(136 days)
R2PTM Destination Slender™ Guiding Sheath is indicated to be used for the introduction of interventional and diagnostic devices in the lower extremities of the peripheral vasculature through an access site, including tut not limited to the radial artery.
The R2PTM Destination Slender™ Guiding Sheath is a low profile guiding sheath designed to perform as a guiding catheter and an introducer sheath. The sheath is coil reinforced, has a radiopaque tip, is hydrophilically coated and is available in 6Fr with a length of 119cm and 149cm. It comes packaged with a dilator and hemostatic valve.
The provided FDA 510(k) summary for the Terumo R2P™ Destination Slender™ Guiding Sheath describes non-clinical performance testing to demonstrate substantial equivalence to predicate devices. It does not include clinical study data or information about AI/ML algorithms. Therefore, many of the requested categories related to clinical studies, expert-derived ground truth, and AI performance metrics cannot be populated from the provided text.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance
The document states that the R2P™ Destination Slender™ Guiding Sheath "met the predetermined acceptance criteria and results support a determination of substantial equivalence." However, the specific quantitative acceptance criteria for each test item are not explicitly listed in the provided tables, only the test items themselves and the reference standards used.
| Test Item | Reference Standard / Test Type | Reported Device Performance |
|---|---|---|
| Three-Point Bend | In-house standard | Met predetermined acceptance criteria |
| Hub Joint Strength | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Tubing Tensile Strength | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Tip Tensile Strength | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Ovalization | In-house standard | Met predetermined acceptance criteria |
| Lubricity and Durability | In-house standard | Met predetermined acceptance criteria |
| Uncoated Length | In-house standard | Met predetermined acceptance criteria |
| Corrosion Resistance | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Gauging | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013, ISO 594-1:1986 | Met predetermined acceptance criteria |
| Liquid Leakage of Luer under Pressure | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013, ISO 594-2:1998 | Met predetermined acceptance criteria |
| Air Leakage | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013, ISO 594-2:1998 | Met predetermined acceptance criteria |
| Separation Force | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013, ISO 594-2:1998 | Met predetermined acceptance criteria |
| Unscrewing Torque | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013, ISO 594-2:1998 | Met predetermined acceptance criteria |
| Ease of Assembly | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013, ISO 594-2:1998 | Met predetermined acceptance criteria |
| Resistance to Overriding | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Stress Cracking | ISO 594-2:1998, ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013, ISO 594-2:1998 | Met predetermined acceptance criteria |
| Simulated Use and Particulate | FDA Guidance Doc 1608 | Met predetermined acceptance criteria |
| Radiodetectability | ISO 11070:2014, ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Visual Inspection of External Surface | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Sheath Tip Inner Diameter | In-house standard | Met predetermined acceptance criteria |
| Sheath Hub Inner Diameter | In-house standard | Met predetermined acceptance criteria |
| Dilator Bump Inner Diameter | In-house standard | Met predetermined acceptance criteria |
| Outer Diameter Measurement | In-house standard | Met predetermined acceptance criteria |
| Effective Length | In-house standard | Met predetermined acceptance criteria |
| Coating Integrity | FDA Guidance Doc 1608 | Met predetermined acceptance criteria |
| Liquid Leakage of the Sheath | ISO 11070:2014 | Met predetermined acceptance criteria |
| Liquid Leakage Through Hemostasis Valve | ISO 11070:2014 | Met predetermined acceptance criteria |
| Torque Strength | FDA Guidance Doc 1608 | Met predetermined acceptance criteria |
| Dilator Tip Inner Diameter | In-house standard | Met predetermined acceptance criteria |
| Dilator Tip Penetration | In-house standard | Met predetermined acceptance criteria |
| Biocompatibility | ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity (Acute), Pyrogenicity, Hemocompatibility, Thrombogenicity, Complement Activation, Physiochemical Testing) | Demonstrated biocompatibility of the finished device |
| Sterilization | ISO 11135:2014 (Ethylene Oxide - SAL 10-6) | Sterility assured, residuals meet EN ISO 10993-7:2008 limits |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document.
- Data Provenance: The document describes "non-clinical tests" and "performance testing" conducted. This refers to laboratory testing of the physical device, not patient data. Therefore, questions of country of origin or retrospective/prospective do not apply in the typical sense for clinical data. The manufacturer is Terumo Medical Corporation, located in the USA (Somerset, NJ and Elkton, MD).
