(380 days)
K21045
K21045
No
The description focuses on hardware modifications and software changes related to pulse count and applicator detection, with no mention of AI or ML algorithms for data analysis, decision-making, or performance enhancement beyond basic device control.
Yes
The device's intended uses, which include relief of muscle aches and pains and increasing local blood circulation, clearly fall under therapeutic applications.
No
The device description and its intended use solely refer to therapeutic applications (pain relief, increased blood circulation, tissue activation) and do not mention any diagnostic capabilities or functions.
No
The device description clearly outlines hardware components such as an electrically powered generator, hand-held applicator, coupling membrane, silicone membrane, and water cartridge. While software is mentioned as being modified, the device is fundamentally a hardware-based system that utilizes acoustic waves.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for the relief of muscle aches and pains, increasing blood circulation, and activating connective tissue. These are therapeutic applications, not diagnostic ones.
- 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 pain relief device, not a device that analyzes biological samples (which is the core function of an IVD).
- No mention of biological samples: There is no mention of the device interacting with or analyzing blood, urine, tissue, or any other biological sample.
- No mention of diagnostic purpose: The description and intended use do not indicate that the device is used to diagnose a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The OW100S (model OW100S-US) is intended for:
- Relief of minor muscle aches and pains
- Temporary increase in local blood circulation
- Activation of connective tissue
Product codes
ISA
Device Description
The OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a high voltage spark in water which creates the acoustic waves that rapidly expand, which in turn are propagated through a coupling membrane attached to the hand-held applicator, which is water-filled. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.
The modification to the OrthoGold 100 (OW100), identified as model OW100S and applicator OP155S, includes the addition of a "break circuit" added to the acoustic wave generator which increases the available pulses per handheld applicator/electrode from 100K pulses to 500K pulses at low energy flux density in the device (increase from 70K to 350K pulses at higher energy flux density). As a consequence of this change, there are minor changes to the applicator and its connection, software and water cartridge of the device. Minor labeling changes are limited to product information and set-up details with regard to attachment and detection of the applicator, and water cartridge handling.
There are no changes to the power output performance, electrode and reflector geometry, total primary electrical energy, energy flux density or penetration as a result of this change. New pressure measurements show little differences to previous measurements, however differences are of statistical nature.
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
The same verification and validation testing was performed for the current device design as the predicate and demonstrated that the OW100S 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 OW100S 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 performance testing demonstrated that the OW100S is substantially equivalent to the predicate device, OW100.
Key Metrics
Not Found
Predicate Device(s)
TRT, OrthoGold 100 (OW100) K21045
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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October 12, 2022
Tissue Regeneration Technologies, LLC DBA as SoftWave TRT % Cherita James Regulatory Consultant M Squared Associates. Inc 127 West 30th Street, 9th Floor New York, New York 10001
Re: K213120
Trade/Device Name: OW100S (model OW100S-US) Regulation Number: 21 CFR 890.5660 Regulation Name: Therapeutic Massager Regulatory Class: Class I Product Code: ISA Dated: September 12, 2022 Received: September 13, 2022
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/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.
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
1
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,
for Tushar Bansal, PhD Acting 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
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Indications for Use
510(k) Number (if known) K213120
Device Name OW100S (model OW100S-US)
Indications for Use (Describe)
The OW100S (model OW100S-US) 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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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.
| Sponsor: | SoftWave TRT, LLC |
|---|---|
| 195 Chastain Meadows CT. | |
| Suite 109 | |
| Kennesaw, GA 30144 |
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 of Submission: | September 12, 2022 |
|---|---|
| Proposed Class: | I |
| Proprietary Name: | OW100S (model OW100S-US) |
| Common Name: | Acoustic wave device |
| Classification Name: | Therapeutic massager |
| Regulation Number: | Section 890.5660 Therapeutic massager |
| Product Codes: | ISA |
| Predicate Device: | TRT, OrthoGold 100 (OW100) K21045 |
Device Description
The OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a high voltage spark in water which creates the acoustic waves that rapidly expand, which in turn are propagated through a coupling membrane attached to the hand-held applicator, which is water-filled. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.
