(263 days)
The T-8000 TherOzone Unit is intended for the reduction of microorganisms in dental unit water lines.
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.
The provided text does not contain the detailed acceptance criteria or the specific study details for the T-8000 TherOzone Unit that would allow for a comprehensive answer to all parts of your request.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Microbial reduction (primary function) | "The performance testing conducted demonstrates that the T-8000 TherOzone Unit is substantially equivalent to the predicate devices." (This is a general statement, not a specific performance metric like "reduces microorganisms by X log") |
| Software Validation | Performed |
| Environmental Evaluation | Performed |
| Functional Verification | Performed |
| Material Compatibility Analysis | Performed |
| Usability Evaluation | Performed |
| Pressure Verification | Performed |
| Environmental Condition Verification | Performed |
What's missing for this table: Specific quantitative acceptance criteria (e.g., "reduce microorganisms by at least 99.9%") and the corresponding quantitative results obtained. The document only states that testing was performed and demonstrated substantial equivalence, but not the actual performance values against defined criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The document only mentions "test units representative of finished devices" for performance testing.
- Data provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable/not specified. The device is a "dental unit water line cleaner." The "ground truth" for microbial reduction would typically be established through laboratory microbial challenge tests, not by human expert assessment of images or clinical cases.
- Qualifications of experts: Not applicable/not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/not specified. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic imaging studies where agreement among human readers is required. This device's primary function is microbial reduction, which relies on objective laboratory measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Yes, implicitly. The performance data section refers to "Performance Data" for the "T-8000 TherOzone Unit" itself, including "Microbial challenge." This suggests the device's ability to reduce microorganisms was tested independently. However, no specific details of the microbial challenge are provided (e.g., type of microorganisms, initial count, final count, methodology).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Most likely objective laboratory measurements of microbial count reduction. The device's indication for use is "reduction of microorganisms in dental unit water lines." This would be verified by standard microbiological testing methods (e.g., plating and colony counting). The document states "Microorganism reduction cycle" and "Microbial challenge" was performed.
8. The sample size for the training set
- Sample size for training set: Not applicable/not specified. This device is a physical water treatment unit, not an AI/machine learning algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
- How ground truth for training set was established: Not applicable, as there is no training set for this type of device.
In summary, the provided document is a 510(k) summary focusing on substantial equivalence to predicate devices for a physical medical device. It does not contain the detailed clinical study design, specific acceptance criteria, or quantitative performance metrics usually found for diagnostic devices or AI-driven systems. The performance data section broadly states that necessary testing was performed to demonstrate substantial equivalence, but lacks the granular details requested in your prompt.
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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.
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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
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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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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 PineOfficial CorrespondentTherOzone USA, Inc.2701 Ocean Park Blvd, Suite 108Santa Monica, CA 90405Phone: 760.809.5178FAX: 760.290.3216Email: beky@cox.net |
| TRADE NAME: | T-8000 TherOzone Unit |
| COMMON NAME: | Accessory, Dental Unit |
| CLASSIFICATIONNAME: | Dental Operative Unit (accessory) |
| DEVICECLASSIFICATION: | 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.
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Technical Characteristics:
The T-8000 TherOzone Unit has similar physical and technical characteristics to the predicate devices, as illustrated in the table below.
