(27 days)
The sam CS Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues and to increase local circulation.
The sam CS Long Duration Ultrasound Device consists of:
- Rechargeable Power Controller and Timer
- Ultrasound Generating Applicators
Single use disposable accessories - Ultrasonic Coupling Patch
The Power Controller can be used to power the Applicator to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with onetime use Ultrasonic Coupling Patches.
The sam CS Long Duration Ultrasound Device contains firmware that controls the timing display and inputs from the power button to activate/deactivate the device. There is no control function of this firmware.
The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria.
The document is a 510(k) premarket notification summary for a medical device (sam CS Long Duration Ultrasound Device). It aims to demonstrate substantial equivalence to a predicate device (sam X1 Long Duration Ultrasound Device, K211513) to gain market clearance from the FDA.
Here's what can be extracted based on your request, highlighting the absence of specific details about acceptance criteria and a detailed study:
1. A table of acceptance criteria and the reported device performance
The document provides a "Substantial Equivalence Summary" (Table 1 on pages 5-6) which compares the subject device (sam CS) to the predicate device (sam X1) across various technical specifications. This table effectively serves as a comparison of performance characteristics, where "Identical" implies the sam CS meets the same reported performance as the sam X1. However, it does not explicitly state pre-defined acceptance criteria (e.g., "Device must achieve X% accuracy," or "Temperature rise must be between Y and Z degrees"). Instead, the acceptance is based on demonstrating equivalence to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (sam CS) |
|---|---|---|
| Indications for Use | Similar to predicate, with intended use remaining the same. | "The sam CS Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues and to increase local circulation." (Subset of predicate's indications) |
| Acoustic Working Frequency | 3MHz ± 20% | 3MHz ± 20% |
| Effective Radiating Area | One: 6 cm², Two: 12 cm² ± 20% | One: 6 cm², Two: 12 cm² ± 20% |
| Beam Nonuniformity Ratio (BNR) | <5:1 ± 20% | <5:1 ± 20% |
| Output Mode | Continuous Wave - 100% duty cycle | Continuous Wave - 100% duty cycle |
| Maximum Timer Setting | 1 Hour +/- 1 minute | 1 Hour +/- 1 minute |
| Beam Maximum Intensity | 0.132 W/cm² ± 20% | 0.132 W/cm² ± 20% |
| Maximum Output Power | Single Applicator: 0.65W ± 20%; Dual Applicator: 1.3W ± 20% | Single Applicator: 0.65W ± 20%; Dual Applicator: 1.3W ± 20% |
| Maximum Effective Intensity | 0.264 W/cm² ± 20% (Not to exceed 3 W/cm²) | 0.264 W/cm² ± 20% |
| Peak Temperature Rise vs. Time and Tissue Depth | 7°C at 1 cm, 4°C at 3 cm, 2°C at 5 cm (Treatment time: 1 hour) | 7°C at 1 cm, 4°C at 3 cm, 2°C at 5 cm (Treatment time: 1 hour) |
| Maximum Patient Contact Surface Temperature | 44 °C | 44 °C |
| Power Supply | 120/240 VAC with 5V DC Input Power Jack and Lithium Battery Powered | 120/240 VAC with 5V DC Input Power Jack and Lithium Battery Powered |
| Leakage Current | 0.3 mA | 0.3 mA |
| Crystal Material | Lead Zirconate-Titanate | Lead Zirconate-Titanate |
| Technology of ultrasound generation | Piezoelectric | Piezoelectric |
| Treatment Mode(s) | Two discrete settings of power at same Frequency | Two discrete settings of power at same Frequency |
| Beam Type | Divergent | Divergent |
| Transducer Diameter | 5 cm | 5 cm |
| Applicator Type | Up to two circular Applicators with 3 MHz output | Up to two circular Applicators with 3 MHz output |
| Applicator Emitting Surface Areas | One Applicator: 5 cm², Two Applicators: 10 cm² | One Applicator: 5 cm², Two Applicators: 10 cm² |
| Applicator Lens Material | TPX | TPX |
| Environmental - Operating Temperature Range | 0°C to +50°C (32°F to +122°F) | 0°C to +50°C (32°F to +122°F) |
| Performance Standards | 21 CFR 1050.10 | 21 CFR 1050.10 |
| Sterility | Non Sterile | Non Sterile |
| Electrical Safety Standards Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 |
| Biocompatibility | Yes | Yes |
| Mechanical safety | Yes | Yes |
| Radiation safety | Not Radioactive | Not Radioactive |
| Software/Firmware | Yes - For measurement of battery level | Yes - For measurement of battery level |
| Output Channels | Two Independent Power Channels | Two Independent Power Channels |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical testing was not necessary to support substantial equivalence of the sam CS device." This implies that no specific "test set" of patient data was used for a clinical performance study of the sam CS device itself. The data provenance of the predecessor device (sam X1) is not provided in this document.
