Who is the manufacturer of ClearPath Disposable Introducer?

Clearmind Biomedical filed the 510(k) submission for ClearPath Disposable Introducer (K210251).

What is the FDA product code for ClearPath Disposable Introducer?

GWG. It is classified under 21 CFR 882.1480 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for ClearPath Disposable Introducer?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ClearPath Disposable Introducer?

MINOP Disposable Introducer 26F (K142315).

Who can help prepare an FDA 510(k) submission like ClearPath Disposable Introducer?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ClearPath Disposable Introducer

K210251 · Clearmind Biomedical · GWG · Apr 2, 2021 · Neurology

Device Facts

Record ID	K210251
Device Name	ClearPath Disposable Introducer
Applicant	Clearmind Biomedical
Product Code	GWG · Neurology
Decision Date	Apr 2, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1480
Device Class	Class 2

Intended Use

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

Device Story

ClearPath Disposable Introducer is a sterile, single-use neurological endoscope introducer consisting of a sheath and a dilator. The device is used by surgeons in an operating room to create a temporary pathway into the brain. The dilator is inserted into the sheath and advanced atraumatically to the target site; an interlocking hub prevents dilator push-back during insertion. Once positioned, the dilator is removed, and the sheath—which is transparent and graduated for depth monitoring—can be split lengthwise to allow for the insertion of a neuroendoscope. The device provides a stable access channel, facilitating endoscopic visualization and surgical intervention within the ventricular system and cerebrum.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, biocompatibility testing per ISO 10993, transit testing per ASTM D4169, and shelf-life studies.

Technological Characteristics

Consists of a sheath and dilator made of polymers. Features an interlocking hub, centimeter graduations, and a transparent sheath. Non-radiopaque. Single-use, sterile. Dimensions: 20 Fr inner diameter, 7.4 mm outer diameter, 120 mm max usable length. No electronic components or software.

Indications for Use

Indicated for patients requiring a temporary pathway into the ventricular system and cerebrum of the brain to facilitate neuroendoscopic procedures.

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Predicate Devices

MINOP Disposable Introducer 26F (K142315)

Reference Devices

MINOP Introducer (K061135)

