wires. Provides access to left heart via interatrial septum.

Clinical Evidence

Bench testing only. Verification testing included tip articulation, leak resistance, kink resistance, dimensional analysis, curve radius, marker band location, detachment force, and side hole performance. Biocompatibility testing performed per ISO 10993 standards (genotoxicity, cytotoxicity, irritation, sensitization, systemic toxicity). Sterilization validated per ISO 11135-1.

Technological Characteristics

Catheter introducer; 8.6F diameter; 74cm length. Materials: polymers with stainless steel braid reinforcement and deflection wires. Features: hemostasis valve, sideport with three-way stopcock, rotating knob for >180° bi-directional deflection. Radiopaque tip marker. Lubricious coating. Sterilized via ethylene oxide. Complies with ISO 10993, ISO 11070, and ISTA P2A standards.

Indications for Use

Indicated for patients requiring introduction of cardiovascular catheters into the heart, including left-sided access via the interatrial septum.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• HeartSpan™ Steerable Introducer Kit (K122431)

Submission Summary (Full Text)

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Merit Medical Systems, Inc. HeartSpan™ Steerable Introducer Kit Special 510(k)

Attachment A 510(k) Summary

## 510(k) Summary Correspondent Name: Merit Medical Systems, Inc. Address: 65 Great Valley Parkway Malvern, PA 19355 General Telephone Number: 610-651-5000 SEP 1 7 2013 Provisions Fax Number: 610-651-5003 Contact Person: Alina Stubbs Date of Preparation: July 08, 2013 Registration Number: 2529252 Trade Name: HeartSpan™ Steerable Introducer Kit Subject Common/Usual Name: Steerable Introducer Kit Device Classification Name: Catheter Introducer (21 CFR §870.1340) Trade Name: HeartSpan™ Steerable Introducer Kit Classification Name: Catheter Introducer (21 CFR §870.1340) Premarket Notification: K122431 Predicate Manufacturer: Merit Medical Systems, Inc. Device 65 Great Vallev Parkway Malvern, PA 19355 (formerly operating as Thomas Medical Products, Inc.) Class II 21 CFR §870.1340 Classification FDA Product Code: DYB Review Panel: Cardiovascular The HeartSpan™ Steerable Introducer Kit is indicated for introducing Intended Use various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

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Merit Medical Systems, Inc. HeartSpan™ Steerable Introducer Kit Special 510(k)

Device

Description

Attachment A 510(k) Summary

The HeartSpan™ Steerable Introducer set consists of a dilator, guide wire, and steerable sheath, which are designed for catheter introduction into the cardiac anatomy. The device is provided sterile (ethylene oxide) and intended for single use only. It is for use in hospitals or healthcare facilities.

The steerable introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer handle includes a rotating knob to enable clockwise and counterclockwise tip deflection >180° with a radius of 10 - 56 mm (measured at 180° deflection) . The steerable introducer also includes distal holes to facilitate aspiration and minimize cavitation, a radiopaque tip marker to improve fluoroscopic visualization, an atraumatic soft tip, and a lubricious coating on the inner and outer surfaces. The dilator is designed to conform to the inner diameter of the sheath, and has a tapered tip.

The materials of construction are primarily polymers with the exception of stainless steel braid reinforcement and deflection wires in the introducer shaft that are completely encapsulated in the sheath wall and do not contact the patient or bodily fluids.

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| Comparison to<br>Predicate | Technical<br>Characteristics | Predicate Device<br>(K122431) | Modified Device<br>(K132164) |
|--------------------------------------------------|------------------------------------------------------|------------------------------------------|--------------------------------------------|
| | Hemostasis valve provided | Yes | Yes |
| | Dilator to Guide wire<br>Compatibility | up to 0.038" | up to 0.038" |
| | Guide wire Design /<br>Dimensions | Standard<br>Non-Coated<br>0.038" x 135cm | Super-Stiff<br>with PTFE<br>0.032" x 180cm |
| | Compatibility with<br>Standard Transseptal<br>Needle | Yes | Yes |
| | Length | 74 cm | 74 cm |
| | French size | 8.6F | 8.6F |
| | Bi-Directional Curving | Yes<br>≥180° in both<br>directions | Yes<br>≥180° in both<br>directions |
| | One-Handed Operation of<br>Curving Mechanism | Yes | Yes |
| | Wire braid reinforcement<br>completely encapsulated | Yes | Yes |
| | Radiopaque tip or marker | Yes | Yes |
| | Soft Atraumatic Tip | Yes | Yes |
| Side port for infusion and<br>contrast injection | Yes | Yes | |

.

