(137 days)
The SteriTite container and MediTray products are a reusable sterilization container system to be used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. It is intended to allow sterilization of the enclosed devices and maintain sterility of the enclosed device until it is used. This container system is compatible for use with the following low temperature sterilizers and cycles identified below:
- STERIS V-Pro 60 (Flexible and Lumen cycle) -
- -STERIS V-Pro s2 (Flexible and Lumen cycle)
- STERIS V-Pro maX 2 (Lumen, Non-Lumen and Flexible cycle) -
- -STERIS V-Pro maX (Lumen, Non-Lumen and Flexible cycle)
- STERRAD 100NX ALLCLEAR (Standard, Flexible,DUO and Express cycle) -
- -Sterizone VP4 (Cycle 1)
Refer to the specific Sterilizer user manual and vendor provided information regarding of appropriate devices and device type. See the following pages for tables of compatible devices and description of the validated loads.
The following table (Table 1) identifies the validated lumen claims of the SteriTite container with MediTray parts in low temperature and pre-vacuum steam sterilizers:
Table 1. SteriTite Container System with MediTray Parts Lumen Claims:
| Sterilizer | Cycle | Lumen Sterilization Claims (I.D. x Length) |
|---|---|---|
| STERIS V-Pro 60 | Flexible | ≥1mm x ≤990mm (Single or Dual Lumen) |
| STERIS V-Pro 60 | Lumen | ≥0.77mm x ≤527mm (Dual Channel) |
| STERIS V-Pro s2 | Flexible | ≥1mm x ≤990mm (Single or Dual Lumen) |
| STERIS V-Pro s2 | Lumen | ≥0.77mm x ≤527mm (Dual Channel) |
| STERIS V-Pro maX 2 | Flexible | ≥1mm x ≤1050mm (Single Lumen) |
| STERIS V-Pro maX 2 | Lumen | ≥0.77mm x ≤527mm (Dual Channel) |
| STERIS V-Pro maX | Flexible | ≥1mm x ≤1050mm (Single Lumen) |
| STERIS V-Pro maX | Lumen | ≥0.77mm x ≤527mm (Dual Channel) |
| STERRAD 100NX | DUO | ≥1mm x ≤875mm (Single Lumen) |
| Sterizone VP4 | Cycle 1 | ≥1.2mm x ≤1955mm (Flexible Lumens) |
| Sterizone VP4 | Cycle 1 | ≥1.45mm x ≤3500mm (Flexible Lumens) |
| Steam | Pre-Vac | ≥2mm x ≤400mm (Stainless Steel Lumen)≥1.2mm x ≤400mm (Flexible Lumen) |
The SteriTite® Universal Container is a rigid, reusable, sealed sterilization packaging system that is compatible with steam, hydrogen peroxide, ethylene oxide, and ozone sterilizers. The SteriTite® container system consists of a family of rigid reusable containers and inserts that provide an effective reusable sterilization packaging system for operating room instruments. The SteriTite® container as previously cleared is available with solid or perforated base. The container is made of anodized aluminum with passivated stainless-steel hardware and silicone gaskets. Each filter retention plate with gaskets and off set vent pattern secures a disposable filter for bacterial barrier filtration. Filter retention plates in lid and base are interchangeable for universal use. A recessed gasket contributes to a knife edge fit between lid and base. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions, and racks provide instrument protection and secure devices for sterilization within the container.
The provided text does not contain information about an AI device. Instead, it describes a medical device, the "SteriTite Container System with MediTray Parts," which is a reusable sterilization container system. The document outlines its indications for use, compatibility with various sterilizers and accessories, maximum load weight recommendations, and non-clinical performance testing.
Therefore, I cannot provide details on the acceptance criteria and study for an AI device as requested by your prompt.
However, if you are interested in the acceptance criteria and study for the SteriTite Container System with MediTray Parts, I can extract that information:
Description of Acceptance Criteria and Study for SteriTite Container System with MediTray Parts:
The SteriTite Container System with MediTray Parts is a reusable sterilization container system. The device was evaluated through non-clinical performance testing to demonstrate its safety, effectiveness, and performance. The testing followed established ANSI/AAMI standards and FDA guidance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Testing | Standard | Purpose | Reported Device Performance |
|---|---|---|---|
| Sterility Maintenance | ANSI/AAMI ST77:2013 (R)2018 | Demonstrate the integrity of the container to maintain sterility of contents over time and with multiple handling events after sterilization. | Pass |
| Whole Package Microbial Challenge | ANSI/AAMI ST77:2013 (R)2018 | Demonstration of whole package integrity following exposure to aerosolized bacteria spores. | Pass |
| Biocompatibility | ANSI AAMI ISO10993-1 | Acute systemic toxicity, primary irritation and sensitization of the subject device. | Pass |
| Material Compatibility / Re-Use Testing | ANSI/AAMI ST77:2013 (R)2018 | Demonstration that the subject device materials are compatible with the intended sterilization cycles. | Pass |
| Simulated Use Testing/Sterilization Efficacy | ANSI AAMI ISO 14937:2009/(R)2013 | Testing was completed to demonstrate sterilization efficacy of the subject device for processing of medical devices with the indicated claims using the identified sterilization processes. | Pass |
2. Sample size used for the test set and the data provenance:
The document states that "All SteriTite containers were tested with inner baskets or trays representative of the products." It does not specify the exact sample size (number of containers, baskets, or trays) used for each test. The provenance of the data is that the "validation testing was conducted at qualified independent laboratories." The data is thus prospective testing specifically for this device's validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a sterilization container system, and its performance is evaluated against physical and biological challenges, not against expert interpretation of data. "Ground truth" in this context refers to established scientific and regulatory standards for sterilization efficacy and device material compatibility.
4. Adjudication method for the test set:
Not applicable in the context of device performance testing against established standards. The results are objective "Pass" or "Fail" based on whether the device meets the criteria outlined in the referenced standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI device.
7. The type of ground truth used:
The ground truth for this device's performance is based on established industry standards for sterilization, biocompatibility, and material compatibility. Specifically, the standards cited are:
- ANSI/AAMI ST77:2013 (R)2018 (Sterility Maintenance, Whole Package Microbial Challenge, Material Compatibility / Re-Use Testing)
- ANSI AAMI ISO10993-1 (Biocompatibility)
- ANSI AAMI ISO 14937:2009/(R)2013 (Simulated Use Testing/Sterilization Efficacy)
- FDA guidance (not specifically named, but implied for regulatory compliance)
- AAMI TIR 12 and ANSI/AAMI ST-79 (additional relevant standards mentioned)
The efficacy testing followed the "overkill method" of sterility assurance and used the bacterial strain G. stearothermophilus as a biological challenge.
8. The sample size for the training set:
Not applicable. This is not an AI device, so there is no training set in the AI sense.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI device.
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October 7, 2022
Image /page/0/Picture/1 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Case Medical, Inc. Michael Polozani Regulatory Affairs 50 West Street Bloomfield, New Jersey 07003
Re: K221492
Trade/Device Name: SteriTite Container System with MediTray Parts Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: May 20, 2022 Received: May 23, 2022
Dear Michael Polozani:
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. 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 located 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.
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
{1}------------------------------------------------
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221492
Device Name
SteriTite Container with MediTray Products
Indications for Use (Describe)
The SteriTite container and MediTray products are a reusable sterilization container system to be used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. It is intended to allow sterilization of the enclosed devices and maintain sterility of the enclosed device until it is used. This container system is compatible for use with the following low temperature sterilizers and cycles identified below:
- STERIS V-Pro 60 (Flexible and Lumen cycle) -
- -STERIS V-Pro s2 (Flexible and Lumen cycle)
- STERIS V-Pro maX 2 (Lumen, Non-Lumen and Flexible cycle) -
- -STERIS V-Pro maX (Lumen, Non-Lumen and Flexible cycle)
- STERRAD 100NX ALLCLEAR (Standard, Flexible,DUO and Express cycle) -
- -Sterizone VP4 (Cycle 1)
Refer to the specific Sterilizer user manual and vendor provided information regarding of appropriate devices and device type. See the following pages for tables of compatible devices and description of the validated loads.
The following table (Table 1) identifies the validated lumen claims of the SteriTite container with MediTray parts in low temperature and pre-vacuum steam sterilizers:
Table 1. SteriTite Container System with MediTray Parts Lumen Claims:
| Sterilizer | Cycle | Lumen Sterilization Claims (I.D. x Length) |
|---|---|---|
| STERIS V-Pro 60 | Flexible | ≥1mm x ≤990mm (Single or Dual Lumen) |
| STERIS V-Pro 60 | Lumen | ≥0.77mm x ≤527mm (Dual Channel) |
| STERIS V-Pro s2 | Flexible | ≥1mm x ≤990mm (Single or Dual Lumen) |
| STERIS V-Pro s2 | Lumen | ≥0.77mm x ≤527mm (Dual Channel) |
| STERIS V-Pro maX 2 | Flexible | ≥1mm x ≤1050mm (Single Lumen) |
| STERIS V-Pro maX 2 | Lumen | ≥0.77mm x ≤527mm (Dual Channel) |
| STERIS V-Pro maX | Flexible | ≥1mm x ≤1050mm (Single Lumen) |
| STERIS V-Pro maX | Lumen | ≥0.77mm x ≤527mm (Dual Channel) |
| STERRAD 100NX | DUO | ≥1mm x ≤875mm (Single Lumen) |
| Sterizone VP4 | Cycle 1 | ≥1.2mm x ≤1955mm (Flexible Lumens) |
| Sterizone VP4 | Cycle 1 | ≥1.45mm x ≤3500mm (Flexible Lumens) |
| Steam | Pre-Vac | ≥2mm x ≤400mm (Stainless Steel Lumen)≥1.2mm x ≤400mm (Flexible Lumen) |
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The following table (Table 2) displays the SteriTite part numbers and the sterilizers they are compatible with.
