(85 days)
The Glidesheath Slender Tibial Pedal Kit is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee.
The Glidesheath Slender Tibial Pedal Kit is used to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee. It consists of an introducer (sheath and dilator), which are packaged together with a mini guide wire, an entry needle and a guide inserter.
During a diagnostic or interventional procedure in a cath lab, the stainless steel entry needle (cannula) is used to gain access to the vein or artery for placement of the mini guide wire. The nitinol mini guide wire is inserted through the cannula into the patient's blood vessel. The wire is used for placement of the sheath and dilator into the vein or artery. The Guide Inserter which is attached to the Mini Guide Wire holder is used to assist the placement of the wire into the needle.
Following guide wire insertion, the cannula is removed and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed and an appropriate catheter can then be inserted through the sheath.
The sheath incorporates a 1-way valve and a 3-way stopcock connected by a side tube. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.
The sheath, dilator, entry needle, mini guide wire and guide inserter are provided in a single package and sterilized together.
The Glidesheath Slender Tibial Pedal Kit is a disposable, ethylene oxide gas sterilized device intended for single use only.
The Glidesheath Slender Tibial Pedal Kit is a medical device, and the provided document is a 510(k) summary for its premarket notification to the FDA. As such, the concept of "acceptance criteria" and "device performance" in this context refers to demonstrating substantial equivalence to a legally marketed predicate device rather than achieving specific quantitative performance metrics typically seen in AI/software medical devices.
The "study" that proves the device meets the acceptance criteria is a combination of non-clinical tests (packaging, cadaver testing) and a comparison to existing PRIME Registry data, rather than a clinical trial directly evaluating the device's efficacy against a predefined standard.
Here's an attempt to extract the requested information, understanding that some categories might not be directly applicable or phrased differently for a medical device clearance like this.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Acceptance Criteria | Reported Device Performance / Evaluation Finding |
|---|---|
| Substantial Equivalence (Overall Acceptance Criteria): Demonstrate that the Glidesheath Slender Tibial Pedal Kit is safe and effective and substantially equivalent to legally marketed predicate devices in its intended use/indications for use, technology/principal of operation, materials, and performance. | The Glidesheath Slender Tibial Pedal Kit is considered substantially equivalent to the predicate device (K142183 Glidesheath Slender) and reference devices (K152173 Glidesheath, K111606 Pinnacle Precision Access System) based on: - Identical materials, formulation, geometry, source, processing, and sterilization method for individual components. - Successful packaging verification testing. - Demonstrated clinical feasibility in cadaver testing. - Favorable comparison to PRIME Registry data. |
| Packaging Durability: Packaging must ensure the durability of the device throughout distribution. | Packaging verification testing was performed, including Visual Inspection (Post Environmental Conditioning and Distribution Simulation), Detecting Seal Leaks by Dye Penetration (ASTM F1929-15), Seal Strength (ASTM F88/F88M-15), and Climatic Stressing (ASTM F2825-10). The packaging was found to be durable. |
| Clinical Feasibility (Cadaver Testing): Device compatible with insertion angles and acceptable for use in Below-The-Knee (BTK) access; protocols used by physicians in standard practice are equivalent to the test protocol. | Cadaver testing using lower leg models demonstrated that the Glidesheath Slender sheath is compatible with insertion angles for ultrasound-guided BTK access in four BTK vessels. The kit and components were deemed acceptable for BTK access. A follow-up survey confirmed physician protocols align with the study's access protocol. |
| Biocompatibility: Meet biological safety requirements for an external communicating device, circulating blood with limited contact (up to 24 hours), per EN ISO 10993-1 and FDA Guidance. | No additional biocompatibility testing was performed as all components are identical to predicate/reference devices in materials, formulation, etc. The device is considered to have substantially equivalent biocompatibility. |
| Sterilization (SAL 10-6): Achieve a Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11135:2014. | The device was adopted into an existing ethylene oxide sterilization process validated via the overkill half-cycle approach to achieve an SAL of 10-6. |
| Sterilant Residuals: Ethylene oxide (EO) and ethylene chlorohydrin (ECH) levels must not exceed average daily doses of 4 mg and 9 mg, respectively, after 24 hours of heated aeration, per EN ISO 10993-7:2008. | Sterilant residual testing demonstrated that EO and ECH levels did not exceed the specified limits after 24 hours of heated aeration. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set for Packaging: The document does not specify the exact sample size for each packaging test (Visual Inspection, Seal Leaks, Seal Strength, Climatic Stressing).
