(181 days)
Not Found
No
The document describes a mechanical infusion system and does not mention any AI or ML components or functionalities.
No
The device is intended for the "administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature." This describes a delivery system for medication and diagnostic agents, not a device that itself provides therapy.
No
The device is intended for the administration of fluids into the peripheral vasculature, which is a therapeutic function, not a diagnostic one.
No
The device description clearly lists multiple hardware components, including catheters, guidewires, syringes, and connectors. There is no mention of software as the primary or sole component.
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 interventional procedure performed directly on the patient's body.
- Device Description: The components described are catheters, guidewires, syringes, and connectors, all designed for delivering substances into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for treatment.
N/A
Intended Use / Indications for Use
The Pulse*Spray System, PRO Infusion Catheter, and its related components, are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.
The Uni*Fuse Infusion System is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
The PulseSpray Catheter is packaged in a kit configuration. The following components are sold in the PulseSpray Infusion Catheter Kits:
·PRO (Pressure Responsive Outlet) Infusion Catheter with longitudinal slits at the distal end. Slits are located at 90° intervals around the catheter. Radiopaque markers on the catheter shaft indicate the active infusion pattern.
· Occluding Guidewire or Occluding Ball Wire which occludes the distal end of the PRO Infusion Catheter. The Occluding Guidewires or Occluding Ball Wires have proximal markers for occlusion position verification.
·1 mL Syringe and finger flange
·10 mL Syringe
·20 mL Syringe
· Y-Connector with Tuohy-Borst adapter
·Dual Check Valve
The Uni*Fuse Catheters are sold in only one configuration, with an occluding guidewire.
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.
- CatheterTensile
- Static Burst
- Catheter Flow Rate
- Catheter Occlusion Tip Durability
- Catheter Temperature Condition
- Catheter Dispersion and Occlusion Seal
- Biocompatibility per ISO 10993-1
Conclusion: 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): 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
§ 870.5150 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
Image /page/0/Picture/1 description: The image shows the seal of 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 image of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2017
AngioDynamics, Inc. Robin Fuller Sr. Manager, Regulatory Affairs 26 Forest Street Marlborough, MA 01752
Re: K163356
Trade/Device Name: Pulse* Spray and Uni*Fuse Infusion Systems Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: April 4, 2017 Received: May 5, 2017
Dear Robin Fuller:
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 of medical devicerelated 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.
1
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.
Sincerely,
Fernando Agnel
Fernando Aguel-S
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) K163356
Device Name Pulse* Spray Infusion System, Uni*Fuse Infusion System
Indications for Use (Describe)
The Pulse*Spray System, PRO Infusion Catheter, and its related components, are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.
The Uni*Fuse Infusion System 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
AngioDynamics PulseSpray and UniFuse Infusion Systems
Traditional 510(k)
Page 1 of 4
510(K) SUMMARY FOR THE
ANGIODYNAMICS, INC. PULSESPRAY AND UNIFUSE INFUSION SYSTEMS
Date Prepared: 10 January 2017
A. Sponsor:
AngioDynamics, Inc.
26 Forest Street
Marlborough, MA 01752
| B. Contact: | Robin Fuller
Sr. Manager Regulatory Affairs |
|-------------|---------------------------------------------------------------------------------|
| | Tel: 508-658-7986 |
| | Fax: 508-658-7976 |
| | Email: RFuller@angiodynamics.com |
Subject Device:
| Trade Name: | AngioDynamics PulseSpray and UniFuse
Infusion Systems |
|--------------------|------------------------------------------------------------|
| Common Name: | Infusion Catheter |
| Regulation Number; | 21 CFR 870.1210 |
| Regulation Name: | Continuous Flush Catheter |
Class II
Product Code:
Classification Panel:
Regulatory Class:
Cardiovascular
KRA
4
AngioDynamics PulseSpray and UniFuse Infusion Systems
Traditional 510(k)
KJ63356
Page 2 of 4
Predicate Device:
| Trade Name: | AngioDynamics PulseSpray and UniFuse
Infusion Systems |
|-----------------------|------------------------------------------------------------|
| 510(k) Reference: | K961763 |
| Common Name: | Infusion Catheter |
| Regulation Number: | 21 CFR 870.1210 |
| Regulation Name: | Continuous Flush Catheter |
| Regulatory Class: | Class II |
| Product Code: | KRA |
| Classification Panel: | Cardiovascular |
5
Traditional 510(k)
Page 3 of 4
C. Device Description:
The PulseSpray Catheter is packaged in a kit configuration. The following components are sold in the PulseSpray Infusion Catheter Kits:
·PRO (Pressure Responsive Outlet) Infusion Catheter with longitudinal slits at the distal end. Slits are located at 90° intervals around the catheter. Radiopaque markers on the catheter shaft indicate the active infusion pattern.
· Occluding Guidewire or Occluding Ball Wire which occludes the distal end of the PRO Infusion Catheter. The Occluding Guidewires or Occluding Ball Wires have proximal markers for occlusion position verification.
·1 mL Syringe and finger flange
- •10 mL Syringe
- ·20 mL Syringe
- · Y-Connector with Tuohy-Borst adapter
- ·Dual Check Valve
The Uni*Fuse Catheters are sold in only one configuration, with an occluding guidewire.
D. Intended Use/Indications for Use:
The Pulse*Spray System, PRO Infusion Catheter, and its related components, are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.
The Uni*Fuse Infusion System 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 the same design and technical characteristics as the predicate device. The purpose of this 510(k) submission is to introduce into commercial distribution a modified AngioDynamics, Inc. PulseSpray and UniFuse Infusion catheter. The modification is a change in the catheters shaft material and hub material.
Beyond the two material changes, the proposed and predicate devices are identical in regards to design, materials, packaging and sterilization to the predicate device. There are no changes being made to any of the accessories provided within the PulseSpray and UniFuse Infusion catheters.
F. Performance Data:
The performance testing included non-clinical bench testing. The following tests were performed.
6
Traditional 510(k)
Page 4 of 4
- CatheterTensile
- Static Burst
- Catheter Flow Rate
- Catheter Occlusion Tip Durability
- Catheter Temperature Condition
- Catheter Dispersion and Occlusion Seal
- Biocompatibility per ISO 10993-1
G. Conclusion:
The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.