The SCORES® Sterilization Container is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit must be used with the SCORES® transfer cart, SCORES® filters, and integrity locks.

The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270° and exposure time of 4 minutes. Use no more than 3 travs per shelf or 25 lbs. per tray.

The SCORES® Unit was tested and validated with rigid instruments containing lumens with an inner diameter of 3.8mm and an overall length of 370mm. Do not use with instruments containing lumens with an inner diameter smaller than 3.8mm and an overall length longer than 370mm.

Use only uncovered, perforated or wire mesh general delivery trays within the SCORES® Sterilization Container.

Device Description

The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit) is a sterilization container and delivery system capable of holding multiple instrument sterilization trays. The S.C.O.R.E.S. container can be loaded with multiple surgical instrument trays needed for a single surgery, steam sterilized, dried in the chamber drying cycle, removed from the autoclave on a transport cart, stored for up to 30 days, and delivered to the surgical suite for opening and use of the contents. The system includes the S.C.O.R.E.S. cabinet with wheels for loading into sterilizers, internal shelves for placement of sterilization trays, a filter system to allow steam penetration and maintain sterility, and an adjustable transport cart to allow for movement of the loaded system.

Instrument trays within the S.C.O.R.E.S Unit do not need to be placed in sterilization containers or wrapped to maintain sterile integrity as the filtered Unit does so. Once opened in the surgical suite and the contents are to be used immediately. The subject device has been extensively tested, and verified to perform in a safe and effective manner.

The S.C.O.R.E.S. Unit is a sterilization cabinet constructed from stainless steel and provided with a filtration system.

The Unit can be loaded with all of the instrumentation needed for a surgical case. Instruments are placed into trays, which need not be wrapped. Individual trays of instruments should weigh no more than 251bs. and up to 12 trays can be arranged on the shelves of the S.C.O.R.E.S. Unit. The loaded unit has a filtration system to allow for steam penetration.

The wheeled Unit is transported on an adjustable cart, which can be adjusted to the height of a prevacuum autoclave chamber. The sealed, loaded unit can be rolled into the chamber and processed in a normal cycle.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the S.C.O.R.E.S. Unit, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Intended Use/Validated Parameters)	Reported Device Performance
Allow sterilization of enclosed materials.	"The S.C.O.R.E.S. Unit... (is) capable of holding multiple instrument sterilization trays... steam sterilized, dried in the chamber drying cycle..." (Implied successful sterilization by this process). "The loaded unit has a filtration system to allow for steam penetration." "Validation was done with prevacuum steam half cycles."
Maintain sterility for up to 30 days until used.	"The product has also been shown to be capable of maintaining sterility of the contents for up to 30 days."
Used in prevacuum steam sterilizers with a prevacuum cycle of 27.0° and exposure time of 4 minutes.	"Validation was done with prevacuum steam half cycles and drying was also accomplished." (Implied successful performance at these parameters). Specific mention of "27.0° and exposure time of 4 minutes" is stated as an intended use condition.
Use no more than 3 trays per shelf.	(Stated as an intended use condition, no explicit performance data beyond this).
Use no more than 25 lbs. per tray.	(Stated as an intended use condition, no explicit performance data beyond this).
Used with rigid instruments containing lumens with an inner diameter of 3.8mm and an overall length of 370mm.	"The SCORES® Unit was tested and validated with rigid instruments containing lumens with an inner diameter of 3.8mm and an overall length of 370mm."
Use only uncovered, perforated or wire mesh general delivery trays within the SCORES® Sterilization Container.	(Stated as an intended use condition, no explicit performance data beyond this).
Must be used with the SCORES® transfer cart, SCORES® filters, and integrity locks.	(Stated as an intended use condition, no explicit performance data beyond this).
Perform in a safe and effective manner.	"The subject device has been extensively tested, and verified to perform in a safe and effective manner." (General statement, specific underlying data not provided).
Substantially equivalent to the Allegiance Genesis Container System for prevacuum sterilization applications.	"The S.C.O.R.E.S. Unit has been determined to be substantially equivalent to the Allegiance Genesis Container System. For prevacuum sterilization applications, the predicate device has similar technical features, indications for use, and the safety and effectiveness of the devices is equivalent."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for specific tests. However, it mentions:

"The subject device has been extensively tested..."
"The SCORES® Unit was tested and validated with rigid instruments containing lumens..."
"Validation was done with prevacuum steam half cycles and drying was also accomplished. Validation was done with an Amsco (Steris) Model 3043."

