ONE TRAY® Sealed Sterilization Container System

K250029 · Innovative Sterilization Technologies · KCT · May 1, 2025 · General Hospital

Device Facts

• Record ID: K250029
• Device Name: ONE TRAY® Sealed Sterilization Container System
• Applicant: Innovative Sterilization Technologies
• Product Code: KCT · General Hospital
• Decision Date: May 1, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The ONE TRAY Container is a reusable rigid sterilization container intended to be used to enclose reusable medical devices that are to be steam sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed devices and maintenance of sterility of the enclosed devices during storage, transport and until used. This container is compatible for use in the following sterilization modalities in the configuration listed below: Prevac Steam 270°F, 4 min exposure 15 minute dry time ONE TRAY® is validated to process a twenty five pound (25 lb) gross weight load (single container plus contents). This includes sterilization of lumens (Stainless Steel and Titanium) 1 mm in diameter or larger with lengths of up to 500 mm. DO NOT STACK ONE TRAY CONTAINERS DURING STERILIZATION. Examples of validated materials that can be processed within the ONE TRAY - Metals: Stainless Steel, Titanium, Aluminum, Thermoplastics: PEEK, Polypropylene, Radel, Thermosetting Polymers: Silicone, Phenolic. The ONE TRAY® sealed sterilization container consists of a line of rigid reusable containers listed in the table below. Healthcare Facilities should follow steam sterilization cycle and storage guidelines as stated in AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

Device Story

Reusable rigid sterilization container system; base and lid constructed of anodized aluminum with silicone gaskets; features perforated lid and base with single-use SMS filters for steam penetration and bacterial barrier. Operates via Prevac steam sterilization (270°F, 4 min exposure, 15 min dry time). Designed for healthcare facilities to process surgical instruments; includes sloped floor to reduce moisture retention and specific vent-to-volume ratios to facilitate sterilant dispersal. Output is a sterile, sealed container for storage and transport. Benefits include maintained sterility for up to 365 days and protection of instruments during handling. Healthcare providers load instruments into the container, process in a steam sterilizer, and use the container to maintain sterility until the point of use.

Clinical Evidence

Bench testing only. Validations included: Sterilization efficacy (BI overkill method, half-cycle), dry time (weight difference <0.2%), microbial aerosol challenge, material compatibility, cytotoxicity (ISO 10993-5), and 365-day sterility maintenance study. All tests passed.

Technological Characteristics

Materials: Anodized aluminum (container/lid), medical-grade silicone (gaskets), polypropylene (SMS filters). Principle: Rigid container with filtered vents for steam penetration. Dimensions: Various sizes (20.142"-23.142" L x 11.616" W x 4.573"-8.573" H). Energy: Steam (Pre-vacuum). Sterilization: Prevac steam 270°F. Connectivity: None. Software: None.

Indications for Use

Indicated for healthcare providers to enclose reusable medical devices (metals, thermoplastics, thermosetting polymers) for steam sterilization, storage, and transport. Supports loads up to 25 lbs, including lumens ≥1mm diameter and ≤500mm length.

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

• Aesculap AICON Container (K214041)

Reference Devices

• IST ONE TRAY® sealed sterilization container (K052567)
• Class 5 Integrator (K012195)
• Tamper Evident Seals (K890763)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

May 1, 2025

Innovative Sterilization Technologies
% Joseph Azary
Regulatory Consultant
Aztech Regulatory &amp; Quality LLC
543 Long Hill Avenue
Shelton, Connecticut 06484

Re: K250029
Trade/Device Name: ONE TRAY® Sealed Sterilization Container System
Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization Wrap
Regulatory Class: Class II
Product Code: KCT
Dated: April 1, 2025
Received: April 1, 2025

Dear Joseph Azary:

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.

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

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K250029 - Joseph Azary
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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" (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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 systems (QS) regulation (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-

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K250029 - Joseph Azary
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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).

