(147 days)
Not Found
No
The description focuses on a standard steam sterilization process controlled by pre-programmed electronic parameters, with no mention of AI or ML.
No.
The device is a sterilizer used to clean medical and dental instruments, not to directly treat patients.
No
The device is a sterilizer that uses steam to kill bio-organisms on heat and moisture stable items. Its purpose is to prepare medical instruments for use, not to diagnose conditions or diseases.
No
The device description clearly outlines a physical steam sterilizer with hardware components like a heating element, sterilization chamber, and electronic control system. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to sterilize medical and dental instruments. This is a process performed on devices, not on biological samples from a patient for diagnostic purposes.
- Device Description: The description details a steam sterilizer that kills microorganisms on items. It does not describe any process involving the analysis of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays
The device is a sterilizer, which is a type of medical device used to prepare other medical devices for use. It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The M4+9 EasyClave is to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items (including dental handpieces) that are compatible with steam sterilization at 270°F. Refer to Standard Cycle Parameters below for detailed information.
Cycle: Unwrapped
Temp/Press/Time (minimums): 132°C (270°F)/ 186 kPa (27 psi) 3:30 minutes
Items to be Sterilized: Instruments and dental handpieces loose on a tray. Open glass or metal canisters. Cassettes. Tubing not used in surgical procedures. Items that are compatible with a maximum temperature of 135°C (276°F). The sterility of unwrapped items is compromised on exposure to a non-sterile environment.
Cycle: Wrapped
Temp/Press/Time (minimums): 132°C (270°F)/ 186 kPa (27 psi) 9 minutes
Items to be Sterilized: Instruments and dental handpieces. Loosely wrapped individual instruments. Multiple layers of instruments separated by fabric. Wrapped trays of loose instruments. Wrapped cassettes. Tubing not used in surgical procedures. Items that are compatible with a maximum temperature of 135°C (276°F).
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The Midmark M4+9 EasyClave Steam Sterilizer uses saturated steam at high pressures and temperatures and to kill infectious bio-organisms. This steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to established time, temperature, and pressure parameters.
Items to be sterilized are placed in the sterilization chamber. The operator chooses a sterilization cycle, and presses the appropriate switch. The sterilizer automatically admits a controlled volume of water to the chamber, heats the water into steam, sterilizes the items, and automatically vents the steam and dries the items after sterilization is complete.
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
medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities
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)
To validate sterility claims for dental handpieces, the M4•9 was tested to the same protocol used to validate these claims for the predicate device. The resulting testing showed that, when used in accordance with Midmark's directions for use, the M4+9 can sterilize dental handpieces to an acceptable SAL.
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
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).
0
JAN 1 0 2000
510(k) SUMMARY The information required by 21 CFR § 807.92 is listed below.
| Submitter: | Midmark Corporation
60 Vista Drive
Versailles, OH 45380
(800) 633-0508 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mike Snyder
Regulatory Coordinator
(937) 526-8390 |
| Date Submitted: | 12/02/99 |
| Device Names: | Proprietary: Midmark M4•9 EasyClave Steam Sterilizer
Common: Steam Sterilizer
Classification: 80FLE: Sterilizer, Steam |
Device to which the Midmark M4+9 EasyClave Steam Sterilizer claims equivalence: Midmark M-11 UltraClave Steam Sterilizer with dental handpiece indications for use, cleared for marketing 4/19/99 on K990189
Device Description:
The Midmark M4+9 EasyClave Steam Sterilizer uses saturated steam at high pressures and temperatures and to kill infectious bio-organisms. This steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to established time, temperature, and pressure parameters.
Items to be sterilized are placed in the sterilization chamber. The operator chooses a sterilization cycle, and presses the appropriate switch. The sterilizer automatically admits a controlled volume of water to the chamber, heats the water into steam, sterilizes the items, and automatically vents the steam and dries the items after sterilization is complete.
Intended Use:
The M4+9 EasyClave is to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items (including dental handpieces) that are compatible with steam sterilization at 270°F. Refer to Standard Cycle Parameters below for detailed information.
1
Indications for Use:
| Cycle | Temp/Press/Time
(minimums) | Items to be Sterilized
(Always consult the item manufacturer's
recommendations for sterilization.) |
|-----------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Unwrapped | 132°C (270°F)/
186 kPa (27 psi)
3:30 minutes | Instruments and dental handpieces loose on a tray.
Open glass or metal canisters. Cassettes. Tubing
not used in surgical procedures. Items that are
compatible with a maximum temperature of 135°C
(276°F). The sterility of unwrapped items is
compromised on exposure to a non-sterile
environment. |
| Wrapped | 132°C (270°F)/
186 kPa (27 psi)
9 minutes | Instruments and dental handpieces. Loosely
wrapped individual instruments. Multiple layers of
instruments separated by fabric. Wrapped trays of
loose instruments. Wrapped cassettes. Tubing not
used in surgical procedures. Items that are compatible
with a maximum temperature of 135°C (276ºF). |
Standard Cycle Parameters
To validate sterility claims for dental handpieces, the M4•9 was tested to the same protocol used to validate these claims for the predicate device. The resulting testing showed that, when used in accordance with Midmark's directions for use, the M4+9 can sterilize dental handpieces to an acceptable SAL.
Technological Characteristics that differ between the Midmark M4•9 EasyClave Steam Sterilizer and its predicate device:
The intended use, principles of operation, safeguards, energy sources, target population, and performance are the same for the proposed device and its predicate.
The physical design, control system, materials of construction, and method of manufacture differ slightly from the predicate device. Both devices, however are designed to the appropriate industrial standards, and the M4+9 meets performance standards that the predicate device does not.
2
Image /page/2/Picture/2 description: The image shows a logo for the Department of Health. The logo features a stylized depiction of an eagle or bird with three curved lines representing its body and wings. To the left of the bird is the text "DEPARTMENT OF HEALTH &". The text is arranged vertically, following the curve of the bird's body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2000
Mr. Mike Snyder Regulatory Coordinator Midmark® Corporation 60 Vista Drive Versailles, Ohio 45380
Re : K992744 Trade Name: Midmark M4●9 EasyClave Steam Sterilizer Class: II Product Code: FLE December 2, 1999 Dated: Received: December 8, 1999
Dear Mr. Snyder:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
3
Page 2 - Mr. Snyder
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaggov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE:
Applicant: Midmark Corporation
Midmark M4•9 EasyClave Steam Sterilizer Device Name:
Indications for Use:
The M4+9 EasyClave is to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items (including dental handpieces) that are compatible with steam sterilization at 270°F. Refer to Standard Cycle Parameters below for detailed information.
| Cycle | Temp/Press/Time
(minimums) | Items to be Sterilized
(Always consult the item manufacturer's
recommendations for sterilization.) |
|-----------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Unwrapped | 132°C (270°F)/
186 kPa (27 psi)
3:30 minutes | Instruments and dental handpieces loose on a tray.
Open glass or metal canisters. Cassettes. Tubing
not used in surgical procedures. Items that are
compatible with a maximum temperature of 135° C
(276° F). The sterility of unwrapped items is
compromised on exposure to a non-sterile
environment. |
| Wrapped | 132°C (270°F)/
186 kPa (27 psi)
9 minutes | Instruments and dental handpieces. Loosely
wrapped individual instruments. Multiple layers of
instruments separated by fabric. Wrapped trays of
loose instruments. Wrapped cassettes. Tubing not
used in surgical procedures. Items that are compatible
with a maximum temperature of 135°C (276°F). |
Standard Cycle Parameters
Clis S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number