| V-Pro s2/60 | V-Pro 1 | V-Pro maX/2 | Sterizone VP4 | STERRAD 100NX |
|---|---|---|---|---|
| Lumen | Lumen Cycle | Lumen | Cycle 1 | Standard,Flex |
| SC02MG | SC02MG | SC02MG | SC02M(G)* | SC02MG |
| SC03MG | SC03MG | SC03MG | SC03M(G)* | SC03MG |
| SC04MG | SC02NG | SC04MG | SC04M(G)* | SC04MG |
| SC02NG | SC03NG | SC02NG | SC02N(G)* | SC02NG |
| SC03NG | SC04FG | SC03NG | SC03N(G)* | SC03NG |
| SC04NLG | SC05FG | SC04NLG | SC04NL(G)* | SC04NLG |
| SC05NLG | SC06FG | SC05NLG | SC05NL(G)* | SC05NLG |
| SC04HG | SC08FG | SC04HG | SC04H(G)* | SC04HG |
| SC05HG | SC04HG | SC05HG | SC05H(G)* | SC05HG |
| SC04QG | SC05HG | SC06HG | SC06H(G)* | SC06HG |
| SC05QG | SC06HG | SC08HG | SC08H(G)* | SC08HG |
| SC04FG | SC08HG | SC04QG | SC04Q(G)* | SC04QG |
| SC04QG | SC05QG | SC05Q(G)* | SC05QG | |
| SC05QG | SC06QG | SC06Q(G)* | SC06QG | |
| SC06QG | SC08QG | SC08Q(G)* | SC08QG | |
| SC08QG | SC04FG | SC04F(G)* | SC04FG | |
| SC04LG | SC05FG | SC04L(G)* | SC05FG | |
| SC06LG | SC06FG | SC06L(G)* | SC06FG | |
| SC05WG | SC08FG | SC08FG | ||
| SC04LG | SC04LG | |||
| SC06LG | SC06LG | |||
| SC05WG | SC05WG |
Table 2. SteriTite Container Compatibility with Low Temperature and Steam Sterilizers
STERRAD 100NX
DUO, Express Cycle
SC02MG SC03MG SC04MG SC02NG SC03NG SC04NLG SC05NLG SC04HG SC05HG SC06HG SC08HG SC04QG SC05QG SC06QG SC04FG SC05FG SC06FG SC08FG SC04LG
{4}------------------------------------------------
*Please note that the SteriTite perforated bottom containers are compatible with the Sterizone VP4 Sterilizer.
Table 2 (Continued). SteriTite Container Compatibility with Low Temperature and Steam Sterilizers
| STERRAD 100S/200 | NX | Steam |
|---|---|---|
| Standard | Standard | Pre-Vac |
| Advanced | Gravity | |
| IUSS | ||
| SC02MG | SC02MG | SC02MG |
| SC03MG | SC03MG | SC03MG |
| SC04MG | SC04MG | SC04MG |
| SC02NG | SC02NG | SC02NG |
| SC03NG | SC03NG | SC03NG |
| SC04NLG | SC04HG | SC04NLG |
| SC05NLG | SC05HG | SC05NLG |
| SC04HG | SC04QG | SC04HG |
| SC05HG | SC05QG | SC05HG |
| SC06HG | SC04FG | SC06HG |
| SC08HG | SC08HG | |
| SC04QG | SC04QG | |
| SC05QG | SC05QG | |
| SC06QG | SC06QG | |
| SC08QG | SC08QG | |
| SC04FG | SC04FG | |
| SC05FG | SC05FG | |
| SC06FG | SC06FG | |
| SC08FG | SC08FG | |
| SC04LG | ||
| SC06LG | ||
| SC08LG | ||
| SC05WG |
The following table identifies which MediTray products are compatible with low temperature sterilizers and steam sterilization:
| MediTray Product | V-PromaX/2 | V-Pro 1 | V-Pros2/60 | STERRAD100NX | STERRAD100s/200 | STERRADNX | STERIZONEVP4 | STEAM |
|---|---|---|---|---|---|---|---|---|
| Baskets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Trays | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Insert Boxes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
{5}------------------------------------------------
| Metal Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
|---|---|---|---|---|---|---|---|---|
| Metal Partitions | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Posts | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Silicone Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Racks | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Stringers | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
The following table (Table 4)identifies which SteriTite accessories are compatible with low temperature sterilizers and steam sterilization:
Table 4. SteriTite Accessories Sterilizer Compatibility Table
| SteriTite Accessories | V-PromaX/2 | V-Pro 1 | V-Pros2/60 | STERRAD100NX | STERRAD100s/200 | STERRADNX | STERIZONEVP4 | Steam |
|---|---|---|---|---|---|---|---|---|
| Baskets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Trays | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Insert Boxes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Metal Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Metal Partitions | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Posts | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Silicone Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Racks | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Stringers | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
The following tables (5-11) identify the sterilizer maximum load weight recommendations with the SteriTite containers:
Table 5. SteriTite Container in V-Pro 60 Maximum Load Weight Recommendations Including Weight of Container
