(135 days)
Not Found
No
The device description and performance studies focus on the mechanical and functional aspects of a steerable guiding sheath, with no mention of AI or ML technologies.
No.
The device is a guiding sheath intended to facilitate the placement of diagnostic and therapeutic devices, not to provide therapy itself.
No
This device is a steerable guiding sheath intended to facilitate the placement of other diagnostic and therapeutic devices, not to perform diagnostic functions itself.
No
The device description clearly outlines physical components (shaft, steerable handle, side port, dilator) and performance studies focus on physical properties and functionality, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the intracardiac placement of diagnostic and therapeutic devices." This describes a device used during a medical procedure to deliver other devices, not a device used to perform a diagnostic test on a sample taken from the body.
- Device Description: The description details a physical device (sheath, handle, side port, dilator) designed for maneuverability and access within the heart. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Measurement of analytes
- Diagnostic interpretation of results
The device is a medical device used for procedural support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The steerable guiding sheath, model Adelante® Destino, is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.
Product codes
DYB
Device Description
The steerable guiding sheath, model Adelante® Destino, is designed to assist with the introduction of intravascular devices into the heart using a steerable feature to provide better maneuverability and easier access to hard-to-reach places in the heart. On the steerable handle there is a side port for aspiration and flushing. The guiding sheath comprises of: shaft, steerable handle and side port. The dilator is included with each sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Functional and performance testing was conducted to assess the safety and effectiveness of the Adelante® Destino.
Tests performed include: Sheath visual and dimensional test, Pull test of sections test, Sheath hub bond test, Freedom from air leakage test, Kink and roll test, Deflection and handle test, Sheath thermal shock test, Dilator visual and dimensional test, Sheath and dilator fit, functionality, and transition test, Device insertion and withdrawal test, Dilator thermal shock test, EtO residual levels testing, Bioburden testing, Endotoxins testing, Product sterility testing. All tests passed their respective acceptance criteria.
The following tests were performed on the Oscor predicate device, Adelante Breezeway, and adopted to the Adelante Destino: Dilator to transseptal needle and guidewire visual and dimensional test, Dilator body to hub bond test, Sheath side port holes flush test, Radio-detectability test.
Conclusion: The test data results support the determination of substantial equivalency to predicate devices and it can be concluded that the device is safe and effective for its Intended Use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
JUN 2 9 2012
Submitted by: Oscor Inc. 3816 De Soto Blvd. Palm Harbor, FL. 34683
June 29, 2012
This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of 21 CFR. Part 807.92.
The assigned 510(k) number is K120459.
1. Contact Person:
Ms. Mila Doskocil Vice President of Regulatory Affairs & Quality Assurance Oscor Inc. 3816 De Soto Blvd.
Palm Harbor, FI. 34683
- Phone: (727) 937-2511
- Fax: (727) 934-9835
2. Device Name and Classification
- Trade Name: Adelante® Destino .
- Common/Usual Name: Steerable Guiding Sheath .
- Classification Name: Introducer, Catheter ●
- Device Class : Class II .
- Regulation Number: 21 CFR 870.1340 .
- Classification Panel : Cardiovascular .
- . Product Code: DYB
3. Substantial Equivalence
The Adelante® Destino is substantially equivalent to the following predicate devices:
-
- Oscor Delivery Sheath, Model Adelante Breezeway 510k #K101497
- St. Jude Medical Agilis NxT Steerable Introducer 510k #K081645 2)
- Medtronic FlexCath Steerable Sheath 510k #K102176 3)
4. Device Description
The steerable guiding sheath, model Adelante® Destino, is designed to assist with the introduction of intravascular devices into the heart using a steerable feature to provide better maneuverability and easier access to hard-to-reach places in the heart. On the steerable handle there is a side port for aspiration and flushing. The guiding sheath comprises of: shaft, steerable handle and side port. The dilator is included with each sheath.
5. Intended Use of the Device
The steerable guiding sheath, model Adelante® Destino, is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.
6. Summary of Technological Characteristics of the Device Compared to the Predicate Devices
The Adelante® Destino Steerable Guiding Sheath has similar technological characteristics as the predicate devices mentioned above. They are similar in materials, function, and intended use. The difference from predicate devices is in the incorporation of a steerable handle to deflect the distal end of the sheath and the reinforcement of the tip using multiple biocompatible materials.
