(29 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a conventional guidewire. There is no mention of AI, ML, image processing, or any software-driven analysis or decision-making.
No
The device is a guidewire designed to facilitate the placement of other interventional devices; it does not directly treat a disease or condition itself.
No
The device is a guidewire intended to facilitate the placement of other interventional devices beyond stenotic peripheral lesions. It does not perform a diagnostic function such as identifying a disease or condition.
No
The device description clearly details a physical guidewire constructed of stainless steel, platinum/tungsten, and coatings, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The BridgePoint Medical Peripheral System is a guidewire intended to facilitate the placement of other interventional devices within blood vessels. It is used in vivo (within the body) during a medical procedure.
- Lack of Specimen Analysis: The device does not analyze any biological specimens. Its function is purely mechanical and procedural.
The information provided clearly describes a medical device used for a therapeutic procedure within the body, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The BridgePoint Medical Peripheral System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.
Product codes (comma separated list FDA assigned to the subject device)
DOX
Device Description
The additional models and modified Mantaray™ Guidewires are conventionally constructed, single use, disposable guidewires that consist of a full-length stainless steel shaft with proximal PTFE coating where the distal portion of the stainless steel core is taper ground to provide distal flexibility. The distal portion also includes a coaxially positioned coil constructed of platinum/tungsten material for visibility under fluoroscopy. The coil is fixed to the stainless steel core wire via silver alloy solder and is coated with hydrophilic coating. The distal tip of the guidewire is supplied with an angled geometry which transitions to a conventional rounded tip. A short extension with an approximate diameter of 0.0035"-0.0065" (which is a monolithic extension of the core wire) extends approximately 0.007" distal of the rounded tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Peripheral lesions
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 additional models and modified Mantaray™ Guidewires have been evaluated using the following in vitro bench testing to confirm the performance characteristics as compared to the predicate device: Tensile, Dimensional, Guidewire Insert & Withdrawal, Flexibility, Fatigue, Torque Surface Defects, Coating, Corrosion, Tip Memory, and Radiopacity. In vivo testing was not deemed necessary based on the significance of the proposed modifications to the baseline device. The shorter length guidewires and modified proximal coating formulation results in a device that meets the original design requirements of the currently marketed Mantaray™ Guidewires as demonstrated in the bench tests above. Animal studies were successfully completed with the currently marketed Mantaray™ Guidewires. Biocompatibility tests were completed to ensure all materials utilized to construct the modified Mantaray™ Guidewires were biocompatible. Biocompatibility tests included: Cytotoxicity, Irritation, Kligman Sensitization, Acute Systemic Cytotoxicity, Hemocompatibility (Direct & Indirect), In Vitro Hemocompatibility, Complement Activation Assay (Indirect), In Vivo Thrombogenicity, Pyrogen, and Unactivated Partial Thromboplastin Time. All test results demonstrated the materials, manufacturing processes, and design of the modified Mantaray™ Guidewires met the established performance criteria and will perform as intended.
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
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
BridgePoint Medical Peripheral System special 510(k)
9. 510(K) SUMMARY
. JUL 1 3 2012
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
K121745 510(k) Number:
Applicant Information:
Date Prepared:
Name: Address:
BridgePoint Medical 13355 10th Ave. N., #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 |
June 13, 2012
Device Information:
| Classification: | Class II Percutaneous Guidewire |
|---|---|
| Trade Name: | Mantaray™ Guidewire |
| Common Name: | Percutaneous Guidewire |
| Classification Name: | Percutaneous Guidewire |
Predicate Devices:
The additional models and modified BridgePoint Medical Mantaray™ Guidewires are substantially equivalent in intended use, method of operation and technical aspects to the following predicate device:
K120881 -- Mantaray™ Guidewires K120533 - BridgePoint Medical Peripheral System
1
Device Description:
The additional models and modified Mantaray™ Guidewires are conventionally constructed, single use, disposable guidewires that consist of a full-length stainless steel shaft with proximal PTFE coating where the distal portion of the stainless steel core is taper ground to provide distal flexibility. The distal portion also includes a coaxially positioned coil constructed of platinum/tungsten material for visibility under fluoroscopy. The coil is fixed to the stainless steel core wire via silver alloy solder and is coated with hydrophilic coating. The distal tip of the guidewire is supplied with an angled geometry which transitions to a conventional rounded tip. A short extension with an approximate diameter of 0.0035"-0.0065" (which is a monolithic extension of the core wire) extends approximately 0.007" distal of the rounded tip.
