(67 days)
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.
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.
The provided text is a 510(k) summary for the BridgePoint Medical Stingray™ Guidewire. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically seen in performance studies for AI/medical imaging devices.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) through comparison of intended use, technological characteristics, and material properties. This is a common pathway for medical device clearance, especially for devices that are structurally similar to already approved products.
Therefore, I cannot populate the table or provide information for most of the requested points, as the provided text does not describe a performance study with acceptance criteria and results in the way you've outlined for AI or diagnostic devices.
Here's how I would address your request based only on the provided text, indicating where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. The document focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance criteria in a quantitative study. | Not applicable. Performance metrics with specific thresholds are not reported. The device is stated to have "similar physical attributes (flexibility, radiopacity, lubricity, extension wire compatibility, etc.)" to predicate devices, and its distal tip is "radiopaque and can be seen with fluoroscopy" and is "highly lubricious." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. This type of information is not relevant for a substantial equivalence claim based on device design and material comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided. Ground truth determination by experts is not described, as there isn't a diagnostic performance study in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. Adjudication methods are not applicable here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC comparative effectiveness study was not performed, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. A standalone performance study was not performed, as this is not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The concept of "ground truth" for a diagnostic outcome is not relevant in this 510(k) submission, which describes a guidewire.
8. The sample size for the training set
- Not applicable. The device is a physical guidewire, not an AI model, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
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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"
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(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.
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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
§ 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.