- Test Set for Cadaver Testing: The document mentions "lower leg models" but does not specify the number of cadavers or individual access attempts.
- Test Set for Clinical Comparison (PRIME Registry): "The first 71 patients treated with the Terumo Glidesheath Slender when undergoing an index endovascular procedure using a tibial access point."
- Data Provenance: The document states this was compared "to a literature based dataset of procedures using radial and femoral access," implying this data might be a mix of prospective collection (for the 71 patients) and retrospective (for the literature comparison). No country of origin is specified for the PRIME Registry data, but generally, medical device registries can be multinational.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Packaging Testing: No external experts are mentioned for ground truth establishment; testing was done against established ASTM/ISO standards.
- Cadaver Testing: The study involved "physicians." A "follow-up survey" was conducted to confirm protocols. The number and specific qualifications of these physicians are not detailed beyond being "physicians" involved in BTK access.
- Clinical Comparison (PRIME Registry): The PRIME Registry data itself is likely based on clinical outcomes and assessments made by healthcare professionals during actual procedures. The document does not specify experts involved in establishing "ground truth" for comparative purposes, rather, it uses existing clinical data.
4. Adjudication Method for the Test Set
- Packaging Testing: Adjudication is inherently built into meeting the criteria of the referenced ASTM/ISO standards. No human adjudication is specified beyond standard quality control procedures.
- Cadaver Testing: The document implies assessment by physicians performing the procedures. No formal adjudication method (e.g., 2+1, 3+1 consensus) for the cadaver test results is described.
- Clinical Comparison (PRIME Registry): The document does not describe any specific adjudication method for the PRIME Registry data or the literature-based dataset. Registry data typically relies on established clinical reporting.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a catheter introducer (hardware), not an AI/software device that would typically involve human readers interpreting output with or without AI assistance. The clinical evaluation focused on comparing the device's performance to predicate devices and existing clinical practices using registry data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, this question is not applicable. The device is a physical medical instrument (catheter introducer kit), not an algorithm or software. Its performance is tied to its physical characteristics and how it functions during a medical procedure, not an algorithm's output.
7. The Type of Ground Truth Used
- Packaging Testing: Ground truth was based on adherence to established international standards (ASTM and ISO).
- Cadaver Testing: Ground truth was based on direct observation of the device's performance and compatibility with BTK access in simulated use, assessed by physicians. This can be considered a form of "expert assessment" in a simulated environment.
- Clinical Comparison (PRIME Registry): Ground truth was established through real-world clinical outcomes and procedural observations recorded in the PRIME Registry and a literature-based dataset. This could be considered a form of "outcomes data" and "clinical assessment."
8. The Sample Size for the Training Set
This question is not applicable. This is a hardware medical device, not a machine learning or AI model, thus there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set for a hardware device.
{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.
August 3, 2018
Terumo Medical Corporation Liang Lu Senior Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, Maryland 21921
Re: K181237
Trade/Device Name: Glidesheath Slender Tibial Pedal Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 24, 2018 Received: May 10, 2018
Dear Liang Lu:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Finn E.
