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.

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.

AI/ML Overview

The provided text does not contain specific acceptance criteria or an analytical study proving the device meets those criteria. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria.

However, based on the information provided, we can infer some aspects related to how performance was demonstrated:

Acceptance Criteria and Reported Device Performance (Inferred):

Acceptance Criteria Category	Reported Device Performance (Inferred from "Preclinical Studies" and "Substantial Equivalence")
Functional Performance (Retrieval)	"in vitro and in vivo laboratory studies to demonstrate that the Reverse Medical ReCruit™ Microcatheter performed as intended under simulated use conditions." This suggests the device successfully retrieved foreign objects as designed in simulated environments. The "intended use" and "operating principle" being similar to the predicate device further implies that its retrieval capability would be comparable and acceptable.
Biocompatibility	"Biocompatibility testing was performed to demonstrate that the device meets ISO 10993-1 requirements and FDA requirements." The device met these established standards.
Safety	Implied by "materials used... 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." and meeting biocompatibility standards.
Compatibility (with guidewires, guide catheters)	"The inner lumen can accommodate a guidewire to aid in placement of the catheter." "The catheter is designed to be used with a guide catheter." "The ReCruit™ Microcatheter can be used in vessel diameters ranging from 2mm to 4mm." These indicate compatibility with specified ancillaries and anatomical ranges.
Visibility (Radiopacity)	"The catheter contains radiopaque markers to facilitate fluoroscopic visualization." This is a design feature ensuring visibility, implicitly meeting a need for accurate placement.

Since this is a 510(k) submission for substantial equivalence, the "study" demonstrating the device meets criteria is primarily focused on demonstrating that its performance characteristics are comparable to a legally marketed predicate device, rather than establishing entirely new performance benchmarks. The preclinical studies mentioned would support this claim of comparable performance.

Here's a breakdown of the other requested information based on the provided text:

Sample size used for the test set and the data provenance:
- Sample size for test set: Not explicitly stated. The text mentions "in vitro and in vivo laboratory studies" but does not quantify the number of tests, simulated retrievals, or animals/models used.
- Data provenance: "in vitro and in vivo laboratory studies." This suggests the studies were conducted in a controlled lab setting, likely by the manufacturer or a contract research organization. The country of origin is not specified but is implied to be related to the submitting company (Reverse Medical Corporation, likely US-based, given FDA submission). The studies would be considered prospective as they were conducted to test the device's performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. For a device like a microcatheter, "ground truth" would likely be established by direct observation of successful retrieval, measurement of forces, or biological responses in established models, rather than expert consensus on diagnostic images. The performance would be assessed against engineering specifications or successful outcomes as defined by the study protocol.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., image reading). For direct device performance studies, success or failure is usually determined by objective criteria defined in the study protocol.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This type of study relates to diagnostic AI devices involving human readers, which is not applicable to a foreign body retrieval microcatheter.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical instrument, not an algorithm. Its performance inherently involves human manipulation (human-in-the-loop).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "in vitro" studies, the ground truth would be based on objective physical measurements and observations (e.g., successful capture and removal of foreign objects, force measurements, catheter trackability, deployment efficacy) against predefined engineering specifications.
- For the "in vivo" studies, the ground truth would be based on direct observation of physiological response and device function in a living system (e.g., successful retrieval, absence of vessel damage, adherence to anatomical constraints) against specified animal model outcomes.
- For biocompatibility, the ground truth is established by conformance to ISO 10993-1 and FDA requirements through specific biological tests.
The sample size for the training set:
- Not applicable/Not provided. This device is not an AI algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. As noted above, there is no "training set" for this physical device.

Summary

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K091563

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 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.

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Reverse Medical Corporation ReCruit™ Foreign Body Retrieval Microcatheter 510(k) Submission

Indications for Use

Summary of substantial equivalence

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.

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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.

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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,

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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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:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over the Counter Use (21 CFR 801 Subpart C)

(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

Regulation Number and Section

§ 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).