(88 days)
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.
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.
The provided text describes a medical device, the NMT Medical Transseptal Sheath Set, and its 510(k) summary for FDA clearance. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, device performance tables, study details (sample sizes, expert involvement, adjudication, MRMC, standalone performance), or ground truth establishment.
The document focuses on demonstrating substantial equivalence to a predicate device (COOK Check-Flo® Transseptal Introducer Sets) based on:
- Indications for Use
- Product Design
- Materials
- Packaging
- Labeling
- Sterilization methods
It mentions that "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." It also states that the device met applicable requirements of ISO-10993-1, ISO-11070, ISO-10555, and ISO 594-2.
Therefore, I cannot provide the detailed information requested in your prompt as it is not present in the given text.
If this were a real-world scenario, you would need to consult detailed test reports and study protocols submitted to the FDA, which are typically much more extensive than a 510(k) summary.
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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: 617-737-0930 Fax: 617-737-0924
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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... .
the country of
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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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three wavy lines extending from its body, representing the department's mission to protect the health of all Americans.
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 (301) 594-4648. 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 (800) 638-2041 or (301) 443-6597 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
the state of the mail of the mail of the states of the states
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production of the trade to the comments of the start of the may be and
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).