HTS Surface Coil is used to image peripheral anatomies, such as, wrist, ankle, Temporo-mandibular Joints (TMJ), Eye, finger and other parts of the body, close to the surface of skin. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System.

HTS Extremity Coil is predominantly used for imaging anatomies, such as, knee, ankle, and wrist. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System.

Device Description

HTS Surface Coil (TM-HTS-SF001-0R35), HTS Extremity Coil (TM-HTS-KN001-0R35). Single-Channel, Receive-Only, LN2 (Liquid Nitrogen) Cooling liquid. HTS Surface Coil is Single Channel surface coil. HTS Extremity Coil is Single Channel Volume coil. Material: ABS.

AI/ML Overview

This document focuses on the substantial equivalence of the HTS Surface Coil and HTS Extremity Coil to a predicate device, rather than providing a study with specific performance metrics and acceptance criteria for the new devices. Therefore, much of the requested information, such as quantitative performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods, is not present in the provided text.

Here's what can be extracted based on the input:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implied by the similarity to the predicate device. The performance is described qualitatively by stating they are "similar" and have "similar safety and effectiveness." No quantitative performance metrics are provided for the filing devices.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Same principle of operation	Works on the same principle
Similar design	Similar design
Constructed of similar materials	Constructed of similar materials (ABS vs. PVC for predicate K022863, but ABS for K092230)
Similar safety and effectiveness	Similar safety and effectiveness
Does not induce new safety issues/warnings	Does not induce other safety issues and warning than already valid for the current cleared RF external coils.
Intended Use aligns with predicate devices (for relevant anatomies and MRI system)	HTS Surface Coil: images peripheral anatomies (wrist, ankle, TMJ, eye, finger, etc.) with Time Medical's 0.35T PICA Whole Body MRI System. HTS Extremity Coil: predominantly images knee, ankle, and wrist with Time Medical's 0.35T PICA Whole Body MRI System. (Matches predicates generally, with specific MRI system compatibility noted).
Technical parameters (T/R, Coil Type, Cooling Liquid) align with predicate devices	T/R: Receive-Only (Matches both predicates) Coil Type: Single Channel Surface Coil (HTS Surface Coil, matches both predicates) / Single Channel Volume Coil (HTS Extremity Coil, differs from predicate K092230 which is surface, but K022863 is also surface) Cooling liquid: LN2 (Matches both predicates)

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This document does not describe a clinical study for testing the device. It's a submission for substantial equivalence based on technical and safety characteristics compared to existing devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth establishment for a specific test set is not mentioned as no such study is detailed.

4. Adjudication Method

Not applicable. No study involving adjudication is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. This document does not describe an MRMC study or any comparison of human reader performance with or without AI assistance. The device in question is an MRI coil, not an AI-powered diagnostic tool.

6. Standalone Performance Study

Not applicable. The document describes an MRI coil, a hardware component, not a standalone algorithm. Its performance is intrinsically tied to the MRI system it's used with.

7. Type of Ground Truth Used

Not applicable. The concept of "ground truth" as typically used in performance studies for diagnostic algorithms does not apply to this regulatory submission for an MRI coil. The assessment revolves around engineering, safety, and functional equivalence to predicate devices.

8. Sample Size for the Training Set

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set or associated ground truth establishment is mentioned.

Summary

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TIME MEDICAL SYSTEMS

510(k) Report for HTS Surface Coil, HTS Extremity Coil

		Attachment 2: 510(k) Summary
	Attachment 2	K112293
	510 (k) Summary	SEP 30 2011
2.1	summary		1
2.2	General Safety and Effectiveness		2
2.3	Substantial Equivalence		2