| Part Number | Total Load Weight inV-Pro s2/60Lumen Cycle | Total Load Weight inV-Pro s2/60Flexible Cycle |
|---|---|---|
| SC02MG | 25 lbs | 11 lbs |
| SC03MG | 25 lbs | 11 lbs |
| SC04MG | 25 lbs | 11 lbs |
| SC02NG | 25 lbs | 11 lbs |
| SC03NG | 25 lbs | 11 lbs |
| SC04NLG | 25 lbs | 11 lbs |
| SC05NLG | 25 lbs | 11 lbs |
| SC04HG | 25 lbs | 11 lbs |
| SC05HG | 25 lbs | 11 lbs |
| SC04QG | 25 lbs | 11 lbs |
| SC05QG | 25 lbs | 11 lbs |
| SC04FG | 25 lbs | 11 lbs |
Table 6. SteriTite Container in STERRAD NX Maximum Load Weight Recommendations Including Weight of Container
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| Part Number | Total Load Weight inNX Standard Cycle | Total Load Weight inNX Advanced Cycle |
|---|---|---|
| SC02MG | 10.7 lbs | 10.7 lbs |
| SC03MG | 10.7 lbs | 10.7 lbs |
| SC04MG | 10.7 lbs | 10.7 lbs |
| SC02NG | 10.7 lbs | 10.7 lbs |
| SC03NG | 10.7 lbs | 10.7 lbs |
| SC04HG | 10.7 lbs | 10.7 lbs |
| SC05HG | 10.7 lbs | 10.7 lbs |
| SC04QG | 10.7 lbs | 10.7 lbs |
| SC05QG | 10.7 lbs | 10.7 lbs |
| SC04FG | 10.7 lbs | 10.7 lbs |
Table 7. SteriTite Container in V-Pro 1 Maximum Load Weight Recommendations Including Weight of Container
| Part Number | Total Load Weight in |
|---|---|
| V-Pro 1 Lumen Cycle | |
| SC02MG | 19.65 lbs |
| SC03MG | 19.65 lbs |
| SC02NG | 19.65 lbs |
| SC03NG | 19.65 lbs |
| SC04FG | 19.65 lbs |
| SC05FG | 19.65 lbs |
| SC06FG | 19.65 lbs |
| SC08FG | 19.65 lbs |
| SC04HG | 19.65 lbs |
| SC05HG | 19.65 lbs |
| SC06HG | 19.65 lbs |
| SC08HG | 19.65 lbs |
| SC04QG | 19.65 lbs |
| SC05QG | 19.65 lbs |
| SC06QG | 19.65 lbs |
| SC08QG | 19.65 lbs |
| SC04LG | 19.65 lbs |
| SC06LG | 19.65 lbs |
| SC08LG | 19.65 lbs |
| SC05WG | 19.65 lbs |
Table 8. SteriTite Container in STERRAD 100s/200 Maximum Load Weight Recommendations Including Weight of Container
| Part Number | Total Load Weight in theSTERRAD 100s/200 Standard Cycle |
|---|---|
| SC02MG | 22 lbs |
| SC03MG | 22 lbs |
| SC04MG | 22 lbs |
| SC02NG | 22 lbs |
| SC03NG | 22 lbs |
| SC04NLG | 22 lbs |
| SC05NLG | 22 lbs |
| SC04HG | 22 lbs |
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| SC05HG | 22 lbs |
|---|---|
| SC06HG | 22 lbs |
| SC08HG | 22 lbs |
| SC04QG | 22 lbs |
| SC05QG | 22 lbs |
| SC06QG | 22 lbs |
| SC08QG | 22 lbs |
| SC04FG | 22 lbs |
| SC05FG | 22 lbs |
| SC06FG | 22 lbs |
| SC08FG | 22 lbs |
Table 9. SteriTite Container in 100NX Maximum Load Weight Recommendations Including Weight of Container.
| Part Number | Total Load Weight in100NX Standard Cycle | Total Load Weight in100NX Flex Cycle | Total Load Weight in100NX DUO Cycle |
|---|---|---|---|
| SC02MG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC03MG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC04MG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC02NG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC03NG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC04NLG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC05NLG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC04HG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC05HG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC06HG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC08HG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC04QG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC05QG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC06QG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC08QG | 21.4 lbs | 21.4 lbs | Not Compatible |
| SC04FG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC05FG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC06FG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC08FG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC04LG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC06LG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC05WG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
Total Load Weight in 100NX Express Cycle
| SC02MG | 10.7lbs |
|---|---|
| SC03MG | 10.7lbs |
| SC04MG | 10.7lbs |
| SC02NG | 10.7lbs |
| SC03NG | 10.7lbs |
| SC04NLG | 10.7lbs |
| SC05NLG | 10.7lbs |
| SC04HG | 10.7lbs |
| SC05HG | 10.7lbs |
| SC06HG | 10.7lbs |
{8}------------------------------------------------
| SC08HG | 10.7lbs |
|---|---|
| SC04QG | 10.7lbs |
| SC05QG | 10.7lbs |
| SC06QG | 10.7lbs |
| SC08QG | Not Compatible |
| SC04FG | 10.7lbs |
| SC05FG | 10.7lbs |
| SC06FG | 10.7lbs |
| SC08FG | 10.7lbs |
| SC04LG | 10.7lbs |
| SC06LG | 10.7lbs |
| SC05WG | 10.7lbs |
