(211 days)
Not Found
No
The device description and performance studies focus on standard ultrasonic diathermy technology with fixed parameters and no mention of adaptive or learning capabilities. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device description and intended use explicitly state that it is for the treatment of selected medical conditions such as pain relief, muscle spasms, joint contractures, and increased circulation, which are therapeutic applications.
No
The device is described as an "Ultrasonic Diathermy Device" 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." This indicates a therapeutic, not diagnostic, function.
No
The device description explicitly details hardware components including a power controller, cable, applicators, and coupling bandages, which are integral to its function of generating and delivering ultrasonic energy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- ZTX Device Function: The ZTX Ultrasonic Diathermy Device applies ultrasonic energy directly to the body tissues to generate heat for therapeutic purposes (pain relief, muscle spasms, etc.). It does not analyze samples taken from the body.
The description clearly indicates that the device is a therapeutic device used for physical treatment, not for diagnostic testing of biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IMI, PFW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed healthcare practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
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 | ACCUSONIC
ADVANTAGE | COMPARISON |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | Ultrasonic Diathermy
Device | Ultrasonic Diathermy
Device | Identical |
| Service Type | Physical Medicine | Physical Medicine | Identical |
| | Therapeutic - Class II | Therapeutic - Class II | Identical |
| Product Code | IMI | IMI | Identical |
| Intended Use | To 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
(21
CFR 890. 5300). | To 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
(21
CFR 890. 5300). | Identical |
| Target Population | People suffering from joint
and muscle conditions
diagnosed by a physician | People suffering from
joint and muscle
conditions diagnosed by a
physician | Identical |
| Output Channels | 2 independent power
channels | 2 independent power
channels | Identical |
| Number of
Treatment Modes | 2 discrete settings of
power at the same
frequency | 450 discrete settings of
ultrasound frequency,
plus width. duty cycle and
power | Different: ZTX has 2
preset output
characteristics while the
predicate has 450
different treatment
modes
As shown in Section 18
performance testing.
ZTX treatment settings
are substantially
equivalent to two of the
predicates treatment
settings. |
| Frequency
(Hz) | 3MHz ± 20% | 1.1MHz ± 20% & 3.3
MHz ± 20% | Different: ZTX operates
at 3MHz. while the
predicate device
operates at both 1.1
MHz and 3.3 MHz |
| Temporal Average
Power for each
Treatment 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 increments
At 3.3 MHz 0-7.5W±
20% in 0.5W increments | The ZTX provides a
subset of the
performance of the
predicate device and is
still as safe and
effective
Different: ZTX
provides a preset
treatment while the
predicate has a larger
range of output powers. |
| Duty Cycle | Continuous - 100% duty
cycle | At 1.1MHz and 3.3 MHz:
Continuous 100% duty
cycle or Pulsed 10, 20%,
and 50% duty cycle | The ZTX provides a
subset of the
performance of the
predicate device and is
still as safe and
effective
Different: ZTX operates
at 100% duty cycle
while the predicate can
operate at 10-100%
duty cycle. |
| Temporal Maximum
Intensity (Watts per
cm²) | 0.264 W/cm² ± 20% | At 1.1MHz: 3W/cm²
At 3.3MHz: 3W/cm² | The ZTX provides a
subset of the
performance of the
predicate device and is
still as safe and
effective
Different: The ZTX
Ultrasonic Diathermy
Device has a lower
maximum intensity
The ZTX provides a
lower maximum
intensity but is still a
subset of the
performance of the
predicate device and is
still as safe and
effective |
| Peak Power (Watts) | 1.3W ± 20% | 12W± 20% | Different: The ZTX
Ultrasonic Diathermy
Device has a lower
maximum power |
| | | | |
| Power Supply | 120/240 VAC with 5V DC
Input Power Jack and
Battery Powered | 120/240V AC Input
Power Jack | subset of the
performance of the
predicate device and
still as safe and
effective
Different: The ZTX
operates in both DC
and AC mode. The
predicate device
operates in AC mode |
| Maximum Battery
Life | 4 Hours | Not battery operated | only.
Different: The ZTX is
battery operated while
the predicate is not.
This does not affect the
safety or efficacy of the
device. |
| Maximum treatment
timer setting | 4 Hours | 0.5 Hours | Different: The ZTX
Ultrasonic Diathermy
Device may be set to
longer treatment
duration.
As shown in Section
and 19 performance
testing. ZTX treatment
settings are identical to
two of the predicate
treatment settings are
substantially
equivalent.
Furthermore, both ZTX
and predicate provide
substantially equivalent
heating and safety
profiles. |
| Therapeutically
Applied | Ultrasound Coupling Gel
or
Ultrasound Coupling
Bandage | Ultrasound Coupling Gel
or
Water Bath | Different: The ZTX
may be applied with a
ZTX ultrasound
coupling bandage |
| Beam Non
Uniformity Ratio
(BNR) | BNR: