(167 days)
The ReFLOW Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary, carotid and peripheral vasculature.
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.
The provided text describes the 510(k) summary for the ReFLOW Aspiration Catheter, which includes performance data derived from non-clinical testing. It does not contain information about acceptance criteria or a study with specific performance metrics such as sensitivity, specificity, or AUC, which are typically used for AI/ML-based device performance evaluations. The data provided focuses on physical and biological characteristics of the device, not a comparative clinical study or AI algorithm performance.
Therefore, many of the requested categories cannot be filled as the information is not present in the provided document.
Here's a breakdown of the available information and what's missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance |
|---|---|---|
| Non-clinical Device Testing | Not explicitly stated as acceptance criteria, but implied to meet "known standards or product specifications" | |
| Dimensional Verification | Successfully completed | |
| Visual Inspection | Successfully completed | |
| Particulate Evaluation | Successfully completed | |
| Tube to Stopcock Tensile Strength | Successfully completed | |
| Tube to Luer Tensile Strength | Successfully completed | |
| RX Notch Tensile Strength (if applicable) | Successfully completed | |
| Hub to Shaft Tensile Strength | Successfully completed | |
| Loading Tool Tensile Strength | Successfully completed | |
| Liquid Leak Pressure Test | Successfully completed | |
| Wall Integrity Test | Successfully completed | |
| Guidewire Loading Test | Successfully completed | |
| Torque Strength | Successfully completed | |
| Coating Adhesion Test | Successfully completed | |
| Kink Resistance | Successfully completed | |
| Liquid Aspiration Leak Test | Successfully completed | |
| Aspiration Flow Rate | Successfully completed | |
| Thromboemboli Aspiration Simulated Use Testing | Successfully completed | |
| Biocompatibility Testing | ||
| Cytotoxicity | Successfully completed | |
| Intracutaneous | Successfully completed | |
| Systemic Toxicity | Successfully completed | |
| Maximum Sensitization | Successfully completed | |
| Material Mediated Pyrogen | Successfully completed | |
| ASTM Hemolysis | Successfully completed | |
| In Vitro Hemolysis | Successfully completed | |
| C3a Complement Activation | Successfully completed | |
| SC5-b Complement Activation | Successfully completed | |
| Partial Thromboplastin Time | Successfully completed | |
| In vivo Thromboresistence | Successfully completed | |
| Limulus Amebocyte Lysate | Successfully completed |
2. Sample size used for the test set and the data provenance
The document describes non-clinical bench and biocompatibility testing. It does not refer to a "test set" in the context of clinical data, AI/ML performance evaluation, or patient-specific samples. The tests were performed on the device itself. Therefore, sample size and data provenance as requested are not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study that uses expert-established ground truth for a test set. The "ground truth" for the non-clinical tests would be the established scientific methods and pass/fail criteria for each specific test (e.g., a certain tensile strength must be achieved, or a certain level of cytotoxicity must not be exceeded).
4. Adjudication method for the test set
Not applicable. There is no test set in the clinical evaluation sense that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML-based device and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML-based device.
7. The type of ground truth used
For the non-clinical and biocompatibility tests, the ground truth is based on established industry standards, scientific methodologies, and product specifications. For example, tensile strength tests have defined failure points, and biocompatibility tests have defined acceptable limits for various biological responses.
8. The sample size for the training set
Not applicable. There is no training set mentioned as this is not an AI/ML-based device.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned as this is not an AI/ML-based device.
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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
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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
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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
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510(K) SUMMARY
| SPONSOR: | Volcano Corporation3661 Valley Centre Drive Suite 200San Diego, CA 92130 |
|---|---|
| CONTACT/SUBMITTER: | Brian ParkSenior Regulatory Affairs SpecialistVolcano Corporation3661 Valley Centre Dr. Suite 200San Diego, CA 92130Tel: (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. 5150Class II Device |
| PREDICATE DEVICE: | Lumen Medical Xtract Aspiration Catheter |
| DEVICE DESCRIPTION: | The ReFLOW Aspiration Catheter is an embolectomycatheter comprised of a catheter shaft and hub. It is 150cmlong and is available in 6F and 7F diameters. |
| INDICATIONS FOR USE: | The ReFLOW Aspiration Catheter is indicated for theremoval of fresh, soft emboli and thrombi from vessels inthe coronary, carotid and peripheral vasculature. |
| COMPARISON OFCHARACTERISTICS: | The proposed device is substantially equivalent tothe predicate device. Both devices are aspiration cathetersconsisting of a catheter shaft and hub. The proposedReFLOW Aspiration Catheter is offered in two sizes,identical to the predicate device. The outer and inner shaftdiameters are identical for both the predicate and proposeddevices. |
| PERFORMANCE DATA: | Non-clinical device testing was conducted to confirm theperformance of the device. Bench testing was conductedagainst known standards or product specifications andevaluated the following: |
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- 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.
§ 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).