The Stat-Mat® Minor multipurpose surgical instrument tray is used for loading an entire kit of surgical instruments for a specific case in order to conveniently organize, sterilize, transport and store the instruments between uses.

The Stat-Mat® Minor is designed using plastic and metal materials that can be reused with prevacuum or gravity displacement steam sterilization methods. The Stat-Mat® Minor should be used only with FDA-cleared and legally marketed sterilization wraps that have been cleared for the sterilization cycles listed below. The Stat-Mat® Minor has been validated with the Dextex II Sterilization Wrap [K800123]. The base containing organized surgical instrumentation can be placed directly on the back table or onto a Mayo Tray. Instruments with lumens were not tested in the Stat-Mat® Minor validation process and are therefore not recommended for use with the Stat-Mat® Minor.

Sterilization cycle parameters:

Cycle Type	Temperature	SterilizationTime	Pre-Vac Pulses	Dry Time
Gravity	250°F (121°C)	30 minutes	none	30 minutes
Pre-vacuum	270°F (132°C)	4 minutes	4	30 minutes

Device Description

The Stat-Mat® Minor is a multipurpose surgical instrument tray that consists of three primary components: a base, cover, and instrument roll. The base and cover are composed of Radel plastic. which meets the requirements for biocompatibility pursuant to ISO-10993 and is compatible with standard steam sterilization methods. The instrument roll is composed of aluminum and is used to keep ringed instruments open during sterilization. The Stat-Mat® does not contact the patient.

AI/ML Overview

The provided text describes a medical device called the Stat-Mat® Minor, a sterilization tray, and details the nonclinical testing performed to validate its sterilization effectiveness. It does not describe an AI medical device or a study involving human readers or AI assistance. Therefore, I cannot provide information on the aspects related to AI, ground truth establishment for AI, MRMC comparative effectiveness studies, or standalone algorithm performance.

Here's the information related to the device and its validation as per the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Stat-Mat® Minor are defined by its ability to achieve sterility assurance under specific steam sterilization cycles, as demonstrated by the inactivation of Geobacillus stearothermophilus spores. The reported performance confirms that these criteria were met.

Acceptance Criterion (Sterilization Effectiveness)	Reported Device Performance
Gravity Displacement Cycle: Sterilization at 121°C for 15 minutes (half-cycle)	The Stat-Mat® Minor was successfully sterilized in a gravity displacement cycle at 121°C for a 15-minute half-cycle. This condition was considered adequate to achieve a sterility assurance level (SAL) of 10⁻⁶ at twice the stated exposure time (i.e., 30 minutes).
Pre-vacuum Cycle: Sterilization at 132°C for 2 minutes (half-cycle)	The Stat-Mat® Minor was successfully sterilized in a pre-vacuum cycle at 132°C for a 2-minute half-cycle. This condition was considered adequate to achieve a sterility assurance level (SAL) of 10⁻⁶ at twice the stated exposure time (i.e., 4 minutes).
Compatibility with specified sterilization wraps and cycles	The Stat-Mat® Minor has been validated with the Dextex II Sterilization Wrap [K800123] for both gravity displacement and pre-vacuum steam sterilization methods, adhering to the specified temperature and time parameters.
Successful sterilization for consecutive and separate half-cycles	The Stat-Mat® Minor was successfully sterilized for three consecutive and separate sterilization half cycles.
Verification of thermocouples and satisfactory controls	The thermocouples passed the verification calibration, and all positive and negative controls were satisfactory.

Detailed Study Information:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The text states, "10 Geobacillus stearothermophilus spore strips and thermocouples were placed in the test articles." It also mentions "The test articles were double-wrapped." The number of "test articles" (Stat-Mat® Minor units) used is not explicitly stated, but it implies a sufficient number were tested to accommodate 10 spore strips and thermocouples.
- Data Provenance: The study was conducted by MacPherson Medical Inc., presumably in the USA. The study design appears to be prospective in nature, as it involves active testing of the device for sterilization efficacy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the study involves a physical device and sterilization efficacy, which is determined by microbiological and physical measurements, not interpretation by human experts. The "ground truth" is objective (sterility or lack thereof).
Adjudication method for the test set:
- Not applicable as the determination of sterility is based on scientific methods (presence/absence of microbial growth, temperature readings), not subjective expert judgment requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation (e.g., radiology images) to assess the impact of AI on reader performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical medical instrument tray, not an AI algorithm.
The type of ground truth used:
- The ground truth used was microbiological efficacy and physical parameter measurement:
  - Microbiological: The inactivation of Geobacillus stearothermophilus spore strips to demonstrate a sterility assurance level (SAL) of 10⁻⁶. This is assessed by culturing the spore strips after sterilization to determine if any viable spores remain.
  - Physical: Thermocouples were used to verify that the required temperatures were reached and maintained within the test articles during the sterilization cycles. This ensures the physical conditions for sterilization were met.
The sample size for the training set:
- Not applicable. This is a nonclinical validation study for a physical device, not an AI algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device validation.