| T-8000TherOzone Unit | Odyssey I DentalWater UnitGermiphene Corp.(K964796) | UltraKleen,Sterilex (K991946) | SubstantialEquivalence | |
|---|---|---|---|---|
| Indications forUse | For the reduction ofmicroorganisms indental unit waterlines. | Indicated to be usedas an in-line waterdisinfecting systemto reducemicroorganisms inthe dental waterlines | The product hasbeen speciallyformulated andclinically proven toclean deposits andcontrol bacterialcontamination inDental Unit WaterLines. | Although minorgrammaticaldifference exist, theintended use of thesubject device issubstantiallyequivalent to thepredicate devices |
| Function | Dental unit waterline cleaner | Dental unit waterline cleaner | Dental unit waterline cleaner | Same. The subjectdevice issubstantiallyequivalent to thepredicate devices. |
| Principle ofOperation | Creates ozone fromair. Ozonated gas(in water) appliedto dental unit waterlines | Creates ozone fromair. Ozonated gas(in water) appliedto dental unit waterlines | Anti-microbialchemical agent | Same. The subjectdevice issubstantiallyequivalent to thepredicate device. |
| Mechanism ofAction | Oxidation, leadingto cell lysis | Oxidation, leadingto cell lysis | OxidationHydrolysisMicrobubbling | Same. The subjectdevice issubstantiallyequivalent to thepredicate device. |
| Patient contact | None | In-line use | None | Same. The subjectdevice issubstantiallyequivalent to thepredicate device. |
| Intended User | Dental professional | Dental professional | Dental professional | Same. The subjectdevice issubstantiallyequivalent to thepredicate devices. |
| Delivery to Site | Direct applicationto dental waterlines | Direct applicationto dental waterlines | Direct applicationto dental waterlines | Same. The subjectdevice issubstantiallyequivalent to thepredicate devices. |
| Microorganism reductioncycle | Daily flush throughwater lines | Continuous flush | Flush withovernight soak | Similar. Thesubject device cyclevaries slightly, butall device cycles |
| T-8000TherOzone Unit | Odyssey I DentalWater UnitGermiphene Corp.(K964796) | UltraKleen,Sterilex (K991946) | SubstantialEquivalence | |
| Materials(wetted) | PolyethyleneFluoropolymers | Polycarbonate,304V stainlesssteel, Kynar,polyethylene | Sodium carbonateSodiumpercarbonateBenzenemethanaminium, N, N-dimethyl-N-tetradecyl-.ChlorideTetrasodium EDTA | effective microorganismreduction. Theminor differencesdo not pose afunctionaldifference,therefore thesubject device issubstantiallyequivalent to thepredicate devices.Similar, subjectdevice and thepredicate device areboth fabricatedfrom commonmedical devicematerials, thereforethe subject deviceand predicatedevice aresubstantiallyequivalent |
| Air Supply | Ambient,compressed to 5-25psi | 60 PSIG, min | N/A | Same. The subjectdevice andpredicate deviceboth use apressurized airsource. Thedifferences inoperatingparameters areminor and do notaffect thefundamentaltechnologytherefore thesubject device andthe predicate deviceare substantiallyequivalent. |
| Electrical | 100-240VAC,50-60Hz,1.5 65 watts | 100-130 VAC, 50-60 Hz, 20 watts,grounded | N/A | Same. The subjectdevice andpredicate deviceboth use electricalpower. Thedifferences inelectricalspecifications are |
| T-8000TherOzone Unit | Odyssey I DentalWater UnitGermiphene Corp.(K964796) | UltraKleen,Sterilex (K991946) | SubstantialEquivalence | |
| Watercapacity | ~ 600mL | 1 liter (1,000 mL) | N/A | minor and do notaffect thefundamentaltechnologytherefore thesubject device andthe predicate deviceare substantiallyequivalent.Same. The minordifferences involume do notaffect thefundamentaltechnologytherefore thesubject device andthe predicate deviceare substantiallyequivalent. |
| Waterrequirements | Distilled only | Distilled only | Distilled only | Same. The subjectdevice issubstantiallyequivalent to thepredicate device. |
| EquipmentWeight (dry) | 12 lbs | 7 lbs | N/A | Same. The minordifferences inequipment weightdo not affect thefundamentaltechnologytherefore thesubject device andthe predicate deviceare substantiallyequivalent. |
| Dimensions | 8"x 9.5" X 18 1/4" | 6" x 6" x 12 ½ " | N/A | Same. The minordifferences inequipmentdimension do notaffect thefundamentaltechnologytherefore thesubject device andthe predicate deviceare substantiallyequivalent. |
| How provided | Non-sterile,reusable | Non-sterile,reusable | Non-sterile, singleuse | Same. The subjectdevice is |
| T-8000TherOzone Unit | Odyssey I DentalWater UnitGermiphene Corp.(K964796) | UltraKleen,Sterilex (K991946) | SubstantialEquivalence | |
| substantiallyequivalent to thepredicate device. |
TherOzone USA, Inc. T-8000 TherOzone Unit
Page 12 of 56 Premarket Notification
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TherOzone USA, Inc.
T-8000 TherOzone Unit
Page 13 of 56
Premarket Notification
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TherOzone USA, Inc.
T-8000 TherOzone Unit
Page 14 of 56
Premarket Notification
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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).
§ 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.