(233 days)
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.
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.
The provided text is a 510(k) summary for the ManaSport+ device, an ultrasonic diathermy device. It discusses the device's substantial equivalence to predicate devices, focusing on its technical characteristics and indications for use. However, it explicitly states that "Clinical testing was not provided in support of this 510(k) application," and therefore, there is no study described that proves the device meets specific performance acceptance criteria via clinical data, nor is there information on ground truth establishment, expert consensus, or MRMC studies.
The document primarily relies on non-clinical testing and comparison to predicate devices, demonstrating substantial equivalence rather than proving performance against quantified clinical acceptance criteria.
Therefore, many of the requested details about acceptance criteria, the study proving the device meets them, sample sizes for test sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text.
The document focuses on demonstrating that the ManaSport+ is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective as those devices, and does not require a new Premarket Approval Application (PMA). This is achieved through non-clinical testing and a comparison of technical specifications.
Here's what can be extracted based on the provided text, while noting the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of clinical performance acceptance criteria and reported device performance against those criteria. Instead, it provides a "Summary of Substantial Equivalence" comparing the ManaSport+ (Subject Device) to its primary predicate (ManaSport) and another predicate (sam 2.0 Long Duration Ultrasound System) based on various technical parameters. The "Equivalence" column in this table indicates if the subject device's parameter is identical, similar, or different, and explains why any differences do not affect safety or effectiveness.
Below is a partial example of how the provided table could be structured to show the comparison, but it's crucial to understand these are technical specifications for substantial equivalence, not clinical performance metrics against acceptance criteria.
| Parameter & Predicate Device(s) | Subject Device (ManaSport+) Reported Value | Primary Predicate Device (ManaSport) Reported Value | Predicate Device (sam 2.0) Reported Value | Equivalence (as stated in document) |
|---|---|---|---|---|
| Product Code | IMI, PFW | IMI, PFW | PFW | Identical |
| Indications for Use | (Detailed list provided in text) | (Detailed list provided in text) | (Detailed list provided in text) | 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 |
| 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. |
| Maximum Value of the Output Power (W ± 20%) | 0.60 | Not Publicly Available | Single Applicator: 0.65W ± 20% Dual Applicator: 1.3W ± 20% | Identical or similar. Therefore, the maximum power does not affect the safety or effectiveness. |
| Compliance with Voluntary Standards? | Yes (lists IEC standards) | Not Publicly Available | Yes (lists IEC standards) | Identical |
| Wireless Control via Bluetooth App | Yes | Not Publicly Available | No | Different. Although the primary predicate and predicate devices do not have the wireless option, such a wireless option is optional to the subject device. Just like the primary predicate device, the subject device can be operated independently to realize all its features, and completely does not rely on the optional wireless communication to realize any of its features. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The document states, "Clinical testing was not provided in support of this 510(k) application." The testing primarily involved non-clinical, bench testing to verify compliance with electrical safety, EMC, and biocompatibility standards, and software verification. There are no "test sets" in the context of clinical or AI performance evaluation.
- Data Provenance: Not applicable for a clinical test set. The document refers to compliance with ISO and IEC standards, which are international standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. As no clinical testing was performed, no ground truth was established by experts for a test set.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not done. The document explicitly states "Clinical testing was not provided."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The ManaSport+ is a physical device (ultrasonic diathermy), not an AI algorithm. Its performance is related to its physical outputs (e.g., ultrasound frequency, power, temperature rise in tissue), which were evaluated through non-clinical bench testing for compliance with standards.
7. The Type of Ground Truth Used
- Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" refers to the established requirements and specifications of the cited voluntary standards (e.g., IEC 60601-1, ISO 10993) which the device's measured performance was compared against.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/algorithm device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No training set for an AI algorithm.
