(233 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not mention any AI/ML capabilities.
Yes
The device is intended to apply ultrasound to generate deep heat within body tissues for the treatment of various medical conditions, including pain relief, muscle spasms, joint contractures, and increased circulation. These applications are therapeutic in nature.
No
The device is intended for therapeutic purposes, specifically to generate deep heat using ultrasound for the treatment of various medical conditions, and not for diagnosing them.
No
The device description explicitly states it is a "portable and rechargeable prescriptive device" intended to "apply ultrasound to the patient's treatment site," indicating it is a hardware device that delivers ultrasound therapy, not solely software. The performance studies also mention testing for electrical safety and electromagnetic compatibility, which are relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes applying ultrasound to generate heat within body tissues for therapeutic purposes (pain relief, muscle spasms, joint contractures, increased circulation). This is a physical therapy modality applied externally to the body.
- Device Description: The device is described as a portable and rechargeable prescriptive device that applies ultrasound to the patient's treatment site. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with bodily specimens or diagnostic purposes.
The device is clearly intended for therapeutic treatment using ultrasound, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
Apply stationary use of ultrasound to:
Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.
Apply continuous movement of ultrasound for:
- Pain.
- Pain relief, muscle spasms, and joint contractures.
- Relief of pain, muscle spasms, and joint contractures that may be associated with:
- Adhesive capsulitis,
- Bursitis with slight calcification,
- Myositis,
- Soft tissue injuries, and
- Shortened tendons due to past injuries and scar tissues.
- Relief of pain, muscle spasms, and joint contractures resulting from:
- Capsular tightness, and
- Capsular scarring.
- Localized increase in blood flow.
- Increased range of motion of contracted joint using heat and stretch techniques.
Product codes (comma separated list FDA assigned to the subject device)
IMI, PFW
Device Description
The ManaSport+ is an adaptation of the previously cleared ManaSport device, which was cleared under K210284. A wireless control option was added to the ManaSport+ and the subject device was evaluated for home use. As a portable and rechargeable prescriptive device in the home or clinical/hospital setting, the subject device is intended to apply ultrasound to the patient's treatment site for selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Ultrasound can be used to apply therapeutic deep heat for the treatment of selected medical conditions such as soft tissue injuries, shortened tendons due to past injuries and scar tissues, relief of pain, muscle spasms and joint contractures.
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
Health Care Professionals and lay users (under prescription)
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)
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.
- (a) ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
- (c) IEC 60601-2-5 "Medical electrical equipment Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment".
- (d) ISO 10993-5 "Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity".
- (e) ISO 10993-10 "Biological evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization".
- (f) IEC 60601-1-11 "Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment".
- (g) IEC 60601-1-6 "Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability".
In addition to the compliance of voluntary standards, the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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March 8, 2023
ManaMed. Inc. % Bill Ouangin Dai Official Correspondent JKH USA, LLC 14271 Jeffrey Rd. #246 Irvine, California 92620
Re: K222098
Trade/Device Name: ManaSport+ Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: Class II Product Code: IMI, PFW Dated: February 8, 2023 Received: February 9, 2023
Dear Bill Quanqin Dai:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Lauren E. Woodard -S
for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K22098
Device Name ManaSport+
Indications for Use (Describe)
Apply stationary use of ultrasound to:
Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.
Apply continuous movement of ultrasound for:
- Pain.
-
- Pain relief, muscle spasms, and joint contractures.
-
- Relief of pain, muscle spasms, and joint contractures that may be associated with:
- · Adhesive capsulitis,
- · Bursitis with slight calcification,
- · Myositis,
- · Soft tissue injuries, and
- · Shortened tendons due to past injuries and scar tissues.
-
- Relief of pain, muscle spasms, and joint contractures resulting from:
- · Capsular tightness, and
- · Capsular scarring.
-
- Localized increase in blood flow.