Related Devices

K990333 — MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 · Medtronic PS Medical · Apr 28, 1999
K142315 — MINOP Disposable Introducer 26F · Aesculap, Inc. · Nov 14, 2014
K200925 — Clarus Peel-Away Introducer Sheath · Clarus Medical, LLC · Mar 18, 2021
K061135 — MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019 · Aesculap · Jul 11, 2006
K172433 — NICO BrainPath · Nico Corporation · Sep 7, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | Category | Comments | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | ClearMind Biomedical 5F, No. 167, Fuxing N. Rd., Songshan Dist., Taipei City 105, Taiwan, R.O.C. +886-2-22697417 | | Correspondent Contact Information: | Craig Coombs Coombs Medical Device Consulting, Inc 1100 Pacific Marina, Suite 806 Alameda, CA 94501 Tel: 510-995-8499 | | Device Common Name: | Neurological Endoscope Introducer | | Device Regulation & Name: | 21 CFR 882.1480 Neurological 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. 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. ## 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. {4}------------------------------------------------ # E. Tabular Comparison of Application and Predicate Devices in Regard to Substantial Equivalence | Characteristic | Application Device: ClearMind Biomedical ClearPathTM Disposable Introducer | Predicate Device: MINOP® Disposable Introducer 26F K142315 | Impact on Substantial Equivalence | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | ClearMind Biomedical | Aesculap | - | | Regulation Number | 21 CFR 882.1480 | 21 CFR 882.1480 | Identical | | Product Code | GWG | GWG | Identical | | Indications for Use | The ClearPathTM Disposable Introducer is indicated to obtain and maintain a temporary pathway into the ventricular system and cerebrum of the brain. | The MINOP® Disposable Introducer is indicated to obtain and maintain a temporary pathway into the ventricular system of the brain. The purpose of the Minop® Disposable Introducer is to obtain and maintain a temporary pathway to the ventricular system of the patient. The Minop® Disposable Introducer is designed to be split lengthwise and peeled down to the skull level of the patient, accommodating different depth requirements. | The Indications for Use are clinically identical. Both devices are intended to provide a temporary pathway into the brain, down to the level of the ventricular system. The access to the ventricular system occurs only after passing through the cerebrum. The application device adds detail that is implicit in the predicate Indications for Use. The application Indication for Use does not repeat the Indications for Use like the predicate does in its second sentence. The application device drops the predicate's design description as unnecessary in an Indications for Use. The differences between the Indications for Use raise no new questions of safety or efficacy. | | Technology | An insert (dilator) is temporarily fixed within a tube (sheath) that can be atraumatically advanced to the target site. The insert is removed and the tube can be split to either side to facilitate the placement of a neuro endoscope. | An insert (obturator) is temporarily fixed within a tube (sheath) that can be atraumatically advanced to the target site. The insert is removed and the tube can be split to either side to facilitate the placement of a neuro endoscope. | Technology is identical. | | Characteristic | Application Device: ClearMind Biomedical ClearPathTM Disposable Introducer | Predicate Device: MINOP® Disposable Introducer 26F K142315 | Impact on Substantial Equivalence | | Design | ClearPathTM Disposable Introducer consists of two main components: sheath and dilator. The sheath is a hollow tube and the dilator is a solid rod that fills the hollow tube as it is advanced through the brain to the target area. After the sheath is confirmed to have been advanced to the target area, it can be peeled in half, down to the level of the skull, to facilitate the advancement of the neuroendoscope. Interlocking hub design that prevents dilator "push back" during insertion. Printed graduation on the sheath to assist the surgeon in determining the depth the introducer has been inserted and prevent advance deeper than desired. Transparent sheath for observing surrounding tissue and brain through an endoscope | The MINOP Disposable Introducer 26F consists of two main components: sheath and obturator. The sheath is a hollow tube and the obturator is a solid rod that fills the hollow tube as it is advanced through the brain to the target area. After the sheath is confirmed to have been advanced to the target area, it can be peeled in half, down to the level of the skull, to facilitate the advancement of the neuroendoscope. Interlocking hub design that prevents obturator "push back" during insertion. Printed graduation on the sheath to assist the surgeon in determining the depth the introducer has been inserted and prevent advance deeper than desired Opaque Sheath. | Similar. The transparent sheath of application device does not raise new risk of safety. | | Inner Diameter of Sheath | 20 Fr (6.68 mm) | 26 Fr (8.67 mm) | The application device is smaller than predicate device by only 2 mm in ID and OD. The 20Fr size is similar to other neuro introducers like the MINOP Introducer (K061135) which ranges in cleared size | | Characteristic | Application Device: ClearMind Biomedical ClearPath™ Disposable Introducer | Predicate Device: MINOP® Disposable Introducer 26F K142315 | Impact on Substantial Equivalence | | Outer Diameter of Sheath | 7.4 mm | 9.33 mm | Same justification as in the cell above. | | Max Useable Sheath Length | 120 mm | 120 mm | Identical | | Dilator OD | 6.6 mm | 8.5 mm | Outer diameter of the application device is smaller than predicate. Each dilator compatible with its sheath and raises no new questions of safety or efficacy. | | Materials | Polymers & Colorant | Not described Some polymers | The material of the application device has been widely used in similar applications in medical devices. The application device has passed appropriate biocompatibility testing. | | Graduations | Graduation 1 to 12 on sheath and in centimeter per grid | Graduation 1 to 12 on sheath and in centimeter per grid | Identical | | Radiopacity | Non-radiopaque | Non-radiopaque | Identical | | Principal Operator | Surgeon | Surgeon | Identical | | Use Location | Operating room | Operating room | Identical | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ #### 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).

ClearPath Disposable Introducer

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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ClearPath Disposable Introducer

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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