(67 days)
Not Found
No
The device description and intended use are focused on the physical construction and function of a guidewire, with no mention of AI/ML capabilities or related data/performance metrics.
No
The device is intended to facilitate the placement of other devices, not to provide therapy itself.
No
The device description and intended use indicate that the Stingray™ Guidewire is used to facilitate the placement of other medical devices (balloon dilatation catheters or other intravascular devices) during therapeutic procedures (PTCA and PTA), rather than for diagnosing a condition.
No
The device description clearly details a physical guidewire constructed of stainless steel, platinum/tungsten, and coatings, which is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- This device, the BridgePoint Medical Stingray™ Guidewire, is an invasive medical device used inside the body during procedures like angioplasty. Its purpose is to guide other devices within blood vessels, not to analyze samples taken from the body.
The description clearly indicates its use in percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA), which are procedures performed directly on the patient's blood vessels.
N/A
Intended Use / Indications for Use
The BridgePoint Medical Stingray™ Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Stingray™ Guidewires are not to be used in cerebral blood vessels.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Stingray™ Guidewire is a conventionally constructed 0.014" diameter, single use, disposable guidewire that consists of a full-length stainless steel shaft with proximal PTFE coating where the distal portion of the shaft 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" (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
coronary and peripheral blood vessels (percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA)), excluding cerebral blood vessels.
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)
Not Found
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
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: K083727
Applicant Information:
FEB 2 0 2009
Date Prepared: December 12, 2008
Name: Address: BridgePoint Medical 2800 Campus Drive, #50 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 Guidewire |
|---|---|
| Trade Name: | Stingray™ Guidewire |
| Common Name: | Percutaneous Guidewire |
| Classification Name: | Percutaneous Guidewire |
Predicate Devices:
The BridgePoint Medical stiff model Stingray™ Guidewire is substantially equivalent in intended use, method of operation and technical aspects to the following predicate devices:
K081187 - standard model Stingray™ Guidewire (f.k.a. Entera™ Percutaneous Coronary Guidewire)
K041531 - Confianza Pro Asahi PTCA Guidewire
K970396 - Triumph™ PTCA Guidewire
Device Description:
The Stingray™ Guidewire is a conventionally constructed 0.014" diameter, single use, disposable guidewire that consists of a full-length stainless steel shaft with proximal PTFE coating where the distal portion of the shaft 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"
1
(which is a monolithic extension of the core wire) extends approximately 0.007" distal of the rounded tip.
Intended Use:
The BridgePoint Medical Stingray™ Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Stingray™ Guidewires are not to be used in cerebral blood vessels.
Comparison to Predicate Devices:
The BridgePoint stiff model Stingray™ Guidewire is substantially equivalent to the standard model Stingray™ Guidewire, K081187, the Confianza Pro Asahi PTCA Guidewire, K041531, and the Triumph™ PTCA Guidewire, K970396 in that they are all designed to facilitate placement of balloon dilatation catheters or other intravascular devices during PTCA.
The BridgePoint Medical stiff model Stingray™ Guidewire is not just substantially equivalent, but is exactly the same as the K081187 - standard model StingrayTM Guidewire, with the only exceptions being the length of the grind/tapers required to produce the desired wire flexibility/support and the removal of the outer distal coil from the distal tip of the wire. The stiff and standard model Stingray™ Guidewires are manufactured using the same processes. The stiff and standard models are produced using the same component materials (core wire, coil, coatings, solder etc.) and have similar physical attributes (flexibility, radiopacity, lubricity, extension wire compatibility, etc).
The distal tips of each device are radiopaque and can be seen with fluoroscopy for precise placement. Both devices are highly lubricious for smooth delivery of multiple devices. They both have stainless steel core wires.
Summary:
Based upon the intended use, description information, and performance evaluation provided in this pre-market notification, the BridgePoint Medical stiff model Stingray™ Guidewires have been shown to be substantially equivalent to currently marketed predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BridgePoint Medical c/o Ms. Jill Munsinger Regulatory Affairs 2800 Campus Drive, Suite 50 Plymouth MN. 55441
FEB 2 0 2009
Re: K083727
. Trade/Device Name: Stingray™ Guidewire, Stiff Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Dated: January 16, 2009 Received: January 21, 2009
Dear Ms. Munsinger:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Booken o s (1) p= device is substantially equivalent (for the indications for referenced in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the eneround date of the Medical Device Amendments, or to devices that prior to may 20, 1970, and cordance 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 therefore, market the act include requirements for annual registration, listing of devices, good connotic pro receive a 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 n your de rio such 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 I least be advisod that 1 Dr. I betermination that your device complies with other requirements of the Act or that 1 Drin has made a determinations 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); an the Act 3 requirements, unstacturing practice requirements as set forth in the quality iabeling (21 CFR Part 807), CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Jill Munsinger
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours.
R. Vachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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8. INDICATIONS FOR USE STATEMENT
510(k) Number: (FBA) K083727
BridgePoint Medical Stingray™ Guidewire Device Name:
Indications For Use:
The BridgePoint Medical Stingray™ Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Stingray Guidewires are not to be used in cerebral blood vessels. 1 - 12 - 12 - 11 - 11 -:
Prescription Use Over-The-Counter Use AND/OR X (Part 2) CFR 801 Subpart D) (21 CFR 807 Subpari 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
urray R. Van Ness
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number_K6832227