The MR Compatible Aspiration System is used for controlled aspiration of blood, cystic components of tumors, abscess, colloid cysts, and cerebrospinal fluid using a manual syringe during surgery of the Ventricle System or Cerebrum.

Device Description

The MCA Kit is an accessory to the cleared ClearPoint System (K171257). The MCA Kit consists of a MCA device guide, guide sheath, stylet, depth stops, cannula (with attached tube) and adapter. The MCA Kit is designed to aid a physician in the removal of specific tissue or fluid types from the brain during image guided surgery. It is MR safe, as all materials are non-metallic. The MCA Kit is comprised of single use only, sterile-packaged disposable components that are packaged together.

AI/ML Overview

The provided document describes the MRI Interventions, Inc.'s MR Compatible Aspiration Kit (MCA Kit) and the studies performed to demonstrate its substantial equivalence to a predicate device, the Penumbra Apollo System (K152699).

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Accuracy Testing	Mean error below 2.0mm and mean angular error below 2.0° for a stereotaxic device intended for general neurological use.	Mean error below 1.0mm, with the highest standard deviation being 0.75mm (X direction) and highest 99% upper confidence limit of 1.48mm (X direction). Mean angular error below 1°, with a standard deviation of 0.34° and 99% upper confidence limit of 0.72°.
MCA-Kit Device Guide – SmartFrame XG Compatibility	Not explicitly stated but implied: Compatibility between the device guide and SmartFrame XG, including secure insertion and retention, stability under loading, and maintained accuracy.	All acceptance criteria were met to demonstrate that the MCA Kit components are compatible with the cleared ClearPoint System SmartFrame XG.
Flow and Leak Testing	Device must be able to aspirate at least 10cc of various simulated materials without leaking or collapsing and at an acceptable flow rate.	The tests demonstrated that the MCA Kit functions as intended and is substantially equivalent to the legally marketed predicate.
Aspiration Test	Device must remain operable for a limited period of time at 29.0 inHg without collapsing, leaking, or failing. Minimal change in inner diameter (I.D.).	All Cannulas tested were able to withstand collapsing, leaking, or failing at a minimum aspiration pressure of 29.0 inHg. Measured change in Rigid section I.D.: 0.0% (12 Fr.), 0.8% (16 Fr.). Measured change in flexible Tubing I.D.: 1.3% (12 Fr.), 2.9% (16 Fr.).

Note: The document sometimes indirectly states the "acceptance criteria" by describing what the results demonstrated/met. For the "Flow and Leak Testing" and "MCA-Kit Device–SmartFrame XG Compatibility," the specific numerical acceptance criteria were not explicitly detailed in the provided text, but the document states they were met.

2. Sample Size Used for the Test Set and Data Provenance

Accuracy Testing: The specific numerical sample size (number of placements) for the accuracy test is not explicitly stated. It mentions that "Placements were performed using the 12 Fr x 30 cm and 16 Fr x 30 cm MCA Kits," representing the smallest and largest outer diameter sizes. However, the total number of repetitions or distinct placements is not given.
MCA-Kit Device Guide – SmartFrame XG Compatibility: Not specified.
Flow and Leak Testing: Not specified.
Aspiration Test: "Twelve Fr. and 16 Fr. Cannulas that have undergone worst-case conditioning were used for this test." The exact number of cannulas tested is not specified beyond indicating both sizes were used.

Data Provenance: This was a bench testing study, not involving human subjects. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the typical clinical sense. The data was generated through controlled laboratory experiments.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a mechanical instrument (aspiration kit). The ground truth for its performance (e.g., accuracy, flow, leak, aspiration capacity) was established via engineering measurements and predefined physical/mechanical standards, not by expert medical interpretations.

4. Adjudication Method for the Test Set

Not applicable. As this was bench testing based on physical measurements and predefined criteria, there was no need for expert adjudication of results.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This device is an aspiration kit, not an imaging or diagnostic device that relies on human reader interpretation. The effectiveness studies focused on the physical performance of the device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, the studies described are standalone performance tests of the device itself (e.g., accuracy, flow, aspiration), without human interaction as part of the measured performance metric, although human operators would have performed the tests. The device does not involve an algorithm.

