(5 days)
K#990829, K#970080, K#003570
Not Found
No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML models. The device description focuses on mechanical operation.
Yes
The device is used for "mechanical declotting in synthetic dialysis grafts" and aims to "restore patency to occluded synthetic dialysis grafts," which indicates a direct treatment of a medical condition.
No
The device is described as a "rotational thrombectomy device" that "permits mechanical declotting" and "macerates clot into particulate size". Its purpose is to "restore patency to occluded synthetic dialysis grafts". These functions are therapeutic, aiming to treat a condition (occluded grafts), rather than to diagnose one.
No
The device description explicitly states it is a "battery operated, hand held, wall contacting, rotational thrombectomy device" and mentions a "rotational wire," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Rex Medical Cleaner™ Rotational Thrombectomy System is a device that is inserted into the body (specifically, synthetic dialysis grafts) to mechanically remove blood clots. This is an in vivo procedure, not an in vitro test.
- Intended Use: The intended use is to "permit mechanical declotting in synthetic dialysis grafts," which is a therapeutic intervention performed directly on the patient's circulatory system.
Therefore, the Rex Medical Cleaner™ Rotational Thrombectomy System is a medical device used for treatment within the body, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Rex Medical Cleaner™ Rotational Thrombectomy System device permits mechanical declotting in synthetic dialysis grafts.
Product codes
MCW
Device Description
The Rex Medical Cleaner™ Rotational Thrombectomy System 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 thrombectomy. 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
synthetic dialysis 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
Performance testing, which includes testing protocols, testing results and conclusions, based on ISO 10555-1, and FDA's "Guidance on Pre-market Notification (510(k)) Submission for Short-Term and Long-Term Intravascular Catheters", was submitted with this submission. Statistical sampling rationale for choosing the number of devices that were tested was based on ISO 2859-1 sampling plans in accordance with our projected lots (batch) size. Testing results revealed that the Rex Medical Cleaner™ Rotational Thrombectomy System device is substantially equivalent to the predicate device. In-Vivo (animal) test studies have proven that the Cleaner™ Rotational Thrombectomy device will macerate clot formation in synthetic dialysis grafts as effectively, efficiently, and as safely as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
K#990829, K#970080, K#003570
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
MAY 27 2003
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 assianed 510(k) number is:
1. Submitter's Identification:
Rex Medical 555 North Lane Suite 6101 Conshohochen, PA 19428
Contact: Mr. Michael Paris
Date Summary Prepared:
April 14, 2003
2. Name of the Device:
Rex Medical Cleaner™ Rotational Thrombectomy System".
3. Predicate Device Information:
-
- K#990829, Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device, Arrow International, Inc., Reading, PA K#970080, Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device, Arrow International, Inc., Reading, PA
-
- K#003570, Solera™ Bacchus™ Thrombectomy Catheter (BTC), Bacchus Vascular, Inc. Santa Clara, CA
4. Device Description:
The Rex Medical Cleaner™ Rotational Thrombectomy System 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 thrombectomy. The Cleaner™ macerates clot into particulate size that is not harmful to the patient.
1
5. Intended Use:
The Rex Medical Cleaner™ Rotational Thrombectomy System device permits mechanical declotting in synthetic dialysis grafts.
2
Comparison to Predicate Devices: 6.
| Attribute | Rex Medical Cleaner™ Rotational
Thrombectomy System (Subject
Device) | Arrow PTD (Predicate Device) |
|-----------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------|
| Catheter Type | Mechanical Thrombectomy Catheter | Mechanical Thrombectomy Catheter |
| Intended Use | Maceration of Clot | Maceration of Clot |
| Catheter Outer Diameter | 6F Sheath Compatible | 6F Sheath Compatible |
| Catheter Length | 65cm | 65cm |
| Drive Wire Diameter | .035" | 0.041" |
| Cleaning Device Wire | .035" Guidewire | Nitinol Basket (0.015" X 4 Wires) |
| Distal Catheter Tip Configuration | Radiopaque Tip | Radiopaque Tip |
| Distal Wire Tip Configuration | Atraumatic Radiopaque Soft Distal
Tip | Atraumatic Radiopaque Soft Distal
Tip |
| Cleaning Device | Sinusoidal Wave formed in Drive
Wire | Wire Basket Added to End of Drive
Wire |
| Activation Switch | Push Button Switch Located on
Handle | Push Button Switch Located on
Handle |
| Means to Protect Distal Wire
Segment | Slide Mechanism on Handle to Slide
Catheter Over Cleaning Device | Slide Mechanism on Handle to Slide
Catheter Over Cleaning Device |
| Side-Port Extension | Located on Handle | Locate on Handle |
| w/Female Luer | | |
| Ergonomic Handle | Yes | Yes |
| Packaging | Tray w/Tyvek Lid | Tray w/Tyvek Lid |
| Energy Transmitted to Graft from
Device (6mm Id Graft) | 22.6J | 31.1J |
.
3
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Performance testing, which includes testing protocols, testing results and conclusions, based on ISO 10555-1, and FDA's "Guidance on Pre-market Notification (510(k)) Submission for Short-Term and Long-Term Intravascular Catheters", was submitted with this submission.
Statistical sampling rationale for choosing the number of devices that were tested was based on ISO 2859-1 sampling plans in accordance with our projected lots (batch) size.
Testing results revealed that the Rex Medical Cleaner™ Rotational Thrombectomy System device is substantially equivalent to the predicate device.
8. Discussion of Clinical Tests Performed:
In-Vivo (animal) test studies have proven that the Cleaner™ Rotational Thrombectomy device will macerate clot formation in synthetic dialysis grafts as effectively, efficiently, and as safely as the predicate device.
ல் Conclusions:
The subject device, Rex Medical Cleaner™ Rotational Thrombectomy System. has the same intended use as the predicate devices, the Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device, and the Solera™ Bacchus™Thrombectomy Catheter (BTC). Moreover, bench testing contained in our submission and the non-clinical testing supplied demonstrates that there are no differences in their technological characteristics, thereby not raising any new questions of safety or effectiveness. Thus, the Rex Medical Cleaner™ Rotational Thrombectomy System is substantially equivalent to the predicate devices.
4
Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle image.
MAY 27 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rex Medical, Inc. c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, NY 11021
Re: K031610
Cleaner™ Rotational Thrombectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Catheter, Peripheral, Atherectomy Regulatory Class: Class II (two) Product Code: MCW Dated: May 21, 2003 Received: May 22, 2003
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. Iisting 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.
5
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,
Kelleher
uckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Exhibit B
ﻨﺪ ﺗﻢ ﺗﺮ
Page _ 1 of
510(k) Number (if known): K031610
Device Name: Rex Medical Cleaner™ Rotational Thrombectomy System
Indications For Use:
The Rex Medical Cleaner™ Rotational Thrombectomy System device permits mechanical declotting in synthetic dialysis grafts.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K031610