(69 days)
The steerable guiding sheath, Destino Reach is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
The Destino Reach Steerable Guiding Sheath is a percutaneous steerable sheath designed to facilitate the intracardiac, renal and peripheral placement of diagnostic and therapeutic devices. The device features an adjustable tip through use of a rotating collar that allows the physician to perform a bi-deflection at the distal tip section of the sheath. The sheath has a hemostatic valve, sideport with stopcock, radiopaque distal tip, contains side flush portholes and is deflectable by rotating the collar incorporated into the handle. The dilator has depth markings and locks onto the sheath. The dilator has a tapered distal tip and an inner lumen recommended for use with 0.035" to 0.038" guidewire and/or transseptal needle.
This document describes the Destino Reach, Steerable Guiding Sheath and does not contain information about an AI/ML powered device. Therefore, it does not provide the specific details requested regarding acceptance criteria and a study proving device performance in the context of AI/ML.
The provided document is a 510(k) summary for a medical device (a steerable guiding sheath) that demonstrates substantial equivalence to predicate devices based on design, manufacturing materials, intended use, principles of operation, and technical characteristics. It details traditional medical device testing and regulatory information.
Based on the provided text, I cannot answer the following questions as they pertain to AI/ML device evaluation:
- A table of acceptance criteria and the reported device performance: The document lists standards followed for traditional medical devices (e.g., risk management, sterilization, biocompatibility), but not acceptance criteria for an AI/ML specific performance.
- Sample size used for the test set and the data provenance: Not applicable to a non-AI/ML device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the context of AI/ML.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide regarding device performance and testing:
The "DEVICE PERFORMANCE" section on page 5 and "TESTING" section on page 6 outline the types of evaluations performed for this traditional medical device:
-
Standards followed:
- BS EN ISO 14971:2012, Medical devices - Application of risk management to medical devices
- AAMI/ANSI/ISO 11135: 2014, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
- AAMI/ANSI/ISO 10993-7:2008, Cor. 2009, Biological evaluation of medical devices, Part 7, Ethylene oxide sterilization residuals.
- ISO 10555-1 2013, Intravascular catheters- Sterile and single use catheters, Part 1, General requirements. (Note: Requirements for flow rate and power injections not followed as this does not apply to an introducer.)
- ISO 11070: 1998, Sterile single-use intravascular catheter introducers. (Note: Requirements for needles do not apply since the product is not packaged with a needle).
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Testing Conducted:
- Functional system testing
- Risk analysis
- Biocompatibility
- Packaging/transportation qualification
The claim is that "Based on this testing, we have determined that the device performs as well as the legally marketed predicate devices identified in this summary." This implies that the device met the performance characteristics expected for its class and intended use, as demonstrated by adherence to recognized standards and specific internal verification and validation tests. However, the exact acceptance criteria thresholds for each test and the specific results are not detailed in this summary.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2015
Jan Flegeau Director of Regulatory Affairs Oscor Inc. 3816 DeSoto Blvd Palm Harbor, FL 34683
Re: K151951
Trade/Device Name: Destino Reach, Steerable Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: July 14, 2015 Received: Aug 24, 2015
Dear Mr. Flegeau:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
M. G. Hilleman
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 Statement
510k Number (if known) K151951
Device Name: Steerable Guiding Sheath, Destino Reach
The steerable guiding sheath, Destino Reach is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
Prescription Use X (Per 21 CFR 801.109) (Optional Format 1-2-96) OR
Over-The-Counter Use _____________
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) SUMMARY
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Oscor Inc. is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number K151951
| DATE: | Septembre 21, 2015 |
|---|---|
| APPLICANT: | OSCOR INC.3816 De Soto BoulevardPalm Harbor, Florida 34683 |
| CONTACT PERSON: | Jan FlégeauDirector of Regulatory AffairsPhone: 727-937-2511Fax: 727-934-9835E-mail: jflegeau@oscor.com |
| TRADE/DEVICE NAME: | Destino Reach, Steerable Guiding Sheath |
| DEVICE CLASSIFICATION NAME: | Introducer, catheter |
| REGULATORY CLASSIFICATION: | II |
REGULATION NUMBER: 870.1340
PRODUCT CODE: DYB
REVIEW ADVISORY COMMITTEE: Cardiovascular
MANUFACTURED BY: Oscor Inc.