-
- Increased range of motion of contracted joint using heat and stretch techniques.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------- | ----------------------------------------------------------- |
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3
510(k) Summary
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter's Information
Submitter: ManaMed. Inc. Address: 5240 W. Charleston Blvd. Las Vegas, NV 89146 Date of Preparation: 03/08/2023
2. Subject Device
Trade/Device Name: ManaSport+ 510(k): K222098 Common Name: Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat Review Panel: Physical Medicine Product Code: IMI, PFW Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Device Class: II Use: Prescription
3. Predicate device
Primary Predicate Device: ManaSport 510(k) Number: K210284 Clearance Date: April 26, 2022 Submitter: ManaMed, Inc.
Predicate Device: sam 2.0 Long Duration Ultrasound System 510(k) Number: K191568 Clearance Date: March 6, 2020 Submitter: ZetrOZ Systems, LLC
4. Description of Subject Device
The ManaSport+ is an adaptation of the previously cleared ManaSport device, which was cleared under K210284. A wireless control option was added to the ManaSport+ and the subject device was evaluated for home use. As a portable and rechargeable prescriptive device in the home or clinical/hospital setting, the subject device is intended to apply ultrasound to the patient's treatment site for selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Ultrasound can be used to apply therapeutic deep heat for the treatment of selected medical conditions such as soft tissue injuries, shortened tendons due to past injuries and scar tissues, relief of pain, muscle spasms and joint contractures.
5. Indications for Use
Apply stationary use of ultrasound to:
Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.
4
Apply continuous movement of ultrasound for:
-
- Pain.
-
- Pain relief, muscle spasms, and joint contractures.
- Relief of pain, muscle spasms, and joint contractures that may be associated with: 3.
- Adhesive capsulitis, ●
- Bursitis with slight calcification, ●
- Myositis, ●
- Soft tissue injuries, and .
- Shortened tendons due to past injuries and scar tissues. ●
-
- Relief of pain, muscle spasms, and joint contractures resulting from:
- Capsular tightness, and ●
- Capsular scarring. .
-
- Localized increase in blood flow.
-
- Increased range of motion of contracted joint using heat and stretch techniques.
6. Summary of Substantial Equivalence
The following Table 1 summarizes the comparison between the subject device and the predicate device, indicating the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate device.
| Parameter &
| Predicate Device(s) | Subject Device | Primary Predicate Device | Predicate Device | Equivalence |
|---|---|---|---|---|
| 510(k)/PMA Number | K222098 | K210284 | K191568 | N/A |
| Submitter | ||||
| /Manufacturer | ManaMed, Inc | ManaMed, Inc. | ZetrOZ Systems, LLC | N/A |
| Device Name/Model | ManaSport+ | ManaSport | sam 2.0 Long Duration Ultrasound | |
| System | N/A | |||
| Product Code | IMI, PFW | IMI, PFW | PFW | Identical |
| Parameter & Predicate | ||||
| Device(s) | Subject Device | Primary Predicate Device | Predicate Device | Equivalence |
| 510(k)/PMA Number | K222098 | K210284 | K191568 | N/A |
| Submitter | ||||
| /Manufacturer | ManaMed, Inc | ManaMed, Inc. | ZetrOZ Systems, LLC | N/A |
| Device Name/Model | ManaSport+ | ManaSport | sam 2.0 Long Duration Ultrasound | |
| System | N/A | |||
| Product Code | IMI, PFW | IMI, PFW | PFW | Identical |
| Indications for Use | Apply stationary use of ultrasound | |||
| to: | ||||
| Generate deep heat within body | ||||
| tissues for the treatment of selected | ||||
| medical conditions such as the | ||||
| relief of pain, the relief of muscle | ||||
| spasms, the treatment of joint | ||||
| contractures, and the local increase | ||||
| in circulation. | ||||
| Apply continuous movement of | ||||
| ultrasound for: | ||||
| Pain. |
Pain relief, muscle
spasms, and joint contractures.
3.
Relief of pain, muscle
spasms, and joint contractures that
may be associated with:
Adhesive capsulitis. | Apply stationary use of ultrasound
to:
Generate deep heat within body
tissues for the treatment of selected
medical conditions such as the
relief of pain, the relief of muscle
spasms, the treatment of joint
contractures, and the local increase
in circulation.
Apply continuous movement of
ultrasound for:
1.
Pain.
