(484 days)
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.
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.
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.
§ 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).