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)
Not applicable, as no clinical testing with a specific test set was conducted for the sam CS device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing with a specific test set was conducted for the sam CS device.
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
Not applicable. This device is an ultrasound diathermy device, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an "algorithm only" performance, often relevant for AI/software devices. While the device does have firmware, it is for control functions like timing and battery level, not for diagnostic or therapeutic algorithms that would require standalone performance evaluation in the context of an "algorithm." The device's primary function is physical energy delivery.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical testing with a specific test set was conducted for the sam CS device. The "ground truth" for the device's technical specifications is established through engineering and physical measurements against recognized standards (e.g., IEC standards).
8. The sample size for the training set
Not applicable, as no machine learning / AI model was trained for the device's primary function.
9. How the ground truth for the training set was established
Not applicable, as no machine learning / AI model was trained for the device's primary function.
In summary:
This 510(k) submission for the "sam CS Long Duration Ultrasound Device" focuses on demonstrating substantial equivalence to an already cleared predicate device ("sam X1 Long Duration Ultrasound Device"). The argument is that since the sam CS device has identical technical specifications and a similar intended use (a subset of the predicate's indications), it poses no new questions of safety or effectiveness. Therefore, clinical performance data and detailed studies on acceptance criteria, test sets, or ground truth were deemed "not necessary" for this particular submission. The "acceptance criteria" here are implicitly that the device's technical characteristics and performance match those of the predicate device.
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October 25, 2023
ZetrOZ Systems, LLC Sabrina Lewis OAR Director 56 Quarry Road Trumbull, Connecticut 06611
Re: K233210
Trade/Device Name: sam CS Long Duration Ultrasound Device Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: PFW Dated: September 28, 2023 Received: September 28, 2023
Dear Sabrina Lewis:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Rehabilitation Devices
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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) K233210
Device Name sam CS Long Duration Ultrasound Device
Indications for Use (Describe)
The sam CS Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues and to increase local circulation.
| 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 - K233210
| Device Trade Name: | sam CS Long Duration Ultrasound Device |
|---|---|
| Manufacturer: | ZetrOZ Systems, LLC56 Quarry RoadTrumbull, CT 06611 |
| Contact: | Ms. Sabrina LewisQAR DirectorPhone: 888-202-9831Email: sabrina@zetroz.com |
| Date Prepared: | October 24, 2023 |
| Classification: | 21 CFR 890.5300; Ultrasonic diathermy. |
| Class: | II |
| Product Code: | PFW |
| Predicate Devices: | sam X1 Long Duration Ultrasound Device (K211513) |
Indications for Use:
The sam CS Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues and to increase local circulation.
Device Description:
The sam CS Long Duration Ultrasound Device consists of:
- Rechargeable Power Controller and Timer ●
- Ultrasound Generating Applicators
Single use disposable accessories
- Ultrasonic Coupling Patch .
The Power Controller can be used to power the Applicator to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with onetime use Ultrasonic Coupling Patches.
The sam CS Long Duration Ultrasound Device contains firmware that controls the timing display and inputs from the power button to activate/deactivate the device. There is no control function of this firmware.
