(90 days)
Not Found
No
The device description and performance studies focus on mechanical properties and function, with no mention of AI/ML terms or capabilities.
No.
The device is described as a "supportive device intended to facilitate guide wire manipulation during interventional procedures", indicating it aids in a procedure rather than directly treating a condition or disease.
No
The device is described as a "supportive device intended to facilitate guide wire manipulation during interventional procedures." Its function is mechanical (applying clamping force) and it does not gather or interpret data about a patient's condition, which is characteristic of a diagnostic device.
No
The device description explicitly states it is a physical device made of polypropylene and polyoxymethylene, intended to be used with guidewires. It is sterilized with ethylene oxide and undergoes physical performance testing.
Based on the provided information, the RADIFOCUS Torque Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate guidewire manipulation during interventional procedures." This describes a device used in vivo (within the body) to assist in a medical procedure.
- Device Description: The description details a mechanical device used to grip and manipulate a guidewire. It does not mention any components or functions related to testing samples of human origin (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening.
IVDs are devices used to examine specimens from the human body to provide information for clinical purposes. The RADIFOCUS Torque Device is a tool used during a clinical procedure, not for analyzing samples from a clinical procedure.
N/A
Intended Use / Indications for Use
RADIFOCUS Torque Device is intended to facilitate guidewire manipulation during interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
MOF, PTL
Device Description
RADIFOCUS Torque Device is a supportive device intended to facilitate guide wire manipulation during interventional procedures.
This product consists of a cap that screws onto the main body of the device (handle) to apply a clamping force on the guide wire. The cap is made of polypropylene and the handle is made of polyoxymethylene. The torque device can be used for the guide wires with diameters of 0.010" to 0.038". RADIFOCUS Torque Device is sterilized with ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 RADIFOCUS Torque Device met the predetermined specifications throughout the shelf life, to verify conformity to the acceptance criteria, and demonstrate substantial equivalence to the predicate device.
The following performance tests were performed on the RADIFOCUS Torque Device:
- Appearance: Meets acceptance criteria
- Fixed strength of guide wire: Meets acceptance criteria
- Fixed strength of cap: Meets acceptance criteria
- Fixable dimension: Meets acceptance criteria
- Guide wire damage: Meets acceptance criteria
- Collet release: Meets acceptance criteria
- Torque slip force: Meets acceptance criteria
The RADIFOCUS Torque Device tested met the predetermined acceptance criteria. Based on the results of the performance testing, the subject RADIFOCUS Torque Device is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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June 29, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below that.
Terumo Medical Products (Hangzhou) Co., Ltd. % Qing Liu Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue. Suite 320 Somerset, New Jersey 08873
Re: K220934
Trade/Device Name: RADIFOCUS Torque Device Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, PTL Dated: March 31, 2022 Received: March 31, 2022
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 (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/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.
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
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K220934
Device Name RADIFOCUS Torque Device
Indications for Use (Describe)
RADIFOCUS Torque Device is intended to facilitate guidewire manipulation during interventional procedures.
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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Image /page/3/Picture/1 description: The image shows the Terumo logo. The logo features a red swoosh above the word "TERUMO" in green. The font is sans-serif and the letters are bold.
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 Medical Products (Hangzhou) Co., Ltd. M4-9-5 Hangzhou Economic and Technological Development Zone, Hangzhou, 310018, People's Republic of China Registration Number: 3004102031
Manufacturer and Sterilization Facility (Applicant)
Terumo Medical Products (Hangzhou) Co., Ltd. M4-9-5 Hangzhou Economic and Technological Development Zone, Hangzhou, 310018, People's Republic of China Registration Number: 3004102031
Contact Person: Qing Liu
Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Ave, Suite 320 Somerset, NJ 08873, USA Tel. (908)842-9016 Fax (410) 398-6079 E-mail: kyo.ryu@terumomedical.com
Date prepared: 6/29/2022
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Image /page/4/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red swoosh above the company name, which is written in green, block letters. The swoosh is curved and tapers to a point on the left side of the logo.
B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | RADIFOCUS Torque Device |
|---|---|
| Common Name: | Torque Device |
| Classification Name: | Catheter Guide Wire |
| Classification Panel: | Neurology, Cardiovascular |
| Regulation: | 21 CFR 870.1330 |
| Product Code: | Primary: MOF, Secondary: PTL |
| Classification: | Class II |
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device to which substantial equivalence is claimed is: K910969 - TORQUE DEVICE FOR A GUIDE WIRE, manufactured by Terumo Corporation, Japan.
