(63 days)
Not Found
No
The description focuses on the mechanical design and function of a microcatheter for foreign object retrieval. There is no mention of AI, ML, image processing, or any software-driven decision-making or analysis.
Yes
The device is designed for the retrieval of intravascular foreign objects, indicating it is used to treat a medical condition by removing harmful foreign bodies.
No
The device is designed for the retrieval of foreign objects, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly details a physical catheter with various components (braided mesh, radiopaque markers, luer fitting, hydrophilic coating, stylet, torque device) and mentions preclinical studies involving in vitro and in vivo testing, 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 is the retrieval of foreign objects from within the body (intravascular). This is a therapeutic/interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical device designed for mechanical retrieval, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, nor is there any indication of providing diagnostic information based on such analysis.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is purely mechanical retrieval within the body.
N/A
Intended Use / Indications for Use
The Reverse Medical ReCruit™ Microcatheter is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and/or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.
Product codes
MMX
Device Description
The Reverse Medical ReCruit™ Microcatheter consists of a flexible, tapered reinforced composite catheter with a braided mesh retrieval element attached to the distal region of the catheter. The inner lumen can accommodate a guidewire to aid in placement of the catheter. The catheter contains radiopaque markers to facilitate fluoroscopic visualization- a distal tip marker, markers at the proximal and distal end of the retrieval element, and circumferentially placed markers within the retrieval element. The retrieval element is deployed through the advancement of a guidewire or the ReAct™ stylet through the lumen to radially expand the retrieval element. The selection of guidewire sizes in accordance with device compatibility allows for guidewires to be used either for navigation and placement or for deployment of the element.
The proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the catheter. The catheter is coated with a hydrophilic coating. The catheter is designed to be used with a guide catheter.
The catheter is offered in various retrieval element sizes to accommodate physician preferences and patient anatomy.
Each ReCruit™ Microcatheter is packaged with a ReAct™ stylet and torque device. The ReAct™ stylet is a stainless steel wire with a platinum tip that may be used to activate the ReCruit™ Microcatheter's retrieval element. The ReCruit™ Microcatheter can be used in vessel diameters ranging from 2mm to 4mm.
Materials used in the Reverse Medical ReCruit™ Foreign Body Retrieval Microcatheter are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate device, and have historically been demonstrated to be both biocompatible and suitable for this use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, neuro and cardiovasculature.
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
Preclinical studies conducted included in vitro and in vivo laboratory studies to demonstrate that the Reverse Medical ReCruit™ Microcatheter performed as intended under simulated use conditions. Biocompatibility testing was performed to demonstrate that the device meets ISO 10993-1 requirements and FDA requirements.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
4. 510(k) Summary
Date prepared
Name
Contact Person
Device name
Common name
Model No.
Classification name
Classification regulation
Predicate devices
Description
July 30, 2009
Reverse Medical Corporation 13900 Alton Parkway Suite 123 Irvine, CA 92618
JUL 80 2009
Amy Eskina Director, Regulatory Quality & Clinical Affairs Reverse Medical Corporation Tel 949-215-0660 ext 234 Fax 949-215-0661
ReCruit™ Microcatheter
Foreign Body Remover
TBD
Percutaneous Retrieval Device
870.5150 MMX
K014109; in-Time Retrieval Device; Clearance date: March 12, 2002
The Reverse Medical ReCruit™ Microcatheter consists of a flexible, tapered reinforced composite catheter with a braided mesh retrieval element attached to the distal region of the catheter. The inner lumen can accommodate a guidewire to aid in placement of the catheter. The catheter contains radiopaque markers to facilitate fluoroscopic visualization- a distal tip marker, markers at the proximal and distal end of the retrieval element, and circumferentially placed markers within the retrieval element. The retrieval element is deployed through the advancement of a guidewire or the ReAct™ stylet through the lumen to radially expand the retrieval element. The selection of guidewire sizes in accordance with device compatibility allows for guidewires to be used either for navigation and placement or for deployment of the element.
The proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the catheter. The catheter is coated with a hydrophilic coating. The catheter is designed to be used with a guide catheter.
The catheter is offered in various retrieval element sizes to accommodate physician preferences and patient anatomy.
Each ReCruit™ Microcatheter is packaged with a ReAct™ stylet and torque device. The ReAct™ stylet is a stainless steel wire with a platinum tip that may be used to activate the ReCruit™ Microcatheter's retrieval element. The ReCruit™ Microcatheter can be used in vessel diameters ranging from 2mm to 4mm.
Materials used in the Reverse Medical ReCruit™ Foreign Body Retrieval Microcatheter are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate device, and have historically been demonstrated to be both biocompatible and suitable for this use.
1
Reverse Medical Corporation ReCruit™ Foreign Body Retrieval Microcatheter 510(k) Submission
Indications for Use
Summary of substantial equivalence
The Reverse Medical ReCruit™ Microcatheter is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and/or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.
Preclinical studies conducted included in vitro and in vivo laboratory studies to demonstrate that the Reverse Medical ReCruit™ Microcatheter performed as intended under simulated use conditions. Biocompatibility testing was performed to demonstrate that the device meets ISO 10993-1 requirements and FDA requirements.
The Reverse Medical ReCruit™ Foreign Body Retrieval Microcatheter has the following similarities to the previously cleared predicate device:
- . Same indications for use;
- . Same intended use;
- . Same intended treatment site;
- . Similar operating principle;
- Similar technological characteristics; .
- Same packaging methods .
- ♪ Same sterilization methods
In. summary, the Reverse Medical ReCruit™ Microcatheter as described in this submission is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1.00 2009
Reverse Medical Corporation c/o Mr. Mark Job Reviewer Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K091563
Trade Name: ReCruit Foreign Body Retrieval Microcatheter Regulation Number: 21 CFR 870.5150 Regulation Name: Percutaneous Retrieval Device Regulatory Class: Class II Product Code: MMX Dated: July 17, 2009 Received: July 21, 2009
Dear Mr. Job:
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 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 - Mr. Mark Job
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 (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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincered yours,
W
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Reverse Medical Corporation ReCruit™ Foreign Body Retrieval Microcatheter 510(k) Submission
- Indications for Use
510(k) Number (if known):
Device Name: Reverse Medical ReCruit™ Microcatheter
Indications for Use:
The Reverse Medical ReCruit™ Microcatheter is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and/or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use (21 CFR 801 Subpart C)
9
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(DivIsion Sign-Off) Division of Catalovascular Devices 510(k) Number