(201 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a sheath system, with no mention of AI or ML capabilities.
No.
Explanation: The device is an introducer sheath system, which is used to facilitate the introduction of other interventional devices into the vasculature. It does not provide any direct therapeutic benefit itself.
No
The device is described as a system for introducing other interventional devices into the vasculature, not for diagnosing conditions. Its components facilitate placement and access, rather than providing diagnostic information.
No
The device description explicitly lists physical components (Sheath, Dilator, Navigating Catheter, RHV) and describes their material properties and physical characteristics, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of interventional devices into the peripheral and neuro vasculature. This describes a device used in vivo (within the body) for a procedural purpose.
- Device Description: The description details physical components like sheaths, dilators, and catheters, which are tools used for accessing and navigating blood vessels. These are not reagents, instruments, or systems used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This device is a procedural tool used during medical interventions.
N/A
Intended Use / Indications for Use
The Route 92 Medical Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Product codes
DQY
Device Description
The Route 92 Medical Sheath System is comprised of a Sheath, a Dilator, a Navigating Catheter, and an RHV (rotating hemostasis valve). The Sheath is a single-lumen, variable stiffness catheter with a radiopaque marker on the distal end. The inner lumen of the catheter is compatible with 8F or smaller catheters. The Dilator may be placed within the Sheath to facilitate percutaneous introduction of the Sheath into a femoral artery. The Dilator has a radiopaque marker at the distal tip. The Navigating Catheter is a single-lumen, variable stiffness catheter with a radiopaque marker at the distal tip. The Navigating Catheter is compatible with the Sheath and has a shaped distal end to facilitate placement. All of the catheters are coated with hydrophilic coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians trained in endovascular techniques
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
Biocompatibility Testing:
- Cytotoxicity - ISO MEM Elution: No cytotoxicity or cell lysis was noted. The test article is non-cytotoxic.
- Sensitization - ISO Guinea Pig Maximization Sensitization Test: No evidence of causing delayed dermal contact sensitization. Test article did not elicit a sensitization response.
- Irritation - ISO Intracutaneous Reactivity: The test article met the requirements.
- Acute Systemic Toxicity – ISO Acute Systemic Injection: No mortality or evidence of systemic toxicity. Requirements met.
- Material Mediated Pyrogenicity: No single animal showed a temperature rise of 0.5℃ or more above its baseline temperature. Met requirements for absence of pyrogens.
- Hemocompatibility - Partial Thromboplastin Time: Met requirements and not statistically different from controls. Considered non-activator of intrinsic coagulation pathway.
- Hemocompatibility - ASTM Hemolysis: Blank corrected hemolytic index above negative control was 0.0% (Direct Method) and 0.4% (Extract Method). Considered non-hemolytic.
- Hemocompatibility - Complement Activation Assay: Complement activation noted would not be expected to result in adverse effects in vivo. Considered a low potential activator of the complement system.
- Hemocompatibility - in-vivo Thromboresistance: Comparable to a legally US-marketed device. No to minimal thrombus formation.
Performance Testing:
- Dimensional Verification: PASS. All samples met predetermined acceptance criteria.
- Luer Integrity: PASS. All samples met predetermined acceptance criteria.
- Tensile Strength: PASS. All samples met predetermined acceptance criteria.
- Kink Resistance: PASS. All samples met predetermined acceptance criteria.
- Torsion Resistance: PASS. All samples met predetermined acceptance criteria.
- Tip Flexibility: PASS. All samples met predetermined acceptance criteria.
- Air Leakage: PASS. All samples met predetermined acceptance criteria.
- Liquid Leakage: PASS. All samples met predetermined acceptance criteria.
- Hydrophilic Coating Integrity: PASS. All samples met predetermined acceptance criteria.
- Particulate Recovery: PASS. All samples met predetermined acceptance criteria.
- Simulated Use Testing: PASS. All samples met predetermined acceptance criteria.
- Packaging Integrity: PASS. All samples met predetermined acceptance criteria.
