The SteriTite universal container system with MediTray products is a reusable sterilization container system intended to be used to enclose other medical devices and instrumentation to be sterilized, transported and stored by health care providers. The container consists of a perforated base and lid with filter retention plates, and disposable polypropylene filters. The SteriTite universal container system is compatible for use with STERRAD 100NX Sterilization (Standard and Flex cycles). The SteriTite container has been validated with stainless steel and porous lumens, inoculated product, insert boxes, multilevel tray systems and various inserts including brackets, posts and partitions. The container may be used for sterilization of medical devices including full instrument sets and mixed loads.

SteriTite universal container system is recommended to be used for sterilization of surfaces and lumens:

In STERRAD 100NX Standard cycle, process stainless steel lumens instruments of 0.7 mm diameter or larger and up to 500 mm in length.
In STERRAD 100NX Flexible cycle, process flexible endoscopes, PE/PTFE Lumen instruments of ≥1.2 mm x ≤835 mm.

120 days of real time Shelf life testing with handling events has been conducted for SteriTite containers after STERRAD 100NX Sterilization.

Reuse testing was performed after 501 STERRAD 100NX Standard cycles.

Device Description

The SteriTite universal container system consists of a family of rigid reusable containers and Inserts that provide an effective sterilization packaging method for operating room instruments. The SteriTite® container for STERRAD 100NX has perforated base. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Each filter retention plate secures a disposable filter for bacterial barrier filtration. 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.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "SteriTite Universal Container System with MediTray Products for STERRAD 100NX". This is a medical device for sterilization packaging, not an AI/ML powered device, therefore, many of the typical acceptance criteria and study components like sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable in the context of AI/ML.

However, based on the information provided for this non-AI/ML medical device, here's a breakdown of the available details:

Acceptance Criteria and Device Performance for SteriTite Universal Container System

The acceptance criteria for this device are implicitly tied to its compatibility and effectiveness in sterilization with the STERRAD 100NX system. The study conducted validated this compatibility and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly list quantified "acceptance criteria" for each performance metric in a pass/fail sense, as would be typical for an AI/ML model. Instead, it describes validated compatibility and performance. The "reported device performance" indicates that these conditions were successfully met.

Acceptance Criterion (Implicit)	Reported Device Performance
Compatibility with STERRAD 100NX Sterilizer (Standard Cycle)	Validated for use with STERRAD 100NX Standard cycle for various container sizes (Full-size, Mid-size, Half-size, Mini-long, Mini-size) and associated MediTray products and accessories. Tested with 10 stainless steel lumens.
Compatibility with STERRAD 100NX Sterilizer (Flex Cycle)	Validated for use with STERRAD 100NX Flex cycle for various container sizes (Full-size, Mid-size, Half-size, Mini-long, Mini-size) and associated MediTray products and accessories. Tested with 1 flexible lumened device plus inserts per container.
Sterilization of Stainless Steel Lumens (Standard Cycle)	Effective for processing stainless steel lumens instruments of 0.7 mm diameter or larger and up to 500 mm in length.
Sterilization of Flexible Lumens (Flex Cycle)	Effective for processing flexible endoscopes, PE/PTFE Lumen instruments of ≥1.2 mm x ≤835 mm.
Shelf-life after Sterilization	Achieved 120 days of real-time shelf life, including handling events, after STERRAD 100NX sterilization.
Reuse Capability	Demonstrated effective performance after 501 STERRAD 100NX Standard cycles.
Compatibility with Specific MediTray Products	Validated for use with Baskets, Trays, Insert Boxes, Metal Brackets, Metal Partitions, Posts, Silicone Brackets, Racks, and Stringers.
Compatibility with Specific SteriTite Accessories	Validated for use with SCF02 Round filter, SCFM02 Rectangular filter, SCS01W Tamper Evident Seals, SCLH2023 Load Card Large, and SCLH2024 Load Card Small.

Study Details (as applicable for a non-AI/ML device):

This section addresses the provided categories, noting when they are not relevant to this type of device.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document specifies "10 stainless steel lumens" for Standard cycle validation and "1 flexible lumened device plus inserts per container" for Flex cycle validation (implicitly meaning multiple containers were tested). It also mentions "501 STERRAD 100NX Standard cycles" for reuse testing. The specific number of containers or load configurations tested for overall compatibility isn't explicitly stated but implied to be comprehensive for the listed products.
- Data Provenance: The validation testing was "conducted at qualified independent laboratories." The country of origin is not explicitly stated but the submission is to the FDA (USA). The study is prospective in nature, as it involves testing the device under controlled conditions.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of an AI/ML device. For this sterilization container, "ground truth" is established through standardized microbiological and physical testing methods (e.g., spore-kill assays, leak tests, sterility assurance level verification). The document states the testing was done "in accordance with FDA guidance and available AAMI standards," implying adherence to established scientific protocols rather than expert consensus on interpretive tasks.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable in the context of an AI/ML device. Adjudication methods are relevant for subjective interpretations, often in medical imaging. The validation here relies on objective measurements and established sterilization efficacy protocols.
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 device is not an AI/ML system, and therefore, no MRMC study involving human readers and AI assistance was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its design and material properties in conjunction with the sterilizer.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" refers to the sterility assurance level (SAL), absence of microbial growth, and integrity/functionality of the container and its contents after sterilization and handling. This is established through validated, objective testing methods (e.g., biological indicators, chemical indicators, leak tests, material compatibility tests, shelf-life studies, reuse cycle testing) according to recognized standards (like AAMI).
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth for it.

