(195 days)
Not Found
No
The description focuses on automated sterilization cycles, record keeping, and cloud connectivity, but does not mention any AI or ML algorithms for decision-making, analysis, or control of the sterilization process.
No
The device is a sterilizer for heat and moisture stable items, not a device directly used for therapy or treatment on a patient. Its function is to prepare instruments for use in medical and dental procedures by killing bio-organisms.
No
Explanation: The device is a sterilizer for medical instruments, not a device used to diagnose medical conditions or diseases.
No
The device is a physical sterilizer that uses steam and pressure to sterilize medical instruments. While it includes software for control, record-keeping, and connectivity, the primary function and components are hardware-based.
Based on the provided text, 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 (like instruments and textiles) using steam. This is a process to render items free of viable microorganisms, not to perform tests on biological samples to diagnose conditions.
- Device Description: The description details a steam sterilizer that uses heat and pressure to kill microorganisms. It does not describe any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The device is a sterilizer, which is a type of medical device used to prepare instruments and materials for use, but it does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Midmark Smart M9® and Smart M11® Sterilizers 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 for detailed information.
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The Midmark Smart M9® and Smart M11® Sterilizers utilize steam flush pressure pulse (SFPP) technology to achieve sterilization on heat and moisture stable items (including dental handbieces) that are compatible with steam sterilization.
The Midmark Smart M9® and Smart M11® Sterilizers are compact, self-contained portable units. They can be placed on any level support surface where an electrical outlet is available with no other installation required. The M9 sterilizer models are the smaller of the models with a 9 in (22.9 cm) diameter x 15 in (38.1 cm) deep stainless-steel chamber. The M 1 sterilizer models have an 11" (27.9 cm) diameter x 18" (45.7 cm) deep stainless-steel chamber.
The Midmark Smart M9® and Smart M11® Sterilizers use saturated steam at high pressure and temperature as the sterilizing agent to kill infectious bio-organisms on items placed in the chamber for processing. They use the dynamic Steam Flush Pressure Pulse (SFPP) cycle type for the pre-set cycles that include a 4-minute 270°F and a 3-minute 275°F cycle for wrapped or pouched instruments (including dental handpieces) and cassettes, a 30-minute 250°F cvcle for textiles and instrument packs requiring a lower temperature. and a 3-minute 270°F cycle for unwrapped instruments. The 3-minute 275°F is added to align with Table B.2 in AAMI TIR12:2020. In the SFPP type cycle, residual air is removed from the chamber and its contents by a series of controlled pressure pulses and steam flushes.
The Midmark Smart M9® and Smart M11® Sterilizers are designed to automate the sterilization process, to the extent possible, and the user interface on the subject models extends this capability to include sterilization record keeping. To use the sterilizer, the operator fills the water reservoir with water (distilled or purified) and loads the included trays with properly cleaned and prepped instruments for sterilization. The loaded trays are then placed inside the chamber, and the chamber door is manually closed by the operator. Based on the cycle parameters that are appropriate for the type of load being processed, the operator then selects the appropriate sterilization cycle on the user interface. On the subject units there are options for the user to enter load type and indicator information. Once the cycle is selected and the operator presses "Start," there is an option to capture the identification of the operator. The sterilizer then automatically performs all the operations necessary to complete the sterilization process without further interaction from the operator. The sterilization cycle is composed of several phases which include Filling, Heating, Sterilization, Venting, and Drying, Audible signals indicate cycle initiation, completion, and/or interruption, and the user interface provides visual communication of device status, operator instructions, and troubleshooting information. The LED light bar also provides an estimate of the cycle progression. At the conclusion of the cycle there is another option to capture the identification of the operator that unloads and approves or rejects the results of the sterilization cycle.
All sterilizer cycle and user maintenance (Routine Care) records are stored internally on an SD card. Midmark has developed a Digital Ecosystem Connectivity Module that is incorporated into the Midmark Smart M9® and Smart M11® Sterilizers which adds the ability to transfer electronic sterilization records to the Midmark cloud and to remotely view the current status of, or cycle history for multiple sterilizers. Optional features and settings that may be distributed to multiple sterilizers from the cloud include distribution of software updates to the connectivity module, compliance settings, and entering the results of biological indicator tests. Connectivity is not needed to perform the sterlizer's intended use, and connecting a sterilizer does not change the intended use.
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)
Non-clinical evaluations were performed for the Midmark Smart M9® and Smart M 1® Sterilizer. A summary of evaluations and results are shown in the table below. Based on these results of studies performed, the Midmark Smart M9® and Smart M11® Sterilizers do not raise new issues of safety or effectiveness.
