(134 days)
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Not Found
No
The summary describes a simple introducer set for pacing leads and catheters, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as an introducer set for pacing leads and catheters, which are tools used for introduction, not for treating a disease or condition itself.
No
The device's intended use is for the introduction of pacing leads and catheters, which is a procedural function, not a diagnostic one. It does not mention analyzing or interpreting any data to identify diseases or conditions.
No
The summary describes "Introducer sets, models Adelante Sigma, Adelante Sigma AT and Adelante Targa" which are physical devices used for introducing leads and catheters. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the introduction of pacing leads and catheters into the body." This describes a device used in vivo (within the living body) for a procedural purpose.
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body.
The description clearly indicates a device used directly on a patient for a medical procedure, not for analyzing samples in a lab.
N/A
Intended Use / Indications for Use
The Introducer sets, models Adelante Sigma, Adelante Sigma AT and Adelante Targa are indicated for the introduction of pacing leads and catheters into the body.
Product codes
DYB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
JUN - 4 2009
Oscor, Inc. c/o Ms. Mila Doskocil Director of Regulatory Affairs/Compliance 3816 De Soto Boulevard Palm Harbor, FL 34683
Re: K090114
Trade/Device Name: Introducer Set, Models Adelante Sigma, Adelante Sigma AT, and Adelante Targa Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 1, 2009
Received: May 5, 2009
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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.
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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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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" (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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. Valenes
Image /page/1/Picture/6 description: The image contains a handwritten symbol or signature on the left side. To the right of the symbol, there are three lines of text, but the text is illegible due to the image quality. The symbol appears to be a stylized letter or a unique design.
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
510(k) Number (if known): K090114
Device Name: Introducer Sets, models Adelante Sigma, Adelante Sigma AT, and Adelante Targa
Indications For Use: The Introducer sets, models Adelante Sigma, Adelante Sigma AT and Adelante Targa are indicated for the introduction of pacing leads and catheters into the body.
Over-The-Counter Use AND/OR Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dana R. Holmes
்vision Sign-Off) Orvision of Cardiovascular Devices
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510(k) Number Ko 9 0 | 4