(133 days)
The R2P (radial to peripheral) SlenGuide is designed for the introduction of interventional and diagnostic devices into the peripheral vasculature of the lower extremities.
The R2P SlenGuide is a single use, ethylene oxide sterilized device that is designed to perform as a guiding catheter for interventional procedures in the peripheral vasculature. It is packaged with a guiding catheter and an inner guide. The guiding catheter features a three-layer construction with a stainless steel mesh, polyamide elastomer, and polytetrafluoroethyelene. The distal end has a hydrophilic coating and a soft-tip visible under fluoroscopy. The inner guide is an accessory device made of polyester elastomer with a flexible distal portion containing tungsten, visible under fluoroscopy.
The provided document describes the R2P SlenGuide, a percutaneous catheter, and its testing to demonstrate substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effect size for AI assistance. Instead, the "acceptance criteria" here refer to meeting standards for safety and performance characteristics through non-clinical testing.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various non-clinical tests performed and states that "Performance testing met the predetermined acceptance criteria." However, it does not explicitly state the numerical acceptance criteria for each test or the specific reported performance results in a detailed, quantitative table. It only confirms that the criteria were met.
For example, for "Peak tensile force," the test procedure is described (measure peak tensile strength), but the acceptable range (e.g., >X Newtons) and the actual measured value are not provided in this summary. The same applies to other tests.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions that performance tests were performed on "non-aged and accelerated aged samples." However, it does not specify the number of samples used for each test.
- Data Provenance: The tests are described as non-clinical performance testing conducted by the manufacturer, Terumo Corporation, or its Ashitaka Factory in Japan. The data is retrospective in the sense that it was collected as part of the device development and regulatory submission process.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the document describes non-clinical performance and biocompatibility testing of a physical medical device (a catheter), not an AI/software device that would require expert-established ground truth for a test set.
4. Adjudication Method
This information is not applicable for the same reason as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable as the device is a physical catheter, not an AI system. There is no mention of human readers or AI assistance in this context.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable as the device is a physical catheter, not an algorithm.
7. Type of Ground Truth Used
This information is not applicable as the document describes non-clinical performance and biocompatibility testing of a physical medical device. The "ground truth" for these tests would be the established scientific and engineering principles and the specific requirements outlined in the referenced ISO and ASTM standards, as well as internal standards.
8. Sample Size for the Training Set
This information is not applicable as the device is a physical catheter, not an AI/machine learning device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
Summary of Non-Clinical Tests Performed (as a proxy for "study")
The study to demonstrate that the device meets performance requirements involved a series of non-clinical, in-vitro tests based on established international standards (ISO and ASTM) and FDA guidance documents. These tests were categorized into performance testing and biocompatibility testing.
Performance Testing (Guiding Catheter & Inner Guide):
- Standards Referenced: ISO 10555-1:2013, ASTM F640-12, USP <788>, FDA Guidance "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters."
- Tests Included:
- Radio-detectability
- Surface quality
- Peak tensile force
- Freedom from leakage
- Hub performance (for Guiding Catheter)
- Distal tip appearance
- Particulate evaluation
- Torque Strength (for Guiding Catheter)
- Coating lubricity (for Guiding Catheter)
- Evaluation of flexibility and kink resistance (for Guiding Catheter)
- Distal tip flexibility (for Guiding Catheter)
- Kink condition (for Guiding Catheter)
- Flexural rigidity
- Distal tip strength (for Guiding Catheter)
- Cleanliness
- Product dimensions
Biocompatibility Testing:
- Standards Referenced: ISO 10993-1, FDA General Program Memorandum #G95-1 (5/1/95), Draft Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993.
- Classification: Externally Communicating Device, Circulating Blood, Limited Contact (<24 hours).
- Biocompatibility Tests Performed (on non-aged and accelerated-aged samples for some tests):
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Pyrogenicity
- Hemolysis
- Thrombogenicity
- Complement Activation (Immunology)
- Physicochemical Profile (Physicochemical and FT-IR)
Conclusion of Testing: "Performance testing met the predetermined acceptance criteria and results support a determination of substantial equivalence." and "Results of the [biocompatibility] testing demonstrate that the device is biocompatible throughout the shelf life of the product."
Sterilization Validation:
- Standard Referenced: 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").
