(259 days)
The Radifocus Optitorque Angiographic Catheter is indicated for use in cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery.
The Radifocus Optitorque Angiographic Catheter is comprised of a two-layer construction featuring stainless steel mesh sandwiched between layers of polyurethane and polyamide elastomers. The shaft inner layer and outer layer contain barium sulfate for visibility and contrast under fluoroscopy. A soft tip is attached to the distal portion of some 4 Fr and all 5 Fr and 6 Fr catheters except those with a pigtail design; a soft tube is attached to the distal portion of 5 Fr and 6 Fr catheters with a pigtail design; the 4 Fr products are available with or without a soft tip. Constructed of flexible, supple polyurethane that is permanently welded to the catheter shaft, the soft tip and soft tube are designed to minimize trauma to the vessel wall. There is no change to the design of the device as a result of this submission.
The device is offered in lengths of 65-120 cm. French sizes and shaft inner diameters are as follows:
| French Size | Shaft Inner Diameter |
|---|---|
| 4 | 1.05mm |
| 5 | 1.22mm |
| 6 | 1.32mm |
It is a disposable device intended for single use only. This device is individually packaged and sterilized by ethylene oxide gas.
The provided 510(k) summary describes a medical device, the Radifocus Optitorque Angiographic Catheter, and its performance testing. However, it does not include information about AI/ML device performance, human reader studies, or ground truth establishment relevant to AI/ML. The entire document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing for a material change.
Therefore, many of the requested items related to AI/ML device performance, sample sizes for test/training sets, expert qualifications, and ground truth establishment cannot be extracted from this document.
Here's the information that can be extracted, along with explanations for the missing items:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance/Results |
|---|---|---|
| ISO Standards | Radio-detectability (ISO 10555-1:2013 Section 4.2, ASTM F640-12) | "All samples tested met the standard applicable to each test." |
| Surface (ISO 10555-1:2013 Section 4.4) | "All samples tested met the standard applicable to each test." | |
| Peak tensile force (ISO 10555-1:2013 Section 4.6) | "All samples tested met the standard applicable to each test." | |
| Freedom from leakage (ISO 10555-1:2013 Section 4.7) | "All samples tested met the standard applicable to each test." | |
| Power injection (ISO 10555-1:2013 Section 4.10, Annex F and G) | "All samples tested met the standard applicable to each test." | |
| Distal tip (ISO 10555-1:2013 Section 4.12) | "All samples tested met the standard applicable to each test." | |
| Flow rate (ISO 10555-1:2013 Section 6.3) | "All samples tested met the standard applicable to each test." | |
| Burst pressure (ISO 10555-1:2013 Section 6.3) | "All samples tested met the standard applicable to each test." | |
| Internal Standards | Shaft stiffness (Stiffness of braided-area) | "Meets acceptance criteria" |
| Torque transmission | "Meets acceptance criteria" | |
| Torque strength | "Meets acceptance criteria" | |
| Tensile strength (Shaft) | "Meets acceptance criteria" | |
| Bending strength | "Meets acceptance criteria" | |
| Cleanliness | "Meets acceptance criteria" | |
| Strength of hub junction | "Meets acceptance criteria" | |
| Tensile Strength of soft tip | "Meets acceptance criteria" | |
| Product dimensions (I.D.; O.D.; Tip I.D.; Tip O.D.; Length) | "Meets acceptance criteria" | |
| Embolic cube testing | "Meets acceptance criteria" | |
| Biocompatibility | Cytotoxicity (non-aged and accelerated aged (3 years)) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. A full list of specific acceptance criteria is not provided, but the overall conclusion indicates meeting standards. |
| Sensitization (non-aged) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. | |
| Intracutaneous Reactivity (non-aged) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. | |
| Systemic Toxicity (acute) (non-aged) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. | |
| Pyrogenicity (non-aged) | Certified to be non-pyrogenic in the unopened and undamaged package. Performed in accordance with ISO 10993-11 (2006), ISO 10993-12 (2012), and USP 35, NF 30, 2012 <151> Pyrogen Test (USP Rabbit Test). | |
| Hemolysis (non-aged and accelerated aged (3 years)) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. | |
| Thrombogenicity (non-aged) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. | |
| Complement Activation (Immunology) (non-aged) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. | |
| Chemical Extraction (non-aged and accelerated aged (3 years)) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. | |
| Sterilization | Sterility Assurance Level (SAL) | Validated to provide a SAL of 10^-6 per ISO 11135:2014. |
| Ethylene Oxide (EO) Residuals | EO will not exceed 4 mg per device and Ethylene Chlorohydrin (ECH) will not exceed 9 mg per device, meeting requirements for limited exposure devices per ISO 10993-7. | |