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 question is not applicable. The testing described is non-clinical performance and biocompatibility testing of a physical medical device. "Ground truth" in the context of expert review for diagnostic AI software is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of clinical data, which is not part of this submission.
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
This question is not applicable. This submission is for a physical medical device (guiding sheath), not AI software, and no clinical studies, especially MRMC, were conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is not an algorithm or AI software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This question is not applicable in the context of clinical "ground truth." For the non-clinical performance tests, the "ground truth" would be established engineering specifications, industry standards (ISO), and in-house standards against which the device's physical properties are measured.
8. The sample size for the training set
This question is not applicable. This device does not involve a "training set" as it is a physical medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
This question is not applicable. As explained above, there is no "training set" for this device.
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October 5, 2017
Terumo Medical Corporation Liang Lu Senior Regulatory Affairs Specialist 950 Elkton Blvd Elkton, Maryland 21921
Re: K171491
Trade/Device Name: R2PTM Destination Slender™ Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 6, 2017 Received: September 7, 2017
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171491
Device Name
R2PTM Destination Slender™ Guiding Sheath
Indications for Use (Describe)
R2P™ Destination Slender™ Guiding Sheath is indicated to be used for the introduction of interventional and diagnostic devices in the lower extremities of the peripheral vasculature through an access site, including tut not limited to the radial artery.
| 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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K171491 510(K) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
Prepared by:
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: May 11, 2017
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B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | R2PTM Destination Slender™ Guiding Sheath |
|---|---|
| Common Name: | Guiding 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:
- . Primary Predicate Device: K052185 - Destination Carotid Guiding Sheath, manufactured by Terumo Medical Corporation, USA
- Reference Device: K161546 R2P SlenGuide, manufactured by Terumo . Corporation
D. REASON FOR 510(k) SUBMISSION
This premarket notification (510(k)) is being submitted for the R2P™ Destination Slender™ Guiding Sheath, 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 R2PTM Destination Slender™ Guiding Sheath is a low profile guiding sheath designed to perform as a guiding catheter and an introducer sheath. The sheath is coil reinforced, has a radiopaque tip, is hydrophilically coated and is available in 6Fr with a length of 119cm and 149cm. It comes packaged with a dilator and hemostatic valve.
F. INDICATIONS FOR USE (807.92(a)(5))
R2P™ Destination Slender™ Guiding Sheath is indicated to be used for the introduction of interventional and diagnostic devices in the lower extremities of the peripheral vasculature through an access site, including but not limited to the radial artery.
G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
The R2PTM Destination Slender™ Guiding Sheath, 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.
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Image /page/5/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word.
A comparison of the technological characteristics is summarized on the table below.
| DeviceCharacteristic | New Device:R2PTM DestinationSlender™ GuidingSheath | Primary Predicate:Destination CarotidGuiding Sheath(K052185) | Reference Device:R2P SlenGuide(K161546) |
|---|---|---|---|
| Manufacturer | Terumo MedicalCorporation | Terumo MedicalCorporation | Terumo Corporation |
| Intended Use /Indications forUse | R2PTM DestinationSlender™ GuidingSheath is indicated tobe used for theintroduction ofinterventional anddiagnostic devices inthe lower extremities ofthe peripheralvasculature through anaccess site, includingbut not limited to theradial artery. | The Destination®Guiding Sheath isdesigned to be used forthe introduction ofinterventional anddiagnostic devices intothe human vasculatureincluding but notlimited to the carotidarteries. | The R2P (radial toperipheral)SlenGuide isdesigned for theintroduction ofinterventional anddiagnostic devicesinto theperipheralvasculature ofthe lower extremities |
| OperationPrinciple | Operated manually orby a manualprocess; | Same | Same |
| Design /Construction | Sheath, Dilator,Hemostatic Valve withside tube and three-waystopcock | Same | Guiding Catheter,Inner Guide |
Table 12.1: Summary of Substantial Equivalence
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Image /page/6/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red curved line above the word "TERUMO" in green. The font is sans-serif and bolded.
