(78 days)
Not Found
No
The device description and performance studies focus on the physical mechanism of acoustic wave generation and delivery, with no mention of AI or ML algorithms for data analysis, treatment planning, or any other function.
Yes
The device is described as relieving minor muscle aches and pains, temporarily increasing local blood circulation, and activating connective tissue, all of which are therapeutic effects.
No
The "Intended Use / Indications for Use" section specifies the device's purpose for "Relief of minor muscle aches and pains", "Temporary increase in local blood circulation", and "Activation of connective tissue", which are all therapeutic or treatment-oriented uses, not diagnostic.
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 with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the relief of muscle aches and pains, increasing blood circulation, and activating connective tissue. These are therapeutic applications performed on the body, not diagnostic tests performed on samples taken from the body.
- Device Description: The device description details a pulsed acoustic wave device that applies energy to the body. This is consistent with a physical therapy or therapeutic device, not an IVD which analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the OrthoGold 100 is a therapeutic device that applies acoustic waves to the body for treatment purposes, not a device that performs diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The OrthoGold 100 is intended for:
- Relief of minor muscle aches and pains
- Temporary increase in local blood circulation
- Activation of connective tissue
Product codes (comma separated list FDA assigned to the subject device)
ISA
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
Not Found
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)
Verification and validation testing was performed and demonstrated that the OrthoGold 100™ meets the design specifications and is safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed. The OrthoGold 100™ software was validated and demonstrated to be of a Moderate level of concern; while hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an an acceptable level. The OrthoGold 100 was tested and demonstrated to conform to the general safety requirements of IEC 60601-1:2005; as well as the electromagnetic compatibility requirements of IEC 60601-1-2:2014 (4th Ed.) and 60601-2-36. Invitro testing was performed to determine applicator displacement, force and penetration depth and was demonstrated to be equivalent to the AW module of the D-Actor 200 predicate device. In addition, probe cover testing and transport verification and validation was also conducted. The performance testing demonstrated that the OrthoGold 100 is substantially equivalent to 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
§ 890.5660 Therapeutic massager.
(a)
Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
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 & 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.
May 5, 2021
Tissue Regeneration Technologies, LLC % Cherita James Regulatory Consultant M Squared Associates, Inc. 127 West 30th St Floor 9 New York, New York 10001
Re: K210451
Trade/Device Name: OrthoGold 100 Regulation Number: 21 CFR 890.5660 Regulation Name: Therapeutic massager Regulatory Class: Class I Product Code: ISA Dated: February 12, 2021 Received: February 16, 2021
Dear Cherita James:
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/cdrl/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 medical devices and radiation-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.
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine 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 intended for:
- Relief of minor muscle aches and pains
- · Temporary increase in local blood circulation
- · Activation of connective tissue
Type of Use (Select one or both, as applicable) y 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
510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for 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 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
Ph: 1-404-402-6844 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Cherita James
M Squared Associates, Inc.
127 West 30th Street
9th Floor
New York, New York 10001
Ph: 347-536-1463
Fax: 703-562-9797
Email: CJames@MSquaredAssociates.com |
| Date prepared: | May 4, 2021 |
| Proposed Class: | I |
| Proprietary Name: | OrthoGold 100™ |
| Proprietary Name: | OrthoGold 100™ |
|---|---|
| Common Name: | Therapeutic Massager |
| Classification Name: | Massager, Therapeutic, Electric |
| Regulation Number: | 21 CFR 890.5660 |
| Product Codes: | ISA |
| Predicate Device: | Storz Medical D-Actor 200 Vibration Massage System K173692 |
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.
5
The technology and performance testing of the OrthoGold 100™ have been cleared previously (K182682). There are no changes to the OrthoGold 100™ regarding device characteristics, software, and device performance since the previous clearance.
Indications for Use
The OrthoGold 100 is intended for:
- Relief of minor muscle aches and pains
- · Temporary increase in local blood circulation
- · Activation of connective tissue
Performance Data
Verification and validation testing was performed and demonstrated that the OrthoGold 100™ meets the design specifications and is safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed. The OrthoGold 100™ software was validated and demonstrated to be of a Moderate level of concern; while hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an acceptable level. The OrthoGold 100 was tested and demonstrated to conform to the general safety requirements of IEC 60601-1:2005; as well as the electromagnetic compatibility requirements of IEC 60601-1-2:2014 (4th Ed.) and 60601-2-36. Invitro testing was performed to determine applicator displacement, force and penetration depth and was demonstrated to be equivalent to the AW module of the D-Actor 200 predicate device. In addition, probe cover testing and transport verification and validation was also conducted. The performance testing demonstrated that the OrthoGold 100 is substantially equivalent to the predicate device.
The OrthoGold 100 is compliant with the following standards:
| Standard | Recognition Number |
|---|---|
| IEC 61846 First edition 1998-04, ultrasonics - pressure pulse lithotripters - characteristics of | |
| fields | 9-7 |
| AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 | |
| (consolidated text) medical electrical equipment - part 1: general requirements for basic safety | |
| and essential performance | 19-4 |
| IEC 60601-1-2:2014 Edition 4, Medical electrical equipment - Part 1-2: General requirements | |
| for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances |
- Requirements and
tests | 19-8 |
| IEC 60601-2-36 Edition 2.0: 2014-04,
Medical electrical equipment - Part 2-36: Particular requirements for the safety of
equipment for extracorporeally induced lithotripsy | 9-119 |
| DRAFT IEC 63045 ED1, Ultrasonics - Non-focusing pressure pulse sources - Characteristics of
fields | N/A |
There are no changes to the standards referenced in the previous submission present no changes to the previously cleared OrthoGold 100.