| Risk Analysis | ISO 14971 Compliance | "A Product Risk Analysis was conducted... and it was determined that any new risks were adequately captured and mitigated." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical performance and biocompatibility testing for a physical medical device. It does not refer to "test sets" in the context of AI/ML models or clinical data. The testing was performed on "samples" of the device, both non-aged and accelerated aged (3 years). The exact number of samples for each test is not specified, only that "All samples tested met the standard applicable to each test."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the information provided. The document concerns a physical medical device and its non-clinical performance, not an AI/ML device that requires expert-established ground truth from clinical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to the information provided. The document concerns a physical medical device and its non-clinical performance, not an AI/ML device that requires adjudication of expert labels.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was conducted or reported in this document. This filing is for a conventional medical device, not an AI/ML diagnostic aid. The document explicitly states: "This 510(k) does not include data from clinical tests."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device described is not an algorithm or AI/ML product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" or acceptance criteria were derived from recognized consensus standards (ISO, ASTM, USP) and the manufacturer's own internal standards for device functionality and safety. For biocompatibility, it was based on ISO 10993 standards and FDA G95-1 guidance.
8. The sample size for the training set
This is not applicable. There is no AI/ML model or "training set" relevant to this device.
9. How the ground truth for the training set was established
This is not applicable. There is no AI/ML model or "training set" relevant to this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 19, 2015
Ashitaka Factory of Terumo Corporation Monika McDole-Russell Senior Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Ave., Suite 320 Somerset, New Jersey 08873
Re: K150232
Trade/Device Name: Radifocus® Optitorque™ Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: September 17, 2015 Received: September 18, 2015
Dear Monika 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 of medical device
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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.
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.
M. A. Hillebrenner
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150232
Device Name
Radifocus Optitorque Angiographic Catheter
Indications for Use (Describe)
The Radifocus Optitorque Angiographic Catheter is indicated for use in carcular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial 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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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:
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K150232 – 510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
Table of Contents
| A. SUBMITTER INFORMATION (807.92(A)(1)). | 2 |
|---|---|
| B. DEVICE NAME (807.92(A)(2)). | 3 |
| C. PREDICATE DEVICE (807.92(A)(3)). | 3 |
| D. REASON FOR 510(K) SUBMISSION. | 3 |
| E. DEVICE DESCRIPTION (807.92(A)(4)). | 4 |
| F. INTENDED USE (807.92(A)(5)). | 4 |
| G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(A)(6)). | 5 |
| H. NON CLINICAL TESTS (807.92(B)(1)) | 7 |
| I. CLINICAL TESTS (807.92(B)(2)) | 11 |
| J. CONCLUSION (807.92(B)(3)). | 11 |
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510(k) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
| Prepared by: | Monika McDole-Russell, MSRA, RAC |
|---|---|
| Senior Regulatory Affairs Specialist | |
| Terumo Medical Corporation | |
| 265 Davidson Avenue | |
| Suite 320 | |
| Somerset, NJ 08873 | |
| Tel. (732) 302-4900 ext. 4273 | |
| Fax (410) 398-6079 |
Prepared for: Owner/Operator
Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-Ku, Tokyo Japan 151-0072 Registration Number: 801 002 6
Manufacturer and Sterilization Facility
Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya Shizuoka 418-0015 Japan Registration No: 968 183 4
- Contact Person: Monika McDole-Russell, MSRA, RAC Senior Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue Suite 320 Somerset, NJ 08873 Tel. (732) 302-4900 ext. 4273 Fax (410) 398-6079
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E-mail: monika.mcdolerussell(@terumomedical.com
Date prepared: October 19, 2015
B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | Radifocus Optitorque Angiographic Catheter |
|---|---|
| Common Name: | Angiographic, Catheter |
| Classification Name: | Diagnostic Intravascular Catheter |
| Classification Panel: | Cardiovascular |
| Regulation: | 21 CFR 870.1200 |
| Product Code: | DQO |
| Classification: | Class II |
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device(s) to which substantial equivalence is claimed is K082736 Radifocus Optitorque Angiographic Catheter, manufactured by Ashitaka Factory of Terumo Corporation in Japan.
