ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL

K113773 · St Jude Medical · KRA · Jan 18, 2012 · Cardiovascular

Device Facts

• Record ID: K113773
• Device Name: ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
• Applicant: St Jude Medical
• Product Code: KRA · Cardiovascular
• Decision Date: Jan 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2

Intended Use

The IS4 Flushing/Funneling tool is to provide a means of flushing the lead and facilitate the insertion of either a guidewire or stylet into the connector pin of the over the wire left heart lead with an IS4 connector.

Device Story

The St. Jude Medical IS4 Flushing/Funneling tool (Model DS0A002) is a manual accessory kit used to prepare cardiac leads for implantation. The tool facilitates the flushing of the lead and assists in the insertion of a guidewire or stylet into the connector pin of an over-the-wire left heart lead featuring an IS4 connector. It is intended for use by clinicians during lead implantation procedures. The device functions as a mechanical aid to ensure proper lead preparation and guidewire/stylet placement, thereby supporting the successful deployment of the cardiac lead system.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual accessory tool for cardiac lead preparation. Designed for IS4 connector compatibility. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring the insertion of a guidewire or stylet into the connector pin of an over-the-wire left heart lead with an IS4 connector.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• IS4 Flushing/Funneling tool (P030054/S173)

Submission Summary (Full Text)

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## Section 4- 510(k) Summary

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| Submitter : | St Jude Medical, CRMD<br>15900 Valley View Court<br>Sylmar, CA 91324<br>Establishment Registration Number: 2017865 | JAN 1 8 2012 | | |
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| Contact Person : | Geena George<br>Regulatory Affairs Specialist<br>Phone [phone]<br>Fax [phone] | | | |
| Date Prepared : | December 21, 2011 | | | |
| Trade Name : | St Jude Medical IS4 Flushing/Funneling tool Accessory kit<br>DS0A002 | | | |
| Classification : | Class II-21 CFR 870.1210<br>Continuous Flush Catheter | | | |
| Product Code : | KRA | | | |
| Predicate Device: | The subject device is equivalent to the following St Jude Medical<br>Device<br>IS4 Flushing/Funneling tool (approved under P030054/S173) | | | |
| Device Description : | The St. Jude Medical IS4 Flushing/funneling tool Accessory kit<br>Model DS0A002 is an individually packaged accessory kit<br>containing one IS4 flushing/funneling tool. | | | |
| Intended Use: | The IS4 Flushing/Funneling tool is to provide a means of flushing<br>the lead and facilitate the insertion of either a guidewire or stylet<br>into the connector pin of the over the wire left heart lead with an<br>IS4 connector. | | | |
| Comparison to<br>Predicate Devices | The St Jude Medical IS4 Flushing/Funneling tool Accessory kit<br>Model DS0A002 has an identical intended use and the same<br>fundamental scientific technology as the predicate device which is<br>commercially available. | | | |
| Conclusion : | St Jude Medical considers the IS4 Flushing/Funneling tool<br>Accessory kit Model DS0A002 to be equivalent to the predicate<br>device listed above. This conclusion is based upon the device<br>similarities in design, technological characteristics, principle of<br>operation, materials and indications for use. | | | |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

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

JAN 1 8 2012

St. Jude Medical, CRMD c/o Ms. Geena George Regulatory Affairs Specialist. 15900 Valley View Court Sylmar, CA 91342

Re: K113773

Trade/Device Name: St. Jude Medical IS4 Flushing/Funneling Tool Accessory Kit DS0A002 Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: December 21, 2011 Received: December 22, 2011

Dear Ms. George:

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. Geena George

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 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" (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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

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

510(k) Number (if known): K113773

Device Name: St Jude Medical IS4 Flushing/Funneling Tool Accessory kit Model DS0A002

Indications for Use: The IS4 Flushing/Funneling Tool is to provide a means of flushing the lead and facilitate the insertion of either a guidewire or stylet into the connector pin of the over the wire left heart lead with an IS4 connector

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRA, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number** K113273