(276 days)
The Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and the Ritter M9D AutoClave® Automatic Sterilizer can 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. Refer to Standard Cycle Parameters on the following page for detailed information.
The Midmark and Ritter M9 and M11 UltraClave and Ritter M9D AutoClave Self-Contained steam sterilizers are designed to sterilize medical, surgical, laboratory, and dental items, using pressurized steam. The M9 UltraClave models include a variation designated as the M9D Autoclave, the only difference being that the M9 UltraClave includes a motor to automatically open the door for drying and the M9D Autoclave is a manual model which requires the operator to open the door for drying. They are self-contained devices that are electrically powered with automatic controls for controlling time and temperature that are designed for safe, easy operation with minimal operator training.
The provided document describes the Midmark and Ritter M9 and M11 UltraClave Automatic Sterilizers and the Ritter M9D AutoClave Automatic Sterilizer, which are self-contained steam sterilizers used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a steam sterilizer, and its performance is evaluated based on its ability to achieve sterility For medical devices, the common performance criteria for sterilization are the achievement of a certain temperature and pressure for a specified duration, resulting in a Sterility Assurance Level (SAL) of 10^-6, meaning the probability of a single viable microorganism remaining after sterilization is one in a million.
The document implicitly defines acceptance criteria through the "Standard Cycle Parameters" and confirms the device's performance through validation studies.
| Acceptance Criterion (Standard Cycle Parameter) | Reported Device Performance (Achieved during validation) |
|---|---|
| Unwrapped Cycle: | |
| Sterilizing Temperature: 270°F (132°C) | Achieved (implicit through successful biological testing and adherence to standard) |
| Sterilizing Time: 3 min. | Achieved (implicit through successful biological testing and adherence to standard) |
| Pressure (Ref): 27.1 psi (186 kPa) | Achieved (implicit through successful biological testing and adherence to standard) |
| Drying Time: 30 min. | Achieved |
| Pouches Cycle: | |
| Sterilizing Temperature: 270°F (132°C) | Achieved (implicit through successful biological testing and adherence to standard) |
| Sterilizing Time: 4 min. | Achieved (implicit through successful biological testing and adherence to standard) |
| Pressure (Ref): 27.1 psi (186 kPa) | Achieved (implicit through successful biological testing and adherence to standard) |
| Drying Time: 30 min. | Achieved |
| Packs Cycle: | |
| Sterilizing Temperature: 250°F (121°C) | Achieved (implicit through successful biological testing and adherence to standard) |
| Sterilizing Time: 30 min. | Achieved (implicit through successful biological testing and adherence to standard) |
| Pressure (Ref): 15 psi (104 kPa) | Achieved (implicit through successful biological testing and adherence to standard) |
| Drying Time: 30 min. | Achieved |
| Handpieces Cycle: | |
| Sterilizing Temperature: 270°F (132°C) | Achieved (implicit through successful biological testing and adherence to standard) |
| Sterilizing Time: 4 min. | Achieved (implicit through successful biological testing and adherence to standard) |
| Pressure (Ref): 27.1 psi (186 kPa) | Achieved (implicit through successful biological testing and adherence to standard) |
| Drying Time: 30 min. | Achieved |
| Microbiological Performance (SAL): | |
| Sterility Assurance Level (SAL): 10⁻⁶ | Achieved (demonstrated through biological indicator overkill method) |
| Physical Performance Requirements: | All aspects of the standard met. |
The document states: "Testing showed that the M9 and M11 UltraClave and the M9D AutoClave Self-Contained Steam Sterilizers meet all aspects of the standard, including physical and microbiological performance requirements."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the physical performance validation, temperature sensors were used to determine the thermal profile of the empty chamber for "three (3) full chamber runs for each pre-programmed cycle parameter" (Unwrapped, Pouches, Packs, Handpieces). For microbiological testing, "biological testing was conducted on fully loaded chambers." No specific number of "fully loaded chambers" or individual biological indicators (BIs) is explicitly stated for the test set, beyond the statement that BIs were inoculated in "most difficult to sterilize locations."
- Data Provenance: The studies were conducted by "MIDMARK Corporation." The country of origin for the data is not explicitly stated, but Midmark Corporation is based in Versailles, Ohio, USA, suggesting the testing was likely conducted in the USA. The data is prospective, generated specifically for these validation studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (steam sterilizer) does not typically involve human experts in establishing the "ground truth" in the same way an AI diagnostic tool would. The ground truth for sterilization efficacy is established by scientific standards and laboratory methods.
- Number of Experts: Not applicable in the context of human interpretation. The "experts" are the scientific and technical personnel who designed and executed the validation protocols based on established sterilization standards.
- Qualifications of Experts: Not explicitly stated, but implied to be qualified personnel in sterilization science, microbiology, and engineering, familiar with relevant standards (e.g., ANSI/AAMI ST55).
