(73 days)
Not Found
No
The device description and intended use describe a mechanical support catheter. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device facilitates the placement of other interventional devices and provides access, but it does not directly treat a condition or restore a function.
No
The device is described as a support catheter used to facilitate placement of interventional devices, and its intended use is to access peripheral vasculature with guide wires, not to diagnose conditions.
No
The device description clearly describes a physical catheter with a shaft, distal tip, radiopaque marker band, and a locking mechanism. It is a hardware device intended for physical manipulation within the vasculature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for accessing the peripheral vasculature and facilitating placement of interventional devices. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description details a physical catheter designed to be inserted into the body (vasculature). This is consistent with an interventional medical device, not a diagnostic test kit or instrument used to analyze samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the PIGGYBACK wire converter is an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The PiggyBack wire converter is intended to be used with guide wires to access the peripheral vasculature and to facilitate placement of interventional devices.
Product codes
DQY
Device Description
The PiggyBack wire converter is a 0.035" outer-diameter support catheter that is compatible with standard 0.014" guide wires. The shaft has a hydrophilic coating to facilitate ease of advancement into the vasculature. The distal tip of the PiggyBack has a radiopaque marker band. The proximal end of the catheter, which remains outside of the patient, has a locking mechanism that secures the PiggyBack onto the 0.014" guide wire. The PiggyBack is provided in three working lengths: 80 cm, 120 cm, and 145 cm.
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)
Technological differences in design and materials have been qualified through biomaterial assessments and verification testing, the results of which did not raise any new safety or performance questions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K083784 Skyway OTW support catheter (Vascular Solutions, Inc.)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Vascular Solutions, Inc.
510(k) Summary 2
JUN 18 2009
Date Prepared: March 31, 2009
Submitter's Name / Contact Person
Manufacturer
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person
Charmaine Sutton, RAC Acting VP of Regulatory Tel: 763.656.4349 (direct); Fax: 763.656.4253 Email: csutton@vascularsolutions.com
General Information
| Trade Name | PiggyBack™ wire converter |
|---|---|
| Common / Usual Name | Percutaneous catheter |
| Classification Name | 870.1250 Catheter, percutaneous |
| Predicate Device | K083784 Skyway OTW support catheter (Vascular Solutions, Inc.) |
Device Description
The PiggyBack wire converter is a 0.035" outer-diameter support catheter that is compatible with standard 0.014" guide wires. The shaft has a hydrophilic coating to facilitate ease of advancement into the vasculature. The distal tip of the PiggyBack has a radiopaque marker band. The proximal end of the catheter, which remains outside of the patient, has a locking mechanism that secures the PiggyBack onto the 0.014" guide wire. The PiggyBack is provided in three working lengths: 80 cm, 120 cm, and 145 cm.
Intended Use / Indications
The PiggyBack wire converter is intended to be used with guide wires to access the peripheral vasculature and to facilitate placement of interventional devices.
Substantial Equivalence and Summary of Studies
The PiggyBack wire converter is substantially equivalent in intended use and indications to the predicate device. Technological differences in design and materials have been qualified through biomaterial assessments and verification testing, the results of which did not raise any new safety or performance questions.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wings, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
JUN 18 2009
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vascular Solutions, Inc. c/o Ms. Charmaine Sutton 6464 Sycamore Ct. Minneapolis, MN 55369
Re: K090977
Trade/Device Name: PiggyBack Wire Converter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II (two) Product Code: DQY Dated: April 2, 2009 Received: April 6, 2009
Dear Ms. Sutton:
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, listing of devices, good manufacturing practice, 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 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.
2
Page 2 - Ms. Charmaine Sutton
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 (OS) 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Dunia R. Voolmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K090977
Device Name: PiggyBackTM wire converter
Indications for Use:
The PIGGYBACK wire converter is intended to be used with guide wires to access the peripheral vasculature and to facilitate placement of interventional devices.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
burner 2
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K0909 77