Table 10. SteriTite Container in V-Pro maX/maX 2 Maximum Load Weight Recommendations Including Weight of Container
| Part Number | Total Load Weight in V-PromaX/maX 2 Lumen Cycle | Total Load Weight in V-PromaX/maX 2 Flex Cycle | Total Load Weight in V-PromaX/maX 2 Non-Lumen Cycle |
|---|---|---|---|
| SC02MG | 19.65 lbs | 24 lbs | 50 lbs |
| SC03MG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04MG | 19.65 lbs | 24 lbs | 50 lbs |
| SC02NG | 19.65 lbs | 24 lbs | 50 lbs |
| SC03NG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04NLG | 19.65 lbs | 24 lbs | 50 lbs |
| SC05NLG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04HG | 19.65 lbs | 24 lbs | 50 lbs |
| SC05HG | 19.65 lbs | 24 lbs | 50 lbs |
| SC06HG | 19.65 lbs | 24 lbs | 50 lbs |
| SC08HG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04QG | 19.65 lbs | 24 lbs | 50 lbs |
| SC05QG | 19.65 lbs | 24 lbs | 50 lbs |
| SC06QG | 19.65 lbs | 24 lbs | 50 lbs |
| SC08QG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04FG | 19.65 lbs | 24 lbs | 50 lbs |
| SC05FG | 19.65 lbs | 24 lbs | 50 lbs |
| SC06FG | 19.65 lbs | 24 lbs | 50 lbs |
| SC08FG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04LG | 19.65 lbs | 24 lbs | 50 lbs |
| SC06LG | 19.65 lbs | 24 lbs | 50 lbs |
| SC08LG | 19.65 lbs | 24 lbs | 50 lbs |
| SC05WG | 19.65 lbs | 24 lbs | 50 lbs |
Table 11. SteriTite Container in Steam Sterilization/IUSS Maximum Load Weight Recommendations Including Weight of Container.
| Part Number | Total Load Weight inSteam Sterilization Pre-Vacuum Cycle | Total Load Weight inSteam Sterilization Gravity Cycle |
|---|---|---|
| SC02MG | 35 lbs | 35 lbs |
| SC03MG | 35 lbs | 35 lbs |
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| SC04MG | 35 lbs | 35 lbs |
|---|---|---|
| SC02NG | 35 lbs | 35 lbs |
| SC03NG | 35 lbs | 35 lbs |
| SC04NLG | 35 lbs | 35 lbs |
| SC05NLG | 35 lbs | 35 lbs |
| SC04HG | 35 lbs | 35 lbs |
| SC05HG | 35 lbs | 35 lbs |
| SC06HG | 35 lbs | 35 lbs |
| SC08HG | 35 lbs | 35 lbs |
| SC04QG | 35 lbs | 35 lbs |
| SC05QG | 35 lbs | 35 lbs |
| SC06QG | 35 lbs | 35 lbs |
| SC08QG | 35 lbs | 35 lbs |
| SC04FG | 35 lbs | 35 lbs |
| SC05FG | 35 lbs | 35 lbs |
| SC06FG | 35 lbs | 35 lbs |
| SC08FG | 35 lbs | 35 lbs |
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
∑ Over-The-Counter Use (21 CFR 801 Subpart C)
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1. 510K Summary
SteriTite Container System with MediTray Parts
| Date Prepared : | 10/4/2022 |
|---|---|
| Company Name : | Case Medical, Inc50 West StreetBloomfield NJ 07003 |
| Contact:EmailOfficeFax | Michael PolozaniMPolozani@casemed.com201-313-1999 x 633201-373-9090 |
| Trade Name | SteriTite Container System with MediTray Parts |
| Common Name | Sterilization Wrap Containers, Trays, Cassettes, and Other Accessories |
| Class of Device | Class II |
| Regulation Number | 21 CFR 880.6850 - Sterilization Wrap |
| Product Code | кст, |
| Review Panel | General Hospital |
| EstablishmentRegistration Number | 2248608 |
| Predicate Device | K212711 -SteriTite Rigid Container Sterilization System with and MediTrayParts |
| Description of Device | The SteriTite® Universal Container is a rigid, reusable, sealed sterilizationpackaging system that is compatible with steam, hydrogen peroxide, ethyleneoxide, and ozone sterilizers. The SteriTite® container system consists of a familyof rigid reusable containers and inserts that provide an effective reusablesterilization packaging system for operating room instruments. The SteriTite®container as previously cleared is available with solid or perforated base. Thecontainer is made of anodized aluminum with passivated stainless-steelhardware and silicone gaskets. Each filter retention plate with gaskets and offset vent pattern secures a disposable filter for bacterial barrier filtration. Filterretention plates in lid and base are interchangeable for universal use. Arecessed gasket contributes to a knife edge fit between lid and base. Variousinstrument trays as well as stacked baskets and inserts including insert boxes,brackets, posts, partitions, and racks provide instrument protection and securedevices for sterilization within the container. |
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2. Indications for Use Summary