1
7. Tests and Conclusions
Functional and performance testing was conducted to assess the safety and effectiveness of the Adelante® Destino. See table below
| Test Name/ Description | Acceptance Criteria | Pass /Fail |
|---|---|---|
| Sheath visual and dimensional test | Visual and dimensional specifications and requirements for the | |
| Destino sheath must be met. | Pass | |
| Pull test of sections test | Joints must withstand a pull force of15 N or 3.37 lbf. | Pass |
| Sheath hub bond test | Sheath to hub joint must withstand a pull force of 15 N or 3.37 | |
| lbf. | Pass | |
| Freedom from air leakage test | Sheath must not leak prior to and after the insertion of the | |
| dilator and a catheter/device. | Pass | |
| Kink and roll test | The device should be free of any kinks and bends (before and | |
| after dilator removal). The sheath body sections must be | ||
| smooth, properly bonded, and free from damages after the roll | ||
| test. | Pass | |
| Deflection and handle test | Assembled sheath should deflect 180 degrees in one direction | |
| and 90 degrees in the other direction. | ||
| Sheath should move less than 20 degrees total after | ||
| introducing test piece ten times. | ||
| Lock should not break or the handle should not separate | ||
| throughout the entire test. | Pass | |
| Sheath thermal shock test | After testing, there shall be no discoloration, broken/frayed | |
| tubing, cracked split caps, or any other constructional defects | ||
| or signs of degradation due to testing. | Pass | |
| Dilator visual and dimensional test | Visual and dimensional specifications and requirements for the | |
| Destino dilator must be met | Pass | |
| Sheath and dilator fit, functionality, and | ||
| transition test | The hubs shall have a female 6% (Luer) taper conical fitting for | |
| syringes. The sheath must allow the insertion of a 8F | ||
| (maximum) device. The dilator must be able to snap/lock into | ||
| the sheath hub. There must be a smooth tapered transition | ||
| between the sheath and dilator tips. The tips must have a | ||
| radius free from sharp edges or damages. Any gap between | ||
| the dilator and sheath must be less than 1 mm. | Pass | |
| Device insertion and withdrawal test | The sheath/dilator tips, as well as the device, must be without | |
| damages after the Seldinger method. | Pass | |
| Dilator thermal shock test | After testing, there shall be no discoloration, broken/frayed | |
| tubing, cracked split caps, or any other constructional defects | ||
| or signs of degradation due to testing. | Pass | |
| EtO residual levels testing | EtO residuals must be within limits | Pass |
| Bioburden testing | Bioburden levels must be within limits | Pass |
| Endotoxins testing | Endotoxins (LAL) levels must be within limits | Pass |
| Product sterility testing | Product must remain sterile | Pass |
The following tests were performed on the Oscor predicate device, Adelante Breezeway, and adopted to the Adelante Destino:
- . Dilator to transseptal needle and guidewire visual and dimensional test
- Dilator body to hub bond test t
- ◆ Sheath side port holes flush test
- . Radio-detectability test
8. Conclusion:
The test data results support the determination of substantial equivalency to predicate devices and it can be concluded that the device is safe and effective for its Intended Use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 9 2012
Oscor, Inc. c/o Ms. Mila Doskocil Vice President of Regulatory Affairs and Quality Assurance/Compliance 3816 De Soto Blvd. Palm Harbor, FL 34683
Re: K120459
Trade Name: Adelante Destino Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II (two) Product Code: DYB Dated: June 18, 2012 Received: June 19, 2012
Dear Ms. Doskocil:
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. Iisting 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.
3
Page 2 - Ms. Mila Doskocil
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
M. G. Willhoite
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
4
Attachment 2
Indications for Use Statement
K120459 510k Number (if known) –
Device Name: Steerable Guiding Sheath, model Adelante Destino
The steerable guiding sheath, model Adelante Destino is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.
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)
M.A. Wilhelmsen
(Division Sian-Off) Division of Cardiovascular Devices
1120459 510(k) Number