← Product Code [FLE](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE) · K163337 # Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer (K163337) _Midmark Corporation · FLE · Aug 31, 2017 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K163337 ## Device Facts - **Applicant:** Midmark Corporation - **Product Code:** [FLE](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE.md) - **Decision Date:** Aug 31, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6880 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## 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 and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization. ## Device Story Self-contained tabletop steam sterilizers; utilize steam-flush pressure-pulse (SFPP) technology to remove air from chamber and processed materials. Inputs: user-selected cycle (Unwrapped, Pouches, Packs, Handpieces) via front panel keypad. Operation: microcontroller-controlled; uses immersion heater to generate steam; sensors (platinum RTD for temperature, pressure transducer) monitor cycle parameters. Outputs: sterilized items; visual status/error codes on LCD; optional thermal printer records cycle stats (time, temp, pressure). M9/M11 models feature automatic door opening for drying; M9D requires manual door operation. Used in clinical/dental settings by staff to ensure instrument sterility; benefits patient by reducing risk of cross-contamination. ## Clinical Evidence No clinical data. Bench testing performed per ANSI/AAMI ST55:2010/(R)2014. Validation included thermal profiling of empty chambers and biological indicator (BI) testing using Geobacillus stearothermophilus (1.0 x 10^6 spores) in fully loaded chambers to confirm a Sterility Assurance Level (SAL) of 10^-6. ## Technological Characteristics Tabletop steam sterilizer; SFPP cycle; stainless steel chamber; high-temp silicon rubber gaskets; 1425W/1500W immersion heater; platinum RTD temperature sensor; PC-mounted gauge pressure transducer; LCD display; thermal printer; microprocessor-controlled; safety features include ASME pressure relief valve (40 psi) and dual auto-reset thermostats (450°F). ## Regulatory 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. ## Predicate Devices - MIDMARK® UltraClave® Steam Sterilizer ([K023348](/device/K023348.md)) - MIDMARK® UltraClave® Steam Sterilizer ([K990189](/device/K990189.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ #### 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.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ | Cycle Type | Cycle Parameters | | | Drying
Time | Items to be Sterilized
(Always consult the item manufacturer's
recommendations 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 for
exposure 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 by
fabric.
• Wrapped trays of loose instruments.
• Wrapped cassettes.
• Wrapped items manufactures recommend for
exposure 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 for
sterilization.
• Items, except liquids, manufacturers
recommend for exposure at 250°F (121°C) for
30 minutes. | | 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 {4}------------------------------------------------ | 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-
ments
2.4 lbs. (1089 grams) or | 2 handpieces with other instru-
ments
1.6 lbs. (726 grams) or | 8 handpieces with other instru-
ments
8.0 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 instruments
2.7 lbs. (1225 grams) or | 2 handpieces with other instruments
1.8 lbs. (816 grams) or | 8 handpieces with other instruments
9.0 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.. | | | | {5}------------------------------------------------ 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 Summary
Prepared | August 28, 2017 | |---------------------------|--------------------------------------------------------------------------------------------------------------| | 510(k) Sponsor
Address | MIDMARK® Corporation
60 Vista Drive
Versailles, Ohio 45380 | | Contact Person | Adam Clutter
Regulatory Affairs Specialist
Phone: (937) 526-8474
FAX: (937) 526-7412 | | Trade Name | MIDMARK® and Ritter® M9 and M11 UltraClave®
and Ritter® M9D AutoClave® Self-Contained Steam
Sterilizer | | Common Name | Table Top Steam Sterilizer | | Classification Name | Sterilizer, Steam
(21 CFR §880.6880
