(89 days)
Not Found
No
The description focuses on a standard steam sterilization process controlled by pre-programmed parameters, with no mention of AI or ML.
No
This device is a sterilizer for equipment, not a device used to treat patients.
No
The device is a sterilizer, used to kill infectious bio-organisms on reusable equipment, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a steam sterilizer that uses saturated steam, high pressures, and temperatures, generated by an electric heating element, indicating it is a hardware device with an electronic control system.
Based on the provided text, the M-11 UltraClave is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to sterilize reusable equipment in various healthcare settings. This is a process performed on instruments, not on biological samples or specimens from the human body for diagnostic purposes.
- Device Description: The device description focuses on using steam, pressure, and temperature to kill bio-organisms on equipment. This is a sterilization process, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on biological sample analysis.
The device is clearly intended for sterilizing medical and dental instruments, which falls under the category of medical devices used for infection control, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The M-11 UltraClave is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat- and moisturestable, reusable equipment. Dental handpieces can be sterilized in the M-11 in the Pouches cycle. This device is not recommended for sterilization of liquids intended for direct patient contact. Refer to Standard Cycle Parameters below for detailed information.
Product codes
FLE
Device Description
The Midmark M-11 Ultraclave 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, summarized below.
Materials to be sterilized are placed in the sterilization chamber. The operator chooses a sterilization cycle, and presses the appropriate switch. The sterilizer automatically fills the chamber, heats the water into steam, sterilizes the items, and automatically vents the steam and cools the chamber 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
To validate sterility claims for dental handpieces, which were not included in the predicate devices indications for use when it was cleared by the FDA, Midmark developed a new test protocol for the M-11. This protocol was designed to evaluate the M-11's ability to sterilize commercially available dental handpieces, when presented as a worst-case challenge.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The resulting testing showed that, when used in accordance with Midmark's directions for use, the M-11 can sterilize dental handpieces to an acceptable SAL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K 998189
h) 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: | James Rile, Regulatory Coordinator
(937) 526-8797 | | | | | | |
| Date Submitted: | January 15, 1999 | | | | | | |
| Device Names: | Proprietary:Midmark M-11 Ultraclave Steam SterilizerCommon:Steam SterilizerClassification:80FLE: Sterilizer, Steam | Proprietary: | Midmark M-11 Ultraclave Steam Sterilizer | Common: | Steam Sterilizer | Classification: | 80FLE: Sterilizer, Steam |
| Proprietary: | Midmark M-11 Ultraclave Steam Sterilizer | | | | | | |
| Common: | Steam Sterilizer | | | | | | |
| Classification: | 80FLE: Sterilizer, Steam | | | | | | |
Device to which the Midmark M-11 Ultraclave Steam Sterilizer with dental handpiece indications for use claims equivalence:
Midmark M-11 Ultraclave Steam Sterilizer, cleared for marketing 11/30/94 on K936181
Device Description:
The Midmark M-11 Ultraclave 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, summarized below.
| CYCLE | TEMPERATURE | PRESSURE | TIME |
|---|---|---|---|
| Unwrapped | 132° C (270° F) | 186 kPa (27 psi) | 3 Minutes |
| Pouches | 132° C (270° F) | 186 kPa (27 psi) | 15 Minutes |
| Liquids | 121° C (250° F) | 104 kPa (15 psi) | 30 Minutes |
| Packs | 121° C (250° F) | 104 kPa (15 psi) | 30 Minutes |
Items to be sterilized are placed in the sterilization chamber. The operator chooses a sterilization cycle, and presses the appropriate switch. The sterilizer automatically fills the chamber, heats the water into steam, sterilizes the items, and automatically vents the steam and cools the chamber after sterilization is complete.
Intended Use:
The M-11 UltraClave is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat- and moisturestable, reusable equipment. Dental handpieces can be sterilized in the M-11 in the Pouches cycle. This device is not recommended for sterilization of liquids intended for
1
direct patient contact. Refer to Standard Cycle Parameters below for detailed information.
Indications for Use:
Standard Cycle Parameters
| 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 minutes | Instruments loose on a tray. Open glass or metal canisters. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 3 minutes. The sterility of unwrapped items is compromised on exposure to a non-sterile environment. |
| Pouches | 132°C (270°F)/
186 kPa (27 psi)
15 minutes | Instruments and dental handpieces. Loosely wrapped individual instruments. Multiple layers of instruments separated by fabric. Wrapped trays of loose instruments. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 15 minutes. |
| Liquids | 121°C (250°F)/
104 kPa (15 psi)
30 minutes | Liquids or gels that could boil over with rapid depressurization. Cycle includes special vent and dry functions. Not recommended for sterilization of liquids intended for direct patient contact. |
| Packs | 121°C (250°F)/
104 kPa (15 psi)
30 minutes | Textiles and surgical packs wrapped for sterilization. Items, except liquids, manufacturers recommend for exposure at 121°C (250°F) for 30 minutes. |
To validate sterility claims for dental handpieces, which were not included in the predicate devices indications for use when it was cleared by the FDA, Midmark developed a new test protocol for the M-11. This protocol was designed to evaluate the M-11's ability to sterilize commercially available dental handpieces, when presented as a worst-case challenge. The resulting testing showed that, when used in accordance with Midmark's directions for use, the M-11 can sterilize dental handpieces to an acceptable SAL.
Technological Characteristics that differ between the Midmark M-11 Ultraclave Steam Sterilizer and its predicate device:
None. The intended use, principles of operation, physical design, control system, safeguards, energy sources, target population, materials of construction, method of manufacture, and performance are the same for the proposed device and its predicate.
(Division Sign-off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number
10
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 1999
Mr. James Rile Regulatory Coordinator Midmark Corporation 60 Vista Drive Versailles, Ohio 45380
Re : K990189 Modification Of: Midmark M-11 Ultraclave Trade Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: January 15, 1999 January 20, 1999 Received:
Dear Mr. Rile:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Please note: this response to your the Federal Register. 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.
3
Page 2 - Mr. Rile
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 requlation (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.fda.gov/cdrh/dsmamain.html".
Sincerely yours, liferan
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
i) STATEMENT OF INDICATIONS FOR USE: KGG C 189
Midmark Corporation Applicant:
Midmark M-11 Ultraclave Steam Sterilizer Device Name:
Indications for Use:
The M-11 UltraClave is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat- and moisturestable, reusable equipment. Dental handpieces can be sterilized in the M-11 in the Pouches cycle. This device is not recommended for sterilization of liquids intended for direct patient contact. 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 minutes | Instruments loose on a tray. Open glass or metal canisters. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 3 minutes. The sterility of unwrapped items is compromised on exposure to a non-sterile environment. | |
| Pouches | 132°C (270°F)/ | |
| 186 kPa (27 psi) | ||
| 15 minutes | Instruments and dental handpieces. Loosely wrapped individual instruments. Multiple layers of instruments separated by fabric. Wrapped trays of loose instruments. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 15 minutes. | |
| Liquids | 121°C (250°F)/ | |
| 104 kPa (15 psi) | ||
| 30 minutes | Liquids or gels that could boil over with rapid depressurization. Cycle includes special vent and dry functions. Not recommended for sterilization of liquids intended for direct patient contact. | |
| Packs | 121°C (250°F)/ | |
| 104 kPa (15 psi) | ||
| 30 minutes | Textiles and surgical packs wrapped for sterilization. Items, except liquids, manufacturers recommend for exposure at 121°C (250°F) for 30 minutes. |
Standard Cycle Parameters
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chine S. Lin
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
Optional Format 1-2-96)