4. Adjudication Method for the Test Set
Not applicable. Sterilization testing is based on objective, quantifiable measures (temperature, pressure, time, and biological indicator kill rates) rather than subjective expert opinion requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a standalone medical device (sterilizer), not an AI algorithm intended for interpretation by human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
Yes, a standalone performance study was conducted. The entire validation process, as described, evaluates the device's intrinsic mechanical and microbiological performance. The sterilizer operates autonomously through software-controlled microcontrollers (as described in the "Device Description") to achieve the specified sterilization cycles. The human operator initiates the cycle and loads/unloads the device, but the sterilization process itself is algorithmic (pre-programmed cycles and control loops) and standalone.
7. Type of Ground Truth Used
The ground truth used is based on established microbiological and physical standards for sterilization, specifically:
- Biological Indicator Overkill Method: This is a gold standard for demonstrating sterilization efficacy. Geobacillus stearothermophilus spores are highly resistant, and their complete inactivation (achieving a 10⁻⁶ SAL) confirms the sterilization process is effective.
- Physical Parameters: Measurement of temperature, pressure, and time profiles within the chamber ensure that the physical conditions required for sterilization were met.
- Reference Standards: The studies were conducted "in accordance with ANSI/AAMI ST55: 2010/(R)2014," a recognized standard for tabletop steam sterilizers, which defines the ground truth for performance requirements.
8. Sample Size for the Training Set
Not applicable. This is a physical device (sterilizer) with an embedded operating algorithm, not an AI model that undergoes "training" on a dataset in the typical machine learning sense. The device's control system is developed through engineering design and robust testing, not statistical training on large datasets.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8. The "ground truth" for the device's operational parameters (e.g., control logic for heating, venting, sterilizing timing) is established through engineering principles, design specifications, and adherence to regulatory and industry standards for steam sterilization.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2017
Midmark Corporation Adam Clutter Regulatory Affairs Specialist 60 Vista Dr. Versailles, Ohio 45380
Re: K163337
Trade/Device Name: Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: August 3, 2017 Received: August 3, 2017
Dear Adam Clutter:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tara A. Ryan -S
Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K163337
Device Name
MIDMARK and Ritter M9 and M11 UltraClave and Ritter M9D AutoClave Self-Contained Steam Sterilizer
Indications for Use (Describe)
The Midmark and Ritter M9 and M11 UltraClave Automatic Sterilizers and the Ritter M9D AutoClave Automatic Sterilizer can 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. Refer to Standard Cycle Parameters on the following page for detailed information.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740
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| Cycle Type | Cycle Parameters | DryingTime | Items to be Sterilized(Always consult the item manufacturer'srecommendations for sterilization.) | ||
|---|---|---|---|---|---|
| Unwrapped | 270°F(132°C) | 3 min. | 27.1 psi(186 kPa) | 30 min. | • Instruments loose on a tray.• Open glass or metal canisters.• Tubing not used in surgical procedures.(Max. length - 40" & Min. inside diameter - .187")• Loose items manufacturers recommend forexposure at 270°F (132°C) for 3 minutes.Note: The sterility of unwrapped items is compro-mised on exposure to a non-sterile environment. |
| Pouches | 270°F(132°C) | 4 min. | 27.1 psi(186 kPa) | 30 min. | • Pouched or loosely wrapped instruments.• Multiple layers of instruments separated byfabric.• Wrapped trays of loose instruments.• Wrapped cassettes.• Wrapped items manufactures recommend forexposure at 270°F (132°C) for 4 minutes. |
| Packs | 250°F(121°C) | 30 min. | 15 psi(104 kPa) | 30 min. | • Textiles and surgical packs wrapped forsterilization.• Items, except liquids, manufacturersrecommend for exposure at 250°F (121°C) for30 minutes. |
| Handpieces | 270°F(132°C) | 4 min. | 27.1 psi(186 kPa) | 30 min. | • Dental handpieces (wrapped or unwrapped).Note: Verify acceptability of sterilizationparameters with handpiece manufacturer. |
| 1. The pressure shown in this table is for reference only. It's the ideal pressure of saturated steamat the sterilization temperature. The pressure shown on the sterilizer display may be higher. |
Standard Cycle Parameters
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| M9 Maximum Capacities | |||
|---|---|---|---|
| Load Type | Large Tray | Small Tray | Total |
| Solid Instruments | 2.4 lbs. (1089 grams) or | 1.6 lbs. (726 grams) or | 8.0 lbs. (3629 grams) or |
| Handpieces | 2 handpieces with other instru-ments2.4 lbs. (1089 grams) or | 2 handpieces with other instru-ments1.6 lbs. (726 grams) or | 8 handpieces with other instru-ments8.0 lbs. (3629 grams) or |
| Packs* | 90 in3 ≤ 1.25 in. thick(1475 cm3 ≤ 3.2 cm thick) | 55 in3 ≤ 0.75 in. thick(901 cm3 ≤ 1.9 cm thick) | 290 in3(4752 cm3) |
Description of Validated Loads
| M11 Maximum Capacities | |||
|---|---|---|---|
| Load Type | Large Tray | Small Tray | Total |
| Solid Instruments | 2.7 lbs., (1225 grams) or | 1.8 lbs., (816 grams) or | 9.0 lbs., (4082 grams) or |
| Handpieces | 2 handpieces with other instruments2.7 lbs. (1225 grams) or | 2 handpieces with other instruments1.8 lbs. (816 grams) or | 8 handpieces with other instruments9.0 lbs. (4082 grams) or |
| Packs* | 145 in3 ≤ 1.5 in. thick(2376 cm3 ≤ 3.8 cm thick) | 108 in3 ≤ 1.5 in. thick(1770 cm3 ≤ 3.8 cm thick) | 505 in3(8275 cm3) |
| *Allow a minimum of 1/4" (6.4 mm) space between each pack, and also from the chamber wall.. |
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Image /page/5/Picture/0 description: The image shows the logo for Midmark. The logo is a dark blue rectangle with the word "MIDMARK" in white, sans-serif font. There is a white swoosh above the word "MIDMARK". Below the logo is the tagline "Because we care." in a smaller, black, sans-serif font.
