(28 days)
Not Found
No
The description focuses on the physical characteristics and function of a catheter and guidewire system for fluid delivery. There is no mention of AI, ML, image processing for analysis, or any data-driven decision-making components. The performance studies described are human factors testing on a simulated model, not validation of an AI/ML algorithm.
Yes
The device is intended for the administration of fluids, including thrombolytic agents, which are used to treat medical conditions (e.g., dissolve blood clots). This function implies a therapeutic purpose.
No
Explanation: The device is described as an "Infusion System" and its intended use is for the "administration of fluids," which is a therapeutic function, not a diagnostic one. While it can be "clearly imaged under imaging," this is for placement verification, not for diagnosing a medical condition.
No
The device description clearly details physical components like catheters, wires, and radiopaque markers, indicating it is a hardware device, not software-only.
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 and pulmonary artery vasculature. This is a therapeutic or interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a catheter designed for delivering substances directly into the bloodstream. This is consistent with a therapeutic or interventional device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device's function is to deliver substances into the body.
N/A
Intended Use / Indications for Use
The UNIFUSE Infusion System with Cooper Wire is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QEY, KRA
Device Description
The proposed UNIFUSE Infusion System with Cooper Wire devices are single-lumen, nylon catheters with longitudinal slits located at 90° intervals around the distal end of the catheter for fluid delivery. An occluding ball wire (or occlusion guidewire) provides end-hole occlusion during fluid delivery. The catheters are available in 4F and 5F diameters and overall lengths of 90cm and 135cm. Additionally, they are available in multiple infusion segment lengths, including 2cm, 5cm, 10cm, and 15cm lengths – the latter two of which are the subject of this proposal. It is also worth noting that the overall length of each catheter remains the same no matter the length of the infusion segment. The active infusion area can be identified under imaging by means of radiopague markers on the catheter shaft at the distal and proximal ends of the infusion segment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Under imaging (e.g. fluoroscopy)
Anatomical Site
peripheral and pulmonary artery 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)
Human Factors Testing: Angiodynamics, Inc. solicited the participation of multiple practicing physicians experienced in the use and placement of infusion catheters to evaluate use of the devices on a simulated-use vascular model. The goal of the testing was to demonstrate the following:
- The devices are able to be navigated-to and used-within the pulmonary artery vasculature;
- The infusion segments are able to be clearly imaged under imaging (and thus confirmed to reside completely within the pulmonary artery vasculature);
- The Directions for Use include adequately detailed instructions in order to enable users to accurately and reliably place and use the device(s) within the pulmonary artery vasculature.
This same human factors testing was therefore executed on the 10cm and 15cm "infusion segment length" configurations proposed herein. Additionally, the predicate 2cm and 5cm "infusion segment length" configurations were also tested again as a means of directly comparing the proposed and predicate devices side-by-side and further demonstrating that these proposed configurations are acceptable for the pulmonary artery vasculature intended usage. To that end, it is confirmed that the results did show that the proposed 10cm "infusion segment length" configurations are able to navigate the vasculature, be placed and used within the pulmonary artery, and have their location confirmed under imaging (e.g. fluoroscopy) – the same conclusions arrived at for those cleared via predicate 510(k) K192864. These determinations justify the expansion of the cleared configurations to include these 10cm and 15cm "infusion segment length" options.
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
November 22, 2021
AngioDynamics, Inc. Brandon Brackett Senior Manager, Global Regulatory Affairs 26 Forest Street, Suite 200 Marlborough, Massachusetts 01752
Re: K202347
Trade/Device Name: UNIFUSE Infusion System with Cooper Wire Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA
Dear Brandon Brackett:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 15, 2020. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.
Sincerely,
Image /page/0/Picture/9 description: The image shows a digital signature. The signature includes the name "Gregory W. O'connell -S". The signature also includes the date and time of the signature, which is "Date: 2021.11.22 13:43:57-05'00'".
