(263 days)
No
The summary describes a device that uses an ozone generator for cleaning and does not mention any AI or ML components or functionalities.
No
The device is described as being "intended for the reduction of microorganisms in dental unit water lines." This indicates a cleaning or maintenance function for equipment, not a direct therapeutic effect on a patient.
No
The device is described as being intended to clean dental unit water lines by reducing microorganisms, which is a maintenance or sterilization function, not a diagnostic one.
No
The device description explicitly states it consists of an ozone generator and dispensing bottles, which are hardware components. The performance studies also include hardware-related testing like Environmental Evaluation, Functional Verification, Pressure Verification, and Material Compatibility Analysis.
Based on the provided information, the T-8000 TherOzone Unit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for the reduction of microorganisms in dental unit water lines." This describes a process applied to equipment (water lines), not a test performed on a biological sample from a patient to diagnose a condition.
- Device Description: The device description mentions an "ozone generator and dispensing bottles" used to "clean dental unit water lines." This aligns with a cleaning or disinfection process for equipment, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition in a patient.
The device is clearly intended for maintaining the cleanliness of dental equipment, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The T-8000 TherOzone Unit is intended for the reduction of microorganisms in dental unit water lines.
Product codes
EIA
Device Description
The T-8000 TherOzone Unit is a device intended to clean dental unit water lines. The device consists of an ozone generator and dispensing bottles.
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
Dental professional
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
Performance Testing included:
- Microbial challenge
- Software Validation
- Environmental Evaluation
- Functional Verification
- Material Compatibility Analysis
- Usability Evaluation
- Pressure Verification
- Environmental Condition Verification
The performance testing conducted demonstrates that the T-8000 TherOzone Unit is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
UltraKleen(K991946), Odyssey Dental Water Unit (K964796)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2015
TherOzone USA. Inc. Ms. Rebecca K Pine Official Correspondent 2701 Ocean Park Blvd, Suite 108 Santa Monica, CA 90405
Re: K141504
Trade/Device Name: T-8000 TherOzone Unit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit (accessory) Regulatory Class: II Product Code: EIA Dated: January 27, 2015 Received: January 28, 2015
Dear Ms. Pine:
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. 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
Page 2 - Ms. Pine
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K141504
Device Name T-8000 TherOzone Unit
Indications for Use (Describe)
The T-8000 TherOzone Unit is intended for the reduction of microorganisms in dental unit water lines.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
6. 510(k) Summary
This 510(k) [K141504] summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | TherOzone USA, Inc. |
|---|---|
| DATE PREPARED: | February 24, 2015 |
| CONTACT PERSON: | Rebecca K Pine |
| Official Correspondent | |
| TherOzone USA, Inc. | |
| 2701 Ocean Park Blvd, Suite 108 | |
| Santa Monica, CA 90405 | |
| Phone: 760.809.5178 | |
| FAX: 760.290.3216 | |
| Email: beky@cox.net | |
| TRADE NAME: | T-8000 TherOzone Unit |
| COMMON NAME: | Accessory, Dental Unit |
| CLASSIFICATION | |
| NAME: | Dental Operative Unit (accessory) |
| DEVICE | |
| CLASSIFICATION: | Class II, per 21 CFR 872.6640 |
| PRODUCT CODE | EIA |
| PREDICATE DEVICES: | UltraKleen(K991946) |
| Odyssey Dental Water Unit (K964796) |
Substantially Equivalent To:
The T-8000 TherOzone Unit is substantially equivalent in intended use, principal of operation and technological characteristics to the existing UltraKleen and the Odyssey Dental Water Unit devices.
Description of the Device Subject to Premarket Notification:
The T-8000 TherOzone Unit is a device intended to clean dental unit water lines. The device consists of an ozone generator and dispensing bottles.
Indication for Use:
The T-8000 TherOzone Unit is intended for the reduction of microorganisms in dental unit water lines.
4
Technical Characteristics:
The T-8000 TherOzone Unit has similar physical and technical characteristics to the predicate devices, as illustrated in the table below.
| | T-8000
TherOzone Unit | Odyssey I Dental
Water Unit
Germiphene Corp.
