(58 days)
The steerable guiding sheath, model Destino Twist 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
Steerable Guiding Sheath, model Destino Twist
The provided document is a 510(k) clearance letter from the FDA for a medical device called "Destino twist, steerable guiding sheath." This type of document is a regulatory approval, not a scientific study report describing acceptance criteria and device performance data from a specific study. Therefore, the requested information about acceptance criteria, performance data, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies cannot be extracted from the provided text.
The document only states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices for its intended use, which is for the introduction of diagnostic and therapeutic devices into the human vasculature. It does not contain any specific performance data or a study description to support these claims.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00003
'April 17, 2014
Oscor Inc. Ms. Laura Sobrin Regulatory Affairs Manager, International 3816 De Soto Blvd. Palm Harbor. Florida 34683
K 140406 Re:
Trade/Device Name: Destino twist, steerable guiding sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: March 25. 2014 Received: March 27, 2014
Dear Ms. Laura Sobrin,
We have reviewed your Section 510(k) premarket notification of intent to market the device we for the read 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 for use stated in the enorosals) to 10gm) the enactment date of the Medical Device Amendments, or 10 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). and Cosmetic rior (110) that the device, subject to the general controls provisions of the Act. The r our may : dieretore, mains of the Act include requirements for annual registration, listing of general controls proving 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 mislcading.
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 docs not mean Picase or advised mat 1 D/A issuance of a samino on the suith other requirements of the Act that 1127 has mace a determinations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (2 I CFT With an the Acts requirements, methaling of a hee reporting (reporting of means and forth related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - Ms. Laura Sobrin
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.
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,
Bram D. Zuckerman -S
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)
Device Name: Steerable Guiding Sheath, model Destino Twist
The steerable guiding sheath, model Destino Twist 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)
Bram D. Zuckerman -S 2014.04.17 10:25:37 -04'00'
§ 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).