(56 days)
Not Found
No
The device description and intended use focus on standard ultrasound therapy parameters (frequency, output mode) and do not mention any AI/ML capabilities or image processing. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are "indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions."
No
The device is described as an ultrasound therapy unit for applying therapeutic deep heat to body tissues, not for diagnostic purposes. Its intended use is for treatment, specifically pain relief, muscle spasms, and joint contractures.
No
The device description explicitly states it is a "portable type ultrasound therapy unit with built in ultrasound transducer" and an "Ultrasound head (probe) is integral with the main body," indicating it is a hardware device that generates ultrasound waves.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply therapeutic deep heat to body tissues for treating medical conditions like pain, muscle spasms, and joint contractures. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is an ultrasound therapy unit that applies ultrasound energy to the body. This is a physical therapy modality, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to deliver therapeutic energy to the body.
N/A
Intended Use / Indications for Use
The US-101L, US-103S are indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.
Product codes
IMI
Device Description
US-101L, US-103S are portable type ultrasound therapy units with built in ultrasound transducer. Ultrasound head (probe) is integral with the main body. Two sizes, US-101L (L size) for 1MHz and US-103S (S size) for 3MHz are available. In the output mode, continuous output (100%) or pulsed output (50%, 40%, 20%, 10%, 5%) are used. These units are intended to treat the affected area by applying the treatment head to skin.
The proposed devices have incorporated similar features as the predicate devices such as the main ultrasound output specification and safety functions.
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
Non-clinical verification and validation testing was conducted on US-101L, US-103S devices, and the results of such testing appear in Section 15 of this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
established in 1916
OCT 26 2011
3-3-3 TOYOTAMA-MINAMI, NERIMA-KU, TOKYO 176-0014 JAPAN
TEL:81-3-3994-8996 FAX:81-3-3994-8012
510(k) Summary
US-101L, US-103S
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
Submitter Name:
ITO CO., LTD. 3-3-3 TOYOTAMA-MINAMI, NERIMA-KU TOKYO, 176-0014 JAPAN TEL: (+81) 3-3994-8996 FAX: (+81) 3-3994-8012
Contact Name:
Haruhisa Okada
June, 9 2011
Data Prepared
Proprietary Name: US-101L, US-103S Common Name: diathermy, ultrasonic, for use in applying therapeutic deep heat Class: II Predicate Device: K032793- US-100 Ultrasound Therapy Unit K024307- Dermosonic Non-Invasive Subdermal Therapy Systemt :
Device Description:
US-101L, US-103S are portable type ultrasound therapy units with built in ultrasound transducer. Ultrasound head (probe) is integral with the main body. Two sizes, US-101L (L size) for 1MHz and US-103S (S size) for 3MHz are available. In the output mode, continuous output (100%) or pulsed output (50%, 40%, 20%, 10%, 5%) are used. These units are intended to treat the affected area by applying the treatment head to skin.
The proposed devices have incorporated similar features as the predicate devices such as the main ultrasound output specification and safety functions.
Detailed comparison of specific US-101L, US-103S features and characteristics to the predicate devices is contained in Section 11, Executive Summary Substantial Equivalence Discussion.
Indications for Use:
The US-101L, US-103S are indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.
Section 5
1
established in 1916
3-3-3 TOYOTAMA-MINAMI, NERIMA-KU, TOKYO 176-0014 JAPAN
TEL:81-3-3994-8996 FAX:81-3-3994-8012
Cited Standards to Determine Substantially Equivalence:
US-101L, US-103S comply with FDA recognized IEC 60601-1, IEC60601-1-2 and IEC60601-2-5.
Non-clinical Testing:
Non-clinical verification and validation testing was conducted on US-101L, US-103S devices, and the results of such testing appear in Section 15 of this submission.
Truthful and Accuracy Statement: 1
IT Oco.,LTD.
Singed by a corporate management representative of the required statement attesting to the truthfulness and accuracy of the information contained in Section 6 of this submission.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 6 2011
Ito Co., Ltd. % TÜV SÜD America, Inc. Mr. Alexander Schapovalov 1775 Old Highway 8 New Brighton, MN 55112-1891
Re: K112520
Trade/Device Name: US-101L, US-103S Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI Dated: October 17, 2011 Received: October 19, 2011
Dear Mr. Schapovalov:
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. 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
3
Page 2 - Mr. Alexander Schapovalov
or any Federal statutes and regulations administered by other Federal agencies. You must or and y 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportaProblem/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) number (if known): KI | 25 20 Device name: US-101L, US-103S Indications for Use:
The US-101L, US-103S are indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.
(Division Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112520
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
Section 4
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