A locking mechanism design allows the Dilator to lock into the Sheath and prevent "push back" during insertion into the brain. The Dilator tip is designed to be atraumatic during insertion. The Sheath is graduated in centimeters to assist the surgeon in determining the Introducer insertion depth. The Sheath's transparency is useful for full endoscopic visualization during insertion.

The proximal end of the Sheath is labeled 20F, indicating the inner diameter of the Sheath.

AI/ML Overview

The provided text is a 510(k) summary for the ClearPath™ Disposable Introducer. It focuses on demonstrating substantial equivalence to a predicate device (MINOP® Disposable Introducer 26F, K142315) rather than providing extensive details about acceptance criteria and a specific study proving device performance against those criteria in the context of an AI/ML device.

Therefore, many of the requested details, such as AI-specific acceptance criteria, sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established, are not available in this document as it pertains to a mechanical medical device, not an AI/ML device.

However, I can extract the available information related to performance and testing from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria (Implied/Direct)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993	Demonstrates compliance with ISO 10993
Device Specifications	Compliance with its specifications and labeling claims	Bench testing demonstrates compliance with its specifications and claims
Transit Performance	Compliance with ASTM D4169	Demonstrates compliance with ASTM D4169
Shelf Life	Sterility for a specified duration	Shelf life studies demonstrate it can be stored sterile for 2 years
Indications for Use	To obtain and maintain a temporary pathway into the ventricular system and cerebrum.	Claims "clinically identical" indications for use as predicate.
Technology	Function as an introducer with dilator and sheath.	"Technology is identical" to predicate device.
Design Features	Interlocking hub, printed graduations.	Features interlocking hub, printed graduations. Transparent sheath noted.

2. Sample size used for the test set and the data provenance:

The document does not specify a "test set" in the context of data for an algorithmic device. The testing described (biocompatibility, bench testing, transit testing, shelf life) refers to physical device testing, not data-driven performance evaluation. Therefore, sample sizes for data-driven testing and data provenance are not applicable or provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the device is a physical medical instrument, not an AI/ML diagnostic or prognostic tool that would require expert-established ground truth from a test set of data.

4. Adjudication method for the test set:

This information is not applicable for the same reasons as point 3.

5. 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:

This information is not applicable as the ClearPath™ Disposable Introducer is a physical medical device, not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable as the device is a physical medical instrument, not an algorithm.

7. The type of ground truth used:

For the performance aspects mentioned (biocompatibility, bench testing, transit testing, shelf life), the "ground truth" would be established by pre-defined engineering specifications, international standards (ISO 10993, ASTM D4169), and validated laboratory testing procedures. There is no "expert consensus" or "pathology" in the context of data for this type of device.

8. The sample size for the training set:

This information is not applicable as the device is not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established:

This information is not applicable for the same reasons as point 8.

In summary, the provided FDA 510(k) document is for a conventional medical device (an introducer) and thus does not contain the detailed AI/ML specific information requested in many of the questions. It uses standard engineering and biocompatibility testing to demonstrate safety and effectiveness and substantial equivalence to a predicate device.

Summary

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April 2, 2021

ClearMind Biomedical % Craig Coombs President Coombs Medical Device Consulting, Inc. 1100 Pacific Marina, Suite 806 Alameda. California 94501

Re: K210251

Trade/Device Name: ClearPath Disposable Introducer Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: January 28, 2021 Received: January 29, 2021

Dear Craig Coombs:

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. Although this letter refers to your product as a device, please be aware 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210251

Device Name ClearPath Disposable Introducer

Indications for Use (Describe)

The ClearPath Disposable Introducer is indicated to obtain and maintain a temporary pathway into the ventricular system and cerebrum of the brain.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Category	Comments
Sponsor:	ClearMind Biomedical5F, No. 167, Fuxing N. Rd., Songshan Dist., TaipeiCity 105, Taiwan, R.O.C.+886-2-22697417
Correspondent ContactInformation:	Craig CoombsCoombs Medical Device Consulting, Inc1100 Pacific Marina, Suite 806Alameda, CA 94501Tel: 510-995-8499
Device Common Name:	Neurological Endoscope Introducer
Device Regulation & Name:	21 CFR 882.1480Neurological Endoscope
Classification & Product Code:	Class II, GWG
510(k) Number:	K210251
Device Proprietary Name:	ClearPath™ Disposable Introducer

ClearPath™ Disposable Introducer 510(k) Summary

Predicate Device Information:

Predicate Device:	MINOP Disposable Introducer 26F
Predicate Device Manufacturer:	Aesculap Inc.
Predicate Device Common Name:	Endoscope, Neurological
Predicate Device Premarket Notification #	K142315
Predicate Device Classification & Name	21 CFR 882.1480
Predicate Device Classification &	Class II
Product Code:	GWG

B. Date Summary Prepared

30 March 2021

C. Description of Device

The ClearPath™ Disposable Introducer is a sterile, single-use, neurological endoscope Introducer, consisting of a Sheath and a Dilator.

The proximal end of the Sheath is labeled 20F, indicating the inner diameter of the Sheath.

D. Indications for Use

The ClearPath Disposable Introducer is indicated to obtain and maintain a temporary pathway into the ventricular system and cerebrum of the brain.