Summary of the technological characteristics of the device compared to the predicate devices:

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The HeartSpan™ Steerable Introducer Kit has been thoroughly tested through verification of product specifications and user requirements. The following quality assurance measures were applied during the development of the HeartSpan™ Steerable Introducer Kit:

- Risk Analysis .
.

.

- Requirements/Specification Reviews
- . Design Reviews
- Performance Testing (Verification) including but not limited to: .

Safety & Performance Tests

- Tip articulation o
- Leak resistance o
- Kink resistance O
- Length 0
- Inner/Outer diameter O
- Curve radius 0
- Marker band location 0
- Tip/tube detachment force O
- Side hole diameter and location o
- Sterilization validation (ethylene oxide)
- Biocompatibility Testing (Verification) .

The results of the testing demonstrated that the modified HeartSpan™ Steerable Introducer Kit meets the predetermined acceptance criteria applicable to safety and efficacy of the device.

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Merit Medical Systems, Inc.
HeartSpan™ Steerable Introducer Kit
Special 510(k)

| International<br>Standards | No performance standards have been established under section 514<br>of the Food, Drug and Cosmetic Act for this device. Performance<br>testing of the modified HeartSpan™ Steerable Introducer Kit was<br>conducted based on the risk analysis and based on the requirements<br>of the following international standards:<br>• ANSI/AAMI/ISO 10993-3:2003 Biological Evaluation of Medical<br>Devices - Part 3: Tests of Genotoxicity, Carcinogenicity, and<br>Reproductive Toxicity<br>• ANSI/AAMI/ISO 10993-4:2002 Biological Evaluation of Medical<br>Devices - Part 4: Selection of Tests for Interactions with Blood<br>• ANSI/AAMI/ISO 10993-5:1999 Biological Evaluation of Medical<br>Devices - Part 5: Tests for In Vitro Cytotoxicity<br>• ANSI/AAMI/ISO 10993-7: 2008, Biological Evaluation of Medical<br>Devices - Part 7: Ethylene Oxide Sterilization Residuals<br>• ANSI/AAMI/ISO 10993-10: 2010, Biological Evaluation of Medical<br>Devices - Part 10: Tests for Irritation and Skin Sensitization<br>• ANSI/AAMI/ISO 10993-11: 2006, Biological Evaluation of Medical<br>Devices - Part 11: Tests for Systemic Toxicity<br>• ISO 11070:1998 Sterile Single-Use Intravascular Catheter<br>Introducers - Annex B<br>• ANSI/AAMI/ISO 11135-1:2007 Sterilization of Health Care<br>Products - Ethylene oxide - Part 1: Requirements for<br>Development, Validation and Routine Control of Sterilization<br>Process for Medical Devices<br>• ISTA P2A (2011) - Packaged-Products 150 lb (68kg) or Less |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>Substantial<br>Equivalence | Merit Medical Systems, Inc. considers the HeartSpan™ Steerable<br>Introducer Kits to be substantially equivalent to the currently<br>marketed predicate device (HeartSpan™ Steerable Introducer Kit<br>K122431). This assessment is based upon analysis of similar<br>technological characteristics, bench testing, and indications for use. |

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

September 17, 2013

Ms. Alina Stubbs Regulatory Affairs Specialist II Merit Medical Systems, Inc. 65 Great Valley Parkway Malvern, PA 19355

Re: K132164

Trade Name: HeartSpan™ Steerable Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DYB Dated: August 16, 2013 Received: August 19, 2013

Dear Ms. Stubbs:

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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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

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Page 2 - Ms. Alina Stubbs

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.

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/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/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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## Section 4 Indications for Use Statement

510(k) Number (if known): K132164

HeartSpan™ Steerable Introducer Kit Device Name:

Indications for Use:

The HeartSpan™ Steerable Introducer Kit is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (Per 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)

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