7. Type of Ground Truth Used

The ground truth used was based on:

Predefined engineering specifications and limits (e.g., 2mm and 2° accuracy limits for stereotaxic devices).
Quantitative physical measurements (e.g., mean error in mm, angular error in degrees, aspiration pressure in inHg, change in inner diameter in percentage).
Qualitative observations of physical integrity (e.g., "without leaking or collapsing," "remains undamaged").

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning or artificial intelligence, so there is no training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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November 20, 2018

MRI Interventions, Inc. % John Smith Partner Hogan Lovells US LLP 555 Thirteenth St. NW Washington, District of Columbia 20004

Re: K181731

Trade/Device Name: MR Compatible Aspiration Kit Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: October 24, 2018 Received: October 24, 2018

Dear John Smith:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

John Marler -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181731

Device Name MR Compatible Aspiration System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Transaction Not in 31 CFR 501.615(a) or (b)	Service Transaction Not in 31 CFR 501.615(c)
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|× | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY MRI Interventions, Inc.'s MR Compatible Aspiration Kit

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Hogan Lovells, US LLP 555 Thirteenth Street, NW Washington, DC 20004 Phone: 202-637-5600 Fax: 202-637-5910 Contact Person: John J. Smith, M.D., J.D.

Date Prepared: November 20, 2018

Name of Device and Name/Address of Sponsor

MR Compatible Aspiration Kit ("MCA Kit")

MRI Interventions, Inc. 5 Musick Irvine, CA 92618

Common or Usual Name:

Neurological Endoscope

Classification 21 C.F.R. § 882.1480

Product Code GWG

Predicate Device Penumbra Apollo System (K152699)

Intended Use / Indications for Use

Device Description

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KitConfiguration	Guide Size(Diameter)	Sheath(Outer)	Cannula Size(Outer Diameter)	Cannula Length(Approximate)	Maximum Target(mm)	Depth
15 Fr – Long	15 Fr	12 Fr	12 Fr	12.2" / 31 cm	120
17 Fr – Long	17 Fr	14 Fr	14 Fr	12.2" / 31 cm	120
19 Fr – Long	19 Fr	16 Fr	16 Fr	12.2" / 31 cm	120
15 Fr – Short	15 Fr	12 Fr	12 Fr	9.4" / 24 cm	70
17 Fr – Short	17 Fr	17 Fr	14 Fr	14 Fr	9.4" / 24 cm	70
19 Fr – Short	19 Fr	19 Fr	16 Fr	16 Fr	9.4" / 24 cm	70

The MCA Kit is available in the following configurations:

Performance Data

Bench testing was performed to verify the MCA Kit's compatibility with the ClearPoint System, accuracy, and substantial equivalence to the predicate aspiration device.

Test	Test Method Summary	Results
AccuracyTesting	The company used the same groundtruth procedure and test methods thatwere used in the accuracy testingprovided in support of K142505 andK171257 for the ClearPoint System.The test set-up utilized only the scalpmount bases and SmartFrame XG,since the MCA Kit must be used withthe SmartFrame XG to allow deviceguide insertion, and the scalp mountbase is the most likely configuration tobe used clinically. Placements wereperformed using the 12 Fr x 30 cm and16 Fr x 30 cm MCA Kits, whichrepresent the smallest and largest ODsizes; accordingly, the test resultssupport the performance of all sizes ofthe MCA kit. Target depth was 125mm from the base-mounting surfacefor all placements.	Results from the company's benchaccuracy tests demonstrated that themean error was below 1.0mm, with thehighest standard deviation being0.75mm in the X direction and highest99% upper confidence limit of 1.48mmin the X direction. The mean angularerror was below 1°, with a standarddeviation of 0.34° and 99% upperconfidence limit of 0.72°. These valuesare below the 2mm and 2° accuracylimits for a stereotaxic device intendedfor general neurological use.
	MCA-Kit DeviceGuide–SmartFrameXGCompatibility	Performance testing was completed toverify that the device guide andSmartFrame XG are compatible perpre-defined acceptance criteria.Testing included insertion andretention of the Device Guide andAdapter to the SmartFrame undertensile and torque loading, stability ofthe Guide Sheath-Stylet and GuideSheath-Cannula under lateral loadingwhen inserted in the SmartFrame, andaccuracy with the SmartFrame.	All acceptance criteria were met todemonstrate that the MCA Kitcomponents are compatible with thecleared ClearPoint System SmartFrameXG.

