(27 days)
The X-Sept Transseptal Sheath and Transition Catheter is indicated for percutaneous introduction of various cardiovascular devices into the left side of the heart through the atrial septum.
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I am sorry, but the provided text focuses on the 510(k) summary for the X-Sept Transseptal Sheath and Transition Catheter, primarily detailing its substantial equivalence to a predicate device and its intended use. It does not contain information about specific acceptance criteria for a study, reported device performance metrics against such criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or the type of ground truth used.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the given input.
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AUG 3 0 2001
Special 510(k): Device Notification August, 2001
Ko12489
Attachment 4 510 (k) Summary
| Sponsor: | Appriva Medical, Inc.777 North Pastroia Ave.Sunnyvale, CA 94043 | |
|---|---|---|
| Device Name: | X-Sept Transseptal Sheath and Transition Catheter (with Dilator) | |
| Contact Person: | Michael KolberVice President, Regulatory Affairs and Quality AssuranceTelephone: 408.616.5203Fax: 408.616.5252Email: mkolber@apprivamed.com | |
| Trade Name | X-Sept Transseptal Sheath and Transition Catheter | |
| Common/Classification Name | Catheter Introducer | |
| Establishment Registration: | 2954914 | |
| Address of Manufacturing Facilityand Sterilization Site | Manufacturing FacilityAppriva Medical,777 North Pastoria AveSunnyvale, CA 94043and/orMedSource Technologies3310 Montgomery DriveSanta Clara, CA 95054 | Sterilization SiteCenturion Sterilization Services301 Catrell DriveHowell, MI 48843 |
| Classification | The FDA has classified devices of this type as Class II devices (21CFR870.1340, Catheter Introducer). | |
| Reason for Pre-market Notification(Substantial Equivalence) | The intended use for the X-Sept Transseptal Sheath and TransitionCatheter (with Dilator) is substantially equivalent to the X-SeptTransseptal Sheath and Transition Catheter marketed by ApprivaMedical, Inc. The intended use is also consistent with the identificationin 21CFR870.1340, which states that a catheter introducer is a sheathused to facilitate placing a catheter through the skin into a vein or artery.The X-Sept Transseptal Sheath and Transition Catheter (with Dilator) issubstantially equivalent in materials and design parameters to theAppriva Medical, Inc, X-Sept Transseptal Sheath and TransitionCatheter. In instances where technological characteristics are different, ithas been demonstrated through biocompatibility and in-vitro (functional)testing that there are no questions raised regarding safety or efficacy ofthe device. | |
| Identification of Predicate Device | Manufacturer and Device NameAppriva Medical, Inc., X-SeptTransseptal Sheath and TransitionCatheter (with Dilator) | 510(k) NumberK002054 |
| Compliance with PerformanceStandards | None are established under Section 514, |
Date
Michael Kolber Vice President, Regulatory Affairs and Quality Assurance
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2001
Mr. Michael Kolber Vice President, Regulatory Affairs and Quality Assurance Appriva Medical, Inc. 777 North Pastroia Ave. Sunnyvale, CA 94043
K012489 Re:
X-Sept Transseptal Sheath and Transition Catheter Regulation Number: 870.1340 Regulatory Class: II (two) Product Code: DYB Dated: August 2, 2001 Received: August 3, 2001
Dear Mr. Kolber:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Michael Kolber
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
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Sincerely yours.
,
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2 Indications for Use Statement
| 510(k) Number: | K002054 K012489 |
|---|---|
| Device Name: | X-Sept Transseptal Sheath and Transition Catheter (with Dilator) |
| Indications for use: | The X-Sept Transseptal Sheath and Transition Catheter is indicatedfor percutaneous introduction of various cardiovascular devices intothe left side of the heart through the atrial septum. |
Division of Cardiovascular & Respiratory Devices
510(k) Number Kel 2489
. . . . .
§ 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).