(211 days)
The ZTX Ultrasonic Diathermy Device is intended 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.
The ZTX Ultrasonic Diathermy Device is a prescription use device. The ZTX Device should only be administered and monitored by a licensed healthcare practitioner.
The ZTX Ultrasonic Diathermy Device consists of a ZTX Ultrasound Power Controller and cable which can be used to power one or two ZTX Ultrasound Applicators simultaneously that each generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per ZTX Ultrasound Applicator. The ZTX Ultrasound Applicators are applied with one time use ZTX Ultrasound Coupling Bandages which hold the ZTX Ultrasound Applicators in place during treatment and allow for the transmission of ultrasound into the body. This provides the operator with the ability to use the device hands-free in a single applicator mode of operation that delivers 0.65W at 3MHz or in a dual applicator mode of operation that provides 1.3W at 3MHz. The ZTX Ultrasound Power Controller displays battery and treatment setting information to the operator and provides control of device treatment time. The ZTX Ultrasound Applicator frequency and power settings are not modifiable by the operator. The ZTX ultrasound applicators and coupling bandage allows for the delivery of ultrasonic energy to tissue at one or two locations simultancously, as determined by a physician. The ZTX Ultrasound Power Controller , ZTX Ultrasound Applicators, interconnecting power cable and ZTX Ultrasound Coupling Bandages comprise the entire ZTX treatment system.
The provided text describes the regulatory submission for the ZTX Ultrasonic Diathermy Device, focusing on its substantial equivalence to a predicate device. It details various technical characteristics and performance testing but does not explicitly define acceptance criteria in terms of specific quantitative thresholds or clinical endpoints for a study.
Instead, the submission states that the ZTX device met performance standards and demonstrated substantially equivalent diathermic heating effects and safety profiles to the predicate device. This implies that the 'acceptance criteria' were essentially demonstrating compliance with regulatory standards (21 CFR 1050.10, IEC 60601-1, IEC 60601-1-2) and showing comparable performance to the predicate.
Given this, I will interpret "acceptance criteria" as the performance standards and substantial equivalence claims mentioned, and "reported device performance" as the documented outcomes against those standards and claims.
Here's the information requested, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with 21 CFR 1050.10 for ultrasonic diathermy devices | All requirements were met (see Section 18). Bench verification testing demonstrated full adherence. |
| Compliance with IEC 60601-1 (General requirements for basic safety and essential performance) | All requirements were met as described in forms 3654 (see Section 17). |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | All requirements were met as described in forms 3654 (see Section 17). |
| Substantially equivalent diathermic heating effects to predicate (ex vivo bovine muscle model) | The ZTX Ultrasonic Diathermy Device demonstrated substantially equivalent diathermic heating effects on an ex vivo bovine muscle model (see Section 18). |
| Substantially equivalent diathermy and safety profiles to predicate (in vivo swine model) | In a direct comparison to the predicate, the ZTX Ultrasonic Diathermy Device demonstrated substantially equivalent diathermy and safety profiles in a GLP structured in vivo swine model (see Section 19). |
| Biocompatibility (sensitization, cytotoxicity) | The ZTX Ultrasonic Diathermy Device and ZTX Ultrasound Coupling Bandage demonstrated biocompatibility in sensitization, and cytotoxicity (see Section 15). |
| Overall safety and effectiveness as predicate device | Across all performance testing, the ZTX Ultrasonic Diathermy Device with ZTX Ultrasound Coupling Bandage was found to be as safe and effective as the predicate device. The ZTX is a scaled-down version of the predicate device with a reduced number of modes and features, but this does not impact the intended therapeutic effect, safety, or effectiveness of the device when used as labeled. Operation and technical characteristics are substantially equivalent to, and as safe and effective as, the predicate device. |
Study Details:
-
Sample size used for the test set and the data provenance:
- Ex vivo bovine muscle model: Sample size not specified. Data provenance: ex vivo, specific country not mentioned.
- In vivo swine model: Sample size not specified. Data provenance: in vivo, GLP structured, specific country not mentioned.
- Biocompatibility: Sample size not specified (e.g., number of test articles or subjects). Data provenance: contract laboratory.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document describes engineering (bench testing) and animal model studies, not studies involving human experts establishing ground truth for perception or diagnostic tasks. Therefore, this information is not applicable in the context of this device's submission. The "ground truth" for the performance tests would be the measured physical parameters (e.g., temperature changes, power output, safety parameters) and biological responses in the animal model.