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E. Tabular Comparison of Application and Predicate Devices in Regard to Substantial Equivalence

Characteristic	Application Device:ClearMind BiomedicalClearPathTMDisposable Introducer	Predicate Device:MINOP® DisposableIntroducer 26FK142315	Impact onSubstantialEquivalence
Company	ClearMind Biomedical	Aesculap	-
RegulationNumber	21 CFR 882.1480	21 CFR 882.1480	Identical
Product Code	GWG	GWG	Identical
Indications for Use	The ClearPathTMDisposable Introducer isindicated to obtain andmaintain a temporarypathway into theventricular system andcerebrum of the brain.	The MINOP®Disposable Introducer isindicated to obtain andmaintain a temporarypathway into theventricular system of thebrain.The purpose of theMinop® DisposableIntroducer is to obtainand maintain atemporary pathway tothe ventricular system ofthe patient.The Minop® DisposableIntroducer is designed tobe split lengthwise andpeeled down to the skulllevel of the patient,accommodatingdifferent depthrequirements.	The Indications forUse are clinicallyidentical.Both devices areintended to provide atemporary pathway intothe brain, down to thelevel of the ventricularsystem. The access tothe ventricular systemoccurs only afterpassing through thecerebrum. Theapplication device addsdetail that is implicit inthe predicateIndications for Use.The applicationIndication for Usedoes not repeat theIndications for Uselike the predicate doesin its second sentence.The application devicedrops the predicate'sdesign description asunnecessary in anIndications for Use.The differencesbetween theIndications for Useraise no new questionsof safety or efficacy.
Technology	An insert (dilator) istemporarily fixed withina tube (sheath) that canbe atraumaticallyadvanced to the targetsite. The insert isremoved and the tubecan be split to either sideto facilitate theplacement of a neuroendoscope.	An insert (obturator) istemporarily fixed withina tube (sheath) that canbe atraumaticallyadvanced to the targetsite. The insert isremoved and the tubecan be split to either sideto facilitate theplacement of a neuroendoscope.	Technology isidentical.
Characteristic	Application Device:ClearMind BiomedicalClearPathTMDisposable Introducer	Predicate Device:MINOP® DisposableIntroducer 26FK142315	Impact onSubstantialEquivalence
Design	ClearPathTM DisposableIntroducer consists oftwo main components:sheath and dilator.The sheath is a hollowtube and the dilator isa solid rod that fillsthe hollow tube as itis advanced throughthe brain to the targetarea.After the sheath isconfirmed to havebeen advanced to thetarget area, it can bepeeled in half, downto the level of theskull, to facilitate theadvancement of theneuroendoscope.Interlocking hub designthat prevents dilator"push back" duringinsertion.Printed graduation onthe sheath to assist thesurgeon indetermining the depththe introducer hasbeen inserted andprevent advancedeeper than desired.Transparent sheath forobservingsurrounding tissueand brain through anendoscope	The MINOP DisposableIntroducer 26F consistsof two maincomponents: sheath andobturator.The sheath is a hollowtube and the obturatoris a solid rod that fillsthe hollow tube as itis advanced throughthe brain to the targetarea.After the sheath isconfirmed to havebeen advanced to thetarget area, it can bepeeled in half, downto the level of theskull, to facilitate theadvancement of theneuroendoscope.Interlocking hub designthat preventsobturator "push back"during insertion.Printed graduation onthe sheath to assist thesurgeon indetermining the depththe introducer hasbeen inserted andprevent advancedeeper than desiredOpaque Sheath.	Similar. Thetransparent sheath ofapplication devicedoes not raise newrisk of safety.
Inner Diameter ofSheath	20 Fr(6.68 mm)	26 Fr(8.67 mm)	The application deviceis smaller thanpredicate device byonly 2 mm in ID andOD. The 20Fr size issimilar to other neurointroducers like theMINOP Introducer(K061135) whichranges in cleared size
Characteristic	Application Device:ClearMind BiomedicalClearPath™Disposable Introducer	Predicate Device:MINOP® DisposableIntroducer 26FK142315	Impact onSubstantialEquivalence
Outer Diameter ofSheath	7.4 mm	9.33 mm	Same justification asin the cell above.
Max UseableSheath Length	120 mm	120 mm	Identical
Dilator OD	6.6 mm	8.5 mm	Outer diameter of theapplication device issmaller than predicate.Each dilatorcompatible with itssheath and raises nonew questions ofsafety or efficacy.
Materials	Polymers & Colorant	Not describedSome polymers	The material of theapplication device hasbeen widely used insimilar applications inmedical devices.The application device haspassed appropriatebiocompatibilitytesting.
Graduations	Graduation 1 to 12 onsheath and in centimeterper grid	Graduation 1 to 12 onsheath and in centimeterper grid	Identical
Radiopacity	Non-radiopaque	Non-radiopaque	Identical
Principal Operator	Surgeon	Surgeon	Identical
Use Location	Operating room	Operating room	Identical

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F. Summary of Supporting Data

Biocompatibility data demonstrates that the device is in compliance with ISO 10993.

Bench testing has demonstrated that the ClearPath™ Disposable Introducer is in compliance with its specifications and its labeling claims.

Transit testing demonstrates that the device is in compliance with ASTM D4169.

Shelf life studies demonstrate that the ClearPath™ Disposable Introducer could be stored in a sterile manner for 2 years.

G. Conclusion

Based on intended use, performance and supporting documentation, ClearMind Biomedical concludes that the ClearPath™ Disposable Introducer is substantially equivalent in intended use, indications for use, technology, principal operator, use location, sterilization method and contact duration of the predicate MINOP® Disposable Introducer 26F device (K142315).

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).