(121 days)
Not Found
Not Found
No
The summary describes a mechanical introducer device and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is an introducer, used to facilitate the placement of other catheters into the heart. It does not actively treat a disease or condition itself.
No
The device is described as an introducer for various cardiovascular catheters, facilitating access to the left side of the heart. Its function is to introduce other catheters, not to diagnose a condition.
No
The intended use clearly describes a physical introducer device used to introduce catheters, indicating it is a hardware device, not software-only.
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 used to introduce catheters into the left side of the heart. This is an invasive procedure performed in vivo (within a living organism).
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health.
The description of the device's function and anatomical site confirms it's used directly within the patient's body, not for testing samples in a lab.
N/A
Intended Use / Indications for Use
The EP Dynamics, Inc. AirBloc™ Transseptal Introducer is used to introduce various cardiovascular catheters into the left side of the heart through the interatrial septum.
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
left side of the heart through the interatrial septum
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
Not Found
Key Metrics
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
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 consists of a stylized eagle with three stars above it, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EP Dynamics. Inc. c/o Albert Rego, Ph.D. 27001 La Paz #314 Mission Viejo, CA 92691
JUL 8 0 2009
Re: K090867
Trade/Device Name: AirBloc™ Transseptal Introducer Common Name: Catheter Introducer Regulation Number: 21 CFR 870.1340 Regulatory Class: II Product Code: DYB Dated: July 17, 2009 Received: July 23, 2009
Dear Dr. Rego:
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.
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.
1
· Page 2 - Albert Rego, Ph.D.
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/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely your
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K090867
Device Name:
AirBloc™ Transseptal Introducer
Indications for Use:
The EP Dynamics, Inc. AirBloc™ Transseptal Introducer is used to introduce various cardiovascular catheters into the left side of the heart through the interatrial septum.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR Over-The-Counter-Use
(Part 12 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _
(Division Sign-Off) Division bit Cardlovascular Devices 510(k) Numbər 109086 F