D. REASON FOR 510(K) SUBMISSION
This premarket notification is being submitted due to a raw material change in the catheter shaft (outer layer) of the device. The current polyamide elastomer material is no longer available from the vendor and has been replaced with an equivalent polyamide elastomer. Biocompatibility testing has been completed to demonstrate that the raw material change has not affected the safety and performance of the device. The IFU is also being revised to update the flow rate table and add a contraindication; the addition of the contraindication is to bring the IFU into alignment with wording recommended in FDA draft guidance Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (issued April 23, 2013). Additionally, a clarification is being made to the wording of the Indications for Use; however, no changes are being made to the actual indications previously cleared under K082736.
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E. DEVICE DESCRIPTION (807.92(a)(4))
The Radifocus Optitorque Angiographic Catheter is comprised of a two-layer construction featuring stainless steel mesh sandwiched between layers of polyurethane and polyamide elastomers. The shaft inner layer and outer layer contain barium sulfate for visibility and contrast under fluoroscopy. A soft tip is attached to the distal portion of some 4 Fr and all 5 Fr and 6 Fr catheters except those with a pigtail design; a soft tube is attached to the distal portion of 5 Fr and 6 Fr catheters with a pigtail design; the 4 Fr products are available with or without a soft tip. Constructed of flexible, supple polyurethane that is permanently welded to the catheter shaft, the soft tip and soft tube are designed to minimize trauma to the vessel wall. There is no change to the design of the device as a result of this submission.
The device is offered in lengths of 65-120 cm. French sizes and shaft inner diameters are as follows:
| French Size | Shaft Inner Diameter |
|---|---|
| 4 | 1.05mm |
| 5 | 1.22mm |
| 6 | 1.32mm |
It is a disposable device intended for single use only. This device is individually packaged and sterilized by ethylene oxide gas.
F. INTENDED USE (807.92(a)(5))
The Radifocus Optitorque Angiographic Catheter is intended for use in cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery.
Note: This intended use is identical to the predicate device, Radifocus Optitorque Angiographic Catheter (K082736).
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G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
The Radifocus Optitorque Angiographic Catheter with the new material, the subject of this Traditional 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the currently marketed Radifocus Optitorque Angiographic Catheter, manufactured by Ashitaka Factory of Terumo Corporation and cleared under K082736.
A comparison of the intended use/indications for use and technological characteristics are summarized in the table below. The raw material change and addition of a contraindication to the IFU do not negatively impact the safety and effectiveness of the device.