- Result: Achieved a Sterility Assurance Level (SAL) of 10-6.
In essence, the "study" demonstrating the device meets its "acceptance criteria" here refers to the comprehensive non-clinical testing outlined above, which confirmed adherence to recognized standards for safety, performance, and biocompatibility, thereby supporting the claim of substantial equivalence to predicate devices.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2016
Terumo Medical Corporation Ms. Monika McDole-Russell Senior Regulatory Affairs Specialist 265 Davidson Avenue, Suite 320 Somerset. NJ 08873
Re: K161546
Trade/Device Name: R2P SlenGuide Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 13, 2016 Received: September 14, 2016
Dear Ms. McDole-Russell:
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 (reporting of medical devicerelated 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 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 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 yours,
Image /page/1/Picture/7 description: The image shows the name "Brian D. Pullin -S" in a large, bold font. The text is black and is set against a light blue background. The letters are clear and easy to read.
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) K161546
Device Name R2PTM SlenGuide™
Indications for Use (Describe)
The R2P (radial to peripheral) SlenGuide is designed for the introduction of interventional and diagnostic devices into the peripheral vasculature of the lower extremities.
| 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
A. SUBMITTER INFORMATION (807.92(a)(1))
| Prepared by: | Monika McDole-Russell, MSRA, RACManager, Regulatory AffairsTerumo Medical CorporationTel. (732) 302-4900 ext.4273Fax (732) 302-4905 |
|---|---|
| -------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- |
| Prepared for: | Owner/Operator |
|---|---|
| Terumo Corporation | |
| 44-1, 2-Chome, Hatagaya | |
| Shibuya-Ku, Tokyo | |
| Japan 151-0072 | |
| Owner/Operator Number: 801 002 6 |
Manufacturer and Sterilization Facility (Applicant)
Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya, Shizuoka 418-0015, Japan Registration Number: 968 183 4
| Contact Person: | Monika McDole-Russell, MSRA, RAC |
|---|---|
| Manager, Regulatory Affairs | |
| Terumo Medical Corporation | |
| 265 Davidson Avenue, Suite 320 | |
| Somerset, NJ 08873 | |
| Tel. | (732) 302-4900 ext.4273 |
| Fax | (732) 302-4905 |
| E-mail: | monika.mcdolerussell@terumomedical.com |
Date prepared: October 7, 2016
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B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | R2PTM SlenGuideTM |
|---|---|
| Common Name: | Guiding Catheter |
| Classification Name: | Percutaneous Catheter |
| Classification Panel: | Cardiovascular |
| Regulation: | 21 CFR 870.1250 |
| Product Code: | DQY |
| Classification: | Class II |
C. PREDICATE DEVICES (807.92(a)(3))
The legally marketed device(s) to which substantial equivalence is claimed are:
- Predicate Device: K972978 Vista Brite Tip Guiding Catheters, manufactured by . Cordis Corporation.
- Reference Device 1: K142819 Shuttle-SL Flexor Tuohy-Borst Side-Arm . Introducer Set, manufactured by Cook, Inc. (hereinafter referred to as "Flexor Introducer Set")*
*Flexor Introducer Set (K142819) is presented as a reference predicate for the Inner Guide.
- Reference Device 2: K090040 Radifocus Glidecath/Glidecath XP, manufactured . by Terumo Corporation.
- Radifocus Glidecath/Glidecath XP (K090040) is presented as a reference predicate for device length.
D. REASON FOR 510(k) SUBMISSION
This premarket notification (510(k)) is being submitted for the R2P SlenGuide, manufactured by Ashitaka Factory of Terumo Corporation, for the purposes of establishing substantial equivalence to a legally marketed predicate device.
E. DEVICE DESCRIPTION (807.92(a)(4))
Principle of Operation Technology
The R2P SlenGuide is operated by manual process.
Design/Construction
The R2P SlenGuide is a single use, ethylene oxide sterilized device that is designed to perform as a guiding catheter for interventional procedures in the peripheral vasculature. It is packaged with a guiding catheter and an inner guide; a description of
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each component is provided below.
Guiding Catheter: features a three-layer construction, which consists of a stainless steel mesh sandwiched between an outer layer of polyamide elastomer and an inner layer of polytetrafluoroethyelene. The distal end has a hydrophilic coating and contains a "soft-tip," which is visible under fluoroscopy.
