(22 days)
Not Found
No
The summary describes a mechanical device for thrombectomy and does not mention any AI or ML components or functionalities.
Yes
The device is designed to restore patency to occluded synthetic dialysis grafts by mechanically declotting them, which is a therapeutic intervention.
No
The device is designed for mechanical declotting and restoring patency to occluded synthetic dialysis grafts, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "battery operated, hand held, wall contacting, rotational thrombectomy device," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "mechanical declotting in synthetic dialysis access grafts." This describes a procedure performed on the patient's body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description details a "battery operated, hand held, wall contacting, rotational thrombectomy device." This is a surgical or interventional device used directly on the patient.
- Lack of IVD Characteristics: The description does not mention analyzing samples like blood, urine, tissue, etc., which is the core function of an IVD.
Therefore, the Cleaner™ Rotational Thrombectomy System Kit is a therapeutic medical device used for a procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cleaner ™ Rotational Thrombectomy System Kit is designed for mechanical declotting in synthetic dialysis access grafts.
Product codes (comma separated list FDA assigned to the subject device)
MCW
Device Description
The Rex Medical Cleaner™ Rotational Thrombectomy System Kit is a battery operated, hand held, wall contacting, rotational thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis grafts. The rotational wire, with integrated soft distal tip, provides an atraumatic approach to mechanical thrombectorny. The Cleaner™ macerates clot into particulate size that is not harmful to the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Verification testing was performed to ensure that the addition of the Inner-Lock Introducer Sheath or the Short Introducer Sheath did not adversely affect the use of the Cleaner™ Rotational Thrombectorny System. Verification testing was also performed to ensure that the change in the rotational velocity of the wire did not affect the safety and effectiveness of the Cleaner™ Rotational Thrombectorny System. Testing proved that there is no effect on the safety and efficacy of the Cleaner™ Rotational Thrombectorny System Kit with the additions and modification noted above.
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.
K031610, K022170, K032569, K033793, K990829, K970080
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
FEB 2 6 2004
Exhibit #1
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:_K040252
Submitter's Identification: 1.
Rex Medical 555 North Lane Suite 6101 Conshohocken, PA 19428 (610) 940-0665
Ms. Susan Goldstein-Falk Contact: Alternate contact: Ms. Denise Flamer
Date Summary Prepared:
January 14, 2004
2. Name of the Device:
Rex Medical Cleaner™ Rotational Thrombectomy System Kit
3. Predicate Device Information:
| Trade Name | 510(k) Number |
|---|---|
| Rex Medical Cleaner™ Rotational Thrombectomy System | K031610 |
| Rex Medical Inner-Lock™ Introducer Sheath | K022170 |
| Rex Medical Short Introducer Sheath | K032569 |
| Cleaner II Rotational Thrombectomy System | K033793 |
| Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device | K990829 |
| Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device | K970080 |
1
4. Device Description:
The Rex Medical Cleaner™ Rotational Thrombectomy System Kit is a battery operated, hand held, wall contacting, rotational thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis grafts. The rotational wire, with integrated soft distal tip, provides an atraumatic approach to mechanical thrombectorny. The Cleaner™ macerates clot into particulate size that is not harmful to the patient.
5. Intended Use:
The Cleaner™ Rotational Thrombectomy System Kit is designed for mechanical declotting in synthetic dialysis access grafts.
6. Comparison to Predicate Devices:
The Cleaner™ Rotational Thrombectomy System Kit is identical to the predicate Cleaner™ Rotational Thrombectomy System with the exception that the kit incorporates either an Inner-Lock™ Introducer Sheath or a Short Introducer Sheath.
The rotational velocity of the wire was originally specified as 4000 ± 500 RPM for the Cleaner™ Rotational Thrombectomy System. The rotational velocity of the wire for the Cleaner™ Rotational Thrombectomy System Kit is being specified as 3000 - 4500 RPM based on additional verification testing.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Verification testing was performed to ensure that the addition of the Inner-Lock Introducer Sheath or the Short Introducer Sheath did not adversely affect the use of the Cleaner™ Rotational Thrombectorny System. Verification testing was also performed to ensure that the change in the rotational velocity of the wire did not affect the safety and effectiveness of the Cleaner™ Rotational Thrombectorny System. Testing proved that there is no effect on the safety and efficacy of the Cleaner™ Rotational Thrombectorny System Kit with the additions and modification noted above.
2
Conclusions: 8.
The subject device, Rex Medical Cleaner™ Rotational Thrombectorny System Kit, has the same intended use as the predicate devices. Verification testing contained in our submission demonstrates that there is no difference in the technological characteristics of the device, thereby not raising any new questions of safety or effectiveness. Thus, the Rex Medical Cleaner™ Rotational Thrombectomy System Kit is substantially equivalent to the predicate devices.
3
Public Health Service
Image /page/3/Picture/11 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 26 2004
Rex Medical c/o Ms. Susan D. Goldstein-Falk Official Correspondent for Rex Medical mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
K040252 Rc:
Trade Name: Cleaner Rotational Thrombectomy System Kit Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: II (two) Product Code: MCW Dated: January 26, 2004 Received: February 04, 2004
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 - Ms. Susan D. 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); good manufacturing practice requirements as set 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. lochner
Bram D
Director
Division
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exhibit B
Page ______ of ___ of __ 1 __
510(k) Number (if known): K# 040252
Device Name: Rex Medical Cleaner ™ Rotational Thrombectomy System Kit
Indications For Use:
The Cleaner ™ Rotational Thrombectomy System Kit is designed for mechanical declotting in synthetic dialysis access grafts.
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (21 CFT 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duns R to drages
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k040252