(208 days)
OW100S K231710
Not Found
No
The document describes a pulsed acoustic wave device and its mechanical/electrical components. There is no mention of AI, ML, image processing, or any data-driven decision-making processes.
Yes
The device is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers and superficial partial thickness second-degree burns, which are therapeutic interventions.
No
The device is described as providing acoustic pressure shockwaves for treatment, not for diagnosis.
No
The device description explicitly details physical components like an electrically powered generator, applicator, coupling membrane, and silicone membrane, indicating it is a hardware device that utilizes software for control or operation, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The OW100S is a therapeutic device that uses acoustic pressure shockwaves to treat specific medical conditions (diabetic foot ulcers and burns). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a treatment modality, not a diagnostic test.
- Device Description: The description details the mechanism of generating and applying acoustic waves, which is consistent with a therapeutic device.
Therefore, the OW100S falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of chronic, fullthickness 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 OW100S 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 OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second dearee burns in adults (22 years or older). The OW100S 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 OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a high voltage spark in water that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.
Model OW100S and applicator OP155S includes a "break circuit" in the acoustic wave generator which increases the available pulses per handheld applicator/electrode from 100K pulses at low energy flux density in the device. Updates to labeling of the OW 100S includes revisions to contraindications/warnings/ cautions which do not raise different questions of safety and effectiveness, as they are in line with currently marketed acoustic wave devices for the same indications for use. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chronic, full-thickness diabetic foot ulcers, superficial partial thickness second degree burns
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)
The same verification and validation testing is applicable 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 OW100s cleared for Class II indications.
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.
TRT, OW100S K231710
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
§ 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 & 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.
July 9, 2024
Softwave/TRT LLC Cherita James Regulatory Consultant 3330 Highway 136 West Woodstock, Georgia 30175
Re: K233937
Trade/Device Name: Ow100s 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: June 11, 2024 Received: June 11, 2024
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Digitally signed by Long H. Chen -Long H. Chen-S
Date: 2024.07.09 11:52:38 -04'00"
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
OW100S
Indications for Use (Describe)
The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of chronic, fullthickness 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 OW100S 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 OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second dearee burns in adults (22 years or older). The OW100S 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)
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3
510(K) SUMMARY
The following information is provided as required by 21 CFR § 807.87 for SoftWaveTRT 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.
- SoftWaveTRT LLC Sponsor: 3330 Highway 136 West Woodstock, GA 30175
- Contact: Cherita James M Squared Associates/a PPG Company 1129 20th St. NW Suite 600 Washington, DC 20036 Ph: 347-536-1463 Email: Cherita.James(@ProPharmaGroup.com
Submitted date: July 8, 2024
| Proposed Class: | II |
|---|---|
| Proprietary Name: | OW100S (model OW100S-US) |
| Common Name: | Acoustic wave device |
| Classification Name: | Extracorporeal shock wave device for treatment of chronic wounds |
| Regulation Number: | Section 878.4685 Extracorporeal shock wave device for treatment of chronic wounds. |
| Product Codes: | PZL |
| Predicate Device: | TRT, OW100S K231710 |
Device Description
The OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a high voltage spark in water that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.
Model OW100S and applicator OP155S includes a "break circuit" in the acoustic wave generator which increases the available pulses per handheld applicator/electrode from 100K pulses at low energy flux density in the device. Updates to labeling of the OW 100S includes revisions to
4
K233937
contraindications/warnings/ cautions which do not raise different questions of safety and effectiveness, as they are in line with currently marketed acoustic wave devices for the same indications for use. 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.
Indications for Use
The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of chronic, fullthickness 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 OW100S 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 OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).
Performance Data
The same verification and validation testing is applicable 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 OW100s cleared for Class II indications.
| 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 |
The OW100S conforms to the following standards:
5
| Standard | Recognition Number |
|---|---|
| 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 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. .
The table below compares the OW100S characteristics to the predicate and reference device. Updates to labeling of the OW100S include revisions to contraindications/warnings/ precautions which do not raise different questions of safety and effectiveness, as they are in line with currently marketed acoustic wave devices for the same indications for use.
