(17 days)
Not Found
No
The summary describes a mechanical catheter for guidewire manipulation and does not mention any computational or algorithmic components indicative of AI/ML.
No
The device is described as a catheter used for directing and supporting a guidewire to access peripheral vasculature, which is a diagnostic or interventional support function, not a therapeutic treatment itself.
No
Explanation: The device is a catheter designed for guiding and supporting a guidewire to access peripheral vasculature, which is an interventional or procedural function, not a diagnostic one.
No
The device description clearly describes a physical catheter with lumens, sideports, a balloon, and a flexible shaft, indicating it is a hardware device.
Based on the provided information, the BridgePoint Medical Mantaray™ Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the peripheral vasculature." This describes a device used within the body for a procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a catheter with lumens, sideports, and a balloon, all designed for manipulating a guidewire within blood vessels. This is consistent with an interventional device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Mantaray™ Catheter's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
The BridgePoint Medical Mantaray™ Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The modified Mantaray™ Catheter is a single use, over-the-wire, disposable, dual lumen percutaneous catheter that facilitates the placement, support and steering of a guidewire into discrete regions of the peripheral vasculature through the central guidewire lumen or through one of two sideports (identified by radiopaque markers). The sideports connect with the central guidewire lumen and facilitate guidewire steering (at an angle to the central lumen) by allowing the guidewire to exit the catheter. The catheter contains a small non-compliant balloon segment used for fluoroscopic orientation on the distal tip of the flexible shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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 modified Mantaray™ Catheters have been evaluated using the following in vitro bench testing to confirm the performance characteristics as compared to the predicate device: Tensile, Burst, Fatigue, Inflation & Deflation Time, Dimensional, Hydration, Guidewire Insert & Withdrawal, Flexibility, Trackability, Guidewire Re-Direction, Markerband Movement & Removal, Markerband & Guidewire Interaction, Kink Resistance, Coating, Torque, Surface Defects, Balloon Protector Removal.
In vivo testing was not deemed necessary based on the significance of the proposed modification to the baseline device. Removal of the coating from the distal 6 cm of the catheter results in a device that meets the original design requirements of the currently marketed Mantaray™ Catheter as demonstrated in the bench tests above. Animal studies were successfully completed with the currently marketed Mantaray™.
Likewise, the removal of coating from the distal 6 cm of the device did not warrant additional biocompatibility testing as all materials are included in the currently marketed Mantaray™ Catheter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
FEB - 3 2012
9. 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 510(k) Number: | K120129 |
|---|---|
| ---------------- | --------- |
Applicant Information:
| Date Prepared: | January 13, 2012 |
|---|---|
| Name: | BridgePoint Medical |
| Address: | 13355 10th Ave. N., Ste. #110 |
| Plymouth, MN 55441 | |
| Phone: 763-225-8500 | |
| Fax: 763-225-8718 |
| Contact Person: | Jill Munsinger |
|---|---|
| Phone Number: | office: 763-225-8510 / cell: 651-270-0572 |
| E-mail: | jmunsinger@bridgepointmedical.com |
Device Information:
| Classification: | Class II Percutaneous Catheter |
|---|---|
| Trade Name: | Mantaray™ Catheter |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter |
Predicate Devices:
The modified BridgePoint Medical Mantaray™ Catheter is substantially equivalent in intended use, method of operation and technical aspects to the following predicate device:
K111963 - Mantaray™ Catheter
Device Description:
The modified Mantaray™ Catheter is a single use, over-the-wire, disposable, dual lumen percutaneous catheter that facilitates the placement, support and steering of a guidewire into discrete regions of the peripheral vasculature through the central guidewire lumen or through one of two sideports (identified by radiopaque markers). The sideports connect with the central guidewire lumen and facilitate guidewire steering (at an angle to the central lumen) by allowing the guidewire to exit the catheter. The catheter contains a small non-compliant balloon segment used for fluoroscopic orientation on the distal tip of the flexible shaft.
1
Intended Use:
The BridgePoint Medical Mantaray™ Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the peripheral vasculature.
Comparison to Predicate Device(s):
The modified Mantaray™ Catheters are substantially equivalent to the current Mantaray™ Catheters, K111963 in that they are both designed to direct, steer, control and support a guidewire in accessing discrete regions of the peripheral vasculature.
The modified Mantaray™ Catheter is constructed of the same materials as the current Mantaray™ Catheter. Modifications were made to remove the coating on the balloon segment, which alleviates the need to soak the device for 10 minutes prior to use. The modified and current Mantaray™ Catheters are manufactured using similar processes and components and have similar physical attributes (balloon performance, trackability, tensile, radiopacity, and torque, etc.).
Both devices include radiopaque markers located within the balloon segment to indicate the location of the guidewire lumen ports.
Performance Data:
The modified Mantaray™ Catheters have been evaluated using the following in vitro bench testing to confirm the performance characteristics as compared to the predicate device:
- Tensile
- . Burst
- . Fatigue
- . Inflation & Deflation Time
- Dimensional .
- . Hydration
- . Guidewire Insert & Withdrawal
- . Flexibility
- . Trackability
- . Guidewire Re-Direction
- Markerband Movement & Removal ●
- Markerband & Guidewire Interaction ◆
- Kink Resistance .
- Coating .
- . Torque
- . Surface Defects
- . Balloon Protector Removal, and
In vivo testing was not deemed necessary based on the significance of the proposed modification to the baseline device. Removal of the coating from the distal 6 cm of the catheter results in a device that meets the original design requirements of the currently
2
marketed Mantaray™ Catheter as demonstrated in the bench tests above. Animal studies were successfully completed with the currently marketed Mantaray™.
Likewise, the removal of coating from the distal 6 cm of the device did not warrant additional biocompatibility testing as all materials are included in the currently marketed Mantaray™ Catheter.
Summary:
Based upon the intended use and descriptive information provided in this pre-market notification, the modified BridgePoint Mantaray™ Catheters have been shown to be substantially equivalent to the currently marketed predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure. The image is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 3 2012
BridgePoint Medical, Inc. c/o Jill Munsinger 13355 10th Ave N Plymouth, MN 55441
Re: K120129
Trade/Device Name: Mantaray™ Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: January 13, 2012 Received: January 17, 2012
Dear Ms. Munsinger:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to viewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered pror to May 2014 sified in accordance with the provisions of the Federal Food. Drug, devices mut have been roomsomed 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, merelore, mains 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 adultier. Trease noter CDFL wire, 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 If your device is classified (boo as or a) Existing major regulations affecting your device can be may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may round in wrther announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Jill Munsinger
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M.J. Hillebrand
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
8. INDICATIONS FOR USE STATEMENT
510(k) Number: (TBA)
BridgePoint Medical Mantaray™ Catheter Device Name:
Indications For Use:
The BridgePoint Medical Mantaray™ Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the peripheral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page I of 1
M.A.Kildenne
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K120129
Page 19 of 82