The SONOMED apparatus is ultrasound equipment for therapy, which has been developed in accordance with the safety standards IEC 60601-2 and IEC 60601-2 and IEC 60601-2-5, class II, type BF, which makes it a safe apparatus of high reliability for the therapist and the patient.

SONOMED is medical electric equipment which provides therapeutic ultrasound treatment. Ultrasound is a mechanic stimulus directed to the body through ultrasonic beam emitted by a transducer/applicator, better known as head. This ultrasound is produced in the head through a piezoelectric crystal and is transmitted to the body through the aluminum surface of the head and a contact agent (gel). Depending on how the ultrasound beam passes through the tissues, its energy is gradually and selectively absorbed being transformed into heat, among other effects. This increase in temperature causes biological changes in the tissues as for instance increase in micro circulation, a reduced perception of pain, a reduction in inflammatory activity and an increase in the reestablishing rate of delicate tissues. The higher the ultrasound frequency, the more superficial will be its absorption.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Sonomed IV / Sonomed V), which establishes substantial equivalence to a predicate device. It does not describe an acceptance criteria study in the typical sense of evaluating the performance of an AI/ML device against specific metrics. Instead, it focuses on comparing the new device's characteristics to a legally marketed predicate device to demonstrate that it is equally safe and effective.

Therefore, many of the requested details about acceptance criteria, device performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this type of regulatory submission. This document describes a comparison of product specifications and adherence to general safety standards.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what is explicitly stated as not applicable:

1. A table of acceptance criteria and the reported device performance

The document doesn't define explicit "acceptance criteria" for a study in the context of AI/ML performance. Instead, it compares the technical specifications and indications for use of the subject device (Sonomed IV / Sonomed V) with a predicate device (Sonopulse, K130888). The acceptance, in this regulatory context, is that the subject device is substantially equivalent to the predicate device.

Characteristic	Acceptance Criteria (Predicate's value/range)	Reported Device Performance (Subject Device)	Equivalent Discussion (Regulatory Conclusion)
Regulation Number	890.5300	890.5300	Same
Indications For Use	See list below	See list below	Same
Product Code	IMI	IMI	The subject device and the predicate has the same classification of the ultrasound, but the predicate has mode functions.
Console/Generator Dimensions	Not available (for predicate)	31 x 18 x 6 cm	Equivalent
Treatment Head Dimensions	Not available (for predicate)	15 x 5 x 4 cm	Equivalent
Console/Generator Weight	Not available (for predicate)	1.2 Kg	Equivalent
Treatment Head Weight	Not available (for predicate)	252 Grams	Equivalent
Power Supply	(AC Line) 100-240V ~50/60Hz	100 - 240V 50/60Hz	Same
Leakage Current	Not available (for predicate)	49 μA (Normal), 86 µA (single fault)	Equivalent
Crystal Material	Not available (for predicate)	PZT	Equivalent
Technology of ultrasound generation	Piezoelectric	Piezoelectric	Same
Treatment Mode(s)	Pulsed, continuous	Pulsed, continuous	Same
Beam Type	Pulsed, continuous (Likely a typo, should be collimated or divergent for predicate judging by context)	Collimated	Same (Assuming predicate is also collimated)
Transducer Diameter	7cm² = 2,98 cm	5cm² = 2,52cm	Equivalent
Acoustic Working Frequency	1MHZ± 5%, 3.3MHz± 5%	1MHZ± 5%, 3.3MHz± 5%	Frequencies of the devices are similar within the error margin. All the frequencies are covered by the regulation number 890.5300.
Effective Radiating Area and Accuracy	Not available (for predicate)	3,2 cm² ±10%	The effective area of all products are similar.
Beam Nonuniformity Ratio	Not available (for predicate)	2.8:1	Similar.
Output Mode	Continuous, Pulsed	Continuous, Pulsed	Same
Maximum Timer Setting	30 minutes	20 minutes	The subject device has a lower treatment time.
Beam Maximum Intensity	Not available (for predicate)	0,1 to 2,0 W/cm² (continuous), 0,1 to 3,0 W/cm² (Pulsed)	Similar.
Maximum Value of the Output Power	Not available (for predicate)	6,4W ± 20%	The maximum power of the predicate is higher but the Beam maximum intensity is the same 2.0w/cm² for the continuous mode.
Maximum Value of the Effective Intensity	Not available (for predicate)	0,1 to 2,0 W/cm² (continuous), 0,1 to 3,0 W/cm² (Pulsed)	Similar.
Temperature Rise (Head in air)	Not available (for predicate)	18-19 ºC for 20 min, 1/3.3 MHz, 6.4W	Not available for comparison
Max Patient Contact Surface Temp	Not available (for predicate)	32 ºC (1MHz), 36 ºC (3.3MHz)	Not available for comparison
Penetration Depth	1Mhz 5cm, 3.3MHz 2cm	1Mhz 5cm, 3.3MHz 2cm	Same