Performance: ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers FDA Recognition Number 14-518; Passed; the results of the evaluation demonstrate compliance of the device to the standards.
Safety: ANSI/UL 61010-1 Third Edition 5/12/2012 / Revised 7/19/2019, Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements FDA Recognition Number 19-41; IEC 61010-2-040:2020 Edition 3.0 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used to Treat Medical Materials; Passed; the results of the evaluation demonstrate compliance of the device to the standards.
EMC: IEC 60601-1-2 Edition 4.1 2020-09 Consolidated Version Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests FDA Recognition Number 19-36; Passed; the results of the evaluation demonstrate compliance of the device to the standards.
Pressure Vessel: American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code, Section VIII, Division 1: 2023 Edition; Passed; the results of the evaluation demonstrate compliance of the device to the standards.
Clinical data was not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 4, 2024
Midmark Corporation Adam Clutter Quality Systems and Regulatory Affairs Manager 60 Vista Drive Versailles, Ohio 45380
Re: K233026
Trade/Device Name: Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: March 7, 2024 Received: March 8, 2024
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Christopher K. Dugard -S
Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical
2
and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233026
Device Name Midmark Smart M9® Sterilizer Midmark Smart M11® Sterilizer
Indications for Use (Describe)
The Midmark Smart M9® and Smart M11® Sterilizers 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 for detailed information.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| X Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
Standard Cycle Parameters
| Cycle Type | Cycle Parameters
Temperature Minimum | Time | Pressure 1 Reference | Drying Time 2 | Items to be Sterilized
(Always follow the item manufacturer's recommendations for sterilization.) | M9 Maximum Capacity 4 | M11 Maximum Capacity 4 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|---------|-----------------------|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Image: Wrapped Cycle Type | 132°C (270°F) | 4 min. | 186 kPa
(27.1 psi) | 30 min. | • Pouched or wrapped items manufacturers recommend for exposure at 132°C (270°F) for 4 minutes.
• Wrapped cassettes.
• Dental Handpieces (wrapped or unwrapped) | 3,629 grams (8.0 lb) or 8 handpieces (2 per tray) with other instruments 3,629 grams (8.0 lb) total | 4,082 grams (9.0 lb) or 8 handpieces (2 per tray) with other instruments 4,082 grams (9.0 lb) total |
| Image: Wrapped Cycle Type | 135°C (275°F) | 3 min. | 214 kPa
(31 psi) | 30 min. | • Pouched or wrapped items manufacturers recommend for exposure at 135°C (275°F) for 3 minutes.
• Wrapped cassettes.
• Dental Handpieces (wrapped or unwrapped) | 3,629 grams (8.0 lb) or 8 handpieces (2 per tray) with other instruments 3,629 grams (8.0 lb) total | 4,082 grams (9.0 lb) or 8 handpieces (2 per tray) with other instruments 4,082 grams (9.0 lb) total |
| Image: Delicate Cycle Type | 121°C (250°F) | 30 min. | 104 kPa
(15 psi) | 30 min. | • Textiles and surgical packs wrapped for sterilization.3
• Items, except liquids, manufacturers recommend for exposure at 121°C (250°F) for 30 minutes. | 3,629 grams (8.0 lb) or 590 grams (1.3 lb) textile load | 4,082 grams (9.0 lb) or 2 packs each @ 590 grams (1.3 lb) textile load |
| Image: Unwrapped Cycle Type | 132°C (270°F) | 3 min. | 186 kPa
(27.1 psi) | 30 min. | • Instruments loose on a tray.
• Open glass or metal canisters.
• Tubing not used in surgical procedures. (Max. length - 40 in and Min. inside diameter - .187 in)
• Loose items manufacturers recommend for exposure at 132°C (270°F) for 3 minutes.
Note: The sterility of unwrapped items is compromised on exposure to a non-sterile environment. | 3,629 grams (8.0 lb) | 4,082 grams (9.0 lb) |
| 1 The pressure is absolute. The pressure inside the chamber is the sum of the atmospheric pressure and the pressure shown in this table. The values are included for reference and may not be exact. | | | | | | | |
The pressures shown in this table are at sea level and a resure of saturated steam at the sterilization temperature The pressures on the sterilizer display may be higher.
-
Dry time can be changed from 5 to 60 minne can be changed from 1 to 5 minutes.) Refer to Standard Cycle Operation.