Product Code 80 FLE) | | Device Classification | Class II | | Review Panel | General Hospital | | 510(k) Number | K163337 | {6}------------------------------------------------ | Model | Brand | Input
Voltage | GTIN
Number | Chamber Size | Door
Operation | |-----------------------|---------|------------------|----------------|--------------------------------------------|-------------------| | M9-04X
UltraClave | Midmark | 115 Vac | 00841709100222 | 9" (22.9 cm) Dia. x
15" (38.1 cm) Deep | Automatic | | | Midmark | 230 Vac | 00841709100239 | 9" (22.9 cm) Dia. x
15" (38.1 cm) Deep | Automatic | | | Ritter | 115 Vac | 00841709100246 | 9" (22.9 cm) Dia. x
15" (38.1 cm) Deep | Automatic | | M9D-042
Autoclave | Ritter | 115 Vac | 00841709100253 | 9" (22.9 cm) Dia. x
15" (38.1 cm) Deep | Manual | | M11-04X
UltraClave | Midmark | 115 Vac | 00841709100277 | 11" (27.9 cm) Dia. x
18" (45.7 cm) Deep | Automatic | | | Midmark | 230 Vac | 00841709100284 | 11" (27.9 cm) Dia. x
18" (45.7 cm) Deep | Automatic | | | Ritter | 115 Vac | 00841709100291 | 11" (27.9 cm) Dia. x
18" (45.7 cm) Deep | Automatic | Table 7-2 Device Models ## Table 7-3 Predicate Devices | Manufacturer
Name | Trade Name | 510(k)
Number | Decision
Date | Model
Number | |-------------------------|------------------------------------------------|------------------|------------------|-----------------| | MIDMARK®
Corporation | MIDMARK®
UltraClave®
Steam
Sterilizer | K023348 | 03/03/2003 | M9/
M9D-02X | | MIDMARK®
Corporation | MIDMARK®
UltraClave®
Steam
Sterilizer | 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. {7}------------------------------------------------ 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 {8}------------------------------------------------ | Cycle
Cycle | Pre-Treatment
(SFPP) | Sterilizing
Temperature | Sterilizing
Time | Pressure
(Ref¹) | Drying
Time | |--------------------|-------------------------|----------------------------|---------------------|-----------------------|----------------| | Unwrapped
Cycle | 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 | | Packs
Cycle | 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-
ments
2.4 lbs. (1089 grams) or | 2 handpieces with other instru-
ments
1.6 lbs. (726 grams) or | 8 handpieces with other instru-
ments
8.0 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-
ments
2.7 lbs. (1225 grams) or | 2 handpieces with other instru-
ments
1.8 lbs. (816 grams) or | 8 handpieces with other instru-
ments
9.0 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. {9}------------------------------------------------ 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... | FILLING
CHAMBER
CHAMBER
IS FULL | | Heating | Display changes as temperature and
pressure in chamber changes.
(Metric units may be displayed if desired). | HEATING - UNWRAPPED
XXX°F XX.X PSI | | Sterilizing | Sterilizing begins when correct
temperature / pressure is reached.
Time remaining in cycle counts down
while current temperature / pressure in
chamber is continuously updated. | STERILIZING
MM:SS XXX°F XX.X PSI | | Ready to Vent | 'READY TO VENT' is displayed when
10 seconds remain in sterilization cycle. | READY TO VENT
XXX°F XX.X PSI | | Fast Vent | When time runs out in sterilizing mode,
the vent valve opens. Steam / water are
released back into the reservoir.
The display changes as temperature and
pressure in chamber changes. | FAST VENT
XXX°F XX.X PSI | | | Caution
Keep 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 to
M9/M11 UltraClave® | An audible signal is emitted to indicate
that the door is about to open.
When pressure in chamber reaches zero,
the door actuates to partially open (drying
mode) position. | DOOR TO OPEN
XXX°F XX.X PSI | | Manual Door Open
Pertains only to
M9D AutoClave | An Audible signal is emitted when pres-
sure inside chambers reaches zero to
indicate Operator to open door. The door
should be opened to the first stop (dry-
ing mode) position. The audible signal
will continue to repeat every minute until
either the door is opened to the DRY (par-
tially opened) position, or by pressing the
STOP button, aborting the DRY cycle. | OPEN DOOR TO DRY
STOP TO ABORT | | | Caution
The processed loads may still be wet if the Dry Cycle is aborted
prior to completion. Always allow processed loads to dry in the
sterilizer before they are handled to avoid re-contamination. | | | Drying | Time of Dry Cycle is counted down. If
desired, the Dry Cycle can be aborted by
pressing the STOP button.
