(56 days)
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.
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 provided text describes a 510(k) summary for the US-101L and US-103S ultrasound therapy units. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria as would be expected for a novel AI/software medical device.
Therefore, much of the requested information cannot be extracted from this document, as it pertains to a different type of device and regulatory submission process.
Here's an attempt to answer the questions based on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission focuses on substantial equivalence to predicate devices based on similar features and safety functions, not on specific performance metrics or acceptance criteria for a new AI/software device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided. The document makes no mention of a "test set" in the context of an AI/software device's performance evaluation. The non-clinical testing mentioned refers to device verification and validation, likely evaluating hardware and software functions (e.g., output accuracy, safety) rather than diagnostic or therapeutic efficacy based on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided. The concept of "ground truth" established by experts for a test set is not applicable to the type of device and submission described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are not relevant to this type of device submission.
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 information is not provided. An MRMC study is not relevant to this traditional ultrasound therapy device. This device does not involve human readers interpreting images or an AI component assisting in diagnosis.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The US-101L and US-103S are physical ultrasound therapy units, not an algorithm or AI software for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided. The concept of "ground truth" for a performance evaluation is not relevant to this device.
8. The sample size for the training set
This information is not provided. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not provided. No training set or ground truth establishment relevant to AI/ML is mentioned.
Summary based on the provided text:
The submission for the US-101L and US-103S ultrasound therapy units is a 510(k) premarket notification. The core of the submission is to demonstrate substantial equivalence to existing predicate devices (K032793- US-100 Ultrasound Therapy Unit and K024307- Dermosonic Non-Invasive Subdermal Therapy System).
The basis for this substantial equivalence is stated as the proposed devices incorporating "similar features as the predicate devices such as the main ultrasound output specification and safety functions."
Non-clinical testing was conducted, and its results are referenced in Section 15 of the submission. This testing likely focused on:
- Compliance with recognized standards (IEC 60601-1, IEC60601-1-2, IEC60601-2-5) related to electrical safety, electromagnetic compatibility, and specific requirements for medical ultrasonic equipment.
- Verification of device specifications (e.g., ultrasound frequency, output power, pulsed modes) against stated claims and comparison to predicate devices.
- Validation of safety functions.
The document does not contain information related to acceptance criteria, performance studies, sample sizes, ground truth, expert involvement, or AI/ML-specific evaluations, which are typically required for novel AI/software medical devices.
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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
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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.
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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
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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
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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
Page 1 of 1
§ 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.