(126 days)
No
The document describes a physical device that generates acoustic waves for treatment and does not mention any software or algorithms that would utilize AI or ML.
Yes
The device is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers, which is a therapeutic purpose.
No
The device is indicated for the treatment of diabetic foot ulcers by delivering acoustic pressure shockwaves, not for diagnosing conditions.
No
The device description clearly outlines physical hardware components including an electrically powered generator, a hand-held applicator, a water-filled coupling membrane, and a silicone membrane. This indicates it is a hardware device that likely includes software for control, but is not software-only.
Based on the provided information, the OrthoGold 100™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a person's health status, diagnose diseases, or monitor treatment.
- OrthoGold 100™ Function: The OrthoGold 100™ is a therapeutic device that delivers acoustic pressure shockwaves directly to the patient's body (specifically, diabetic foot ulcers) to promote healing. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it is for the treatment of diabetic foot ulcers, not for diagnosis or analysis of samples.
- Device Description: The description details a system for generating and applying acoustic waves, not for processing or analyzing biological samples.
Therefore, the OrthoGold 100™ is a therapeutic 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 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.
Product codes
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
foot (for diabetic foot ulcers)
Indicated Patient Age Range
adult (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 - 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 contains 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.
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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: 703-562-9800 x251
Fax: 703-562-9797
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:
Tissue Regeneration
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
Characteristic | Subject Device
OrthoGold 100 | Reference
Predicate
OrthoGold 100 | Primary Predicate Device
dermaPACE System | Comparison |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | To be assigned | K182682 | DEN160037 | 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 | Activation of
connective
tissue | Intended for 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
dermaPACE System is indicated for
adult (22 years and older), diabetic
patients presenting with diabetic | Identical |
The table below compares the OrthoGold 100 characteristics to the predicate devices.
5
| Product
Characteristic | Subject Device
OrthoGold 100 | Reference
Predicate
OrthoGold 100 | Primary Predicate Device
dermaPACE System | Comparison |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------|
| | 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. | | foot ulcers greater than 30 days in
duration and is indicated for use in
conjunction with standard diabetic
ulcer care. | |
| Modes of Action | Unfocused pressure pulses | | Focused pressure | Similar |
| Mechanisms of
Action | Extracorporeally induced unfocused pressure
pulses | | Extracorporeally induced focused
pressure pulses | Similar |
| Maximum and
Minimum
intensity settings | 1 to 16 | | 1 to 6 | Similar |
| Number and size
of treatment
applicator heads | OP155
Size: 230 x ø 70 mm | | 1 applicator (size not available) | Similar |
| Operating mode | Continuous | | Continuous | Similar |
| Pulse repeat rate
(1/s) | 1 - 8 Hz | | 1-4 Hz | Similar |
| Number of pulses
(min and max) | 300 - 1300 | | 500 to Specific Value Not
Available | Similar |
| Maximum
operating
temperature | Room temperature | | Specific Value Not Available | Similar |
| Type of acoustic
wave generation | Electro hydraulic, spark gap under water
caused by discharge of high voltage
condensers | | Electro hydraulic, spark gap under
water caused by discharge of high
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.