Sincerely,

Christopher K. Dugard -S

Christopher K. Dugard, M.S.
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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K250029

Device Name
ONE TRAY® Sealed Sterilization Container System

Indications for Use (Describe)
The ONE TRAY Container is a reusable rigid sterilization container intended to be used to enclose reusable medical devices that are to be steam sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed devices and maintenance of sterility of 1he enclosed devices during storage, transport and until used. This container is compatible for use in the following sterilization modalities in the configuration listed below:

Prevac Steam
270°F, 4 min exposure
15 minute dry time

ONE TRAY® is validated to process a twenty five pound (25 lb) gross weight load (single container plus contents). This includes sterilization of lumens (Stainless Steel and Titanium) 1 mm in diameter or larger with lengths of up to 500 mm.

DO NOT STACK ONE TRAY CONTAINERS DURING STERILIZATION.

Examples of validated materials that can be processed within the ONE TRAY - Metals: Stainless Steel, Titanium, Aluminum, Thermoplastics: PEEK, Polypropylene, Radel, Thermosetting Polymers: Silicone, Phenolic.

The ONE TRAY® sealed sterilization container consists of a line of rigid reusable containers listed in the table below. Healthcare Facilities should follow steam sterilization cycle and storage guidelines as stated in AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

| Catalog# | Length (in) | Width (in) | Height (in) |
| --- | --- | --- | --- |
| M2104DT | 20.142 | 11.616 | 4.573 |
| M2106DT | 20.142 | 11.616 | 6.573 |
| M2108DT | 20.142 | 11.616 | 8.573 |
| M2404DT | 23.142 | 11.616 | 4.573 |
| M2406DT | 23.142 | 11.616 | 6.573 |
| M2408DT | 23.142 | 11.616 | 8.573 |

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.

FORM FDA 3881 (6/20)
Page 1 of 2
PSC Publishing Services [phone]

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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 (6/20)
Page 2 of 2

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K250029

# 510(k) Summary

## 1. SUBMITTER/510(K) HOLDER

Innovative Sterilization Technologies, LLC
7625 Paragon Road, Suite A
Dayton, OH 45459

Contact Name: Walt Oko / Executive
Email: [e-mail]
Telephone: [phone]

Date: April 16, 2025

Prepared By: Joseph Azary / Aztech Regulatory &amp; Quality LLC

## 2. DEVICE NAME

Proprietary Name: ONE TRAY® Sealed Sterilization Container
Common/Usual Name: Sterilization Container
Classification Name: Sterilization Wrap Containers, Trays, Cassettes and other Accessories
Classification Regulation: 21 CFR 880.6850
Product code: KCT
Classification: Class 2
Medical Specialty (Panel): Infection Control Devices Branch

## 3. PREDICATE DEVICES

- Predicate Device - Aesculap AICON Container – K214041
- Reference Device - IST ONE TRAY® sealed sterilization container – K052567

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K250029

# 4. DEVICE DESCRIPTION

The ONE TRAY® Sealed Sterilization Container is a sealed rigid container with a lid and base containing a rectangular patterned group of perforations to permit steam penetration of sterilant.

Single use SMS filters cover each vented area and are held firmly in place by a perforated stainless steel filter cover. This assembly permits the penetration of steam during the sterilization process and serves as a bacterial and fluid barrier at the conclusion of the sterilization cycle.

ONE TRAY® Sealed Sterilization Containers are a reusable device whose base and lid are composed of anodized aluminum to prevent corrosion.

The gaskets used in the ONE TRAY® Sealed Sterilization Containers are made from medical grade silicone material identical to that used by predicate containers. The lid is firmly secured to the base with a cam-locking latch at each end.