-
Adjudication method for the test set:
- This concept is typically relevant for human-in-the-loop studies involving subjective interpretations (e.g., medical imaging reviews). For the bench and animal model testing described, adjudication in this sense is not applicable. The 'adjudication' would be the scientific interpretation and analysis of the quantitative results by qualified individuals, though no specific multi-expert adjudication process is described.
-
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:
- No MRMC or human-in-the-loop study with human readers/AI assistance was conducted or mentioned. This information is not applicable as the device is an ultrasonic diathermy device, not an AI-powered diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The ZTX device does not contain software or firmware that controls its functionality, nor does it have a microprocessor or CPU. It's a hardware-based therapeutic device. Therefore, a standalone algorithm-only performance study is not applicable. The performance testing described is of the physical device's output and effects.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench testing: Ground truth was based on measurements of physical parameters (e.g., power, frequency, beam characteristics) and diathermic heating effects (temperature changes) in an ex vivo model, compared to established standards and the predicate device's performance.
- In vivo swine model: Ground truth was based on physiological responses and safety profiles observed in the animal model, compared to the predicate device.
- Biocompatibility: Ground truth was based on established assays for sensitization and cytotoxicity.
-
The sample size for the training set:
- The ZTX device is a hardware-based therapeutic device without software, firmware, or AI components that would require a "training set" in the computational sense. Therefore, this question is not applicable. The device was designed and then tested against performance standards and a predicate.
-
How the ground truth for the training set was established:
- As there is no "training set" in the context of this device, this question is not applicable.
{0}------------------------------------------------
K130978
SECTION 5. 510(k) SUMMARY
In accordance with the Safe Medical Devices Act of 1990 and the final rule concerning 510(k) Summaries published in the Federal Register on December 14, 1995, page 64287 (Vol. 59, No. 239), with an effective date of March 14, 1995, ZetrOZ has prepared this 510(k) Summary in compliance with 21 CFR Part 807.93 which is included below.
Date prepared: April 8th 2013
SECTION 5.1 REASON FOR SUBMISSION
The ZTX Ultrasonic Diathermy Device is a new device and ZetrOZ INC is therefore submitting a new 510(k) to FDA for clearance to market and distribute the device into interstate commerce in the United States of America.
SUBMITTER/510(K) HOLDER SECTION 5.2
| Name: | ZetrOZ, INC |
|---|---|
| Address: | 56 Quarry Rd. Trumbull, CT 06611 |
| Contact Person: | Dr. George K. Lewis Jr. |
| Telephone: | 888-202-9831 Ext. 700 |
April 8" 2013 Date Prepared:
DEVICE NAME SECTION 5.3
| Proprietary Name: | ZTX |
|---|---|
| Common/Usual Name: | Ultrasonic Diathermy device |
| Classification Name: | Ultrasonic Diathermy Device (21 CFR 890.5300) |
| Review Panel: | Physical Medicine |
| Product Code | IMI |
| Class: | II |
| Performance Standard: | 21 CFR 1050.10 (April 1, 2012) |
SECTION 5.4 INTENDED USE
ZTX is intended to supply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, muscle spasms, joint contractures, and increase local circulation.
The ZTX Ultrasonic Diathermy Device is a prescription use device. The ZTX Device should only be administered and monitored by a licensed healthcare practitioner.
.
DEVICE DESCRIPTION OVERVIEW SECTION 5.5
Section 11 of this submission contains a detailed description of the ZTX Ultrasonic Diathermy Device. This section is intended as a brief introduction to the device.
{1}------------------------------------------------
The ZTX Ultrasonic Diathermy Device consists of a ZTX Ultrasound Power Controller and cable which can be used to power one or two ZTX Ultrasound Applicators simultaneously that each generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per ZTX Ultrasound Applicator. The ZTX Ultrasound Applicators are applied with one time use ZTX Ultrasound Coupling Bandages which hold the ZTX Ultrasound Applicators in place during treatment and allow for the transmission of ultrasound into the body. This provides the operator with the ability to use the device hands-free in a single applicator mode of operation that delivers 0.65W at 3MHz or in a dual applicator mode of operation that provides 1.3W at 3MHz. The ZTX Ultrasound Power Controller displays battery and treatment setting information to the operator and provides control of device treatment time. The ZTX Ultrasound Applicator frequency and power settings are not modifiable by the operator. The ZTX ultrasound applicators and coupling bandage allows for the delivery of ultrasonic energy to tissue at one or two locations simultancously, as determined by a physician. The ZTX Ultrasound Power Controller , ZTX Ultrasound Applicators, interconnecting power cable and ZTX Ultrasound Coupling Bandages comprise the entire ZTX treatment system.
