(201 days)
The Route 92 Medical Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
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.
The provided text describes the 510(k) summary for the Route 92 Medical Sheath System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish new acceptance criteria and prove its performance. Therefore, the information requested about acceptance criteria and a study proving the device meets those specific acceptance criteria (as would be applied to a novel device or AI software) is not directly present in the provided document.
Instead, the document details non-clinical testing to demonstrate the device's safety and performance against established standards and equivalence to a predicate device. The "acceptance criteria" here are implicitly the "PASS" results for each test, indicating conformity to pre-determined specifications or regulatory requirements.
Here's an attempt to answer your questions based on the provided text, while acknowledging the focus on substantial equivalence:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission, the acceptance criteria are not explicitly defined numerical targets specific to a new AI model's performance but rather general standards and successful completion of tests demonstrating safety and equivalence.
| Test Category | Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity - ISO MEM Elution | No cytotoxicity or cell lysis (reactivity grade < 2) | PASS (Non-cytotoxic) |
| Sensitization - ISO Guinea Pig Maximization | No evidence of delayed dermal contact sensitization | PASS (No sensitization) | |
| Irritation - ISO Intracutaneous Reactivity | Difference between test article and control mean score = 0.0 | PASS (Requirements met) | |
| Acute Systemic Toxicity – ISO Acute Systemic Injection | No mortality or evidence of systemic toxicity | PASS (Requirements met) | |
| Material Mediated Pyrogenicity | No single animal temperature rise ≥ 0.5℃; total rise < USP limits | PASS (Absence of pyrogens) | |
| Hemocompatibility - Partial Thromboplastin Time | Not statistically different from negative control/reference material | PASS (Non-activator of coagulation) | |
| Hemocompatibility - ASTM Hemolysis | Hemolytic index above negative control within acceptable limits | PASS (Non-hemolytic) | |
| Hemocompatibility - Complement Activation Assay | Complement activation not expected to result in adverse in vivo effects compared to legally marketed device | PASS (Low potential activator) | |
| Hemocompatibility - in-vivo Thromboresistance | Comparable to legally US-marketed device; no to minimal thrombus formation | PASS (Comparable to predicate) | |
| Performance Testing | Dimensional Verification | Conformance to specifications | PASS |
| Luer Integrity | Met pre-determined acceptance criteria (per ISO 80369-7:2016) | PASS | |
| Tensile Strength | Met pre-determined acceptance criteria | PASS | |
| Kink Resistance | Met pre-determined acceptance criteria | PASS | |
| Torsion Resistance | Met pre-determined acceptance criteria | PASS | |
| Tip Flexibility | Met pre-determined acceptance criteria | PASS | |
| Air Leakage | Met pre-determined acceptance criteria (per ISO 10555-1:2013 Annex D) | PASS | |
| Liquid Leakage | Met pre-determined acceptance criteria (per ISO 10555-1:2013 Annex C) | PASS | |
| Hydrophilic Coating Integrity | Met pre-determined acceptance criteria after multiple cycles | PASS | |
| Particulate Recovery | Met pre-determined acceptance criteria (per USP <788>) | PASS | |
| Simulated Use Testing | Deliverability and compatibility with accessory devices evaluated | PASS | |
| Packaging Integrity | Met pre-determined acceptance criteria (per ISO 11607-1/2) | PASS | |
| Radiopacity | Radiopacity evaluation in an animal model | PASS |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document generally states "All samples met the pre-determined acceptance criteria" for performance tests and provides results for biocompatibility tests (e.g., "All animals treated had were clinically normal" for acute systemic toxicity). It does not specify precise sample sizes for each non-clinical test.
- Sample Size: Not explicitly stated for most tests, often referred to as "all samples" or "animals" depending on the test type.
- Data Provenance: Not applicable in the context of these non-clinical, lab-based tests on device components/products. The tests are designed to evaluate the physical and biological characteristics of the device itself, not data from human subjects or retrospective/prospective studies in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The tests conducted are non-clinical, laboratory-based evaluations of device properties (e.g., tensile strength, biocompatibility, dimensions). They do not involve expert interpretation of data or images to establish a "ground truth" as would be required for an AI-powered diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for non-clinical, laboratory-based testing of device characteristics. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies involving human interpretation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The provided document is for a "Percutaneous Catheter" device, which is a physical medical instrument, not an AI software. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable as the tests are non-clinical hardware evaluations. The "ground truth" broadly refers to the established scientific and engineering principles, international standards (e.g., ISO), and pre-determined specifications against which the device's performance is measured.
8. The sample size for the training set
This is not applicable as the device is a physical medical instrument and no AI/machine learning model was trained.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for an AI/machine learning model.
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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
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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
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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 Medical1700 S. El Camino Real, Suite 206San Mateo, CA 94022Phone: 650-581-1179Fax: 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 CFR870.1250) |
| 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 SheathSystem(Subject Device) |
|---|---|---|
| Indications forUse | The Long Sheath is indicated for theintroduction of interventional devices into theperipheral, coronary, and neuro vasculature. | The Route 92 Medical SheathSystem is indicated for theintroduction of interventional |
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| Attribute | TNI Manufacturing, Inc. Long Sheath, K152876(Predicate Device) | Route 92 Medical SheathSystem(Subject Device) |
|---|---|---|
| devices into the peripheral andneuro vasculature. | ||
| DeviceDescription | A single-lumen flexible, variable stiffnesscatheter with a hydrophilically-coated, shaft anda 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 neurovasculature |
| Method of Action | Inserted at a vascular access point to provideaccess to the target site and once in place,provides a reinforcing conduit for otherintravascular devices. Includes component(s) tofacilitate percutaneous introduction andintravascular tracking of the device. | Same as predicate device |
| LubriciousCoating | 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 themanufacture of medical devices | Same as predicate device |
| Dimensions | ||
| WorkingLength(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 (<24 hours). A summary of the biocompatibility testing is provided below.
