(80 days)
Not Found
No
The summary describes a physical guide wire and its intended use and testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a guide wire intended to facilitate the placement of other therapeutic devices (balloon dilatation catheters), but it does not directly treat a disease or condition itself.
No
The device is described as a guide wire intended to facilitate the placement of balloon dilatation catheters. Its function is to assist in a medical procedure, not to identify a disease, condition, or health status.
No
The device description clearly describes a physical guide wire constructed from stainless steel with a PTFE coating and a radiopaque coil tip. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the VP Wires are used to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA). This is a procedure performed in vivo (within the body).
- Device Description: The description details a physical guide wire used for navigation within blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body during a procedure like angioplasty.
N/A
Intended Use / Indications for Use
The VP Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
Product codes
DQX
Device Description
The FlowCardia VP Wire is a steerable guide wire with an outer diameter of 0.014" and The FlowCardia VI Wire is a steerable gatus ATS y are constructed from a stainless steel available in 105 cm of 500 on overall rengths for each design. The proximal end of the core wire is coated with polytetrfluoroethylene (PTFE). A short radiopaque coil tip is soldered to the distal end of the core wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Animal, Bench, and Biocompatibility testing was conducted according to the relevant Animal, Donom, and 20 demonstrate that the FlowCardia VP Guide Wires met the acceptance criteria and performed similarly to the predicate devices. The following functional tests were performed: Tensile Strength, Torque Strength, Torqueability, Tip Itunctional tests were periority, Biocompatibility, and Catheter Compatibility. No new safety or effectiveness issues were raised during the testing.
Key Metrics
Not Found
Predicate Device(s)
K022762, K031277, K032615, K990639
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for FLOWCARDIA, INC. The logo features the company name in bold, uppercase letters. Below the name is a horizontal line that extends to the right, where it transforms into a sine wave. The sine wave terminates at a stylized heart shape.
510(k) Summary of Safety and Effectiveness
| Application Date: | April 25, 2005 |
|---|---|
| Submission Type: | JUL 1 5 2005 |
| 510(k), Traditional | |
| Applicant | FlowCardia, Inc. (Owner) |
| Manufacturing | 745 N. Pastoria Avenue |
| Address: | Sunnyvale, CA 94085 |
| Ph: (408) 617-0352, Fx: (408) 617-9198 | |
| Contact person: Richard Spano | |
| Establishment | |
| Registration: | 3005007189 |
| (Same as above) | |
| Device Common Name: | Guidewire |
| Device Trade Name: | VP Wire GW140ST (.014" 165cm, Standard) |
| VP Wire GW140SO (.014" 165cm, Soft) | |
| VP Wire GW143ST (.014" 300cm, Standard) | |
| VP Wire GW143SO (.014" 300cm, Soft) | |
| Device | |
| Classification: | Class II (21CFR 870.1330), CDRH Code DQX, |
| Cardiovascular Panel | |
| Reason for 510(k): | New Device Submission |
| Substantially | |
| equivalent to: | K022762 (original), K031277 (special), K032615 |
| (special) Asahi Wire, product code: DQX | |
| K990639 CROSS IT 300XT, product code: DQX | |
| Contact Sterilizer: | Nutek Corporation (Reg. No. 2950103) |
| 30958 San Antonio St | |
| Hayward, CA 94544 | |
| Special Controls: | No applicable mandatory performance standards or |
| special controls exist for this device. |
745 North Pastoria Avenue, Sunnyvale, CA 94085-2918 Phone: (408) 617-0352 Fax (408) 617-9198
1
Device Description
The FlowCardia VP Wire is a steerable guide wire with an outer diameter of 0.014" and The FlowCardia VI Wire is a steerable gatus ATS y are constructed from a stainless steel available in 105 cm of 500 on overall rengths for each design. The proximal end of the core wire is coated with polytetrfluoroethylene (PTFE). A short radiopaque coil tip is soldered to the distal end of the core wire.
Intended Use
The VP Wires are intended to facilitate the placement of balloon dilatation catheters during The VI with are interned to fashions in the many angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
Technological Characteristics as Compared to Predicate Device:
The FlowCardia VP Wires are constructed from the same materials, offered in the same I he Flowedra +1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 devices and other PTCA Guide Wires that are currently on the market.
Performance Data:
Animal, Bench, and Biocompatibility testing was conducted according to the relevant Animal, Donom, and 20 demonstrate that the FlowCardia VP Guide Wires met the acceptance criteria and performed similarly to the predicate devices. The following functional tests were performed: Tensile Strength, Torque Strength, Torqueability, Tip Itunctional tests were periority, Biocompatibility, and Catheter Compatibility. No new safety or effectiveness issues were raised during the testing.
Conclusion:
The FlowCardia VP Guide Wires are substantially equivalent to the claimed predicates devices and other currently marketed PTCA Guide Wires.
Premarket Notification [510(k)] Number
745 North Pastoria Avenue, Sunnyvale, CA 94085-2918 Phone: (408) 617-0352 Fax (408) 617-9198
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines forming its body and wings. The eagle is positioned above a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 2005
,
Flowcardia, Inc. c/o Mr. Richard Spano Vice President, Operations and Quality 745 North Pastoria Avenue Sunnyvale, CA 94085-2918
K051062 Re:
Trade/Device Name: FlowCardia VP Wires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: April 25, 2005 Received: May 3, 2005
Dear Mr. Spano:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 5 ro(x) premained is substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manator production Device Americal processor of to commerce pror to May 20, 1976, the ensordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accessfired in as a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval a and Cosment Act (Act) that do not require approval controls provisions of the Act. The You may, increfore, market the act include requirements for annual registration, listing of general controls provisions of the revelopment of the prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device ts classified (soc accroy als. Existing major regulations affecting your device can may be subject to suer adultions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ovas acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 Teast be advised that I Drivedants of your device complies with other requirements of the Act that I Dri has intace a and regulations administered by other Federal agencies. You must of any I caefar statutes and regirements, including, but not limited to: registration and listing (21
3
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sett CFR Part 807); labeling (21 CFR Part 801); good manufacturing prices.
forth in the quality systems (21 CFR Part 820); and if applicable, the electronic
forth in the quality s forth in the quality systems (QS) regulation (2) CFR of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Sect product radiation control provisions (Sections 331-342 of the room Section 510(k)
This letter will allow you to begin marketing your device as described in your device to a l This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA inch sciffection for your device and thu premarket notification. The FDA finding of substantial equivalence of 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
ntitled, If you desire specific advice for your device on our lacemits the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note the regulation o contact the Office of Compliance at (240) 276-0120. Process and 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may "Misbranding by reference to premarket nonitically (21 Cr I Fr I fire Division of Small
other general information on your responsibilities under the Act from the Division of other general information on your responsibilities and its toll-free number (800) 638-2041 or 141-Manufacturers, Internet address http://www.fda.gov/cdrl/industry/support/index.html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.
Sincerely yours,
Donna R. Vichen
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number (if known): _ Kosto 62
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Device Name: FlowCardia VP Wires
Indications for Use:
The VP Wires are intended to facilitate the placement of balloon dilatation catheters during.
The are intended to facilitate that