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K250029

# Specifications and Configurations

The ONE TRAY® sealed sterilization container consists of a line of rigid reusable containers in various sizes. Innovative Sterilization Technologies intends to produce the following products:

| Model | Model Description |
| --- | --- |
| M2104DT | (L) 20.142" x (H) 4.573" x (W) 11.616" |
| M2106DT | (L) 20.142" x (H) 6.573" x (W) 11.616" |
| M2108DT | (L) 20.142" x (H) 8.573" x (W) 11.616" |
| M2404DT | (L) 23.142" x (H) 4.573"x(W)11.616" |
| M2406DT | (L) 23.142" x (H) 6.573"x(W)11.616" |
| M2408DT | (L) 23.142" x (H) 8.573" x (W) 11.616" |

# Vent to Volume Ratios

The ONE TRAY® Sealed Sterilization Containers include filter vents in both the lid and base with covers for each filter element. These characteristics are common in other sterilization containers. The filtered vents in ONE TRAY® Sealed Sterilization Containers take advantage of the thermodynamic performance of a heated sterilizing media to facilitate the expeditious and complete introduction of the sterilant throughout the container.

The ONE TRAY® Sealed Sterilization Containers have one centrally located rectangular vent in the lid. The perforated area in this vent comprises approximately 30% of the surface area in the lid. Two vents of identical size and shape are laterally displaced and proximal to each end wall in the floor of the container. As steam is introduced through the dedicated entry vent in the lid of the ONE TRAY® Sealed Sterilization Container, the heated sterilant moves laterally to displace the relatively cooler atmosphere at the top of the container. As this process continues, the sterilant displaces the atmosphere within the container proceeding from the top to the bottom.

The location of the two vents in the floor force the steam to exit at the lateral extremes, which assist in reducing the presence of the usual "cool" spots in the bottom corners. This process occurs quickly due to the two vents having twice the surface area and vapor exchange capacity of the single vent in the lid. See Figure 1. Collectively, the number, size, and positional interrelationship of the filtered vents in ONE TRAY® Sealed Sterilization Container creates a unique flow pattern that insures the expeditious dispersal of the sterilizing media throughout the sealed container. In addition, the sloped floor addresses the issue of retained moisture. See Table 1 below for a breakdown of the vent to volume ratios of the various container configurations.

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K250029

FIGURE 1

TABLE 1

| Model | Vent to Volume Ratio |
| --- | --- |
| M2104DT | 25.3 |
| M2106DT | 38.6 |
| M2108DT | 51.8 |
| M2404DT | 29.0 |
| M2406DT | 44.1 |
| M2408DT | 59.3 |

# Microbial Barrier Properties of the Filter

The ONE TRAY® Sealed Sterilization Container utilizes a proprietary set of three SMS filters. These filters act not only as particulate barriers, but also as fluid barriers. The design of the filters ensure proper alignment and use.

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K250029

# 5. INDICATIONS FOR USE

The ONE TRAY® Container is a reusable rigid sterilization container intended to be used to enclose reusable medical devices that are to be steam sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed devices and maintenance of sterility of the enclosed devices during storage, transport and until used. This container is compatible for use in the following sterilization modalities in the configuration listed below:

- Prevac Steam
- 270°F, 4 min exposure
- 15-minute dry time

ONE TRAY® is validated to process a twenty five pound (25 lb) gross weight load (single container plus contents). This includes sterilization of lumens (Stainless Steel and Titanium) 1 mm in diameter or larger with lengths of up to 500 mm.

DO NOT STACK ONE TRAY® CONTAINERS DURING STERILIZATION

Examples of validated materials that can be processed within the ONE TRAY®- Metals: Stainless Steel, Titanium, Aluminum, Thermoplastics: PEEK, Polypropylene, Radel, Thermosetting Polymers: Silicone, Phenolic

The ONE TRAY® sealed sterilization container consists of a line of rigid reusable containers listed in the table below. Healthcare Facilities should follow steam sterilization cycle and storage guidelines as stated in AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

| Model | Model Description |
| --- | --- |
| M2104DT | (L) 20.142" x (H) 4.573" x (W) 11.616" |
| M2106DT | (L) 20.142" x (H) 6.573" x (W) 11.616" |
| M2108DT | (L) 20.142" x (H) 8.573" x (W) 11.616" |
| M2404DT | (L) 23.142" x (H) 4.573"x(W)11.616" |
| M2406DT | (L) 23.142" x (H) 6.573"x(W)11.616" |
| M2408DT | (L) 23.142" x (H) 8.573" x (W) 11.616" |