A reference device (Flexor Tuohy-Borst Side-Arm Introducer, K142819) was chosen as the control device for SC5b-9 Complement Activation Assay and in vivo Thromboresistance evaluation.
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| Test | Results | Conclusions |
|---|---|---|
| Cytotoxicity - ISO MEMElution | No cytotoxicity or cell lysis was noted in anyof the test wells (reactivity grade = 0). Thetest article extract met the requirements ofthe test as the grade was less than 2. | The test article is non-cytotoxic. |
| Sensitization - ISOGuinea Pig MaximizationSensitization Test(Sodium Chloride USPSolution and Sesame Oil) | The test article extracts showed no evidenceof causing delayed dermal contactsensitization in the guinea pig (no findings inclinical observations and grade = 0 fordermal reactions). The test article was notconsidered a sensitizer in the test. | Test article did not elicit asensitization response. |
| Irritation - ISOIntracutaneous Reactivity(Sodium Chloride USPSolution and Sesame Oil) | The test article met the requirements of thetest since the difference between each testarticle extract overall mean score andcorresponding control extract overall meanscore was 0.0 and 0.0 for sodium chlorideand sesame oil test article extracts,respectively. | Requirements of the ISOintracutaneous reactivitytest have been met for thetest article. |
| Acute Systemic Toxicity– ISO Acute SystemicInjection (SodiumChloride USP Solutionand Sesame Oil) | There was no mortality or evidence ofsystemic toxicity from the injected extracts.All animals treated had were clinicallynormal throughout the study as compared tocontrol mice. | Requirements of the ISOacute systemic injectiontest have been met for thetest article. |
| Material MediatedPyrogenicity | No single animal showed a temperature riseof 0.5℃ or more above its baselinetemperature. The total rise of the rabbits'temperature during 3 hours was 0.2 ℃. Thetotal rise of rabbit temperatures during the 3-hour observation period was withinacceptable USP requirements. The test articlemet the requirements for the absence ofpyrogens. | The test article met therequirements for theabsence of pyrogens. |
| Hemocompatibility -Partial ThromboplastinTime | The test articles met the requirements of thetest and were not different statistically fromthe negative control and the negativereference material. | The test article isconsidered to be a non-activator of the intrinsiccoagulation pathway. |
| Hemocompatibility -ASTM Hemolysis | Blank corrected hemolytic index above thenegative control:Direct Method: 0.0%Extract Method: 0.4% | The test article isconsidered non-hemolytic. |
| Hemocompatibility -Complement ActivationAssay | When compared to a legally US-marketeddevice, the complement activation noted inthe test article would not be expected toresult in adverse effects in vivo. | The test article isconsidered to be a lowpotential activator of thecomplement system. |
| Test | Results | Conclusions |
| Hemocompatibility - in-vivo Thromboresistance | When compared to a legally US-marketeddevice, the test articles and control articleswere comparable. No to minimal thrombusformation was noted with both test andcontrol articles. | The test article iscomparable to a legallyUS-marketed device. |
II
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Performance Testing
The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical Sheath System is suitable for its intended use.
| Test | Test Method | Results |
|---|---|---|
| DimensionalVerification | Device dimensions were measuredto confirm conformance to thespecifications | PASSAll samples met the pre-determinedacceptance criteria |
| Luer Integrity | Tested per ISO 80369-7:2016 | PASSAll samples met the pre-determinedacceptance criteria |
| Tensile Strength | The tensile strength of the cathetersections and bonds was tested | PASSAll samples met the pre-determinedacceptance criteria |
| Kink Resistance | Test specimen segments wereformed into a defined benddiameter to evaluate kink resistance | PASSAll samples met the pre-determinedacceptance criteria |
| TorsionResistance | The test specimens were rotated toevaluate integrity after rotation | PASSAll samples met the pre-determinedacceptance criteria |
| Tip Flexibility | Test specimens were tested for tipflexibility | PASSAll samples met the pre-determinedacceptance criteria |
| Air Leakage | Tested per ISO 10555-1:2013Annex D. | PASSAll samples met the pre-determinedacceptance criteria |
| Liquid Leakage | Tested per ISO 10555-1:2013Annex C. | PASSAll samples met the pre-determinedacceptance criteria |
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| Test | Test Method | Results |
|---|---|---|
| HydrophilicCoating Integrity | The integrity of the hydrophiliccoating was evaluated aftermultiple insertion and withdrawalcycles. | PASSAll samples met the pre-determinedacceptance criteria |
| ParticulateRecovery | After multiple insertion andwithdrawal cycles, the effluentwater flushed from the model wastested per USP <788>. | PASSAll samples met the pre-determinedacceptance criteria |
| Simulated UseTesting | Deliverability and compatibilitywith accessory devices wasevaluated in a vascular model | PASSAll samples met the pre-determinedacceptance criteria |
| PackagingIntegrity | ISO 11607-1 Part 1ISO 11607-2 Part 2 | PASSAll samples met the pre-determinedacceptance criteria |
| Radiopacity | Radiopacity of the device wasevaluated in an animal model underfluoroscopy | PASSAll samples met the pre-determinedacceptance 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.
§ 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).