CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter

K142235 · St Jude Medical · DQY · Dec 18, 2014 · Cardiovascular

Device Facts

• Record ID: K142235
• Device Name: CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner 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 Aim™, MediGuide Enabled™ slittable inner catheter (subselector/cannulator) is designed for intracardiac access of the coronary sinus and subselection 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 leads and guidewires. In addition, CPS Aim™, MediGuide Enabled™ slittable inner catheters (subselector/cannulator) can work with outer guide catheters as a system. The CPS Aim™, MediGuide Enabled™ slittable inner catheter is used with the MediGuide™ System to enable realtime tip positioning and navigation within the anatomy. The MediGuide™ system is indicated for use as an adjunct to fluoroscopy.

Device Story

Slittable inner guide catheter; facilitates coronary sinus cannulation and venous subselection during cardiac lead implantation. Contains integrated magnetic sensor; enables real-time tip tracking/navigation via MediGuide System. Functions as conduit for contrast media, guidewires, and leads; can operate as dual-catheter assembly with outer guide catheters. Used in clinical settings by physicians; provides real-time anatomical positioning data as adjunct to fluoroscopy. Enhances navigation precision; reduces reliance on fluoroscopy; improves procedural efficiency for lead placement.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included package integrity, seal strength, leak testing, dimensional/kink/tensile/flex/torque/slit force testing, electrical integrity, radiopacity, polarity, and static accuracy. All tests met specified design and performance requirements.

Technological Characteristics

Slittable inner catheter with integrated magnetic sensor for tracking. Materials and biocompatibility equivalent to predicates. Features include radiopacity, rotation capacity, and torque control. Designed for use with MediGuide System (electromagnetic tracking). Sterilization and packaging consistent with established standards.

Indications for Use

Indicated for patients undergoing cardiac implantation procedures requiring intracardiac access to the coronary sinus and venous system for lead or guidewire delivery. Used as an adjunct to fluoroscopy for real-time tip positioning and navigation.

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 Aim™ SL Slittable Inner Catheter (K090613)
• MediGuide Guided Measurement Catheter (GMC) (K091780)

Submission Summary (Full Text)

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Public Health Service

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 Sr. Regulatory Affairs Specialist 15900 Valley View Court Sylmar, California 91342

Re: K142235

> Trade/Device Name: CPS Aim™ MediGuide Enabled™ Slittable Inner Guide Catheter Models DS2M051, DS2M052, DS2M053, DS2M054 and DS2M055 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: November 21, 2014 Received: November 24, 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

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Page 2 - Mr. Price

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 (OS) 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 vours.

# 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 Aim™ MediGuide Enabled™ Slittable Inner Guide Catheter Device Name: Models DS2M051, DS2M052, DS2M053, DS2M054 and DS2M055

Indications for Use: The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slittable inner catheter (subselector/cannulator) is designed for intracardiac access of the coronary sinus and subselection 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 leads and guidewires. In addition, CPS Aim™, MediGuide Enabled™ slittable inner catheters (subselector/cannulator) can work with outer guide catheters as a system. The CPS Aim™, MediGuide Enabled™ slittable inner catheter is used with the MediGuide™ System to enable realtime tip positioning and navigation within the anatomy. The MediGuide™ system is indicated for use as an adjunct to fluoroscopy.

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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™ Inner Catheter Traditional 510(k) St. Jude Medical

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Image /page/3/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of a green square grid on the left side and the text "St. Jude Medical" on the right side. The text is in a serif font and is black in color. The logo is simple and professional.

### 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 Aim™ MediGuide Enabled™ Slittable Inner Guide Catheter Models<br>DS2M051, DS2M052, DS2M053, DS2M054, and DS2M055 |
| 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>MediGuide Devices |
| | St Jude Medical CPS Aim™ SL Slittable Inner Catheter (K090613)<br>cleared on July 7, 2009 |
| | MediGuide Guided Measurement Catheter (GMC) (K091780) cleared on<br>October 16, 2009 |
| Device Description: | The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slittable inner<br>catheter (subselector/cannulator) is used to facilitate left heart lead<br>delivery procedures. The CPS Aim, MediGuide Enabled slittable inner<br>catheter (subselector/cannulator) contains a magnetic sensor allowing it to<br>be tracked using the MediGuide™ System. The inner catheter facilitates<br>cannulation of the coronary sinus or subselection of branch veins off of the<br>coronary sinus/great cardiac vein during surgical implantation procedures.<br>It may also be used for the delivery of contrast medium and St. Jude<br>Medical™ devices, including guidewires. |
| | When used in conjunction with outer guide catheters, the CPS Aim,<br>MediGuide Enabled slittable inner catheter (subselector/cannulator) can<br>function as a dual-catheter assembly. |

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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 with a tilted square in the center, followed by the text "ST. JUDE MEDICAL" in a sans-serif font. The word "MEDICAL" is followed by the registered trademark symbol.

The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slittable inner Intended Use: catheter (subselector/cannulator) is designed for intracardiac access of the coronary sinus and subselection 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 leads and guidewires. In addition, CPS Aim™, MediGuide Enabled™ slittable inner catheters (subselector/cannulator) can work with outer guide catheters as a system. The CPS Aim™, MediGuide Enabled™ slittable inner catheter is used with the MediGuide™ System to enable realtime tip positioning and navigation within the anatomy. The MediGuide™ system is indicated for use as an adjunct to fluoroscopy.

## Comparison to

- Predicate Devices The St Jude Medical CPS Aim™ MediGuide Enabled™ slittable inner guide catheter and accessories have a similar intended use and the same fundamental scientific technology as the predicate devices. All technological characteristics of CPS Aim™ MediGuide EnabledTM slittable inner catheter and accessories 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 Aim™ MediGuide EnabledTM slittable inner catheter 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 testing with the CPS Aim™ MediGuide Enabled™ slittable inner catheter demonstrated that it met all specified design and performance specifications.
- Conclusion : St Jude Medical considers the CPS Aim™ MediGuide Enabled™ slittable inner catheter and accessories to be equivalent to the predicate devices listed above. This conclusion is based upon the device similarities in

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Image /page/5/Picture/0 description: The image contains the logo for St. Jude Medical. The logo consists of a green square grid on the left and the words "ST. JUDE MEDICAL" in a serif font on the right. The grid is made up of smaller squares, with one square slightly tilted.

K142235

design, technological characteristics, principle of operation, materials and indications for use.