Donaldson -S
Digitally signed by Finn E. Donaldson -
S
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=20009796
73, cn=Finn E. Donaldson -S
Date: 2018.08.03 15:29:23 -04'00'
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K181237
Device Name Glidesheath Slender Tibial Pedal Kit
Indications for Use (Describe)
The Glidesheath Slender Tibial Pedal Kit is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(K) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
Prepared bv:
Liang Lu Senior Regulatory Affairs Specialist Terumo Medical Corporation Tel. (410) 392-7321 Fax (410) 398-6079
Prepared for: Owner/Operator Terumo Medical Corporation 2101 Cottontail Lane
Somerset, NJ 08873, USA Registration Number: 2243441
Manufacturer (510(k) Applicant)
Terumo Medical Corporation 950 Elkton Boulevard, Elkton, MD 21921 Registration Number: 1118880
Sterilization Facility
Steris Isomedix Services Inc. 3459 South Clinton Ave South Plainfield, NJ 07080 Registration Number: 2246552
Contact Person: Liang Lu
Senior Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard, Elkton, MD 21921 Tel. (410) 392-7321 Fax (410) 398-6079 E-mail: liang.lu@terumomedical.com
Date prepared: August 3, 2018
{4}------------------------------------------------
B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | Glidesheath Slender Tibial Pedal Kit |
|---|---|
| Common Name: | Introducer Sheath |
| Classification Name: | Catheter Introducer |
| Classification Panel: | Cardiovascular |
| Regulation: | 21 CFR 870.1340 |
| Product Code: | DYB |
| Classification: | Class II |
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device(s) to which substantial equivalence is claimed are:
- Predicate Device: K142183 Glidesheath Slender, manufactured by Terumo . Corporation
- Reference Device 1: K152173 Glidesheath, manufactured by Terumo ● Medical Corporation
- Reference Device 2: K111606 - Pinnacle Precision Access System, manufactured by Terumo Medical Corporation
D. REASON FOR 510(k) SUBMISSION
This premarket notification (510(k)) is being submitted for the Glidesheath Slender Tibial Pedal Kit, manufactured by Terumo Medical Corporation, for the purposes of establishing substantial equivalence to a legally marketed predicate device.
E. DEVICE DESCRIPTION (807.92(a)(4))
The Glidesheath Slender Tibial Pedal Kit is used to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee. It consists of an introducer (sheath and dilator), which are packaged together with a mini guide wire, an entry needle and a guide inserter.
During a diagnostic or interventional procedure in a cath lab, the stainless steel entry needle (cannula) is used to gain access to the vein or artery for placement of the mini guide wire. The nitinol mini guide wire is inserted through the cannula into the patient's blood vessel. The wire is used for placement of the sheath and dilator into the vein or artery. The Guide Inserter which is attached to the Mini Guide Wire holder is used to assist the placement of the wire into the needle.
Following guide wire insertion, the cannula is removed and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed and an appropriate catheter can then be inserted through the sheath.
The sheath incorporates a 1-way valve and a 3-way stopcock connected by a side tube. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.
{5}------------------------------------------------
The sheath, dilator, entry needle, mini guide wire and guide inserter are provided in a single package and sterilized together.
The Glidesheath Slender Tibial Pedal Kit is a disposable, ethylene oxide gas sterilized device intended for single use only.
F. INDICATIONS FOR USE (807.92(a)(5))
The Glidesheath Slender Tibial Pedal Kit is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee.
G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
The Glidesheath Slender Tibial Pedal Kit, subject of this 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the predicate device, manufactured by Terumo Medical Corporation.
A comparison of the technological characteristics is summarized on the table below.