4
The modification to the OrthoGold 100 (OW100) , identified as model OW100S and applicator OP155S, includes the addition of a "break circuit" added to the acoustic wave generator which increases the available pulses per handheld applicator/electrode from 100K pulses to 500K pulses at low energy flux density in the device (increase from 70K to 350K pulses at higher energy flux density). As a consequence of this change, there are minor changes to the applicator and its connection, software and water cartridge of the device. Minor labeling changes are limited to product information and set-up details with regard to attachment and detection of the applicator, and water cartridge handling.
There are no changes to the power output performance, electrode and reflector geometry, total primary electrical energy, energy flux density or penetration as a result of this change. New pressure measurements show little differences to previous measurements, however differences are of statistical nature.
Indications for Use
The OW100S is intended for:
- -Relief of minor muscles aches and pains
-Temporary increase in local blood circulation
-Activation of connective tissue.
Performance Data
The same verification and validation testing was performed for the current device design as the predicate and demonstrated that the OW100S 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 OW100S 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 performance testing demonstrated that the OW100S is substantially equivalent to the predicate device, OW100.
| The OW100S conforms to 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 | 19-8 |
5
| Standard | Recognition Number |
|---|---|
| tests | |
| 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 |
| IEC 60601-1-6 Edition 3.1 2013-10 | |
| Medical electrical equipment - Part 1-6: General requirements for basic safety and | |
| essential performance - Collateral standard: Usability | 5-89 |
| IEC 63045-2020: Ultrasonics - Non-focusing short pressure pulse sources including | |
| ballistic pressure pulse sources - Characteristics of fields | N/A |
| IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes | |
| [Including Amendment 1 (2016)] | 13-79 |
Substantial Equivalence
The modified OrthoGold 100, identified as OW100S, has the following similarities to those which
previously received 510(k) concurrence:
- . has the same indicated use,
- uses the same operating principle, .
- incorporates the same materials .
- incorporates the same basic device design, with the addition of the "break circuit" and minor . changes to the applicator, water cartridge, and software
The table below compares the OW100S characteristics to the predicate device.
| Product Characteristic | Subject Device
OW100S | Predicate Device
OrthoGold 100 (OW100) | Comparison |
|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K213120 | K210451 | NA |
| Indications for Use | The OW100S is intended for:
-Relief of minor muscles aches
and pains
-Temporary increase in local blood
circulation
-Activation of connective tissue. | The OrthoGold 100 is intended for:
-Relief of minor muscles aches and
pains
-Temporary increase in local blood
circulation
-Activation of connective tissue. | OW100S has the
same indications
and intended use
as the OW100 |
| Modes of Action | Unfocused pressure pulses | Unfocused pressure pulses | identical, no
change |
| Mechanisms of Action | Extracorporeally induced
unfocused pressure pulses | Extracorporeally induced unfocused
pressure pulses | identical, no
change |
| Maximum and Minimum
intensity settings | 1 to 16 | 1 to 16 | identical, no
change |
| Number and size of
treatment applicator heads | OP155S
Size: 230 x Ø 70 mm | OP155
Size: 230 x Ø 70 mm | identical, no
change |
| Product Characteristic | Subject Device
OW100S | Predicate Device
OrthoGold 100 (OW100) | Comparison |
| Electrode lifetime | E1-E10: 500K sw
E11-E16: 350K sw | E1-E10: 100K sw
E-11-E16: 70K sw | Break circuit
and modified
water cartridge
solution reduce
the wear of
electrodes over
time, but there is
no change to
device outputs at
selected energy
level, and
therefore no
change to
safety/effectiven
ess in treatment |
| Cartridge solution and
conductivity | Potassium bromide solution
2300μS/cm | Silver chloride solution 600μS/cm | Modified
solution to
support
extended
electrode life.
no change to
device outputs at
selected energy
level, and
therefore no
change to
safety/effectiven
ess in treatment |
| Type of application (e.g.,
continuous vibration at a
fixed frequency); | Continuous at various frequencies | Continuous at various frequencies | identical, no
change |
| Maximum and minimum
vibration frequency | Frequency of 1 - 8 Hz in steps of
0.5 Hz | Frequency of 1 - 8 Hz in steps of
0.5 Hz | identical, no
change |
| Driving Power | High voltage 2 - 7 kV
Capacitor: 0,2 uF | High voltage 2 - 7 kV
Capacitor: 0,2 uF | identical, no
change |
| Power Supply | 115 VAC | 115 VAC | identical, no
change |
| Maximum penetration
depth | 37.4 mm at energy level 16 | 25.4 mm at energy level 16 | similar, higher
max.penetration
depth due to
tolerances and
several
statistical
effects.
