(261 days)
The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.
The St Jude Medical Nanostim Introducer Kit is designed to perform as a guiding sheath for introduction of diagnostic and interventional devices. The Nanostim™ Introducer Kit is comprised of an Introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in 18F and one length of 30 cm. The introducer sheath is fitted with a hemostasis valve to prevent blood loss and minimize air introduction during introducer insertion and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration and fluid infusion. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath.
This document is a 510(k) summary for the St. Jude Medical Nanostim Introducer Kit and does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance, nor does it involve expert reviews or clinical trials in the way typically associated with AI/ML medical devices. The document concerns a physical medical device (catheter introducer) and its substantial equivalence to predicate devices.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets those criteria, as the provided document does not contain this information in the context you've outlined.
The document discusses:
- The device's intended use and technological characteristics.
- Non-clinical testing (e.g., visual, dimensional, tensile, leak tests, biocompatibility).
- A statement that clinical evaluation is not required.
- A comparison to predicate devices to establish substantial equivalence.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2014
St. Jude Medical, Inc. Mr. Hassan Labay Sr. Manager, Regulatory Affairs 776 Palomar Avenue Sunnyvale, CA 94085
Re: K140793
Trade/Device Name: Nanostim Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 21, 2014 Received: November 24, 2014
Dear Mr. Labay:
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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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140793
Device Name The Nanostim™ Introducer Kit
Indications for Use (Describe)
The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number:
Applicant Information:
| Owner Name: | St. Jude Medical, Inc. |
|---|---|
| Address: | 667 Palomar AvenueSunnyvale, CA. 94085Office: 650-404-5800 |
| Contact Person: | Hassan Labay |
| Phone Number: | 408 522 6222 |
| Facsimile Number: | 650 404 2773 |
Date Prepared: 3/28/2014
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | St. Jude Medical Nanostim™ Introducer Kit |
| Common name: | Introducer, Catheter |
| Classification name: | Catheter Introducer (21 CFR 870.1340/DYB) |
Predicate Devices:
The St Jude Medical Nanostim Introducer Kit is substantially equivalent in intended use and method of operation to the cleared Medtronic Mirca Introducer (K132030) and Medtronic Sentrant Introducer Sheath (K123990).
Device Description:
The St Jude Medical Nanostim Introducer Kit is designed to perform as a guiding sheath for introduction of diagnostic and interventional devices. The Nanostim™ Introducer Kit is comprised of an Introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in 18F and one length of 30 cm. The introducer sheath is fitted with a hemostasis valve to prevent blood loss and minimize air introduction during introducer insertion and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration and fluid infusion. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath.
St Jude Medical Nanostim Introducer Kit Traditional 510(k) Submission
Section 8-1 510(k) Summary
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Intended Use:
The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.
Summary of Technological Characteristics in Comparison to Predicate Device:
The St Jude Medical Nanostim Introducer Kit and the predicate devices (Medtronic Micra Introducer (K132030) and Sentrant Introducer Sheath (K123990)) have similar indication for use, technological characteristics and performance. Both the subject device and the predicate devices are designed to provide a conduit for delivery of diagnostic and other interventional devices. The minor differences in wording for intended use statements of the respective products do not alter the intended patient or clinical effect, and, therefore, the Nanostim Introducer Kit is substantially equivalent with respect to intended use. In addition, the minor differences in length and size do not present any new issues of safety or effectiveness. Moreover, performance testing demonstrates that the Nanostim Introducer Kit performs in a substantially equivalent manner.
Summary of Non-Clinical Testing:
Design verification and validation testing was performed to ensure that the Nanostim Introducer Kit met design specifications and customer requirements. Testing activities includes:
- Visual test ●
- . Dimensional measurement test
- Tensile test .
- Leak Test ●
- Liquid leakage under pressure (flow rate test) ●
- Side Port Torque ●
Biocompatibility Testing:
Biocompatibility testing for the Nanostim Introducer Kit has been completed in accordance with the International Standard ISO-10993-1:2009 "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing" for an external communicating device with limited exposure (contact with circulating blood is <24 hours).
Summary of Clinical Testing:
Clinical evaluation is not required for the Nanostim Introducer Kit.
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Substantial equivalence:
The results of bench testing and compliance with applicable standards provide reasonable assurance that the Nanostim Introducer Kit has been designed and tested to assure conformance to the requirements for its indications for use.
St Jude Medical considers the Nanostim Introducer Kit to be substantially equivalent to the legally marketed predicate devices because it has similar intended use and similar indications, technological characteristics and performance. The minor differences between the subject device and the predicate devices do not alter the intended patient or clinical effect and, therefore, the Nanostim Introducer Kit is substantially equivalent to currently marketed predicate devices.
St Jude Medical Nanostim Introducer Kit Traditional 510(k) Submission
Section 8-3 510(k) Summary
§ 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).