(22 days)
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.
The Outback LTD Re-Entry Catheter is a sterile (via Ethylene Oxide sterilization) device and is intended for single use only.
Here's an analysis of the provided text regarding the Outback LTD Re-Entry Catheter, focusing on acceptance criteria and study details:
Overall Assessment:
The provided document (K083814) is a 510(k) summary for a medical device – a re-entry catheter. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. As such, much of the requested information (like specific acceptance criteria values, sample sizes for test/training, expert details, MRMC studies, standalone performance, and ground truth types) is not present in the provided text. The submission relies solely on non-clinical in-vitro bench testing for its substantial equivalence claim, not clinical studies.
Description of Acceptance Criteria and Study to Prove Device Meets Them
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantitative acceptance criteria or detailed performance data are not explicitly stated. The submission's "Summary of Substantial Equivalence" indicates:
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Substantial Equivalence to Predicate Device (K043534) | "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." |
| Functionality consistent with "facilitating placement and positioning of guidewires and catheters within the peripheral vasculature." | Not explicitly quantified, but assumed to be met through bench testing supporting substantial equivalence. |
| Safety and biocompatibility | Assumed to be met through substantial equivalence to the predicate, which would have undergone its own safety assessments (not detailed here). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "non-clinical in-vitro bench testing" data was collected. No specific number of tests/samples is provided.
- Data Provenance: The data is from non-clinical in-vitro bench testing. The country of origin is not explicitly stated, but the manufacturer (Cordis Corporation) is a Johnson & Johnson Company, likely based in the US (given the regulatory submission to FDA). The data is not clinical (i.e., not from human subjects) and would be considered experimental/bench data, not retrospective or prospective in the clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable / Not Specified. For non-clinical bench testing focused on device functionality and substantial equivalence, "ground truth" as established by medical experts (like radiologists for image analysis) is generally not relevant. The "ground truth" would be the measured physical properties or performance of the device against engineering specifications. The document does not mention any expert involvement in establishing ground truth for the bench tests.
4. Adjudication Method for the Test Set
- Not Applicable / Not Specified. Since the testing is described as non-clinical in-vitro bench testing, an adjudication method (like 2+1, 3+1, etc., typically used for reconciling expert opinions in clinical ground truth establishment) is not described or implied.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is a type of clinical comparative effectiveness study involving human readers' performance with and without AI assistance. The provided document explicitly states that substantial equivalence was demonstrated via "non-clinical in-vitro bench testing," indicating no clinical human-reader studies were conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This device is a physical medical catheter, not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant. The substantial equivalence was based on the physical device's performance in bench tests.
7. The Type of Ground Truth Used
- Not explicitly stated in terms of "ground truth" for clinical data. For the non-clinical in-vitro bench testing, the "ground truth" would be implicitly defined by the engineering specifications and performance characteristics expected of such a catheter, and the performance observed in the predicate device (K043534). This would typically involve physical measurements, material properties, and functional tests (e.g., re-entry success rates in a simulated vessel model, guidewire trackability, etc.). The document does not detail these specific "ground truths."
8. The Sample Size for the Training Set
- Not Applicable / Not Specified. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. Again, no training set for an algorithm exists for this device.
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Cordis Corporation, a Johnson & Johnson Company Outback LTD Re-Entry Catheter
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510(k) Premarket Notification .
510(k) Summary
JAN 1 3 2009
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| Proprietary Name | Common or Usual Name |
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| Outback® LTD™ Re-Entry Catheter | Catheter, percutaneous21 CFR 870.1250Product Code: DQY |
| Name ofPredicateDevices | The device is substantially equivalent to:Outback LTD Re-Entry Catheter (510(k) # K043534) | |
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| Classification | Class II | |
| PerformanceStandards | Performance standards have not been established by the FDA under section514 of the Food, Drug and Cosmetic Act. | |
| Indication forUse | The Outback LTD Re-Entry Catheter is intended to facilitate placement andpositioning of guidewires and catheters within the peripheral vasculature. TheOutback LTD Re-Entry Catheter is not intended for use in the coronary orcerebral vasculature. | |
| DeviceDescription | The Outback LTD Re-Entry Catheter is a sterile (via Ethylene Oxidesterilization) device and is intended for single use only. | |
| Summary ofSubstantialEquivalence | The Outback LTD Re-Entry Catheter is substantially equivalent to thepredicate device. The substantial equivalence to the predicate device has beendemonstrated 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
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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
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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
Page 506
§ 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).