NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC

K034025 · Nmt Medical, Inc. · DYB · Mar 26, 2004 · Cardiovascular

Device Facts

• Record ID: K034025
• Device Name: NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC
• Applicant: Nmt Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Mar 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The NMT Transseptal Sheath Set is indicated for percutaneous introduction of various cardiovascular devices into the left side of the heart through the atrial septum.

Device Story

The NMT Medical Transseptal Sheath Set is a catheter-based system designed for percutaneous access to the left side of the heart. The system includes two configurations: a long sheath set (75cm sheath, 81cm dilator) and a short sheath set (12cm sheath, 19cm dilator). The device is used by clinicians to facilitate the introduction of various cardiovascular devices through the atrial septum. It functions as a conduit for interventional procedures. The device is a mechanical instrument; it does not involve electronic processing, software, or algorithms.

Clinical Evidence

Bench testing only. In-vitro and biocompatibility testing conducted to compare performance against the predicate device. No clinical data presented.

Technological Characteristics

Mechanical catheter introducer system. Materials comply with ISO-10993-1 (biocompatibility). Design adheres to ISO-11070, ISO-10555, and ISO 594-2 standards. System includes long (75cm sheath/81cm dilator) and short (12cm sheath/19cm dilator) configurations. No energy source, software, or connectivity.

Indications for Use

Indicated for percutaneous introduction of cardiovascular devices into the left side of the heart via the atrial septum.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• COOK Check-Flo® Transseptal Introducer Sets (K034025)

Submission Summary (Full Text)

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# 510(k) Summary

510(k) Number: K034025

Date Prepared December 23, 2003

Submitter's Name, Address, Telephone Number NMT Medical, Inc. 27 Wormwood Street Boston, MA 02210 Phone: [phone] Fax: [phone]

Contact Person Anne M. Kulis Vice President, Regulatory Affairs

Device Name Proprietary Name: Common Name: Classification Name:

NMT Medical Transseptal Sheath Set Introducer, Introducer Sheath, Sheath Catheter Introducer

Device Classification Class II, §870.1340

Predicate Device COOK Check-Flo® Transseptal Introducer Sets COOK Incorporated

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## Device Description

The NMT Medical Transseptal Sheath Set consists of a long and short introducer sheath set. The long sheath set is comprised of a curved 75cm length introducer sheath and curved 81 cm length dilator. The short sheath set is comprised of a straight 12cm length introducer sheath and straight 19cm length dilator.

#### Intended Use

The NMT Transseptal Sheath Set is indicated for percutaneous introduction of various cardiovascular devices into the left side of the heart through the atrial septum.

# Summary of Technological Characteristics of Current Device Compared to the Predicate Device

The technical characteristics of the applicant device are substantially equivalent to the predicate device with respect to indications for use, product design, materials, packaging, labeling and sterilization methods.

## Support of Substantial Equivalence

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In-vitro and biocompatibility tests were conducted to compare the NMT Transseptal Sheath Set to the predicate device. Test results demonstrate that the applicant device met performance specification requirements and is substantially equivalent to the predicate device. Additionally, the NMT Medical Transseptal Sheath Set met the applicable requirements of ISO-10993-1. ISO-11070, ISO-10555 and ISO 594-2. Additionally, indications for use of the applicant device and the predicate device are substantially equivalent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2004

NMT Medical, Inc. c/o Ms. Anne M. Kulis Vice President, Regulatory Affairs 27 Wormwood Street Boston, MA 02210

Re: K034025

> NMT Medical Transseptal Sheath Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: December 23, 2003 Reccived: December 29, 2003

Dear Ms. Kulis:

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 associated in the 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). and ovometier fore, 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.

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Page 2 -- Ms. Anne M. Kulis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a bevice complies with other requirements of the Act that FDA has made a decemmation that your administered by other Federal agencies. You must of any Federal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, morading, and manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice in the CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2001). Beeting your device as described in your Section 510(k) I ms letter will anow you to begin mailoung of substantial equivalence of your device to a legally prematication. "The PDA managsification 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), please If you desire specific acries 101 y at [phone]. Also, please note the regulation entitled, Comaci the Office of Compilance an (est notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

(201) 115 057 6rda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

una R. Vuchner

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): K034025

Device Name: NMT Medical Transseptal Sheath Set

Indications For Use:

The NMT Medical Transseptal Sheath Set is indicated for percutaneous introduction of various cardiovascular devices into the left side of the hear through the atrial septum.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dama R. Vichner

(Division Sign-Off) Division of Cardiovascular Devices

510(K) Number K03402

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