(155 days)
The Miele G 7881 Dental Thermal Disinfector is intended to clean and high-level disinfect heat stable reusable dental instruments and accessories using a thermal process. The cycle parameters for high-level disinfection are 93℃ for 10 minutes. The Miele G7881 Dental Thermal Disinfector also has the following cleaning and high-level disinfection cycles:
The G7881 Dental Thermal Disinfector is a washer/disinfector for aqueous cleaning and simultaneous thermal disinfection of dental instruments and accessories. It operates with three spray arms on three different levels. A powerful circulation pump moves 2.8 gallons of water at a rate of 105 gallons/minute. The specially designed jets on the spray arms spray the water onto the wash load at a low pressure (About 13 psi) to prevent any goods from being washed off the racks.
The complete unit is made of electro-polished stainless steel, the exterior is additionally powder coated. The unit is equipped with a microcomputer control. An integrated water softener ensures consistently high water quality; the steam condenser comes standard and minimizes contaminated aerosols and odor affecting the environment.
Acceptance Criteria and Device Performance for Miele G7881 Dental Thermal Disinfector
Based on the provided 510(k) summary, the device is a Miele G7881 Dental Thermal Disinfector, and the review focuses on its "high-level disinfection" capabilities. The crucial point is that the regulatory submission states that the cycle parameters for high-level disinfection have not been changed from the legally marketed predicate device (Miele G7781 Dental Thermal Disinfector, K950518), and therefore, additional testing was not deemed necessary for these specific parameters.
However, the document does refer to prior studies that support the predicate device's performance.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for High-Level Disinfection) | Reported Device Performance (Miele G7881 & predicate G7781) |
|---|---|
| Log Reduction of Microorganisms | A 6-log reduction of an appropriate myco bacterium species. |
| Temperature | 93°C (200°F) |
| Time at Temperature | 10 minutes (minimum) |
| Cleaning Effectiveness | Cleans instruments contaminated with blood "extremely well." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for this submission (G7881). The document indicates that since the high-level disinfection cycle parameters were not changed from the predicate device (G7781), additional testing for these parameters was not necessary. The 6-log reduction performance refers to studies conducted for the predicate device (K950518). Information regarding the specific sample size of microorganisms or instruments used in those prior studies is not provided in this document.
- Data Provenance: The document states that "additional testing was done in accordance with German Health Authority guidelines Federal Health Report 1980:23:364-35-65." This suggests the efficacy studies, including the log reduction data, may have originated from Germany and were likely prospective studies designed to validate the disinfection parameters according to those guidelines. (Retrospective vs. Prospective is not explicitly stated, but efficacy studies for device clearance are typically prospective.)
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Efficacy studies for disinfection devices typically rely on objective laboratory methods (e.g., culturing microorganisms before and after treatment) rather than expert consensus on subjective assessments.
4. Adjudication Method for the Test Set
This information is not applicable to the type of efficacy testing described (microbiological log reduction). Adjudication methods like "2+1" are typically used for subjectively assessed endpoints (e.g., imaging interpretation).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is not relevant for a device like a thermal disinfector, which performs a physical or chemical process. MRMC studies are typically used to assess the effectiveness of diagnostic tools where human interpretation of data is involved (e.g., radiologists reading images).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence. The performance claims are based on the device's ability to achieve specific physical parameters (temperature and time) and its resulting microbiological reduction, independent of human intervention during the disinfection cycle. The device's efficacy is measured intrinsically, not through human interaction with an algorithm.
7. The Type of Ground Truth Used
- Microbiological Efficacy: The primary ground truth for the "high-level disinfection" claim is direct microbiological testing demonstrating a 6-log reduction of an appropriate myco bacterium species. This is an objective, quantitative measure of microbial inactivation.
- Cleaning Efficacy: The claim that it "cleans instruments contaminated with blood, extremely well" implies visual inspection and possibly other objective assessments of residual soil, though specific methods are not detailed.
8. The Sample Size for the Training Set
This information is not provided as the Miele G7881 Dental Thermal Disinfector is not an AI/ML-based device that would typically have a "training set" in the context of machine learning. Its performance is based on engineered physical parameters and validated through microbiological testing.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as the device does not employ machine learning or AI that would require a "training set" with established ground truth in the conventional sense. The "ground truth" for its function (disinfection efficacy) is established through laboratory validation of its physical processes and their biological outcomes.
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NOV 1 2 2003
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510 (K) Summary
This 510 (K) Summary information is being submitted in accordance with the requirements of SDMA 1990 and 21 CFR807.81 Subpart E- Pre-market Notification Procedures.