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K250029

# Sterilization Parameters

| Sterilization Parameters for the ONE TRAY® Reusable Sterilization Container | | | |
| --- | --- | --- | --- |
| Sterilization Method | Cycle Parameters | Total System | Containers, Accessories & Validated Contents |
| Dynamic Air Removal (Pre-Vacuum) Steam | Exposure Temperature: 270°F (132°C) | <25 lbs. | ONE TRAY® Sterilization Container System
ONE TRAY® Processing Kit
Devices: conjoined and mated surfaces, cannulated, implants and trays/cassettes. |
| | Exposure Time: minimum 4 minutes | | |
| | Dry Time Cycle: 15 minutes | | Intrinsically Stable Materials: metals, thermoplastics and thermosetting polymers with constant use temperatures above 132°C. |
| | Stacking Not Permitted | | |
| Examples of device types:
○ Conjoined or mated surfaces devices include: forceps, clamps, compressors, bending pliers, ratchet/ T handles, and retractors.
○ Cannulated devices include: drill bits/ taps, guides, screwdrivers insertion shafts, and cannulated screws.
○ Implant devices include: solid and cannulated screws, connectors, plates and spacers.
Examples of intrinsically stable materials:
Metals- Stainless Steel, Titanium alloys and Aluminum.
Thermoplastics - PEEK, Polypropylene, Radel.
Thermosetting polymers- Phenolic and Silicone. | | | |

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K250029

| ONE TRAY® Sealed Sterilization Container and Accessory Configurations Supported by Validation Data | | |
| --- | --- | --- |
| Modality- Dynamic Air Removal (Pre-Vacuum) Steam | | |
| | Contents / Configuration | Validation Details |
| | Devices: | |
| | Conjoined/ Mated Surfaces | Yes |
| | Lumen/ Cannulation: Ø3mm x 400mm | Yes |
| | Lumen/ Cannulation: Ø1mm x 500mm | Yes |
| | Trays/ Cassettes | Yes |
| | Materials: Intrinsically stable- metals, thermoplastics and thermosetting polymers with constant use temperatures above 132°C. | Yes |
| | Accessories | |
| | | |
| | (3) Single Use SMS Filters | Yes |
| | (1) Class 5 Integrator (510(k) K012195) | Yes |
| | (2) Tamper Evident Seals with indicator dot (510(k) K890763) | Yes |
| | (2) Load ID Cards | n/a |
| | Maximum Total Weight (Container plus Contents) | <25 lbs. |
| | Stacking | Not permitted |

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| ONE TRAY® Sterilization Container Compatibility, Contents, Accessories and Maximum Allowable Weight | | | | |
| --- | --- | --- | --- | --- |
| Container | Graphic Case Dimensions (L x H x W), in. | Contents | Required Accessories | Max. Weight (loaded) |
| ONE TRAY® Model | 20.142 x 4.573.x.11.616 (Part # M2104DT) | Intrinsically Stable Materials: metals, thermoplastics and thermosetting polymers with constant use temperatures above 132°C. | (1) ONE TRAY® Processing Kit (Part # OTK-210) | 25 lbs. |
| | 20.142 x 6.573.x.11.616 (Part # M2106DT) | Devices: conjoined and mated surfaces, cannulated (sizes Ø1mm x 500mm), implants and trays/cassettes. | | |
| | 20.142 x 8.573.x.11.616 (Part # M2108DT) | | | |
| | 23.142 x 4.573.x.11.616 (Part # M2404DT) | Intrinsically Stable Materials: metals, thermoplastics and thermosetting polymers with constant use temperatures above 132°C. | (1) ONE TRAY® Processing Kit (Part # OTK-210) | 25 lbs. |
| | 23.142 x 6.573.x.11.616 (Part # M2406DT) | Devices: conjoined and mated surfaces, cannulated (sizes Ø1mm x 500mm), implants and trays/cassettes. | | |
| | 23.142 x 8.573.x.11.616 (Part # M2408DT) | | | |