Note: A statement of substantial equivalence to another product is required by 21CFR807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is, therefore, not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, "…a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seq. (1977)
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| DeviceCharacteristic | Predicate Device: Radifocus OptitorqueAngiographic Catheter (K082736) | Subject Device: Radifocus OptitorqueAngiographic Catheter | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Manufacturer | Ashitaka Factory of Terumo Corporation | Same | ||||||||||||||||
| Intended Use/Indications for Use | Indicationsfor Use | The Radifocus Optitorque AngiographicCatheter is intended for cardiac andvascular procedures. It is designed todeliver radiopaque media, guide wires,catheters, and therapeutic agents toselected sites in the vascular system. Thedifferent shapes are designed toselectively engage arteries from accesssites such as the femoral, radial, andbrachial artery. | The Radifocus Optitorque AngiographicCatheter is indicated for use in cardiacand vascular procedures. It is designed todeliver radiopaque media, guide wires,catheters, and therapeutic agents toselected sites in the vascular system. Thedifferent shapes are designed toselectively engage arteries from accesssites such as the femoral, radial, andbrachial artery. | |||||||||||||||
| Contraindic-ations | ContraindicationsclearedunderK082736 | ContraindicationsclearedunderK082736, plus the following statement:"Patients with a contraindication to anti-platelet and/or anti-coagulation therapy" | ||||||||||||||||
| WarningsandPrecautions | Warnings and precautions cleared underK082736 | Warnings and precautions cleared underK082736, plus the maximum flow rate ofsaline was added in accordance with 6.3.(i) of ISO 10555-1:2013. | ||||||||||||||||
| OperationPrinciple | Manual | Same | ||||||||||||||||
| Design /Construction | Catheter assembly (shaft, hub, softtip/soft tube, strain relief/inserter, hubsupport tube (4 Fr only))Fr Distal Part Proximal Part 4 Soft tip Strain Relief Inserter 5, 6 Soft tip Strain Relief Soft tube Inserter | Same | ||||||||||||||||
| Materials | Shaft●o Inner Layer - Polyamideelastomer, Polyurethaneelastomero Braid - Stainless steelo Outer Layer - Polyamideelastomer, Polyurethaneelastomer | Shaft●o Inner Layer - Sameo Braid - Sameo Outer Layer - Polyamideelastomer, Polyurethaneelastomer |
Table 5.1: Device Comparison Table
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| DeviceCharacteristic | Predicate Device: Radifocus OptitorqueAngiographic Catheter (K082736) | Subject Device: Radifocus OptitorqueAngiographic Catheter | |
|---|---|---|---|
| Package | Soft tip – Polyurethane elastomer●Soft tube (5 and 6 Fr only) -●Polyurethane elastomerStrain relief – Polyamide elastomer●Hub – Polyamide●Hub support tube (4 Fr only) -●Polyurethane elastomerInserter – Polyethylene●Adhesive - Cyanoacrylate· Paperboard mount• individual package• Unit box· Shipping carton• Pouch | Soft tip - Same●Soft tube (5 and 6 Fr only) – Same●Strain relief - Same●Hub - Same●Hub support tube (4 Fr only) – Same●Inserter - Same●Adhesive - Same●Same | |
| pecifications | Sizes/ShaftInnerDiameter | 4 Fr / 1.05mm5 Fr / 1.22mm6 Fr / 1.32mm | Same |
| Lengths | 65-120 cm | Same | |
| MaximumLabeledInjectionPressure | 4 Fr: 750 psi5 Fr and 6 Fr: 1000 psi | Same | |
| Sterilization | Ethylene oxide | Same |
H. NON CLINICAL TESTS (807.92(b)(1))
Performance
Performance testing was conducted to ensure the safety and effectiveness of the Radifocus Optitorque Angiographic Catheter with the new raw material throughout the device's shelf life, verify conformity to the applicable parts of ISO standards, and demonstrate substantial equivalence to the predicate device.
No new issues of safety and effectiveness were raised with the testing performed.
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The following tests were performed on non-aged and accelerated aged (3 yr.) samples according to currently accepted ISO standards:
| Test | Standard |
|---|---|
| Radio-detectability | ISO 10555-1:2013 Section 4.2ASTM F640-12 |
| Surface | ISO 10555-1:2013 Section 4.4 |
| Peak tensile force | ISO 10555-1:2013 Section 4.6 |
| Freedom from leakage | ISO 10555-1:2013 Section 4.7 |
| Power injection | ISO 10555-1:2013 Section 4.10Annex F and Annex G |
| Distal tip | ISO 10555-1:2013 Section 4.12 |
| Flow rateBurst pressure | ISO 10555-1:2013 Section 6.3 |
Table 5.2: Performance Testing per ISO Standards
All samples tested met the standard applicable to each test.