Indications for Use:

Therapeutic Ultrasound
Pain relief
Reduction of muscle spasms
Localized increase in blood flow
Increase range of motion of contracted joints using heat and stretch techniques

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as the submission is for a physical medical device (ultrasound equipment), not an algorithm that processes data. The "test set" in this context refers to non-clinical performance data and adherence to international standards, not a dataset of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth in the context of an AI/ML algorithm evaluation is not relevant for this type of device submission. The device's performance is established by meeting technical specifications and safety standards, as detailed in the non-clinical performance data section.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are relevant for consensus-based ground truth establishment, which is not part of this device's evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. An MRMC study is used to evaluate the diagnostic performance of software, often AI, in conjunction with human interpretation. This device is an ultrasonic diathermy machine, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a physical therapeutic ultrasound machine, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable. The "ground truth" for this device's safety and effectiveness is its adherence to established technical specifications and international safety standards (e.g., IEC 60601 series, ISO 10993-1).

8. The sample size for the training set

This information is not applicable. There is no training set for this type of physical therapeutic device.

9. How the ground truth for the training set was established

This information is not applicable. There is no training set for this type of physical therapeutic device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):

The study described in this 510(k) summary is a non-clinical performance evaluation and comparison to a predicate device.

Objective: To demonstrate that the Sonomed IV and Sonomed V devices are substantially equivalent to the legally marketed predicate device, Sonopulse (K130888), in terms of intended use, principles of operation, and output characteristics, and that they meet general safety and essential performance requirements.
Methodology:
- Indications for Use Comparison: The indications for use of the subject devices were directly compared to those of the predicate device and found to be identical.
- Technological Characteristics Comparison (Table 5.2 SE comparison): Key technical specifications of the Sonomed IV/V (e.g., regulation number, product code, power supply, treatment modes, acoustic frequency, penetration depth, output power, etc.) were compared against the predicate device (where available). The discussion highlights similarities and minor differences, concluding they are equivalent or that differences do not raise new questions of safety or effectiveness.
- Non-Clinical Performance Data: The Sonomed devices were tested in accordance with several international standards to ensure basic safety and essential performance. These standards include:
  - IEC 60601-1 (General requirements for basic safety and essential performance)
  - IEC 60601-1-2 (Electromagnetic disturbances)
  - IEC 60601-2-5 (Particular requirements for ultrasonic physiotherapy equipment)
  - IEC 62304 (Medical device software – Software life cycle processes)
  - ISO 10993-1 (Biological evaluation of medical devices)
Clinical Data: No clinical data were included in this submission. The determination of substantial equivalence was based solely on non-clinical performance and technological comparison.
Conclusion: The documentation submitted concluded that the subject devices have comparable features and performance and are therefore substantially equivalent to the identified predicate device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

December 23, 2021

Carci Industria E Comercio De Aparelhos Cirurgicos E Orto % Bruno Milhoci Regulatory Affairs Specialist PR Servicos Regulatorios Administrativos Ltda Rua Alice Aem Saadi, 855/ 2404 Ribeirao Preto, SP 14096-570 Brazil

Re: K202788

Trade/Device Name: Sonomed IV, Sonomed V Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI Dated: February 19, 2021 Received: February 19, 2021

Dear Bruno Milhoci:

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 medical devices and radiation-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.

for Amber Ballard, PhD Assistant Director, Neurodegenerative Devices Team 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) K202788

Device Name Sonomed IV Sonomed V

Indications for Use (Describe)

Therapeutic Ultrasound
Pain relief
Reduction of muscle spasms
Localized increase in blood flow
Increase range of motion of contracted joints using heat and stretch techniques

Type of Use (Select one or both, as applicable)
-------------------------------------------------