Midmark Corporation 60 Vista Drive Versailles, Ohio 45380-0286 1-800-MIDMARK midmark.com
510(k) Summary
Table 7-1 Administrative Information
| Date SummaryPrepared | August 28, 2017 |
|---|---|
| 510(k) SponsorAddress | MIDMARK® Corporation60 Vista DriveVersailles, Ohio 45380 |
| Contact Person | Adam ClutterRegulatory Affairs SpecialistPhone: (937) 526-8474FAX: (937) 526-7412 |
| Trade Name | MIDMARK® and Ritter® M9 and M11 UltraClave®and Ritter® M9D AutoClave® Self-Contained SteamSterilizer |
| Common Name | Table Top Steam Sterilizer |
| Classification Name | Sterilizer, Steam(21 CFR §880.6880Product Code 80 FLE) |
| Device Classification | Class II |
| Review Panel | General Hospital |
| 510(k) Number | K163337 |
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| Model | Brand | InputVoltage | GTINNumber | Chamber Size | DoorOperation |
|---|---|---|---|---|---|
| M9-04XUltraClave | Midmark | 115 Vac | 00841709100222 | 9" (22.9 cm) Dia. x15" (38.1 cm) Deep | Automatic |
| Midmark | 230 Vac | 00841709100239 | 9" (22.9 cm) Dia. x15" (38.1 cm) Deep | Automatic | |
| Ritter | 115 Vac | 00841709100246 | 9" (22.9 cm) Dia. x15" (38.1 cm) Deep | Automatic | |
| M9D-042Autoclave | Ritter | 115 Vac | 00841709100253 | 9" (22.9 cm) Dia. x15" (38.1 cm) Deep | Manual |
| M11-04XUltraClave | Midmark | 115 Vac | 00841709100277 | 11" (27.9 cm) Dia. x18" (45.7 cm) Deep | Automatic |
| Midmark | 230 Vac | 00841709100284 | 11" (27.9 cm) Dia. x18" (45.7 cm) Deep | Automatic | |
| Ritter | 115 Vac | 00841709100291 | 11" (27.9 cm) Dia. x18" (45.7 cm) Deep | Automatic |
Table 7-2 Device Models
Table 7-3 Predicate Devices
| ManufacturerName | Trade Name | 510(k)Number | DecisionDate | ModelNumber |
|---|---|---|---|---|
| MIDMARK®Corporation | MIDMARK®UltraClave®SteamSterilizer | K023348 | 03/03/2003 | M9/M9D-02X |
| MIDMARK®Corporation | MIDMARK®UltraClave®SteamSterilizer | K990189 | 04/19/1999 | M11-00X |
Device Description
The Midmark and Ritter M9 and M11 UltraClave and Ritter M9D AutoClave Self-Contained steam sterilizers are designed to sterilize medical, surgical, laboratory, and dental items, using pressurized steam. The M9 UltraClave models include a variation designated as the M9D Autoclave, the only difference being that the M9 UltraClave includes a motor to automatically open the door for drying and the M9D Autoclave is a manual model which requires the operator to open the door for drying. They are self-contained devices that are electrically powered with automatic controls for controlling time and temperature that are designed for safe, easy operation with minimal operator training.
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The Midmark and Ritter M9 and M11 UltraClave and RitterM9D AutoClave Self-Contained steam sterilizers have an overall chamber dimension / volume size of 9" (22.9 cm) x 15" (38.1 cm) / 0.47 ft (13.4 L) for the M9 and 11" (27.9 cm) x 18" (45.7cm) / 0.87 ft (24.6 L) for the M11.
The steam sterilizers operating temperatures of the preset cycles are 250°F +6°F/-0°F (121°C +3°C/-0°C) and 270°F +6°F/-0°F (132°C +3°C/-0) which utilize a steam-flush pressure-pulse (SFPP) cycle consisting of three (3) or four (4) sequential steam flushes and pressure pulses to remove air from the sterilizing chamber and processed materials. SFPP cycles rely on diffusion of residual air in the steam and subsequent flushing of the air-steam mixture from the sterilizer resulting in shorter cycle times than gravity displacement sterilizers. Air removal is achieved with the sterilizing chamber pressure at above atmospheric pressure.