Geometry of
reflector in
applicator,
which defines
acoustic field,
remained
unchanged |
| Product Characteristic | Subject Device
OW100S | Predicate Device
OrthoGold 100 (OW100) | Comparison |
| Energy flow density
PIIT [mJ/mm2] | 0.00020 - 0.04900
at energy level 1 - 16 | 0.00017 - 0.04403
at energy level 1 - 16 | similar, values
of energy flow
density slightly
higher due to
tolerances and
several
statistical effects |
| Operating mode | Continuous | Continuous | identical, no
change |
| Pulse repeat rate (1/s) | 1 - 8 Hz | 1 - 8 Hz | identical, no
change |
| Number of pulses (min
and max) | 500-2000/ session | 500-2000/ session | identical, no
change |
| Maximum operating
temperature | Room temperature | Room temperature | identical, no
change |
| 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 | identical |
| Peak compressional
acoustic pressure
pc [Mpa] | 11.20 at energy level 16 | 9.27
at energy level 16 | similar, values
of peak
compressioneal
acoustic
pressure slightly
higher due to
tolerances and
several
statistical effects |
| Peak rarefactional acoustic
pressure
pcr[Mpa] | 1.22 at energy level 16 | -1.52 at energy level 16 | similar, values
of rarefractional
acoustic
pressure slightly
lower due to
tolerances and
several
statistical effects |
| Description of the spatial
distribution of the acoustic
pressure and intensity | Unfocused acoustic pressure field,
see pressure measurements | Unfocused acoustic pressure field,
see pressure measurements | Similar, no
change |
| Positive peak pressure
amplitude (MPa)
pc [Mpa] | 0.61 - 11.20at energy level 1 - 16 | 0.43 - 9.27
at energy level 1 - 16 | similar, values
of positive peak
pressure
amplitude
slightly higher
due to tolerances
and several
statistical effects |
| Negative peak pressure
amplitude (MPa)
pcr[Mpa] | -0.17 to - 1.22MPa
at energy level 1 - 16 | -0.17 to -1.52 MPa
at energy level 1 - 16 | similar, values
of negative peak
pressure
amplitude
slightly lower
due to tolerances and
several
statistical effects |
| Product Characteristic | Subject Device
OW100S | Predicate Device
OrthoGold 100 (OW100) | Comparison |
| | | | due to tolerances
and several
statistical effects |
| Derived focal acoustic
pulse energy (mJ)
EbT [mJ] | 0.020- 3.370 at energy level 1 - 16 | 0.022 - 2.278
at energy level 1 - 16 | similar values of
derived focal
acoustic pulse
energy differ
due to tolerances
and several
statistical effects |
| Derived pulse -intensity
integral, integrated over
total temporal integration
limits
PIIT [mJ/mm2] | 0.00020-0.04900 mJ/mm2
at energy level 1 - 16 | 0.00017 - 0.04403 mJ/mm2
at energy level 1 - 16 | similar, values
of derived pulse-
intensity integtal
slightly higher
due to tolerances
and several
statistical effects |
| Rise time (ns)
(10% - 90%) tr [us] | 1.08 - 0.18 at energy level 1 - 16 | 1.89 - 0.28 at energy level 1 - 16 | similar, values
of rise time
differ due to
tolerances and
several
statistical effects |
| Compressional pulse
duration (us)
tFWHMpc [uS] | 0.79 - 0.82 us at energy level 1 -
16 | 1.23 - 0.77 us at energy level 1 - 16 | similar, values
of
compressional
pulse duration
differ due to
tolerances and
several
statistical effects |
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7
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Clinical Information
Not applicable. Bench and performance testing support the substantial equivale in this submission.
Conclusion
The OW100S has the same indications for use and similar design features as compared with the predicate device system. The OW100S described in this submission is, in our opinion, substantially equivalent to the predicate, OrthoGold 100 (OW100). The proposed device performs as well as the legally marketed predicate device. Any differences between the subject and predicate device would not render the device NSE, affect the safety or effectiveness, or raise different questions of safety and effectiveness.