Summary

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REVISED 510(k) SUMMARY

JUN 2 3 2011

KII0500

MacPherson Medical's Stat-Mat® Minor

Submitter:

MacPherson Medical Inc.

930 Main Street, Suite 202

Acton, MA 01720

Phone: (978) 800-4641

Facsimile: (866) 280-2078

Contact Person: Brad MacPherson

Date Prepared: June 21, 2011

Device Name:

Stat-Mat® Minor

Sponsor:

MacPherson Medical Inc.

930 Main Street, Suite 202

Acton, MA 01720

Common or Usual Name

Sterilization Tray

Classification Name

Accessory to sterilization wrap

Predicate Devices

PolyVac's Surgical Instrument Delivery Systems (K012105)

Riley Medical, Inc.'s MetaPak Multi-Purpose Instrument Tray (K993535)

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Device Description

Intended Use / Indications for Use

Cycle Type	Temperature	SterilizationTime	Pre-Vac Pulses	Dry Time
Gravity	250°F (121°C)	30 minutes	none	30 minutes
Pre-vacuum	270°F (132°C)	4 minutes	4	30 minutes

Sterilization cycle parameters

Technological Characteristics

The Stat-Mat® Minor includes a quick release cover and ringed instrument separator. The Stat-Mat® Minor can be wrapped in CSR wrap with no sharp edges. It is made of durable materials that are appropriate for holding general surgical instruments and withstanding standard steam sterilization methods. It has ample holes to allow steam to circulate for sterilization.

Performance Data (Nonclinical Testing)

The company conducted testing to validate gravity displacement and pre-vacuum steam sterilization of the Stat-Mat® Minor. 10° Geobacillus stearothermophilus spore strips and thermocouples were placed in the test articles. The test articles were double-wrapped in a cleared sterilization wrap and placed in the sterilization chamber. The test articles were successfully sterilized in a pre-vacuum cycle at 132° for a 2-minute half-cycle and a gravity

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displacement cycle at 121° for a 15-minute half-cycle. The Stat-Mat® Minor was successfully sterilized for three consecutive and separate sterilization half cycles. The cycle conditions were considered adequate to achieve a sterility assurance level of 10 ° at twice the stated exposure time. The thermocouples passed the verification calibration, and all positive and negative controls were satisfactory.

Conclusion: The results of the sterilization testing performed demonstrate that the Stat-Mat® Minor is as safe, as effective, and performs as well as the predicate devices.

Substantial Equivalence

The Stat-Mat® Minor is as safe and effective as Polyvac's Surgical Instrument Delivery Systems or Riley Medical, Inc.'s MetaPak Multi-purpose Instrument Tray. The Stat-Mat® Minor has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Stat-Mat® Minor and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Stat-Mat® Minor is as safe and effective as Polyvac's Surgical Instrument Delivery Systems or Riley Medical, Inc.'s MetaPak Multipurpose Instrument Tray. Thus, the Stat-Mat® Minor is substantially equivalent.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes forming its body and wings. The eagle appears to be in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MacPherson Medical, Incorporated C/O Mr. Howard Holstein Hogan Lovells US, LLP Columbia Square 555 13th Street, NW Washington, D.C. 20004

JUN 2 3 2011

Re: K110500 Trade/Device Name: Stat-Mat® Minor Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: June 16, 2011 Received: June 16, 2011

Dear Mr. Holstein:

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.

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Page 2 - Mr. Holstein

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 (reporting of medical device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours.
Susan Punner

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Indications for Use Statement

	110500
510(k) Number (if known):	1
	CALLER SELECTRACTED COLLECTION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLECTION CONTRACTOR COLLEGION CONTRACTOR

Device Name: Stat-Mat® Minor

Indications for Use:

Sterilization cycle parameters:

Cycle Type	Temperature	SterilizationTime	Pre-Vac Pulses	Dry Time
Gravity	250°F (121°C)	30 minutes	none	30 minutes
Pre-vacuum	270°F (132°C)	4 minutes	4	30 minutes

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH. Office of Dev

E. Sindretta F. Clavijo-Will

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

WDC - 038100/000001 - 3261988 v2

KI10500 510(k) Number:

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).