(21 days)
The Germ Terminator Toothbrush Sanitizer is designed to sanitize up to two manual toothbrushes or two toothbrush heads between uses. The Germ Terminator Toothbrush Sanitizer is intended for home use and will be available "over the counter."
The Germ Terminator uses steam heat to sanitize two manual toothbrushcs or two toothbrush heads. Water is poured into a reservoir in the device's housing and it is heated to its boiling point. Water is thereby converted into steam, which sanitizes the toothbrushes in the housing. The stcam cycle is followed by a drying cycle.
The provided text describes a 510(k) premarket notification for the "Germ Terminator Toothbrush Sanitizer." It details the device's function, intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to fill out the requested table and answer all the questions about acceptance criteria and a study proving device performance as a medical device in the typical sense of AI/algorithm performance.
The submission is for a physical device (toothbrush sanitizer), not an AI/algorithmic medical device, which is why much of the requested information (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not present in the document.
The document indicates "Laboratory testing demonstrated that toothbrushes treated in the Germ Terminator are effectively sanitized," but it does not provide the specifics of this testing in terms of acceptance criteria or performance metrics beyond this general statement.
Therefore, I will extract what information is available and explicitly state where the requested information is absent or not applicable to this type of device submission.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sanitization Efficacy | "Testing demonstrated that the toothbrushes treated in the Germ Terminator were sanitized.""Laboratory testing demonstrated that toothbrushes treated in the Germ Terminator are effectively sanitized." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided document. The document only states "Laboratory testing."
- Data Provenance: Not specified in the provided document.
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. For a physical device like a toothbrush sanitizer, "ground truth" is typically established through microbiological testing standards and results, not via expert consensus on image interpretation or diagnosis.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, not for objective laboratory testing of sanitization efficacy.
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, an MRMC comparative effectiveness study was not done. This type of study is specific to imaging devices or AI algorithms where human readers interpret data, typically in a diagnostic context. This device is a physical sanitizer.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not applicable. This device is a physical sanitizing unit, not an algorithm. The "standalone" performance here refers to its inherent sanitization capability, which was reportedly tested in a lab.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Likely microbiological test results demonstrating the reduction or elimination of specific microorganisms. The document uses the general term "sanitized" which implies a measurable reduction in microbial load to a safe level, based on established public health standards for sanitization.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. This is not an AI/ML device.
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MAY 1 0 2002
8.0 510(k) Summary
| Submitted by: | David Link, Vice PresidentEXPERTech Associates, Inc.100 Main Street, Suite 120Phone (978) 371-0066Fax (978) 371-1676 |
|---|---|
| --------------- | -------------------------------------------------------------------------------------------------------------------------------------- |
April 30, 2002 Date of summary
Germ Terminator Toothbrush Sanitizer Device name
Toothbrush Sanitizer Common name
Classification name Toothbrush, Manual
The subject device is substantially equivalent to the Otres Toothbrush Predicate devicc Sanitizer (K003517).
The Germ Terminator uses steam heat to sanitize two manual toothbrushcs Description or two toothbrush heads. Water is poured into a reservoir in the device's housing and it is heated to its boiling point. Water is thereby converted into steam, which sanitizes the toothbrushes in the housing. The stcam cycle is followed by a drying cycle. Testing demonstrated that the toothbrushes treated in the Germ Terminator were sanitized.
The Germ Terminator is designed to sanitize up to two manual Intended use toothbrushes or two toothbrush heads between uses. The Germ Terminator is intended for over the counter use.
The subject device sanitizes by means of steam heat and the predicate Tcchnological device sanitizes by means of activated oxygen (ozone). Characteristics
Laboratory testing demonstrated that toothbrushes treated in the Germ Testing Terminator are effectively sanitized.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of what appears to be a caduceus, a symbol often associated with healthcare. The caduceus is depicted with a single staff entwined by two snakes.
MAY 1 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Germ Terminator Corporation Mr. Donald J. Sherratt Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01779
Re: K021258
Trade/Device Name: Germ Terminator GT 100 Toothbrush Sanitizer Regulation Number: 872.6855 Regulation Name: Toothbrush, Manual Regulatory Class: I Product Code: MCF Dated: May 2, 2002 Received: May 3, 2002
Dear Mr. Sherratt:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 statutes and regulations administered by other Federal agencies.
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Page 2 - Mr. Sherratt
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely vours,
Patruco Cucurella
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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of Page_
510(k) Number (if known):
Device Name: Germ Terminator Toothhrush Sanitizer
Indications For Usc:
The Germ Terminator Toothbrush Sanitizer is designed to sanitize up to two manual toothbrushes or two toothbrush heads between uses.
The Germ Terminator Toothbrush Sanitizer is intended for home use and will be available "over the counter."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ryan
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 872.6855 Manual toothbrush.
(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(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 § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.