Inner Guide: is an accessory device for the guiding catheter. Its purpose is to help direct the guiding catheter to the lesion, and once achieved, the inner guide is removed, in order to proceed with the interventional procedure. It is comprised of polyester elastomer, and the distal portion is a flexible polyester elastomer, containing tungsten, which is visible under fluoroscopy.
Materials
The materials for the R2P SlenGuide are provided in the table below.
| Name of Component | Raw Material | ||
|---|---|---|---|
| GuidingCatheter | Shaft | Polyamide elastomerPigment | |
| Outer layer* | Distalpart | Polyamide elastomerPigment | |
| Soft-tip | Polyamide elastomerTungsten | ||
| Inner layer* | Polytetrafluoroethylene | ||
| Braid† | Stainless steel | ||
| Hub* | Polyamide 12Pigment | ||
| Hydrophilic polymer coating* | Dimethyl acrylic amide -glycidyl methacrylatecopolymer | ||
| Anti-kink protector | Polyester elastomerPigment | ||
| InnerGuide | Shaft* | Distal part | Polyester elastomerTungsten |
| Proximal part | Polyester elastomer | ||
| Hub* | Polyamide | ||
| Lock adaptor | Polycarbonate | ||
| Adhesive | Cyanoacrylate |
Table 5.1: List of Materials
*Blood contacting material.
*Soft-tip is not braided.
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Specifications
The specifications for the R2P SlenGuide are provided in the table below.
| Part | Specification |
|---|---|
| Catheter Size | 7Fr. |
| Catheter ID/OD | 2.20 mm/2.37 mm |
| Catheter Effective Lengths* | 120 and 150 cm |
| Inner Guide ID/OD | 1.15 mm/2.10 mm |
| Inner Guide Extended Length† | 30 mm |
| Accepts Guide Wire Diameter | 0.035" |
Table 5.2: R2P SlenGuide Specifications
*The length from the proximal anti-kink protector to the guiding catheter distal tip. *The length that the inner guide extends past the guiding catheter's tip.
F. INDICATIONS FOR USE (807.92(a)(5))
The R2P (radial to peripheral) SlenGuide is designed for the introduction of interventional and diagnostic devices into the peripheral vasculature of the lower extremities.
G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
The R2P SlenGuide, subject of this Traditional 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to:
- Predicate Device: K972978 Vista Brite Tip Guiding Catheters, manufactured by . Cordis Corporation.
- Reference Device 1: K142819 Flexor Introducer Set*, manufactured by Cook, . Inc.
*Flexor Introducer Set (K142819) is presented as a reference predicate for the Inner Guide.
- Reference Device 2: K090040 Radifocus Glidecath/Glidecath XP*, manufactured . by Terumo Corporation.
- Radifocus Glidecath/Glidecath XP (K090040) is presented as a reference predicate for device length.
A comparison of the technological characteristics is summarized in the table below.
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| Device Characteristic | New Device:Guiding Catheter of R2PSlenGuide | Predicate Device:Vista Brite TipGuiding Catheters(K972978)* | Reference Device 1:Flexor Introducer Set(K142819)* | Reference Device 2:Radifocus Glidecathor Glidecath XP(K090040) | |
|---|---|---|---|---|---|
| Manufacturer | Terumo Corporation | Cordis Corporation | Cook, Inc. | Terumo Corporation | |
| IntendedUse/Indication forUse | The R2P (radial toperipheral) SlenGuide isdesigned for theintroduction ofinterventional anddiagnostic devices into theperipheral vasculature ofthe lower extremities | The guiding catheter isintended for use forintravascularintroduction ofinterventional /diagnostic devices intothe coronary orperipheral vascularsystems | Flexor Introducers andGuiding Sheaths areintended to introducetherapeutic ordiagnostic devices intothe vasculature,excluding coronary andneuro vasculature | The Radifocus Glidecath(or Radifocus GlidecathXP) is intended for use inangiographic procedures.It delivers radiopaquemedia and therapeuticagents to selected sites inthe vascular system. It isalso used to lead a guidewire or catheter into thetarget site. | |
| Operation Principle | Manual | same | same | same | |
