(63 days)
No
The device description and performance studies focus on the mechanical and material properties of a disposable introducer, with no mention of AI or ML capabilities.
No
The device is described as an "introducer," which is used to create and maintain a pathway for other instruments, rather than directly treating a condition or disease. Its function is to facilitate access for therapeutic devices, not to provide therapy itself.
No
The device is described as an "Introducer" used to "obtain and maintain a temporary pathway" for access, which is an interventional or surgical function, not a diagnostic one. It facilitates access for other procedures rather than providing diagnostic information itself.
No
The device description clearly states it is a physical, sterile, single-use neurological endoscope introducer consisting of a Sheath and a Dilator, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain and maintain a temporary pathway into the ventricular system and cerebrum of the brain." This describes a surgical tool used directly on a patient's body for access, not a device used to examine specimens (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description details a physical instrument (Sheath and Dilator) designed for insertion into the brain. This aligns with a surgical device, not an IVD.
- Anatomical Site: The device is used in the "ventricular system and cerebrum of the brain," which is an in-vivo application. IVDs are used in vitro (outside the body).
- Performance Studies: The performance studies focus on biocompatibility, bench testing against specifications, transit testing, and shelf life. These are typical evaluations for a surgical device, not the analytical and clinical performance studies expected for an IVD.
In summary, the ClearPath Disposable Introducer is a surgical instrument used for accessing the brain, not a device used for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
GWG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricular system and cerebrum of the brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Principal Operator: Surgeon
Use Location: Operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
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)
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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).