| Materials | Sheath Assembly | Sheath Assembly | Guiding Catheter: |
|---|---|---|---|
| Tubing: | Tubing: | Outer layer: | |
| Inner Layer: PTFE | Inner Layer: PTFE | Polyamide elastomer(Nylon) | |
| Middle Coil Layer: | Middle Coil Layer: | Middle Braid Layer: | |
| Stainless Steel | Stainless Steel | Stainless steel | |
| Outer Layer: Nylon | Outer Layer: Nylon | Inner layer: | |
| Polytetrafluoroethylene | |||
| Radiopaque Tip: Nylonwith Tungsten | Tip: NylonRadiopaque Band:Gold | Radiopaque Tip:Polyamide Elastomer(Nylon) with Tungsten | |
| Hydrophilic Coating:Polyvinylpyrrolidone-based coating | Hydrophilic Coating:Polyvinylpyrrolidone-based coating | Hydrophilic Coating:Dimethyl acrylic amide- glycidyl methacrylate | |
| Hub: Nylon | Hub: Nylon | Hub: Polyamide 12 | |
| Anti-kink protector:Nylon | Anti-kink protector:Polyester Elastomer | ||
| Dilator AssemblyTubing: PolypropyleneHub: Polypropylene//ThermoplasticElastomer BlendCoating: SiliconeCaulking Pin: Stainlesssteel | Dilator AssemblySame | Inner Guide:Shaft: PolyesterElastomer withTungstenHub: PolyamideLock Adaptor:polycarbonate |
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Image /page/7/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green. The font is sans-serif and bold.
| Cross Cut Valve | Cross Cut Valve | None | |
|---|---|---|---|
| Valve Assembly: | Valve Assembly: | ||
| Housing: | Same | ||
| Polypropylene | |||
| Cap: Polypropylene | |||
| Luer Lock Collar: | |||
| Polycarbonate | |||
| Valve: Silicone Rubber | |||
| Elastomer | |||
| Sidetube: | |||
| polybutadiene | |||
| Silicone: Non-reactive | |||
| silicone oil 1000cst | |||
| Side Tube Assembly: | Side Tube Assembly: | ||
| Body: Polybutadiene | Same | ||
| 3Way (3WSC) | 3Way (3WSC) | ||
| Stopcock Assembly: | Stopcock Assembly: | ||
| Body: Polycarbonate | Same | ||
| Locking | |||
| Pin: Polyethylene | |||
| Cap: Polyethylene and | |||
| Colorant | |||
| Handle: Polyethylene | |||
| and Colorant | Tuohy-Borst Valve | ||
| Lock Adaptor: | Similar material as | ||
| Polycarbonate | Cross Cut Valve | ||
| Package | Unit Pouch | Unit Pouch | Unit Pouch |
| Shelf Box | Shelf Box | Shelf Box | |
| Shipping Carton | Shipping Carton | Shipping Carton |
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Image /page/8/Picture/1 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red arc above the letters "TE". The font is bold and sans-serif. The logo is simple and modern.
| Specifications | Sheath Size: 6 Fr. | Sheath Size: 6-7 Fr. | Catheter Size: 7Fr |
|---|---|---|---|
| Sheath ID/OD(nominal): | Sheath ID/OD(nominal): | I.D.: 2.20 mm (0.087") | |
| 6Fr.: 0.087"/0.100"(2.2mm /2.5mm) | 6Fr.: 0.087"/0.111"7Fr.: 0.100"/0.122" | O.D.: 2.37 mm(0.093") | |
| Sheath Length:119cm, 149cm | Sheath Length:80-110cm | Effective lengths:120cm, 150cm | |
| Hydrophilic Coating:full effective length | Hydrophilic Coating:Distal 15cm | ||
| Distal Shape: Straight | Distal Shapes: Straight,Angled (40 degrees) | ||
| Dilator ID/OD(nominal): | Dilator ID/OD(nominal): | Inner GuideAccepts guide wirediameter: 0.035" | |
| 0.039"/0.086" | 6Fr.: 0.045”/0.084"7Fr.: 0.045”/0.097" | ||
| Dilator ExtendedLength: 5cm | Dilator ExtendedLength: 5cm | ||
| Sterilization | Ethylene Oxide(validated inaccordance with ANSI/ AAMI / ISO 11135-1to achieve SAL 10-6) | Same | Same |
| Shelf life | 30 months | Same | 36 months |
| DisposableSingle Use | Yes | Same | Same |
H. NON-CLINICAL TESTS (807.92(b)(1))
Performance
Performance testing was conducted to ensure that the R2P™ Destination Slender™ Guiding Sheath met the applicable design and performance requirements throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device.