When Drying time reaches 0:00... | DRYING
MM:SS

DRY CYCLE
COMPLETE | | Cycle Complete | An audible signal is emitted for 10
seconds. | SELECT CYCLE | {10}------------------------------------------------ | Item | M9/M11 UltraClave and M9D AutoClave | |------------------------------------------------------|------------------------------------------------------------------------------------------------| | Chamber Dimensions
M9/M9D | 9" (22.9 cm) x 15" (38.1 cm) / Stainless Steel | | M11 | 11" (27.9 cm) x 18" (45.7cm) / Stainless Steel | | Chamber Volume
M9/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 Latch
M9/M11 | Manual Double Bolt Latch w/Automatic Opening | | M9D | Manual Double Bolt Latch | | Door Gaskets
(M9/M9D & M11) | High Temperature Silicon Rubber | | Trays
M9/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 Reservoir
M9/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 (Motor
Driven) | | M9D | Manual Door (Operator manually opens door) | | (All models incorporate an
active 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, {11}------------------------------------------------ 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's
recommendations 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 for
exposure 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 {12}------------------------------------------------ | 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 instruments
2.4 lbs. (1089 grams) or | 2 handpieces with other instruments
1.6 lbs. (726 grams) or | 8 handpieces with other instruments
8.0 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 instruments
2.7 lbs. (1225 grams) or | 2 handpieces with other instruments
1.8 lbs. (816 grams) or | 8 handpieces with other instruments
9.0 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 | PREDICATE
MIDMARK M9 UltraClave | NEW MODELS
MIDMARK & Ritter M9
UltraClave & Ritter M9D
Autoclave | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Clearance | K023348 | K163337 | | Midmark Models #s | M9-02X & M9D-02X | M9-04X & M9D-042 | | Type of Steam
Sterilizer | Tabletop
Dynamic-Air-Removal (SFPP) | Same | | Intended Use
(Same for all models) | The M9 UltraClaveTM is
intended to be used in medical
and dental offices, hospitals,
clinics, nursing homes,
laboratories, and other facilities
to sterilize heat and moisture
stable reusable items (including
dental handpieces) that are
compatible with steam | 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 reusable | | | | | | | sterilization. | items (including dental handpieces) that are compatible with steam sterilization. | | Indications for Use:
(Cycle Comparison) | Parameters
(Sterilize Time/Temp./Dry
Time¹) | 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 Based
Embedded Control | Same w/ Modifications to
Incorporate a Real Time Clock
(RTC) & Power Supply for New
Printer Accessory | | User Controls | Membrane Type Switches | Same | | Temperature Sensor | Platinum RTD | Same | | Pressure Sensor | PC Mounted Gauge Pressure
Transducer | Same | | Process Monitors: | | | | Display Type | LCD
(2 row x 20 character) | Same | | Operator Alerts | Audible Alarms & Visual
Signals Displaying Status,
Instructions & Self-Diagnostic
Error Codes on LCD Display | Same | | Printer Accessory
(Optional) | 5 VDC, 24 Character
Dot Matrix Printer
Records: Cycle Stats. - Time,
Temp. & Press. | 5 VDC, 24 Character
Thermal Printer
Records: Sterilizer ID, Date &
Time in Addition to Cycle Stats.
- Time, Temp. & Press. | | Safety Features: | | | | Overpressure Protection | ASME press. relief valve (40
psi) | Same | | Overheat Protection | Dual Auto-Reset Thermostats
450°F (232°C) | Same | | Door Interlock | High Integrity Safety Switch | Same | | CHARACTERISTIC | PREDICATE
MIDMARK M11 UltraClave | NEW MODELS
MIDMARK & Ritter M11
UltraClave | | 510(k) Clearance | K990189 | K163337 | | Midmark Models #s | M11-0XX | M11-04X | | Type of Steam
Sterilizer | Tabletop
Gravity Displacement | Tabletop
Dynamic-Air-Removal (SFPP) | | Intended Use
(Same for all models) | The M11 UltraClave is intended
to be used in medical and dental
offices, hospitals, clinics, nursing
homes, laboratories, and other
facilities to sterilize heat and
moisture stable, reusable
equipment. Dental handpieces
can be sterilized in the M11 in
the Pouches cycle. This device is
not recommended for
sterilization of liquids intended
for direct patient contact. | 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
reusable items (including
dental handpieces) that are
compatible with steam
sterilization. | | 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/A
Cleared for Handpieces in
Pouches Cycle | 4 min./ 270°F (132°C) / 30 min. | | Programmable 1 | N/A | N/A | | Programmable 2 | N/A | N/A | | Controls: | |… --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K163337](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLE/K163337) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com