Summary of Device Performance and Acceptance Criteria (Based on Non-Clinical Data):
The ManaSport+ device demonstrated performance primarily through non-clinical tests to ensure compliance with recognized voluntary standards for medical devices. The "acceptance criteria" here are the requirements outlined in these standards for:
- Electrical Safety: IEC 60601-1, IEC 60601-2-5 (for ultrasonic physiotherapy equipment)
- Electromagnetic Compatibility (EMC): IEC 60601-1-2
- Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and skin sensitization)
- Home Healthcare Environment Requirements: IEC 60601-1-11
- Usability: IEC 60601-1-6
- Software Verification: FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The document asserts that the device conformed to or complied with these standards. For example, regarding temperature rise, it states "Meets IEC 60601-2-5, section 201.11 Protection against excessive temperature and other HAZARDS." Specific values for temperature rise in tissue are also given (e.g., "7.6°C at 1 cm / 3.3°C at 2 cm / 1.4°C at 3 cm / Max treatment time: 20 min"), and these are compared to the predicate devices as "Identical or similar. This value of the subject device is identical to that of the primary predicate device, and smaller than that of the predicate device. Therefore, it does not affect the safety or effectiveness."
In conclusion, for the ManaSport+ device, its "acceptance criteria" were primarily defined by compliance with a comprehensive set of international electrical safety, EMC, biocompatibility, and usability standards, and its "performance" was demonstrated through non-clinical testing against these standards, as well as by showing substantial equivalence to existing cleared devices with similar indications for use. No clinical trial data was submitted or required for its 510(k) clearance.
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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.
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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
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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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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 UltrasoundSystem | N/A |
| Product Code | IMI, PFW | IMI, PFW | PFW | Identical |
| Parameter & PredicateDevice(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 UltrasoundSystem | N/A |
| Product Code | IMI, PFW | IMI, PFW | PFW | Identical |
| Indications for Use | Apply stationary use of ultrasoundto:Generate deep heat within bodytissues for the treatment of selectedmedical conditions such as therelief of pain, the relief of musclespasms, the treatment of jointcontractures, and the local increasein circulation.Apply continuous movement ofultrasound for:Pain.1.2.Pain relief, musclespasms, and joint contractures.3.Relief of pain, musclespasms, and joint contractures thatmay be associated with:Adhesive capsulitis. | Apply stationary use of ultrasoundto:Generate deep heat within bodytissues for the treatment of selectedmedical conditions such as therelief of pain, the relief of musclespasms, the treatment of jointcontractures, and the local increasein circulation.Apply continuous movement ofultrasound for:1.Pain.2.Pain relief, musclespasms, and joint contractures.Relief of pain, muscle3.spasms, and joint contractures thatmay be associated with:Adhesive capsulitis. | The sam 2.0 Long Duration UltrasoundDevice is intended for home use toapply ultrasonic energy to generate deepheat within body tissues for thetreatment of selected medical conditionssuch as the relief of pain, the relief ofmuscle spasms, the treatment of jointcontractures, and the local increase incirculation. | Identical |
Table 1. Comparison between the subject device and the predicate device
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| 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 | <0.3mA | Not Publicly Available | 0.3mA | Identical | |
| Crystal material | PZT | Not Publicly Available | Lead Zirconate-Titanate | Identical | |
| Technology of Ultrasound generation | Piezoelectric | Not Publicly Available | Piezoelectric | Identical | |
| Output Mode | Continuous Wave - 100% duty cycle | Not Publicly Available | Continuous Wave - 100% duty cycle | Identical | |
| Ratio of temporalmaximum outputpower to the outputpower | 1:1 | Not Publicly Available | Not Publicly Available | Identical | |
| Deviation | $\pm$ 20% | Not Publicly Available | $\pm$ 20% | Identical | |
| Maximum Value of theOutput Power (W$\pm$ 20%) | 0.60 | Not Publicly Available | Single Applicator: 0.65W $\pm$ 20%Dual Applicator:1.3W $\pm$ 20% | Identical or similar. Therefore, themaximum power does not affect thesafety or effectiveness. | |