{6}------------------------------------------------
Table 1: Summary of Substantial Equivalence
| DeviceCharacteristic | New Device:Glidesheath Slender Tibial Pedal Kit | Predicate:Glidesheath Slender (K142183) |
|---|---|---|
| Manufacturer | Terumo Medical Corporation | Terumo Corporation |
| Intended Use /Indications forUse | The Glidesheath Slender TibialPedal Kit is indicated to facilitateplacing a catheter through the skininto the lower extremity peripheralvasculature below the knee. | The Glidesheath Slender is used tofacilitate placing a catheter throughthe skin into the radial artery. |
| OperationPrinciple | Operated manually or by a manualprocess | Same |
| Design /Construction | Sheath, Dilator,Guide Wire, Guide Inserter, EntryNeedle | Sheath, Dilator,Guide Wire, Guide Inserter, EntryNeedle,Surflo IV catheter |
| Materials | Sheath assemblyTube:Ethylene-Tetrafluoroethylene(ETFE) copolymer,Bismuth trioxide, Colorant, SiliconeoilHydrophilic Coating: Dimethylacrylamide-glycidyl methacrylatecopolymerHousing: PolypropyleneCap: PolypropyleneValve: Silicone RubberCaulking Pin: Stainless SteelSheath support:Styrene-ethylene-butylene-styreneblock copolymer, ColorantSide tube:PolybutadieneThree-way stopcock:Holder: Polycarbonate;Cock: Polyethylene;Fastener pin: PolyethyleneDilator assemblyTube: Polypropylene, Bismuthsubcarbonate, Colorant, Silicone oilHub: Polypropylene, Colorant | Note: Sheath and Dilator areIdentical to the subject deviceSheath AssemblyIdenticalIdenticalIdenticalIdenticalIdenticalIdenticalIdenticalIdenticalDilator AssemblyIdenticalIdentical |
| Mini guide wire | Mini Guide Wire | |
| Core: Nitinol (Nickel TitaniumAlloy) | Nitinol (Nickel Titanium Alloy),Tungsten,Polyurethane | |
| Coil: Palladium | ||
| Adhesive: Epoxy Adhesive | ||
| Guide inserter | Guide inserter | |
| High-density polyethylene (HDPE),Colorant | Polyethylene | |
| Stainless steel entry needle | Stainless steel entry needle | |
| Cannula:Stainless Steel, Silicone oil | Cannula:Stainless Steel | |
| Hub: Styrene-Butadiene copolymer | Hub: Polycarbonate | |
| Protective Sleeve: Polypropylene | Surflo IV Catheter:Ethylene-Tetrafluoroethylene(ETFE) copolymer, Barium sulfate;Polypropylene; Stainless Steel;Polystyrene, Polyester-Chlorinatedpolyvinyl chloride; Polycarbonate | |
| Package | Unit PouchShelf BoxShipping Carton | Unit PouchShelf BoxShipping Carton |
| Specifications | Sheath Size: 5 Fr.Sheath Length: 10 cmHydrophilic Coating: full effectivelength (10 cm) | Sheath Size: 5,6,7 Fr.;Sheath Length: 10,16 cmHydrophilic Coating: full effectivelength (10, 16 cm) |
| Dilator applicable to Guide WireOD: 0.021"Dilator Length: 15.5 cm | Dilator applicable to Guide WireOD: 0.018,0.021,0.025,0.035"Dilator Length: 15.5 and 21.5 cm | |
| Guide Wire OD: 0.021"Guide Wire Length: 43 cm | Guide Wire OD:0.018,0.021,0.025,0.035"Guide Wire Length:43,80 cm | |
| Entry Needle Type:21/19 (G)Entry Needle Length: 70 mm | Entry Needle Type:21/20 (G)Entry Needle Length: 35 mm | |
| Surflo IV Catheter Type:18,20,22(G);Length: 25,32,51,64(mm) | ||
| Sterilization | Ethylene Oxide (validated inaccordance with ISO 11135 toachieve SAL 10-6) | Same |
| Shelf life | 30 months | Same |
| Disposable SingleUse | Yes | Same |
{7}------------------------------------------------
{8}------------------------------------------------
H. NON-CLINICAL TESTS (807.92(b)(1)) Performance
All components of the Glidesheath Slender Tibial Pedal Kit come from the predicate device and reference devices. They are identical in materials, formulation, geometry, source (manufacturer), processing, chemicals, and intended patient exposure and utilize the same sterilization method (Ethylene Oxide) as those in the predicate devices and reference devices. All components are packaged together in a pouch, labeled, and sterilized as a finished good for the Glidesheath Slender Tibial Pedal kit. Therefore, no design verification testing was performed on the individual components to demonstrate the substantial equivalence of the proposed Glidesheath Slender Tibial Pedal kit.