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
September 15, 2020
AngioDynamics, Inc. Brandon Brackett Senior Manager, Global Regulatory Affairs 26 Forest Street, Suite 200 Marlborough, Massachusetts 01752
Re: K202347
Trade/Device Name: UNIFUSE Infusion System with Cooper Wire Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: August 17, 2020 Received: August 18, 2020
Dear Brandon Brackett:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
2
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sara M. by Sara M. Royce ROYCE -S Date: 2020.09.15 For 16:23:40 -04'00 Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Digitally signed
Enclosure
3
Indications for Use
510(k) Number (if known) K202347
Device Name
UNIFUSE Infusion System with Cooper Wire
Indications for Use (Describe)
The UNIFUSE Infusion System with Cooper Wire is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery 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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510(k) Summary for the "UNIFUSE Infusion System with Cooper Wire"
Date Prepared: September 15, 2020
Sponsor
Angiodynamics, Inc. 26 Forest Street Marlborough, MA 01752 USA
Regulatory Contact Brandon M. Brackett, RAC
Senior Manager, Global Regulatory Affairs AngioDynamics, Inc. Telephone: 1-508-658-7984 Facsimile: 1-508-658-7976 Email: bbrackett@angiodynamics.com
Subject Device
- Trade Name: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Classification Panel:
Predicate Device
- 510(k) Reference Trade Name: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Classification Panel:
UNIFUSE Infusion System with Cooper Wire Infusion Catheter 21CFR870.1210 Catheter, Continuous Flush Class 2 KRA Cardiovascular Devices
K192864
UNI*FUSE™ Infusion System with Cooper Wire Infusion Catheter 21CFR870.1210 Catheter, Continuous Flush Class 2 KRA Cardiovascular Devices
Purpose
The purpose of this Special 510(k) is to introduce into commercial distribution a slight expansion of the UNIFUSE Infusion Catheter with Cooper Wire devices recently cleared under predicate 510(k) K192864; specifically, to expand the range of available configurations to include those with 10cm and 15cm "infusion segment lengths". This would be an addition to those 2cm and 5cm "infusion segment length" configurations recently cleared via that predicate 510(k), and in sum would expand the current range of "infusion segment length" options as follows:
- Current range of "Infusion Segment Length" options (via predicate K192864): 2cm, 5cm ●
- Proposed range of "Infusion Segment length" options: 2cm, 5cm, 10cm, 15cm
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Aside from this "infusion segment length" difference, there are no other modifications being proposed to the device – catheter overall length, diameter, device materials, Indications for Use, device labeling, and all other device attributes remain identical to those cleared via predicate 510(k) K192864.
Device Description
The proposed UNIFUSE Infusion System with Cooper Wire devices are single-lumen, nylon catheters with longitudinal slits located at 90° intervals around the distal end of the catheter for fluid delivery. An occluding ball wire (or occlusion guidewire) provides end-hole occlusion during fluid delivery. The catheters are available in 4F and 5F diameters and overall lengths of 90cm and 135cm. Additionally, they are available in multiple infusion segment lengths, including 2cm, 5cm, 10cm, and 15cm lengths – the latter two of which are the subject of this proposal. It is also worth noting that the overall length of each catheter remains the same no matter the length of the infusion segment. The active infusion area can be identified under imaging by means of radiopague markers on the catheter shaft at the distal and proximal ends of the infusion segment. As shown in Table 1 below, all of these characteristics are substantially equivalent to those of the predicate devices.
The proposed UNIFUSE Infusion System with Cooper Wire devices are intended for administration of fluids such as thrombolytics and contrast media into vessels that are impacted by thrombus, including the peripheral and pulmonary artery vasculature. Given the minimal physical differences of the vessels for which the device is intended to access (e.g. diameter, structure, tortuousness), the operating principle mechanism of action, and intended use is the same independent of anatomical location, use in the pulmonary artery is equivalent to other areas of the vasculature that the device is currently indicated for.
Indications for Use/Intended Use
The UNIFUSE Infusion System with Cooper Wire is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature.
Comparison of Similarities and Differences in Technological Characteristics and Performance
The proposed UNIFUSE Infusion System with Cooper Wire and the predicate UNIFUSE Infusion System with Cooper Wire (K192864) are identical to one another (and therefore substantially equivalent) in all terms, not limited to design, materials of manufacture, specifications, Indications for Use, and sizes and/or configurations, as depicted in the comparison via Table 1 below. The sole difference is the proposed 10cm and 15cm "infusion segment length" attribute.
| Table 1: Comparison of Similarities and Differences in Technological Characteristics and Performance
Proposed UNIFUSE Infusion System with Cooper Wire vs.
| Predicate UNIFUSE Infusion System with Cooper Wire (K192864) | |||
|---|---|---|---|
| Proposed UNIFUSE Infusion | |||
| System with Cooper Wire | Predicate UNIFUSE Infusion | ||
| System with Cooper Wire | |||
| (K192864) | Comparison | ||
| ProCode | KRA | KRA | Identical |
| Regulation | |||
| Number | 21CFR870.1210 | 21CFR870.1210 | Identical |
| Regulation Name | Catheter, Continuous Flush | Catheter, Continuous Flush | Identical |
| Regulatory Class | Class 2 | Class 2 | Identical |
| Indications for | |||
| Use | The UNIFUSE Infusion System | ||
| with Cooper Wire is intended | |||
| for the administration of fluids, | The UNIFUSE Infusion System | ||
| with Cooper Wire is intended | |||
| for the administration of fluids, | Identical |
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| Table 1: Comparison of Similarities and Differences in Technological Characteristics and Performance | |||
|---|---|---|---|
| Proposed UNIFUSE Infusion System with Cooper Wire vs. | |||
| Predicate UNIFUSE Infusion System with Cooper Wire (K192864) | |||
| Proposed UNIFUSE Infusion System with Cooper Wire | Predicate UNIFUSE Infusion System with Cooper Wire (K192864) | Comparison | |
| including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature. | including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature. | ||
| Catheter Diameter (F) | 4F, 5F | 4F, 5F | Identical |
| Catheter Length (cm) | 90cm, 135cm | 90cm, 135cm | Identical |
| Catheter Infusion Segment Length (cm) | 2cm, 5cm | 2cm, 5cm, 10cm, 15cm | Substantially Equivalent |
| Materials | All materials are commonly used for this type of medical device and are biocompatible in accordance with ISO 10993-1. | All materials are commonly used for this type of medical device and are biocompatible in accordance with ISO 10993-1. | Identical |
Furthermore, the proposed UNFUSE Infusion System with Cooper Wire devices and predicate UNIFUSE Infusion System with Cooper Wire devices are incorporative of the identical operating principle, mechanism of action, intended use, and Indications for Use as one another (in addition to exhibiting identical overall design, materials of manufacture, sizes/configurations, and all other device attributes). Based upon the conclusions above, all previous biocompatibility, sterilization, shelf-life, and general performance testing supporting the predicate UNIFUSE Infusion System with Cooper Wire devices remains supportive of the proposed UNIFUSE Infusion System with Cooper Wire devices – the sole difference is that AngioDynamics, Inc. executed the same "human factors" testing conducted in support of K192864, in order to evaluate the 10cm and 15cm "infusion segment length" configurations proposed herein.