The operation of the sterilizer is controlled by a software controlled microcontroller internal to the unit. The software provides for user control of the device via a keypad on the unit's front panel. The same software is used for the Midmark and Ritter M9 and M11 UltraClave" and Ritter M9D AutoClave® Self-Contained Steam Sterilizers.
Image /page/7/Picture/3 description: The image shows a front panel of a machine with several buttons and a display screen. The display screen reads "SELECT CYCLE". There are buttons labeled "P", "1", and "2", as well as buttons with icons representing "Unwrapped", "Pouches", "Packs", and "Handpieces". There are also green "Start" and red "Stop" buttons.
Figure 7-1 Front Panel
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| CycleCycle | Pre-Treatment(SFPP) | SterilizingTemperature | SterilizingTime | Pressure(Ref¹) | DryingTime |
|---|---|---|---|---|---|
| UnwrappedCycle | 3 Pulses | 270°F(132°C) | 3 min | 27.1 psi(186 kPa) | 30 min |
| Pouches Cycle | 3 Pulses | 270°F(132°C) | 4 min | 27.1 psi(186 kPa) | 30 min |
| PacksCycle | 3 Pulses | 250°F(121°C) | 30 min | 15 psi(104 kPa) | 30 min |
| Handpiece Cycle | 4 Pulses | 270°F(132°C) | 4 min | 27.1 psi(186 kPa) | 30 min |
Table 7-4 Cycle Parameters for M9/M11 UltraClave and M9D AutoClave
Table 7-5 Description of Validated Loads
| M9 Maximum Capacities | |||
|---|---|---|---|
| Load Type | Large Tray | Small Tray | Total |
| Solid Instruments | 2.4 lbs. (1089 grams) or | 1.6 lbs. (726 grams) or | 8.0 lbs. (3629 grams) or |
| Handpieces | 2 handpieces with other instru-ments2.4 lbs. (1089 grams) or | 2 handpieces with other instru-ments1.6 lbs. (726 grams) or | 8 handpieces with other instru-ments8.0 lbs. (3629 grams) or |
| Packs* | 90 in3 ≤ 1.25 in. thick(1475 cm3 ≤ 3.2 cm thick) | 55 in3 ≤ .75 in. thick(901 cm3 ≤ 1.9 cm thick) | 290 in3(4752 cm3) |
| M11 Maximum Capacities | |||
|---|---|---|---|
| Load Type | Large Tray | Small Tray | Total |
| Solid Instruments | 2.7 lbs., (1225 grams) or | 1.8 lbs., (816 grams) or | 9.0 lbs., (4082 grams) or |
| Handpieces | 2 handpieces with other instru-ments2.7 lbs. (1225 grams) or | 2 handpieces with other instru-ments1.8 lbs. (816 grams) or | 8 handpieces with other instru-ments9.0 lbs. (4082 grams) or |
| Packs* | 145 in3 ≤ 1.5 in. thick(2376 cm3 ≤ 3.8 cm thick) | 108 in3 ≤ 1.5 in. thick(1770 cm3 ≤ 3.8 cm thick) | 505 in3(8275 cm3) |
| *Allow a minimum of 1/4" (6.4 mm) space between each pack, and also from the chamber wall. |
1 The pressure shown in this table is for reference only. It's the ideal pressure of saturated steam at the sterilization temperature.
