(155 days)
Not Found
No
The document describes a thermal disinfector with a microcomputer control, but there is no mention of AI or ML capabilities. The focus is on the physical and thermal processes for cleaning and disinfection.
No
The device is a dental instrument washer/disinfector, used for cleaning and disinfecting medical instruments, not for treating a disease or condition in a patient.
No
This device is a thermal disinfector for cleaning and high-level disinfecting dental instruments, not for diagnosing medical conditions.
No
The device description clearly outlines a physical washer/disinfector unit made of stainless steel with spray arms, a pump, and a water softener. While it has a microcomputer control, the core function and components are hardware-based.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The Miele G 7881 Dental Thermal Disinfector is used to clean and disinfect dental instruments, which are used on the body, but the device itself does not analyze or test any biological samples from a patient.
- The intended use is for cleaning and disinfection of instruments. The description clearly states its purpose is to clean and high-level disinfect reusable dental instruments. This is a process applied to medical devices, not a diagnostic test performed on a patient sample.
- The performance metrics are related to disinfection efficacy. The key metrics mentioned are a "6-log reduction of an appropriate myco bacterium species" and reducing "the amount of live bacteria on the instruments by more than log-6." These are measures of how well the device disinfects, not diagnostic performance metrics like sensitivity, specificity, or AUC which are common for IVDs.
The device is a medical device, specifically a washer/disinfector for reusable medical instruments, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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: Wash
- Pre-wash: X Cold water intake
- Cleaning and/or thermal disinfection: X Cleaning 60°C/3'
- Interim rinse I with Neutralization: Not Found
- Interim rinse II: X Cold water intake
- Final rinse 1) and/or disinfection: X Rinse 65°C/1' (DI) DOS 2
- Drying (extra program): X
Program: Rinse (cold)
- Pre-wash: Not Found
- Cleaning and/or thermal disinfection: Not Found
- Interim rinse I with Neutralization: X Rinse Cold water
- Interim rinse II: Not Found
- Final rinse 1) and/or disinfection: Not Found
- Drying (extra program): Not Found
Program: Drain
- Pre-wash: Susanna F. Barw (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K081799
- Cleaning and/or thermal disinfection: Not Found
- Interim rinse I with Neutralization: Not Found
- Interim rinse II: Not Found
- Final rinse 1) and/or disinfection: Not Found
- Drying (extra program): Not Found
Program: Disinfection vario
- Pre-wash: X Cold Water Intake
- Cleaning and/or thermal disinfection: X Cleaning 55°C/5'
- Interim rinse I with Neutralization: X DOS 3
- Interim rinse II: X Cold Water intake
- Final rinse 1) and/or disinfection: X Rinse and Disinfection 93°C/10'
- Drying (extra program): X
Program: Disinfection 93°C-10'
- Pre-wash: Not Found
- Cleaning and/or thermal disinfection: X Disinfection 93°C/10'
- Interim rinse I with Neutralization: X DOS 3
- Interim rinse II: Not Found
- Final rinse 1) and/or disinfection: X Rinse 75°C/3' (DI) DOS 2
- Drying (extra program): X
Product codes (comma separated list FDA assigned to the subject device)
LDS
Device Description
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.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The high level disinfection showed a 6-log reduction of an appropriate myco bacterium species.
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.
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
§ 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.
0
NOV 1 2 2003
Image /page/0/Picture/1 description: The image shows the word "Miele" in a bold, sans-serif font. The word is white and is set against a black background. The letters are large and fill the frame, making the brand name easily recognizable. The image appears to be a logo or branding element for the company Miele.
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 Marketed | |
| Device | Substantial equivalence of the Miele G7881 Dental Thermal Disinfector exists to |
| the Miele G7781 Dental Thermal Disinfector (K950518). The cycle parameters | |
| for high-level disinfection have not been changed from the G7781 Dental | |
| Thermal Disinfector. | |
| Description | 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. | |
| Functional design | 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. | |
| 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 parameters | |
| are easy to control, therefore, errors are improbable. The cycle parameters for | |
| high level disinfection have not been changed from the G7781 Dental Thermal | |
| Disinfector. | |
| Intended Use | High Level Disinfection |
| The G7881 Dental Thermal Disinfector is suitable for automatic treatment of | |
| dental instruments and accessories. It cleans and in the disinfection programs | |
| simultaneously disinfects at 93°C/200°F instruments and accessories. The high | |
| level disinfection showed a 6-log reduction of an appropriate myco bacterium | |
| species. Since the cycle parameters have not been changed from the G7781 Dental | |
| Thermal Disinfector additional testing was not necessary. |
1
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.
2
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.
3
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them that resemble waves or ribbons. The overall design is simple and monochromatic.
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.
4
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
5
Image /page/5/Picture/0 description: The image shows the word "Miele" in a bold, sans-serif font. The letters are white and stand out against a black background. The word appears to be a logo or brand name, possibly for a company or product.
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. Cleaning | |||||
| and/or | ||||||
| thermal | ||||||
| disinfection | 3. Interim | |||||
| rinse I | ||||||
| with | ||||||
| Neutralization | 4. Interim | |||||
| rinse II | 5. Final | |||||
| rinse 1) | ||||||
| and/or | ||||||
| disinfection | 6. Drying | |||||
| (extra | ||||||
| program) | ||||||
| Wash | X | |||||
| Cold | ||||||
| water | ||||||
| intake | X | |||||
| Cleaning | ||||||
| 60°C/3' | X | |||||
| Cold water | ||||||
| intake | X | |||||
| Rinse | ||||||
| 65°C/1' | ||||||
| (DI) | ||||||
| DOS 2 | X | |||||
| Rinse (cold) | X | |||||
| Rinse | ||||||
| Cold water | ||||||
| Drain | Susanna F. Barw | |||||
| (Division Sign-Off) | ||||||
| Division of Anesthesiology, General Hospital, | ||||||
| Infection Control, Dental Devices | ||||||
| 510(k) Number: K081799 | ||||||
| Disinfection | ||||||
| vario | X | |||||
| Cold | ||||||
| Water | ||||||
| Intake | X | |||||
| Cleaning | ||||||
| 55°C/5' | X | |||||
| DOS 3 | X | |||||
| Cold Water | ||||||
| intake | X | |||||
| Rinse and | ||||||
| Disinfection | ||||||
| 93°C/10' | X | |||||
| Disinfection | ||||||
| 93°C-10' | X | |||||
| Disinfection | ||||||
| 93°C/10' | X | |||||
| DOS 3 | X | |||||
| Rinse | ||||||
| 75°C/3' | ||||||
| (DI) | ||||||
| DOS 2 | X |
X= Sections included in a program (with temperature/temperature holding time)