Since the packaging configurations of the needle in the Glidesheath Slender Tibial Pedal Kit were different from the reference device (K152173), packaging testing was re-evaluated. The following packaging verification testing was performed to ensure the durability of the proposed Glidesheath Slender Tibial Pedal kit packaging throughout distribution:
- . Visual Inspection (Post Environmental Conditioning and Distribution Simulation)
Cadaver Testing
To evaluate the clinical feasibility of the Glidesheath Slender Tibial Pedal kit, devices were tested in a simulated use situation using cadaver lower leg models to test arterial access at specific BTK (below-the-knee) arterial access sites. It was demonstrated that the Glidesheath Slender sheath is compatible with the insertion angles used in ultrasound guided BTK access protocols in the four BTK vessels tested. The study also demonstrated that the kit and its components are acceptable for use in BTK access. The study along with a follow-up survey confirmed that the protocols used by physicians in standard practice are equivalent to the access protocol used in the simulated use study. This provides confidence that the results from the testing are applicable to the broader BTK operator community. Therefore, the results of the feasibility study ensure the substantial equivalence of the proposed Glidesheath Slender Tibial Pedal kit.
Standards referenced in the testing of the proposed Glidesheath Slender Tibial Pedal kit by Terumo Medical Corporation are provided in Table 2 below.
{9}------------------------------------------------
| Standard Designation | Standard Name | FDARecognition #(if applicable) |
|---|---|---|
| ISO 10993-1: 2009Cor. 1:2010 | Biological Evaluation of Medical Devices - Part1: Evaluation and Testing Within a RiskManagement Process | 2-220 |
| ISO 10993-7: 2008Cor.1:2009 | Biological Evaluation of Medical Devices - Part7: Ethylene Oxide Sterilization Residuals | 14-408 |
| USP 38 <85> | Bacterial Endotoxins Test (Sterility) | NA |
| ISO 11135: 2014 | Sterilization Of Health-Care Products - EthyleneOxide - Requirements For The Development,Validation And Routine Control Of ASterilization Process For Medical Devices(Sterility) | 14-452 |
| ASTM D4169-14 | Standard Practice for Performance Testing ofShipping Containers and Systems | NA |
| ASTM F1929-15 | Standard Test Method for Detecting Seal Leaksin Porous Medical Packaging by Dye Penetration | 14-484 |
| ASTM F88/F88M-15 | Standard Test Method for Seal Strength ofFlexible Barrier Materials | 14-482 |
| ASTM F2825-10(Reapproved 2015) | Standard Practice for Climatic Stressing ofPackaging Systems for Single Parcel Delivery | 14-344 |
| Table 2: Standards Referenced in Testing of the Glidesheath Slender Tibial Pedal Kit | |||
|---|---|---|---|
Biocompatibility
Biocompatibility classification is based on the FDA Guidance Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process."
Glidesheath Slender Tibial Pedal kit is categorized as an external communicating device, circulating blood with limited contact duration (up to 24 hours). The biological evaluation of Glidesheath Slender Tibial Pedal kit was performed per EN ISO 10993-1 and FDA Guidance on Use of International Standard ISO 10993-1.
All components of the Glidesheath Slender Tibial Pedal kit are identical in materials, formulation, geometry, source (manufacturer), processing, chemicals, and intended patient exposure and utilize the same sterilization method (Ethylene Oxide) as those in the predicate device and reference devices. Therefore, no additional biocompatibility testing was performed, and the Glidesheath Slender Tibial Pedal kit is considered to have substantially equivalent biocompatibility for the indicated use.
Sterilization
Glidesheath Slender Tibial Pedal kit was adopted into an existing ethylene oxide sterilization process validated via the overkill half cycle approach in accordance with ISO 11135:2014, Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization
{10}------------------------------------------------
process for medical devices. The microbiological and performance qualifications for the existing sterilization process used for the reference devices were leveraged to provide a Sterility Assurance Level (SAL) of 10-6.
Glidesheath Slender Tibial Pedal kit is a limited exposure device. Sterilant residual testing was performed to demonstrate that after 24 hours of heated aeration, the level of residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) do not exceed an average daily dose of 4 mg and 9 mg respectively per EN ISO 10993-7:2008.
CLINICAL TESTS (807.92(b)(2)) I.
This 510(k) included a summary of the PRIME Registry data. The first 71 patients treated with the Terumo Glidesheath Slender when undergoing an index endovascular procedure using a tibial access point was compared to a literature based dataset of procedures using radial and femoral access. No issues that may affect the determination of substantial equivalence were noted in the comparison.
J. CONCLUSION (807.92(b)(3))
In summary, the Glidesheath Slender Tibial Pedal kit, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).