(276 days)
Not Found
No
The document describes a standard steam sterilizer with automatic controls for time and temperature, and there is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a sterilizer for medical and dental items, not a device used to treat or diagnose a disease or condition in a patient.
No
The device is a sterilizer designed to clean medical instruments, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "Self-Contained steam sterilizer" and mentions physical components like a motor and controls for time and temperature, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to sterilize heat and moisture stable items using steam. This is a process applied to medical devices and instruments, not a test performed on biological samples to diagnose a condition or provide information about a physiological state.
- Device Description: The description clearly states it's a steam sterilizer designed to sterilize medical, surgical, laboratory, and dental items.
- No mention of biological samples or diagnostic testing: The document focuses on the sterilization process and its validation, not on analyzing biological samples.
- Performance Studies: The performance studies described are related to the efficacy of the sterilization process (killing microorganisms), not the accuracy of a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / 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 items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters on the following page for detailed information.
Product codes
FLE
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 data was not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sterility assurance level (SAL) of 10%
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
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
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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 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: | | |
| Main Controller | Micro Processor Based
Embedded Control | Similar w/ Improved
Microcontroller &
Modifications to Incorporate a
Real Time Clock (RTC) &
Power Supply for New Printer
Accessory |
| User Controls | Momentary Tactile Switches | Momentary Membrane
Switches |
| Temperature Sensor | Integrated-Circuit Temp. Sensor | Platinum RTD |
| Pressure Sensor | PC Mounted Gauge Pressure
Transducer | Same |
| Process Monitors: | | |
| Display Type | Array of 7 Segment Red LEDs | LCD
(2 row x 20 character) |
| Operator Alerts | Audible Alarms & Visual Signals
Displaying Status & Self-
Diagnostic Error Codes | Audible Alarms & Visual
Signals Displaying Status,
Instructions & Self-Diagnostic
Error Codes on LCD Display |
| 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
295°F (146°C) | Dual Auto-Reset Thermostats
450°F (232°C) |
| Door Interlock | High Integrity Safety Switch | Same |
Table 7-8 M9 Technological Characteristics Comparison
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14
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 Height
w/Printer | 16.1 in. (40.9 cm) | 18.1 in. (50.0 cm) |
| Required Counter
Area | 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 Empty
Reservoir | 73 lbs. (33.1 kg) | 99 lbs. (44.9 kg) |
| Weight with Shipping
Carton | 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 be
connected into an electrical circuit with other appliances or equipment unless circuit is rated
for 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, Fast
Acting, 1/4" x 1 1/4" | F2....15 Amp, 250 V, Fast
Acting, 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, Fast
Acting, 5 x 20 mm | F2....8 Amp, 250 V, Fast
Acting, 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 ISO
13485 and ISO 9001
Certified Company | UL61010-1, 2nd Edition
IEC 61010-2-040:2005, 1st Edition
CAN/CSA C22.2, No. 61010-1, 2nd Edition
CSA C22.2, No. 61010-2-040-07 Part 2-040, 1st Edition
ANSI/AAMI/IEC 62304
ANSI/AAMI ST55:2010/(R)2014
EMC: IEC 60601-1-2 Edition 4.0 2014-02
CISPR 11:2009, A1:2010 Class A, Group 1
IEC 61000-3-2:2014, Part 3-2
IEC 61000-3-3:2013, Part 3-3 | |
16
17
| 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)