Summary

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JUL - 1 2011

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5. 510(K) Summary of Safety and Effectiveness

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SteriTite Universal Container System with MediTray Products for STERRAD 100NX

510(k) Number (if known): K110682

Date Prepared:	2/24/2011
Company Name:	Case Medical, Inc.19 Empire BlvdSouth Hackensack, NJ 07606
Contact:	Tania LupuPhone: 201-313-1999 ext.229Fax: 201-373-9090Email: tlupu@casemed.com
Trade Name:	SteriTite® Universal Container System & MediTray Products
Common Name:	Sterilization container with disposable filter.
Regulation number:	880.6850
Classification name:	Sterilization Wrap
Class of Device:	Class II device
Product Code:	80FRG
Review Panel:	General Hospital
Establishment Registration Number:	2248608

5.1 Substantial Equivalence:

Case Medical believes that the SteriTite universal container system is substantially equivalent to:

. SteriTite® universal container system -anodized- previously cleared for STERRAD NX, 510(K) #K080558.
. Aesculap® SterilContainer S non-anodized previously cleared for STERRAD 100NX, 510(k) K093493.

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5.2 Description of the Device:

5.3 Indications for Use:

SteriTite universal container system is recommended to be used for sterilization of surfaces and lumens:

In STERRAD 100NX Standard cycle, process stainless steel lumens instruments of 0.7 ﮯ mm diameter or larger and up to 500 mm in length.
In STERRAD 100NX Flexible cycle, process flexible endoscopes, PE/PTFE Lumen ー instruments of ≥1.2 mm x ≤835 mm.

120 days of real time Shelf life testing with handling events has been conducted for SteriTite containers after STERRAD 100NX Sterilization.

Reuse testing was performed after 501 STERRAD 100NX Standard cycles.

The following tables identify which products with disposable filter may be sterilized in each (Standard and Flex) STERRAD 100NX sterilization cycle.

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Part Number	Description	Total Loaded containerweight (Lbs)
SC04FG	4" high Full-size w/ perforated base	22
SC06FG	6" high Full-size w/ perforated base	22
SC08FG	8" high Full-size w/ perforated base	22
SC04QG	4" high Mid-size w/ perforated base	19
SC06QG	6" high Mid-size w/ perforated base	19
SC08QG	8" high Mid-size w/ perforated base	19
SC04HG	4" high Half-size w/ perforated base	14
SC06HG	6" high Half-size w/ perforated base	14
SC08HG	8" high Half-size w/ perforated base	14
SC02NG	2" high mini long - w/ perforated base	10
SC03NG	3" high mini long size w/ perforated base	10
SC02MG	2" high mini-size w/ perforated base	6
SC03MG	3" high mini-size w/ perforated base	6
SC04MG	4" high mini-size w/ perforated base	6

Table 1. SteriTite Universal Container System in STERRAD 100NX Standard Cycle

Note: SteriTite Containers have been validated with 10 stainless steel lumens.

Table 2. SteriTite Universal Container System in STERRAD 100NX Flex Cycle

Part Number	Description	Total Loaded containerweight (Lbs)
SC04FG	4" high Full-size w/ perforated base	16
SC06FG	6" high Full-size w/ perforated base	16
SC08FG	8" high Full-size w/ perforated base	16
SC04QG	4" high Mid-size w/ perforated base	16
SC06QG	6" high Mid-size w/ perforated base	16
SC08QG	8" high Mid-size w/ perforated base	16
SC04HG	4" high Half-size w/ perforated base	16
SC06HG	6" high Half-size w/ perforated base	16
SC08HG	8" high Half-size w/ perforated base	16
SC02NG	2" high mini long - w/ perforated base	10
SC03NG	3" high mini long size w/ perforated base	10
SC02MG	2" high mini-size w/ perforated base	6
SC03MG	3" high mini-size w/ perforated base	6
SC04MG	4" high mini-size w/ perforated base	6

Note: SteriTite containers have been validated with 1 flexible lumened device plus inserts per container.

