(167 days)
Not Found
Not Found
No
The summary describes a mechanical aspiration catheter and its performance testing, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes.
The device is indicated for the removal of emboli and thrombi, which are related to treating a medical condition.
No.
The device is indicated for the removal of emboli and thrombi, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is comprised of a catheter shaft and hub, which are physical hardware components. The performance studies also focus on physical properties and biocompatibility of the hardware.
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 removal of emboli and thrombi from blood vessels within the body. This is a therapeutic intervention performed in vivo (within a living organism).
- Device Description: The device is a catheter designed for physical aspiration within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples in vitro (outside the body), such as blood, urine, or tissue. There is no indication of it being used for diagnosis based on analyzing biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically remove blockages from blood vessels, which is a treatment, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The ReFLOW Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary, carotid and peripheral vasculature.
Product codes
QEZ, DXE
Device Description
The ReFLOW Aspiration Catheter is an embolectomy catheter comprised of a catheter shaft and hub. It is 150cm long and is available in 6F and 7F diameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels in the coronary, carotid and 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)
Non-clinical device testing was conducted to confirm the performance of the device. Bench testing was conducted against known standards or product specifications and evaluated the following:
- Dimensional Verification
- Visual Inspection
- Particulate Evaluation
- Tube to Stopcock Tensile Strength
- Tube to Luer Tensile Strength
- RX Notch Tensile Strength
- Hub to Shaft Tensile Strength
- Loading Tool Tensile Strength
- Liquid Leak Pressure Test
- Wall Integrity Test
- Guidewire Loading Test
- Torque Strength
- Coating Adhesion Test
- Kink Resistance
- Liquid Aspiration Leak Test
- Aspiration Flow Rate
- Thromboemboli Aspiration Simulated Use Testing
Biocompatibility testing was conducted on the device and the following tests were successfully completed:
- Cytotoxicity
- Intracutaneous
- Systemic Toxicity
- Maximum Sensitization
- Material Mediated Pyrogen
- ASTM Hemolysis
- In Vitro Hemolysis
- C3a Complement Activation
- SC5-b Complement Activation
- Partial Thromboplastin Time
- In vivo Thromboresistence
- Limulus Amebocyte Lysate
Completion of these tests concluded the ReFLOW catheter is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Lumen Medical Xtract Aspiration Catheter
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & 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.
July 27, 2020
Volcano Corporation Brian Park Sr.Regulatory Specialist 3661 Valley Center Dr Suite 200 San Diego, California 92130
Re: K123482
Trade/Device Name: ReFLOW Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ
Dear Brian Park:
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 April 29, 2013. Specifically, FDA is updating this SE Letter 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/Figure/9 description: The image shows the name "Gregory W. O'connell -S" in a large, bold font. The text is black and appears to be part of a document or title. The background is plain, with a watermark visible.
Digitally signed by Gregory W. O'connell -S Date: 2020.07.27 07:55:58
Gregory O'Connell Assistant Director Plaque Modification Devices Team 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design, symbolizing health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2013
Volcano Corporation Brian Park, Senior Regulatory Affairs Specialist 3661 Valley Centre Drive, Suite 200 San Diego, CA 92130
Re: K123482
Trade/Device Name: ReFLOW Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: April 25, 2013 Received: April 26, 2013
Dear Mr. Park:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/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 Small Manufacturers, International and Consumer Assistance 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 yours.
Matthew G. Hillebrenner
for
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number K123482
Page 1 of 1
Device Name ReFLOW® Aspiration Catheter
Indications for Use The ReFLOW Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary, carotid and peripheral vasculature.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over the Counter Use _______
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Matthew G Nillebrenner
4
510(K) SUMMARY
| SPONSOR: | Volcano Corporation
3661 Valley Centre Drive Suite 200
San Diego, CA 92130 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Brian Park
Senior Regulatory Affairs Specialist
Volcano Corporation
3661 Valley Centre Dr. Suite 200
San Diego, CA 92130
Tel: (858) 720-4176 |
| DATE OF SUBMISSION: | April 5, 2013 |
| DEVICE: | Volcano ReFLOW® Aspiration Catheter |
| Trade Name: | ReFLOW Aspiration Catheter |
| Common Name: | Catheter, Embolectomy |
| Classification: | 21 CFR Part 870. 5150
Class II Device |
| PREDICATE DEVICE: | Lumen Medical Xtract Aspiration Catheter |
| DEVICE DESCRIPTION: | The ReFLOW Aspiration Catheter is an embolectomy
catheter comprised of a catheter shaft and hub. It is 150cm
long and is available in 6F and 7F diameters. |
| INDICATIONS FOR USE: | The ReFLOW Aspiration Catheter is indicated for the
removal of fresh, soft emboli and thrombi from vessels in
the coronary, carotid and peripheral vasculature. |
| COMPARISON OF
CHARACTERISTICS: | The proposed device is substantially equivalent to
the predicate device. Both devices are aspiration catheters
consisting of a catheter shaft and hub. The proposed
ReFLOW Aspiration Catheter is offered in two sizes,
identical to the predicate device. The outer and inner shaft
diameters are identical for both the predicate and proposed
devices. |
| PERFORMANCE DATA: | Non-clinical device testing was conducted to confirm the
performance of the device. Bench testing was conducted
against known standards or product specifications and
evaluated the following: |
5
- Dimensional Verification ●
- Visual Inspection
- Particulate Evaluation ●
- Tube to Stopcock Tensile Strength
- Tube to Luer Tensile Strength
- RX Notch Tensile Strength
- Hub to Shaft Tensile Strength
- Loading Tool Tensile Strength ●
- Liquid Leak Pressure Test
- Wall Integrity Test
- Guidewire Loading Test
- Torque Strength ●
- Coating Adhesion Test ●
- Kink Resistance
- Liquid Aspiration Leak Test ●
- Aspiration Flow Rate
- Thromboemboli Aspiration Simulated Use Testing ●
Biocompatibility testing was conducted on the device and the following tests were successfully completed:
- Cytotoxicity .
- . Intracutaneous
- Systemic Toxicity ●
- Maximum Sensitization ●
- Material Mediated Pyrogen ●
- ASTM Hemolysis ●
- . In Vitro Hemolysis
- C3a Complement Activation .
- SC5-b Complement Activation ●
- Partial Thromboplastin Time ●
- In vivo Thromboresistence ●
- Limulus Amebocyte Lysate .
Completion of these tests concluded the ReFLOW catheter is substantially equivalent to the predicate device.