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Sonomed IV / Sonomed V

510(k) Summary

Administrative information

Sponsor	CARCI Indústria e Comércio de AparelhosCirúrgicos e Ortopédicos Ltda.R. Padre Machado, 82–São Paulo – SP – BrazilTelephone: +55 (11) 5621 2791
Contact Person and Preparer	Bruno Milhoci de SouzaRegulatory Affairs SpecialistPassarini Regulatory AffairsE-Mail: bruno@rapassarini.com.brTelephone + 55 (16) 3421 8488
Data Prepared	SEPT-15-2020
DEVICE NAME AND CLASSIFICATION
Trade/ Proprietary Name	Sonomed V and Sonomed IV
Common Name	Ultrasonic Therapy
Primary Classification Name	Ultrasonic Diathermy for Use In ApplyingTherapeutic Deep Heat
Primary Classification regulation	21 CFR 890.5300
Primary Product Code	IMI
Classification Panel	Physical Medicine
Reviewing Branch	Physical Medicine
PREDICATE DEVICE INFORMATION
Predicate Manufacturer	Ibramed
Predicate Trade Name	Sonopulse
Predicate 510(k)	K130888

{4}------------------------------------------------

Indications For Use

Therapeutic Ultrasound:

Pain relief
Reduction of muscle spasms
Localized increase in blood flow
Increase range of motion of contracted joints using heat and stretchtechniques

Subject Device Description

CARCI Indústria e Comércio de Aparelhos Cirúrgicos e Ortopédicos Ltda.

{5}------------------------------------------------

Technological Characteristics

Ultrasound in physiotherapy has successfully and efficiently been used in orthopedics and traumatology for quite a long time.

With this background, Carci developed state-of-the-art ultrasound equipment with multifrequency transducer in 1 MHz and 3 MHz for precise and adequate treatment, in conformity with the type of tissue involved.

	ﮐ	anic	5.1

	K number/Manufacturer	Indications for use statement
Subject Device	Carci	Therapeutic Ultrasound- Pain relief- Reduction of muscle spasms- Localized increase in blood flow- Increase range of motion of contractedjoints using heat and stretch techniques
Predicate device	K130888Ibramen	Therapeutic Ultrasound- Pain relief- Reduction of muscle spasms- Localized increase in blood flow- Increase range of motion of contractedjoints using heat and stretch techniques

