BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208

K122587 · St Jude Medical · DRC · Feb 7, 2013 · Cardiovascular

Device Facts

• Record ID: K122587
• Device Name: BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
• Applicant: St Jude Medical
• Product Code: DRC · Cardiovascular
• Decision Date: Feb 7, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BRKTM Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.

Device Story

The BRK Transseptal Needle is a manual surgical instrument used by physicians during transseptal catheterization. It consists of a curved, beveled stainless steel needle and a straight stainless steel stylet. The device is designed to be used in conjunction with a St. Jude Medical Transseptal Introducer set. The needle features a pointer flange for orientation and a 2-way stopcock for aspiration, fluid injection, blood sampling, and pressure monitoring. The stylet facilitates needle advancement within the dilator. By puncturing the interatrial septum, the device enables left heart access, facilitating subsequent cardiac procedures. It is operated by a physician in a clinical setting.

Clinical Evidence

No clinical data. Bench testing and biocompatibility testing (ISO 10993-1) were performed to verify the design modification.

Technological Characteristics

Stainless steel needle and stylet; curved distal section with abrupt diameter step-down; beveled tip; 2-way stopcock; pointer flange; manual operation; sterile.

Indications for Use

Indicated for patients undergoing transseptal catheterization procedures requiring puncture of the interatrial septum to gain left heart access.

Regulatory Classification

Identification

A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.

Special Controls

*Classification.* Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• BRKTM Transseptal Needle (K072278)

Submission Summary (Full Text)

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| 510(k) Summary | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K122587 |
| Submitter Information: | |
| Date Prepared: | August 16, 2012 |
| Submitter Name &<br>Address: | St. Jude Medical - Atrial Fibrillation Division |
| | 14901 DeVeau Place |
| | Minnetonka, MN 55345 |
| | Establishment Registration Number: 3005188751 |
| Contact Person: | Harlan Jones |
| | Senior Regulatory Affairs Specialist |
| | Phone [phone] |
| | Fax [phone] |
| | [e-mail] |
| Device Information: | |
| Trade Name: | BRKTM Transseptal Needle |
| Common Name: | Transseptal Needle |
| Classification Name: | Trocar |
| Class: | Class II, 21 CFR 870.1390, Product Code DRC |
| Predicate Device: | BRKTM Transseptal Needle<br>(K072278). |
| Device Description: | The St. Jude Medical BRKTM Transseptal Needle consists of a<br>luminal stainless steel needle and solid stainless steel stylet.<br>The distal section of the needle is curved to facilitate<br>positioning within the heart when used with a St. Jude<br>Medical Transseptal Introducer set. Within this curved<br>section, there is an abrupt step down in the outer diameter of<br>the needle to mate with the internal diameter of the dilator of<br>the St. Jude Medical Transseptal Introducer set. The distal tip<br>of the needle is beveled to facilitate the puncture process. |
| | The proximal end of the needle is configured with a pointer<br>flange (indicating distal curve orientation) and is fitted with a<br>2-way stopcock to provide needle lumen access for aspiration,<br>fluid injection/infusion, blood sampling, pressure monitoring,<br>and stylet and/or guidewire insertion.<br>The stylet is straight and isodiametric throughout its length.<br>The proximal end of the stylet is fitted with a curved clip to<br>lock onto the proximal needle hub when inserted into the<br>needle lumen. The stylet is designed to facilitate needle<br>advancement within the dilator. |
| Intended Use:<br>(Indications for Use) | The BRKTM Transseptal Needle is used to puncture the<br>interatrial septum during a transseptal catheterization<br>procedure to gain left heart access. |
| Comparison to<br>Predicate Devices | The modified BRK™ Transseptal Needle has the same<br>intended use and fundamental scientific technology as the<br>predicate device. The technological characteristics of the<br>modified BRK™ Transseptal Needle are substantially<br>equivalent to the predicate device including packaging,<br>biocompatibility, sterilization, and labeling. Through<br>biocompatibility and design verification testing it was<br>demonstrated that the adhesive change does not adversely<br>affect the safety and effectiveness. |
| Summary on Non-<br>Clinical Testing | Bench testing and biocompatibility testing were performed to<br>verify the device modification. It was concluded that the<br>modified BRK™ Transseptal Needle design meets the<br>product specification and intended use. Biocompatibility was<br>confirmed in accordance with ISO 10993-1. |
| Statement of<br>Equivalence | The modified St. Jude Medical BRK™ Transseptal Needle<br>has the same indications for use and technological<br>characteristics as the predicate device. Based on this and the<br>data provided in this pre-market notification, St. Jude<br>Medical's modified BRK™ Transseptal Needle has been<br>shown to be substantially equivalent to the predicate. |

BRK™ Transseptal Needles

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Special 510(k)

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St. Jude Medical

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Special 510(k)

St. Jude Medical

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the caduceus in a circular fashion.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

> FEB 7 2013

St. Jude Medical Mr. Harlan Jones 14901 Deveau Pl. Minnetonka, MN 55345-2126 US

Re: K122587

Trade/Device Name: BRK Transseptal Needle model 407200, 407201, 407205, 407206, 407207, G407208 Regulation Number: 21 CFR 870.1390 Regulation Name: Trocar Regulatory Class: Class II Product Code: DRC Dated: January 10, 2013 Received: January 11, 2013

Dear Mr. Jones:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Mr. Harlan Jones

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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Bram D. Zuckerman

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):

K122587

Device Name: BRK™ Transseptal Needle

Indications for Use:

The BRK™ Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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 of Cardiovascular Devices

Site Number K122587