(23 days)
Not Found
No
The 510(k) summary describes a guiding catheter, a mechanical device used for intravascular introduction of other devices. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on material properties and mechanical equivalence.
No
The device is a guiding catheter used for the intravascular introduction of other interventional devices, not for diagnosing, treating, or preventing disease itself.
No
The device is described as a "guiding catheter designed for the intravascular introduction of interventional devices," which indicates an interventional/therapeutic purpose rather than a diagnostic one. Its stated function is to deliver other devices, not to collect diagnostic information or perform analysis.
No
The device description explicitly states it is a guiding catheter, which is a physical medical device used for intravascular introduction of other devices. The performance studies also focus on physical characteristics and testing of the catheter material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the intravascular introduction of interventional devices." This describes a device used within the body to facilitate a medical procedure, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description details a catheter used for guiding other devices within blood vessels. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the SCHNEIDER GUIDER® Softip® guiding catheter is an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SCHNEIDER GUIDER® Softip® guiding catheter is designed for the intravascular introduction of interventional devices.
Product codes
DOY
Device Description
The SCHNEIDER GUIDER® guiding catheter is manufactured in four French sizes (6 through 9 FR) and multiple distal stem configurations and lengths. In addition, within each French size, catheters will be offered with differing handling characteristics to allow flexibility in meeting physician preferences.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intravascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The equivalence of the SCHNEIDER GUIDER® Softip® guiding catheter with new stem material was demonstrated through comparison of design with the original and summary of the design control activities undertaken to verify equivalence of the added material. Testing included biocompatibility, tip tensile pull, pressure injection leak test and shape recovery. The results of design control activities indicated that the modified SCHNEIDER GUIDER® Softip® guiding catheters are equivalent to the currently marketed SCHNEIDER GUIDER® Softip® guiding catheters and are, therefore, safe for the intended use.
Key Metrics
Not Found
Predicate Device(s)
SCHNEIDER GUIDER® Softip® guiding catheters
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
MAY | 3 1998
510(k) Summary for SCHNEIDER GUIDER® Softip® guiding catheter
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. The assigned 510(k) number is __________________________________________________________________________________________________
| Date Prepared: | April 15, 1996 |
|---|---|
| Sponsor: | Schneider (USA) Inc |
| 5905 Nathan Lane | |
| Plymouth, MN 55442 | |
| Phone: (612)550-5500 | |
| Contact: | Maria Brittle |
| Sr. Regulatory Affairs Specialist | |
| Trade/Proprietary Name: | SCHNEIDER GUIDER® Softip® guiding catheters |
| Classification: | Class II |
| Equivalent Devices | SCHNEIDER GUIDER® Softip® guiding catheters |
Device Description
The SCHNEIDER GUIDER® guiding catheter is manufactured in four French sizes (6 through 9 FR) and multiple distal stem configurations and lengths. In addition, within each French size, catheters will be offered with differing handling characteristics to allow flexibility in meeting physician preferences.
Intended Use
The SCHNEIDER GUIDER® Softip® guiding catheter is designed for the intravascular introduction of interventional devices.
Technological Characteristics
The equivalence of the SCHNEIDER GUIDER® Softip® guiding catheter with new stem material was demonstrated through comparison of design with the original and summary of the design control activities undertaken to verify equivalence of the added material. Testing included biocompatibility, tip tensile pull, pressure injection leak test and shape recovery.
The results of design control activities indicated that the modified SCHNEIDER GUIDER® Softip® guiding catheters are equivalent to the currently marketed SCHNEIDER GUIDER® Softip® guiding catheters and are, therefore, safe for the intended use.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of a human figure, with three profiles overlapping to create a sense of depth and community. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 1998
Ms. Marie Brittle Sr. Regulatory Affairs Specialist Schneider (USA) Inc. Pfizer Hospital Products Group 5905 Nathan Lane Minneapolis, MN 55442
Re: K981413 Trade Name: SCHNEIDER GUIDER® Softip® Guiding Catheters Requlatory Class: II Product Code: DOY Dated: April 17, 1998 Received: April 20, 1998
Dear Ms. Brittle:
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 qeneral 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
2
Page 2 - Ms. Maria Brittle
under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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) 594-4618. 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 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".
Sincerely yours,
Thomas J. Callahan, Ph.D.
Division o Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SCHNEIDER GUIDER Softip™ Guiding Catherer
Page of
510(k) Number (if known):
Device Name:
SCHNEIDER GUIDER Softip® Guiding Catheter
Indications for Use:
The SCHNEIDER GUIDER Softip® Guiding Catheter is designed for the intravascular introduction of interventional devices.
Taca A. Re
JIVISION 64-6 Division of Cardiovascular, Respiratory, nd Neurological Devices : ロツk) Numbs: …… 1198/413
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)