SteriTite Container System with MediTray Products

K252854 · Case Medical, Inc. · KCT · Jun 3, 2026 · General Hospital

Device Facts

• Record ID: K252854
• Device Name: SteriTite Container System with MediTray Products
• Applicant: Case Medical, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Jun 3, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Indications for Use

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 devices until it is used.

Device Story

Reusable rigid container system; anodized aluminum base, stainless-steel hardware, silicone gaskets; includes disposable filters, tamper-evident seals, perforated vents. Used in clinical settings for instrument sterilization/storage. Input: medical devices placed inside container. Operation: container acts as barrier during sterilization (steam or low-temp) and transport. Output: sterile enclosed instruments. Benefits: maintains sterility of instruments until point of use; protects instruments during handling. Healthcare providers load instruments into containers, process in compatible sterilizers, and store until needed.

Clinical Evidence

No clinical data. Bench testing only. Sterilization efficacy validated using 'overkill method' with G. stearothermophilus biological indicators. Testing performed per ANSI/AAMI ST77, AAMI TIR 12, ANSI/AAMI ST79, and ISO 14937. Maintenance of sterility, whole package microbial challenge, and biocompatibility (ISO 10993-1) testing all passed.

Technological Characteristics

Materials: Anodized aluminum, passivated stainless-steel hardware, silicone gaskets. Design: Rigid container with knife-edge lid/base fit, offset vent pattern, disposable filter, latching mechanism. Sterilization: Steam (SFPP, gravity) and low-temperature (STERRAD 100NX). Standards: ANSI/AAMI ST77, ANSI/AAMI ST79, ISO 14937, ISO 10993-1. Connectivity: None (mechanical device).

Indications for Use

Indicated for use by healthcare providers to enclose, sterilize, transport, and store medical devices. Compatible with specific steam sterilization cycles (SFPP) and low-temperature sterilization (STERRAD 100NX Express and DUO cycles for surface sterilization).

Regulatory Classification

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.

Predicate Devices

• SteriTite Rigid Container Sterilization System with and MediTray products (K240898)

Submission Summary (Full Text)

{0}


June 3, 2026

Case Medical, Inc.
Marcia Frieze
CEO
50 West Street
Bloomfield, New Jersey 07003

Re: K252854

Trade/Device Name: SteriTite Container System with MediTray Products
Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization Wrap
Regulatory Class: Class II
Product Code: KCT
Dated: May 4, 2026
Received: May 4, 2026

Dear Marcia Frieze:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K252854 - Marcia Frieze

Page 2

(https://www.fda.gov/media/99812/download) and 'Deciding When to Submit a 510(k) for a Software Change to an Existing Device' (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ('UDI Rule'). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, 'Misbranding by reference to premarket notification' (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

{2}

K252854 - Marcia Frieze

Page 3

Sincerely,

**STEPHEN A. ANISKO -S** Digitally signed by
STEPHEN A. ANISKO -S
Date: 2026.06.03
13:05:32 -04'00'

Stephen Anisko
Acting Assistant Director
DHT4C: Division of Infection
Control Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

{3}

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

# Indications for Use

510(k) Number (if known)
K252854

Device Name
SteriTite® Container System 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 devices until it is used.

The perforated bottom container configuration is compatible for use with the following steam sterilization cycles:

Steam Cycle with Steam Flush Pressure Pulses (SFPP):

-At 132°C for 4 minutes with a 30-minute dry time
-At 135°C for 3 minutes with a 30-minute dry time

Note: The validation studies were performed using a 4 SFPP cycle with a validation load consisting of unwrapped metal items with a total weight of 25 lbs. (including the SteriTite container).

In addition, the SteriTite container, also available with a solid bottom, is compatible with low-temperature sterilizers, and is compatible with the following sterilizers and cycles identified below:

- SteriTite solid bottom Container: STERRAD 100NX - Express Cycle (surface sterilization of medical devices only; no lumens).

Note: The validation studies were performed using a validation load consisting of a da Vinci X/Xi 8mm Endoscope with a total weight of 22.4 lbs. (including the SteriTite container).

