(58 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any performance metrics typically associated with AI/ML algorithms. The device description is for a physical guiding sheath.
No.
The device (steerable guiding sheath) is intended for the introduction of other diagnostic and therapeutic devices, not therapeutic in itself.
No
Explanation: The "Intended Use / Indications for Use" states that the device is intended for the "introduction of diagnostic and therapeutic devices," meaning it facilitates the use of other devices, but is not itself a diagnostic device.
No
The device description explicitly states "Steerable Guiding Sheath, model Destino Twist," which is a physical medical device used for introduction into the vasculature. This is not a software-only 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 the device is for the "introduction of diagnostic and therapeutic devices into the human vasculature". This describes a device used in vivo (within the body) for accessing and delivering other devices.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform such tests.
- Device Description: The description "Steerable Guiding Sheath" further supports its role as a tool for accessing and navigating within the body, not for analyzing samples.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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
Product codes
DYB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human vasculature, including but not limited to intracardiac, renal or other peripheral placements.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized graphic of three horizontal bars, each with a curved end, resembling a stylized human figure.
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
1
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
2
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'