(246 days)
No
The description explicitly states the device is operated through a manual process and there is no mention of AI, ML, or related concepts.
No
The device is a guidewire used to facilitate the placement of catheters, which is a diagnostic or interventional tool, not a therapeutic agent itself.
Yes
The "Intended Use / Indications for Use" states that the device is "designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures." This explicitly mentions diagnostic procedures.
No
The device description explicitly states it is a "Glidewire," which is a physical medical device used to direct catheters. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures." This describes a device used within the body for guiding other instruments, not for testing samples outside the body.
- Device Description: The description focuses on the physical characteristics and operation of a guidewire, which is a medical device used in procedures, not for in vitro testing.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely procedural and within the body.
N/A
Intended Use / Indications for Use
The R2P Radifocus Glidewire Advantage is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.
Product codes
DQX
Device Description
The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), are both operated through a manual process.
The R2P Radifocus Glidewire Advantage (0.018") consists of a Nickel Titanium alloy and stainless steel core wire. A polyurethane and hydrophilic coating is applied to the distal portion of the wire.
• Core wire (proximal portion)
• Core wire (intermediate portion)
• Core wire (distal portion)
• First coating (distal portion)
• Second coating (distal portion)
Under coat
• PTFE spiral coating (intermediate portion)
Under coating
Spiral coating
• Edge protection part
Metal part
Solder
• Tip coil marker
• Tip coil marker adhesive
• Silicone coating (proximal portion)
The R2P Radifocus Glidewire Advantage (0.035") consists of a Nickel Titanium alloy core wire. A polyurethane and hydrophilic coating is applied to the distal portion of the wire.
• Core wire (proximal portion)
• Core wire (intermediate portion)
• Core wire (distal portion)
• First coating (distal portion)
• Second coating (distal portion)
Under coat
• PTFE spiral coating (intermediate portion)
Under coating
Top coating
Spiral coating:
• Edge protection part
Metal part
Solder
• Silicone coating (proximal portion)
Specifications:
Diameter of Wire: 0.018", 0.035"
Length of Wire: 400, 450 and 500cm (for 0.018"); 350, 400, and 450cm (for 0.035")
Distal Tip Shape: Angled, J Shaped (Available only in 400 and 450cm lengths for 0.035")
Accessory Device: Guide wire inserter, Guide wire clip
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to ensure the safety and effectiveness of R2P Radifocus Glidewire Advantage throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device.
Test Items: Dimensional Verification, Visual Inspection, Simulated Use, Tensile Strength and Tip Pull, Torque Strength, Torqueability, Coating integrity, Particulate evaluation, Lubricity, Corrosion resistance, Kink Resistance, Tip flexibility, Radiopacity.
Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K063372, K163004, K033742, K172073, K150445
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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Terumo Medical Corporation Qing Liu Regulatory Affairs Specialist 265 Davidson Avenue, Suite 320 Somerset, New Jersey 08873
Re: K240818
Trade/Device Name: R2P Radifocus Glidewire Advantage Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: March 25, 2024 Received: November 1, 2024
Dear Qing Liu:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Samuel G. Raben -S
for 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
3
Indications for Use
Submission Number (if known)
Device Name
R2P Radifocus Glidewire Advantage
Indications for Use (Describe)
The R2P Radifocus Glidewire Advantage is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.
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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4
510(K) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
| Prepared by: | Qing Liu |
|---|---|
| Regulatory Affairs Specialist | |
| Terumo Medical Corporation | |
| Tel. (908) 842-9016 | |
| 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: Qing Liu
Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873 Tel. (908) 842-9016 Fax (410) 398-6079 E-mail: kyo.ryu@terumomedical.com
March 25, 2024 Date prepared:
5
B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | R2P Radifocus Glidewire Advantage |
|---|---|
| Common Name: | Guide Wire |
| Classification Name: | Catheter Guide Wire |
| Classification Panel: | Cardiovascular |
| Regulation: | 21 CFR 870.1330 |
| Product Code: | DQX |
| Classification: | Class II |
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device to which substantial equivalence is claimed is:
Predicate Device: K152740 - Radifocus Glidewire, manufactured by Ashitaka Factory of Terumo Corporation.
Reference Devices:
-
K063372 Radifocus Glidewire Advantage, Ashitaka Factory of Terumo Corporation
-
K163004 Radifocus Glidewire Advantage Track, Ashitaka Factory of Terumo Corporation
-
K033742 BOSTON SCIENTIFIC V-18 CONTROL WIRE, BOSTON SCIENTIFIC CORP
-
K172073 Hi-Torque Command 18 Guide Wire, Abbott Vascular
-
K150445 ASAHI Peripheral Guide Wires (ASAHI Gladius, ASAHI Halberd, and ASAHI Gaia PV), ASAHI Intecc Co., Ltd.