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Table 7-6 Cycle Sequence and Display M9/M11 UltraClave and M9D AutoClave
| Stage of Cycle | Description | Display |
|---|---|---|
| Filling | Chamber begins filling with water.When water reaches the proper level... | FILLINGCHAMBERCHAMBERIS FULL |
| Heating | Display changes as temperature andpressure in chamber changes.(Metric units may be displayed if desired). | HEATING - UNWRAPPEDXXX°F XX.X PSI |
| Sterilizing | Sterilizing begins when correcttemperature / pressure is reached.Time remaining in cycle counts downwhile current temperature / pressure inchamber is continuously updated. | STERILIZINGMM:SS XXX°F XX.X PSI |
| Ready to Vent | 'READY TO VENT' is displayed when10 seconds remain in sterilization cycle. | READY TO VENTXXX°F XX.X PSI |
| Fast Vent | When time runs out in sterilizing mode,the vent valve opens. Steam / water arereleased back into the reservoir.The display changes as temperature andpressure in chamber changes. | FAST VENTXXX°F XX.X PSI |
| CautionKeep clear when M9/M11 door is ready to open!Failure to do so could result in severe bums from steam being released. | ||
| Door To Open(automatic)Pertains only toM9/M11 UltraClave® | An audible signal is emitted to indicatethat the door is about to open.When pressure in chamber reaches zero,the door actuates to partially open (dryingmode) position. | DOOR TO OPENXXX°F XX.X PSI |
| Manual Door OpenPertains only toM9D AutoClave | An Audible signal is emitted when pres-sure inside chambers reaches zero toindicate Operator to open door. The doorshould be opened to the first stop (dry-ing mode) position. The audible signalwill continue to repeat every minute untileither the door is opened to the DRY (par-tially opened) position, or by pressing theSTOP button, aborting the DRY cycle. | OPEN DOOR TO DRYSTOP TO ABORT |
| CautionThe processed loads may still be wet if the Dry Cycle is abortedprior to completion. Always allow processed loads to dry in thesterilizer before they are handled to avoid re-contamination. | ||
| Drying | Time of Dry Cycle is counted down. Ifdesired, the Dry Cycle can be aborted bypressing the STOP button.When Drying time reaches 0:00... | DRYINGMM:SSDRY CYCLECOMPLETE |
| Cycle Complete | An audible signal is emitted for 10seconds. | SELECT CYCLE |
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| Item | M9/M11 UltraClave and M9D AutoClave |
|---|---|
| Chamber DimensionsM9/M9D | 9" (22.9 cm) x 15" (38.1 cm) / Stainless Steel |
| M11 | 11" (27.9 cm) x 18" (45.7cm) / Stainless Steel |
| Chamber VolumeM9/M9D | 0.47 ft³ (13.4 L) |
| M11 | 0.87 ft³ (24.6 L) |
| Double Hinged Door(M9/M9D & M11) | Carbon Steel w/ Stainless Steel Liner |
| Door LatchM9/M11 | Manual Double Bolt Latch w/Automatic Opening |
| M9D | Manual Double Bolt Latch |
| Door Gaskets(M9/M9D & M11) | High Temperature Silicon Rubber |
| TraysM9/M9D | 2 small (5.6"W x 12"L x .9"D)2 large (7.3"W x 12"L x .9"D)(Perforated Stainless Steel) |
| M11 | 2 small (6.6"W x 15"L x 1.1"D)2 large (9"W x 15"L x 1.1"D)(Perforated Stainless Steel) |
| Tray Rack(M9/M9D & M11) | Formed Stainless Steel Sheet |
| Water ReservoirM9/M9D | Polyethylene Plastic - 1.1 gal (4.16 L) |
| M11 | Polyethylene Plastic - 1.4 gal (5.3 L) |
| Water Fill System(M9/M9D & M11) | Gravity fill w/ Chamber Water Level Sensor |
| Water Fill Valve(M9/M9D & M11) | Electronic Solenoid |
| Heater(M9/M9D & M11) | 1425 Watt Immersion Heater (115 volt models)1500 Watt Immersion Heater (230 volt models) |
| Air Removal Valve(M9/M9D & M11) | Electronic Solenoid |
| Vent Valve(M9/M9D & M11) | Electronic Solenoid |
| Dry Cycle Features M9/M11 | Door Automatically Opens Partially (MotorDriven) |
| M9D | Manual Door (Operator manually opens door) |
| (All models incorporate anactive drying system.) |
Table 7-7 Design / Materials
Indications for Use
"The Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and the Ritter M9D AutoClave® Automatic Sterilizer can be used in medical offices, hospitals, clinics,
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nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters on the following page for detailed information."
| Cycle Type | Cycle Parameters | Drying Time | Items to be Sterilized(Always consult the item manufacturer'srecommendations for sterilization.) | ||
|---|---|---|---|---|---|
| Temp.(Min.) | Time | Press.¹(Ref.) | |||
