(337 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts. The device is described as "computerized" but the performance studies focus on electrical safety and tissue heating, not algorithmic performance.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is indicated for "Therapeutic Massager" and "Ultrasonic Diathermy," which are therapeutic applications.
No
The intended uses listed for the device (therapeutic massager for muscle relief, improved circulation, cellulite reduction, and ultrasonic diathermy for pain relief, muscle spasms, and joint contractures) are all therapeutic or palliative in nature, not diagnostic.
No
The device description explicitly states that the MC1 is supplied with two handpieces, one ultrasonic and one for computerized body massage, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes therapeutic applications (muscle aches, pain relief, circulation, cellulite reduction, muscle spasms, joint contractures). These are all treatments applied to the body, not tests performed on samples taken from the body.
- Device Description: The device description details a massager and ultrasound diathermy system with handpieces for direct application to the body. This aligns with therapeutic devices, not diagnostic ones that analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is entirely therapeutic and applied externally.
N/A
Intended Use / Indications for Use
The MC1 is indicated for:
a) Therapeutic Massager:
- Provides temporary relief of minor muscle aches and pains;
- Relieves muscle spasms,
- Temporarily improves local blood circulation;
- Temporarily reduces the appearance of cellulite.
b) Ultrasonic Diathermy: - Relief of pain;
- Muscle spasms;
- Joint contractures;
- NOT for the treatment of malignancies.
Product codes
ISA, IMI
Device Description
The MC1 is a computerized body massager and ultrasound diathermy system. The MC1 is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massage.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The MC1 was tested and found to conform with IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility and IEC 60601-2-5 for electrical safety in ultrasonic physiotherapy equipment. The MED Sculpt was found to conform with these same electrical safety standards. Performance data was presented which showed that the MC1 performed similarly to the previously cleared MED Sculpt in terms of tissue heating. Specifically, testing showed that the MC1 increases tissue temperature as required for ultrasonic diathermy. The two 1 MHz ultrasound transducers can be considered equivalent to the MED Sculpt in terms of heating tissue temperature to at least 40° C. These results are similar to those reported for the MED Sculpt.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K053041, K024307, K982830, K883893
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
MAY - 6 2010
510(k) Summary For the General Project MC1
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
Submitter:
General Project, S.r.I. Via della Gora 13/19-15/19 50025 Montespertoli, Florence Italy
Contact Person:
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Tel: 978-207-1245 Fax: 978-824-2541
Summary Preparation Date:
- Names
Trade Name: Common Name: Classification Name: MC1 Ultrasound and Massager Therapeutic Massager Diathermy, Ultrasonic, For Use in Applying Therapeutic Deep heat. Product Codes: ISA (21 CFR 890.5660), IMI (21 CFR 890.5300)
3. Legally Marketed Predicate Devices
The MC1 is substantially equivalent to the following devices: MED Sculpt, manufactured by General Project (K053041), Dermosonic, manufactured by Sybaritic, Inc. (K024307), Forte CPS 400 Combo (K982830), manufactured by Chattanooga Group, Inc. and Omnisound 3000 (K883893), manufactured by Physio Technology, Inc.
April 26, 2010
1
4. Device Description
The MC1 is a computerized body massager and ultrasound diathermy system. The MC1 is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massage.
5. Intended Use
The MC1 is indicated for:
- a) Therapeutic Massager:
-
- Provides temporary relief of minor muscle aches and pains
-
- Relieves muscle spasms
-
- Temporarily improves blood circulation
-
- Temporarily reduces the appearance of cellulite
-
- b) Ultrasonic Diathermy:
-
- Relief of pain
-
- Muscle spasms
-
- Joint contractures
-
- NOT for the treatment of malignancies
-
6. Substantial Equivalence
The MC1 is substantially equivalent to the identified predicate devices. The MC1 has the same indications for use as the General Project MED Sculpt and the Sybaritic Dermosonic. Regarding technological characteristics, the MC1 includes both massage and ultrasound diathermy handpieces as do the General Project MED Sculpt and the Sybaritic Dermosonic. The Chattanooga Group, Inc. Forte CPS 400 Combo and the Physio Technology, Inc. Omnisound 3000 are ultrasound based devices only. Differences between the MC1 and the identified predicate devices were evaluated in performance testing and the MC1 was found to be substantially equivalent to the identified predicate devices.
7. Performance Data
The MC1 was tested and found to conform with IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility and IEC 60601-2-5 for electrical safety in ultrasonic physiotherapy equipment. The MED Sculpt was found to conform with these same electrical safety standards. Performance data was presented which showed that the MC1 performed similarly to the previously cleared MED Sculpt in terms of tissue heating. Specifically, testing showed that the MC1 increases tissue temperature as required for ultrasonic diathermy. The two 1 MHz ultrasound transducers can be considered equivalent to the MED Sculpt in terms of heating tissue temperature to at least 40° C. These results are similar to those reported for the MED Sculpt.
8. Conclusion
The MC1 is substantially equivalent to the identified predicate devices in terms of indications for use, electrical safety testing and performance testing which indicated that the MC1 and the MED Sculpt were substantially equivalent in terms of tissue heating.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
General Project, S.r.l % O'Connell Regulatory Consultants, Inc. Ms. Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864
MAY - 6 2010
Re: K091615
Trade/Device Name: MC1 Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: II Product Code: IMI, ISA Dated: April 26, 2010 Received: April 27, 2010
Dear Ms. O'Connell:
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 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Maureen O'Connell
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,
Mark N. Melkerson Director Division of Surgical, Orthopedi and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ---------------------------------------------------------------------------------------------
Device Name:
The MC1 is indicated for:
- a) Therapeutic Massager:
-
- Provides temporary relief of minor muscle aches and pains;
-
- Relieves muscle spasms,
-
- Temporarily improves local blood circulation;
-
- Temporarily reduces the appearance of cellulite.
-
b) Ultrasonic Diathermy:
-
- Relief of pain;
-
- Muscle spasms;
-
- Joint contractures;
-
- NOT for the treatment of malignancies.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
- X
Prescription Use (Per 21 CFR 801.109) OR
Over The Counter Use (Optional Format 1-2-96)
Page 1 of 1
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Number K091615
510(k) Number