(92 days)
The product (FineCross M3) is intended to be percutaneously into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. The product should not be used in cerebral and peripheral vessels.
FineCross M3 is a single use, ethylene oxide sterilized device that is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. FineCross M3 features a three-layer construction, which consists of a stainless steel mesh braid sandwiched between an outer layer of polyester elastomer and an inner layer of polytetrafluoroethylene. The outer surface of the catheter is coated with hydrophilic polymer.
Here's an analysis of the provided text regarding the acceptance criteria and study for the FineCross M3 device, structured to answer your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a list of performance tests conducted on the FineCross M3 device. For each test, it states that "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." However, it does not provide specific numerical or qualitative values for the acceptance criteria, nor does it detail the specific reported device performance values for each test. Instead, it offers a general statement of compliance.
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Radio-detectability | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Surface | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Peak tensile force | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Freedom from leakage | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Flowrate | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Distal tip | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Fluid leakage | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Sub-atmospheric pressure air leakage | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Stress cracking | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Resistance to separation from axial load | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Resistance to separation from unscrewing | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Resistance to overriding | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Torque strength | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Kink strength of catheter shaft | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Compatibility with guide wire | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Product dimension | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Exterior sliding characteristics (early phase) | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Particulate evaluation | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Coating Integrity | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Butting resistance | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Strength of distal part | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
| Simulated use Usability test | Predetermined acceptance criteria (not specified) | Met acceptance criteria |
Biocompatibility Testing:
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cytotoxicity | Compliance with ISO 10993-1 and FDA Guidance | Demonstrate device is biocompatible |
| Sensitization | Compliance with ISO 10993-1 and FDA Guidance | Demonstrate device is biocompatible |
| Intracutaneous Reactivity | Compliance with ISO 10993-1 and FDA Guidance | Demonstrate device is biocompatible |
| Acute Systemic Toxicity | Compliance with ISO 10993-1 and FDA Guidance | Demonstrate device is biocompatible |
| Pyrogenicity | Compliance with ISO 10993-1 and FDA Guidance | Demonstrate device is biocompatible |
| Hemolysis | Compliance with ISO 10993-1 and FDA Guidance | Demonstrate device is biocompatible |
| Thrombogenicity (with and without anticoagulant agent) | Compliance with ISO 10993-1 and FDA Guidance | Demonstrate device is biocompatible |
| Complement Activation (C3a and SC5b-9) | Compliance with ISO 10993-1 and FDA Guidance | Demonstrate device is biocompatible |
| Physicochemical Profile (Physicochemical and FT-IR) | Compliance with ISO 10993-1 and FDA Guidance | Demonstrate device is biocompatible |
| Accelerated-aged (2 years) Cytotoxicity | Compliance with ISO 10993-1 and FDA Guidance (to show biocompatibility maintained throughout shelf life) | Demonstrate device is biocompatible throughout shelf life |
| Accelerated-aged (2 years) Hemolysis | Compliance with ISO 10993-1 and FDA Guidance (to show biocompatibility maintained throughout shelf life) | Demonstrate device is biocompatible throughout shelf life |
| Accelerated-aged (2 years) Physicochemical Profile | Compliance with ISO 10993-1 and FDA Guidance (to show biocompatibility maintained throughout shelf life) | Demonstrate device is biocompatible throughout shelf life |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each of the performance or biocompatibility tests. It only states that tests were performed on "non-aged and accelerated aged samples" for performance testing (except Radio-detectability and Simulated Use Usability) and on "non-aged, sterile, whole device" and "accelerated-aged (2 years), sterile, whole device" for biocompatibility.
The data provenance is industrial (manufacturer-conducted testing) and likely combines both novel testing for this specific device and potentially established testing protocols based on industry standards. It is not patient or clinical data, so terms like "retrospective" or "prospective" are not applicable in this context. The country of origin for the manufacturing and testing is Japan (Ashitaka Factory of Terumo Corporation).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes non-clinical performance and biocompatibility testing of a medical device (a microcatheter). It does not involve diagnostic interpretation or patient data where "ground truth" would typically be established by human experts like radiologists. Therefore, this information is not applicable to the provided document. The ground truth for these tests is based on objective, measurable physical and chemical properties and engineering standards.
4. Adjudication Method for the Test Set
As this document describes non-clinical performance and biocompatibility testing, an "adjudication method" in the context of expert consensus (like 2+1 or 3+1 for clinical interpretations) is not applicable. The results of these tests are determined by adherence to pre-defined scientific and engineering protocols and acceptance criteria.
