TRANSSEPTAL NEEDLE/TROCAR

K011727 · Thomas Medical Products, Inc. · DRC · May 2, 2002 · Cardiovascular

Device Facts

• Record ID: K011727
• Device Name: TRANSSEPTAL NEEDLE/TROCAR
• Applicant: Thomas Medical Products, Inc.
• Product Code: DRC · Cardiovascular
• Decision Date: May 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used to create the primary puncture in the interatrial septum when passing an introducer and/or catheter through the septum from the right side of the heart to the left side.

Device Story

Transseptal needle designed for cardiac interventional procedures; features specifically curved distal portion for anatomical positioning; includes proximal stopcock for air aspiration, fluid infusion, blood sampling, and pressure monitoring; includes needle shield with pointer for curve orientation. Used by physicians in clinical settings to create primary puncture in interatrial septum, facilitating passage of introducers or catheters from right to left atrium. Device enables access for left-sided cardiac procedures.

Clinical Evidence

Bench testing only. Testing included hub pull test, hub-to-stopcock pull test, wire-to-handle pull test, and needle-to-hub torque force. All samples passed protocol requirements.

Technological Characteristics

Stainless steel needle with proximal stopcock; curved distal geometry; needle shield with orientation pointer. Mechanical device; no energy source, software, or electronics.

Indications for Use

Indicated for patients requiring transseptal catheterization to access the left side of the heart from the right side via the interatrial septum.

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

• Cook, Transseptal Needle
• Daig, Transseptal Needle
• C.R. Bard, USCI® Brockenbrough® Needles

Submission Summary (Full Text)

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510(k) Notification

## III.

### 510(k) SUMMARY (As required by 21 C.F.R. 807.92)

#### A. Submitter Information

Submitter's Name: Address:

Telephone Number: Facsimile: Contact Person: Title: Date Submission Prepared:

Thomas Medical Products, Inc. 65 Great Valley Parkway Malvern, PA 19355 [phone] [phone] Tim Stoudt Manager, Quality Engineering May 25, 2001

#### B. Device Information

| Trade name: | Not assigned at this time. |
|-----------------------|-------------------------------|
| Classification Names: | Trocar (21 C.F.R. §870. 1390) |

Accessories

Predicate Devices:

Device Description:

The Thomas Medical Transseptal Needle consists of a specifically curved distal portion to accommodate positioning in the cardiac anatomy when used in conjunction with a transseptal introducer. A stopcock is attached to the proximal end of the needle for air aspiration, fluid infusion, blood sampling and pressure monitoring. A pointer is included on the needle shield to show orientation of the curve.

Cook, Transseptal Needle, Daig, Transseptal Needle and C.R. Bard, USCI® Brockenbrough® Needles and

Intended Use:

The Transseptal Needle is designed to create the primary puncture in the interatrial septum when passing an introducer and/or catheter through the septum from the right side of the heart to the left side.

#### C. Comparison of Required Technological Characteristics

The technological characteristics of the Modified Device are the same as the Predicate Device.

#### D. Substantial Equivalence

The Thomas Medical Products Transseptal Needle has the same general intended use/indications for use and technological characteristics as other legally marketed devices. Therefore, based on the similarities in intended use and technological characteristics, the Thomas Medical Products Transseptal Needle is substantially equivalent to the legally marketed predicate devices.

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### Qualification Testing D.

Thomas Medical Products qualification testing of the Transseptal Needle included Thomas Mouron. Froudon quality of Hub pull test, Hub to Stopcock pull test, Wire to Handle pull test and Needle to Hub torque force. All samples passed the protocol qualification testing requirements.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tim Stoudt Manager, Quality Engineering Thomas Medical Products, Inc. 65 Great Valley Parkway Malvern, PA 19355

> K011727 Transseptal Needle/Trocar Regulation Number: 870.1390 Regulation Name: Trocar Regulatory Class: II (two) Product Code: 74 DRC Dated: March 11, 2002 Received: March 12, 2002

Dear Mr. Stoudt:

Re:

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 for association 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

**MAY 02 2002**

Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the logo is a stylized design featuring three abstract shapes that resemble birds in flight.

**MAY 02 2002**

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Page 2 - Mr. Tim Stoudt

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Darlene Hill

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Page | | of | |
|------|--|----|--|
|------|--|----|--|

| 510(k) Number (if known): | K011727 |
|---------------------------|--------------------|
| Device Name: | Transseptal Needle |
| Indications For Use: | |

Used to create the primary puncture in the interatrial septum when passing an introducer
and/or catheter through the septum from the right side of the heart to the left side.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﺎ Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

Qeetu
Division of Cardiovascular & Respiratory Devices'
510(k) Number R011727

(Optional Format 1-2-96)