OrthoGold

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November 26, 2019 Tissue Regeneration Technologies LLC % Jennifer Daudelin Regulatory Consultant III M Squared Associates, Inc 575 Eight Avenue, St. Suite 1212 New York, New York 10018 Re: K191961 Trade/Device Name: OrthoGold Regulation Number: 21 CFR 878.4685 Regulation Name: Extracorporeal Shock Wave Device for Treatment of Chronic Wounds Regulatory Class: Class II Product Code: PZL Dated: October 28, 2019 Received: October 29, 2019 Dear Jennifer Daudelin: 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Long Chen Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) Device Name OrthoGold 100 #### Indications for Use (Describe) The OrthoGold 100™ is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OrthoGold 100 is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><span style="font-size: 1.2em; margin-right: 0.2em;"> </span>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size: 1.2em; margin-right: 0.2em;"> </span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ # Section 5: 510(k) Summary # K191961 The following information is provided as required by 21 CFR § 807.87 for the Tissue Regeneration Technologies, LLC 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based. The safety and effectiveness of the OrthoGold 100™ is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device(s). | Sponsor: | Tissue Regeneration Technologies, LLC<br>251 Heritage Walk<br>Woodstock, GA 30188 | | | | |---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|---------|-------| | Contact: | Jennifer A. Daudelin, M.S.J.<br>M Squared Associates, Inc.<br>575 Eighth Avenue, Suite 1212<br>New York, NY 10018<br>Ph: 703-562-9800 x251<br>Fax: 703-562-9797<br>Email: jdaudelin@msquaredassociates.com | | | | | Date Prepared: | November 25, 2019 | | | | | Proposed Class: | II | | | | | Proprietary Name: | OrthoGold 100TM | | | | | Common Name: | Extracorporeal shock wave device for treatment of chronic wounds | | | | | Classification Name: | Extracorporeal shock wave device for treatment of chronic wounds | | | | | Regulation Number: | 21 CFR 878.4685 | | | | | Product Codes: | PZL | | | | | Predicate Device(s): | | | | | | Manufacturer | Device Name | 510(k) Number | Procode | Class | | Sanuwave, Inc. | dermaPACE System | DEN160037 | PZL | II | | Reference Device:<br>Tissue Regeneration<br>Technologies, LLC | OrthoGold 100TM | K182682 | ISA | I | {4}------------------------------------------------ ## Indications for Use The OrthoGold 100™ is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OrthoGold 100 is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. ### Device Description The OrthoGold 100™ is a pulsed acoustic wave device. It includes an electrically powered generator to generate transient compressed air that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached to the hand-held applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel. ### Performance Data – Non-Clinical The OrthoGold 100™ has been evaluated through non-clinical performance testing. The OrthoGold 100™ was tested for electrical safety and electromagnetic compatibility and pressure field measurements. In addition, probe cover testing and transport verification and validation was The testing demonstrated that the OrthoGold 100™ met performance also conducted. requirements and is substantially equivalent to the predicate device. | Product<br>Characteristic | Subject Device<br>OrthoGold 100 | Reference<br>Predicate<br>OrthoGold 100 | Primary Predicate Device<br>dermaPACE System | Comparison | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | 510(k) Number | To be assigned | K182682 | DEN160037 | NA | | Indications for<br>Use | Intended for treatment of<br>chronic, full-thickness<br>diabetic foot ulcers with<br>wound areas measuring no<br>larger than 16 cm2, which<br>extend through the<br>epidermis, dermis, tendon,<br>or capsule, but without<br>bone exposure. The<br>OrthoGold 100 is | Activation of<br>connective<br>tissue | Intended for the treatment of<br>chronic, full-thickness diabetic foot<br>ulcers with wound areas measuring<br>no larger than 16 cm2, which<br>extend through the epidermis,<br>dermis, tendon, or capsule, but<br>without bone exposure. The<br>dermaPACE System is indicated for<br>adult (22 years and older), diabetic<br>patients presenting with diabetic | Identical | The table below compares the OrthoGold 100 characteristics to the predicate devices. {5}------------------------------------------------ | Product<br>Characteristic | Subject Device<br>OrthoGold 100 | Reference<br>Predicate<br>OrthoGold 100 | Primary Predicate Device<br>dermaPACE System | Comparison | |-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------| | | indicated for adult (22<br>years and older), diabetic<br>patients presenting with<br>diabetic foot ulcers greater<br>than 30 days in duration<br>and is indicated for use in<br>conjunction with standard<br>diabetic ulcer care. | | foot ulcers greater than 30 days in<br>duration and is indicated for use in<br>conjunction with standard diabetic<br>ulcer care. | | | Modes of Action | Unfocused pressure pulses | | Focused pressure | Similar | | Mechanisms of<br>Action | Extracorporeally induced unfocused pressure<br>pulses | | Extracorporeally induced focused<br>pressure pulses | Similar | | Maximum and<br>Minimum<br>intensity settings | 1 to 16 | | 1 to 6 | Similar | | Number and size<br>of treatment<br>applicator heads | OP155<br>Size: 230 x ø 70 mm | | 1 applicator (size not available) | Similar | | Operating mode | Continuous | | Continuous | Similar | | Pulse repeat rate<br>(1/s) | 1 - 8 Hz | | 1-4 Hz | Similar | | Number of pulses<br>(min and max) | 300 - 1300 | | 500 to Specific Value Not<br>Available | Similar | | Maximum<br>operating<br>temperature | Room temperature | | Specific Value Not Available | Similar | | Type of acoustic<br>wave generation | Electro hydraulic, spark gap under water<br>caused by discharge of high voltage<br>condensers | | Electro hydraulic, spark gap under<br>water caused by discharge of high<br>voltage condensers | Similar | ## Performance Data - Clinical A literature review represents the published literature with the subject device through systematic, comprehensive literature searches and those articles known to the manufacturer. These studies demonstrate the successful clinical use with the OrthoGold technology in 224 diabetic foot ulcers. The studies show significant results in complete wound healing and reduction of wound area. The data from these studies establish the efficacy of the subject device to treat chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure and the safety of the device as shown with the lack of adverse events. {6}------------------------------------------------ ## Substantial Equivalence The OrthoGold 100™ has the same indications for use and similar design features as compared with the predicate systems. The bench testing and clinical data demonstrates that the performance characteristics of the OrthoGold 100™ are equivalent to those of the other legally marketed extracorporeal shock wave devices, and therefore supports a determination of Substantial Equivalence for the proposed indications for use. Different questions of safety and effectiveness were not raised between the subject and predicate devices.