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The system is intended for prescription home use to apply ultrasonic energy for a long duration (1 hour) to generate deep heat within body tissues and to increase local circulation.
| Table 1: Substantial Equivalence Summary | ||||
|---|---|---|---|---|
| Information | ZetrOZ sam CS LongDuration UltrasoundDevice(Subject) | ZetrOZ sam X1 LongDuration UltrasoundDevice(K211513) | Comparison(to sam X1) | |
| Classification Name | Ultrasonic DiathermyDevice | Ultrasonic DiathermyDevice | Identical | |
| Service Type | Physical Medicine | Physical Medicine | Identical | |
| Classification | 21 CFR 890.5300 | 21 CFR 890.5300 | Identical | |
| Class | II | II | Identical | |
| Indications | The sam CS LongDuration UltrasoundDevice is intended forhome use to applyultrasonic energy togenerate deep heat withinbody tissues and toincrease local circulation. | The sam X1 LongDuration UltrasoundDevice is intended forhome use to applyultrasonic energy togenerate deep heat withinbody tissues for thetreatment of selectedmedical conditions such asthe relief of pain, the reliefof muscle spasms, thetreatment of jointcontractures, and the localincrease in circulation. | Similar. Theindication statement isa subset of theprevious indication foruse. The intended useremains the same. | |
| Manufacturer | ZetrOZ | ZetrOZ | Identical | |
| Console/GeneratorDimensions (L x W x Hcm) | 3.4 cm x 3.4 cm x 1.4 cm | 3.4 cm x 3.4 cm x 1.4 cm | Identical | |
| Treatment HeadDimensions (L x W x Hcm) | 3.81 cm L x 3.30 cm W x1.14 cm H | 3.81 cm L x 3.30 cm W x1.14 cm H | Identical | |
| Console/Generator Weight(kg) | 0.02 kg | 0.02 kg | Identical | |
| Treatment Head Weight(kg) | 0.01 kg | 0.01 kg | Identical | |
| Power Supply | 120/240 VAC with 5V DCInput Power Jack andLithium Battery Powered | 120/240 VAC with 5V DCInput Power Jack andLithium Battery Powered | Identical | |
| Leakage Current | 0.3 mA | 0.3 mA | Identical | |
| Crystal Material | Lead Zirconate-Titanate | Lead Zirconate-Titanate | Identical | |
| Technology of ultrasoundgeneration (e.g.,piezoelectric,magnetoconstructive) | Piezoelectric | Piezoelectric | Identical | |
| Treatment Mode(s) | Two discrete settings ofpower at same Frequency | Two discrete settings ofpower at same Frequency | Identical | |
| Beam Type (collimated ordivergent) | Divergent | Divergent | Identical | |
| Transducer Diameter (cm) | 5 cm | 5 cm | Identical | |
| Information | ZetrOZ sam CS LongDuration UltrasoundDevice(Subject) | ZetrOZ sam X1 LongDuration UltrasoundDevice(K211513) | Comparison(to sam X1) | |
| Acoustic WorkingFrequency and Accuracy(MHz) | 3MHz ± 20% | 3MHz ± 20% | Identical | |
| Effective Radiating Areaand Accuracy (cm2) | One: 6 cm2Two:12 cm2± 20% | One: 6 cm2Two:12 cm2± 20% | Identical | |
| Beam Nonuniformity Ratioand Accuracy | BNR: <5:1 ± 20% | BNR: <5:1 ± 20% | Identical | |
| Output Mode: (ContinuousWave/Amplitude –Modulated Wave) | Continuous Wave - 100%duty cycle | Continuous Wave - 100%duty cycle | Identical | |
| Maximum Timer Settingand Accuracy | 1 Hour +/- 1 minute | 1 Hour +/- 1 minute | Identical | |
| Beam Maximum Intensityand Accuracy (W/cm2) | 0.132 W/cm2 ± 20% | 0.132 W/cm2 ± 20% | Identical | |
| Maximum Value of theOutput Power (RatedOutput Power) andAccuracy (W) | Single Applicator:0.65W ± 20%Dual Applicator:1.3W ± 20% | Single Applicator:0.65W ± 20%Dual Applicator:1.3W ± 20% | Identical | |
| Maximum Value of theEffective Intensity andAccuracy (Not to exceed 3W/cm2 *) | 0.264 W/cm2 ± 20% | 0.264 W/cm2 ± 20% | Identical | |
