(175 days)
The Premere™ Delivery Sheath is indicated for use in intravascular introduction of therapeutic devices into the left atrium of the heart through the septal wall.
The Premere™ Delivery Sheath consists of a non-tapered catheter introducer and an obturator. The distal portion is tapered to facilitate positioning and crossing the atrial septum. The Premere™ Delivery Sheath is intended to provide a pathway for introduction of therapeutic devices into the right and left atrium.
The delivery sheath is fitted with a hemostasis valve at the proximal end to allow insertion of devices while minimizing blood loss and a side port with a three-way stopcock for infusion, blood sampling and pressure monitoring. The sheath is provided with a stainless steel braid and a radiopaque material on outer jacket with a high-contrast radiopaque marker at the tip.
The obturator is radiopaque with a tapered tip and is compatible with a 0.038" guiding wire.
The provided text does not contain information about acceptance criteria and a study proving a device meets them. The document is a 510(k) summary for the Premere™ Delivery Sheath, which describes the device, its indication for use, and claims substantial equivalence to predicate devices. It also lists performance data that was provided in the 510(k) submission, including various ISO standards and specific tests (dimensional verification, tensile strength, leak/burst), and in-vivo testing in a swine model. The FDA's letter states that the device is substantially equivalent based on the provided information.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information. This type of detailed study information is typically found in the full performance data sections of a 510(k) submission, which are often not publicly available in this summarized format.
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SECTION 2. 510(K) SUMMARY
Administrative Information 2.1
Name and address 2.1.1
Submitted by: Velocimed Inc 11400 73rd Avenue North, Suite 134 Minneapolis, MN 55369
| Contact Person: | John Carline |
|---|---|
| Telephone No.: | 763-463-4742 |
| Facsimile No.: | 763-488-9780 |
2.1.2 Device Name
Trade Name Common Name Classification Name Product Code Classification
Premere™ Delivery Sheath Catheter Introducer, Sheath Introducer Introducer, Catheter DYB Class II
2.2 INDICATION FOR USE
The Premere™ Delivery Sheath is indicated for use in intravascular introduction of therapeutic devices into the left atrium of the heart through the septal wall.
Device Description 2.3
The Premere™ Delivery Sheath consists of a non-tapered catheter introducer and an The I retirere - Donvery Sheath solistal portion to facilitate positioning and crossing the outial septum. The Premere™ Delivery Sheath is intended to provide a pathway for atral sopiali. "The Premis of therapeutic devices into the right and left atrium.
The delivery sheath is fitted with a hemostasis valve at the proximal end to allow insertion of devices while minimizing blood loss and a side port with a three-way hisettion of devices with infusion, blood sampling and pressure monitoring. The Stopeoux to provided to inless steel braid and a radiopaque material on outer jacket with a high-contrast radiopaque marker at the tip.
The obturator is radiopaque with a tapered tip and is compatible with a 0.038" guiding wire.
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SUBSTANTIAL EQUIVALENCE 2.4
The Premere™ Delivery Sheath covered by this substantially equivalent to another legally marketed Catheter Introducer:
- X-Sept Transseptal Sheath (K012489, Appriva Medical, Inc) .
- A-Sept Transseptal Sheath (1101210), Tapper Sheath Introducer Set (K970229, . Arrow International Inc) and,
- Fast-Cath Transseptal Catheter Introducer (K964518, Daig Corp.). .
The Premere™ Delivery Sheath has the same general indication for use, similar principles I he Premere -- Denvery Sheath has and stars gristics as the previously cleared predicate of operation, and shilliar technologroum enation Delivery Catheter and the predicate devices do not raise new questions of safety or efficacy.
Performance Data 2.5
The performance test data is provided in the 510(k) submission. The performance data I he performance test data is provides with Velocimed product specifications and the applicable product safety standards:
- ISO 10555-1:1995(E) Sterile, Single-Use Intravascular Catheters -- Part 1: . General Requirements.
- ISO 10555-2:1996(E) Sterile, Single-Use Intravascular Catheters Part 2: . Angiographic Catheters.
- ISO 10993-1: 1997(E) Biological Evaluation of Medical Devices. .
- ISO 1073-1. 1994(E) Medical Devices Validation and routine control of ethylene . oxide sterilization.
- ISO 11607: 1997(E) Packaging for terminally sterilized medical devices. .
- 150 1100 4169-01 Standard Practice for Performance Testing of Shipping . Container and Systems.
Performance test included dimensional verification, tensile strength, and leak/burst Ferrormance tost moraded annonenand safety of the delivery sheath was verified in-vivo in the swine model. Test results demonstrate that the device meets or exceeds the the swife model. " Fest results demonstations substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white.
MAY - 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Velomiced, Inc. c/o Mr. John Carline Manager of Regulatory Affairs 6550 Wedgwood Road N, Suite 150 Minneapolis, MN 55311
Re: K043084 Trade Name: Premiere™ Delivery Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II (two) Product Code: DYB Dated: March 30, 2005 Received: April 01, 2005
Dear Mr. Carline:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have leviewed your bector b 10(a) fee device is substantially equivalent (for the indications ferenced above and nave determined a vices and a marketed predicate devices marketed in interstate for use stated in the encrosule) to regally to regally the Medical Device American of to commerce prior to May 20, 1778, the encordance with the provisions of the Federal Food, Drug. devices mall have been recaliss in acceramed of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvide on trols provisions of the Act. The You may, merciole, manxet the devices, belject of the more of registration, listing of
general controls provisions of the Act include requirements for annual registration, li general controls provisions of the riot 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 ( If your device is classified (see above) movel mass areoulstions affecting your device can
may be subject to such additional controls. Existing major regulations EDA mov may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peaching your device in the Federal Register.
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Page 2 – Ms. Penelope H. Greco
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri 3 issualite or our device complies with other requirements of the Act that I DA has made a dolorimiation and Joinistered by other Federal agencies. You must or ally it cut all the Act's requirements and and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 807), good the start 820); and if applicable, the electronic 10111 m me quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declons or device as described in your Section 510(k) I ins letter will anow you to oegin maneting your maneting of your device to a legally premarket nothcation. THC PDA miang of castification 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 advice for Jour acon 2011-01-20. Also, please note the regulation entitled, comacities of Computible at (21 th ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Misolanding by icrerchee to premaxionsibilities under the Act from the Division of Small other general International and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Diama R. bo dines
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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SECTION 14. INDICATION FOR USE
1043064 510(k) Number;__
Device Name: Premere™ Delivery Sheath
Indication for Use
The Premere™ Delivery Sheath is indicated for use in intravascular introduction of therapeutic
ed for the country of the best the samel wall The Premere - Denvery Bircuth is neart through the septal wall.
Prescription Use: ____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) OR
Over-The Counter Use: (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)
Dwina P. Kirchner
(Division Sign-Off) (Division Olgh Sign of Cardiovascular Devices
510(k) Number K043084
§ 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).