-
Allow a minimum of 6.4 mm (1/4 in) space between each pack and from the chamber wall.
-
The default dry time may need increased due to variation, wrapping materials and the environment to completely dry the chamber contents at these capacities.
5
Image /page/5/Picture/1 description: The image shows the word "midmark" in a sans-serif font. Above the word is a logo consisting of two overlapping shapes. The shape on the left is blue, and the shape on the right is pink. The two shapes together form an "M" shape.
Designing better care."™
Midmark Corporation 60 Vista Drive Versailles, Ohio 45380 1-800-MIDMARK midmark.com
As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR §807.92, a 510(k) summary is provided below with the required information.
Table 1. Administrative Information Date Summary March 28, 2024 Prepared 510(k) Sponsor Midmark Corporation Address 60 Vista Drive Versailles, Ohio 45380 Contact Person Adam Clutter Quality Systems and Regulatory Affairs Manager Email: aclutter@midmark.com Phone: 937-526-8474 Fax: 937-526-8482 Midmark Smart M9® Sterilizer, Trade Name Midmark Smart M11® Sterilizer Common Name Table Top Steam Sterilizer Classification Name 21 CFR §880.6880 Steam sterilizer (Product Code FLE) Device Classification Class II Review Panel General Hospital
1. Administrative Information
2. Equivalent Predicate Comparators
| Table 2. Predicate Device | |||
|---|---|---|---|
| Manufacturer Name | Trade Name | 510(k) No. | Decision Date |
6
| Table 2. Predicate Device | |||
|---|---|---|---|
| Midmark Corporation | Midmark and Ritter M9 and M11 | ||
| UltraClave® Automatic Sterilizers and | |||
| Ritter M9D AutoClave® Automatic | |||
| Sterilizers | K163337 | August 31, 2017 |
3. Indications for Use
The Midmark Smart M9® and Smart M11® Sterilizers 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. Refer to Standard Cycle Parameters for detailed information.
Standard Cycle Parameters
| Cycle Type | Temperature
Minimum | Time | Pressure 1
Reference | Drying
Time 2 | Items to be Sterilized
(Always follow the item manufacturer's
recommendations
for sterilization.) | M9
Maximum
Capacity 4 | M11
Maximum
Capacity 4 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|---------|-------------------------|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Wrapped | 132°C (270°F) | 4 min. | 186 kPa
(27.1 psi) | 30 min. | • Pouched or wrapped items manufacturers
recommend for exposure at 132°C (270°F)
for 4 minutes.
• Wrapped cassettes.
• Dental Handpieces (wrapped or unwrapped) | 3,629 grams (8.0 lb)
or 8 handpieces
(2 per tray)
with other
instruments 3,629
grams (8.0 lb) total | 4,082 grams (9.0 lb)
or 8 handpieces
(2 per tray)
with other
instruments 4,082
grams (9.0 lb) total |
| Wrapped | 135°C (275°F) | 3 min. | 214 kPa
(31 psi) | 30 min. | • Pouched or wrapped items manufacturers
recommend for exposure at 135°C (275°F)
for 3 minutes.
• Wrapped cassettes.
• Dental Handpieces (wrapped or unwrapped) | 3,629 grams (8.0 lb)
or 8 handpieces
(2 per tray)
with other
instruments 3,629
grams (8.0 lb) total | 4,082 grams (9.0 lb)
or 8 handpieces
(2 per tray)
with other
instruments 4,082
grams (9.0 lb) total |
| Delicate | 121°C (250°F) | 30 min. | 104 kPa
(15 psi) | 30 min. | • Textiles and surgical packs wrapped for
sterilization.3
• Items, except liquids, manufacturers
recommend for exposure at 121°C (250°F)
for 30 minutes. | 3,629 grams (8.0 lb)
or
590 grams (1.3 lb)
textile load | 4,082 grams (9.0 lb)
or
2 packs each @
590 grams (1.3 lb)
textile load |
| Unwrapped | 132°C (270°F) | 3 min. | 186 kPa
(27.1 psi) | 30 min. | • Instruments loose on a tray.
• Open glass or metal canisters.
• Tubing not used in surgical procedures.
(Max. length - 40 in and Min. inside
diameter - .187 in)
• Loose items manufacturers recommend for
exposure at 132°C (270°F) for 3 minutes.
Note: The sterility of unwrapped items is
compromised on exposure to a non-sterile
environment. | 3,629 grams (8.0 lb) | 4,082 grams (9.0 lb) |
| 1. The pressures shown in this table are at sea level and are for reference only. These are the ideal pressure of saturated steam at the sterilization temperature.
