(143 days)
Not Found
No
The provided text describes a physical device that generates acoustic waves for burn treatment. There is no mention of AI, ML, image processing, or any data-driven algorithms for diagnosis, treatment planning, or device control. The performance study focuses on clinical outcomes of the physical therapy.
Yes
The device is used to treat superficial partial thickness second-degree burns.
No
Explanation: The device is described as a pulsed acoustic wave device used for the treatment of superficial partial thickness second degree burns, not for diagnosing medical conditions. Its function is to provide acoustic pressure shockwaves for therapeutic purposes, as evidenced by the "Intended Use / Indications for Use" and "Device Description" sections.
No
The device description clearly outlines hardware components including an electrically powered generator, hand-held applicator, coupling membrane, and silicone membrane, indicating it is a physical device that utilizes acoustic waves.
Based on the provided information, the OrthoGold 100™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- OrthoGold 100™ Function: The OrthoGold 100™ is a therapeutic device that applies acoustic pressure shockwaves directly to the body (specifically, to burn wounds) for treatment. It does not analyze any specimens taken from the body.
Therefore, the OrthoGold 100™ falls under the category of a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The OrthoGold 100™ is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years and older). The OrthoGold 100 is indicated for use in conjunction with standard of care burn treatment(s).
Product codes (comma separated list FDA assigned to the subject device)
PZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults (22 years and older)
Intended User / Care Setting
Not Found
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)
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 also conducted. The testing demonstrated that the OrthoGold 100™ met performance requirements and is substantially equivalent to the predicate device.
Performance Data - Animal: A study investigated the role of ESWT on the early proinflammatory response using a severe, full-thickness and highly inflammatory cutaneous burn wound in a murine model. Various wound-healing parameters were measured and leukocyte infiltration quantitated. The study demonstrated that ESWT of burn wounds 1hour post wounding significantly blunts some immune responses in the wound and attenuates activity at the wound margin. The authors speculate that ESWT may be a potential therapeutic modality to treat severe wounds wherein excessive inflammatory responses involving increased levels of inflammatory cells, proinflammatory cytokines and proteases may become self-resolving allowing wound healing to progresses by way of normal physiological repair processes. The study supports the safe and effective use of the OrthoGold in second-degree burn.
Performance Data – Clinical: A prospective randomized controlled study of 44 patients in each group demonstrated that treatment with the OrthoGold 100 device in addition to standard of care was safe and effective to treat superficial second-degree burn wounds. Adult patients presenting with superficial second-degree burns involving the epidermis and extending into the dermis were included in the study. Patients were excluded with first degree burns, second degree deep dermal and third-degree burns. In addition, the exclusion criteria included patients with insulin dependent diabetes mellitus, dialysis dependent renal failure, ongoing systemic therapy for malignancy, dermatologic disease, ongoing corticosteroid therapy, and active drug abuse. The control group included 18 males and 4 females who received standard of care burn treatment, which consisted of wound debridement and daily antiseptic dressing changes. The treatment group included 14 males and 8 females who underwent the same standard of care burn treatment in addition to ESWT administered within 24 hours of burn wound debridement. The ESWT group received a single application of unfocused shock wave therapy to the study burn.
Results showed that the mean time to ≥95% epithelialization of the treated burns was significantly shorter for those treated with the OrthoGold device compared to standard of care alone, 9.6 ± 1.7 days for the ESWT group versus 12.5 ± 2.2 days for the control group (p
§ 878.4685 Extracorporeal shock wave device for treatment of chronic wounds.
(a)
Identification. An extracorporeal shock wave device for treatment of chronic wounds is a prescription device that focuses acoustic shock waves onto the dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must be conducted to demonstrate that the system produces anticipated and reproducible acoustic pressure shock waves.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate that the reusable components of the device can be reprocessed for subsequent use.
(4) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety of the device.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Performance data must support the use life of the system by demonstrating continued system functionality over the labeled use life.
(7) Physician labeling must include:
(i) Information on how the device operates and the typical course of treatment;
(ii) A detailed summary of the device's technical parameters;
(iii) Validated methods and instructions for reprocessing of any reusable components; and
(iv) Instructions for preventing hearing loss by use of hearing protection.
(8) Patient labeling must include:
(i) Relevant contraindications, warnings, precautions, adverse effects, and complications;
(ii) Information on how the device operates and the typical course of treatment;
(iii) The probable risks and benefits associated with the use of the device;
(iv) Post-procedure care instructions; and
(v) Alternative treatments.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 28, 2020
Tissue Regeneration Technologies, LLC % Jennifer Daudelin Official Correspondent M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New York, New York 10018
Re: K200926
Trade/Device Name: OrthoGold 100 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: August 26, 2020 Received: August 27, 2020
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, Ph.D. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
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 superficial partial thickness second degree burns in adults (22 years and older). The OrthoGold 100 is indicated for use in conjunction with standard of care burn treatment(s).