| Sites | Activity | FDA EstablishmentRegistration |
|---|---|---|
| 3816 De Soto BoulevardPalm Harbor, Florida 34683 | Design, development,manufacture | 1035166 |
| 4875 Palm Harbor Blvd.Palm Harbor FL 34683 | Design, development,manufacture, sterilization | 3010274750 |
| 1053 Progress CourtPalm Harbor FL 34683 | Final pack and Labeling | 3010938037 |
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STERILIZATION SITES: 1. International Sterilization Laboratory Inc. (ISL) 217 Sampey Road Groveland, FL 34736 Or 2. Oscor DMB Sterilizer 3816 De Soto Boulevard Palm Harbor, Florida 34683 INTENDED USE: The Destino Reach, steerable guiding sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements. DEVICE DESCRIPTION The Destino Reach Steerable Guiding Sheath is a percutaneous steerable sheath designed to facilitate the intracardiac, renal and peripheral placement of diagnostic and therapeutic devices. The device features an adjustable tip through use of a rotating collar that allows the physician to perform a bi-deflection at the distal tip section of the sheath. The sheath has a hemostatic valve, sideport with stopcock, radiopaque distal tip, contains side flush portholes and is deflectable by rotating the collar incorporated into the handle. The dilator has depth markings and locks onto the sheath. The dilator has a tapered distal tip and an inner lumen recommended for use with 0.035" to
0.038" guidewire and/or transseptal needle.
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| REASON FOR PREMARKETNOTIFICATION: | New device submission seeking 510(k) clearancefor the Destino Reach, steerable guiding sheath. |
|---|---|
| PREDICATE DEVICES510(k) # and DESCRIPTION | Adelante Destino, steerable guiding sheathK120459 (original submission) andK122960 (modified intended use) |
| Destino Twist, steerable guiding sheathK140406 | |
| MODIFICATION TO PREDICATEDEVICES | The rotating collar/twisting mechanism in thehandle of the Destino Twist (K140406) was addedto the Adelante Destino (K120459 and K122960) tocreate the proposed device Destino Reach. |
| Rationale for these changes: physician preference/customer demand for a bi-directional tip deflectionsteerable guiding sheath with a rotating collartwisting mechanism instead of a deflection lever. | |
| Intended use of the modified device, as describedin the labeling, has not changed as a result of themodifications. | |
| DEVICE PERFORMANCE | Standards followed include:BS EN ISO 14971:2012, Medical devicesApplication of risk management to medical devices |
| AAMI/ANSI/ISO 11135: 2014, Sterilization ofhealth-care products Ethylene oxide -Requirements for the development, validation androutine control of a sterilization process for medicaldevices | |
| AAMI/ANSI/ISO 10993-7:2008, Cor. 2009,Biological evaluation of medical devices, Part 7,Ethylene oxide sterilization residuals | |
| ISO 10555-1 2013, Intravascular catheters- Sterileand single use catheters, Part 1, Generalrequirements. (Requirements for flow rate andpower injections not followed as this does not applyto an introducer.) |
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ISO 11070: 1998. Sterile single-use intravascular catheter introducers. (Requirements for needles do not apply since the product is not packaged with a needle).
TESTING: Oscor Inc. conducted verification and validation testing including functional system testing, risk analysis, biocompatibility and packaging/transportation qualification. Based on this testing, we have determined that the device performs as well as the legally marketed predicate devices identified in this summary.
CONFIDENTIALITY STATEMENT: Oscor Inc. considers this 510(k) notification as confidential commercial information. Oscor Inc. has taken precautions to protect the existence of this submission. To the best of our knowledge, neither Oscor nor any other party has disclosed information concerning this submission through advertisements of any other manner. There have been no prior submissions for the subject device.
SUBSTANTIAL EQUIVALENCE: Oscor Inc. considers the Destino Reach as substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the Adelante Destino K120459 (original submission) and K122960 (modified intended use) and the Destino Twist, steerable guiding sheath K140406.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).