(K964796) | UltraKleen,
Sterilex (K991946) | Substantial
Equivalence |
|--------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | For the reduction of
microorganisms in
dental unit water
lines. | Indicated to be used
as an in-line water
disinfecting system
to reduce
microorganisms in
the dental water
lines | The product has
been specially
formulated and
clinically proven to
clean deposits and
control bacterial
contamination in
Dental Unit Water
Lines. | Although minor
grammatical
difference exist, the
intended use of the
subject device is
substantially
equivalent to the
predicate devices |
| Function | Dental unit water
line cleaner | Dental unit water
line cleaner | Dental unit water
line cleaner | Same. The subject
device is
substantially
equivalent to the
predicate devices. |
| Principle of
Operation | Creates ozone from
air. Ozonated gas
(in water) applied
to dental unit water
lines | Creates ozone from
air. Ozonated gas
(in water) applied
to dental unit water
lines | Anti-microbial
chemical agent | Same. The subject
device is
substantially
equivalent to the
predicate device. |
| Mechanism of
Action | Oxidation, leading
to cell lysis | Oxidation, leading
to cell lysis | Oxidation
Hydrolysis
Microbubbling | Same. The subject
device is
substantially
equivalent to the
predicate device. |
| Patient contact | None | In-line use | None | Same. The subject
device is
substantially
equivalent to the
predicate device. |
| Intended User | Dental professional | Dental professional | Dental professional | Same. The subject
device is
substantially
equivalent to the
predicate devices. |
| Delivery to Site | Direct application
to dental water
lines | Direct application
to dental water
lines | Direct application
to dental water
lines | Same. The subject
device is
substantially
equivalent to the
predicate devices. |
| Microorganis
m reduction
cycle | Daily flush through
water lines | Continuous flush | Flush with
overnight soak | Similar. The
subject device cycle
varies slightly, but
all device cycles |
| | T-8000
TherOzone Unit | Odyssey I Dental
Water Unit
Germiphene Corp.
(K964796) | UltraKleen,
Sterilex (K991946) | Substantial
Equivalence |
| Materials
(wetted) | Polyethylene
Fluoropolymers | Polycarbonate,
304V stainless
steel, Kynar,
polyethylene | Sodium carbonate
Sodium
percarbonate
Benzenemethanaminium, N, N-
dimethyl-N-
tetradecyl-.
Chloride
Tetrasodium EDTA | effective microorganism
reduction. The
minor differences
do not pose a
functional
difference,
therefore the
subject device is
substantially
equivalent to the
predicate devices.
Similar, subject
device and the
predicate device are
both fabricated
from common
medical device
materials, therefore
the subject device
and predicate
device are
substantially
equivalent |
| Air Supply | Ambient,
compressed to 5-
25psi | 60 PSIG, min | N/A | Same. The subject
device and
predicate device
both use a
pressurized air
source. The
differences in
operating
parameters are
minor and do not
affect the
fundamental
technology
therefore the
subject device and
the predicate device
are substantially
equivalent. |
| Electrical | 100-240VAC,50-
60Hz,1.5 65 watts | 100-130 VAC, 50-
60 Hz, 20 watts,
grounded | N/A | Same. The subject
device and
predicate device
both use electrical
power. The
differences in
electrical
specifications are |
| | T-8000
TherOzone Unit | Odyssey I Dental
Water Unit
Germiphene Corp.
(K964796) | UltraKleen,
Sterilex (K991946) | Substantial
Equivalence |
| Water
capacity | ~ 600mL | 1 liter (1,000 mL) | N/A | minor and do not
affect the
fundamental
technology
therefore the
subject device and
the predicate device
are substantially
equivalent.
Same. The minor
differences in
volume do not
affect the
fundamental
technology
therefore the
subject device and
the predicate device
are substantially
equivalent. |
| Water
requirements | Distilled only | Distilled only | Distilled only | Same. The subject
device is
substantially
equivalent to the
predicate device. |
| Equipment
Weight (dry) | 12 lbs | 7 lbs | N/A | Same. The minor
differences in
equipment weight
do not affect the
fundamental
technology
therefore the
subject device and
the predicate device
are substantially
equivalent. |
| Dimensions | 8"x 9.5" X 18 1/4" | 6" x 6" x 12 ½ " | N/A | Same. The minor
differences in
equipment
dimension do not
affect the
fundamental
technology
therefore the
subject device and
the predicate device
are substantially
equivalent. |
| How provided | Non-sterile,
reusable | Non-sterile,
reusable | Non-sterile, single
use | Same. The subject
device is |
| T-8000
TherOzone Unit | Odyssey I Dental
Water Unit
Germiphene Corp.
(K964796) | UltraKleen,
Sterilex (K991946) | Substantial
Equivalence | |
| | | | substantially
equivalent to the
predicate device. | |
TherOzone USA, Inc. T-8000 TherOzone Unit
Page 12 of 56 Premarket Notification
5
TherOzone USA, Inc.
T-8000 TherOzone Unit
Page 13 of 56
Premarket Notification
6
TherOzone USA, Inc.
T-8000 TherOzone Unit
Page 14 of 56
Premarket Notification
7
Performance Data:
All necessary verification and validation testing has been performed for the T-8000 TherOzone Unit to assure substantial equivalence to the predicate devices and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Performance Testing included:
- Microbial challenge
- Software Validation ●
- Environmental Evaluation ●
- Functional Verification
- Material Compatibility Analysis
- Usability Evaluation
- Pressure Verification ●
- Environmental Condition Verification
The performance testing conducted demonstrates that the T-8000 TherOzone Unit is substantially equivalent to the predicate devices.
Basis for Determination of Substantial Equivalence:
Based on the intended use, indications for use, technological characteristics, performance data and nonclinical tests performed, the subject T-8000 TherOzone Unit is substantially equivalent and is as safe and as effective as the legally marketed predicate devices, UltraKleen(K991946) and Odyssey Dental Water Unit (K964796).