The SteriTite container and MediTray products are a reusable sterilization container system to be used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. It is intended to allow sterilization of the enclosed devices and maintain sterility of the enclosed device until it is used. This container system is compatible for use with the following low temperature sterilizer and cycle identified below:
- -STERRAD 100NX ALLCLEAR-Express Cycle
The following table (Table 1) displays the SteriTite part numbers and the sterilizers they are compatible with:
| V-Pro s2/60LumenFlex | V-Pro 1Lumen | V-Promax/maX2LumenFlexNon-Lumen | SterizoneVP4Cycle 1 | 100NXStandardFlex | 100NXDUOExpress** | 100S/200Standard | NXAdvancedStandard | SteamPre-vacGravityIUSS |
|---|---|---|---|---|---|---|---|---|
| SC02MG | SC02MG | SC02MG | SC02M(G)* | SC02MG | SC02MG | SC02MG | SC02MG | SC02MG |
| SC03MG | SC03MG | SC03MG | SC03M(G)* | SC03MG | SC03MG | SC03MG | SC03MG | SC03MG |
| SC04MG | SC02NG | SC04MG | SC04M(G)* | SC04MG | SC04MG | SC04MG | SC04MG | SC04MG |
| SC02NG | SC03NG | SC02NG | SC02N(G)* | SC02NG | SC02NG | SC02NG | SC02NG | SC02NG |
| SC03NG | SC04NLG | SC03NG | SC03N(G)* | SC03NG | SC03NG | SC03NG | SC03NG | SC03NG |
| SC04NLG | SC05NLG | SC04NLG | SC04NL(G)* | SC04NLG | SC04NLG | SC04NLG | SC04NLG | SC04NLG |
| SC05NLG | SC04FG | SC05NLG | SC05NL(G)* | SC05NLG | SC05NLG | SC05NLG | SC05NLG | SC05NLG |
| SC04HG | SC05FG | SC04HG | SC04H(G)* | SC04HG | SC04HG | SC04HG | SC04HG | SC04HG |
| SC05HG | SC06FG | SC05HG | SC05H(G)* | SC05HG | SC05HG | SC05HG | SC05HG | SC05HG |
| SC04QG | SC08FG | SC06HG | SC06H(G)* | SC06HG | SC06HG | SC06HG | SC04QG | SC06HG |
| SC05QG | SC04HG | SC08HG | SC08H(G)* | SC08HG | SC08HG | SC08HG | SC05QG | SC08HG |
| SC04FG | SC05HG | SC04QG | SC04Q(G)* | SC04QG | SC04QG | SC04QG | SC04FG | SC04QG |
| SC06HG | SC05QG | SC05Q(G)* | SC05QG | SC05QG | SC05QG | SC05QG | ||
| SC08HG | SC06QG | SC06Q(G)* | SC06QG | SC06QG | SC06QG | SC06QG | ||
| SC04QG | SC08QG | SC08Q(G)* | SC08QG | SC04FG | SC08QG | SC08QG | ||
| SC05QG | SC04FG | SC04F(G)* | SC04FG | SC05FG | SC04FG | SC04FG | ||
| SC06QG | SC05FG | SC04L(G)* | SC05FG | SC06FG | SC05FG | SC05FG | ||
| SC08QG | SC06FG | SC06L(G)* | SC06FG | SC08FG | SC06FG | SC06FG | ||
| SC04LG | SC08FG | SC08L(G)* | SC08FG | SC04LG | SC08FG | SC08FG | ||
| SC06LG | SC04LG | SC04LG | SC06LG | SC04LG | SC04LG | |||
| SC05WG | SC06LG | SC06LG | SC05WG | SC06LG | SC06LG | |||
| SC05WG | SC05WG | SC05WG | SC08LG | |||||
| SC05WG |
Table 1. SteriTite Container Compatibility Table with Low Temperature and Steam Sterilizers
*Please note that the SteriTite perforated bottom containers are compatible with the Sterizone VP4 Sterilizer. **The Express cycle would be added to the Compatibility Table in the Case Medical IFU
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K221492
The following table identifies which MediTray products are compatible with ow temperature sterilizers and steam sterilization:
| MediTray Product | V-PromaX/2 | V-Pro 1 | V-Pros2/60 | STERRAD100NX | STERRAD100S/200 | STERRADNX | STERIZONEVP4 | Steam |
|---|---|---|---|---|---|---|---|---|
| Baskets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Trays | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Insert Boxes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Metal Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Metal Partitions | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Posts | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Silicone Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Racks | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Stringers | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Table 3. MediTray Products Sterilizer Compatibility Table
The following table identifies which SteriTite accessories are compatible with low temperature sterilizers and steam sterilization:
Table 4. SteriTite Accessories Sterilizer Compatibility Table
| SteriTite Accessories | V-PromaX/2 | V-Pro 1 | V-Pros2/60 | STERRAD100NX | STERRAD100S/200 | STERRADNX | STERIZONEVP4 | Steam |
|---|---|---|---|---|---|---|---|---|
| SCF02 Round filter | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| SCFM02 Rectangular filter | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| SCS01W Tamper Evident Seals | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| SCLH2O23 Load Card Large | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| SCLH2O24 Load Card Small | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
The following tables (5-11) identify the sterilizer maximum load weight recommendations with the SteriTite containers:
Table 5. SteriTite Container in V-Pro 60 Manufacturer's Maximum Load Weight Recommendations Including Weight of Container
| PartNumber | Total Load Weight in V-Pros2/60 Lumen Cycle | Total Load Weight in V-Pros2/60 Flexible Cycle |
|---|---|---|
| SC02MG | 25lbs | 11lbs |
| SC03MG | 25lbs | 11lbs |
| SC04MG | 25lbs | 11lbs |
| SC02NG | 25lbs | 11lbs |
| SC03NG | 25lbs | 11lbs |
| SC04NLG | 25lbs | 11lbs |
| SC05NLG | 25lbs | 11lbs |
| SC04HG | 25lbs | 11lbs |
| SC05HG | 25lbs | 11lbs |
| SC04QG | 25lbs | 11lbs |
| SC05QG | 25lbs | 11lbs |
| SC04FG | 25lbs | 11lbs |
{13}------------------------------------------------
| PartNumber | Total Load Weightin NXStandard Cycle | Total Load Weightin NXAdvanced Cycle |
|---|---|---|
| SC02MG | 10.7lbs | 10.7lbs |
| SC03MG | 10.7lbs | 10.7lbs |
| SC04MG | 10.7lbs | 10.7lbs |
| SC02NG | 10.7lbs | 10.7lbs |
| SC03NG | 10.7lbs | 10.7lbs |
| SC04HG | 10.7lbs | 10.7lbs |
| SC05HG | 10.7lbs | 10.7lbs |
| SC04QG | 10.7lbs | 10.7lbs |
| SC05QG | 10.7lbs | 10.7lbs |
| SC04FG | 10.7lbs | 10.7lbs |
Table 6. SteriTite Container in STERRAD NX Manufacturer's Maximum Load Weight Recommendations Including Weight of Container
Table 7. SteriTite Container in V-Pro 1 Maximum Load Weight Recommendations Including Weight of Container
| PartNumber | Total Load Weight in V-Pro 1Lumen Cycle |
|---|---|
| SC02MG | 19.65lbs |
| SC03MG | 19.65lbs |
| SC02NG | 19.65lbs |
| SC03NG | 19.65lbs |
| SC04FG | 19.65lbs |
| SC05FG | 19.65lbs |
| SC06FG | 19.65lbs |
| SC08FG | 19.65lbs |
| SC04HG | 19.65lbs |
| SC05HG | 19.65lbs |
| SC06HG | 19.65lbs |
| SC08HG | 19.65lbs |
| SC04QG | 19.65lbs |
| SC05QG | 19.65lbs |
| SC06QG | 19.65lbs |
| SC08QG | 19.65lbs |
| SC04LG | 19.65lbs |
| SC06LG | 19.65lbs |
| SC08LG | 19.65lbs |
| SC05WG | 19.65lbs |
Table 8. SteriTite Container in STERRAD 100s/200 Maximum Load Weight Recommendations Including Weight of Container
| Part Number | Total Load Weight inthe STERRAD 100s/200Standard Cycle |
|---|---|
| SC02MG | 22lbs |
| SC03MG | 22lbs |
| SC04MG | 22lbs |
| SC02NG | 22lbs |
| SC03NG | 22lbs |
| SC04NLG | 22lbs |
| SC05NLG | 22lbs |
| SC04HG | 22lbs |
| SC05HG | 22lbs |
| SC06HG | 22lbs |
| SC08HG | 22lbs |
| SC04QG | 22lbs |
| SC05QG | 22lbs |
| SC06QG | 22lbs |
| SC08QG | 22lbs |
| SC04FG | 22lbs |
| SC05FG | 22lbs |
| SC06FG | 22lbs |
| SC08FG | 22lbs |
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Table 9. SteriTite Container in 100NX Maximum Load Weight Recommendations Including Weight of Container
| Part | Total Weight in 100NXStandard Cycle | Total Weight in 100NXFlexible Cycle | Total Weight in 100NXDUO Cycle | Total Weight in 100NXExpress Cycle |
|---|---|---|---|---|
| Number | ||||
| SC02MG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC03MG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC04MG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC02NG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC03NG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC04NLG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC05NLG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC04HG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC05HG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC06HG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC08HG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC04QG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC05QG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC06QG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC08QG | 21.4lbs | 21.4lbs | Not Compatible | Not Compatible |
| SC04FG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC05FG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC06FG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC08FG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC04LG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC06LG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC05WG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
Table 10. SteriTite Container in V-Pro maX/maX 2 Maximum Load Weight Recommendations Including Weight of Container
| PartNumber | Total Load Weight inV-Pro maX/maX2Lumen Cycle | Total Load Weight inV-Pro maX/maX2 FlexCycle | Total Load Weight in V-Pro maX/maX2 Non-Lumen Cycle |
|---|---|---|---|
| SC02MG | 19.65lbs | 24lbs | 50lbs |
| SC03MG | 19.65lbs | 24lbs | 50lbs |
| SC04MG | 19.65lbs | 24lbs | 50lbs |