| Product | Miele G7881 Dental Thermal Disinfector |
|---|---|
| 510 (K) number | K031799 |
| Legally MarketedDevice | Substantial equivalence of the Miele G7881 Dental Thermal Disinfector exists tothe Miele G7781 Dental Thermal Disinfector (K950518). The cycle parametersfor high-level disinfection have not been changed from the G7781 DentalThermal Disinfector. |
| Description | The G7881 Dental Thermal Disinfector is a washer/disinfector for aqueouscleaning and simultaneous thermal disinfection of dental instruments andaccessories. It operates with three spray arms on three different levels. Apowerful circulation pump moves 2.8 gallons of water at a rate of 105gallons/minute. The specially designed jets on the spray arms spray the wateronto the wash load at a low pressure (About 13 psi) to prevent any goods frombeing washed off the racks. |
| Functional design | The complete unit is made of electro-polished stainless steel, the exterior isadditionally powder coated. The unit is equipped with a microcomputer control.An integrated water softener ensures consistently high water quality; the steamcondenser comes standard and minimizes contaminated aerosols and odoraffecting the environment. |
| Performance | The Thermal Disinfection Process |
| Characteristics | The thermal disinfection process relies upon the two physical parameters,temperature (93°C/200°F) and time (10 minutes) minimum. These parametersare easy to control, therefore, errors are improbable. The cycle parameters forhigh level disinfection have not been changed from the G7781 Dental ThermalDisinfector. |
| Intended Use | High Level Disinfection |
| The G7881 Dental Thermal Disinfector is suitable for automatic treatment ofdental instruments and accessories. It cleans and in the disinfection programssimultaneously disinfects at 93°C/200°F instruments and accessories. The highlevel disinfection showed a 6-log reduction of an appropriate myco bacteriumspecies. Since the cycle parameters have not been changed from the G7781 DentalThermal Disinfector additional testing was not necessary. |
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KC 317 99
Instruments suitable for processing in the thermal disinfector
All instruments, accessories and other items to be cleaned and disinfected in the G7881 Dental Thermal Disinfector must be heat resistant to a temperature of up to 95°C/203°F and corrosion resistant in the presence of heat and alkalinity.
Comparison to Legally marketed Device
G7881 External size: H33.5"xW23.5"xD23.5"
Wash chamber Size H19.5"xW21"x19.5"
Circulation Pump with a turnover volume of 105 Gallons/minute
3 spray arms
Thermal disinfection at 93°C/200°F/10 minutes
Microcomputer control for higher accuracy and safety
Digital display
Disinfection control light for higher level of safety
26 Fault codes displayed for easy servicing
Optional dosing system for liquid detergents for accurate and reproducible dosage
One liquid door dispenser
Programmable alarm when program is finished
G7781 External size: H33.5"xW23.5"xD23.5"
Wash chamber Size H19.5"xW21"x19.5"
Circulation Pump with a turnover volume of 105 Gallons/minute
3 spray arms
Thermal disinfection at 93°C/200°F/10 minutes
Microcomputer control for higher accuracy and safety
Digital display
Disinfection control light for higher level of safety
9 Fault codes displayed for easy servicing
Optional dosing system for liquid detergents for accurate and reproducible dosage
One liquid door dispenser
No alarm sounds when program is finished
Non-clinical tests
Changes for G7881 are limited to the control panel. Because high level disinfection cycles parameters were not changed from K950518 it was not necessary to perform additional testing, however additional testing was done in accordance with German Health Authority guidelines Federal Health Report 1980:23:364-35-65.
All studies proved physical removal or thermal inactivation to a sufficient degree.
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Conclusions The G 7881 Dental Thermal Disinfector does clean instruments contaminated with blood, extremely well.
The surface temperatures reach 93°C/200° for at least 10 minutes resulting in high-level disinfection. The cycle parameters from the predicate device are retained for the G7881 Dental Thermal Disinfector. The wash action combined with the thermal inactivation reduces the amount of live bacteria on the instruments by more than log-6 as demonstrated in the previous submission.
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Public Health Service
NOV 1 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Polinski Regulatory Affairs Miele Inc. 9 Independence Way Princeton, New Jersey 08540
Re: K031799
Trade/Device Name: Milele G7881 Dental Thermal Disinfector Regulation Number: 880.6992 Regulation Name: Medical Washer-Disinfector Regulatory Class: II Product Code: LDS Dated: October 13, 2003 Received: October 14, 2003
Dear Mr. Polinski:
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.
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Page 2 -Mr. Polinski
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); 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patrice Curenton, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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October 2003
Statement of Indication for Use
The Miele G 7881 Dental Thermal Disinfector is intended to clean and high-level disinfect heat stable reusable dental instruments and accessories using a thermal process. The cycle parameters for high-level disinfection are 93℃ for 10 minutes. The Miele G7881 Dental Thermal Disinfector also has the following cleaning and high-level disinfection cycles:
| Program | Program Description | |||||
|---|---|---|---|---|---|---|
| 1. Pre-wash | 2. Cleaningand/orthermaldisinfection | 3. Interimrinse IwithNeutralization | 4. Interimrinse II | 5. Finalrinse 1)and/ordisinfection | 6. Drying(extraprogram) | |
| Wash | XColdwaterintake | XCleaning60°C/3' | XCold waterintake | XRinse65°C/1'(DI)DOS 2 | X | |
| Rinse (cold) | XRinseCold water | |||||
| Drain | Susanna F. Barw(Division Sign-Off)Division of Anesthesiology, General Hospital,Infection Control, Dental Devices510(k) Number: K081799 | |||||
| Disinfectionvario | XColdWaterIntake | XCleaning55°C/5' | XDOS 3 | XCold Waterintake | XRinse andDisinfection93°C/10' | X |
| Disinfection93°C-10' | XDisinfection93°C/10' | XDOS 3 | XRinse75°C/3'(DI)DOS 2 | X |
X= Sections included in a program (with temperature/temperature holding time)
§ 880.6991 Medical washer.
(a)
Identification. A medical washer is a device that is intended for general medical purposes to clean and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.