(147 days)
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.
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.
The provided text describes the Midmark M4-9 EasyClave Steam Sterilizer and its equivalence to a predicate device, the Midmark M-11 UltraClave Steam Sterilizer. However, the document does not contain detailed information about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement in the way typically found in performance studies for AI/software devices.
The information provided only states that:
1. Acceptance Criteria and Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilization of dental handpieces to an acceptable SAL (Sterility Assurance Level) when used with specific 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." Specific Cycle Parameters: - Unwrapped: 132°C (270°F) / 186 kPa (27 psi) / 3:30 minutes - Wrapped: 132°C (270°F) / 186 kPa (27 psi) / 9 minutes |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "the M4•9 was tested to the same protocol used to validate these claims for the predicate device," but the sample size of items or runs for this protocol is not mentioned.
- Data Provenance: Not specified. It's an in-house validation for a medical device manufacturer. The country of origin and whether it was retrospective or prospective is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. This is a validation study for a physical sterilization device, not a diagnostic or AI-powered imaging device that would typically rely on expert human interpretation for ground truth. The "ground truth" for sterilization is achieving a specific sterility assurance level (SAL), which is determined by microbiological testing, not human expert consensus on images or data.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: Not applicable. This is a sterilization validation based on physical parameters and microbiological results, not a study involving human readers or interpretation requiring adjudication.
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. This is not an AI or software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. The device is a steam sterilizer, its "performance" is its ability to sterilize. "Standalone" in this context would refer to its operation according to its pre-programmed cycles. The document confirms it "can sterilize dental handpieces to an acceptable SAL."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: Achieving an "acceptable SAL (Sterility Assurance Level)." This is typically established through biological indicator testing (e.g., spore strips) and monitoring physical parameters (temperature, pressure, time) to ensure the destruction of microorganisms. It is a scientific, objective measure of sterility, not expert consensus or pathology in the human diagnostic sense.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is a physical sterilizer. It does not use a "training set" in the machine learning sense. Its programming is based on established sterilization principles and engineering, not data-driven learning.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As above, there is no "training set" for this type of device. The "ground truth" for its design and pre-programmed cycles would be based on the scientific principles of heat and moisture sterilization to achieve microbial inactivation, which has been established through extensive research and standards in microbiology and sterilization practices.
{0}------------------------------------------------
JAN 1 0 2000
510(k) SUMMARY The information required by 21 CFR § 807.92 is listed below.
| Submitter: | Midmark Corporation60 Vista DriveVersailles, OH 45380(800) 633-0508 |
|---|---|
| Contact Person: | Mike SnyderRegulatory Coordinator(937) 526-8390 |
| Date Submitted: | 12/02/99 |
| Device Names: | Proprietary: Midmark M4•9 EasyClave Steam SterilizerCommon: Steam SterilizerClassification: 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'srecommendations 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. Tubingnot used in surgical procedures. Items that arecompatible with a maximum temperature of 135°C(276°F). The sterility of unwrapped items iscompromised on exposure to a non-sterileenvironment. |
| Wrapped | 132°C (270°F)/186 kPa (27 psi)9 minutes | Instruments and dental handpieces. Looselywrapped individual instruments. Multiple layers ofinstruments separated by fabric. Wrapped trays ofloose instruments. Wrapped cassettes. Tubing notused in surgical procedures. Items that are compatiblewith 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'srecommendations 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. Tubingnot used in surgical procedures. Items that arecompatible with a maximum temperature of 135° C(276° F). The sterility of unwrapped items iscompromised on exposure to a non-sterileenvironment. |
| Wrapped | 132°C (270°F)/186 kPa (27 psi)9 minutes | Instruments and dental handpieces. Looselywrapped individual instruments. Multiple layers ofinstruments separated by fabric. Wrapped trays ofloose instruments. Wrapped cassettes. Tubing notused in surgical procedures. Items that are compatiblewith 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
§ 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).