D. REASON FOR 510(k) SUBMISSION
This traditional 510(k) for R2P Radifocus Glidewire Advantage is being submitted for a new device for the purposes of establishing substantial equivalence to a legally marketed predicate device.
6
E. DEVICE DESCRIPTION (807.92(a)(4))
Principle of Operation Technology
The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), are both operated through a manual process.
Design/Construction
The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), exhibit some differences in design and construction.
Terumo has confirmed that these differences don't introduce any new concerns in safety and performance compared to the predicate device.
Table 1 provides details on the materials used in the construction and Table 2 provides specifications of R2P Radifocus Glidewire Advantage.
| Raw material | Patient contact | |
|---|---|---|
| 0.018" | 0.035" | |
| Stainless steel | Nickel-Titanium alloy | Direct |
| Nickel-Titanium alloy | Direct | |
| Polyurethane containing tungsten | Direct | |
| Hydrophilic polymer | Direct | |
| Polytetrafluoroethylene (PTFE) | Non-contact | |
| Polytetrafluoroethylene (PTFE)/ Colorant | Direct | |
| Platinum/ Iridium (Pt/Ir) | Direct | |
| Tin/Silver (Sn/Ag) | Direct | |
| Gold (Au) | None | Non-contact |
| Modified acrylate | None | Non-contact |
| Silicone oil | Indirect | |
| Polyethylene | Indirect | |
| Polypropylene | Non-contact | |
| Polypropylene/ Colorant | Indirect | |
| Styrene-ethylenebutylene-styrene block copolymer | Indirect |
7
| Table 2: Specifications | |
|---|---|
| Part | Specification |
| Diameter of Wire | 0.018" |
| 0.035" | |
| Length of Wire | 400, 450 and 500cm |
| 350, 400, and 450cm | |
| Distal Tip Shape | Angled |
| Angled | |
| J Shaped (Available only in 400 and 450cm lengths) | |
| Accessory Device | Guide wire inserter, Guide wire clip |
Specifications
F. INDICATIONS FOR USE (807.92(a)(5))
The R2P Radifocus Glidewire Advantage is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.
G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
R2P Radifocus Glidewire Advantage, the subject device of this Traditional 510(k), is substantially equivalent in its Intended Use/Indication for Use and Technological Characteristics to the predicate device, Radifocus Glidewire (K152740).
In addition to the above-listed primary predicate, Terumo has identified the following reference devices. These are market leading devices with the similar intended use and basic design as the subject device.
-
K063372 Radifocus Glidewire Advantage, Ashitaka Factory of Terumo Corporation
-
K163004 Radifocus Glidewire Advantage Track, Ashitaka Factory of Terumo Corporation
The comparison of the technological characteristics is summarized in Table 3.A and 3.B.
8
| Comparison of
Device
Characteristics | Subject device:
R2P Radifocus Glidewire Advantage | Predicate Device: Radifocus
Glidewire(K152740) | Reference Device 1: Radifocus
Glidewire Advantage (K063372) | Comparison of
Device
Characteristics | Subject device:
R2P Radifocus Glidewire Advantage | Predicate Device: Radifocus
Glidewire(K152740) | Reference Device 2: Radifocus
Glidewire Advantage Track
(K163004) |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Ashitaka Factory of Terumo Corp. | Same | Same | Manufacturer | Ashitaka Factory of Terumo Corp. | Same | Same |
| Intended
Use/Indication
for Use | The R2P Radifocus Glidewire
Advantage is designed to direct a
catheter to the desired anatomical
location in the peripheral vasculature
during diagnostic or interventional
procedures. This device is not intended
for neurovascular or coronary
interventions. | Same | The GLIDEWIRE
ADVANTAGE is designed to
direct a catheter to the desired
anatomical location in the
peripheral vasculature during
diagnostic or interventional
procedures. | Intended
Use/Indication for
Use | The R2P Radifocus Glidewire
Advantage is designed to direct a
catheter to the desired anatomical
location in the peripheral vasculature
during diagnostic or interventional
procedures. This device is not intended
for neurovascular or coronary
interventions. | Same | Same |
| Operation
Principle | Manual | Same | Same | Operation
Principle | Manual | Same | Same |
| Design/
Construction | The R2P Radifocus Glidewire
Advantage (0.035") consists of a
Nickel Titanium alloy core wire. A
polyurethane and hydrophilic coating is
applied to the distal portion of the wire.
