CPS Direct MediGuide Enabled outer catheter

K142239 · St Jude Medical · DQY · Dec 18, 2014 · Cardiovascular

Device Facts

• Record ID: K142239
• Device Name: CPS Direct MediGuide Enabled outer catheter
• Applicant: St Jude Medical
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The St. Jude Medical™ CPS Direct™, MediGuide Enabled™ slittable outer guide catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical™ devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. The CPS Direct™, MediGuide Enabled™ slittable outer guide catheter are used with the MediGuide System to enable real-time tip positioning and navigation. The MediGuide system is indicated for use as an adjunct to fluoroscopy. In addition, the CPS Direct™, MediGuide Enabled™ slittable outer guide catheters can work with inner catheters as a system.

Device Story

Slittable outer guide catheter provides intracardiac access to venous system; serves as conduit for contrast media, implantable left heart leads, and delivery tools. Features integrated hemostasis valve and sideport for fluid management. Distal tip contains sensor coil for real-time navigation via MediGuide System and tungsten stripes for fluoroscopic visibility. Used in cardiac procedures by physicians; functions as adjunct to fluoroscopy. MediGuide System tracks catheter tip position, providing real-time visualization to assist navigation. Device supports inner catheters; enables precise lead/tool delivery. Benefits include improved navigation accuracy and reduced blood loss during implantation.

Clinical Evidence

No clinical data. Bench testing only. Verification included package integrity, seal strength, leak testing, dimensional/kink/tensile/flex/torque/rotation testing, electrical integrity, radiopacity, and static accuracy.

Technological Characteristics

PEBAX shaft with stainless steel braid reinforcement; progressively decreasing durometer; atraumatic distal tip. Integrated hemostasis valve and sideport. Sensor coil for electromagnetic tracking; tungsten stripes for radiopacity. Sterilized device.

Indications for Use

Indicated for patients requiring intracardiac access to the venous system for delivery of contrast media, implantable left heart leads, and delivery tools, and for fluid support where minimizing blood loss is required.

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

• St Jude Medical CPS Direct™, MediGuide Enabled™ Slittable Outer Guide Catheter (K120296)

Submission Summary (Full Text)

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

December 18, 2014

St. Jude Medical Zachary Price Senior Regulatory Affairs Specialist 15900 Valley View Court Sylmar, California 91342

Re: K142239

> Trade/Device Name: CPS Direct™ Mediguide Enabled™ Slittable Outer Guide Catheter Models DS2M041, DS2M042, DS2M043, DS2M044 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: November 19, 2014 Received: November 20, 2014

Dear Mr. Price,

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

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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 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,

# Melissa A. Torres -S

For

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

Enclosure

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#### Indications for Use

CPS Direct™ MediGuide Enabled™ Slittable Outer Guide Catheter Device Name: Models DS2M041, DS2M042, DS2M043, DS2M044

Indications for Use: The St. Jude Medical™ CPS Direct™, MediGuide Enabled™ slittable outer guide catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical™ devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. The CPS Direct™, MediGuide Enabled™ slittable outer guide catheter are used with the MediGuide System to enable real-time tip positioning and navigation. The MediGuide system is indicated for use as an adjunct to fluoroscopy. In addition, the CPS Direct™, MediGuide Enabled™ slittable outer guide catheters can work with inner catheters as a system.

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

> CPS Direct™ MediGuide Enabled™ Outer Catheter Traditional 510(k) St. Jude Medical

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### 510(k) Summary

| Submitter: | St Jude Medical, CRMD<br>15900 Valley View Court<br>Sylmar, CA 91324<br>Establishment Registration Number: 2017865 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Zachary Price<br>Senior Regulatory Affairs Specialist<br>Phone [phone]<br>Fax [phone] |
| Date Prepared: | August 12, 2014 |
| Trade Name: | CPS DirectTM MediGuide EnabledTM Slittable Outer Guide Catheter<br>Models DS2M041, DS2M042, DS2M043, and DS2M044 |
| Classification: | Class II - 21 CFR 870.1250<br>Catheter Percutaneous |
| Product Code: | DQY |
| Predicate Device: | The subject device is equivalent to the following St Jude Medical and<br>MediGuideTM Devices |
| | St Jude Medical CPS DirectTM, MediGuide EnabledTM Slittable Outer<br>Guide Catheter (K120296 cleared on May 11, 2012) |
| Device Description: | The St. Jude Medical CPS DirectTM, MediGuide EnabledTM outer catheter<br>is made from PEBAX and reinforced with a stainless steel braid. The<br>shaft has progressively decreasing durometers of PEBAX form the<br>proximal to the distal end with a soft, atraumatic distal tip. The distal end<br>is embedded with a sensor coil to enable device tip projection onto the<br>MediGuideTM system and tungsten stripes for fluoroscopic visibility. The<br>hub contains an integrated hemostasis valve and a molded slit channel.<br>The hub contains a sideport with extension tubing for contrast delivery,<br>aspiration or saline flush using a 3-way stopcock. In addition, the hub<br>contains a port for the connector cable. |
| Intended Use: | The St Jude Medical CPS DirectTM MediGuide EnabledTM slittable outer<br>guide catheter is designed for intracardiac access of the venous system of<br>the heart and to serve as a conduit during implantation for the delivery of<br>contrast medium and St. Jude Medical devices (including implantable left<br>heart leads and delivery tools), and support of fluids where minimizing |

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Image /page/4/Picture/0 description: The image contains the logo for St. Jude Medical. The logo consists of a green square grid on the left, with one square tilted. To the right of the grid is the text "ST. JUDE MEDICAL" in a sans-serif font. The word "MEDICAL" has a trademark symbol next to it.

blood loss is essential. The CPS Direct™ MediGuide Enabled™ slittable outer guide catheter is used with the MediGuide™ System to enable realtime tip positioning and navigation. The MediGuide™ system is indicated for use as an adjunct to fluoroscopy. In addition, the CPS Direct™ MediGuide Enabled™ slittable outer guide catheters can work with inner catheters as a system

Comparison to Predicate Devices: The St Jude Medical CPS Direct™ MediGuide Enabled™ slittable outer guide catheter (from herein referenced as CPS Direct™ MediGuide Enabled™ outer catheter kit) has a similar intended use and the same fundamental scientific technology as the predicate devices. All technological characteristics of CPS Direct™ MediGuide Enabled™ outer catheter kit are substantially equivalent to the predicate devices including packaging, biocompatibility, sterilization, and labeling. Where differences exist between the subject device and the predicate devices, performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the subject device.

## Performance Testing

(non-clinical): Product verification was performed on the CPS Direct™ MediGuide Enabled™ outer catheter kit to confirm that it meets the design requirements and applicable industry standards. Testing included evaluations of (1) package integrity, (2) seal strength, (3) saline and aspiration leak testing, (4) visual inspection, (5) dimensional testing, (6) kink testing, (7) compatibility testing, (8) electrical integrity, (9) tensile testing, (10) rotation capacity, (11) torque testing, (12) slit force, (13) flex testing, (14) radiopacity testing, (15) polarity, and (16) static accuracy. This evaluation of the mechanical, functional, and biocompatibility properties of the CPS Direct™ MediGuide Enabled™ outer catheter kit demonstrated that it met all specified design and performance specifications.

- St Jude Medical considers the CPS Direct™ MediGuide Enabled™ outer Conclusion: catheter kit to be equivalent to the predicate devices listed above. This conclusion is based upon the device similarities in design, technological characteristics, and principle of operation, materials and indications for use.