- SteriTite solid bottom Container: STERRAD 100NX - DUO Cycle (surface sterilization of medical devices only; no lumens).

Note: The validation studies were performed using a validation load consisting of non-lumened devices with a total weight of 13.2 lbs. (including the SteriTite container).

Refer to the specific Sterilizer user manual for information regarding the processing of appropriate devices and device types. See labeling for tables of compatible devices and maximum load weight recommendations including the weight of the sterilization container.

FORM FDA 3881 (8/23)

Page 1 of 5

PSC Publishing Services [phone] EF

{4}

The following tables (Table 1 and Table 2) display the SteriTite part numbers and the sterilizers they are compatible with:

Table 1. SteriTite Perforated Bottom Container Compatibility with SFPP and Pre vacuum Steam Sterilizers.

| Part Number | Description | SFPP | Gravity Steam |
| --- | --- | --- | --- |
| SC02MG | 2" High Mini-Size w/ Perforated Base | Yes | Yes |
| SC03MG | 3" High Mini-Size w/ Perforated Base | Yes | Yes |
| SC04MG | 4" High Mini-Size w/ Perforated Base | Yes | Yes |
| SC02NG | 2" High Narrow-Size w/ Perforated Base | Yes | Yes |
| SC03NG | 3" High Narrow-Size w/ Perforated Base | Yes | Yes |
| SC03NLG | 3" High Narrow Long-Size w/ Perforated Base | N/A | Yes |
| SC04NLG | 4" High Narrow Long-Size w/ Perforated Base | N/A | Yes |
| SC05NLG | 5" High Narrow Long -Size w/ Perforated Base | N/A | Yes |
| SC04HG | 4" High Half-Size w/ Perforated Base | Yes | Yes |
| SC05HG | 5" High Half-size w/ Perforated Base | Yes | Yes |
| SC06HG | 6" High Half-Size w/ Perforated Base | Yes | Yes |
| SC08HG | 8" High Half-Size w/ Perforated Base | N/A | Yes |
| SC04QG | 4" High 3/4 Size w/ Perforated Base | Yes | Yes |
| SC05QG | 5" High 3/4 Size w/ Perforated Base | Yes | Yes |
| SC06QG | 6" High 3/4 Size w/ Perforated Base | Yes | Yes |
| SC08QG | 8" High 3/4 Size w/ Perforated Base | N/A | Yes |
| SC04FG | 4" High Full-size w/ Perforated Base | Yes | Yes |
| SC05FG | 5" High Full-size w/ Perforated Base | Yes | Yes |
| SC06FG | 6" High Full-size w/ Perforated Base | Yes | Yes |
| SC08FG | 8" High Full-size w/ Perforated Base | N/A | Yes |
| SC04LG | 4" High Long-size w/ Perforated Base | N/A | Yes |
| SC06LG | 6" High Long-size w/ Perforated Base | N/A | Yes |
| SC08LG | 8" High Long-size w/ Perforated Base | N/A | Yes |
| SC05WG | 5" High Wide Size w/ Perforated Base | N/A | Yes |

Note: Perforated bottom containers with part numbers with suffix (G) may be used in any sterilization modality. SteriTite containers with solid bottom may be used in pre-vacuum steam sterilization as well as low temperature modalities. N/A notes that the specified container does not fit into the sterilizer chamber because of length or width.

FORM FDA 3881 (8/23)

Page 2 of 5

PSC Publishing Services [phone]

EF

{5}

Table 2. SteriTite Solid Bottom Container Compatibility with STERRAD 100NX and Steris V-Pro sterilizers

