(22 days)
Not Found
No
The summary describes a mechanical catheter for guidewire placement and does not mention any AI/ML terms or capabilities.
No
The device is intended to facilitate placement and positioning of guidewires and catheters, not to treat a medical condition directly.
No
The device is described as facilitating placement and positioning of guidewires and catheters, which is an interventional function, not a diagnostic one.
No
The device description clearly states it is a "catheter," which is a physical, hardware medical device. There is no mention of software as the primary or sole component.
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 for facilitating placement and positioning of guidewires and catheters within the peripheral vasculature. This describes a device used in vivo (inside the body) for a procedural purpose.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. The Outback LTD Re-Entry Catheter does not perform any such testing on bodily samples.
- Device Description: The description focuses on the physical characteristics and sterilization of a catheter, which is consistent with an in vivo medical device.
Therefore, the Outback LTD Re-Entry Catheter is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Outback LTD Re-Entry Catheter is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The Outback LTD Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY, PDU
Device Description
The Outback LTD Re-Entry Catheter is a sterile (via Ethylene Oxide sterilization) device and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature. The Outback LTD Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The substantial equivalence to the predicate device has been demonstrated via data collected from non-clinical in-vitro bench testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Outback LTD Re-Entry Catheter (510(k) # K043534)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Cordis Corporation, a Johnson & Johnson Company Outback LTD Re-Entry Catheter
・ .
510(k) Premarket Notification .
510(k) Summary
JAN 1 3 2009
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The name of the device is:
Provisions
General
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| Proprietary Name | Common or Usual Name |
|---|---|
| Outback® LTD™ Re-Entry Catheter | Catheter, percutaneous |
| 21 CFR 870.1250 | |
| Product Code: DQY |
| Name of
Predicate
Devices | The device is substantially equivalent to:
Outback LTD Re-Entry Catheter (510(k) # K043534) | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Classification | Class II | |
| Performance
Standards | Performance standards have not been established by the FDA under section
514 of the Food, Drug and Cosmetic Act. | |
| Indication for
Use | The Outback LTD Re-Entry Catheter is intended to facilitate placement and
positioning of guidewires and catheters within the peripheral vasculature. The
Outback LTD Re-Entry Catheter is not intended for use in the coronary or
cerebral vasculature. | |
| Device
Description | The Outback LTD Re-Entry Catheter is a sterile (via Ethylene Oxide
sterilization) device and is intended for single use only. | |
| Summary of
Substantial
Equivalence | The Outback LTD Re-Entry Catheter is substantially equivalent to the
predicate device. The substantial equivalence to the predicate device has been
demonstrated via data collected from non-clinical in-vitro bench testing. | |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized design of an abstract human figure. The figure is composed of three curved lines that form the shape of a person in motion. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cordis Corporation Ms. Karen Wilk Regulatory Affairs Manager 7 Power Horn Drive Warren, NJ 07059
Re: K083814
Trade/Device Name: Outback LTD Re-Entry Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: December 19, 2008 Received: December 22, 2008
SEP 1 8 2013
Dear Ms. Wilk:
This letter corrects our substantially equivalent letter of January 13, 2009.
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
2
Page 2 - Ms. Karen Wilk
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 forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Zhn.Z
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Premarket Notification
1 of
Cordis Corporation, a Johnson & Johnson Company Outback LTD Re-Entry Catheter
Indications for Use
510/k) Number (if known): 1083814
Device Name: Outback LTD Re-Entry Catheter
Indication for Use: The Outback LTD Re-Entry Catheter is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The Outback LTD Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.
Prescription Use _X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLRASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Bvaluation (ODE)
Dummer R. V. Holmes
(Division or Office)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k o 8 38 | 4
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