(30 days)
Not Found
No
The summary describes a mechanical catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as facilitating placement and positioning of guidewires and catheters, which are tools used in therapeutic procedures, rather than directly treating a disease or condition itself.
No
The device is described as a re-entry catheter intended to facilitate the placement of guidewires and catheters. Its function is to aid in a medical procedure, not to diagnose a condition.
No
The device description clearly outlines physical components (Cannula, Catheter shaft, Deployment handle) and performance studies focus on physical characteristics and testing, indicating it is a hardware device.
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 the placement and positioning of guidewires and catheters within the peripheral vasculature. This is an in vivo procedure (within a living organism).
- Device Description: The description details a catheter designed for use within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body's internal structures in the way this catheter does.
N/A
Intended Use / Indications for Use
The OUTBACK® Elite Re-Entry Catheter is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The OUTBACK® Elite Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.
Product codes
PDU
Device Description
The OUTBACK® Elite Re-Entry Catheter is a single-use device designed to facilitate placement and positioning of guidewires within the peripheral vasculature. The device consists of three primary elements: 1) Cannula, 2) Catheter shaft, and 3) Deployment handle with deployment control slide. The OUTBACK® Elite Re-Entry Catheter is supplied sterile and is available in two useable lengths.
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
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 following performance data were provided in support of the substantial equivalence determination:
Biocompatibility Testing:
- In vitro Cytotoxicity MEM Elution
- In vitro Hemolysis - ASTM Extract & Direct Contact
- USP Containers - Plastics, Physicochemical Tests
Device Dimensional and Functional Testing:
- Device Joint Tensile Strength
- Catheter Torqueability
- Device Joint Torque to Failure
Packaging and Sterilization Testing:
- Sterilization Validation
- Sterilization Loading Configuration Evaluation
- Bioburden
- EO residuals
- Bacterial Endotoxin
- NPRT
- D-Value
- Blue Dye Penetration
- Peel Strength
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three heads, representing health, services, and people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2015
Cordis Corporation Michelle Ragozzino Rodgers, Ph.D. Senior Regulatory Affairs Specialist 6500 Paseo Padre Parkway Fremont, California 94555
Re: K150836
Trade/Device Name: OUTBACK Elite Re-Entry Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: March 26, 2015 Received: March 30, 2015
Dear Dr. Ragozzino Rodgers:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150836
Device Name OUTBACK Elite Re-Entry Catheter
Indications for Use (Describe)
The OUTBACK Elite Re-Entry Catheter is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The OUTBACK Elite Re-Entry Catheter is not intended for use in the coronary or cerebral vaculature.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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2. 510(K) SUMMARY
I. SUBMITTER
Cordis Corporation, a Johnson & Johnson Company 6500 Paseo Padre Parkway Fremont, CA 94555
Contact Person: Michelle Ragozzino Rodgers, Ph.D. (510) 248-2450 Tel: (510) 248-2533 Fax:
Date Prepared: March 26, 2015
II. DEVICE
Name of Device: OUTBACK® Elite Re-Entry Catheter Common Name: Percutaneous catheter Classification Name: Catheter for Crossing Total Occlusions (21 CFR §870.1250) Regulatory Class: Class II Product Code: PDU
III. PREDICATE DEVICE
OUTBACK® LTD™ Re-Entry Catheter, previously cleared on 1/13/2009 under K083814
DEVICE DESCRIPTION IV.
The OUTBACK® Elite Re-Entry Catheter is a single-use device designed to facilitate placement and positioning of guidewires within the peripheral vasculature. The device consists of three primary elements: 1) Cannula, 2) Catheter shaft, and 3) Deployment handle with deployment control slide. The OUTBACK® Elite Re-Entry Catheter is supplied sterile and is available in two useable lengths.
V. INDICATIONS FOR USE
The OUTBACK® Elite Re-Entry Catheter is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The OUTBACK® Elite Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The OUTBACK® Elite Re-Entry Catheter is identical to the predicate OUTBACK® LTD™ Re-Entry Catheter in its basic design, intended use. Indications for Use statement, contraindications, mechanism of action, operating principle, sterilization method and Sterility Assurance Level (SAL). The changes to the subject device relative to the predicate are limited to a modified deployment handle, a modified packaging design, the addition of a shorter length device, and labeling updates. No modifications were made to the direct patient-contacting components (i.e.
4
the cannula and the catheter shaft) of the subject device other than the addition of a shorter length product code, in which catheter useable length is the only change. Other dimensional specifications, including the nosecone OD, catheter shaft OD, cannula reach, sheath compatibility and guidewire compatibility are identical to the predicate. Design verification and validation testing demonstrate that the catheter continues to meet all previous performance specifications and that none of the critical clinical performance parameters have changed.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility Testing
Biocompatibility testing was performed on finished and sterilized OUTBACK® Elite Re-Entry Catheters in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR Part 58 and per ISO 10993-1:2009/Cor 1:2010 Biological evaluation of medical devices - Part 1. Biocompatibility testing included the following:
- In vitro Cytotoxicity MEM Elution ●
- In vitro Hemolysis - ASTM Extract & Direct Contact
- . USP Containers - Plastics, Physicochemical Tests
Device Dimensional and Functional Testing
- Device Joint Tensile Strength
- o Catheter Torqueability
- Device Joint Torque to Failure o
Packaging and Sterilization Testing
- Sterilization Validation
- o Sterilization Loading Configuration Evaluation
- o Bioburden
- EO residuals ●
- Bacterial Endotoxin ●
- NPRT
- D-Value ●
- Blue Dye Penetration ●
- Peel Strength o
VIII. CONCLUSIONS
The subject OUTBACK® Elite Re-Entry Catheter is the same in basic design and has the identical intended use as the legally marketed predicate, OUTBACK® LTD™ Re-Entry Catheter. The modifications made to the handle design and packaging and the addition of a shorter 80 cm
5
device do not alter the fundamental scientific technology of the device's operating principles, mechanism of action, intended use, or the indication for use of the device. The design modifications made to the OUTBACK® Elite Re-Entry Catheter were verified and validated through a series of tests ensuring that the subject catheter meets all specifications and that the performance and functionality are substantially equivalent to the predicate device. The OUTBACK® Elite Re-Entry Catheter continues to meet all previous performance specifications and none of the critical clinical performance parameters have changed. The modifications do not raise new questions of safety and effectiveness. OUTBACK® Elite Re-Entry Catheter can be used according to its intended use and in an equivalent manner to the predicate device. The OUTBACK® Elite Re-Entry Catheter is substantially equivalent to the predicate OUTBACK® LTDTM Re-Entry Catheter.