Who is the manufacturer of ZTX ULTRASONIC DIATHERMY DEVICE?

Zetroz, Inc. filed the 510(k) submission for ZTX ULTRASONIC DIATHERMY DEVICE (K130978).

What is the FDA product code for ZTX ULTRASONIC DIATHERMY DEVICE?

PFW. It is classified under 21 CFR 890.5300 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for ZTX ULTRASONIC DIATHERMY DEVICE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ZTX ULTRASONIC DIATHERMY DEVICE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ZTX ULTRASONIC DIATHERMY DEVICE

K130978 · Zetroz, Inc. · PFW · Nov 6, 2013 · Physical Medicine

Device Facts

Record ID	K130978
Device Name	ZTX ULTRASONIC DIATHERMY DEVICE
Applicant	Zetroz, Inc.
Product Code	PFW · Physical Medicine
Decision Date	Nov 6, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.5300
Device Class	Class 2
Attributes	Therapeutic

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 Story

ZTX Ultrasonic Diathermy Device delivers therapeutic ultrasonic energy to body tissues. System comprises power controller, cable, and one or two applicators held in place by single-use coupling bandages. Operates at 3 MHz frequency; delivers 0.65W (single applicator) or 1.3W (dual applicator) power. Used in clinical settings by healthcare practitioners to treat pain, muscle spasms, and joint contractures. Controller manages treatment time and displays battery status. Device provides hands-free application. Benefits include deep tissue heating to improve circulation and alleviate musculoskeletal conditions. No operator-adjustable frequency or power settings.

Clinical Evidence

No human clinical trials. Evidence includes bench testing per 21 CFR 1050.10, IEC 60601-1, and IEC 60601-1-2. Ex vivo bovine muscle model demonstrated equivalent diathermic heating. GLP-compliant in vivo swine model confirmed safety and efficacy profiles equivalent to predicate. Biocompatibility testing (sensitization, cytotoxicity) performed on applicators and coupling bandages.

Technological Characteristics

Lead Zirconate-Titanate piezo-crystals; Ultem applicator lens; ABS plastic coupling bandage. 3 MHz frequency; 0.65W/1.3W power output. Diverging beam type. Battery-powered or 120/240 VAC. Non-sterile. Complies with 21 CFR 1050.10, IEC 60601-1, and IEC 60601-1-2.

Indications for Use

Indicated for patients requiring deep tissue heating for relief of pain, muscle spasms, joint contractures, and increased local circulation. Prescription use only; administered and monitored by licensed healthcare practitioners.

Regulatory Classification

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.

Predicate Devices

Accusonic Advantage (K120171)

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Submission Summary (Full Text)

{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: <5:1 ± 20% | BNR <5:1 ± 20% | Identical | | Applicator Type | Up to two circular Applicators with 3 MHz output | Up to two circular Applicators with 1.1 MHz and 3.3 MHz capability | Different: The ZTX Ultrasonic Diathermy Device provides a single frequency output while the predicate provides two | Table 5.1: Substantial equivalence table for ZTX and Accusonic Advantage Predicate. {3}------------------------------------------------ : : . {4}------------------------------------------------ . : : : : : : {5}------------------------------------------------ | Applicator Type Applicator Emitting Surface Areas (cm²) | Up to two circular Applicators One Applicator : 5 cm² Two Applicators : 10 cm² | Up to two circular Applicators One Applicator : 5 cm² Two Applicators : 10 cm² | Identical | |---------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Effective Radiating Area (ERA) | One: 6 cm² Two:12 cm² ± 20% | One: 5 cm² Two:10 cm² ± 20% | Different: The ZTX provides a slightly larger ERA. This does not affect the safety or efficacy of the ZTX. | | Beam Type | Diverging | Collimated | Different: The ZTX Ultrasound Applicator spreads the ultrasound field as the energy is delivered into the patient. This does not affect the safety or efficacy of the ZTX. | | Piezo-Crystal Material | Lead Zirconate-Titanate | Lead Zirconate-Titanate | Identical | | Coupling Bandage | ABS Plastic with integrated coupling medium | None | Different: The ZTX Ultrasonic Diathermy Device includes a coupling bandage while the predicate does not. This does not affect the safety or efficacy of the ZTX. | | Applicator Lens Material | Ultem | Aluminum | Different: The ZTX Ultrasonic Diathermy Device is made from biocompatible plastic while the predicate is made from biocompatible aluminum. The different applicator materials do not affect the safety or efficacy of the ZTX. | | Environmental - Operating Temperature Range | 0°C to +50°C (32°F to +122°F) | 0°C to +50°C (32°F- +122°F) | Identical | | Performance Standards | 21 CFR 1050.10 | 21 CFR 1050.10 | Identical | | Sterility | Non Sterile | Non Sterile | Identical | | Designed to meet Electrical Safety | IEC 60601-1 IEC 60601-1-2 | IEC 60601-1 IEC 60601-1-2 | Identical | . . . . : . . . . {6}------------------------------------------------ | Power Controller Size | 2.4 x 2.79 x 0.74 in | 9.5 x 4.7 x 9.5 in | Different: The ZTX Ultrasonic Diathermy Device is smaller than the predicate device. This does not affect the safety or efficacy of the ZTX. | |-----------------------------------------------------------|-----------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Individual Applicator Size | 1.52 x 1.30 x 0.45 in | Aprox~1.6 in Diameter 5 in Length | Different: The ZTX Ultrasound Applicator is smaller than the predicate. This does not affect the safety or efficacy of the ZTX. | | Biocompatibility | Yes | Yes | Identical | | Mechanical safety | Yes | Yes | Identical | | Radiation safety (if not radioactive state as such) | Not Radioactive | Not Radioactive | Identical | | Software/Firmware | No | Yes: MODERATE LOC | Different: The ZTX Ultrasonic Diathermy Device does not include any software, unlike the predicate. This does not affect the safety or efficacy 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 ____________________________________________________________________________________________________________________________________________________________________

ZTX ULTRASONIC DIATHERMY DEVICE

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

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Regulatory Classification

Identification

Predicate Devices

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ZTX ULTRASONIC DIATHERMY DEVICE

Device Facts

Intended Use

Device Story

Clinical Evidence

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Predicate Devices

Related Devices

Submission Summary (Full Text)

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