(119 days)
Not Found
No
The device description focuses on mechanical action and a battery-operated motor, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is used for mechanical declotting in dialysis fistulae and grafts, which is a therapeutic intervention.
No
The device is described as a "Rotational Thrombectomy System" indicated for the "mechanical declotting" of vessels, which describes a therapeutic action, not a diagnostic one. Its function is to remove clots, not to detect or analyze them.
No
The device description clearly states it is a "7F percutaneous mechanical thrombectomy catheter" and includes a "handle contains a battery operated motor that spins a flexible 'S' shaped guidewire". This indicates it is a physical medical device with hardware components, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Cleaner™ Rotational Thrombectomy System is a mechanical device used inside the body to physically break up blood clots in dialysis access points. It does not analyze or test any bodily fluids or tissues.
The device description clearly indicates it's a percutaneous mechanical thrombectomy catheter used for a therapeutic procedure, not a diagnostic test.
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.
Product codes (comma separated list FDA assigned to the subject device)
MCW
Device Description
The Cleaner 1" Rotational Thrombectomy System is a 7F percutaneous mechanical thrombectomy catheter. It is a sterile, single use disposable device. Its handle contains a battery operated motor that spins a flexible "S" shaped guidewire at approximately 4000rpm. The wall contacting rotational wire, with integrated soft distal tip, permits atraumatic mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts. The wire creates a fluid vortex as it spins that macerates clot and allows it to be aspirated through the introducer sheath.
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
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: All . Sing performed on the Cleaner "M Rotational Thrombectomy System was derived from the risk assessment which evaluated the safety and effectiveness of the design modifications to the guidewire. Test methodology and acceptance criteria were derived from within Rex Medical and from related ISO standards for evaluation of this device.
Result: 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.
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
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for REX MEDICAL. The logo is in black and features a stylized, curved shape on the left side. The text "REX MEDICAL" is written in bold, sans-serif font, with each letter connected to the next.
19428
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
| The assigned 510(k) number is: | K120346 |
|---|---|
| Submitter: | Rex Medical, L.P. |
| 1100 E. Hector Street, Suite 245 | |
| Conshohocken, PA 19428 | |
| Contact Person: | Nicholas Ciccarelli |
| Design Engineer | |
| Phone: (610) 940-0665 x109 | |
| Fax: (610) 940-1590 | |
| Email: nciccarelli@rexmedical.com | |
| Date Prepared: | February 1, 2012 |
| Trade Name: | Cleaner TM Rotational Thrombectomy System |
| Common Name: | Peripheral Atherectomy Catheter (21 CFR 870.4875, Product Code MCW) |
| Predicate Device(s): | Cleaner TM Rotational Thrombectomy System |
| K091029 |
| K091029 | Cleaner TM Rotational Thrombectomy System |
|---|---|
| K060904 | Cleaner TM Rotational Thrombectomy System |
Device Description
The Cleaner "1" Rotational Thrombectomy System is a 7F percutaneous mechanical thrombectomy catheter. It is a sterile, single use disposable device. Its handle contains a battery operated motor that spins a flexible "S" shaped guidewire at approximately 4000rpm. The wall contacting rotational wire, with integrated soft distal tip, permits atraumatic mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts. The wire creates a fluid vortex as it spins that macerates clot and allows it to be aspirated through the introducer sheath.
Intended Use:
The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
Technological Characteristics:
The Cleaner™ Rotational Thrombectomy System is similar with regards to materials, intended use, principles of operation and technological characteristics to the predicate device. Results of
1
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:
All . Sing performed on the Cleaner "M Rotational Thrombectomy System was derived from the risk assessment which evaluated the safety and effectiveness of the design modifications to the guidewire. Test methodology and acceptance criteria were derived from within Rex Medical and from related ISO standards for evaluation of this device.
Conclusion:
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side and a stylized symbol on the right. The symbol is a stylized depiction of a caduceus, a traditional symbol of medicine, featuring a staff with a snake winding around it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 1 2012
Rex Medical c/o Ms. Susan Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
Re: K120346
Trade/Device Name: Cleaner Rotational Thrombectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II (two) Product Code: MCW Dated: May 1, 2012 Received: May 4, 2012
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.
3
Page 2 - Ms. Susan Goldstein-Falk
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 forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
W.G. Hilleham
C-Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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REX MEDICAL
1100 East Hector Street, Conshohocken, PA 19428
Special 510(k): Device Modification Cleaner IM Rotational Thrombectomy System
Indications for Use
1205 510(k) Number (if known):
Device Name: Cleaner™ Rotational Thrombectomy System
Indications For Use:
The Cleaner 10 Rotational Thrombectorny System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The Counter Use (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.S. Hillham
ion Sian-l (Division of Cardiovascular Devices,
510(k) Number C120346