| SC02NG | 19.65lbs | 24lbs | 50lbs |
| SC03NG | 19.65lbs | 24lbs | 50lbs |
| SC04NLG | 19.65lbs | 24lbs | 50lbs |
| SC05NLG | 19.65lbs | 24lbs | 50lbs |
| SC04HG | 19.65lbs | 24lbs | 50lbs |
| SC05HG | 19.65lbs | 24lbs | 50lbs |
| SC06HG | 19.65lbs | 24lbs | 50lbs |
| SC08HG | 19.65lbs | 24lbs | 50lbs |
| SC04QG | 19.65lbs | 24lbs | 50lbs |
| SC05QG | 19.65lbs | 24lbs | 50lbs |
| SC06QG | 19.65lbs | 24lbs | 50lbs |
| SC08QG | 19.65lbs | 24lbs | 50lbs |
| SC04FG | 19.65lbs | 24lbs | 50lbs |
| SC05FG | 19.65lbs | 24lbs | 50lbs |
| SC06FG | 19.65lbs | 24lbs | 50lbs |
| SC08FG | 19.65lbs | 24lbs | 50lbs |
| SC04LG | 19.65lbs | 24lbs | 50lbs |
| SC06LG | 19.65lbs | 24lbs | 50lbs |
| SC08LG | 19.65lbs | 24lbs | 50lbs |
| SC05WG | 19.65lbs | 24lbs | 50lbs |
{15}------------------------------------------------
| PartNumber | Total Load Weight inSteam SterilizationPre-Vacuum Cycle | Total Load Weight inSteam SterilizationGravity Cycle |
|---|---|---|
| SC02MG | 35lbs | 35lbs |
| SC03MG | 35lbs | 35lbs |
| SC04MG | 35lbs | 35lbs |
| SC02NG | 35lbs | 35lbs |
| SC03NG | 35lbs | 35lbs |
| SC04NLG | 35lbs | 35lbs |
| SC05NLG | 35lbs | 35lbs |
| SC04HG | 35lbs | 35lbs |
| SC05HG | 35lbs | 35lbs |
| SC06HG | 35lbs | 35lbs |
| SC08HG | 35lbs | 35lbs |
| SC04QG | 35lbs | 35lbs |
| SC05QG | 35lbs | 35lbs |
| SC06QG | 35lbs | 35lbs |
| SC08QG | 35lbs | 35lbs |
| SC04FG | 35lbs | 35lbs |
| SC05FG | 35lbs | 35lbs |
| SC06FG | 35lbs | 35lbs |
| SC08FG | 35lbs | 35lbs |
| SC04LG | 35lbs | 35lbs |
| SC06LG | 35lbs | 35lbs |
| SC08LG | 35lbs | 35lbs |
| SC05WG | 35lbs | 35lbs |
Table 11. SteriTite Container in Steam Sterilization/IUSS Maximum Load Weight Recommendations Including Weight of Container
Technological Comparison
All functional and design characteristics are the same as the previously cleared in K212711 and show equivalent performance characteristics. The SteriTite container system is the same container system previously cleared and demonstrated the same technical and performance characteristics previously. Sterilization efficacy testing has been conducted to support new indications.
Non-Clinical Performance Testing
Case Medical, Inc. follows the "overkill method" of sterility assurance to show an elimination of a biological challenge. All SteriTite containers were tested with inner baskets or trays representative of the of products. Testing was designed to simulate worst-case scenarios with half cycles utilized with end of shelf-life concentrations of hydrogen peroxide for low temperature sterilization. The bacterial strain G. stearothermophilus was used in all testing due to its resistance to moist heat and hydrogen peroxide. The validation testing was conducted at qualified independent laboratories in accordance with FDA guidance and available ANSI/AAMI standards such as ANSI/AAMI ST77, AAMI TIR 12 and ANSI/AMMI ST-79.
{16}------------------------------------------------
Based on the testing performed on the SteriTite container and MediTray parts, the device has demonstrated compatibility with the sterilizers indicated above. Results are summarized in Table 12 below.
Table 12. Summary of Performance Testing
| Performance Testing | Standard | Purpose | Results |
|---|---|---|---|
| Sterility Maintenance | ANSI/AAMI ST77:2013(R)2018 | Demonstrate the integrity of thecontainer to maintain sterility of contentsover time and with multiple handlingevents after sterilization. | Pass |
| Whole PackageMicrobial Challenge | ANSI/AAMI ST77:2013(R)2018 | Demonstration of whole package integrityfollowing exposure to aerosolizedbacteria spores. | Pass |
| Biocompatibility | ANSI AAMI ISO10993-1 | Acute systemic toxicity, primary irritationand sensitization of the subject device. | Pass |
| MaterialCompatibility / Re-Use Testing | ANSI/AAMI ST77:2013(R)2018 | Demonstration that the subject devicematerials are compatible with theintended sterilization cycles. | Pass |
| Simulated UseTesting/SterilizationEfficacy | ANSI AAMI ISO14937:2009/(R)2013 | Testing was completed to demonstratesterilization efficacy of the subject devicefor processing of medical devices withthe indicated claims using the identifiedsterilization processes. | Pass |
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission for the SteriTite Universal Container System and MediTray Products, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K212711.
§ 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).