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.

AI/ML Overview

The provided text describes a 510(k) submission for the RADIFOCUS Torque Device, a medical device intended to facilitate guidewire manipulation. It specifically states that no clinical tests were performed or deemed necessary for this submission. The evaluation relies on non-clinical performance testing and comparison to a predicate device.

Therefore, the requested information regarding acceptance criteria and a study proving device performance cannot be fully provided in the context of a clinical study with human subjects, given that no such study was conducted or required.

However, based on the provided text, I can infer the "acceptance criteria" and "study" refers to the non-clinical performance testing conducted.

Here's the breakdown of what can be extracted from the provided text regarding the non-clinical performance testing:

1. A table of acceptance criteria and the reported device performance:

The document states: "The RADIFOCUS Torque Device tested met the predetermined acceptance criteria." While the specific numerical or qualitative acceptance criteria for each test are not detailed, the results are uniformly positive.

Performance Test	Acceptance Criteria (Implied)	Reported Device Performance
Appearance	Meets predetermined criteria	Meets acceptance criteria
Fixed strength of guide wire	Meets predetermined criteria	Meets acceptance criteria
Fixed strength of cap	Meets predetermined criteria	Meets acceptance criteria
Fixable dimension	Meets predetermined criteria	Meets acceptance criteria
Guide wire damage	Meets predetermined criteria	Meets acceptance criteria
Collet release	Meets predetermined criteria	Meets acceptance criteria
Torque slip force	Meets predetermined criteria	Meets acceptance criteria

2. Sample size used for the test set and the data provenance:

Sample size: Not specified. The document only mentions "Performance testing was conducted."
Data provenance: Not specified. It's implied to be internal testing by the manufacturer (Terumo Medical Products (Hangzhou) Co., Ltd.) given the context of a 510(k) submission and the lack of external study details. The testing is retrospective in the sense that it was conducted before the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as there was no clinical study involving human subjects or expert assessment of clinical outcomes. The "ground truth" for the non-clinical performance tests would be the established engineering specifications and measurement standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable for non-clinical performance testing of a medical device. Adjudication methods are typically used in clinical studies for interpretation of imaging or clinical events.

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:

This is not applicable. The device is a physical torque device, not an AI-assisted diagnostic tool. No MRMC study was mentioned or implied.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable as the device is not an algorithm or AI. The performance testing was for the physical device.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" was established by predetermined specifications and engineering standards for mechanical performance (e.g., strength, dimensions, torque).

8. The sample size for the training set:

This is not applicable as there was no AI/algorithm that required a training set. This is a physical medical device.

9. How the ground truth for the training set was established:

This is not applicable for the same reason as above.

Summary

{0}------------------------------------------------

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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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

{4}------------------------------------------------

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.

{5}------------------------------------------------

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.

DeviceCharacteristic	Subject Device:RADIFOCUS TorqueDevice (K220934)	Predicate Device:TORQUE DEVICE FOR AGUIDE WIRE (K910969)
Manufacturer	Terumo Medical Products(Hangzhou) Co., Ltd.	Terumo Corporation
OperationPrinciple	Manual	Same
Design /Construction	This product consists of a cap and ahandle with a clamp.	Same
Materials	· Cap - Polypropylene• Handle –Polyoxymethylene	Same
Package	• Unit pouch• Shelf box• Large shelf box	Same
Specifications	Compatible with guide wires thatrange from 0.010" (0.26 mm) to0.038" (0.97 mm) in diameter.	Compatible with guide wires thatrange from 0.014" (0.36 mm) to0.038" (0.97 mm) diameter.
Sterilization	Ethylene Oxide (validated inaccordance 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.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word.

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.

{7}------------------------------------------------

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.

Regulation Number and Section

§ 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.