SECTION 5.6 PERFORMANCE TESTING
The ZTX Ultrasonic Diathermy Device was evaluated by ZetrOZ Inc. testing to the performance standards set forth under 21 CFR 1050.10 (April 1, 2012) for ultrasonic diathermy devices and demonstrated that all requirements were met (see Section 18). Third party verification testing of IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Version 2, 1988 + A1:1991 + A2:1995) and IEC 60601-1-2 Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility (Version 3, 2012) was conducted and showed that all requirements were met as described in forms 3654 for each standard cited (see Section 17). In a series of bench testing experiments, the ZTX Ultrasonic Diathermy Device demonstrated i substantially equivalent diathermic heating effects on an ex vivo bovine muscle model (see Section 18). Additionally, bench verification testing was completed to demonstrate full adherence to the diathermy ultrasonic performance standard of 21 CFR 1050.10 (April 1. 2012) (sec Section 18).
In a direct comparison to the predicate, the ZTX Ultrasonic Diathermy Device demonstrated substantially equivalent diathermy and safety profiles in a GLP structured in vivo swine model (see Section 19). The ZTX Ultrasonic Diathermy Device and ZTX Ultrasound Coupling Bandage demonstrated biocompatibility in sensitization, and cytotoxicity (see Section 15). Across all performance testing, the ZTX Ultrasonic Diathermy Device with ZTX Ultrasound Coupling Bandage was found to be as safe and effective as the predicate device
SECTION 5.7 SUBSTANTIAL EQUIVALENCE SUMMARY
5.7.1 Predicate Devices
The ZTX Ultrasound Diathermy Device is substantially equivalent to the METRON MEDICAL AUSTRALIA PTY LTD, ACCUSONIC ADVANTAGE (K120171). Section 12 contains a detailed comparison of the ZTX Ultrasound Diathermy Device with the
{2}------------------------------------------------
predicate device. Below is the substantial equivalence table for the ZTX and Accusonic Advantage devices.
| Characteristic | ZTX | ACCUSONICADVANTAGE | COMPARISON |
|---|---|---|---|
| Classification Name | Ultrasonic DiathermyDevice | Ultrasonic DiathermyDevice | Identical |
| Service Type | Physical Medicine | Physical Medicine | Identical |
| Therapeutic - Class II | Therapeutic - Class II | Identical | |
| Product Code | IMI | IMI | Identical |
| Intended Use | To apply ultrasonicenergy to generate deepheat within body tissuesfor the treatment ofselected medicalconditions such as reliefof pain, muscle spasms,joint contractures andincrease local circulation(21CFR 890. 5300). | To apply ultrasonicenergy to generate deepheat within body tissuesfor the treatment ofselected medicalconditions such as reliefof pain, muscle spasms.joint contractures andincrease local circulation(21CFR 890. 5300). | Identical |
| Target Population | People suffering from jointand muscle conditionsdiagnosed by a physician | People suffering fromjoint and muscleconditions diagnosed by aphysician | Identical |
| Output Channels | 2 independent powerchannels | 2 independent powerchannels | Identical |
| Number ofTreatment Modes | 2 discrete settings ofpower at the samefrequency | 450 discrete settings ofultrasound frequency,plus width. duty cycle andpower | Different: ZTX has 2preset outputcharacteristics while thepredicate has 450different treatmentmodesAs shown in Section 18performance testing.ZTX treatment settingsare substantiallyequivalent to two of thepredicates treatmentsettings. |
| Frequency(Hz) | 3MHz ± 20% | 1.1MHz ± 20% & 3.3MHz ± 20% | Different: ZTX operatesat 3MHz. while thepredicate deviceoperates at both 1.1MHz and 3.3 MHz |
| Temporal AveragePower for eachTreatment Mode(Watts) | Single Applicator:At 3MHz: 0.65W ± 20%Dual Applicator:At 3MHz: 1.3W ± 20% | Single Applicator:At 1.1MHz: 0-12W±20% in 0.5W incrementsAt 3.3 MHz 0-7.5W±20% in 0.5W increments | The ZTX provides asubset of theperformance of thepredicate device and isstill as safe andeffectiveDifferent: ZTXprovides a presettreatment while thepredicate has a largerrange of output powers. |
