(89 days)
The 1.4 Fr MAPCath Sensor Stylet is designed to be used with the NAVIGATOR Cathotors (CVCc) by indicating the position and direction of the CVC tip inside the body during the catheter insertion procedure.
The sensor stylet described in this 510(k) submission is the same product described in Bard Access Systems 510(k) (reference K935380).
I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) summary for a medical device (1.4 Fr MAPCath sensor stylet) and focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as you've requested.
The document states:
- The device is "substantially equivalent (same product) to the 1.4 Fr sensor stylet described in Bard Access Systems submission K935380 and substantially equivalent in design, use and function to the Navion SMART-WIRE sensor described in submission K901263."
- "The sensor stylet described in this 510(k) submission is the same product described in Bard Access Systems 510(k) (reference K935380)."
This indicates that the submission relies on the prior clearances and the equivalence of the device, rather than presenting new performance study data against defined acceptance criteria.
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Image /page/0/Picture/0 description: The image shows the logo for Navion Biomedical. The logo consists of a circle with horizontal lines and an arrow pointing upwards. To the right of the circle is the word "NAVION" in large, bold letters, and below that is the word "BIOMEDICAL" in smaller letters.
K97-305:7
NOV 1 2 1997
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
The design, use and function of the 1.4 Fr MAPCath sensor stylet described in this pre-market notification are substantially equivalent (same product) to the 1.4 Fr sensor stylet described in Bard Access Systems submission K935380 and substantially equivalent in design, use and function to the Navion SMART-WIRE sensor described in submission K901263.
A table comparing the physical features of the proposed 1.4 Fr MAPCath sensor stylet to the one that received concurrence under K935380 and the original sensor stylet in K901263 is shown in Exhibit 6.
The 510(k) "Substantial Equivalence Decision-Making Process" decision tree (exhibit 7) was used to make the substantial equivalence determination. The decision tree questions and answers are as follows:
1.0 Does the new device have same indication statements?
Yes. The sensor stylet described in this 510(k) submission has the same indications for use as the current Navion MAPCath (SMART-WIRE) sensor stylet and the current Bard Access Systems sensor stylet. They are designed, when used in conjunction with the catheter locator instrument, to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure
2.0 Does new device have same technological characteristics, e.g., design, material, etc.?
Yes. The sensor stylet described in this 510(k) submission is the same product described in Bard Access Systems 510(k) (reference K935380).
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Are the descriptive characteristics precise enough to ensure equivalence? 3.0
Yes. The sensor stylet described in this 510(k) submission is the same product that received concurrence under K935380.
Sandy A. Kay
Donald A Kay President, Navion Biomedical Corp.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard NOV | 2 |9:9g ville MD 20850
Mr. Donald A. Kay ·President Navion Biomedical Corporation 312 Tosca Drive Stoughton, Massachusetts 02072
K973057 Re : 1.4 Fr MAPcath Sensor Stylet Trade Name: Regulatory Class: Unclassified Product Code: LJS Dated: August 7, 1997 Received: August 15, 1997
Dear Mr. Kay:
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 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 The general controls provisions of the Act 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 Existing major be subject to such additional controls. regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the Good Manufacturinq Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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 Please note: this response to your the Federal Reqister. 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. Kay
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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97) Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page l of
וכענ K97 510(k) Number (if known):
SENSOR STYLET 1.4 FR MAPCATH Device Name:__
Indications For Use:
The 1.4 Fr MAPCath Sensor Stylet is designed to be used with the The 1.4 FF MAPCath Sensor Directument to aid in the placement of NAVIGATOR Cathotors (CVCc) by indicating the position and direction of the CVC tip inside the body during the catheter insertion procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANQTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patrucia Cucente
Deision Sign-Off) Dission of Dental, Infection Control, and General Hospital Devices
, 10(k) Number________________________________________________________________________________________________________________________________________________________________
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”