| Part Number | Description | STERRAD 100NX | V-Pro s2/60 | V-Pro maX/maX2 |
| --- | --- | --- | --- | --- |
| SC02M | 2" High Mini-Size w/ Solid Base | Yes | Yes | Yes |
| SC03M | 3" High Mini-Size w/ Solid Base | Yes | Yes | Yes |
| SC04M | 4" High Mini-Size w/ Solid Base | Yes | Yes | Yes |
| SC02N | 2" High Narrow-Size w/ Solid Base | Yes | Yes | Yes |
| SC03N | 3" High Narrow-Size w/ Solid Base | Yes | Yes | Yes |
| SC03NL | 3" High Narrow Long-Size w/ Solid Base | Yes | Yes | Yes |
| SC04NL | 4" High Narrow Long-Size w/ Solid Base | Yes | Yes | Yes |
| SC05NL | 5" High Narrow Long -Size w/ Solid Base | Yes | Yes | Yes |
| SC04H | 4" High Half-Size w/ Solid Base | Yes | Yes | Yes |
| SC05H | 5" High Half-size w/ Solid Base | Yes | Yes | Yes |
| SC06H | 6" High Half-Size w/ Solid Base | Yes | Yes | Yes |
| SC08H | 8" High Half-Size w/ Solid Base | Yes | Yes | Yes |
| SC04Q | 4" High 3/4 Size w/ Solid Base | Yes | Yes | Yes |
| SC05Q | 5" High 3/4 Size w/ Solid Base | Yes | Yes | Yes |
| SC06Q | 6" High 3/4 Size w/ Solid Base | Yes | Yes | Yes |
| SC08Q | 8" High 3/4 Size w/ Solid Base | Yes | Yes | Yes |
| SC04F | 4" High Full-size w/ Solid Base | Yes | Yes | Yes |
| SC05F | 5" High Full-size w/ Solid Base | Yes | Yes | Yes |
| SC06F | 6" High Full-size w/ Solid Base | Yes | Yes | Yes |
| SC08F | 8" High Full-size w/ Solid Base | Yes | Yes | Yes |
| SC04L | 4" High Long-size w/ Solid Base | Yes | N/A | Yes |
| SC06L | 6" High Long-size w/ Solid Base | Yes | N/A | Yes |
| SC08L | 8" High Long-size w/ Solid Base | Yes | N/A | Yes |
| SC05W | 5" High Wide Size w/ Solid Base | Yes | N/A | Yes |

Note: Perforated bottom containers with part numbers with suffix (G) may be used in any sterilization modality. SteriTite containers with solid bottom may be used in pre-vacuum steam sterilization as well as low temperature modalities such as EtO, V-Pro, and in STERRAD sterilizers for surface sterilization have no G as a suffix in the part number.
N/A notates that the specified container does not fit into the sterilizer chamber because of length or width.

FORM FDA 3881 (8/23)

Page 3 of 5

PSC Publishing Services [phone] EF

{6}

Table 3. SteriTite Container maximum load weight in Steam Sterilization

| Part Number | Total Load Weight in Pre-Vacuum Cycle | Total Load Weight in Gravity Cycle | Total Load Weight in SFPP |
| --- | --- | --- | --- |
| SC02M(G) | 35lbs | 35lbs | 25lbs |
| SC03M(G) | 35lbs | 35lbs | 25lbs |
| SC04M(G) | 35lbs | 35lbs | 25lbs |
| SC02N(G) | 35lbs | 35lbs | 25lbs |
| SC03N(G) | 35lbs | 35lbs | 25lbs |
| SC03NL(G) | 35lbs | 35lbs | N/A |
| SC04NL(G) | 35lbs | 35lbs | N/A |
| SC05NL(G) | 35lbs | 35lbs | N/A |
| SC04H(G) | 35lbs | 35lbs | 25lbs |
| SC05H(G) | 35lbs | 35lbs | 25lbs |
| SC06H(G) | 35lbs | 35lbs | 25lbs |
| SC08H(G) | 35lbs | 35lbs | N/A |
| SC04Q(G) | 35lbs | 35lbs | 25lbs |
| SC05Q(G) | 35lbs | 35lbs | 25lbs |
| SC06Q(G) | 35lbs | 35lbs | 25lbs |
| SC08Q(G) | 35lbs | 35lbs | N/A |
| SC04F(G) | 35lbs | 35lbs | 25lbs |
| SC05F(G) | 35lbs | 35lbs | 25lbs |
| SC06F(G) | 35lbs | 35lbs | 25lbs |
| SC08F(G) | 35lbs | 35lbs | N/A |
| SC04L(G) | 35lbs | 35lbs | N/A |
| SC06L(G) | 35lbs | 35lbs | N/A |
| SC08L(G) | 35lbs | 35lbs | N/A |
| SC05W(G) | 35lbs | 35lbs | N/A |

N/A notes that the specified container does not fit into the sterilizer chamber because of length or width.