| Duty Cycle | Continuous - 100% dutycycle | At 1.1MHz and 3.3 MHz:Continuous 100% dutycycle or Pulsed 10, 20%,and 50% duty cycle | The ZTX provides asubset of theperformance of thepredicate device and isstill as safe andeffectiveDifferent: ZTX operatesat 100% duty cyclewhile the predicate canoperate at 10-100%duty cycle. |
| Temporal MaximumIntensity (Watts percm²) | 0.264 W/cm² ± 20% | At 1.1MHz: 3W/cm²At 3.3MHz: 3W/cm² | The ZTX provides asubset of theperformance of thepredicate device and isstill as safe andeffectiveDifferent: The ZTXUltrasonic DiathermyDevice has a lowermaximum intensityThe ZTX provides alower maximumintensity but is still asubset of theperformance of thepredicate device and isstill as safe andeffective |
| Peak Power (Watts) | 1.3W ± 20% | 12W± 20% | Different: The ZTXUltrasonic DiathermyDevice has a lowermaximum power |
| Power Supply | 120/240 VAC with 5V DCInput Power Jack andBattery Powered | 120/240V AC InputPower Jack | subset of theperformance of thepredicate device andstill as safe andeffectiveDifferent: The ZTXoperates in both DCand AC mode. Thepredicate deviceoperates in AC mode |
| Maximum BatteryLife | 4 Hours | Not battery operated | only.Different: The ZTX isbattery operated whilethe predicate is not.This does not affect thesafety or efficacy of thedevice. |
| Maximum treatmenttimer setting | 4 Hours | 0.5 Hours | Different: The ZTXUltrasonic DiathermyDevice may be set tolonger treatmentduration.As shown in Sectionand 19 performancetesting. ZTX treatmentsettings are identical totwo of the predicatetreatment settings aresubstantiallyequivalent.Furthermore, both ZTXand predicate providesubstantially equivalentheating and safetyprofiles. |
| TherapeuticallyApplied | Ultrasound Coupling GelorUltrasound CouplingBandage | Ultrasound Coupling GelorWater Bath | Different: The ZTXmay be applied with aZTX ultrasoundcoupling bandage |
| Beam NonUniformity Ratio(BNR) | BNR: <5:1 ± 20% | BNR <5:1 ± 20% | Identical |
| Applicator Type | Up to two circularApplicators with 3 MHzoutput | Up to two circularApplicators with 1.1 MHzand 3.3 MHz capability | Different: The ZTXUltrasonic DiathermyDevice provides asingle frequency outputwhile the predicateprovides two |
Table 5.1: Substantial equivalence table for ZTX and Accusonic Advantage Predicate.
{3}------------------------------------------------
:
:
.
{4}------------------------------------------------
.
: : : : :
:
{5}------------------------------------------------
| 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 |
|---|---|---|---|
| Effective RadiatingArea (ERA) | One: 6 cm²Two:12 cm²± 20% | One: 5 cm²Two:10 cm²± 20% | Different: The ZTXprovides a slightlylarger ERA. This doesnot affect the safety orefficacy of the ZTX. |
| Beam Type | Diverging | Collimated | Different: The ZTXUltrasound Applicatorspreads the ultrasoundfield as the energy isdelivered into thepatient. This does notaffect the safety orefficacy of the ZTX. |
| Piezo-CrystalMaterial | Lead Zirconate-Titanate | Lead Zirconate-Titanate | Identical |
| Coupling Bandage | ABS Plastic withintegrated couplingmedium | None | Different: The ZTXUltrasonic DiathermyDevice includes acoupling bandage whilethe predicate does not.This does not affect thesafety or efficacy of theZTX. |
| Applicator LensMaterial | Ultem | Aluminum | Different: The ZTXUltrasonic DiathermyDevice is made frombiocompatible plasticwhile the predicate ismade frombiocompatiblealuminum. Thedifferent applicatormaterials do not affectthe safety or efficacy ofthe ZTX. |
| Environmental -OperatingTemperature Range | 0°C to +50°C (32°F to+122°F) | 0°C to +50°C (32°F-+122°F) | Identical |
| PerformanceStandards | 21 CFR 1050.10 | 21 CFR 1050.10 | Identical |
| Sterility | Non Sterile | Non Sterile | Identical |
| Designed to meetElectrical Safety | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 | Identical |
. .
.
.
:
.
.
.
.