2.
Pain relief, muscle
spasms, and joint contractures.
Relief of pain, muscle
3.
spasms, and joint contractures that
may be associated with:
Adhesive capsulitis. | The sam 2.0 Long Duration Ultrasound
Device is intended for home use to
apply ultrasonic energy to generate deep
heat within body tissues for the
treatment of selected medical conditions
such as the relief of pain, the relief of
muscle spasms, the treatment of joint
contractures, and the local increase in
circulation. | Identical |
Table 1. Comparison between the subject device and the predicate device
5
| Bursitis with slight calcification, Myositis, Soft tissue injuries, and Shortened tendons due to past injuries and scar tissues. 4. Relief of pain, muscle spasms, and joint contractures resulting from: Capsular tightness, and Capsular scarring. 5. Localized increase in blood flow. | Bursitis with slight calcification, Myositis, Soft tissue injuries, and Shortened tendons due to past injuries and scar tissues. 4. Relief of pain, muscle spasms, and joint contractures resulting from: Capsular tightness, and Capsular scarring. 5. Localized increase in blood flow. |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
6
| 6. Increased range of motion of contracted joint using heat and stretch techniques. | 6. Increased range of motion of contracted joint using heat and stretch techniques. | ||||
|---|---|---|---|---|---|
| Intended Users | Health Care Professionals and lay users (under prescription) | Not Publicly Available | Health Care Professionals and lay users (under prescription) | Identical | |
| Prescription or OTC | Prescription | Not Publicly Available | Prescription | Identical | |
| Power Source(s) | 120/240 Vac with 5Vdc Input and rechargeable 3.7Vdc battery | Not Publicly Available | 120/240 VAC with 5V DC Input Power Jack and Lithium Battery Powered | Identical | |
| Number of Output | 1 | Not Publicly Available | 1-2 | Identical | |
| Software/Firmware/Microprocessor Control? | Yes | Not Publicly Available | Yes | Identical | |
| Automatic No-Load Trip? | Yes | Not Publicly Available | Not Publicly Available | Identical | |
| Automatic Shut Off? | Yes | Not Publicly Available | Not Publicly Available | Identical | |
| User Override Control? | Yes | Not Publicly Available | Not Publicly Available | Identical | |
| Indicator Display: | On/Off Status? | Yes | Not Publicly Available | Not Publicly Available | Identical |
| Low Battery? | Yes | Not Publicly Available | Not Publicly Available | Identical | |
| Voltage / Current Level? | Yes | Not Publicly Available | Not Publicly Available | Identical | |
| Timer Range (minutes) | 0-20 | Not Publicly Available | 0-240 | Identical or similar. This does not affect the safety or effectiveness. | |
| Compliance with Voluntary Standards? | Yes | Not Publicly Available | Yes | Identical | |
| Biocompatibility? | Yes | Not Publicly Available | Yes | Identical | |
| Sterility | Non-Sterile | Not Publicly Available | Non-sterile | Identical | |
| Housing construction material | ABS | Not Publicly Available | ABS | Identical | |
| Console/Generator Dimensions (mm) [L x W x H] | 140×56×24 | Not Publicly Available | 61×70.9×18.8 | Identical or similar. This does not affect the safety or effectiveness. | |
| Console/Generator Weight (kg) | 0.13 | Not Publicly Available | 0.01 | Identical or similar. This does not affect the safety or effectiveness. | |
| Treatment head dimensions (mm) [L x W x H] | 30 x 30 x 12 | Not Publicly Available | 38.1 x 33 x 11.4 | Identical or similar. This does not affect the safety or effectiveness. | |
| Treatment Head Weight (kg) | 0.031 | Not Publicly Available | 0.10 | Identical or similar. This does not affect the safety or effectiveness. | |
| Functions and design | Ultrasound | Not Publicly Available | Ultrasound | Identical | |
| Frequency (MHz) | 1.5 | Not Publicly Available | 3 | Identical or small. The frequency of the subject device is identical to that of the primary predicate device, and smaller than that of the predicate device. Therefore, the frequency does not affect the safety or effectiveness. | |
| Leakage current |