| Image: Unwrapped | 270°F(132°C) | 3 min. | 27.1 psi(186 kPa) | 30 min. | • Instruments loose on a tray.• Open glass or metal canisters.• Tubing not used in surgical procedures.(Max. length - 40" & Min. inside diameter - .187")• Loose items manufacturers recommend forexposure at 270°F (132°C) for 3 minutes.Note: The sterility of unwrapped items is compromised on exposure to a non-sterile environment. |
| Image: Pouches | 270°F(132°C) | 4 min. | 27.1 psi(186 kPa) | 30 min. | • Pouched or loosely wrapped instruments.• Multiple layers of instruments separated by fabric.• Wrapped trays of loose instruments.• Wrapped cassettes.• Wrapped items manufactures recommend for exposure at 270°F (132°C) for 4 minutes. |
| Image: Packs | 250°F(121°C) | 30 min. | 15 psi(104 kPa) | 30 min. | • Textiles and surgical packs wrapped for sterilization.• Items, except liquids, manufacturers recommend for exposure at 250°F (121°C) for 30 minutes. |
| Image: Handpieces | 270°F(132°C) | 4 min. | 27.1 psi(186 kPa) | 30 min. | • Dental handpieces (wrapped or unwrapped).Note: Verify acceptability of sterilization parameters with handpiece manufacturer. |
| 1. The pressure shown in this table is for reference only. It's the ideal pressure of saturated steam at the sterilization temperature. The pressure shown on the sterilizer display may be higher. |
Standard Cycle Parameters
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| M9 Maximum Capacities | |||
|---|---|---|---|
| Load Type | Large Tray | Small Tray | Total |
| Solid Instruments | 2.4 lbs. (1089 grams) or | 1.6 lbs. (726 grams) or | 8.0 lbs. (3629 grams) or |
| Handpieces | 2 handpieces with other instruments2.4 lbs. (1089 grams) or | 2 handpieces with other instruments1.6 lbs. (726 grams) or | 8 handpieces with other instruments8.0 lbs. (3629 grams) or |
| Packs* | 90 in3 ≤ 1.25 in. thick(1475 cm3 ≤ 3.2 cm thick) | 55 in3 ≤ .75 in. thick(901 cm3 ≤ 1.9 cm thick) | 290 in3(4752 cm3) |
| M11 Maximum Capacities | |||
| Load Type | Large Tray | Small Tray | Total |
| Solid Instruments | 2.7 lbs., (1225 grams) or | 1.8 lbs., (816 grams) or | 9.0 lbs., (4082 grams) or |
| Handpieces | 2 handpieces with other instruments2.7 lbs. (1225 grams) or | 2 handpieces with other instruments1.8 lbs. (816 grams) or | 8 handpieces with other instruments9.0 lbs. (4082 grams) or |
| Packs* | 145 in3 ≤ 1.5 in. thick(2376 cm3 ≤ 3.8 cm thick) | 108 in3 ≤ 1.5 in. thick(1770 cm3 ≤ 3.8 cm thick) | 505 in3(8275 cm3) |
Description of Validated Loads
Technological Characteristics
The intended use, technological characteristics (i.e., design, material, energy source) principles of operation, safeguards, target population, and performance are the same for the proposed devices and their corresponding predicate devices.
| CHARACTERISTIC | PREDICATEMIDMARK M9 UltraClave | NEW MODELSMIDMARK & Ritter M9UltraClave & Ritter M9DAutoclave |
|---|---|---|
| 510(k) Clearance | K023348 | K163337 |
| Midmark Models #s | M9-02X & M9D-02X | M9-04X & M9D-042 |
| Type of SteamSterilizer | TabletopDynamic-Air-Removal (SFPP) | Same |
| Intended Use(Same for all models) | The M9 UltraClaveTM isintended to be used in medicaland dental offices, hospitals,clinics, nursing homes,laboratories, and other facilitiesto sterilize heat and moisturestable reusable items (includingdental handpieces) that arecompatible with steam | The Midmark and Ritter M9 andM11 UltraClave® AutomaticSterilizers and the Ritter M9DAutoClave® Automatic Sterilizercan be used in medical anddental offices, hospitals, clinics,nursing homes, laboratories, andother facilities to sterilize heatand moisture stable reusable |
| sterilization. | items (including dental handpieces) that are compatible with steam sterilization. | |
| Indications for Use:(Cycle Comparison) | Parameters(Sterilize Time/Temp./DryTime¹) | Parameters(Sterilize Time/Temp./Dry Time) |
| Unwrapped Cycle | 3 min./ 270°F (132°C) / 30 min. | Same |
| Pouches Cycle | 6 min./ 270°F (132°C) / 30 min. | 4 min./ 270°F (132°C)/ 30 min. |
| Packs Cycle | 30 min./ 250°F (121°C)/30 min. | Same |
| Handpiece Cycle | 6 min./ 270°F (132°C) / 30 min. | 4 min./ 270°F (132°C)/ 30 min. |
| Programmable 1 | 3-90 min./ 230-275°F / 30 min.(110-135°C) | N/A |
| Programmable 2 | 3-90 min./ 230-275°F / 30 min.(110-135°C) | N/A |
| Controls: | ||
| Main Controller | Micro Processor BasedEmbedded Control | Same w/ Modifications toIncorporate a Real Time Clock(RTC) & Power Supply for NewPrinter Accessory |