2.1 SUMMARY

، ﺗﺴ

ComparisonElement	Filing Device	Predicate Device
510(k) Number	TBD	K092230(MonaOrthopedicMRI System)(an accessoryof LNH)	K022863
Product Code	MOS	MOS
Applicant	Time Medical	Time Medical	University of Hong Kong
Regulation Number	892.1000	892.1000	892.1000
Panel	Radiology	Radiology	Radiology
Class	Class II	Class II	Class II
Device Name (ModelNumber)	HTS Surface Coil(TM-HTS-SF001-0R35),HTS Extremity Coil(TM-HTS-KN001-0R35)	HTS Coil asAccessory ofthe MONA MRISystem	HTS Coil(HTS Coil)
Characteristics	HTS Surface Coil		HTS ExtremityCoil	K092230	K022863
Intended Use	HTS Surface Coil isused to imageperipheralanatomies, such as,wrist, ankle,Temporo-mandibularJoints (TMJ), Eye,finger and otherparts of the body,close to the surfaceof skin. It iscompatible to beused with TimeMedical's 0.35TPICA Whole BodyMRI System.		HTS ExtremityCoil ispredominantlyused forimaginganatomies,such as, knee,ankle, andwrist. It iscompatible tobe used withTime Medical's0.35T PICAWhole BodyMRI System.	HTS SurfaceCoil is used toimageperipheralanatomiessuch as, Wrist,Ankle, TMJ,Eye, Fingerand other partsof the body,close to thesurface of theskin.	MRI surface coil forperipheralanatomical imagingAnatomical region:Temporo-mandibularjoint (TMJ), wristand other anatomiesthat are no deeperthan 1.5 inches fromthe skin.
Applicable Systems	Time Medical,Pica Whole-bodyMRI System		Time Medical,Pica Whole-bodyMRI System	Time Medical,MonaOrthopedicMRI System	GE0.2T Signa ProfileMRI System
Mode of Operation	Single-Channel		Single-Channel	Single-Channel	Single-Channel
Coil Configuration (Linear,Quad, array, etc)	Single Channelsurface coil		Single ChannelVolume coil	Single Channelsurface coil	Single Channelsurface coil

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Safety
SAR (T/R Coils)	N/A, ReceiveOnly Coil	N/A, ReceiveOnly Coil	N/A, ReceiveOnly Coil	N/A, Receive OnlyCoil
Power Input Protection (T/R Coils)	N/A, ReceiveOnly Coil	N/A, ReceiveOnly Coil	N/A, ReceiveOnly Coil	N/A, Receive OnlyCoil
Material	ABS	ABS	ABS	PVC

TechnologicalParameter	Filing Device:HTS Surface Coil	HTS Extremity Coil	Predicate Device:HTS Coil as Accessory ofK092230 (Mona Orthopedic MRI System)	HTS Coil (K022863)
T/R	Receive-Only	Receive-Only	Receive-Only	Receive-Only
Coil Type	Single ChannelSurface Coil	Single ChannelVolume Coil	Single ChannelSurface Coil	Single ChannelSurface Coil
Cooling liquid	LN2 (LiquidNitrogen)	LN2 (LiquidNitrogen)	LN2 (LiquidNitrogen)	LN2 (LiquidNitrogen)

2.2 GENERAL SAFETY AND EFFECTIVENESS

The technological characteristics of Time Medical's HTS Surface Coil and HTS Extremity Coil are similar to the predicate device. They work on the same principle, have similar design, are constructed of similar materials and are of similar safety and effectiveness.

lt does not induce other safety issues and warning than already valid for the current cleared RF external coils.

2.3 SUBSTANTIAL EQUIVALENCE

The HTS Surface coil and the HTS Extremity Coil are substantially equivalent to the other HTS coil(s) which has been cleared for commercial distribution as part of Time Medical Limited's MONA Orthopedic MRI System (ref. K092230), and the HTS coil of University of Hong Kong (K022863).

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Time Medical Systems, Inc. % Mr. John Baby Director-Regulatory Affairs Time Medical Limited, G/F Bio-Informatics Centre No. 2 Science Park West Avenue Hong Kong Science Park, Shatin, New Territories. Hong Kong CHINA

SEP 3 0 2011

Re: KI12293

Trade/Device Name: HTS Surface Coil, HTS Extremity Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 1. 2011 Received: August 10. 2011

Dear Mr. Baby:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809): medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Report for HTS Surface Coil, HTS Extremity Coil

TIME MEDICAL

Attachment 3: Indications of Use

Indications for Use

510(k) Number (if known):

Device Name: HTS Surface Coil, HTS Extremity Coil

Indications for Use:

HTS Surface Coil is used to image peripheral anatomies, such as, wrist, ankle, Temporomandibular Joints (TMJ), Eye, finger and other parts of the body, close to the surface of skin. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System.

HTS Extremity Coil is predominantly used for imaging anatomies, such as, knee, ankle, and wrist. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System.

Prescription Use _____x______x

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Pastel

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K112293

Page 1 of 1

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.