The pressures on the sterilizer display may be higher.
2. Dry time can be changed from 5 to 60 minutes. (IUSS dry time can be changed from 1 to 5 minutes.) Refer to Standard Cycle Operation.
3. Allow a minimum of 6.4 mm (1/4 in) space between each pack and from the chamber wall.
4. The default dry time may need increased due to variations in load configuration, wrapping materials and the environment to completely dry the chamber | | | | | | | |
4. Models
Table 3. Models
| Model Name | Model Number | Input Voltage |
|---|---|---|
| Midmark Smart M9® Sterilizer | M9-050 | 115V |
| Midmark Smart M9® Sterilizer | M9-052 | 115V |
| Midmark Smart M11® Sterilizer | M11-050 | 115V |
7
Midmark® Smart Sterilizers 510(k) Summary
| Table 3. Models | ||
|---|---|---|
| Model Name | Model Number | Input Voltage |
| M11-051 | 230V | |
| M11-052 | 115V |
5. Device Description
The Midmark Smart M9® and Smart M11® Sterilizers utilize steam flush pressure pulse (SFPP) technology to achieve sterilization on heat and moisture stable items (including dental handbieces) that are compatible with steam sterilization.
The Midmark Smart M9® and Smart M11® Sterilizers are compact, self-contained portable units. They can be placed on any level support surface where an electrical outlet is available with no other installation required. The M9 sterilizer models are the smaller of the models with a 9 in (22.9 cm) diameter x 15 in (38.1 cm) deep stainless-steel chamber. The M 1 sterilizer models have an 11" (27.9 cm) diameter x 18" (45.7 cm) deep stainless-steel chamber.
The Midmark Smart M9® and Smart M11® Sterilizers use saturated steam at high pressure and temperature as the sterilizing agent to kill infectious bio-organisms on items placed in the chamber for processing. They use the dynamic Steam Flush Pressure Pulse (SFPP) cycle type for the pre-set cycles that include a 4-minute 270°F and a 3-minute 275°F cycle for wrapped or pouched instruments (including dental handpieces) and cassettes, a 30-minute 250°F cvcle for textiles and instrument packs requiring a lower temperature. and a 3-minute 270°F cycle for unwrapped instruments. The 3-minute 275°F is added to align with Table B.2 in AAMI TIR12:2020. In the SFPP type cycle, residual air is removed from the chamber and its contents by a series of controlled pressure pulses and steam flushes.
The Midmark Smart M9® and Smart M11® Sterilizers are designed to automate the sterilization process, to the extent possible, and the user interface on the subject models extends this capability to include sterilization record keeping. To use the sterilizer, the operator fills the water reservoir with water (distilled or purified) and loads the included trays with properly cleaned and prepped instruments for sterilization. The loaded trays are then placed inside the chamber, and the chamber door is manually closed by the operator. Based on the cycle parameters that are appropriate for the type of load being processed, the operator then selects the appropriate sterilization cycle on the user interface. On the subject units there are options for the user to enter load type and indicator information. Once the cycle is selected and the operator presses "Start," there is an option to capture the identification of the operator. The sterilizer then automatically performs all the operations necessary to complete the sterilization process without further interaction from the operator. The sterilization cycle is composed of several phases which include Filling, Heating, Sterilization, Venting, and Drying, Audible signals indicate cycle initiation, completion, and/or interruption, and the user interface provides visual communication of device status, operator instructions, and troubleshooting information. The LED light bar also provides an estimate of the cycle progression. At the conclusion of the cycle there is another option to capture the identification of the operator that unloads and approves or rejects the results of the sterilization cycle.
8
Midmark® Smart Sterilizers 510(k) Summary
All sterilizer cycle and user maintenance (Routine Care) records are stored internally on an SD card. Midmark has developed a Digital Ecosystem Connectivity Module that is incorporated into the Midmark Smart M9® and Smart M11® Sterilizers which adds the ability to transfer electronic sterilization records to the Midmark cloud and to remotely view the current status of, or cycle history for multiple sterilizers. Optional features and settings that may be distributed to multiple sterilizers from the cloud include distribution of software updates to the connectivity module, compliance settings, and entering the results of biological indicator tests. Connectivity is not needed to perform the sterlizer's intended use, and connecting a sterilizer does not change the intended use. Device specifications are provided in Table 4.