The data provenance is not specified in terms of country of origin, but it is implied to be prospective validation testing conducted for the purpose of this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The validation appears to be based on engineering and microbiological performance testing rather than expert-driven ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the device (sterilization container), adjudication by experts in the context of imaging or diagnostic accuracy is not typically applicable. The "ground truth" would be objective measurements of sterility, steam penetration, and material integrity.

5. 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 relevant for diagnostic devices where human readers interpret output, which is not the case for a sterilization container.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This question is not applicable to this device. The S.C.O.R.E.S. Unit is a physical medical device, not an algorithm or AI system. Its performance is inherent to its design and manufacturing, not an automated interpretation.

7. The Type of Ground Truth Used

The ground truth used for this device would be based on objective performance metrics and scientific testing, including:

Sterilization efficacy: Measured by biological indicators or other validated methods to confirm the death of microorganisms after sterilization cycles.
Sterility maintenance: Measured by microbiological testing over the 30-day period to ensure no contamination.
Physical integrity: Testing of filters, seals, and structural components under various conditions.
Steam penetration: Measurement of steam reaching all parts of the contained instruments.
Drying effectiveness: Measurement of residual moisture.

8. The Sample Size for the Training Set

This information is not applicable as the S.C.O.R.E.S. Unit is a physical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the reasons stated in point 8.

Summary

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JUL 26 2012

510(k) Summary Pursuant to 21 CFR 807.92

K110898

Date of preparation: 5 July 2012

Submitted By: 1.
AmMed Surgical Equipment, LLC 3801 Corporex Park Drive, Suite 120 Tampa, Florida 33619

Contact: David C. Furr FDC Services, LLC 8708 Capehart Cove Austin, Texas 78733 512-906-9654
Product: S.C.O.R.E.S Units. Self Contained Operating Room Equipment Sterilization Containers Regulation: 880.6850. Sterilization Wrap Class II Product Code: KCT

4. Common/Trade Name:

S.C.O.R.E.S Units

Sterilization Wrap/Container

Description:

{1}------------------------------------------------

Intended Use:

The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 27.0° and exposure time of 4 minutes. Use no more than 3 trays per shelf or 25 lbs. per tray.

Use only uncovered, perforated or wire mesh general delivery trays within the SCORES® Sterilization Container.

Technological Characteristics:

The S.C.O.R.E.S. Unit is a sterilization cabinet constructed from stainless steel and provided with a filtration system.

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The S.C.O.R.E.S. Unit has been validated in accordance with relevant industry standards using a hospital steam sterilizer. Validation was done with prevacuum steam half cycles and drying was also accomplished. Validation was done with an Amsco (Steris) Model 3043.

The product has also been shown to be capable of maintaining sterility of the contents for up to 30 days.

Substantial Equivalence:

The S.C.O.R.E.S. Unit has been determined to be substantially equivalent to the Allegiance Genesis Container System. For prevacuum sterilization applications, the predicate device has similar technical features, indications for use, and the safety and effectiveness of the devices is equivalent.

Conclusions:

The predicate devices and the AmMed Surgical S.C.O.R.E.S Unit container system share similar indications, technology, and application. Although the S.C.O.R.E.S. unit holds more equipment, the device is essentially equivalent to the predicate device products in key areas of performance that affect safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a single snake entwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

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

JUL 2 6 2012

Ammed Surgical Equipment, LLC C/O Mr. David C. Furr FDC Services, LLC 8708 Capehart Cove Austin, Texas 78733

Re: K110898

Trade/Device Name: Scores Unit Sterilization Container Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: July 5, 2012 Received: July 13, 2012

Dear Mr. Furr:

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. Furr

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/ucm115809.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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

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

K110898 . 510(k) Number:

Device Name: SCORES® Unit Sterilization Container

Indications for Use:

The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270° and exposure time of 4 minutes. Use no more than 3 travs per shelf or 25 lbs. per tray.

Use only uncovered, perforated or wire mesh general delivery trays within the SCORES® Sterilization Container.

Prescription Use
(per CFR 801.109)

Over-the-counter use	X
----------------------	---

Concurrence of CDRH

E. Mitchell F. O'Quinn - Williams

Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, Deneral Devices Division of Arcel. Dental Devices

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).