Comparison of Performance Data
As touched on above, the proposed UNIFUSE Infusion System with Cooper Wire devices and predicate UNIFUSE Infusion System with Cooper Wire devices are the same device as one another, and as a result the performance testing that AngioDynamics, Inc. has on file for the predicate devices remains supportive of the proposed devices (the sole difference being the "human factors" testing executed on the proposed 10cm and 15cm "infusion segment length" configurations). Please refer to Table 2, below:
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| Table 2: Summary of Performance Testing |
|---|
| Proposed and Predicate UNIFUSE Infusion System with Cooper Wire |
| -Slit Pattern Radiopacity |
| -Catheter Degradation |
| -Catheter Pressure |
| -Catheter-to-Occlusion Wire Configuration (Slow Infusion Compatibility) |
| -Catheter/Accessory Compatibility |
| -Catheter/Fluid Compatibility |
| -Catheter Hub-to-Shaft Joint Kink Resistance |
| -Occlusion Wire Flexibility |
| -Occlusion Wire Flow |
| -Occlusion Wire Seal |
| -Hub-to-Wire Bond/Connection |
| -Distal Spring Tip-to-Mandrel Connection |
| -Occlusion Wire Withdrawal |
| -Human Factors Testing |
Human Factors Testing: In support of predicate 510(k) K192864, AngioDynamics, Inc. had conducted a human factors study on the UNIFUSE Infusion System with Cooper Wire configurations proposed therein. Specifically, Angiodynamics, Inc. solicited the participation of multiple practicing physicians experienced in the use and placement of infusion catheters to evaluate use of the devices on a simulated-use vascular model. The goal of the testing was to demonstrate the following:
- The devices are able to be navigated-to and used-within the pulmonary artery vasculature;
- . The infusion segments are able to be clearly imaged under imaging (and thus confirmed to reside completely within the pulmonary artery vasculature);
- The Directions for Use include adequately detailed instructions in order to enable users to accurately and reliably place and use the device(s) within the pulmonary artery vasculature.
This same human factors testing was therefore executed on the 10cm and 15cm "infusion segment length" configurations proposed herein. Additionally, the predicate 2cm and 5cm "infusion segment length" configurations were also tested again as a means of directly comparing the proposed and predicate devices side-by-side and further demonstrating that these proposed configurations are acceptable for the pulmonary artery vasculature intended usage. To that end, it is confirmed that the results did show that the proposed 10cm "infusion segment length" configurations are able to navigate the vasculature, be placed and used within the pulmonary artery, and have their location confirmed under imaging (e.g. fluoroscopy) – the same conclusions arrived at for those cleared via predicate 510(k) K192864. These determinations justify the expansion of the cleared configurations to include these 10cm and 15cm "infusion segment length" options.
510(k) Summary Conclusions
In conclusion, assessment of the similarities and differences of the proposed and predicate UNIFUSE Infusion System with Cooper Wire devices are identical and thus substantially equivalent to one another; specifically:
- . The proposed and predicate device have the identical ProCode, Regulation Number, Regulation Name, and Regulatory Class as one another;
- The proposed and predicate device have identical Indications for Use and/or Intended Uses;
8
- The proposed and predicate devices incorporate the identical operating principle, mechanism of ● action, and are intended for the same patient populations; and,
- . The proposed and predicate employ an identical overall design, materials of manufacture, performance testing, sizes, and configurations, aside from the 10cm and 15cm "infusion segment length" options being proposed herein.
Additionally, results of human factors testing on the proposed UNIFUSE Infusion System with Cooper Wire provide further evidence that the devices are able to be used in the pulmonary artery vasculature, as are the predicate devices. Lastly, the Special 510(k) was determined to be the most appropriate pathway for premarket notification based upon having met the criteria for such a submission type via FDA's Guidance Document, "The Special 510(k) Program – Guidance for Industry and Food and Drug Administration Staff" (September 13, 2019).
The sum of these evaluations and determinations lead AngioDynamics, Inc. to conclude that substantial equivalence has been demonstrated, and that the existing data, additional testing, and clinical evaluation determinations have confirmed that there are no new questions of safety or effectiveness.