6
Clinical Data
Clinical performance data is not relied upon to eastanblish the substantial equivalence of the subject and predicate device.
| Product Characteristic | Subject Device
OrthoGold 100™ | Predicate Device
D-Actor 200 | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | K210451 | K173692 | NA |
| Indications for Use | Relief of minor muscle aches
and pains
Temporary increase in local
blood circulation
Activation of connective tissue | Relief of minor muscle aches
and pains
Temporary increase in local
blood circulation
Activation of connective tissue | Equivalent |
| Modes of Action | Unfocused pressure pulses | Radial (unfocused) pressure
waves, or extracorporeal pulse
activation respectively | Similar |
| Mechanisms of Action | Extracorporeally induced
unfocused pressure pulses | Pneumatically generated
vibrations + unfocused pressure
pulses | Equivalent |
| Maximum and
Minimum intensity
settings | 1 to 16 | 1-5 bar | Similar |
| Number and size of
treatment applicator
heads | OP155
Size: 230 x Ø 70 mm | 4: 6mmOD, 15mmOD,
20mmOD, 35mmOD | Similar |
| Maximum and
minimum displacements
of applicator heads | Not Applicable | 0.6 - 2.0 mm | NA |
| Type of application
(e.g., continuous
vibration at a fixed
frequency); | Continuous at various
frequencies | Continuous at various
frequencies | Similar |
| Product Characteristic | Subject Device
OrthoGold 100TM | Predicate Device
D-Actor 200 | Comparison |
| Maximum and
minimum vibration
frequency | Frequency of 1 - 8 Hz in steps
of 0.5 Hz | 1-21 Hz | Similar |
| Driving Power | High voltage 2 - 7 kV
Capacitor: 0,2 uF | 1-5 bar | Similar |
| Power Supply | 115 VAC | 500 VA | Similar |
| Maximum penetration
depth | 25.4 mm at energy level 16 | 32mm | Similar |
| Energy flow density
PIIT [mJ/mm2] | 0.00017 - 0.04403
at energy level 1 - 16 | Values of ultrasonic pulse:
5bar/0.284mJ/mm2
3bar/0.176mJ/mm2 | Similar |
| Operating mode | Continuous | Continuous | Similar |
| Projectile mass (g) | Not Applicable | 3 | NA |
| Pulse repeat rate (1/s) | 1 - 8 Hz | 1-21 Hz | Similar |
| Number of pulses (min
and max) | 500 - 2000 | Variable | Similar |
| Maximum operating
temperature | Room temperature | 10-40C | Similar |
| Type of acoustic wave
generation | Electro hydraulic, spark gap
under water caused by
discharge of high voltage
condensers | Pneumatic/ballistic | Similar |
| Peak compressional
acoustic pressure
pc [MPa] | 9.27
at energy level 16 | 18.5 | Similar |
| Peak rarefactional
acoustic pressure
pcr[MPa] | -1.52 at energy level 16 | 6.8MPa at 5 bar | Similar |
| Product Characteristic | Subject Device | Predicate Device | |
| | OrthoGold 100TM | D-Actor 200 | Comparison |
| Description of the
spatial distribution of
the acoustic pressure
and intensity | Unfocused acoustic pressure
field, see pressure
measurements | Specific Value Not Available | Similar |
| Positive peak pressure
amplitude (MPa)
pc [MPa] | 0.43 - 9.27
at energy level 1 - 16 | 5 bar/18.5MPa
3bar/13.4MPa | Similar |
| Negative peak pressure
amplitude (MPa)
pcr[MPa] | -0.17 to -1.52 MPa
at energy level 1 - 16 | Values of ultrasonic pulse:
5bar/6.8MPa 3bar/5.0MPa | Similar |
| Derived focal acoustic
pulse energy (mJ)
EbT [mJ] | 0.022 - 2.278
at energy level 1 - 16 | Values of ultrasonic pulse:
5bar/6.5mJ
3bar/2.4mJ | Similar |
| Derived pulse -intensity
integral, integrated over 0.00017 - 0.04403 mJ/mm2
total temporal
integration limits
PIIT [mJ/mm2] | at energy level 1 - 16 | Values of ultrasonic pulse
5bar/0.284mJ/mm2
3bar/0.176mJ/mm2 | Similar |
| Rise time (ns)
(10% - 90%) tr [µs] | 1.89 - 0.28 at energy level 1 -
16 | Ultrasonic pulse: 2.5µs
Sonic pulse: 25µs – 2.5ms | Similar |
| Compressional pulse
duration (µs)
tFWHMpc [µS] | 1.23 - 0.77 µs at energy level 1
- 16 | Ultrasonic pulse: 5.0µs
Sonic pulse: 50µs – 5.0ms | Similar |
The table below compares the OrthoGold 100 characteristics to the predicate device.
7
8
Technological Characteristics and Substantial Equivalence
The OrthoGold 100 has the same indications for use and similar design features as compared with the predicate system. The bench testing demonstrates that the performance characteristics of the OrthoGold 100 are equivalent to those of other legally marketed therapeutic massagers, and therefore supports a determination of Substantial Equivalence for the proposed indications for use. Any differences between
9
K210451
the subject and predicate device would not render the device NSE, affect the safety or effectiveness, or raise different questions of safety and effectiveness.