(25 days)
Not Found
No
The summary describes a mechanical catheter kit and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is used for the administration of fluids, including thrombolytic agents, rather than directly treating a disease or condition itself.
No
The device is described as an "Infusion Catheter Kit" intended for "administration of fluids," which is a therapeutic function, not diagnostic.
No
The device description clearly lists physical components like guidewires, needles, caps, and catheters, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration of fluids into the peripheral vasculature. This is a therapeutic or procedural use, not a diagnostic test performed on samples taken from the body.
- Device Description: The components described (catheters, guidewire, needle, caps) are all used for delivering substances into the body, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to determining the state of a disease or condition in vitro.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body).
N/A
Intended Use / Indications for Use
The SpeedLyser Infusion Catheter Kit is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.
Product codes
KRA
Device Description
The SpeedLyser Infusion Catheter Kit includes a variety of related components including:
- 0.018" Guidewire .
- 21 Gauge Entry Needle
- Non-Vented Caps (2)
The SpeedLyser catheter consists of the outer 5F catheter and an occluding 3F catheter. The outer 5F catheter is designed with slits along the shaft to provide optimal distribution of lytic over a thrombosed graft length.
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)
The performance testing included non-clinical bench testing. The following tests were performed.
- · Hub to Shaft Tensile (3F Occluding Catheter and 5F Infusion Catheter)
- · Shaft Tensile (3F Occluding Catheter and 5F Infusion Catheter)
- · Print Adhesion
- Gel Shots
- · Biocompatibility per ISO 10993-1
Based upon successful results of testing and responses to questions posed within FDA's 510(k) Decision-Making Tree, the proposed device is determined to be substantially equivalent.
The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be connected.
February 21, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
AngioDynamics, Inc. Teri Juckett Regulatory Affairs Manager 603 Oueensbury Avenue Oueensbury, NY 12804
Re: K170258
Trade/Device Name: SpeedLyser Infusion Catheter Kit Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: January 27, 2017 Received: January 27, 2017
Dear Teri Juckett:
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. 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.
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
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
Mude Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170258
Device Name SpeedLyser Infusion Catheter Kit
Indications for Use (Describe)
The SpeedLyser Infusion Catheter Kit is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.
| Type of Use (Select one or both, as applicable) |
|---|
| Research Use (Per 21 CFR 201.3 and Part D) |
| Over-The-Counter Use (21 CFR 201.66) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Angiodynamics. The logo consists of a stylized, intertwined shape in blue and red, followed by the word "angiodynamics" in blue, lowercase letters. The intertwined shape is on the left side of the logo, and the word "angiodynamics" is on the right side.
510(K) SUMMARY FOR THE ANGIODYNAMICS, INC. SPEEDLYSER INFUSION CATHETER KIT
Date Prepared: 27 January 2017
| A. Sponsor: | AngioDynamics, Inc.
10 Glens Falls Technical Park
Glens falls, New York, 12801 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------|
| B. Contact: | Teri Juckett
Manager Regulatory Affairs
Tel: 518-795-1142
Fax: 518-742-4323
Email: tjuckett@angiodynamics.com) |
| Subject Device: | |
| Trade Name: | AngioDynamics SpeedLyser Infusion Cat |
| Trade Name: | AngioDynamics SpeedLyser Infusion Catheter Kit |
|---|---|
| Common Name: | Infusion Catheters |
| Regulation Number: | 21 CFR 870.1210 |
| Regulation Name: | Continuous Flush Catheter |
| Regulatory Class: | Class II, Product Code KRA |
| Classification Panel: | Cardiovascular |
Predicate Device:
Trade Name: 510(k) Reference: Common Name: Regulation Number; Regulation Name: Regulatory Class: Classification Panel:
AngioDynamics SpeedLyser Infusion Catheter Kit K033443 Infusion Catheters 21 CFR 870.1210 Continuous Flush Catheter Class II. Product Code KRA Cardiovascular
C. Device Description:
The SpeedLyser Infusion Catheter Kit includes a variety of related components including:
- 0.018" Guidewire .
- 21 Gauge Entry Needle
- Non-Vented Caps (2)
4
The SpeedLyser catheter consists of the outer 5F catheter and an occluding 3F catheter. The outer 5F catheter is designed with slits along the shaft to provide optimal distribution of lytic over a thrombosed graft length.
D. Intended Use/Indications for Use:
The SpeedLyser Infusion Catheter Kit is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.
E. Summary of Similarities and Differences in Technology Characteristics and Performance:
The proposed device has similar materials, design, and technical characteristics as the predicate device. The purpose of this 510(k) submission is to introduce into commercial distribution a modified AngioDynamics SpeedLyser catheter. There are two modifications. The first modification is to the material used to mold the hub of the 5F catheter. The second modification is being made material used to extrude the 3F and 5F catheter shafts.
F. Performance Data:
The performance testing included non-clinical bench testing. The following tests were performed.
- · Hub to Shaft Tensile (3F Occluding Catheter and 5F Infusion Catheter)
- · Shaft Tensile (3F Occluding Catheter and 5F Infusion Catheter)
- · Print Adhesion
- Gel Shots
- · Biocompatibility per ISO 10993-1
G. Conclusion:
Based upon successful results of testing and responses to questions posed within FDA's 510(k) Decision-Making Tree, the proposed device is determined to be substantially equivalent.
The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.