The Clarus Peel-Away Introducer Sheath is a thin-walled, cylindrical device that is placed in position so that it provides a communicating passageway through brain tissue. This is accomplished by fitting the sheath securely over an obturator, advancing both devices through the tissue together as a unit. A hole through the distal tip of the obturator aids in placement by allowing pressurized cerebrospinal fluid to egress once the ventricular system is reached. The proximal hub on the obturator is rotated, unlocking it from the sheath, and the obturator is removed from the sheath, leaving the sheath alone in the desired position acting to hold the penetrated site in an open condition. The peel away sheath is capable of being pulled apart lengthwise to allow varying insertion depths into brain tissue. The proximal end of the sheath has tab handles that are provided to facilitate grasping and tearing. At this point, a regulatorily cleared device can be inserted through the sheath for patient procedures.

AI/ML Overview

The provided text describes the Clarus Peel-Away Introducer Sheath and its substantial equivalence determination. Here's a breakdown of the acceptance criteria and study details based on the provided FDA 510(k) summary:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for the Clarus Peel-Away Introducer Sheath were based on demonstrating substantial equivalence to predicate and reference devices, primarily through biocompatibility and mechanical testing. The reported device performance indicates that the device passed all tests and had comparable results to the predicate/reference devices.

Acceptance Criteria Category	Specific Test/Description	Performance/Results
Biocompatibility	Cytotoxicity	Acceptable (demonstrating safety for intended use)
	Sensitization	Acceptable (demonstrating safety for intended use)
	Irritation	Acceptable (demonstrating safety for intended use)
	Systemic Toxicity	Acceptable (demonstrating safety for intended use)
	Hemocompatibility	Acceptable (demonstrating safety for intended use)
	Material-Mediated Endotoxin	Acceptable (demonstrating safety for intended use)
Mechanical Testing	Fluid Patency (Visual inspection for cleanliness and manufacturing quality)	Pass. All devices had comparable results.
	Prolapse Force (Resistance to deformation while advancing distal end into flat plate)	Pass. All devices had comparable results.
	Peak Tensile Force (Measure of inner obturator/dilator and sheath hub per ISO 11070)	Pass. All devices had comparable results.
	Peel Force (Force required to break hub and peel sheath)	Pass. All devices had comparable results.
Overall Equivalence	Comparison of Design, Materials, Construction, Environment of Use	Substantially equivalent to predicate/reference devices

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for the biocompatibility or mechanical testing. It mentions "Components of the Clarus Peel-Away Introducer Sheath and predicate devices were tested," implying that multiple units were tested, but no specific numbers are provided.

The data provenance is not specified regarding country of origin or whether studies were retrospective or prospective. Given this is a 510(k) submission for a medical device, the testing would generally be prospective to generate data for the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the type of device and testing described. The acceptance criteria for this device are based on objective performance characteristics (biocompatibility, mechanical properties) rather than interpretation requiring expert consensus. There were no "ground truth" labels established by experts in the context of image interpretation or diagnostic accuracy studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this device's evaluation relies on objective physical and material property tests rather than diagnostic interpretation requiring adjudication.

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

Not applicable. This device is a physical introducer sheath, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For biocompatibility testing, the "ground truth" is adherence to established international standards (ISO 10993-1) and the successful completion of specific biological tests, with "acceptable" results serving as the ground truth for safety.

For mechanical testing, the "ground truth" is typically defined by engineering specifications, material properties, and comparison to the performance of predicate devices that are already deemed safe and effective. "Pass" results and "comparable results" to predicates served as the ground truth for performance.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not based on machine learning or AI models that require training data.

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

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 18, 2021

Clarus Medical, LLC Mark Brown Director, Operations 13355 10th Ave N Suite 110 Plymouth, Minnesota 55441

Re: K200925

Trade/Device Name: Peel-Away Introducer Sheath Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: February 11, 2021 Received: February 16, 2021

Dear Mark Brown:

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) K200925

Device Name Clarus Peel-Away Introducer Sheath

Indications for Use (Describe)

The Clarus Peel-Away Introducer Sheath is intended to be used in indications requiring access through the brain into the ventricular system.

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

Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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510(K) Summarv

A. General Information:

510(K) Submission Number:	K200925
Submitter:	Clarus Medical, LLC13355 10th Ave NorthMinneapolis, MN 55441763-525-8403
Establishment Number:	2183911
Contact:	Mark F. BrownDirector of Operationsmbrown@clarus-medical.com
Date Prepared:	April 3, 2020

B. Trade Name:

Common Name:	Clarus Peel-Away Introducer Sheath
Product Code:	Endoscope Introducer
C.F.R Section:	GWG
Class:	882.1480
	II

C. Predicate Device:

510(k) Number	Description
K990333	Medtronic Peelaway Introducer Sheath

D. Reference Devices:
510(k) Number	Description
K883607	Codman® Peel-Away Catheter Introducer
K120617	Martech Medical Products Super Sheath Introducer

E. Device Description:

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The Peel-Away Introducer Sheath has the following parts:

Image /page/4/Figure/2 description: The image contains two figures, labeled as Figure 1 and Figure 2, which depict medical instruments. Figure 1 shows a detailed view of an obturator hub with labels pointing to the conical luer fitting, peel-away sheath tab, peel-away sheath tubing, and obturator tubing. Figure 2 presents a side-by-side comparison of a peel-away sheath and an obturator.

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Component description:

Obturator hub: The obturator hub is injection molded directly onto the obturator tubing with high-density polyethylene (HDPE) resin. The hubs are color coded to indicate the French size. Also, the French size number is molded onto the side of the hub

Obturator tubing: The tubing for the obturator is extruded using high-density polyethylene (HDPE) resin with 15% barium sulfate to aid in visualization under fluoroscopy.

