DESTINO TWIST, STEERABLE GUIDING SHEATH

K140406 · Oscor, Inc. · DYB · Apr 17, 2014 · Cardiovascular

Device Facts

• Record ID: K140406
• Device Name: DESTINO TWIST, STEERABLE GUIDING SHEATH
• Applicant: Oscor, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 17, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended 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

Device Story

Destino Twist is a steerable guiding sheath used by physicians to facilitate the introduction of diagnostic and therapeutic devices into the human vasculature. The device provides a steerable pathway for catheter access to target sites, including intracardiac, renal, and peripheral locations. It is intended for clinical use in hospital or interventional settings. The device is not for use in neural vasculature. By providing steerability, it assists the clinician in navigating complex vascular anatomy to deliver interventional tools, potentially improving procedural efficiency and access to target treatment areas.

Clinical Evidence

Bench testing only.

Technological Characteristics

Steerable guiding sheath; catheter introducer design. Materials are biocompatible for vascular use. Features a steerable mechanism for navigation. Sterilized for single use.

Indications for Use

Indicated for introduction of diagnostic and therapeutic devices into human vasculature, including intracardiac, renal, or peripheral placements. Contraindicated for neural placements.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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'