Intended Use:
The BridgePoint Medical Mantaray™ Guidewires when used as part of the BridgePoint Medical Peripheral system are intended to facilitate placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.
Comparison to Predicate Device(s):
The additional models and modified Mantaray™ Guidewires are substantially equivalent to the previously cleared Mantaray™ Guidewires that are utilized in the BridgePoint Medical Peripheral System, K120533, in that they are all designed to facilitate placement of conventional guidewires beyond stenotic peripheral lesions prior to placement of other interventional devices.
The additional models of Mantaray™ Guidewires are a result of modifications to the overall guidewire length as compared to previously cleared models. The additional models of Mantaray™ Guidewires and previously cleared Mantaray™ Guidewires are manufactured using the same general processes and components and have the same physical attributes (flexibility, radiopacity, lubricity, tensile, torque, etc.). The distal tips of each device are radiopaque and can be seen with fluoroscopy for precise placement. All devices are highly lubricious for smooth delivery of multiple devices.
The modifications made to the originally cleared Mantaray™ Guidewires include a modification in the core wire material and colorant compound used in the proximal PTFE coating. The core wire material is being modified from 304 stainless steel to 302 stainless steel. The PTFE colorant is being modified from chromium oxide green (CAS 1308-38-9) to cobalt titanate green (CAS 68186-85-6). Both of the new materials (core wire and proximal coating colorant) are currently used on other legally marketed devices within the same classification regulation for the same intended use.
2
BridgePoint Medical Peripheral System special 510(k)
Performance Data:
The additional models and modified Mantaray™ Guidewires have been evaluated using the following in vitro bench testing to confirm the performance characteristics as compared to the predicate device:
●
-
Tensile .
-
· Dimensional
-
· Guidewire Insert & Withdrawal
-
Flexibility .
-
Fatigue .
-
Torque Surface Defects .
Coating -
Corrosion ●
-
Tip Memory, and
-
Radiopacity
In vivo testing was not deemed necessary based on the significance of the proposed modifications to the baseline device. The shorter length guidewires and modified proximal coating formulation results in a device that meets the original design requirements of the currently marketed Mantaray™ Guidewires as demonstrated in the bench tests above. Animal studies were successfully completed with the currently. marketed Mantaray™ Guidewires.
Biocompatibility tests were completed to ensure all materials utilized to construct the modified Mantaray™ Guidewires were biocompatible. Biocompatibility tests included:
-
Cytotoxicity
Irritation -
Kligman Sensitization .
Acute Systemic Cytotoxicity -
Hemocompatibility (Direct & Indirect) .
-
. In Vitro Hemocompatibility
-
Complement Activation Assay (Indirect) ●
-
In Vivo Thrombogenicity, and ●
-
Pyrogen -.
. -
Unactivated Partial Thromboplastin Time.
All test results demonstrated the materials, manufacturing processes, and design of the modified Mantaray™ Guidewires met the established performance criteria and will perform as intended.
Summary:
Based upon the intended use and descriptive information provided in this pre-market notification, the additional models and modifications to the BridgePoint MantarayTM Guidewires have been shown to be substantially equivalent to the currently marketed predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 3 2012
BridgePoint Medical, Inc. c/o Jill Munsinger 13355 10th Ave N, Ste. 110 Plymouth, MN 55441
Re: K121745
Trade/Device Name: BridgePoint Medical Peripheral System: Mantaray™ Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DOX Dated: June 13, 2012 Received: June 14, 2012
Dear Ms. Munsinger:
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. Ilsting 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.
4
Page 2 – Ms. Jill Munsinger
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 155aazes or wouldevice complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or any I cutial statues and reguirements, including, but not limited to: registration and listing (21 Comply with an the Fee 816qurt Part 801); medical device reporting (reporting of medical CI K Fart 607), adoling (21 CFR 803); good manufacturing practice requirements as set device-related adverse ovents) (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 II you desire specific ad rios 10. Jour Venters Offices/CDRH/CDRHOffices/ucm115809.htm for go to happen with working and Radiological Health's (CDRH's) Office of Compliance. Also, please mote the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 rou may obtain outer generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (000) 050 x fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hilliker
- Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
5
BridgePoint Medical Peripheral System special 510(k)
8. INDICATIONS FOR USE STATEMENT
K121745 510(k) Number: (TBA) KASALS
Device Name: BridgePoint Medical Peripheral System
Indications For Use:
The BridgePoint Medical Peripheral System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.
Prescription Use (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 1 of 1
CMGtkillebe
(Division Sian-Off) Division of Čardiovascular Devices
510(k) Number