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
There was no MRMC comparative effectiveness study and no AI component mentioned in this 510(k) submission. This K-submission is for a medical device (microcatheter), not an AI/software-as-a-medical-device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical medical instrument (microcatheter), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert concensus, pathology, outcomes data, etc)
For the performance tests, the "ground truth" is defined by engineering specifications, material science principles, and established industry standards. For example, the freedom from leakage is tested against a standard preventing fluid escape, and material biocompatibility is tested against ISO 10993 standards and FDA guidance. This is not a "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
There is no training set in this context. This is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set mentioned in the document.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The logos are displayed side-by-side.
March 3, 2021
Terumo Medical Corporation Vaibhav Sivaramakrishan Regulatory Affairs Specialist II 265 Davidson Ave., Suite 320 Somerset, New Jersey 08873
Re: K203521
Trade/Device Name: FineCross M3 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 30, 2020 Received: December 1, 2020
Dear Vaibhav Sivaramakrishan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203521
Device Name FineCross M3
Indications for Use (Describe)
The product (FineCross M3) is intended to be percutaneously into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. The product should not be used in cerebral and peripheral vessels.
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) |
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Image /page/3/Picture/2 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green. The swoosh is curved and points to the right, and the word "TERUMO" is in a bold, sans-serif font.
510(K) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
Prepared by: Vaibhav Sivaramakrishan Regulatory Affairs Specialist II Terumo Medical Corporation Tel. (609) 613-3958 Fax (410) 398-6079
| Prepared for: | Owner/Operator |
|---|---|
| Terumo Corporation | |
| 44-1, 2-Chome, Hatagaya | |
| Shibuya-Ku, Tokyo | |
| Japan 151-0072 | |
| Owner/Operator Number: 8010026 |
Manufacturer and Sterilization Facility (Applicant) Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya, Shizuoka 418-0015, Japan Registration Number: 9681834
- Contact Person: Vaibhav Sivaramakrishan Regulatory Affairs Specialist II Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873 Tel. (609) 613-3958 Fax (410) 398-6079 E-mail: vai.sivaramakrishan@terumomedical.com
Date prepared: November 30, 2020
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B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | FineCross M3 |
|---|---|
| Common Name: | Microcatheter |
| Classification Name: | Catheter, Percutaneous |
| Classification Panel: | Cardiovascular |
| Regulation: | 21 CFR 870.1250 |
| Product Code: | DQY |
| Classification: | Class II |
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device to which substantial equivalence is claimed is:
Predicate Device: K082519 - FINECROSS MG Coronary Micro-Guide catheter, manufactured by Ashitaka Factory of Terumo Corporation.
Reference Devices:
-
- K152447: ASAHI Caravel, Asahi Intecc co., ltd.
-
- K191560: Turnpike LP Catheter, Vascular Solution LLC.
D. REASON FOR 510(k) SUBMISSION
This traditional 510(k) for FineCross M3 is being submitted for the new device for the purposes of establishing substantial equivalence to a legally marketed predicate device.
E. DEVICE DESCRIPTION (807.92(a)(4))
Principle of Operation Technology
FineCross M3 submitted in this 510(k) and its predicate (K082519) are operated by a manual process.
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Image /page/5/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red arc above the word "TERUMO" in green, block letters. The arc is positioned above and to the left of the word, creating a sense of motion.
Design/Construction
FineCross M3 is a single use, ethylene oxide sterilized device that is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography.
FineCross M3 features a three-layer construction, which consists of a stainless steel mesh braid sandwiched between an outer layer of polyester elastomer and an inner layer of polytetrafluoroethylene. The outer surface of the catheter is coated with hydrophilic polymer.