| Temporal average power(W $\pm$ 20%) | 0.60 | Not Publicly Available | Not Publicly Available | Identical or similar. Therefore, thetemporal average power does not affectthe safety or effectiveness. | |
| Maximum value of theeffective intensity (W/cm²$\pm$20%) | 0.16 | Not Publicly Available | 0.264 | Identical or similar. Therefore, themaximum effective intensity does notaffect the safety or effectiveness. | |
| Beam MaximumIntensity and Accuracy(W/cm² $\pm$ 20%) | 0.16 | Not Publicly Available | 0.132 | Identical or similar. Therefore, thebean maximum intensity does not affectthe safety or effectiveness. | |
| Duty factor | 100% | Not Publicly Available | 100% | Identical | |
| Beam Type | Collimated | Not Publicly Available | Divergent | Identical or similar. This does not affectthe safety or effectiveness. | |
| Applicator size | Area: 3.9 or 5 cm² | Not Publicly Available | Up to two circular Applicators OneApplicator: 5 cm2Two Applicators : 10 cm2 | Identical | |
| Maximum patient contactsurface temperature of thetreatment head undersimulated or actual useconditions for alloperating conditions(continually operated formaximumtreatment time) (°C) | Meets IEC 60601-2-5,section 201.11 Protection againstexcessive temperature and otherHAZARDS. | Not Publicly Available | 44 °C | Identical | |
| Peak Temperature Risevs. Time and TissueDepth to MaximumTreatment Time (for fixedTreatment HeadPlacement) (°C) | 7.6°C at 1 cm3.3°C at 2 cm1.4°C at 3 cmMax treatment time: 20 min | Not Publicly Available | 8°C at 1 cm 6°C at 3 cm 3°C at 5 cmMax treatment time: 4 hours | Identical or similar. This value of thesubject device is identical to that of theprimary predicate device, and smallerthan that of the predicate device.Therefore, it does not affectthe safety or effectiveness. | |
| Beam Non-UniformityRatio | 4 $\pm$ 20% | Not Publicly Available | <5 $\pm$ 20% | Identical or similar. Therefore, the beamnon-uniformity ratio does notaffect the safety or effectiveness. | |
| Effective Radiating Area(cm2) | 3.9 or 5 $\pm$ 20% | Not Publicly Available | One: 6 cm2 Two:12 cm2$\pm$ 20% | Identical or smaller. Therefore, theeffective radiating area does notaffect the safety or effectiveness. | |
| Electrical SafetyStandards Compliance | IEC 60601-1IEC 60601-2-5IEC 60601-1-2IEC 60601-1-11IEC 60601-1-6Wireless Coexistence Cybersecurity | Not Publicly Available | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | Identical or similar with IEC 60601- 1-11 and IEC 60601-1-6 added | |
| Wireless Control viaBluetooth App | Yes | Not Publicly Available | No | Different. Although the primarypredicate and predicate devices do nothave the wireless option, such a wirelessoption is optional to the subject device.Just like the primary predicate device,the subject device can be operatedindependently to realize all its features,and completely does not rely on theoptional wireless communication torealize any of its features. |
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7. Substantial Equivalence
The subject and primary predicate device are identical except for the modification made (Home Use & Wireless Option). The home use added to the subject device is supported by IEC 60601-1-11 as well as IEC 60601-1-6, just like the secondary predicate K191568 that has the home use. Although the primary predicate and predicate devices do not have the wireless option is option is optional to the subject device. Just like the primary predicate device can be operated independently to realize all its features, and completely does not rely on the optional wireless communication to realize any of its features. Supported by the wireless coexistence and cybersecurity, the wireless option does not affect any technical specifications, features, intended use, safety, and effectiveness of the subject device when compared to the primary predicate device.
Therefore, the differences between the subject device and the predicate device do not raise any new issues of safety or effectiveness. Also, those differences do not affect the intended use or alter the fundamental technology of the device. There are no new safety or effectiveness issues concerning the subject device, which offers substantially equivalent technical specifications, features, intended use, safety, and effectiveness to the predicate device.
8. Non-Clinical Tests Performed
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.
9. Clinical Testing
Clinical testing was not provided in support of this 510(k) application.
10. Conclusion
The test and comparison performed demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the predicate device that has been legally marketed in the United States.
§ 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.