K Number

Device Name

HTS EXTREMITY COIL, HTS SURFACE COIL

Manufacturer

TIME MEDICAL SYSTEMS INC

Date Cleared

2011-09-30

(51 days)

Product Code

MOS

Regulation Number

892.1000

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K092230, K022863

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes passive MRI coils and does not mention any software or processing capabilities, let alone AI/ML.

Therapeutic

No
The device is described as being used for "imaging peripheral anatomies" and is compatible with an "MRI System," which are diagnostic rather than therapeutic functions.

Diagnostic

Yes
The device is described as an accessory for an MRI system ("Magnetic resonance diagnostic device") and is used to "image peripheral anatomies," which is a diagnostic purpose.

SaMD (Software as a Medical Device)

The device description explicitly details physical hardware components (coils, materials, cooling liquid) and their function in imaging, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The provided description clearly states that these devices are coils used with an MRI system to image peripheral anatomies. They are accessories for a magnetic resonance diagnostic device.
No Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device directly interacts with the patient's body to generate images.

Therefore, based on the intended use and device description, these coils are accessories for an in vivo (within the living body) diagnostic imaging system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

MOS

Device Description

The HTS Surface Coil is a single-channel surface coil, and the HTS Extremity Coil is a single-channel volume coil. Both are receive-only coils, use LN2 (Liquid Nitrogen) for cooling, and are constructed of ABS material. They are designed to be compatible with Time Medical's 0.35T PICA Whole Body MRI System.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MRI

Anatomical Site

HTS Surface Coil: peripheral anatomies, such as, wrist, ankle, Temporo-mandibular Joints (TMJ), Eye, finger and other parts of the body, close to the surface of skin.
HTS Extremity Coil: anatomies, such as, knee, ankle, and wrist.

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

K092230, K022863

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

| Comparison

Element	Filing Device	Predicate Device
510(k) Number	TBD	K092230
(Mona
Orthopedic
MRI System)
(an accessory
of 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 (Model
Number)	HTS Surface Coil
(TM-HTS-SF001-0R35),
HTS Extremity Coil
(TM-HTS-KN001-0R35)	HTS Coil as
Accessory of
the MONA MRI
System	HTS Coil
(HTS Coil)
Characteristics	HTS Surface Coil		HTS Extremity
Coil	K092230	K022863
Intended Use	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.	HTS Surface
Coil is used to
image
peripheral
anatomies
such as, Wrist,
Ankle, TMJ,
Eye, Finger
and other parts
of the body,
close to the
surface of the
skin.	MRI surface coil for
peripheral
anatomical imaging

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

| Technological
Parameter | Filing Device:
HTS Surface Coil | HTS Extremity Coil | Predicate Device:
HTS Coil as Accessory of
K092230 (Mona Orthopedic MRI System) | HTS Coil (K022863) |
|----------------------------|------------------------------------|-------------------------------|---------------------------------------------------------------------------------------|--------------------------------|
| T/R | Receive-Only | Receive-Only | Receive-Only | Receive-Only |
| Coil Type | Single Channel
Surface Coil | Single Channel
Volume Coil | Single Channel
Surface Coil | Single Channel
Surface Coil |
| Cooling liquid | LN2 (Liquid
Nitrogen) | LN2 (Liquid
Nitrogen) | LN2 (Liquid
Nitrogen) | LN2 (Liquid
Nitrogen) |

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).

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

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

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

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