FORM FDA 3881 (8/23)

Page 4 of 5

PSC Publishing Services [phone] EF

{7}

Table 4. SteriTite Container in 100NX Maximum Load Weight

| Part Number | Total Load Weight in 100NX Standard Cycle | Total Load Weight in 100NX Flexible Cycle | Total Load Weight in 100NX DUO Cycle | Total Load Weight in 100NX Express Cycle |
| --- | --- | --- | --- | --- |
| SC02M(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC03M(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC04M(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC02N(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC03N(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC03NL(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC04NL(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC05NL(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC04H(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC05H(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC06H(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC08H(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC04Q(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC05Q(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC06Q(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC08Q(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC04F(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC05F(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC06F(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC08F(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC04L(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC06L(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC08L(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC05W(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |

Note: For Surface sterilization solid-bottom containers can be used. 22.4 lbs per shelf, where applicable. A solid-bottom container can be used in the Express, and DUO cycles for surface sterilization only. For the sterilization of lumened devices, SteriTite perforated bottom container suffix G must be used.

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)

**CONTINUE ON A SEPARATE PAGE IF NEEDED.**

This section applies only to requirements of the Paperwork Reduction Act of 1995.

**\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\***

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[e-mail]

*"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."*

FORM FDA 3881 (8/23)

Page 5 of 5

PSC Publishing Services [phone] EF

{8}

# 510(k) Summary

# K252854

# SteriTite Container System with MediTray Products

Date Prepared: 06/02/26

Company Name: Case Medical, Inc
50 West Street
Bloomfield NJ 07003

Contact: Marcia Frieze
Email: [e-mail]
Office: 201-313-1999 x 225
Fax: [phone]

Trade Name: SteriTite Container System with MediTray Products

Common Name: SteriTite Universal Container System

Class of Device: Class II

Product Code: KCT

Review Panel: General Hospital

Establishment
Registration Number: 2248608

Predicate Device: K240898 -SteriTite Rigid Container Sterilization System with and MediTray products

Description of Device: The SteriTite® Universal 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, disposable single use filter, tamper evident seal, and perforated vents for sterilant penetration and air removal.

1

K252854

{9}

**Indications for Use:** 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 devices until it is used.

The perforated bottom container configuration is compatible for use with the following steam sterilization cycles:

Steam Cycle with Steam Flush Pressure Pulses (SFPP):

-At 132°C for 4 minutes with a 30-minute dry time

-At 135°C for 3 minutes with a 30-minute dry time

Note: The validation studies were performed using a 4 SFPP pulse cycle with a validation load consisting of unwrapped metal items with a total weight of 25 lbs. (including the SteriTite container).

In addition, the SteriTite container, also available with a solid bottom, is compatible with low-temperature sterilizers, and is compatible with the following sterilizers and cycles identified below:

- SteriTite solid bottom Container: STERRAD 100NX - Express Cycle (surface sterilization of medical devices only; no lumens).

Note: The validation studies were performed using a validation load consisting of a da Vinci X/Xi 8mm Endoscope with a total weight of 22.4 lbs. (including the SteriTite container).

- SteriTite solid bottom Container: STERRAD 100NX - DUO Cycle (surface sterilization of medical devices only; no lumens).

Note: The validation studies were performed using a validation load consisting of non-lumened devices with a total weight of 13.2 lbs. (including the SteriTite container).

Refer to the specific Sterilizer user manual for information regarding the processing of appropriate devices and device types. See labeling for tables of compatible devices and maximum load weight recommendations including the weight of the sterilization container.