Materials
The materials for FineCross M3 are provided in Table 5.1.
| No. | Raw material | Patient Contact |
|---|---|---|
| 1* | Polyester elastomerColorant | Direct |
| 2 | Stainless steel | Non-contact |
| 3* | Polytetrafluoroethylene | Direct |
| 4 | Au (Gold) | Non-contact |
| 5* | Dimethyl acrylamide-glycidylmethacrylate copolymer | Direct |
| 6 | Acrylic resin | Non-contact |
| 7* | Polyamide | Indirect |
| 8 | Polyester elastomerColorant | Non-contact |
Table 5.1: List of Materials
- Blood contacting material (External communicating Device, Circulating Blood, Limited Contact (<24 hours)
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Specifications
The specifications for FineCross M3 are provided in Table 5.2.
| Part | Specifications |
|---|---|
| Catheter Size: | Distal 1.8 Fr. / Proximal 2.5Fr. |
| Catheter OD: | Distal OD 0.61mmProximal OD 0.84mm |
| Catheter Effective Lengths*: | 1300mm, 1500mm |
| Hydrophilic Coating Length: | 750mm, 950mm |
| Maximum guidewire outer diameter: | 0.014" |
| Table 5.2: FineCross M3 Specifications | ||
|---|---|---|
| ---------------------------------------- | -- | -- |
*The length from the proximal anti-kink protector to distal end of catheter shaft.
F. INDICATIONS FOR USE (807.92(a)(5))
The product (FineCross M3) is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. The product should not be used in cerebral and peripheral vessels.
The indications for use are equivalent to the predicate (K082519).
G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
FineCross M3, the subject of this Traditional 510(k), is substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the predicate, K082519 - FINECROSS MG Coronary Micro-Guide catheter, manufactured by Ashitaka Factory of Terumo Corporation.
In addition to the above-listed primary predicate, Terumo has identified the following reference devices. These are market leading devices with the same intended use and basic design as the subject device. Since these devices are frequently used in clinical practice, Terumo felt it was appropriate to use them as references when setting the acceptance criteria for FineCross M3 performance testing.
-
- Asahi Intecc co., Itd. ASAHI Caravel (K152447)
-
- Vascular Solution LLC., Turnpike LP Catheter (K191560)
The comparison of the technological characteristics is summarized in Table 5.3.
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| Table 5.3: Summary of Comparative Information | ||||
|---|---|---|---|---|
| DeviceCharacteristic | Subject Device:FineCross M3 | Predicate Device:FINECROSS MG CoronaryMicro-Guide catheter(K082519) | Reference Device #1:ASAHI Caravel(K152447) | Reference Device #2:Turnpike LP Catheter(K191560) |
| Manufacturer | Ashitaka Factory of TerumoCorporation | Same | Asahi Intecc co., ltd. | Vascular Solution LLC. |
| Intended Use/Indications forUse | The product (FineCross M3) isintended to be percutaneouslyintroduced into blood vesselsand support a guide wire whileperforming PCI (percutaneouscoronary intervention). Theproduct is also intended forinjection of radiopaquecontrast media forangiography. The productshould not be used in cerebraland peripheral vessels. | The product (Finecross™ MG)is intended to bepercutaneously introduced intoblood vessels and support aguide wire while performingPCI (percutaneous coronaryintervention. The product isalso intended for injection ofradiopaque contrast media forangiography. | This microcatheter isintended to provide supportto facilitate the placementof guide wires in thecoronary and peripheralvasculatures, and can beused to exchange one guidewire for another.This microcatheter is alsointended to assist in thedelivery of contrast mediainto the coronary andperipheral vasculatures.Do not use thismicrocatheter other thanfor use in the coronary andperipheral vasculatures. | The Turnpike catheters areintended to be used to accessdiscrete regions of thecoronary and/or peripheralvasculature.They may be used to facilitateplacement and exchange ofguidewires and tosubselectively infuse/deliverdiagnostic and therapeuticagents. |
| OperationPrinciple | Manual | Same | Same | Same |
| DeviceCharacteristic | Subject Device:FineCross M3 | Predicate Device:FINECROSS MG CoronaryMicro-Guide catheter(K082519) | Reference Device #1:ASAHI Caravel(K152447) | Reference Device #2:Turnpike LP Catheter(K191560) |
| Design/Construction | Three layer constructioncatheter shaft with hydrophiliccoating, distal tip and hub | Same | Multi layers constructioncatheter shaft withhydrophilic coating, distaltip and hub | Multi layers constructioncatheter shaft with hydrophiliccoating, distal tip and hub |