- Radiopacity: PASS. All samples met predetermined acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
TNI Manufacturing, Inc. Long Sheath (K152876)
Reference Device(s)
Flexor Tuohy-Borst Side-Arm Introducer, K142819
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
January 13, 2020
Route 92 Medical Inc. Kathy Tansey Senior Director of Regulatory Affairs and Quality Assurance 1700 S. El Camino Real, Suite 206 San Mateo, California 94402
Re: K191717
Trade/Device Name: Base Camp™ Sheath System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 12, 2019 Received: December 13, 2019
Dear Kathy Tansey:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,
Xiaolin Zheng, Ph.D., M.S. 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) K191717
Device Name Base Camp Sheath System
Indications for Use (Describe)
The Route 92 Medical Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
| 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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510(k) Summary
| Sponsor: | Route 92 Medical
1700 S. El Camino Real, Suite 206
San Mateo, CA 94022
Phone: 650-581-1179
Fax: 650-343-5827 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kathy Tansey |
| Date Prepared: | June 25, 2019 |
| Device Trade Name: | Base Camp™ Sheath System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter (Product Code DQY, 21 CFR
870.1250) |
| Legally Marketed Predicate Device: | TNI Manufacturing, Inc. Long Sheath (K152876) |
Device Description
The Route 92 Medical Sheath System is comprised of a Sheath, a Dilator, a Navigating Catheter, and an RHV (rotating hemostasis valve). The Sheath is a single-lumen, variable stiffness catheter with a radiopaque marker on the distal end. The inner lumen of the catheter is compatible with 8F or smaller catheters. The Dilator may be placed within the Sheath to facilitate percutaneous introduction of the Sheath into a femoral artery. The Dilator has a radiopaque marker at the distal tip. The Navigating Catheter is a single-lumen, variable stiffness catheter with a radiopaque marker at the distal tip. The Navigating Catheter is compatible with the Sheath and has a shaped distal end to facilitate placement. All of the catheters are coated with hydrophilic coating.
Indications for Use
The Route 92 Medical Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Comparison to Predicate Device
The intended use, method of action, design, and materials of the Route 92 Medical Sheath System are substantially equivalent to the TNI Manufacturing, Inc. Long Sheath (K152876) predicate device as shown in the following table.
| Attribute | TNI Manufacturing, Inc. Long Sheath, K152876
(Predicate Device) | Route 92 Medical Sheath
System
(Subject Device) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Indications for
Use | The Long Sheath is indicated for the
introduction of interventional devices into the
peripheral, coronary, and neuro vasculature. | The Route 92 Medical Sheath
System is indicated for the
introduction of interventional |
4
| Attribute | TNI Manufacturing, Inc. Long Sheath, K152876
(Predicate Device) | Route 92 Medical Sheath
System
(Subject Device) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| | | devices into the peripheral and
neuro vasculature. |
| Device
Description | A single-lumen flexible, variable stiffness
catheter with a hydrophilically-coated, shaft and
a radiopaque marker band on the distal end. | Same as predicate |
| User | Physicians trained in endovascular techniques | Same as predicate |
| Anatomical Sites | Peripheral, coronary and neuro vasculature | Peripheral and neuro
vasculature |
| Method of Action | Inserted at a vascular access point to provide
access to the target site and once in place,
provides a reinforcing conduit for other
intravascular devices. Includes component(s) to
facilitate percutaneous introduction and
intravascular tracking of the device. | Same as predicate device |
| Lubricious
Coating | Hydrophilic coating | Same as predicate device |
| Packaging | Tyvek pouch, packaging card and SBS carton | Same as predicate device |
| Sterilization | Ethylene oxide | Same as predicate device |
| Materials | Polymers and metals commonly used in the
manufacture of medical devices | Same as predicate device |
| Dimensions | | |
| Working
Length(s) | 70, 80, 90 cm | 90 cm |
| Inner Diameter
(min) | 0.088" | 0.106" |
| Outer Diameter | 0.109" | 0.122" |
Non-Clinical Testing
Biocompatibility Testing
The Route 92 Medical Sheath System is constructed using materials that are commonly used in the medical device industry. All patient contacting components have been evaluated for biocompatibility in accordance with ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The Route 92 Medical Sheath System is classified per ISO 10993-1 as externally communicating with limited circulating blood contact (. | PASS
All samples met the pre-determined
acceptance criteria |
| Simulated Use
Testing | Deliverability and compatibility
with accessory devices was
evaluated in a vascular model | PASS
All samples met the pre-determined
acceptance criteria |
| Packaging
Integrity | ISO 11607-1 Part 1
ISO 11607-2 Part 2 | PASS
All samples met the pre-determined
acceptance criteria |
| Radiopacity | Radiopacity of the device was
evaluated in an animal model under
fluoroscopy | PASS
All samples met the pre-determined
acceptance criteria |
Substantial Equivalence
The Route 92 Medical Sheath System is substantially equivalent to the predicate TNI Manufacturing, Inc. Long Sheath (K152876) in intended use, design, principles of operation, technology and performance. The successful completion of biocompatibility testing and performance testing demonstrates that the Route 92 Medical Sheath System is safe and effective for its intended use and substantially equivalent to the predicate device.