(345 days)
No
The device description and performance studies focus on the mechanical and material properties of a physical introducer sheath, with no mention of software, algorithms, or data processing related to AI/ML.
No.
The device facilitates access through brain tissue for other devices, rather than directly treating a condition itself.
No
The device is an introducer sheath designed to create and maintain a passageway for other devices into the ventricular system, not to diagnose a condition.
No
The device description clearly outlines a physical, cylindrical device made of materials that are inserted into the brain. It also mentions mechanical testing and biocompatibility testing, which are relevant to hardware components, not software.
Based on the provided information, the Clarus Peel-Away Introducer Sheath is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide access through the brain into the ventricular system for the insertion of other devices. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The device is a physical tool used to create and maintain a passageway within the body. It does not involve the examination of specimens (like blood, urine, tissue) outside of the body.
- Anatomical Site: The device is used within the brain and ventricular system, which are internal anatomical sites. IVDs typically analyze samples taken from the body.
- Input Imaging Modality: Fluoroscopy is used for visualization during the procedure, which is a common imaging technique for guiding interventional procedures, not for analyzing in vitro samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Clarus Peel-Away Introducer Sheath does not fit this definition. It is a surgical access device.
N/A
Intended Use / Indications for Use
The Clarus Peel-Away Introducer Sheath is intended to be used in indications requiring access through the brain into the ventricular system.
Product codes (comma separated list FDA assigned to the subject device)
GWG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain, ventricular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician in a healthcare facility
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 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
Key results: 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:
- Fluid Patency: Visually inspect inside diameter for cleanliness and quality of manufacturing.
- Prolapse Force: Resistance to deformation of device while advancing distal end into flat plate. Force was measured.
- Peek Tensile Force: Measure peak tensile force of inner obturator/dilator and sheath hub per ISO 11070.
- Peel Force: Each sheath is gripped and force measure to break hub, and peel sheath.
Key results: All devices had comparable results for Fluid Patency, Prolapse Force, Peek Tensile Force, and Peel Force. 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. No clinical studies were required for the Clarus Peel-Away Introducer Sheath to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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) 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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3
510(K) Summarv
A. General Information:
| 510(K) Submission Number: | K200925 |
|---|---|
| Submitter: | Clarus Medical, LLC |
| 13355 10th Ave North | |
| Minneapolis, MN 55441 | |
| 763-525-8403 | |
| Establishment Number: | 2183911 |
| Contact: | Mark F. Brown |
| Director of Operations | |
| mbrown@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:
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.
4
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.
5
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.
6
| Subject Device | Predicate Devices | Reference Device | Reference Device | |
|---|---|---|---|---|
| Trade Name | Clarus Peel-Away | |||
| Introducer Sheath | Medtronic | |||
| Peelaway | ||||
| Introducer Sheath | Codman® Peel- | |||
| Away Catheter | ||||
| Introducer | Martech Medical | |||
| Products PTFE Super | ||||
| Sheath Introducer | ||||
| 510(k) | K200925 | K990333 | K883607 | K120617 |
| Indications | ||||
| for Use | The Clarus Peel- | |||
| Away Introducer | ||||
| Sheath is a device | ||||
| used to make a | ||||
| channel through the | ||||
| brain into the | ||||
| ventricular system. | The Introducer | |||
| Sheath is a device | ||||
| used to | ||||
| make a channel | ||||
| through the brain | ||||
| into the ventricular | ||||
| system. | The Peel-Away | |||
| Catheter Introducer | ||||
| assists in placing a | ||||
| catheter in the | ||||
| ventricle when | ||||
| hydrocephalus | ||||
| shunting is | ||||
| indicated and when | ||||
| using an | ||||
| endoscope. | The PTFE Super | |||
| Sheath Introducers are | ||||
| intended to obtain | ||||
| central venous access | ||||
| to facilitate catheter | ||||
| insertion or placing | ||||
| pacing leads into the | ||||
| central venous system. | ||||
| Image | ||||
| Product | ||||
| Code | GWG | GWG | GYK | DYB |
| Enviornment | ||||
| of use | Rx Only | Rx Only | Rx Only | Rx Only |
| Sheath | ||||
| Diameter | ||||
| and Length | 12F, 14F, 15F | |||
| 8-13cm | 12F, 14F, 15F | |||
| 9.5cm | 9F, 11F, 12.5F, | |||
| 14F | ||||
| 14.7cm | 5F through 18F | |||
| 10cm and 13.5cm | ||||
| Sterilization | ||||
| method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Conditions | ||||
| supplied | Sterile, single use | Sterile, single use | Sterile, single use | Sterile, single use |
| Device | ||||
| components | Peel-away Sheath, | |||
| obturator | Peel-away Sheath, | |||
| obturator | Peel-away Sheath, | |||
| obturator | Peel-away Sheath, | |||
| dilator |
7
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 (