{6}------------------------------------------------

Table 5.2 SE comparison

Trade Name	Subject Device		Predicate Device	Equivalent discussion
information/Manufacturer	Sonomed IVCarci	Sonomed VCarci	K130888/ SonopulseIbramed
Regulation Number	890.5300	890.5300	890.5300	Same
Indications For Use	TherapeuticUltrasound- Pain relief- Reduction of musclespasms- Localized increase inblood flow- Increase range ofmotion of contractedjoints using heat andstretch techniques	TherapeuticUltrasound- Pain relief- Reduction of musclespasms- Localized increase inblood flow- Increase range ofmotion of contractedjoints using heat andstretch techniques	Therapeutic Ultrasound- Pain relief- Reduction of musclespasms- Localized increase inblood flow- Increase range ofmotion of contractedjoints using heat andstretch techniques	Same
Product Code	IMI	IMI	IMI	The subject deviceand the predicatehas the sameclassification of theultrasound, but thepredicate hasmodefunctions
Console/GeneratorDimensions (L x W x Hcm)	31 x 18 x 6	31 x 18 x 6	Not available	Equivalent
Treatment HeadDimensions (L x W x Hcm)	15 cm x 5 cm x 4 cm	15 cm x 5 cm x 4 cm	Not available	Equivalent
Console/GeneratorWeight (kg)	1.2 Kg	1.2 Kg	Not available	Equivalent
Treatment HeadWeight (kg)	252 Grams	252 Grams	Not available	Equivalent
Power Supply	100 - 240V 50/60Hz	100 - 240V 50/60Hz	(AC Line) 100-240V~50/60Hz	Same
Leakage Current	49 μA (Normal)86 µA (single fault)	49μA (Normal)86 µA (single fault)	Not available	Equivalent
Crystal Material	PZT	PZT	Not available	Equivalent
Technology ofultrasound generation	Piezoelectric	Piezoelectric	Piezoelectric	Same
Treatment Mode(s)	Pulsed, continuous	Pulsed, continuous	Pulsed, continuous	Same
Beam Type (collimatedor divergent)	Collimated	Collimated	Pulsed, continuous	Same
Transducer Diameter(cm)	5cm² = 2,52cm	5cm² = 2,52cm	7cm² = 2,98 cm	Equivalent
Acoustic WorkingFrequency andAccuracy (MHz)	1MHZ± 5%3.3MHz± 5%	1MHZ± 5%3.3MHz± 5%	1MHZ± 5%3.3MHz± 5%	Frequencies of thedevices are similarwithin the errormargin. All thefrequencies arecovered by the
				regulation number890.5300
Effective RadiatingArea and Accuracy(cm2)	3,2 cm² ±10%	3,2 cm² ±10%	Not available	The effective areaof all products aresimilar
Beam NonuniformityRatio (not to exceed8*) and Accuracy	2.8:1	2.8:1	Not available	Similar.
Output Mode:(ContinuousWave/Amplitude -Modulated Wave)	ContinuousPulsed	ContinuousPulsed	ContinuousPulsed	Same
Maximum TimerSetting and Accuracy(not to exceed 30min*)	20 minutes	20 minutes	30 minutes	The subject devicehas a lowertreatment time.
Beam MaximumIntensity and Accuracy(W/cm2)	0,1 to 2,0 W/cm²(continuous mode)0,1 to 3,0 W/cm²(Pulsed)	0,1 to 2,0 W/cm²(continuous mode)0,1 to 3,0 W/cm²(Pulsed)	Not available	Similar.
Maximum Value of theOutput Power (RatedOutput Power) andAccuracy (W)	6,4W ± 20%	6,4W ± 20%	Not available	The maximumpower of thepredicate is higherbut the Beammaximumintensity is thesame 2.0w/cm²for the continuousmode.
Maximum Value of theEffective Intensity andAccuracy (Not toexceed 3 W/cm2 *)	0,1 to 2,0 W/cm²(continuous mode)0,1 to 3,0 W/cm²(Pulsed)	0,1 to 2,0 W/cm²(continuous mode)0,1 to 3,0 W/cm²(Pulsed)	Not available	Similar.
Peak TemperatureRise vs. Time andTissue Depth toMaximum TreatmentTime (for fixedTreatment HeadPlacement) (deg C)	Head in the airElevation oftemperature raise 18ºC for 20 minutes, 1MHz, 6.4WElevation oftemperature raise 19ºC for 20 minutes, 3.3MHz, 6.4WEffective depth 3cmfor 1MHz and 1cm for3MHz	Head in the airElevation oftemperature raise 18ºC for 20 minutes, 1MHz, 6.4WElevation oftemperature raise 19ºC for 20 minutes, 3.3MHz, 6.4WEffective depth 3cmfor 1MHz and 1cm for3MHz	Not available	Not available forcomparison
Maximum PatientContact SurfaceTemperature ofTreatment Head underSimulated or ActualUse Conditions for allOperating Conditions(Continually operatedfor maximum	Head in the MMT32 ºC for 1MHzcontinuous use 6.4W36 ºC for 3.3MHzcontinuous use 6.4W	Head in the MMT32 ºC for 1MHzcontinuous use 6.4W36 ºC for 3.3MHzcontinuous use 6.4W	Not available	Not available forcomparison
treatment time) (degC)
Penetration Depth(cm)	1Mhz 5cm3.3MHz 2cm	1Mhz 5cm3.3MHz 2cm	1Mhz 5cm3.3MHz 2cm	Same

CARCI Indústria e Comércio de Aparelhos Cirúrgicos e Ortopédicos Ltda.

{7}------------------------------------------------

CARCI Indústria e Comércio de Aparelhos Cirúrgicos e Ortopédicos Ltda.

{8}------------------------------------------------

Discussion:

The subject device and the predicate device have similar intended use, principles of operation, and output characteristics. Of note:

-Treatment time: the predicate has a higher treatment time, if the practitioner needs more than 20 minutes the treatment could be restarted.
-Piezoelectric Material: They have the same Zirconia ceramic piezoelectric family.
-Maximum Value of the Output Power: The output power of the predicate is higher, as the ERA is larger, the output density power is equal.
-Penetration depth: The subject device and the sonopulse has the same penetration depth

Non-Clinical Performance Data:

The Sonomed was tested in accordance with these standards:

IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-5 Medical electrical equipment – Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
. IEC 62304 Medical device software – Software life cycle processes

{9}------------------------------------------------

. ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Clinical performance Data:

No clinical data were included in this submission.

Conclusion:

The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate device.

Regulation Number and Section

§ 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.