| Product
Characteristic | Subject Device
OW100S | Primary Predicate
device
OW100S | Comparison |
|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| 510(k) Number | TBD | K231710 | NA |
| Product code | PZL | PZL | Same |
| Indications for Use | The OrthoGold 100
OW100S 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
OW100S 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 | The OrthoGold 100
OW100S 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
OW100S 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 | OW100S has the same
indications and intended use
as the OW100S in K231710 |
| Product
Characteristic | Subject Device
OW100S | Primary Predicate
device
OW100S | Comparison |
| | standard diabetic ulcer
care. | standard diabetic ulcer
care. | |
| | The OrthoGold 100 OW100S
is indicated to provide
acoustic pressure shockwaves
in the treatment of superficial
partial thickness second
degree burns in adults (22
years or older). The
OrthoGold 100 OW100S is
indicated for use in
conjunction with standard of
care burn treatment(s). | The OrthoGold 100 OW100S
is indicated to provide
acoustic pressure shockwaves
in the treatment of superficial
partial thickness second
degree burns in adults (22
years or older). The
OrthoGold 100 OW100S is
indicated for use in
conjunction with standard of
care burn treatment(s). | |
| Modes of Action | Unfocused pressure pulses | Unfocused pressure pulses | identical to primary predicate
OW100S, no change |
| Mechanisms of Action | Extracorporeally induced
unfocused pressure pulses | Extracorporeally induced
unfocused pressure pulses | identical to primary predicate
OW100S, no change |
| Maximum and
Minimum intensity
settings | 1 to 16 | 1 to 16 | identical to primary predicate
OW100S, no change |
| Number and size of
treatment applicator
heads | OP155S
Size: 230 x Ø 70 mm | OP155S
Size: 230 x Ø 70 mm | identical to primary predicate
OW100S, no change |
| Electrode lifetime | E1-E10: 500K sw
E11-E16: 350K sw | E1-E10: 500K sw
E11-E16: 350K sw | identical to primary predicate
OW100S, no change |
| Cartridge solution and
conductivity | Potassium bromide solution
2300µS/cm | Potassium bromide solution
2300µS/cm | identical to primary predicate
OW100S, no change |
| Type of application
(e.g., continuous
vibration at a fixed
frequency); | Continuous at various
frequencies | Continuous at various
frequencies | identical to primary predicate
OW100S, 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 to primary predicate
OW100S, no change |
| Driving Power | High voltage 2 - 7 kV
Capacitor: 0,2 uF | High voltage 2 - 7 kV
Capacitor: 0,2 uF | identical to primary predicate
OW100S, no change |
| Power Supply | 115 VAC | 115 VAC | identical to primary predicate
OW100S, no change |
| Maximum penetration
depth | 37.4 mm at energy level 16 | 37.4 mm at energy level 16 | identical to primary predicate
OW100S, no change |
| Energy flow density
PIIT [mJ/mm2] | 0.00020 - 0.04900 at energy
level 1 - 16 | 0.00020 - 0.04900 at energy
level 1 - 16 | identical to primary predicate
OW100S, no change |
| Operating mode | Continuous | Continuous | identical to primary predicate
OW100S, no change |
| Pulse repeat rate (1/s) | 1 - 8 Hz | 1 - 8 Hz | identical to primary predicate
OW100S, no change |
| Product
Characteristic | Subject Device
OW100S | Primary Predicate
device
OW100S | Comparison |
| Number of pulses (min
and max) | 500-2000/ session | 500-2000/ session | identical to primary predicate
OW100S, no change |
| Maximum operating
temperature | Room temperature | Room temperature | identical to primary predicate
OW100S, 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 to primary predicate
OW100S, no change |
| Peak compressional
acoustic pressure
pc [Mpa] | 11.20 at energy level 16 | 11.20 at energy level 16 | identical to primary predicate
OW100S, no change |
| Peak rarefactional
acoustic pressure
pcr[Mpa] | 1.22 at energy level 16 | 1.22 at energy level 16 | identical to primary predicate
OW100S, no change |
| 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 | identical to primary predicate
OW100S, no change |
| Positive peak pressure
amplitude (MPa)
pc [Mpa] | 0.61 - 11.20 at energy level
1 - 16 | 0.61 - 11.20 at energy level
1 - 16 | identical to primary predicate
OW100S, no change |
| Negative peak pressure
amplitude (MPa)
pcr[Mpa] | -0.17 to – 1.22MPa at energy
level 1 - 16 | -0.17 to – 1.22MPa at energy
level 1 - 16 | identical to primary predicate
OW100S, no change |
| Derived focal acoustic
pulse energy (mJ)
EbT [mJ] | 0.020- 3.370 at energy level 1 - 16 | 0.020- 3.370 at energy level 1 - 16 | identical to primary predicate
OW100S, no change |
| Derived pulse -intensity
integral, integrated over
total temporal
integration limits
PIIT [mJ/mm2] | 0.00020-0.04900 mJ/mm2 | 0.00020-0.04900 mJ/mm2 | identical to primary predicate
OW100S, no change |
| Rise time (ns)
(10% - 90%) tr [us] | 1.08 – 0.18 at energy level 1 - 16 | 1.08 – 0.18 at energy level 1 - 16 | identical to primary predicate
OW100S, no change |
| Compressional pulse
duration (us)
tFWHMpc [uS] | 0.79 - 0.82 us at energy level
1 - 16 | 0.79 - 0.82 us at energy level
1 - 16 | identical to primary predicate
OW100S, no change |
6
7
Similarities
The OW100S is identical to the previously cleared OW100S previously cleared under K231710. There are no changes to the power output performance, electrode and reflector geometry, total primary electrical energy, energy flux density or wave penetration as a result of these changes.
User interactions with the device are the same. The change requires no revisions to the recommended treatment parameters when compared to prior submissions.
Differences
8
K233937
Labeling changes to contraindications, warnings, and precautions
This submission concerns revisions and clarifications in labeling contraindications, warnings, and precautions. The changes are implemented to align the labeling with currently marketed acoustic wave devices for the identical indications for use, as well as to clarify and omit information that was duplicated in these sections in prior submissions. In some instances, text is revised to clarify the intent of the statement, or to present statements more appropriately for instance as a warning rather than precaution.
Clinical Information
Not applicable. Bench and performance testing support the substantial equivalence in this submission.
Conclusion
The OW100S has the same indications for use and identical design features as compared with the Primary predicate device system. The OW100S described in this submission is, in our opinion, substantially equivalent to the predicate. 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.