| Design/Construction | GuidingCatheter | Single lumen catheter,stainless steel braid wire,catheter, radiopaque tip,and hub | same | N/A | Single lumen catheter,stainless steel braidwire, cathetercontaining radiopaquematerial(tungsten orbarium sulfate) andhub |
| Inner Guide | Made by plastic materials,featuring a distal taper thatallows for smoothtransition with theappropriately sized guidewire | N/A | same | N/A | |
| Device Characteristic | New Device:Guiding Catheter of R2PSlenGuide | Predicate Device:Vista Brite TipGuiding Catheters(K972978)* | Reference Device 1:Flexor Introducer Set(K142819)* | Reference Device 2:Radifocus Glidecathor Glidecath XP(K090040) | |
| Materials | Guiding Catheter | • Outer layer:Polyamide elastomer(Nylon)• Braid: Stainless steel• Inner layer:Polytetrafluoroethylene | same | N/A | |
| InnerGuide | • Shaft: Polyesterelastomer | N/A | • Shaft: Polyamideelastomer (Nylon)or Polyethylene | N/A | |
| Package | • Individual package onwhich the product labeland thepeel-off labels areattached• 1 unit per package | same | same | same | |
| Specifications | Guiding Catheter | • Effective lengths: 120cm, 150 cm• French size: 7Fr• O.D.: 2.37 mm• I.D.: 2.20 mm (0.087") | • Effective lengths:55 cm, 90 cm, 95cm• French size: 7Fr• O.D.: Soft tip:2.30 mm• I.D.: 2.0 mm(0.078") | N/A | • Effectivelengths: 30 - 150cm• French size:5Fr, 4Fr• O.D.:5Fr 1.70 mm4Fr 1.40mm• I.D.:5Fr 122mm(Doublebraided)1.12 mm(Singlebraided)4Fr 1.05 mm |
| Device Characteristic | New Device:Guiding Catheter of R2PSlenGuide | Predicate Device:Vista Brite TipGuiding Catheters(K972978)* | Reference Device 1:Flexor Introducer Set(K142819)* | Reference Device 2:Radifocus Glidecathor Glidecath XP(K090040) | |
| ุการ อนเล | Accepts guide wire●diameter: 0.035" | N/A | Accepts guide wire●diameter: 0.018",0.035", and 0.038" | N/A | |
| Sterilization | Ethylene oxide | same | same | same |
Table 5.3: Summary of Comparative Information
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*Based on publicly available information on the devices.
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H. NON CLINICAL TESTS (807.92(b)(1))
Performance Testing
Performance testing was conducted to ensure that the R2P SlenGuide met the applicable design and performance requirements throughout its shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device. With the exception of the Radiodetectability] and Cleanliness tests2, the following performance tests were performed on non-aged and accelerated aged samples. The following tables provide a list of performance tests that were performed on the R2P SlenGuide.
| Component | Test | Standard | Test Method |
|---|---|---|---|
| GuidingCatheter | Radio-detectability | ISO 10555-1:2013Section 4.2,ASTM F640-12 | Test samples using X-ray equipment,that are tested according to ASTMF640-12 |
| Surface quality | ISO 10555-1:2013Section 4.4 | Check external surfaces of samples witha magnifier (x 2.5 times or more) | |
| Peak tensileforce | ISO 10555-1:2013Section 4.6VIII.A.7 of FDAGuidance3 | Using an autograph, measure peaktensile strength of samples | |
| Freedom fromleakage | ISO 10555-1:2013Section 4.7 | Using a syringe filled with water, applyand maintain pressure to the catheter,and then inspect for liquid and airleakage | |
| Hubperformance | ISO 10555-1:2013Section 4.8ISO 594-2: 1998 | Test hubs for gauging, liquid leakage,air leakage, separation force,unscrewing torque, ease of assembly,resistance to overriding, and stresscracking | |
| Distal tipappearance | ISO 10555-1:2013Section 4.12 | Check physical appearance of distal tipwith a microscope (x 10 times or more) | |
| Particulateevaluation | VIII.A.13 of FDAGuidance3USP <788>In-house Standard | Slide samples into an apparatus filledwith purified water, andmeasure/evaluate residual particles |
Table 5.4: Summary of Performance Testing - Guiding Catheter
1 Only non-aged sample was tested since the amount of contrast media contained in the product would not change over time.
2 Only non-aged sample was tested since the particulates inside the catheter lumen would not increase over time.
3 Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary
Angioplasty (PTCA) Catheters, September 8, 2010.
