(222 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a sheath system, with no mention of AI or ML capabilities.
No
The device is described as a system for introducing interventional devices into the vasculature, not as a device that provides therapy itself.
No
The device is described as an "8F Modified Sheath System" intended for the introduction of interventional devices into the vasculature, not for diagnosing medical conditions. Its components and functions (e.g., facilitating percutaneous introduction, accommodating other catheters) are all related to interventional procedures, not diagnosis. The performance studies focus on physical and biological compatibility tests, not diagnostic accuracy.
No
The device description clearly outlines physical components (Sheath, Navigating Catheter, RHV, Dilator) and describes their material properties and physical characteristics. The performance studies also focus on physical testing of these components.
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, not for testing samples in vitro (outside the body).
- Device Description: The description details a system of catheters and a valve designed for insertion into blood vessels. This aligns with an interventional medical device, not a diagnostic test performed on biological samples.
- 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 examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural for delivering other devices within the body.
N/A
Intended Use / Indications for Use
The 8F Modified Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQY
Device Description
The 8F Modified Sheath System is comprised of a Sheath, 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 singlelumen, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing:
- Study Type: Biocompatibility testing in accordance with ISO 10993-1. For the 8F Modified Sheath (externally communicating with limited circulating blood contact (
§ 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
October 2, 2024
Route 92 Medical, Inc. Kirsten Valley Chief Operating Officer 155 Bovet Road, Suite 100 San Mateo, California 94402
Re: K240529
Trade/Device Name: 8F Modified Sheath System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: August 29, 2024 Received: September 3, 2024
Dear Kirsten Valley:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Naira Muradyan -S
Naira Muradyan, 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) K240529
Device Name 8F Modified Sheath System
Indications for Use (Describe)
The 8F Modified Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K240529 510(k) Summary
| Sponsor: | Route 92 Medical, Inc.
155 Bovet Road, Suite 100
San Mateo, CA 94402 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kirsten Valley
650-581-1179 |
| Date Prepared: | September 30, 2024 |
| Device Name: | 8F Modified Sheath System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Percutaneous, Neurovasculature (Product Code
QJP, 21 CFR 870.1250)
Catheter, Percutaneous (Product Code DQY, 21 CFR
870.1250) |
| Legally Marketed Predicate Device: | Base Camp® Sheath System (K191717, Route 92 Medical) |
Device Description
The 8F Modified Sheath System is comprised of a Sheath, 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 singlelumen, 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 8F Modified 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 8F Modified Sheath System are substantially equivalent to the K191717 predicate device as shown in the following table.
| Attribute | Base Camp Sheath System,
K191717 (Predicate Device) | 8F Modified Sheath System,
K240529 (Subject Device) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory
Classification | Catheter, Percutaneous, 21 CFR 870.1250 | Catheter, Percutaneous,
Neurovasculature, 21 CFR
870.1250 |
| Attribute | Base Camp Sheath System,
K191717 (Predicate Device) | 8F Modified Sheath System,
K240529 (Subject Device) |
| | | Catheter, Percutaneous, 21
CFR 870.1250 |
| Product Code | DQY, Catheter, Percutaneous | QJP, Catheter, Percutaneous,
Neurovasculature |
| | | DQY, Catheter, Percutaneous |
| Indications for
Use | The Route 92 Medical Sheath is indicated for
the introduction of interventional devices into
the peripheral and neuro vasculature. | The 8F Modified Sheath
System is indicated for the
introduction of interventional
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 device |
| User | Physicians trained in endovascular techniques | Same as predicate device |
| Anatomical Sites | Peripheral and neuro vasculature | Same as predicate device |
| 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 |
| How Supplied | Sterile, single-use | Same as predicate device |
| Packaging | Tyvek pouch, packaging card, and SBS carton | Same as predicate device |
| Sterilization | Ethylene oxide (EtO) | Same as predicate device |
| Shelf-Life | 8 months | 6 months |
| Accessories
Included | Dilator, Navigating Catheter, and Rotating
Hemostasis Valve | Same as predicate device |
| Dimensions | | |
| Sheath | | |
| Working
Length(s) | 90 cm | 90 cm and 80 cm |
| Overall Length | 96 cm | 96 cm and 86 cm |
| Coating Length | 8 cm | Same as predicate device |
| Inner Diameter | 0.106" | Same as predicate device |
| Outer Diameter | 0.122" | Same as predicate device |
| | | |
1
5
6
| Attribute | Base Camp Sheath System,
K191717 (Predicate Device) | 8F Modified Sheath System,
K240529 (Subject Device) | | |
|--------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|--|--|
| Tip
Configuration/
Shape | Straight | Straight | | |
| Materials | Polymers and metals commonly used in the
manufacture of medical devices | Same as predicate device | | |
| Marker Band | Yes | Yes | | |
| Dilator | | | | |
| Working
Length(s) | 103 cm | Same as predicate device | | |
| Overall Length | 106 cm | Same as predicate device | | |
| Coating Length | 15 cm | Same as predicate device | | |
| Inner Diameter
(Distal) | 0.040" | Same as predicate device | | |
| Inner Diameter
(Proximal) | 0.044" | Same as predicate device | | |
| Outer Diameter
(Distal) | 0.050" | Same as predicate device | | |
| Outer Diameter
(Proximal) | 0.102" | Same as predicate device | | |
| Tip
Configuration/
Shape | Straight | Same as predicate device | | |
| Materials | Polymers and metals commonly used in the
manufacture of medical devices | Same as predicate device | | |
| Marker Band | Yes | Same as predicate device | | |
| Navigating Catheter | | | | |
| Working
Length(s) | 113 cm | Same as predicate device | | |
| Overall Length | 116 cm | Same as predicate device | | |
| Coating Length | 40 cm | Same as predicate device | | |
| Inner Diameter | 0.040" | Same as predicate device | | |
| Outer Diameter
(Distal) | 0.070" | Same as predicate device | | |
| Outer Diameter
(Proximal) | 0.104" | Same as predicate device | | |
7
| Attribute | Base Camp Sheath System,
K191717 (Predicate Device) | 8F Modified Sheath System,
K240529 (Subject Device) |
|--------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|
| Tip
Configuration/
Shape | Angled | Same as predicate device |
| Materials | Polymers and metals commonly used in the
manufacture of medical devices | Same as predicate device |
| Marker Band | Yes | Same as predicate device |
Non-Clinical Testing
Biocompatibility Testing
The 8F Modified 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 Dilator, Navigating Catheter, and Rotating Hemostasis Valve are identical in materials and manufacturing to those previously cleared in K191717.
The 8F Modified Sheath is classified per ISO 10993-1 as externally communicating with limited circulating blood contact (