(28 days)
Not Found
No
The summary describes a mechanical catheter with no mention of AI/ML features or data processing beyond visualization under fluoroscopy.
No.
The device facilitates the placement and positioning of catheters and does not directly treat or alleviate a disease or condition.
No
The device's intended use is to "facilitate placement and positioning of catheters," which is an interventional/therapeutic procedure, not a diagnostic one. While it allows for visualization under fluoroscopy, this is for guidance during the procedure, not for diagnosing a condition.
No
The device description clearly details a physical catheter with a shaft, guide, and handle mechanism, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to facilitate placement and positioning of catheters within the peripheral vasculature." This describes a device used in vivo (within the body) for a procedural purpose, not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: The description details a catheter and guide system designed for insertion into blood vessels. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, the Outback Catheter is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Outback Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Outback Catheter is not intended for use in the coronary or cerebral vasculature.
Product codes
74DQY, DQY
Device Description
The Outback catheter features a 6 Fr. steel-braided polyimide and polyurethane shaft through which a single-lumen steel-braided polyimide guide is housed. The guide is extendable and steerable from the tip of the catheter shaft, and features a radiopaque multi-beveled guide tip allowing for visualization under fluoroscopy. A radiopaque index on the catheter shaft is oriented to the steerable guide tip. The proximal end of the Outback Catheter features a rotating hemostasis valve through which the guide is extended and retracted via a rotational handle mechanism.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
JAN 11 2002
Perclose, Special 510(k) Application Outback™ Catheter Confidential
VII. SPECIAL 510(K) SUMMARY
| | A. Sponsor/Submitter: | Perclose, An Abbott Laboratories Company
400 Saginaw Drive
Redwood City, CA 94063
Tel: (650) 474-3000
Fax: (650) 474-3020 |
|--|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | B. Contact Person: | Sevrina Ciucci
Regulatory Affairs Coordinator
(650) 474-3164 |
| | C. Date of Submission: | December 12, 2001 |
| | D. Trade (Brand) Name: | Outback™ Catheter |
| | E. Common Name: | Percutaneous Catheter |
| | F. Classification: | Class II |
| | G. Classification Name: | Percutaneous Catheter, 21 CFR Part 870.1250 |
| | H. Product Code: | 74DQY |
| | I. Predicate Device: | Outback™ Catheter (K001577) |
J. Intended Use:
The Outback Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Outback Catheter is not intended for use in the coronary or cerebral vasculature.
K. Device Description:
The Outback catheter features a 6 Fr. steel-braided polyimide and polyurethane shaft through which a single-lumen steel-braided polyimide guide is housed. The guide is extendable and steerable from the tip of the catheter shaft, and features a radiopaque multi-beveled guide tip allowing for visualization under fluoroscopy. A radiopaque index on the catheter shaft is oriented to the steerable guide tip. The proximal end of the Outback Catheter features a rotating hemostasis valve through which the guide is extended and retracted via a rotational handle mechanism.
L. Summary of Substantial Equivalence:
Perclose has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that the Outback Catheter is equivalent to currently marketed predicate device.
1
The Outback Catheter has the same intended use and technological characteristics as the Outback Catherer has the battle of scientific testing have ensured that all the predicate device (18001977). Results of costs were introduced and physical properties are appropriate for the intended use.
In conclusion, the Outback Catheter has been shown to be equivalent to the Class II
n is he conce In conclusion, the Outback Catheter has over the count of the device is based.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2002
Ms. Sevrina Ciucci Regulatory Affairs Perclose, An Abbott Laboratories Company 400 Saginaw Drive Redwood City, CA 94063
Re: K014117 Trade Name: Outback™ Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: December 12, 2001 Received: December 14, 2001
Dear Ms. Ciucci:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Sevrina Ciucci
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dr has intatutes and regulations administered by other Federal agencies. You must or any I coclar sunated and regerments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 8077, adoling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yours of substantial equivalence of your device to a legally promatics noticated 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 21 1 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oivision 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
Sincerely yours,
Deeda Telke
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
V. INDICATIONS FOR USE STATEMENT
Special 510(k) Number:
Device Name:
Indications for Use:
The Outback Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Outback Catheter is not intended for use in the coronary or cerebral vasculature.
There is no change to the Indications for Use.
Prescription Use
(Per 21 CFR 801.109)
KO14117
Outback™ 0.035" Catheter
Division of Cardiovascular & Respiratory Devices
510(k) Number B014117