(222 days)
The 8F Modified Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
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.
The provided text describes the 8F Modified Sheath System and its substantial equivalence to a predicate device (Base Camp® Sheath System, K191717) for FDA clearance. The document focuses on non-clinical testing to demonstrate performance.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests and their outcomes, uniformly indicating "PASS" and that "The pre-determined acceptance criteria were met." However, it does not explicitly state the specific quantitative acceptance criteria for each test. It only reports that the device met them.
| Test | Test Method | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Device dimensions were measured to confirm conformance to the specifications. | PASS |
| Luer Integrity | Tested per ISO 80369-7:2016. | PASS |
| Tensile Strength | The tensile strength of the catheter sections and bonds was tested. | PASS |
| Kink Resistance | Test specimen segments were formed into a defined bend diameter to evaluate kink resistance. | PASS |
| Torsion Resistance | The test specimens were rotated to evaluate integrity after rotation. | PASS |
| Tip Flexibility | Test specimens were tested for tip flexibility. | PASS |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | PASS |
| Liquid Leakage | Tested per ISO 10555-1:2013 Annex C. | PASS |
| Hydrophilic Coating Integrity | The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles in a vascular model. | PASS |
| Simulated Use Testing | Deliverability and compatibility with accessory devices were evaluated in a vascular model. | PASS |
| Static Burst Pressure Testing | Tested per ISO 10555-1:2013 Annex F. | PASS |
| Particulate Testing | The size and quantity of particulate matter generated during simulated use testing were determined. | PASS |
| Delivery/Retrieval Force Testing | The forces to deliver and retrieve the subject device in an anatomical model were measured. | PASS |
Biocompatibility Testing Acceptance
For biocompatibility, the acceptance criteria are generally qualitative for these types of tests and are implicitly met when the "Conclusion" states no adverse reactions or that requirements were met.
| Test | Conclusion |
|---|---|
| Sensitization | Test article did not elicit a sensitization response. |
| Irritation | Requirements of the ISO intracutaneous reactivity test have been met for the test article. |
| Acute Systemic Toxicity | Requirements of the ISO acute systemic injection test have been met for the test article. |
| Material Mediated Pyrogenicity | The test article met the requirements for the absence of pyrogens. |
| Cytotoxicity | The test article is non-cytotoxic. |
| Hemocompatibility – ASTM Hemolysis | The test article is considered non-hemolytic. |
| Hemocompatibility - Thrombogenicity: ASTM Partial Thromboplastin Time Assay | The test article met the requirements of the test. |
| Hemocompatibility - Complement Activation Assay | The test article is a non-activator of the complement system. |
| Hemocompatibility - Thrombogenicity: ASTM Platelet/Leukocyte Count | The test article met the requirements of the test. |
| Hemocompatibility - Thrombogenicity: Comparative Surface Assessment | The test article does not have any features that would increase thrombogenicity risk. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each of the performance or biocompatibility tests. It refers to "test specimens" or animals (e.g., "guinea pig," "rabbits," "mice") for biocompatibility, but without specific numbers.
- Data Provenance: The data provenance is from non-clinical bench testing and laboratory animal testing. There is no information provided about the country of origin, but given it's an FDA submission, the tests were conducted to international standards (e.g., ISO, ASTM) which are globally recognized. All testing appears to be prospective (conducted specifically for this submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a submission for a medical device (catheter system) where "ground truth" in the clinical sense (e.g., diagnosis, outcome) is not relevant for the non-clinical and biocompatibility studies presented. The "truth" or acceptance is determined by predefined engineering specifications and regulatory standards (ISO, ASTM). The document does not mention the use of human experts to establish ground truth for this type of testing.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation of data (e.g., medical imaging) to resolve discrepancies. The studies described are objective performance and biocompatibility tests where a result either meets or does not meet a predefined standard.
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
Not applicable. This is a physical medical device (catheter system), not an AI/software device. No MRMC study was conducted or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the concept of "ground truth" in the clinical diagnostic sense is not applicable here. For the performance and biocompatibility studies, the "ground truth" is defined by:
- Pre-determined engineering specifications: For dimensional verification, tensile strength, kink resistance, etc.
- International standards and regulatory guidelines: Such as ISO 80369-7:2016 for Luer Integrity, ISO 10555-1:2013 for leakage and burst pressure, and ISO 10993-1 for biocompatibility.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this traditional medical device submission. Training sets are relevant for machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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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.
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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 100San Mateo, CA 94402 |
|---|---|
| Contact: | Kirsten Valley650-581-1179 |
| Date Prepared: | September 30, 2024 |
| Device Name: | 8F Modified Sheath System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Percutaneous, Neurovasculature (Product CodeQJP, 21 CFR 870.1250)Catheter, Percutaneous (Product Code DQY, 21 CFR870.1250) |
| 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) |
|---|---|---|
| RegulatoryClassification | Catheter, Percutaneous, 21 CFR 870.1250 | Catheter, Percutaneous,Neurovasculature, 21 CFR870.1250 |
| Attribute | Base Camp Sheath System,K191717 (Predicate Device) | 8F Modified Sheath System,K240529 (Subject Device) |
| Catheter, Percutaneous, 21CFR 870.1250 | ||
| Product Code | DQY, Catheter, Percutaneous | QJP, Catheter, Percutaneous,Neurovasculature |
| DQY, Catheter, Percutaneous | ||
| Indications forUse | The Route 92 Medical Sheath is indicated forthe introduction of interventional devices intothe peripheral and neuro vasculature. | The 8F Modified SheathSystem is indicated for theintroduction of interventionaldevices 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 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 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 |
| 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 |
| AccessoriesIncluded | Dilator, Navigating Catheter, and RotatingHemostasis Valve | Same as predicate device |
| Dimensions | ||
| Sheath | ||
| WorkingLength(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
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| Attribute | Base Camp Sheath System,K191717 (Predicate Device) | 8F Modified Sheath System,K240529 (Subject Device) | ||
|---|---|---|---|---|
| TipConfiguration/Shape | Straight | Straight | ||
| Materials | Polymers and metals commonly used in themanufacture of medical devices | Same as predicate device | ||
| Marker Band | Yes | Yes | ||
| Dilator | ||||
| WorkingLength(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 | ||
| TipConfiguration/Shape | Straight | Same as predicate device | ||
| Materials | Polymers and metals commonly used in themanufacture of medical devices | Same as predicate device | ||
| Marker Band | Yes | Same as predicate device | ||
| Navigating Catheter | ||||
| WorkingLength(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 |
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| Attribute | Base Camp Sheath System,K191717 (Predicate Device) | 8F Modified Sheath System,K240529 (Subject Device) |
|---|---|---|
| TipConfiguration/Shape | Angled | Same as predicate device |
| Materials | Polymers and metals commonly used in themanufacture 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 (<24 hours). A summary of the biocompatibility testing conducted on the 8F Modified Sheath is provided below.
