(121 days)
No
The document describes a physical surgical instrument tray and its sterilization validation, with no mention of AI or ML technology.
No
Explanation: The device is a surgical instrument tray used for organizing, sterilizing, transporting, and storing instruments, not for treating or diagnosing a medical condition. It's an accessory to sterilization and surgical instrument management.
No
The device is a surgical instrument tray used for organizing, sterilizing, storing, and transporting surgical instruments, not for diagnosing medical conditions.
No
The device is a physical surgical instrument tray made of plastic and metal, designed for organizing, sterilizing, transporting, and storing instruments. It is not software.
Based on the provided information, the Stat-Mat® Minor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "loading an entire kit of surgical instruments for a specific case in order to conveniently organize, sterilize, transport and store the instruments between uses." This describes a device used in the process of preparing surgical instruments, not for testing samples from the human body.
- Device Description: The description details the materials and components of a surgical instrument tray designed for sterilization and organization. It explicitly states that the device "does not contact the patient."
- Performance Studies: The performance studies focus on the effectiveness of sterilization within the tray, which is relevant to surgical instrument processing, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Stat-Mat® Minor falls under the category of a surgical instrument accessory or sterilization container, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
KCT
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.
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
Not Found
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
The company conducted testing to validate gravity displacement and pre-vacuum steam sterilization of the Stat-Mat® Minor. 10⁶ 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 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 10⁻⁶ at twice the stated exposure time. The thermocouples passed the verification calibration, and all positive and negative controls were satisfactory.
Key Metrics
Not Found
Predicate Device(s)
PolyVac's Surgical Instrument Delivery Systems (K012105), Riley Medical, Inc.'s MetaPak Multi-Purpose Instrument Tray (K993535)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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)
1
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.
Intended Use / Indications for Use
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.
| Cycle Type | Temperature | Sterilization
Time | 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
2
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.
3
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.
4
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
5
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:
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 | Sterilization
Time | 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: