(442 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
Explanation: The device is an introducer for catheters, meaning it facilitates the insertion of other devices. It does not provide any direct therapeutic benefit itself, such as treating a disease or condition. Its function is purely instrumental for diagnostic or therapeutic procedures performed by other catheters.
No
The device is described as an introducer for cardiovascular catheters, indicating its role in facilitating interventional procedures, not in diagnosing a condition.
No
The device is described as a "Transseptal Introducer," which is a physical medical device used to introduce catheters. There is no mention of software being 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 to introduce catheters into the heart, which is an in vivo procedure (performed within a living organism).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool for accessing a specific anatomical location within the body for a therapeutic or diagnostic procedure, but it doesn't perform the diagnostic analysis itself.
N/A
Intended Use / Indications for Use
The EP Dynamics, Inc., LineBacker™ 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 2 3 2012
EP Dynamics, Inc. c/o Albert Rego, PhD Regulatory Consultant 27001 La Paz Road, Suite 312 Mission Viejo, CA 92691
Re: K111603
Trade/Device Name: LineBacker Transseptal Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: August 3, 2012 Received: August 7, 2012
Dear Dr. Rego:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass bared in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1977, ins 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 r ou may, thereferey minuss of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. " Teace noter, 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 IT your device is clussified (boo above). Existing major regulations affecting your device can be may of subject to additions, Title 21, Parts 800 to 898. In addition, FDA may round in further announcements concerning your device in the Federal Register.
1
Page 2 - Dr. Albert Rego
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/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" (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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hilleber
/ Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
000087
411603
510(k) Number (if known): Unknown
LineBacker™ Transseptal Introducer Device Name:
Indications for Use:
The EP Dynamics, Inc., LineBacker™ Transseptal Introducer is used to introduce various cardiovascular catheters into the left side of the heart through the interatrial septum.
Prescription Use × (Part 12 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (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 __
Vandervoort Mr. Wheeler
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number L111603