Peel-away Sheath tabs: The peel-away sheath tabs are injection molded directly onto the sheath tubing with high-density polyethylene (HDPE) resin. The molded tabs incorporate a slot to allow the obturator hub to lock onto the sheath.

Peel-away sheath: The sheath tubing is extruded using Polytetrafluoroethylene PTFE resin with 9% Bismuth oxide to aid in visualization under fluoroscopy.

F. Intended Use:

The Clarus Peel-Away Introducer Sheath is intended to be used in indications requiring access through the brain into the ventricular system.

G. Comparison to Predicate and reference Devices:

The Clarus Peel-Away Introducer Sheath is substantially equivalent to the predicate and reference devices based on the following technological elements:

. Design: The predicate and reference devices all have a two-part design, a peelaway sheath and an inner obturator introducer. Both parts lock together.
. Materials: The materials of the subject device and the Medtronic predicate device are very similar, and the Martech Medical Products PTFE Super Sheath reference device are identical in terms of materials.
Construction: The construction of the subject device and predicate Medtronic . Peelaway Introducer Sheath are very similar. They both include two parts, a peelaway sheath and a blunt distal tip obturator, which fits inside the sheath.
Environment of Use: The Clarus Peel-Away Introducer Sheath and the Medtronic . Peelaway Introducer Sheath must be used by a physician in a healthcare facility.

The following technological differences exist between the subject and predicate devices:

. The way in which the outer sheath and obturator lock together is different. The subject device locks to the sheath by rotating the obturator a quarter turn engaging two side tabs into the sheath. The predicate device snaps together.
The way in which fluid can be drained is different. The subject device has a small hole at ● the distal tip of the obturator to aid in placement by allowing pressurized cerebrospinal fluid to egress once the ventricular system is reached. The predicate device does not have this feature which requires the user to completely remove the obturator to relieve pressurized fluid. The Codman reference device obturator distal tip designs are identical. They both have a hole through the side to aids in placement by allowing pressurized cerebrospinal fluid to egress once the ventricular system is reached.

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	Subject Device	Predicate Devices	Reference Device	Reference Device
Trade Name	Clarus Peel-AwayIntroducer Sheath	MedtronicPeelawayIntroducer Sheath	Codman® Peel-Away CatheterIntroducer	Martech MedicalProducts PTFE SuperSheath Introducer
510(k)	K200925	K990333	K883607	K120617
Indicationsfor Use	The Clarus Peel-Away IntroducerSheath is a deviceused to make achannel through thebrain into theventricular system.	The IntroducerSheath is a deviceused tomake a channelthrough the braininto the ventricularsystem.	The Peel-AwayCatheter Introducerassists in placing acatheter in theventricle whenhydrocephalusshunting isindicated and whenusing anendoscope.	The PTFE SuperSheath Introducers areintended to obtaincentral venous accessto facilitate catheterinsertion or placingpacing leads into thecentral venous system.
Image
ProductCode	GWG	GWG	GYK	DYB
Enviornmentof use	Rx Only	Rx Only	Rx Only	Rx Only
SheathDiameterand Length	12F, 14F, 15F8-13cm	12F, 14F, 15F9.5cm	9F, 11F, 12.5F,14F14.7cm	5F through 18F10cm and 13.5cm
Sterilizationmethod	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
Conditionssupplied	Sterile, single use	Sterile, single use	Sterile, single use	Sterile, single use
Devicecomponents	Peel-away Sheath,obturator	Peel-away Sheath,obturator	Peel-away Sheath,obturator	Peel-away Sheath,dilator

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H. Performance Data:

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the Clarus Peel-Away Introducer Sheath was conducted with the following FDA quidance, "Use of International Standards ISO 10993-1,"Biological evaluation of medical devices - Part 1: Evaluation and testing within risk management process". The battery of testing included the following tests:

. Cytotoxicity
Sensitization ●
Irritation ●
. Systemic Toxicity
Hemocompatibility ●
Material-Mediated Endotoxin ●

The nature of body contact and the related device category: Category: External Communicating device Contact: Circulating Blood Contact Duration: limited (<24 hours)

The selected tests are appropriate based on the intended use for the Clarus Peel-Away Introducer Sheath. All tests results are acceptable demonstrating the Clarus Peel-Away Introducer Sheath is safe for its intended use.

Mechanical Testing:

Components of the Clarus Peel-Away Introducer Sheath and predicate devices were tested for:

Test performed	Description	Test results
Fluid Patency	Visually inspect inside diameter forcleanliness and quality of manufacturing.	Pass. All devices hadcomparable results.
Prolapse Force	Resistance to deformation of device whileadvancing distal end into flat plate. Forcewas measured.	Pass. All devices hadcomparable results.
Peek TensileForce	Measure peak tensile force of innerobturator/dilator and sheath hub per ISO11070.	Pass. All devices hadcomparable results.
Peel Force	Each sheath is gripped and force measure tobreak hub, and peel sheath.	Pass. All devices hadcomparable results.

The subject device and predicate devices were found to be substantially equivalent in performance.

Clinical and animal Studies:

No animal studies were required (other than biocompatibility testing) for the Clarus Peel-Away Introducer Sheath.

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No clinical studies were required for the Clarus Peel-Away Introducer Sheath to support substantial equivalence.

l. Conclusion

The non-clinical data supports the safety of the device and performance verification & validation testing demonstrate that the Clarus Peel-Away Introducer Sheath should perform as intended in the specified use conditions. Testing demonstrates that the Clarus Peel-Away Introducer Sheath is substantially equivalent to the predicate device.

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).