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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."
4
Tissue Regeneration Technologies, LLC
Section 5: 510(k) Summary
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
251 Heritage Walk
Woodstock, GA 30188 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jennifer A. Daudelin, M.S.J.
M Squared Associates, Inc.
575 Eighth Avenue, Suite 1212
New York, NY 10018
Ph: 347-954-0395
Fax: 703-562-9797
Email: jdaudelin@msquaredassociates.com |
| Date Prepared: | April 6, 2020 |
| Proposed Class: | II |
| Proprietary Name: | OrthoGold 100™ |
| 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: | |
| Manufacturer | Device Name | 510(k) Number | Procode | Class |
|---|---|---|---|---|
| Tissue Regeneration | ||||
| Technologies, LLC | OrthoGold 100TM | K191961 | PZL | II |
5
Tissue Regeneration Technologies, LLC
Indications for Use
The OrthoGold 100™ is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years and older). The OrthoGold 100 is indicated for use in conjunction with standard of care burn treatment(s).
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 Characteristic | Predicate Device
OrthoGold 100 | Subject Predicate
OrthoGold 100 | Comparison |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| 510(k) Number | K191961 | To be assigned | NA |
| Indications for Use | Intended for 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. | The OrthoGold 100™
is indicated to provide
acoustic pressure
shockwaves in the
treatment of superficial
partial thickness
second degree burns in
adults (22 years and
older). The OrthoGold
100 is indicated for use
in conjunction with
standard of care burn
treatment(s). | Both the subject and predicate
device are intended to apply
acoustic waves to dermal
wounds |
The table below compares the OrthoGold 100 characteristics to the predicate devices.
6
| Product Characteristic | Predicate Device
OrthoGold 100 | Subject Predicate
OrthoGold 100 | Comparison |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------|------------|
| Modes of Action | Unfocused pressure pulses | | Similar |
| Mechanisms of Action | Extracorporeally induced unfocused pressure pulses | | Similar |
| Maximum and
Minimum intensity
settings | 1 to 16 | | Similar |
| Number and size of
treatment applicator
heads | OP155
Size: 230 x Ø 70 mm | | Similar |
| Operating mode | Continuous | | Similar |
| Pulse repeat rate (1/s) | 1 - 8 Hz | | Similar |
| Number of pulses (min
and max) | 300 - 1300 | | Similar |
| Maximum operating
temperature | Room temperature | | Similar |
| Type of acoustic wave
generation | Electro hydraulic, spark gap under water caused by
discharge of high voltage condensers | | Similar |
Performance Data -Animal
A study investigated the role of ESWT on the early proinflammatory response using a severe, full-thickness and highly inflammatory cutaneous burn wound in a murine model. Various wound-healing parameters were measured and leukocyte infiltration quantitated. The study demonstrated that ESWT of burn wounds 1hour post wounding significantly blunts some immune responses in the wound and attenuates activity at the wound margin. The authors speculate that ESWT may be a potential therapeutic modality to treat severe wounds wherein excessive inflammatory responses involving increased levels of inflammatory cells, proinflammatory cytokines and proteases may become self-resolving allowing wound healing to progresses by way of normal physiological repair processes. The study supports the safe and effective use of the OrthoGold in second-degree burn.
Performance Data – Clinical
A prospective randomized controlled study of 44 patients in each group) demonstrated that treatment with the OrthoGold 100 device in addition to standard of care was safe and effective to treat superficial second-degree burn wounds. Adult patients presenting with superficial second-
7
degree burns involving the epidermis and extending into the dermis were included in the study. Patients were excluded with first degree burns, second degree deep dermal and third-degree burns. In addition, the exclusion criteria included patients with insulin dependent diabetes mellitus, dialysis dependent renal failure, ongoing systemic therapy for malignancy, dermatologic disease, ongoing corticosteroid therapy, and active drug abuse. The control group included 18 males and 4 females who received standard of care burn treatment, which consisted of wound debridement and daily antiseptic dressing changes. The treatment group included 14 males and 8 females who underwent the same standard of care burn treatment in addition to ESWT administered within 24 hours of burn wound debridement. The ESWT group received a single application of unfocused shock wave therapy to the study burn.
Results showed that the mean time to ≥95% epithelialization of the treated burns was significantly shorter for those treated with the OrthoGold device compared to standard of care alone, 9.6 ± 1.7 days for the ESWT group versus 12.5 ± 2.2 days for the control group (p