| Materials | - Polyester elastomer w/pigment*- Stainless steel- Polytetrafluoroethylene*- Au (Gold)- Dimethyl acrylamide-glycidyl methacrylatecopolymer*- Polyamide*- Polyester elastomer w/pigment- Acrylic resin* blood contacting material | - Polyester elastomer w/pigment*- Stainless steel- Polytetrafluoroethylene*- Au (Gold)- Dimethyl acrylamide-glycidyl methacrylatecopolymer*- Polyamide*- Polyester elastomer w/pigment- Acrylic resin*blood contacting material | Information not publiclyavailable. | Information not publiclyavailable. |
| Package | • Individual package on whichthe product label and the | Same | Same | Same |
| DeviceCharacteristic | Subject Device:FineCross M3 | Predicate Device:FINECROSS MG CoronaryMicro-Guide catheter(K082519) | Reference Device #1:ASAHI Caravel(K152447) | Reference Device #2:Turnpike LP Catheter(K191560) |
| peel-off labels are attached• 1 unit per package | ||||
| Specifications | • Effective lengths:1300mm, 1500mm• Catheter size:Distal 1.8 Fr. / Proximal2.5Fr.• Catheter OD:Distal:0.61mmProximal:0.84mm• Maximum guidewire outerdiameter: 0.014" | • Effective lengths:1300mm,1500mm• Catheter size:Distal 1.8 Fr. / Proximal2.6Fr.• Catheter OD:Distal:0.60mmProximal:0.87mm• Maximum guidewireouter diameter: 0.014" | • Effective lengths:1350mm,1500mm• Catheter size:Distal 1.9 Fr. /Proximal 2.6Fr.• Catheter OD:Distal:0.62mmProximal:0.85mm• Maximum guidewireouter diameter:Unknown | • Effective lengths:1350mm,1500mm• Catheter size:Distal 2.2 Fr. / Proximal2.9Fr.• Catheter OD:Distal:0.74mmProximal:0.97mm• Maximum guidewireouter diameter: 0.014" |
| Sterilization | Ethylene oxide | Same | Same | Same |
| Shelf life | 24 months | Same | unknown | unknown |
of Ca ative Info Tahle 5 3. Cr noti
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Image /page/9/Picture/1 description: The image shows the Terumo logo. The logo consists of the word "TERUMO" in green, with a red arc above the "T". The font is bold and sans-serif. The logo is simple and modern.
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Image /page/10/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red arc above the company name, which is written in green, sans-serif font. The arc is positioned above and slightly to the left of the word "TERUMO."
H. NON CLINICAL TESTS (807.92(b)(1))
Performance Testing
Performance testing was conducted to ensure the substantial equivalence of FineCross M3 throughout the shelf life and to verify conformity to the applicable external and internal standards. With the exception of the Radio-detectability and Simulated Use Usability tests, the following performance tests were performed on non-aged and accelerated aged samples. Table 5.4 provides a list of performance tests that were performed on FineCross M3.
| Test Item |
|---|
| Radio-detectability |
| Surface |
| Peak tensile force |
| Freedom from leakage |
| Flowrate |
| Distal tip |
| Fluid leakage |
| Sub-atmospheric pressure air leakage |
| Stress cracking |
| Resistance to separation from axial load |
| Resistance to separation from unscrewing |
| Resistance to overriding |
| Torque strength |
| Kink strength of catheter shaft |
| Compatibility with guide wire |
| Product dimension |
| Exterior sliding characteristics (early phase) |
| Particulate evaluation |
| Coating Integrity |
| Butting resistance |
| Strength of distal part |
| Simulated use Usability test |
Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life.
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Biocompatibility
In accordance with ISO 10993-1, FineCross M3 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 Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Screening tests were performed on accelerated aged devices to show that the biocompatibility is maintained throughout the shelf life of the product. The table below provides a list of biocompatibility tests conducted on FineCross M3.
| Non-aged, sterile, whole device |
|---|
| Cytotoxicity |
| Sensitization |
| Intracutaneous Reactivity |
| Acute Systemic Toxicity |
| Pyrogenicity |
| Hemolysis |
| Thrombogenicity (with and without anticoagulant agent) |
| Complement Activation (C3a and SC5b-9) |
| Physicochemical Profile (Physicochemical and FT-IR) |
| Accelerated-aged (2 years), sterile, whole device |
| Cytotoxicity |
| Hemolysis |
| Physicochemical Profile (Physicochemical and FT-IR) |
Table 5.5: Summary of ISO 10993 Biocompatibility Testing
Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product.
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Sterilization
The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2018, 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, FineCross M3, subject of this 510(k), is substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the predicate, K082519 - FINECROSS MG Coronary Micro-Guide catheter, manufactured by Ashitaka Factory of Terumo 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).