Additionally, performance testing other than to the above ISO Standards was performed on the device in accordance with Terumo's internal standards. The device complies with the acceptance criteria established for each test based on the predicate:
Table 5.3: Performance Testing per Internal Standards
| Performance Test | Results |
|---|---|
| Shaft stiffness (Stiffness of braided-area) | Meets acceptance criteria |
| Torque transmission | Meets acceptance criteria |
| Torque strength | Meets acceptance criteria |
| Tensile strength (Shaft) | Meets acceptance criteria |
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| Performance Test | Results |
|---|---|
| Bending strength | Meets acceptance criteria |
| Cleanliness | Meets acceptance criteria |
| Strength of hub junction | Meets acceptance criteria |
| Tensile Strength of soft tip | Meets acceptance criteria |
| Product dimensions(I.D.; O.D.; Tip I.D.; Tip O.D.; Length) | Meets acceptance criteria |
| Embolic cube testing | Meets acceptance criteria |
Performance testing demonstrates that the Radifocus Optitorque Angiographic Catheter with the new raw material conforms to the recognized consensus ISO standards, is substantially equivalent to the predicate device, and is acceptable for clinical use throughout its shelf life.
Biocompatibility
The Radifocus Optitorque Angiographic Catheter with the new raw material is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (<24 hours). This is the same classification as the predicate Radifocus Optitorque Angiographic Catheter (K082736).
The finished device's blood/body 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, "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." Tests were also performed on accelerated aged devices to ensure that biocompatibility is maintained throughout the shelf life of the product: results of the testing demonstrate that the device remains biocompatible throughout its shelf life.
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Table 5.4: Biocompatibility Testing
| Testing performed on non-aged, sterile, whole devices |
|---|
| Cytotoxicity |
| Sensitization |
| Intracutaneous Reactivity |
| Systemic Toxicity (acute) |
| Pyrogenicity |
| Hemolysis |
| Thrombogenicity |
| Complement Activation (Immunology) |
| Chemical Extraction |
| Testing performed on accelerated-aged (3 years),sterile, whole devices |
| Cytotoxicity |
| Hemolysis |
| Chemical Extraction |
Pyrogen Testing
The Radifocus Optitorque Angiographic Catheter with the new raw material is certified to be non-pyrogenic in the unopened and undamaged package. Pyrogen testing was performed in accordance with applicable ISO standards 10993-11 (2006) and ISO 10993-12 (2012) as well as United States Pharmacopeia 35, National Formulary 30, 2012 <151 > Pyrogen Test (USP Rabbit Test).
Sterilization
The sterilization conditions have been validated according to ISO 11135: 2014, Sterilization of Health Care Products - Ethylene Oxide - Requirements for development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of 10th. No changes have been made to the sterilization process for this device as a result of this submission.
Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) will meet requirements for limited exposure devices (contact up to 24 hours) prior to use based on ISO 10993-7, Biological Evaluation of medical devices- Part 7: Ethylene Oxide Sterilization residuals. Residual EO will not exceed 4 mg per device and residual ECH will not exceed 9 mg per device.
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Risk Analysis
A Product Risk Analysis was conducted in accordance with ISO 14971, taking into account the modifications to the previous device, and it was determined that any new risks were adequately captured and mitigated.
I. CLINICAL TESTS (807.92(b)(2))
This 510(k) does not include data from clinical tests.
J. CONCLUSION (807.92(b)(3))
The Radifocus Optitorque Angiographic catheter with the new materials is substantially equivalent in intended use, principles of operation, design features, materials, performance and fundamental scientific technology when compared to the predicate Radifocus Optitorque (K082736). Verification testing was conducted and demonstrated that the modified device meets the design inputs and meets the same or equivalent requirements as the predicate Radifocus Optitorque for both ISO 10555-1 and internal standards. The differences between the predicate and proposed devices do not raise any new issues regarding safety and effectiveness. Therefore, the Radifocus Optitorque Angiographic catheter with the new materials is considered substantially equivalent to the predicate device.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).