(150 days)
Not Found
No
The device description focuses on mechanical rotation and fluid dynamics, with no mention of AI/ML terms or functionalities.
Yes
The device is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts, and for mechanical declotting and controlled/selective infusion in the peripheral vascular, all of which are direct medical interventions to restore function or treat a diseased state.
No
The device is described as a "Rotational Thrombectomy System" indicated for "mechanical declotting" and "infusion of physician-specified fluids." Its function involves breaking up clots and delivering solutions, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines a physical system involving a rotating wire, catheter, and infusion capabilities, 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 clearly describes a device used within the body (in vivo) for mechanical declotting and infusion in blood vessels. IVD devices are used to examine specimens outside the body (in vitro), such as blood, urine, or tissue samples, to diagnose or monitor conditions.
- Device Description: The description details a percutaneous system with a rotating wire and infusion capabilities, designed to interact directly with blood clots within vessels. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Anatomical Site: The specified anatomical sites (dialysis fistulae, grafts, peripheral vascular) are all locations within the living body.
- Performance Studies: The performance study mentioned is an animal study assessing device performance in restoring vessel patency, which is an in vivo function.
Therefore, the Cleaner™ Rotational Thrombectomy System is an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vascular.
Product codes (comma separated list FDA assigned to the subject device)
QEW, KRA
Device Description
The Cleaner™ Rotational Thrombectomy System is a percutaneous infusion system that utilizes a rotating sinusoidal wire to increase the dispersion of delivered solution. The devices employ mechanical rotation of a flexible "S" shaped dispersion wire at 4000 RPM which creates a fluid vortex within the treatment site. Contrast media and physician specified solutions, including thrombolytics, may be infused through the catheter lumen to a side hole at the distal end. The dispersion wire uses mechanical rotation to allow the infused solution to penetrate the clot increasing the effectiveness of the treatment. Any residual clot can be aspirated through an introducer sheath prior to restoration of flow. The distal soft tip is a radiopaque a-traumatic tip on the distal end of the dispersion wire. The devices are sterile and single-use disposable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
native vessel dialysis fistulae and synthetic dialysis access grafts, 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 Performance Testing: The expanded indications for use to include controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. are based on the bench testing and animal data presented in the performance section of the submission. A GLP animal study was conducted utilizing the Cleaner Rotational Thrombectomy System to assess device performance at restoring vessel patency in the peripheral vasculature. The animal testing show the Cleaner Rotational Thrombectomy System successfully restores patency to occluded vessels. Bench testing included: infusion testing of the predicate device to the proposed device, Electrical Safety, and EMC testing.
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.
K013635, K950907, K091029, K120346
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
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July 29, 2020
Rex Medical, L.P. % MDI Consultants, Inc. Susan Goldstein-Falk 55 Northern Boulbevard Great Neck, New York 11021
Re: K141617
Trade/Device Name: Cleaner Rotational Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW, KRA
Dear Susan Goldstein-Falk:
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 November 14, 2014. 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,
Digitally signed by Gregory Gregory W. W. O'connell -S O'connell -S Date: 2020.07.29 19:20:18 -04'00
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2014
Rex Medical, L.P. % Susan Goldstein-Falk MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
Re: K141617
Trade/Device Name: Cleaner Rotational Thrombectomy System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: October 6, 2014 Received: October 7, 2014
Dear Ms. Goldstein-Falk,
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
2
the quality systems (OS) 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.
Sincerely yours.
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Cleaner™ Rotational Thrombectomy System
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vascular.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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4
510(k) Summary
The assigned 510(k) number is:_____K141617
| Submitter: | Rex Medical, L.P.
555 East North Lane, Suite 5035
Conshohocken, PA 19428 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Colin Valentis
Development Engineer
Phone: (610) 940-0665 x106
Fax: (610) 940-1590
Email: cvalentis@rexmedical.com |
| Date Prepared: | September 19th, 2014 |
| Trade Name: | Cleaner™ Rotational Thrombectomy System |
| Common Name: | Thrombectomy catheter |
Classification Name: Continuous Flush Catheter (21 CFR 870.1210, Product Code KRA) Peripheral Atherectomy Catheter (21 CFR 870.4875, Product Code MCW)
Predicate Device(s):
| K013635 | Trellis Peripheral Infusion System |
|---|---|
| K950907 | Pulse*Spray Infusion System |
| K091029 | Cleaner™ Rotational Thrombectomy System |
| K120346 | Cleaner™ Rotational Thrombectomy System |
Device Description:
The Cleaner™ Rotational Thrombectomy System is a percutaneous infusion system that utilizes a rotating sinusoidal wire to increase the dispersion of delivered solution. The devices employ mechanical rotation of a flexible "S" shaped dispersion wire at 4000 RPM which creates a fluid vortex within the treatment site. Contrast media and physician specified solutions, including thrombolytics, may be infused through the catheter lumen to a side hole at the distal end. The dispersion wire uses mechanical rotation to allow the infused solution to penetrate the clot increasing the effectiveness of the treatment. Any residual clot can be aspirated through an introducer sheath prior to restoration of flow. The distal soft tip is a radiopaque a-traumatic tip on the distal end of the dispersion wire. The devices are sterile and single-use disposable.
5
Intended Use:
The Cleaner™ rotational thrombectomy system is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vasculature.
Technological Characteristics:
The Cleaner™ Rotational Thrombectomy System is similar with regard to materials, intended use, principles of operation and technological characteristics to the predicate device. Any differences that may exist do not significantly affect the safety and efficacy of the device. Results of bench testing and animal studies demonstrate Cleaner™ Rotational Thrombectomy System is as safe and effective as the legally marketed predicate device.
Non-Clinical Performance Testing:
The expanded indications for use to include controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. are based on the bench testing and animal data presented in the performance section of the submission. A GLP animal study was conducted utilizing the Cleaner Rotational Thrombectomy System to assess device performance at restoring vessel patency in the peripheral vasculature. The animal testing show the Cleaner Rotational Thrombectomy System successfully restores patency to occluded vessels. Bench testing included: infusion testing of the predicate device to the proposed device, Electrical Safety, and EMC testing.
Conclusions:
Rex Medical considers the Cleaner™ Rotational Thrombectomy System to be substantially equivalent to the predicate devices listed above. The conclusions are based on performance testing and similarities in indications for use, materials, technological characteristics, principle of operation and design features.