| User Controls | Membrane Type Switches | Same |
| Temperature Sensor | Platinum RTD | Same |
| Pressure Sensor | PC Mounted Gauge PressureTransducer | Same |
| Process Monitors: | ||
| Display Type | LCD(2 row x 20 character) | Same |
| Operator Alerts | Audible Alarms & VisualSignals Displaying Status,Instructions & Self-DiagnosticError Codes on LCD Display | Same |
| Printer Accessory(Optional) | 5 VDC, 24 CharacterDot Matrix PrinterRecords: Cycle Stats. - Time,Temp. & Press. | 5 VDC, 24 CharacterThermal PrinterRecords: Sterilizer ID, Date &Time in Addition to Cycle Stats.- Time, Temp. & Press. |
| Safety Features: | ||
| Overpressure Protection | ASME press. relief valve (40psi) | Same |
| Overheat Protection | Dual Auto-Reset Thermostats450°F (232°C) | Same |
| Door Interlock | High Integrity Safety Switch | Same |
| CHARACTERISTIC | PREDICATEMIDMARK M11 UltraClave | NEW MODELSMIDMARK & Ritter M11UltraClave |
| 510(k) Clearance | K990189 | K163337 |
| Midmark Models #s | M11-0XX | M11-04X |
| Type of SteamSterilizer | TabletopGravity Displacement | TabletopDynamic-Air-Removal (SFPP) |
| Intended Use(Same for all models) | The M11 UltraClave is intendedto be used in medical and dentaloffices, hospitals, clinics, nursinghomes, laboratories, and otherfacilities to sterilize heat andmoisture stable, reusableequipment. Dental handpiecescan be sterilized in the M11 inthe Pouches cycle. This device isnot recommended forsterilization of liquids intendedfor direct patient contact. | The Midmark and Ritter M9and M11 UltraClave®Automatic Sterilizers and theRitter M9D AutoClave®Automatic Sterilizer can beused in medical and dentaloffices, hospitals, clinics,nursing homes, laboratories,and other facilities to sterilizeheat and moisture stablereusable items (includingdental handpieces) that arecompatible with steamsterilization. |
| Indications for Use:(Cycle Comparison) | Parameters(Sterilize Time/Temp./Dry Time) | Parameters(Sterilize Time/Temp./Dry Time) |
| Unwrapped Cycle | 3 min./ 270°F (132°C) / 30 min. | Same |
| Pouches Cycle | 15 min./ 270°F (132°C) / 30 min. | 4 min./ 270°F (132°C) / 30 min. |
| Packs Cycle | 30 min./ 250°F (121°C)/30 min. | Same |
| Liquids | 30 min./ 250°F (121°C) / NA | N/A |
| Handpiece Cycle | N/ACleared for Handpieces inPouches Cycle | 4 min./ 270°F (132°C) / 30 min. |
| Programmable 1 | N/A | N/A |
| Programmable 2 | N/A | N/A |
| Controls: | ||
| Main Controller | Micro Processor BasedEmbedded Control | Similar w/ ImprovedMicrocontroller &Modifications to Incorporate aReal Time Clock (RTC) &Power Supply for New PrinterAccessory |
| User Controls | Momentary Tactile Switches | Momentary MembraneSwitches |
| Temperature Sensor | Integrated-Circuit Temp. Sensor | Platinum RTD |
| Pressure Sensor | PC Mounted Gauge PressureTransducer | Same |
| Process Monitors: | ||
| Display Type | Array of 7 Segment Red LEDs | LCD(2 row x 20 character) |
| Operator Alerts | Audible Alarms & Visual SignalsDisplaying Status & Self-Diagnostic Error Codes | Audible Alarms & VisualSignals Displaying Status,Instructions & Self-DiagnosticError Codes on LCD Display |
| Printer Accessory(Optional) | 5 VDC, 24 CharacterDot Matrix PrinterRecords: Cycle Stats. - Time,Temp. & Press. | 5 VDC, 24 CharacterThermal PrinterRecords: Sterilizer ID, Date &Time in addition to CycleStats. - Time, Temp. & Press. |
| Safety Features: | ||
| Overpressure Protection | ASME press. relief valve (40 psi) | Same |
| Overheat Protection | Dual Auto-Reset Thermostats295°F (146°C) | Dual Auto-Reset Thermostats450°F (232°C) |
| Door Interlock | High Integrity Safety Switch | Same |
Table 7-8 M9 Technological Characteristics Comparison
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Table 7-9 M11 Technological Characteristics Comparison
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TABLE 7-10 Specification & Certifications Summary
| M9 UltraClave /M9D Autoclave | M11 UltraClave | |
|---|---|---|
| Physical Dimensions | ||
| Overall Length w/Plug | 20.38 in. (51.8 cm) | 23.8 in. (60.5 cm) |
| Overall Width | 15.3 in. (38.9 cm) | 17.8 in. (45.2 cm) |
| Overall Heightw/Printer | 16.1 in. (40.9 cm) | 18.1 in. (50.0 cm) |
| Required CounterArea | 15.3 in. x 18 in.(38.9 cm x 45.7 cm) | 17.8. x 21 in. (45.2 cm x 53.3 cm) |
| Chamber Size | 9 in. dia. x 15 deep(22.9 cm x 38.1 cm) | 11 in. dia. x 18 in. deep (27.9 cm x 45.7 cm) |
| Trays, Large (2) | 7 5/16 in. x 12 in. x 7/8 in.(18.6 cm x 30.5 cm x 2.2 cm) | 9 in. x 15 in. x 1 1/8 in.(22.9 cm x 38 cm x 2.9 cm) |