D. DEVICE DESCRIPTION (807.92(a)(4))
RADIFOCUS Torque Device is a supportive device intended to facilitate guide wire manipulation during interventional procedures.
This product consists of a cap that screws onto the main body of the device (handle) to apply a clamping force on the guide wire. The cap is made of polypropylene and the handle is made of polyoxymethylene. The torque device can be used for the guide wires with diameters of 0.010" to 0.038". RADIFOCUS Torque Device is sterilized with ethylene oxide.
E. INDICATIONS FOR USE (807.92(a)(5))
RADIFOCUS Torque Device is intended to facilitate guidewire manipulation during interventional procedures.
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Image /page/5/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red curved line above the word "TERUMO" in green. The red curved line is positioned above and to the left of the word "TERUMO", creating a dynamic and modern look. The font used for "TERUMO" is bold and sans-serif, contributing to the logo's clean and professional appearance.
F. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS (807.92(a)(6)) RADIFOCUS Torque Device, the subject of this 510(k), is substantially equivalent in its intended use, technology, principle of operation, materials, and performance to the TORQUE DEVICE FOR A GUIDE WIRE, manufactured by Terumo Corporation, Japan (K910969).
The comparison of the technological characteristics is summarized in the table below.
| Device
Characteristic | Subject Device:
RADIFOCUS Torque
Device (K220934) | Predicate Device:
TORQUE DEVICE FOR A
GUIDE WIRE (K910969) |
|---------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Manufacturer | Terumo Medical Products
(Hangzhou) Co., Ltd. | Terumo Corporation |
| Operation
Principle | Manual | Same |
| Design /
Construction | This product consists of a cap and a
handle with a clamp. | Same |
| Materials | · Cap - Polypropylene
• Handle –Polyoxymethylene | Same |
| Package | • Unit pouch
• Shelf box
• Large shelf box | Same |
| Specifications | Compatible with guide wires that
range from 0.010" (0.26 mm) to
0.038" (0.97 mm) in diameter. | Compatible with guide wires that
range from 0.014" (0.36 mm) to
0.038" (0.97 mm) diameter. |
| Sterilization | Ethylene Oxide (validated in
accordance with ANSI / AAMI /
ISO 11135-1 to achieve SAL 10-6) | Same |
| Disposable,
Single Use | Yes | Same |
G. NON-CLINICAL TESTS (807.92(b)(1))
Performance
Performance testing was conducted to ensure the RADIFOCUS Torque Device met the predetermined specifications throughout the shelf life, to verify conformity to the acceptance criteria, and demonstrate substantial equivalence to the predicate device.
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No new issues of safety and effectiveness were raised with the testing performed. The following performance tests were performed on the RADIFOCUS Torque Device:
| Performance Test | Results |
|---|---|
| Appearance | Meets acceptance criteria |
| Fixed strength of guide wire | Meets acceptance criteria |
| Fixed strength of cap | Meets acceptance criteria |
| Fixable dimension | Meets acceptance criteria |
| Guide wire damage | Meets acceptance criteria |
| Collet release | Meets acceptance criteria |
| Torque slip force | Meets acceptance criteria |
The RADIFOCUS Torque Device tested met the predetermined acceptance criteria. Based on the results of the performance testing, the subject RADIFOCUS Torque Device is substantially equivalent to the predicate.
Biocompatibility
The RADIFOCUS Torque Device is a non-tissue contacting medical device, therefore, this 510(k) submission does not include biocompatibility data.
Sterilization
The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices.
The sterilization process was validated utilizing the overkill half cycle approach to provide a Sterility Assurance Level (SAL) of 10-6.
Post sterilization, RADIFOCUS Torque Device product meets the maximum residue limits in accordance with ISO 10993-7: 2008.
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Image /page/7/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, block letters. The arc is positioned above and to the left of the word "TERUMO."
The maximum allowable residue levels are:
| - Ethylene oxide (EtO): | 4 mg/device |
|---|---|
| - Ethylene chlorohydrin (ECH): | 9 mg/device |
Risk Analysis
A Product Risk Analysis was conducted in accordance with ISO 14971, and it was determined that there were no new issues of safety or effectiveness.
H. CLINICAL TESTS (807.92(b)(2))
This 510(k) submission does not include data from clinical tests, which were not deemed necessary.
I. CONCLUSION (807.92(b)(3))
In summary, the RADIFOCUS Torque Device, subject of this 510(k), is substantially equivalent in its intended use, technology, principle of operation, materials, and performance to the primary predicate device K910969 – TORQUE DEVICE FOR A GUIDE WIRE manufactured by Terumo Corporation, Japan.