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| Component | Test | Standard | Test Method |
|---|---|---|---|
| Torque Strength | VIII.A.10 of FDAGuidanceIn-house Standard3 | Confirm R2P Slenguide has appropriatetorque strength by measuring therotation of the catheter, when twistingoff | |
| Coatinglubricity | VIII.A.12 of FDAGuidance3In-house Standard | After the particulate evaluation test,visually evaluate coating undermagnification. Then, after pushing andpulling samples in an apparatus,confirm coating lubricity by measuringsliding forces | |
| Evaluation offlexibility andkink resistance | VIII.A.9 of FDAGuidance3In-house Standard | Wind samples around mandrels, untilthe samples have kinked, and recordmandrel size that caused samples tokink | |
| Distal tipflexibility | In-house Standard | Measure tip force when samples arepushed by an apparatus | |
| Kink condition | In-house Standard | Kink the samples, and visually inspectwith a magnifying glass | |
| Flexural rigidity | In-house Standard | Samples are set on an apparatus, andmaximum force is applied, in order tomeasure shaft strength | |
| Distal tipstrength | VIII.A.8 of FDAGuidance3In-house Standard | Samples are clamped and pulled tomeasure tensile strength | |
| Cleanliness | In-house Standard | Water is injected into the samples and isvisually inspected for foreign matter | |
| Productdimensions | In-house Standard | Measure by inner and outer diameter,effective length, and extended length |
Table 5.5: Summary of Performance Testing – Inner Guide
| Component | Test | Standard | Test Method |
|---|---|---|---|
| Inner Guide | Radio-detectability | ISO 10555-1:2013Section 4.2ASTM F640-12 | Test samples using X-ray equipment, when tested according to ASTM F640-12 |
| Surface quality | ISO 10555-1:2013Section 4.4 | Check external surfaces of samples with a magnifier (x 2.5 times or more) | |
| Peak tensile force | ISO 10555-1:2013Section 4.6VIII.A.7 of FDAGuidance3 | Using an autograph, measure peak tensile strength of samples | |
| Freedom fromleakage | ISO 10555-1:2013Section 4.7 | Using a syringe filled with water, apply and maintain pressure to the catheter, and then inspect for liquid and air leakage | |
| Distal tipappearance | ISO 10555-1:2013Section 4.12 | Check physical appearance of distal tip with a microscope (x 10 times or more) |
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| Flexural rigidity | In-house Standard | Samples are set on an apparatus, andmaximum force is applied, in order tomeasure shaft strength | |
|---|---|---|---|
| Cleanliness | In-house Standard | Water is injected into the samples and isvisually inspected for foreign matter | |
| Product dimensions | In-house Standard | Measure by inner and outer diameter,effective length, and extended length |
Performance testing met the predetermined acceptance criteria and results support a determination of substantial equivalence.
Biocompatibility
In accordance with ISO 10993-1, the R2P SlenGuide is classified as: Externally Communicating Device, Circulating Blood, Limited Contact (<24 hours). The finished device's patient contacting parts were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and Draft Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." Screening tests were performed on accelerated aged devices to show that biocompatibility is maintained throughout the shelf life of the product. The table below provides a list of biocompatibility tests conducted on the R2P SlenGuide.
| Non-aged, sterile, whole device |
|---|
| Cytotoxicity |
| Sensitization |
| Intracutaneous Reactivity |
| Acute Systemic Toxicity |
| Pyrogenicity |
| Hemoloysis |
| Thrombogencity |
| Complement Activation (Immunology) |
| Physicochemical Profile (Physicochemical and FT-IR) |
| Accelerated-aged (3 years), sterile, whole device |
| Cytotoxicity |
| Hemolysis |
| Physicochemical Profile (Physicochemical and FT-IR) |
Table 5.6: Summary of ISO 10993 Biocompatibility Testing
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Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product.
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, to provide a Sterility Assurance Level (SAL) of 10-6.
I. CLINICAL TESTS (807.92(b)(2))
This 510(k) does not include data from clinical tests.
J. CONCLUSION (807.92(b)(3))
In summary, the R2P SlenGuide, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to:
- Predicate Device: K972978 Vista Brite Tip Guiding Catheters, manufactured by . Cordis Corporation.
§ 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).