| Trays, Small (2) | 5 5/8 in. x 12 in. x 7/8 in.(14.3 cm x 30.5 cm x 2.2 cm) | 6 5/8 in. x 15 in. x 1 1/8 in.(16.8 cm x 38 cm x 2.9 cm) |
| Weights: | ||
| Weight with EmptyReservoir | 73 lbs. (33.1 kg) | 99 lbs. (44.9 kg) |
| Weight with ShippingCarton | 81 lbs. (36.7 kg) | 131 lbs. (59.4 kg) |
| Water Reservoir | 1.1 gal (4.16 L)Usable volume is 0.5 gallons(1.9 liters) | 1.4 gal (5.3 L)Usable volume is 1.0 gallons(3.8 liters) |
| Electrical Rating: | ||
| Note: A separate (dedicated) circuit is required for these sterilizers. Sterilizer should not beconnected into an electrical circuit with other appliances or equipment unless circuit is ratedfor the additional load. | ||
| 115 Volt models | 115 VAC (± 10%), 12 Amp,50/60 Hz | 115 VAC (± 10%), 12 Amp,50/60 Hz |
| 230 Volt models | 230 VAC (± 10%), 6.4 Amp,50/60 Hz | 230 VAC (± 10%), 6.4 Amp,50/60 Hz |
| Fuse Ratings: | ||
| 115 VAC | F1....0.25 Amp, 250 V, Slo-blo,1/4" x 1 1/4" | F1....0.25 Amp, 250 V, Slo-blo,1/4" x 1 1/4" |
| F2....15 Amp, 250 V, FastActing, 1/4" x 1 1/4" | F2....15 Amp, 250 V, FastActing, 1/4" x 1 1/4" | |
| 230 VAC | F1....0.125 Amp, 250 V, Slo-blo, 5 x 20 mm | F1....0.125 Amp, 250 V, Slo-blo, 5 x 20 mm |
| F2....8 Amp, 250 V, FastActing, 5 x 20 mm | F2....8 Amp, 250 V, FastActing, 5 x 20 mm | |
| Other Ratings: | ||
| Chamber Press. Rating | 40 psi (275.8 kPa) | 40 psi (275.8 kPa) |
| Safety Valve Setting | 40 psi (275.8 kPa) | 40 psi (275.8 kPa) |
| Heat Emission | 5000 BTU/hr. during operation | 5000 BTU/hr. during operation |
| Operating Environment: Device approved for INDOOR USE ONLY | ||
| Ambient Temp. Range | 68°F to 104°F (+20°C to +40°C) | |
| Humidity | Less than 80% (non-condensing)(Pollution Degree 2, in accordance to IEC664) | |
| Operating Altitude | Less than 9842 ft. (3000m) above sea level | |
| Certifications: | ||
| ASME Boiler & Pressure Vessel Code, Section VIII, Div. 1 | ||
| Canadian Registration Number:OH13037.541637908YTN;V0024.2 | Canadian Registration Number:OH13037.541637908YTN;U9601.2 | |
| Midmark is an ISO13485 and ISO 9001Certified Company | UL61010-1, 2nd EditionIEC 61010-2-040:2005, 1st EditionCAN/CSA C22.2, No. 61010-1, 2nd EditionCSA C22.2, No. 61010-2-040-07 Part 2-040, 1st EditionANSI/AAMI/IEC 62304ANSI/AAMI ST55:2010/(R)2014EMC: IEC 60601-1-2 Edition 4.0 2014-02CISPR 11:2009, A1:2010 Class A, Group 1IEC 61000-3-2:2014, Part 3-2IEC 61000-3-3:2013, Part 3-3 |
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| Accessory | M9 UltraClave /M9D Autoclave | M11 UltraClave |
|---|---|---|
| Speed-Clean, 1 bottle (16 oz.) | 002-0396-00 | 002-0396-00 |
| Speed-Clean, 1 Case (12 – 16 oz. bottles) | 002-0396-05 | 002-0396-05 |
| Thermal Printer | 9A599001 | 9A599001 |
| Horizontal Cassette Rack | N/A | 9A215001 |
| Vertical Cassette Rack | N/A | 9A215002 |
TABLE 7-11 List of Accessories
Non-Clinical Performance Data
MIDMARK conducted validation studies in accordance with ANSI/AAMI ST55: 2010/(R)2014. Testing showed that the M9 and M11 UltraClave and the M9D AutoClave Self-Contained Steam Sterilizers meet all aspects of the standard, including physical and microbiological performance requirements.
Individual protocols were performed to validate the sterilization efficacy of each type of preprogrammed cycle of the proposed M9/M9D and M11 Self-Contained Steam Sterilizers.
Initially, temperature sensors were used to determine the thermal profile of the empty chamber. Testing was performed for all pre-programmed cycles for a total of three (3) full chamber runs for each pre-programmed cycle parameter.
Additionally, biological testing was conducted on fully loaded chambers. The sterility assurance level (SAL) of 10% was evaluated using the biological indicator (BI) overkill method. The SAL was achieved by inoculating the most difficult to sterilize locations with a minimum of 1.0 X 100 spores of Geobacillus stearothermophilus and processing at one-half of the full cycle exposure time and evaluating the BIs for total BI lethality.
Clinical Performance Data
Clinical data was not required.
Other Information
None
Conclusion
The results from the validation studies and biological testing for the M9/M9D and the M11 demonstrates the subject devices are as safe, as effective, and performs as well or better than the predicate devices: M9/M9D-02X (K023348) and M11-00X (K990189)
§ 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).