The following table provides a list of the performance tests that were performed on the proposed R2P™ Destination Slender™ Guiding Sheath.
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Image /page/9/Picture/1 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red swoosh above the letters "TE". The font is bold and sans-serif. The logo is simple and modern.
| Table 5.4: Summary of Performance Testing | ||
|---|---|---|
| Test Item | Reference | Component(Sheath,Dilator, CCVAssembly) |
| Three-Point Bend | In-house standard | Sheath |
| Hub Joint Strength | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| Tubing Tensile Strength | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| Tip Tensile Strength | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| Ovalization | In-house standard | Sheath |
| Lubricity and Durability | In-house standard | Sheath |
| Uncoated Length | In-house standard | Sheath |
| Corrosion Resistance | ISO 11070:2014 | Sheath, Dilator |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| Gauging | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| ISO 594-1:1986 | ||
| Liquid Leakage of Luerunder Pressure | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| ISO 594-2:1998 | ||
| Air Leakage | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| ISO 594-2:1998 | ||
| Separation Force | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| ISO 594-2:1998 | ||
| Unscrewing Torque | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| ISO 594-2:1998 | ||
| Ease of Assembly | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| Test Item | Reference | Component(Sheath,Dilator, CCVAssembly) |
| ISO 594-2:1998 | ||
| Resistance to Overriding | ISO 11070:2014ISO 10555-1:2009ISO 10555-1:2013 | Sheath |
| Stress Cracking | ISO 594-2:1998ISO 11070:2014ISO 10555-1:2009ISO 10555-1:2013ISO 594-2:1998 | Sheath |
| Simulated Use andParticulate* | FDA Guidance Doc 1608 | Sheath, Dilator,CCV |
| Radiodetectability | ISO 11070:2014ISO 10555-1:2013 | Sheath, Dilator |
| Visual Inspection ofExternal Surface | ISO 11070:2014ISO 10555-1:2009ISO 10555-1:2013 | Sheath, Dilator |
| Sheath Tip Inner Diameter | In-house standard | Sheath |
| Sheath Hub Inner Diameter | In-house standard | Sheath |
| Dilator Bump InnerDiameter | In-house standard | Dilator |
| Outer DiameterMeasurement | In-house standard | Sheath, Dilator |
| Effective Length | In-house standard | Sheath, Dilator |
| Coating Integrity | FDA Guidance Doc 1608 | Sheath |
| Liquid Leakage of theSheath | ISO 11070:2014 | Sheath |
| Liquid Leakage ThroughHemostasis Valve | ISO 11070:2014 | CCV |
| Torque Strength | FDA Guidance Doc 1608 | Sheath |
| Dilator Tip Inner Diameter | In-house standard | Dilator |
| Dilator Tip Penetration | In-house standard | Dilator |
Table 5.4: Summary of Performance Testing
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The R2P™ Destination Slender™ Guiding Sheath tested met the predetermined acceptance criteria and results support a determination of substantial equivalence. Based on the results of the performance testing, the proposed R2PTM Destination Slender™ Guiding Sheath is substantially equivalent.
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Image /page/11/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red curved line above the word "TERUMO" in green. The word "TERUMO" is in a bold, sans-serif font.
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."
The R2PTM Destination Slender™ Guiding Sheath is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (<24 hours).
The following tests are recommended by FDA and ISO 10993-1 to be performed per this device classification:
-
- Cytotoxicity
-
- Sensitization
-
- Intracutaneous Reactivity
-
- Systemic Toxicity (Acute)
-
- Pyrogenicity
-
- Hemocompatibility
-
- Thrombogenicity
-
- Complement Activation (Immunology)
-
- Physiochemical Testing
Results of the testing demonstrate biocompatibility of the finished R2PTM Destination Slender™ Guiding Sheath.
Sterilization
The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
The sterilization process was validated utilizing the overkill half cycle approach to provide a Sterility Assurance Level (SAL) of 10-6.
R2P™ Destination Slender™ Guiding Sheath is a limited exposure device. 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.
I. CLINICAL TESTS (807.92(b)(2))
This 510(k) does not include data from clinical tests.
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Image /page/12/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red curved line above the word "TERUMO" in green, block letters. The red line appears to be a stylized representation of a blood vessel or a medical device.
J. CONCLUSION (807.92(b)(3))
In summary, the R2PTM Destination Slender™ Guiding Sheath, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate device(s):
§ 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).