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Flow and LeakTesting	Testing was conducted to confirm thatthe device could aspirate at least 10ccof various materials simulating blood,clotted blood, cystic components oftumors, abcesses, colloid cysts, andcerebrospinal fluid without leaking orcollapsing and at an acceptable flowrate.	The tests demonstrated that the MCAKit functions as intended and issubstantially equivalent to the legallymarketed predicate
Aspiration Test	Testing was performed to confirm thedevice remains operable for a limitedperiod of time at 29.0 inHg for the MCAKit Cannulas Twelve Fr. and 16 Fr.Cannulas that have undergone worst-case conditioning were used for thistest. Plugged cannulas wereevaluated under high vacuumgenerated by a pump to create worst-case conditions. The change in deviceinner diameter (I.D.) was measured toconfirm that the device's integrity wasmaintained during the aspiration. Thedevice was also verified to remainundamaged after exposure to theconditions.	All Cannulas tested were able towithstand collapsing, leaking, or failingin any other manner when experiencinga minimum aspiration pressure of 29.0 inHg. The measured change in theRigid section I.D. of the Cannulas was0.0% for the 12 Fr., and 0.8% for the 16Fr. The flexible Tubing had a measuredchange in I.D. of 1.3% for the 12 Fr. and2.9% for the 16 Fr. Cannulas. Thedevice can operate for a limited periodof time at an aspiration pressure of 29.0 inHg without failing.

The MCA Kit complies with the following recognized consensus standards:

. ANSI/AAMI/ISO 11137-2: Sterilization of Health Care Products – Radiation – Establishing the sterilization dose - Method VDmax
ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within . a risk management process
ASTM F2096-11: Standard Test Method for Detecting Gross Leaks in Packaging by Internal ● Pressurization (Bubble Test)
ASTM D4196-16: Standard Test Method for Confirming the Sterility of Membrane Filters ●
. ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Substantial Equivalence

The Apollo System and MR Compatible Aspiration Kit have substantially similar intended use and indications for use. The table below presents a comparison of the technological characteristics of the MR Compatible Aspiration Kit and those of the predicate device.

	Apollo SystemK152699	MR Compatible Aspiration Kit
Wand(Cannula)O.D / I.D.	1 size:Body = .083" / .069"Distal Tip = .072" / .059"	3 sizes:12F = .158" / .138"14F = .183" / .163"16F = .208" / .190"

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	Apollo SystemK152699	MR Compatible Aspiration Kit
Usable Length	27.2 cm	Maximum insertion length is 12.5cm due to height of SmartFrame
BasicOperatingPrinciple	AC power is converted from the generator into vibrational energy to the distal tip of the wand, which removes tissue and/or fluids through and aspiration lumen	Manual actuation of the syringe plunger provides vacuum to the distal tip of the cannula which removes tissue and/or fluids through the aspiration lumen
Aspiration	0–29 in.HG	0–29 in.HG
DisposableComponents	Wand Collection Canister, filter and pump-canister tubing Irrigation Tubing	Cannula w/ tubing Stylet Guide Sheath Depth Stop SmartFrame Adapter and Device Guide
PowerRequirements	100">–115V (60Hz),100V (50Hz)	N/AManual Control
Navigation	Image Guidance	Image Guidance

Conclusion

The MCA Kit and Apollo System have substantially similar intended use and indications for use, as well as similar technological characteristics. The minor technological differences in the MCA Kit compared to the Apollo System do not raise new questions of safety or effectiveness. The MCA Kit's accuracy, compatibility with the ClearPoint System SmartFrame XG, flow, leak, and aspiration testing further confirm that the device performs as intended and is substantially equivalent to the legally marketed predicate.

Regulation Number and Section

§ 882.1480 Neurological endoscope.

(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).