| Test | Results | Conclusions |
|---|---|---|
| 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. The testarticle was not considered a sensitizer in thetest. | 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 were not greater than 1.0 for sodiumchloride and sesame oil test article extracts. | 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 were clinically normalthroughout the study as compared to controlmice. | 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 rabbits'temperatures during the 3-hour observationperiod was within acceptable USPrequirements. | The test article met therequirements for theabsence of pyrogens. |
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| Test | Results | Conclusions |
|---|---|---|
| Cytotoxicity - ISO MEMElution | No cytotoxicity or cell lysis was noted in anyof the test wells. The test article extract metthe requirements of the test as the grade wasless than 2. | The test article is non-cytotoxic. |
| Hemocompatibility –ASTM Hemolysis | The test articles (via the direct contactmethod and indirect contact method) wereboth rated non-hemolytic. | The test article isconsidered non-hemolytic. |
| Hemocompatibility -Thrombogenicity: ASTMPartial ThromboplastinTime Assay | The test article average clotting time was notlower and was not statistically significantwhen compared to the negative control.The test article average clotting time was notlower and was not statistically significantwhen compared to the vehicle control. | The test article met therequirements of the test. |
| Hemocompatibility -Complement ActivationAssay | The SC5b-9 concentration of the test articlewas not statistically higher than the activatednormal human serum, the negative control,or the comparator test article. | The test article is a non-activator of thecomplement system. |
| Hemocompatibility -Thrombogenicity: ASTMPlatelet/Leukocyte Count | The test article average platelet count wassimilar to the comparator test article, 80 to120% of the vehicle control, and at least 30%above the positive control. | The test article met therequirements of the test. |
| Hemocompatibility -Thrombogenicity:Comparative SurfaceAssessment | 40x magnification images taken of thesubject device and predicate device showcomparable surface morphologies. | The test article does nothave any features thatwould increasethrombogenicity risk. |
Performance Testing
The successful completion of the performance testing listed in the following table demonstrates that the 8F Medical Modified Sheath System is suitable for its intended use.
| Test | Test Method | Results |
|---|---|---|
| DimensionalVerification | Device dimensions were measured toconfirm conformance to thespecifications. | PASSThe pre-determined acceptance criteriawere met. |
| Luer Integrity | Tested per ISO 80369-7:2016. | PASSThe pre-determined acceptance criteriawere met. |
| Test | Test Method | Results |
| Tensile Strength | The tensile strength of the cathetersections and bonds was tested. | PASSThe pre-determined acceptance criteriawere met. |
| Kink Resistance | Test specimen segments were formedinto a defined bend diameter to evaluatekink resistance. | PASSThe pre-determined acceptance criteriawere met. |
| TorsionResistance | The test specimens were rotated toevaluate integrity after rotation. | PASSThe pre-determined acceptance criteriawere met. |
| Tip Flexibility | Test specimens were tested for tipflexibility. | PASSThe pre-determined acceptance criteriawere met. |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | PASSThe pre-determined acceptance criteriawere met. |
| Liquid Leakage | Tested per ISO 10555-1:2013 Annex C. | PASSThe pre-determined acceptance criteriawere met. |
| HydrophilicCoating Integrity | The integrity of the hydrophilic coatingwas evaluated after multiple insertionand withdrawal cycles in a vascularmodel. | PASSThe pre-determined acceptance criteriawere met. |
| Simulated UseTesting | Deliverability and compatibility withaccessory devices were evaluated in avascular model. | PASSThe pre-determined acceptance criteriawere met. |
| Static BurstPressure Testing | Tested per ISO 10555-1:2013 Annex F. | PASSThe pre-determined acceptance criteriawere met. |
| ParticulateTesting | The size and quantity of particulatematter generated during simulated usetesting were determined. | PASSThe pre-determined acceptance criteriawere met. |
| Delivery/RetrievalForce Testing | The forces to deliver and retrieve thesubject device in an anatomical modelwere measured. | PASS |
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Clinical Data and Animal Testing
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Substantial equivalence was established based on non-clinical bench performance data. Clinical and animal testing data were not deemed necessary.
Sterilization
The 8F Modified Sheath System is sterilized using a validated EtO process with a sterility assurance level of 1x10 · validated per the overkill method in accordance with ISO 11135, "Sterilization of Health-Care Products - Ethylene Oxide - Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices".
Substantial Equivalence
The 8F Modified Sheath System is substantially equivalent to the predicate Route 92 Medical's Base Camp Sheath System (K191717) in intended use, design, principles of operation, technology, and performance. The successful completion of biocompatibility testing and performance testing demonstrates that the 8F Modified 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).