(21 days)
Not Found
No
The description focuses on a physical process (steam heat) for sanitization and does not mention any computational or learning components.
No.
A therapeutic device is one that treats or prevents a disease. This device sanitizes toothbrushes, which is a maintenance activity for a personal hygiene item, not a direct treatment or prevention for a disease in a person.
No
Explanation: The device is a toothbrush sanitizer that uses steam heat to sanitize toothbrushes. It does not perform any diagnostic functions like detecting, diagnosing, treating, curing, or preventing disease.
No
The device description clearly states it uses steam heat generated by heating water in a reservoir within the device's housing, indicating it is a hardware device with a physical mechanism for sanitization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to sanitize toothbrushes, which are external objects. IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The mechanism of action is steam heat for sanitization, not analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical elements of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
The Germ Terminator Toothbrush Sanitizer is a device for cleaning and sanitizing personal hygiene items, not for diagnosing or monitoring health conditions through in vitro testing.
N/A
Intended Use / Indications for Use
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."
Product codes
MCF
Device Description
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. Testing demonstrated that the toothbrushes treated in the Germ Terminator were sanitized.
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
home use / over the counter use
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
Laboratory testing demonstrated that toothbrushes treated in the Germ Terminator are effectively sanitized.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing demonstrated that the toothbrushes treated in the Germ Terminator were sanitized.
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.
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
§ 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.
0
MAY 1 0 2002
8.0 510(k) Summary
| Submitted by: | David Link, Vice President
EXPERTech Associates, Inc.
100 Main Street, Suite 120
Phone (978) 371-0066
Fax (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.
1
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.
2
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
3
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)