(25 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical action, not data processing or algorithmic decision-making.
Yes
The device is designed for mechanical declotting to restore patency to occluded synthetic dialysis access grafts, which is a therapeutic intervention.
No
Explanation: The device is designed for mechanical declotting and restoring patency to occluded synthetic dialysis access grafts, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "percutaneous mechanical thrombectomy device," indicating it is a physical device used for a medical procedure, not software.
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 of synthetic dialysis access grafts." This is a therapeutic procedure performed directly on a patient's body to remove a clot.
- Device Description: The device is described as a "percutaneous mechanical thrombectomy device." This further confirms its use in a therapeutic procedure within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The description of the Rex Medical Cleaner™ does not involve any such specimen analysis.
Therefore, the Rex Medical Cleaner™ Rotational Thrombectomy System is a medical device used for a therapeutic intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Rex Medical Cleaner™ Rotational Thrombectomy System is designed for mechanical declotting of synthetic dialysis access grafts.
Product codes
MCW
Device Description
The Rex Medical Cleaner™ Rotational Thrombectomy System is percutaneous mechanical thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis access grafts. The device is used in exactly the same manner as the predicate devices.
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
Non-Clinical Tests: All testing performed on the Cleaner™ Rotational Thrombectomy System was derived from the risk assessment which evaluated the safety and effectiveness of the design changes to the guidewire. Test methodology and acceptance criteria were derived from within Rex Medical and from related ISO standards for evaluation of this device.
Clinical Tests: Not Applicable
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Exhibit #1
APE 28 11
Special 510(k): Device Modification Cleaner™ Rotational Thrombectorny System
Image /page/0/Picture/3 description: The image shows the logo for REX MEDICAL. The logo consists of the text "REX MEDICAL" in a bold, sans-serif font. A curved graphic element is placed to the left of the text, partially encircling the "R" in "REX". The logo is in black and white.
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: __ K 06 0904
1. Submitter's Identification:
Rex Medical, LP 1100 East Hector Street, Suite 245 Conshohocken, PA 19428
Contact: Mr. John Leedle
Date Summary Prepared: February 9, 2006
2. Name of the Device:
Cleaner™ Rotational Thrombectomy System
3. Predicate Device Information:
K031610, Cleaner™ Rotational Thrombectomy System K040252, Cleaner™ Rotational Thrombectomy System Kit
4. Device Description:
The Rex Medical Cleaner™ Rotational Thrombectomy System is percutaneous mechanical thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis access grafts. The device is used in exactly the same manner as the predicate devices.
5. Intended Use:
The Cleaner™ Rotational Thrombectomy System is designed for mechanical declotting of synthetic dialysis access grafts.
1
6. Comparison to Predicate Devices:
The Cleaner™ Rotational Thrombectomy System is identical to the predicate Cleaner™ Rotational Thrombectomy Systems with some design improvements added to the rotational guidewire. A flexible safety core was added to the inside of the rotational guidewire and a lubricious coating was added over the macerating element.
7. Discussion of Non-Clinical Tests Performed:
All testing performed on the Cleaner™ Rotational Thrombectomy System was derived from the risk assessment which evaluated the safety and effectiveness of the design changes to the guidewire. Test methodology and acceptance criteria were derived from within Rex Medical and from related ISO standards for evaluation of this device.
8. Discussion of Clinical Tests Performed:
Not Applicable
ல் Conclusions:
The subject device, Cleaner™ Rotational Thrombectomy System, has identical indications for use as the predicate Cleaner™ Rotational Thrombectomy Systems (K040252 and K031610). The verification testing contained in our submission demonstrates that there are no differences in their technological characteristics due to the device modification, thereby not raising any new issues of safety or effectiveness. The Cleaner™ Rotational Thrombectorny System is therefore substantially equivalent to the predicate Cleaner™ Rotational Thrombectomy Systems (K040252 and K031610).
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2005
Rex Medical c/o Ms. Susan Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11021
Re: K060904
Trade Name: Rex Medical Cleaner™ Rotational System Regulation Number: 21CFR §870.4875 Regulation Name: Thrombectomy Catheter Regulatory Class: II (two) Product Code: MCW Dated: February 9, 2006 Received: April 03, 2006
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 mav publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. 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); 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 (240) 276-0120 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/industry/support/index.html.
Sincerely yours.
Duna R. Luchner
Image /page/3/Picture/5 description: The image contains a signature and the words "Br." and "Di.". The signature is a stylized symbol with curved lines and sharp angles. The letters "Br." and "Di." are positioned to the right of the signature, suggesting they might be initials or an abbreviation related to the signature.
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exhibit B
Indications for Use
of of of 1 a Page 1
510(k) Number (if known): K060904
Device Name: Cleaner ™ Rotational Thrombectomy System
Indications For Use:
The Rex Medical Cleaner™ Rotational Thrombectomy System is designed for mechanical declotting of synthetic dialysis access grafts.
Prescription Use _ X (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dougher 12 - Va
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices
510(k) Number 166904