{6}------------------------------------------------
| Power ControllerSize | 2.4 x 2.79 x 0.74 in | 9.5 x 4.7 x 9.5 in | Different: The ZTXUltrasonic DiathermyDevice is smaller thanthe predicate device.This does not affect thesafety or efficacy of theZTX. |
|---|---|---|---|
| IndividualApplicator Size | 1.52 x 1.30 x 0.45 in | Aprox~1.6 in Diameter5 in Length | Different: The ZTXUltrasound Applicatoris smaller than thepredicate. This does notaffect the safety orefficacy of the ZTX. |
| Biocompatibility | Yes | Yes | Identical |
| Mechanical safety | Yes | Yes | Identical |
| Radiation safety (ifnot radioactive stateas such) | Not Radioactive | Not Radioactive | Identical |
| Software/Firmware | No | Yes: MODERATE LOC | Different: The ZTXUltrasonic DiathermyDevice does not includeany software, unlike thepredicate. This does notaffect the safety orefficacy of the ZTX. |
5.7.2 Summary
This pre-market notification demonstrates Substantial Equivalence of the ZetrOZ ZTX Ultrasound Diathermy Device to the predicate Accusonic Advantage as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
{7}------------------------------------------------
SECTION 5.8 . . SOFTWARE/FIRMWARE
The ZTX Ultrasonic Diathermy Device has no software or firmware and no volatile memory. The ZTX Ultrasonic Diathermy Device has no microprocessor. CPU or programmable device that changes or controls the functionality of the device.
However, there is an internal battery fuel gauge integrated circuit (IC) that requires data to be downloaded to the device's non-volatile memory during manufacturing to configure the IC to recognize the battery characteristics required for full and empty battery capacity detection. This commercially available IC has limited functions: it monitors the battery capacity. it drives the LED fuel level display, and prevents the setting of treatment time in excess of current battery capacity.
SECTION 5.9 LABELING OVERVIEW
5.9.1 Claims
ZetrOZ makes the following claims for the ZTX Ultrasonic Diathermy Device:
The ZTX Ultrasonic Diathermy Device will apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain. muscle spasms, joint contractures, and increase local circulation.
The ZTX Ultrasonic Diathermy Device is a prescription use device. The ZTX Device should only be administered and monitored by a licensed healthcare practitioner.
5.9.2 Labeling
Instructions for use, ZTX Ultrasound Power Controller labeling, ZTX Ultrasound Applicator labeling, ZTX Ultrasound Coupling Bandage labeling, and promotional literature are contained in Section 13 of this submission.
SECTION 5.10 CONCLUSION
The ZTX Ultrasonic Diathermy Device intended use, and indications statement for use, are substantially equivalent to the previously cleared predicate device. Furthermore, the ZTX Ultrasonic Diathermy Device has the same intended use and target population as the predicate device. ZetrOZ has demonstrated through performance testing on the ZTX Ultrasonic Diathermy Device that it is substantially equivalent to the predicate device. This was shown in a series of bench testing, in vivo swine testing, contract laboratory biocompatibility testing, and verification and validation testing of the ZTX Ultrasonic Diathermy Device. The ZTX is a scaled down version of the predicate device with reduced number of modes and features compared to the predicate device. This however does not impact the intended therapeutic effect, safety, or effectiveness of the device when used as labeled. Therefore, operation, and technical characteristics of the ZTX system are substantially equivalent to, and as safe and effective as, the predicate device.
{8}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Cantrol Center - W066-G609 Silver Spring MD 20993-0002
December 6, 2013
ZetrOZ INC George K. Lewis, Jr., PhD Chief Scientific Officer 56 Quarry Road Trumbull, CT 0661 1
Re: K130978
Trade/Device Name: ZTX Ultrasonic Diathermy Device Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: PFW Dated: October 31, 2013 Received: November 4, 2013
Dear Dr. 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register,
Please be advised that FDA's issuance of a substantial equivalence determination does not mean . that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
{9}------------------------------------------------
Page 2 - Dr. George K. Lewis, Jr.
. : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fdg.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (2)CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{10}------------------------------------------------
Indications for Use
510(k) Number (if known): K130978
Device Name: ZTX Ultrasonic Diathermy Device
Indications For Use:
· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
The ZTX Ultrasonic Diathermy Device is intended 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.
The ZTX Ultrasonic Diathermy Device is a prescription use device. The ZTX Device should only be administered and monitored by a licensed healthcare practitioner.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
.
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whanq -S
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.