(154 days)
No
The description focuses on the mechanical and structural features of a guiding sheath, with no mention of AI or ML capabilities.
No
The device is described as a "guiding sheath" designed to "facilitate the delivery of therapeutic devices into the heart," indicating it is an accessory for therapy rather than a therapeutic device itself.
No
The device description clearly states it is designed for "introducing various cardiovascular catheters into the heart" and to "facilitate the delivery of therapeutic devices," indicating its primary function is for interventional procedures, not diagnosis.
No
The device description clearly describes a physical catheter introducer (guiding sheath) with mechanical features (adjustable tip geometry, hemostatic valve, sideport) and radiopaque material for visualization under fluoroscopy. This 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 is for "introducing various cardiovascular catheters into the heart." This describes a device used in vivo (within the body) for a medical procedure, not a device used in vitro (outside the body) to examine specimens like blood or tissue for diagnostic purposes.
- Device Description: The description details a physical catheter introducer designed for insertion into the body. It mentions features like steerability, a hemostatic valve, and a sideport, all related to facilitating a medical procedure within the cardiovascular system.
- Anatomical Site: The anatomical site is the "Heart," which is an internal organ. IVDs typically analyze samples taken from the body, not devices inserted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the MobiCath™ Bidirectional Guiding Sheath is a medical device used for a therapeutic or interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bidirectional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Product codes
DYB
Device Description
The MobiCath™ Bidirectional Guiding Sheath is an 8.5 French, flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry that allows deflection of the distal portion of the device bi-directionally 150°. This feature provides steerability to facilitate the delivery of therapeutic devices into the heart including the left atrium, using minimally invasive techniques. The sheath is fitted with a hemostatic valve which minimizes blood loss and air intake by providing hemostasis sealing to venous pressures as well as reduce dilator insertion and removal force. The sheath is also equipped with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock. The sheath and dilator contain radiopaque material for visualization under fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Heart, including the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The MobiCath™ Bidirectional Guiding Sheath passed all verification specification criteria for dimensional, strength, functional, packaging, sterilization, biocompatibility and shelf life tests. Test results confirm the device performs as intended without raising additional questions of safety and efficacy when compared to the predicates. Given the similar technological characteristics and principles of operation of the MobiCath™ Bidirectional Guiding Sheath and the predicate devices, it was determined that no animal or clinical study was deemed necessary.
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
Greatbatch Medical Traditional Premarket Notification SI O(k)
MobiCath Bi-Directional Guiding Sheath
Image /page/0/Picture/2 description: The image shows the logo for Greatbatch Medical. The logo consists of a hexagon shape made up of six smaller hexagons, with one of the hexagons filled in black. To the right of the hexagon shape is the word "Greatbatch" in a bold, sans-serif font, with the word "Medical" underneath it in a smaller font.
510(k) Summary
NOV 26 20:0
5.1 Applicant Information
| Submitter's Name: | Greatbatch Medical |
|---|---|
| Address: | 2300 Berkshire Lane North |
| Minneapolis, MN 55441 | |
| Establishment Registration No. | 2183787 |
| Contact Person: | Kristi Fox |
| Regulator Affairs Specialist | |
| kfox@greatbatchmedical.com | |
| 763-951-8205 (phone) | |
| (763) 559-0148 (fax) | |
| Sterilization Facility: | Steris, Inc. |
| 380 90 th Avenue Northwest | |
| Minneapolis, MN 55433 | |
| (763) 786-2929 (phone) | |
| (763) 786-8199 (fax) | |
| Establishment Registration No. 2183744 |
5.2 Device Information
Trade Name: MobiCath™ Bi-Directional Guiding Sheath Classification Name: Introducer, Catheter Product Code: DYB Regulation: Class II 21 CFR 870.1340 Panel: Cardiovascular
5.3 Device Description
The MobiCath™ Bidirectional Guiding Sheath is an 8.5 French, flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry that allows deflection of the distal portion of the device bi-directionally 150°. This feature provides steerability to facilitate the delivery of therapeutic devices into the heart including the left atrium, using minimally invasive techniques. The sheath is fitted with a hemostatic valve which minimizes blood loss and air intake by providing hemostasis sealing to venous pressures as well as reduce dilator insertion and removal force. The sheath is also equipped with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock. The sheath and dilator contain radiopaque material for visualization under fluoroscopy.
1
5.4 Indications for Use
The Bidirectional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Predicate Device Comparison / Technological Characteristics ર્ડ. ર
The MobiCath™ Bidirectional Guiding Sheath has the same indication for use, technological characteristics and principles of operation as the market cleared St. Jude Medical Agilis™ NxT Steerable Introducer (K083402). In addition, functional characteristics of the MobiCath™ Bidirectional Guiding Sheath are substantially equivalent to the Agilis NxT Stecrable Introducer and the market cleared Enpath Medical Steerable Sheath (K061119) including materials, dimensions, and method of construction. Where dimensional and material differences exist between the proposed device and the predicate devices, performance and biocompatibility testing were performed to demonstrate that these differences do not raise questions of safety or efficacy.
Summary of Testing ર્સ્વર્સ્વ
The MobiCath™ Bidirectional Guiding Sheath passed all verification specification criteria for dimensional, strength, functional, packaging, sterilization, biocompatibility and shelf life tests. Test results confirm the device performs as intended without raising additional questions of safety and efficacy when compared to the predicates. Given the similar technological characteristics and principles of operation of the MobiCath™ Bidirectional Guiding Sheath and the predicate devices, it was determined that no animal or clinical study was deemed necessary.
5.7 Statement of Equivalence
The MobiCath™ Bidirectional Guiding Sheath has the same indication for use, technological characteristics and principles of operation as the market cleared St. Jude Medical Agilis™ NxT Steerable Introducer (K083402). In addition, the technological characteristics and principles of operation of the MobiCath™ Bidirectional Guiding Sheath are similar the market cleared Enpath Medical Steerable Sheath (K061119). Therefore, the MobiCath™ Bidirectional Guiding Sheath is substantially equivalent to the previously cleared St. Jude Medical Agilis™ NxT Steerable Introducer (K083402) and Enpath Medical Stecrable Sheath (K061119).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted as a white abstract shape resembling a bird or a wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2015
Greatbatch Medical Ms. Kristi Fox Regulatory Affairs Specialist 2300 Berkshire Lane North Minneapolis, Minnesota 55441
Re: K101784
Trade/Device Name: MobiCath Bi-Directional Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 26, 2010 Received: November 26, 2010
Dear Ms. Fox:
This letter corrects our substantially equivalent letter of November 26, 2010.
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. 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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
3
Page 2 - Ms. Kristi Fox
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 Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Cynthia Chang -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
MobiCath Bi-Directional Guiding Sheath
Indications for Use Statement
| 510(k) Number (if known): | K101784 |
|---|---|
| --------------------------- | --------- |
NOV 26 20:0
Device Name: MobiCath Bi-Directional Guiding Sheath
Indications for Use:
The Bidirectional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Prescription Use ___ X AND/OR
. •
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
(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)
WM
510(k) Numl
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