• Core wire (proximal portion)
• Core wire (intermediate portion)
• Core wire (distal portion)
• First coating (distal portion)
• Second coating (distal portion)
Under coat
• PTFE spiral coating (intermediate
portion)
Under coating
Top coating
Spiral coating:
• Edge protection part
Metal part
Solder
• Silicone coating (proximal portion) | Fully hydrophilic guide Wire
• Core wire
• First Coating
• Second Coating
Under coat | Same
• Core wire (proximal and distal
portion)
• First coating (distal portion)
• Second coating (distal portion)
Under coat
• PTFE spiral coating proximal
portion)
Under coating
Top coating
Spiral coating
• Edge protection part
Metal part
Solder
Third coating on edge protection | Design/
Construction | The R2P Radifocus Glidewire
Advantage (0.018") consists of a
Nickel Titanium alloy and stainless
steel core wire. A polyurethane and
hydrophilic coating is applied to the
distal portion of the wire.
• Core wire (proximal portion)
• Core wire (intermediate portion)
• Core wire (distal portion)
• First coating (distal portion)
• Second coating (distal portion)
Under coat
• PTFE spiral coating (intermediate
portion)
Under coating
Spiral coating
• Edge protection part
Metal part
Solder
• Tip coil marker
• Tip coil marker adhesive
• Silicone coating (proximal portion) | Fully hydrophilic guide Wire. | Same |
| Package | Individual package on which the
product label and the peel-off labels are
attached. 1 unit per package | Same | Same | | | • Core wire
• First Coating
• Second Coating
Under coat | • Core wire (proximal portion)
• Core wire (distal portion)
• First coating (distal portion)
• Second coating (distal portion)
Under coat
• PTFE spiral coating (proximal
portion)
Under coating
Top coating
Spiral coating
• Edge protection part
Metal part
Solder
Third coating on edge protection
• Tip coil marker
• Tip coil marker adhesive |
| Specifications | • Diameter of Wire:
0.035" | • Diameter of Wire:
0.035" | • Diameter of Wire:
0.018 - 0.038" | Package | Individual package on which the
product label and the peel-off labels
are attached. 1 unit per package | Same | Same |
| | • Length of Wire:
350,400,450 cm | • Length of Wire:
260, 300, 350, 400, 450cm | • Length of Wire:
150 - 300 cm | Specifications | • Diameter of Wire:
0.018"
• Length of Wire:
400,450,500 cm
• Shapes of Wire (distal tip)
Angled
• Accessory Devices:
Guide wire inserter
Guide wire clip | • Diameter of Wire:
0.035"
• Length of Wire:
260, 300, 350, 400, 450cm
• Shapes of Wire (distal tip)
Angled, Straight
• Accessory Devices:
Guide wire inserter | • Diameter of Wire:
0.014 and 0.018"
• Length of Wire:
180 and 300 cm
• Shapes of Wire (distal tip):
Angled
• Accessory Devices:
Guide wire inserter |
| | • Shapes of Wire (distal tip)
350,400,450 cm: Angled
400,450 cm: J Shaped | • Shapes of Wire (distal tip)
Angled, Straight | • Shapes of Wire (distal tip):
Angled, straight, J Shaped | Sterilization | Ethylene oxide | Same | Same |
| | • Accessory Devices:
Guide wire inserter
Guide wire clip | • Accessory Devices:
Guide wire inserter | • Accessory Devices:
Guide wire inserter | Shelf Life | 24 months | Same | Same |
| Sterilization | Ethylene oxide | Same | Same | | | | |
Table 3.A: 0.035" vs. Predicate Device and Reference Device 1
9
Table 3.B: 0.018" vs. Predicate Device and Reference Device 2
10
H. NON CLINICAL TESTS (807.92(b)(1))
Performance Testing
Performance testing was conducted to ensure the safety and effectiveness of R2P Radifocus Glidewire Advantage throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device.Table 4 provides a list of performance tests that were performed on R2P Radifocus Glidewire Advantage.
| Test Item |
|---|
| Dimensional Verification |
| Visual Inspection |
| Simulated Use |
| Tensile Strength and Tip Pull |
| Torque Strength |
| Torqueability |
| Coating integrity |
| Particulate evaluation |
| Lubricity |
| Corrosion resistance |
| Kink Resistance |
| Tip flexibility |
| Radiopacity |
Table 4: Summary of Performance Testing
Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life.
Biocompatibility
In accordance with ISO 10993-1, R2P Radifocus Glidewire Advantage is classified as: Externally Communicating Device, Circulating Blood, Limited Contact (In vivo Thrombogenicity |
| In vivo Thrombogenicity(HEPARINIZED) |
| Accelerated-aged (2 years), whole device |
| Cytotoxicity |
| Hemolysis (Direct and Indirect) |
| Physicochemical |
| FT-IR tests |
Table 5: Summary of ISO 10993 Biocompatibility Testing
Sterilization
The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014/Amd 1:2018, 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.
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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, R2P Radifocus Glidewire Advantage, subject of this 510(k), is substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the predicate, Radifocus Glidewire (K152740), manufactured by Ashitaka Factory of Terumo Corporation.