2

K252854

{10}

The following tables (Table 1 and Table 2) display the SteriTite part numbers and the sterilizers they are compatible with:

Table 1. SteriTite Perforated Bottom Container Compatibility with SFPP and Pre vacuum Steam Sterilizers.

| Part Number | Description | SFPP | Gravity Steam |
| --- | --- | --- | --- |
| SC02MG | 2" High Mini-Size w/ Perforated Base | Yes | Yes |
| SC03MG | 3" High Mini-Size w/ Perforated Base | Yes | Yes |
| SC04MG | 4" High Mini-Size w/ Perforated Base | Yes | Yes |
| SC02NG | 2" High Narrow-Size w/ Perforated Base | Yes | Yes |
| SC03NG | 3" High Narrow-Size w/ Perforated Base | Yes | Yes |
| SC03NLG | 3" High Narrow Long-Size w/ Perforated Base | N/A | Yes |
| SC04NLG | 4" High Narrow Long-Size w/ Perforated Base | N/A | Yes |
| SC05NLG | 5" High Narrow Long -Size w/ Perforated Base | N/A | Yes |
| SC04HG | 4" High Half-Size w/ Perforated Base | Yes | Yes |
| SC05HG | 5" High Half-size w/ Perforated Base | Yes | Yes |
| SC06HG | 6" High Half-Size w/ Perforated Base | Yes | Yes |
| SC08HG | 8" High Half-Size w/ Perforated Base | N/A | Yes |
| SC04QG | 4" High 3/4 Size w/ Perforated Base | Yes | Yes |
| SC05QG | 5" High 3/4 Size w/ Perforated Base | Yes | Yes |
| SC06QG | 6" High 3/4 Size w/ Perforated Base | Yes | Yes |
| SC08QG | 8" High 3/4 Size w/ Perforated Base | N/A | Yes |
| SC04FG | 4" High Full-size w/ Perforated Base | Yes | Yes |
| SC05FG | 5" High Full-size w/ Perforated Base | Yes | Yes |
| SC06FG | 6" High Full-size w/ Perforated Base | Yes | Yes |
| SC08FG | 8" High Full-size w/ Perforated Base | N/A | Yes |
| SC04LG | 4" High Long-size w/ Perforated Base | N/A | Yes |
| SC06LG | 6" High Long-size w/ Perforated Base | N/A | Yes |
| SC08LG | 8" High Long-size w/ Perforated Base | N/A | Yes |
| SC05WG | 5" High Wide Size w/ Perforated Base | N/A | Yes |

Note: Perforated bottom containers with part numbers with suffix (G) may be used in any sterilization modality. SteriTite containers with solid bottom may be used in pre-vacuum steam sterilization as well as low temperature modalities. N/A notes that the specified container does not fit into the sterilizer chamber because of length or width.