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MediTray Products	STERRAD 100NX
Baskets	X
Trays	X
Insert Boxes	X
Metal Brackets	X
Metal Partitions	X
Posts	X
Silicone Brackets	X
Racks	X
Stringers	X

Table 3. Meditray Products Compatibility

Table 4. SteriTite Accessories Compatibility

SteriTite Accessories	STERRAD 100NX
SCF02 Round filter	X
SCFM02 Rectangular filter	X
SCS01W Tamper Evident Seals	X
SCLH2023 Load Card Large	X
SCLH2024 Load Card Small	X

Technological Characteristics (compared to the predicate(s)): 5.4

The SteriTite container system for STERRAD 100NX Sterilization is the same SteriTite container previously cleared for steam, STERRAD 100, 100S, 200, NX, as well as EtO, Ozone and Hydrogen Peroxide (V-pro1 ) Sterilization. Case Medical's SteriTite universal container and MediTray products are compatible with STERRAD 100NX (Standard and Flex cycles). All containers are of equivalent sizes, have gasketed lids with latching mechanism and offer tamper evident features and external indicator as predicate devices. The SteriTite sealed container in this submission is the same container previously cleared.

5.5 Performance Data:

All required testing per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" was completed. The SteriTite universal container system with MediTray products were fully validated for STERRAD 100NX Sterilization (Standard and Flex cycles). The validation testing was conducted at qualified independent laboratories in accordance with FDA guidance and available AAMI standards.

5.5 Conclusion:

All data presented demonstrate Substantial Equivalence to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL - 1 2011

Ms. Tania Lupu QA/QC Director Case Medical, Incorporated 19 Empire Boulevard South Hackensack, New Jersey 07606

Re: K110682

Trade/Device Name: SteriTite Universal Container System and MediTray Products Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: May 10, 2011 Received: June 3, 2011

Dear Ms. Lupu:

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, 1n addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Ms. Lupu

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony O.mat

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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4. Indication for Use Statement

510(k) Number (if known): K110682

Device Name: SteriTite Universal Container System and MediTray Products

Indications for use:

SteriTite universal container system is recommended to be used for sterilization of surfaces and lumens:

ー In STERRAD 100NX Standard cycle, process stainless steel lumens instruments of 0.7 mm diameter or larger and up to 500 mm in length.
-In STERRAD 100NX .Elexible cycle, process flexible endoscopes, PE/PTFE Lumen instruments of ≥1.2 mm x ≤835 mm.

120 days of real time Shelf life testing with handling events has been conducted for SteriTite containers after STERRAD 100NX Sterilization.

Reuse testing was performed after 501 STERRAD 100NX Standard cycles.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

nce of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Claire S. Marshall & Elizabeth Claiborne Williams

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110682

Page 1 of 3

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The following tables identify which products with disposable filter may be sterilized in each (Standard and Flex) STERRAD 100NX sterilization cycle.

Part Number	Description	Total Loaded containerweight (Lbs)
SC04FG	4" high Full-size w/ perforated base	22
SC06FG	6" high Full-size w/ perforated base	22
SC08FG	8" high Full-size w/ perforated base	22
SC04QG	4" high Mid-size w/ perforated base	19
SC06QG	6" high Mid-size w/ perforated base	19
SC08QG	8" high Mid-size w/ perforated base	19
SC04HG	4" high Half-size w/ perforated base	14
SC06HG	6" high Half-size w/ perforated base	14
SC08HG	8" high Half-size w/ perforated base	14
SC02NG	2" high mini long - w/ perforated base	10
SC03NG	3" high mini long size w/ perforated base	10
SC02MG	2" high mini-size w/ perforated base	6
SC03MG	3" high mini-size w/ perforated base	6
SC04MG	4" high mini-size w/ perforated base	6

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------Table 1. SteriTite Universal Container System in STERRAD 100NX Standard Cycle

Note: SteriTite Containers have been validated with 10 stainless steel lumens.

Table 2. SteriTite Universal Container System in STERRAD 100NX Flex Cycle

Part Number	Description	Total Loaded containerweight (Lbs)
SC04FG	4" high Full-size w/ perforated base	16
SC06FG	6" high Full-size w/ perforated base	16
SC08FG	8" high Full-size w/ perforated base	16
SC04QG	4" high Mid-size w/ perforated base	16
SC06QG	6" high Mid-size w/ perforated base	16
SC08QG	8" high Mid-size w/ perforated base	16
SC04HG	4" high Half-size w/ perforated base	16
SC06HG	6" high Half-size w/ perforated base	16
SC08HG	8" high Half-size w/ perforated base	16
SC02NG	2" high mini long - w/ perforated base	10
SC03NG	3" high mini long size w/ perforated base	10
SC02MG	2" high mini-size w/ perforated base	6
SC03MG	3" high mini-size w/ perforated base	6
SC04MG	4" high mini-size w/ perforated base	6

Note: SteriTite containers have been validated with 1 flexible lumened device plus inserts per container.

Page 2 of 3

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Table 3. MediTray Products Compatibility

MediTray Products	STERRAD 100NX
Baskets	X
Trays	X
Insert Boxes	X
Metal Brackets	X
Metal Partitions	X
Posts	X
Silicone Brackets	X
Racks	X
Stringers	X

Table 4. SteriTite Accessories Compatibility

SteriTite Accessories	STERRAD 100NX
SCF02 Round filter	X
SCFM02 Rectangular filter	X
SCS01W Tamper Evident Seals	X
SCLH2O23 Load Card Large	X
SCLH2O24 Load Card Small	X

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).