| For Amplitude ModulatedWaves | Not Amplitude Modulated | Not Amplitude Modulated | Identical | |
| Peak Temperature Rise vs.Time and Tissue Depth toMaximum Treatment Time(for fixed Treatment HeadPlacement) (deg C) | 7°C at 1 cm4°C at 3 cm2°C at 5 cmTreatment time: 1 hour | 7°C at 1 cm4°C at 3 cm2°C at 5 cmTreatment time: 1 hour | Identical | |
| Maximum Patient ContactSurface Temperature ofTreatment Head underSimulated or Actual UseConditions for allOperating Conditions(Continually operated formaximum treatment time)(deg C) | 44 °C | 44 °C | Identical | |
| Therapeutically Applied | Ultrasound Coupling Patch | Ultrasound Coupling Patch | Identical | |
| Applicator Type | Up to two circularApplicators with 3 MHzoutput | Up to two circularApplicators with 3 MHzoutput | Identical | |
| Applicator TypeApplicator EmittingSurface Areas (cm2) | Up to two circularApplicatorsOne Applicator : 5 cm2Two Applicators :10 cm2 | Up to two circularApplicatorsOne Applicator : 5 cm2Two Applicators : 10 cm2 | Identical | |
| Coupling Bandage | ABS Plastic withintegrated couplingmedium | ABS Plastic withintegrated couplingmedium | Identical | |
| ZetrOZ sam CS LongDuration UltrasoundDevice | ZetrOZ sam X1 LongDuration UltrasoundDevice | Comparison | ||
| Information | (Subject) | (K211513) | (to sam X1) | |
| Applicator Lens Material | TPX | TPX | Identical | |
| Environmental - OperatingTemperature Range | 0°C to +50°C (32°F to+122°F) | 0°C to +50°C (32°F to+122°F) | Identical | |
| Performance Standards | 21 CFR 1050.10 | 21 CFR 1050.10 | Identical | |
| Sterility | Non Sterile | Non Sterile | Identical | |
| Designed to meet ElectricalSafety Standards | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | Identical | |
| Biocompatibility | Yes | Yes | Identical | |
| Mechanical safety | Yes | Yes | Identical | |
| Radiation safety (if notradioactive state as such) | Not Radioactive | Not Radioactive | Identical | |
| Software/Firmware | Yes - For measurement ofbattery level | Yes - For measurement ofbattery level | Identical | |
| Output Channels | Two Independent PowerChannels | Two Independent PowerChannels | Identical |
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Substantial Equivalence:
The sam CS Long Duration Ultrasound Device is substantially equivalent to the predicate device with respect to intended use, design, function, and performance. The purpose of this special 510(k) is to adjust the indications for use statement. The output and strength of the signal are identical to the predicate.
Non-Clinical Performance Data:
The sam CS Long Duration Ultrasound Device is in accordance with these recognized consensus standards:
IEC 60601-1 Ed. 3.1 2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Ed. 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-1-11 Ed. 2.0 2015-01 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 ISO 10993 Biological evaluation of medical devices - Part 1-Ed. 5-2018: Evaluation and testing within a risk management process; Part 5 Ed. 3-2009: Tests for in vitro cytotoxicity; Part 10 Ed. 3-2010: Tests for irritation and skin sensitization
Clinical Performance Data:
Clinical testing was not necessary to support substantial equivalence of the sam CS device.
Conclusion:
The sam CS Long Duration Ultrasound Device possesses the same intended use and technological characteristics as the predicate device. Therefore, the sam CS Long Duration Ultrasound Device is substantially equivalent to the legally marketed predicate.
§ 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.