| Table 4. Specifications | |||
|---|---|---|---|
| Specification | Smart M9® Sterilizer | Smart M11® Sterilizer | |
| Physical dimensions: | |||
| Overall Length with Plug | 20.5 in (52.0 cm) | 23.5 in (59.7 cm) | |
| Overall Width | 15.8 in (40.1 cm) | 17.8 in (45.2 cm) | |
| Overall Height | 16.6 in (42.2 cm) | 18.6 in (47.2 cm) | |
| Required Support Surface | 19.8 in x 23.5 in | ||
| (50.3 cm x 59.7 cm) | 21.8 in x 26.5 in | ||
| (55.4 cm x 67.3 cm) | |||
| Chamber Size | 9 in diameter x 15 in deep | ||
| (22.9 cm x 38.1 cm) | 11 in diameter x 18 in deep | ||
| (27.9 cm x 45.7 cm) | |||
| Trays, Large | 7-5/16 in x 12 in x 7/8 in | ||
| (18.6 cm x 30.5 cm x 2.2 cm) | 9-1/8 in x 15-1/4 in x 7/8 in | ||
| (23 cm x 38.7 cm x 2.2 cm) | |||
| Trays, Small | 5-5/8 in x 12 in x 7/8 in | ||
| (14.3 cm x 30.5 cm x 2.2 cm) | 6-3/4 in x 15-1/4 in x 7/8 in | ||
| (17 cm x 38.7 cm x 2.2 cm) | |||
| Weights: | |||
| Weight with Empty Reservoir | 82 lb. (37.2 kg) | 99 lb. (44.9 kg) | |
| Weight with Shipping Carton | 92 lb. (41.7 kg) | 131 lb. (59.4 kg) | |
| Water Reservoir Capacity | 1.1 gallons (4.1 liters) full, | ||
| 0.6 gallons (2.3 liters) usable | 1.4 gallons (5.3 liters) full, | ||
| 0.8 gallons (3.0 liters) usable | |||
| Electrical Ratings: | |||
| 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, 12 Amp, 50/60 Hz | 115 VAC, 12 Amp, 50/60 Hz | |
| 230 Volt Models | Not Applicable | 230 VAC, 6.4 Amp, 50/60 Hz | |
| Table 4. Specifications | |||
| Specification | Smart M9® Sterilizer | Smart M11® Sterilizer | |
| 115 VAC | F1 | 15 Amp, 250 V, Fast Acting, | |
| 0.250 in Dia. x 1.250 in L | |||
| (6.35 mm x 31.75 mm) | 15 Amp, 250 V, Fast Acting, | ||
| 0.250 in Dia. x 1.250 in L | |||
| (6.35 mm x 31.75 mm) | |||
| F2 | 15 Amp, 250 V, Fast Acting, | ||
| 0.250 in Dia. x 1.250 in L | |||
| (6.35 mm x 31.75 mm) | 15 Amp, 250 V, Fast Acting, | ||
| 0.250 in Dia. x 1.250 in L | |||
| (6.35 mm x 31.75 mm) | |||
| F3 | 2.5 Amp, 250 V, Time | ||
| Delay/Slow-Blow, | |||
| 5.20 mm Dia. x 20.00 mm L | |||
| (0.205 in x 0.787 in) | 2.5 Amp, 250 V, Time | ||
| Delay/Slow-Blow, | |||
| 5.20 mm Dia. x 20.00 mm L | |||
| (0.205 in x 0.787 in) | |||
| 230 VAC | F1 | Not Applicable | 8 Amp, 250 V, Fast Acting, |
| 5.20 mm Dia. x 20.00 mm L | |||
| (0.205 in x 0.787 in) | |||
| F2 | Not Applicable | 8 Amp, 250 V, Fast Acting, | |
| 5.20 mm Dia. x 20.00 mm L | |||
| (0.205 in x 0.787 in) | |||
| F3 | Not Applicable | 2.5 Amp, 250 V, Time | |
| Delay/Slow-Blow, | |||
| 0.250 in Dia. x 1.250 in L | |||
| (6.35 mm x 31.75 mm) | |||
| Safety Valve Setting | 43 psi (296 kPa) | 43 psi (296 kPa) | |
| Heat Emission | 5000 BTU / hr. during | ||
| operation | 5000 BTU / hr. during | ||
| operation | |||
| Operating Environment: | |||
| Ambient Temperature Range | 68°F to 104°F (+20°C to +40°C) | 68°F to 104°F (+20°C to +40°C) | |
| Relative Humidity |