3

K252854

{11}

**Table 2. SteriTite Solid Bottom Container Compatibility with STERRAD 100NX and Steris V-Pro sterilizers**

| Part Number | Description | STERRAD 100NX | V-Pro s2/60 | V-Pro maX/maX2 |
| --- | --- | --- | --- | --- |
| SC02M | 2' High Mini-Size w/ Solid Base | Yes | Yes | Yes |
| SC03M | 3' High Mini-Size w/ Solid Base | Yes | Yes | Yes |
| SC04M | 4' High Mini-Size w/ Solid Base | Yes | Yes | Yes |
| SC02N | 2' High Narrow-Size w/ Solid Base | Yes | Yes | Yes |
| SC03N | 3' High Narrow-Size w/ Solid Base | Yes | Yes | Yes |
| SC03NL | 3' High Narrow Long-Size w/ Solid Base | Yes | Yes | Yes |
| SC04NL | 4' High Narrow Long-Size w/ Solid Base | Yes | Yes | Yes |
| SC05NL | 5' High Narrow Long -Size w/ Solid Base | Yes | Yes | Yes |
| SC04H | 4' High Half-Size w/ Solid Base | Yes | Yes | Yes |
| SC05H | 5' High Half-size w/ Solid Base | Yes | Yes | Yes |
| SC06H | 6' High Half-Size w/ Solid Base | Yes | Yes | Yes |
| SC08H | 8' High Half-Size w/ Solid Base | Yes | Yes | Yes |
| SC04Q | 4' High 3/4 Size w/ Solid Base | Yes | Yes | Yes |
| SC05Q | 5' High 3/4 Size w/ Solid Base | Yes | Yes | Yes |
| SC06Q | 6' High 3/4 Size w/ Solid Base | Yes | Yes | Yes |
| SC08Q | 8' High 3/4 Size w/ Solid Base | Yes | Yes | Yes |
| SC04F | 4' High Full-size w/ Solid Base | Yes | Yes | Yes |
| SC05F | 5' High Full-size w/ Solid Base | Yes | Yes | Yes |
| SC06F | 6' High Full-size w/ Solid Base | Yes | Yes | Yes |
| SC08F | 8' High Full-size w/ Solid Base | Yes | Yes | Yes |
| SC04L | 4' High Long-size w/ Solid Base | Yes | N/A | Yes |
| SC06L | 6' High Long-size w/ Solid Base | Yes | N/A | Yes |
| SC08L | 8' High Long-size w/ Solid Base | Yes | N/A | Yes |
| SC05W | 5' High Wide Size w/ Solid Base | Yes | N/A | Yes |

Note: Perforated bottom containers with part numbers with suffix (G) may be used in any sterilization modality. SteriTite containers with solid bottom may be used in pre-vacuum steam sterilization as well as low temperature modalities such as EtO, V-Pro, and in STERRAD sterilizers for surface sterilization have no G as a suffix in the part number.

N/A notes that the specified container does not fit into the sterilizer chamber because of length or width.

4

K252854

{12}

**Table 3. SteriTite Container maximum load weight in Steam Sterilization**

| Part Number | Pre-vacuum Steam Cycle | Gravity Cycle | SFPP Cycle |
| --- | --- | --- | --- |
| SC02M(G) | 35lbs | 35lbs | 25lbs |
| SC03M(G) | 35lbs | 35lbs | 25lbs |
| SC04M(G) | 35lbs | 35lbs | 25lbs |
| SC02N(G) | 35lbs | 35lbs | 25lbs |
| SC03N(G) | 35lbs | 35lbs | 25lbs |
| SC03NL(G) | 35lbs | 35lbs | N/A |
| SC04NL(G) | 35lbs | 35lbs | N/A |
| SC05NL(G) | 35lbs | 35lbs | N/A |
| SC04H(G) | 35lbs | 35lbs | 25lbs |
| SC05H(G) | 35lbs | 35lbs | 25lbs |
| SC06H(G) | 35lbs | 35lbs | 25lbs |
| SC08H(G) | 35lbs | 35lbs | N/A |
| SC04Q(G) | 35lbs | 35lbs | 25lbs |
| SC05Q(G) | 35lbs | 35lbs | 25lbs |
| SC06Q(G) | 35lbs | 35lbs | 25lbs |
| SC08Q(G) | 35lbs | 35lbs | N/A |
| SC04F(G) | 35lbs | 35lbs | 25lbs |
| SC05F(G) | 35lbs | 35lbs | 25lbs |
| SC06F(G) | 35lbs | 35lbs | 25lbs |
| SC08F(G) | 35lbs | 35lbs | N/A |
| SC04L(G) | 35lbs | 35lbs | N/A |
| SC06L(G) | 35lbs | 35lbs | N/A |
| SC08L(G) | 35lbs | 35lbs | N/A |
| SC05W(G) | 35lbs | 35lbs | N/A |

N/A notes that the specified container does not fit into the sterilizer chamber because of length or width.

5

K252854

{13}

**Table 4. SteriTite Container in STERRAD 100NX Maximum Load Weight**

| Part Number | Total Load Weight in 100NX Standard Cycle | Total Load Weight in 100NX Flexible Cycle | Total Load Weight in 100NX DUO Cycle | Total Load Weight in 100NX Express Cycle |
| --- | --- | --- | --- | --- |
| SC02M(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC03M(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC04M(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC02N(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC03N(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC03NL(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC04NL(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC05NL(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC04H(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC05H(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC06H(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC08H(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC04Q(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC05Q(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC06Q(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC08Q(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC04F(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC05F(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC06F(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC08F(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC04L(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC06L(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC08L(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |
| SC05W(G) | 21.4 lbs | 21.4 lbs | 13.2 lbs | 22.4 lbs |

Note: For Surface sterilization solid-bottom containers can be used. 22.4 lbs per shelf, where applicable. A solid-bottom container can be used in the Express, and DUO cycles for surface sterilization only. For the sterilization of lumened devices, SteriTite perforated bottom container suffix G must be used.

6

K252854

{14}

### Comparison of Technological Characteristics

All SteriTite containers are the same units as previously cleared, containing the same characteristics, such as knife edge fit between lid and base, anodized aluminum and passivated stainless-steel materials of construction, offset vent pattern, gasketed lids with latching mechanism, tamper evident features, and external labeling, seals and indicators. The SteriTite® sealed container in this submission is the same container previously cleared in the predicate submission. The subject device includes additional sterilization cycle claims.

| Element | Predicate K240898 | Subject Device K252854 | Comparison |
| --- | --- | --- | --- |
| Indications for Use | 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. The solid and perforated bottom container configurations are compatible for use with the following low temperature sterilizers and cycles identified below: - STERIS V-Pro 60: Flexible and Lumen cycle (Solid and perforated bottom container) - STERIS V-Pro s2: Flexible and Lumen cycle (Solid and perforated bottom container) - STERIS V-Pro maX 2: Lumen, Non-Lumen and Flexible cycle (Solid and perforated bottom container) - STERIS V-Pro maX: Lumen, Non-Lumen and Flexible cycle (Solid and perforated bottom container) | 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 devices until it is used. The perforated bottom container configuration is compatible for use with the following steam sterilization cycles: Steam Cycle with Steam Flush Pressure Pulses (SFPP): - At 132°C for 4 minutes with a 30-minute dry time - At 135°C for 3 minutes with a 30-minute dry time Note: The validation studies were performed using a 4 SFPP pulse cycle with a validation load consisting of unwrapped metal items with a total weight of 25 lbs. (including the SteriTite container). In addition, the SteriTite container, also available with a solid bottom, is compatible with low-temperature sterilizers, and is compatible with the following sterilizers and cycles identified below: - SteriTite solid bottom Container: STERRAD 100NX - Express Cycle (surface sterilization of medical devices only; no lumens). Note: The validation studies were performed using a validation load consisting of a da Vinci X/Xi 8mm Endoscope with a total weight of 22.4 lbs. (including the SteriTite container). - SteriTite solid bottom Container: STERRAD 100NX - DUO Cycle (surface sterilization of medical devices only; no lumens). Note: The validation studies were performed using a validation load consisting of non-lumened devices with a total weight of 13.2 lbs. (including the SteriTite container). | Similar; Different sterilization cycle claims for the subject device. Performance testing was done to support these new sterilization cycle claims. |

7

K252854

{15}

| Element | Predicate K240898 | Subject Device K252854 | Comparison |
| --- | --- | --- | --- |
| Materials of construction | Anodized aluminum Stainless steel hardware Silicone gaskets | Same | Same |
| Device Design | •Off set vent pattern •Disposable filter in lid •Interchangeable filter retention plates •Recessed gasket | Same | Same |
| Sterilant Penetration for Low Temperature Sterilization | Lumens and Surface sterilization | Surface sterilization only | Different |
| Maintenance of Sterility | One year | One year | Same |
| Patient Contact | Indirect | Indirect | Same |
| Reusable | Yes | Yes | Same |

### 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 MediTray line 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 ST79.

| Performance Testing | Standard | Purpose | Results |
| --- | --- | --- | --- |
| Maintenance of Sterility | 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 | Demonstrated sterilization efficacy of the subject device for processing medical devices using the identified sterilization processes. | Pass |

8

K252854

{16}

## Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission for the SteriTite 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 K240898.

9

K252854