## 6. TECHNOLOGICAL CHARACTERISTICS

Below is a table providing a comparison of the technological characteristics between the subject, predicate and reference devices.

| Characteristic | Subject Device-ONE TRAY® Product Code: KCT | Predicate Device- Aesculap Aicon (K214041) Product Code: KCT | Reference Device-ONE TRAY® (K052567) Product Code: KCT | Discussion |
| --- | --- | --- | --- | --- |
| Intended Use | The ONE TRAY Container is a | The AESCULAP Aicon Container is a | ONE TRAY sealed sterilization | Same |

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| | reusable rigid sterilization container intended to be used to enclose reusable medical devices that are to be steam sterilized by a health care provider. It is intended to allow sterilization of the enclosed devices and maintenance of sterility of the enclosed devices during storage, transport and until used. | reusable rigid sterilization container intended to be used to enclose other medical devices that are to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical devices and also maintain sterility of the enclosed device during transport and until used. | containers are intended to be used to hold temperature tolerant medical devices, surgical supplies, single instruments, multiple instruments or an instrument set for immediate use following flash sterilization. This includes sterilization of lumens 3mm in diameter or larger with lengths of up to 400mm. | |
| --- | --- | --- | --- | --- |
| Sterilization Modalities | Prevac Steam 270°F 4 min Exposure with 15-minute dry time | Prevac Steam 270°F 4 min Exposure with 20-minute dry time Ethylene Oxide, Steris VPRO and Sterrad. | Prevac Steam 270°F 4 min Exposure with NO dry time required | Similar Subject device does not have additional modalities |
| Material | Container: Anodized aluminum Lid: Anodized aluminum Gasket: Silicone | Container: Anodized aluminum Lid: Anodized aluminum Gasket: Silicone | Container: Anodized aluminum Lid: Anodized aluminum Gasket: Silicone | Same |
| Filter Type & Material | Single use (Polypropylene) | Single use (Polypropylene) | Single use (Polypropylene) | Same |
| Container Design | Perforated bottom with perforated lid | Solid bottom with enhanced drying system with Perforated Lid | Perforated bottom with perforated lid | Subject device and reference device have perforated bottoms, whereas the predicate has a solid bottom |
| Dimensions | (LxHxW) 20.142 x | (LxWxH) 23.25 x | (LxWxH) 20.5 x | Similar size |

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| | 4.573.x.11.616”
20.142 x
6.573.x.11.616”
20.142 x
8.573.x.11.616”
23.142 x
4.573.x.11.616”
23.142 x
6.573.x.11.616”
23.142 x
8.573.x.11.616” | 11.25 x 4.25”
23.25 x 11.25 x 5.5”
23.25 x 11.25 x 6”
23.25 x 11.25 x 8”
23.25 x 11.25 x
10.5”
18.5 x 11.25 x 4.25”
18.5 x 11.25 x 5.5”
18.5 x 11.25 x 6”
18.5 x 11.25 x 8”
11.75 x 11.25 x 4.25
11.75 x 11.25 x 5.5
11.75 x 11.25 x 6
11.75 x 11.25 x 8
11.75 x 11.25 x 10.5
7.5 x 12.5 x 1.875”
7.5 x 12.5 x 2.5”
7.5 x 12.5 x 3.625”
7.5 x 12.5 x 5.125” | 11.5 x 3”
20.5 x 11.5 x 5”
23.5 x 11.5 x 3”
23.5 x 11.5 x 5” | ranges |
| --- | --- | --- | --- | --- |
| Maintenance
of sterility | 365 days | 365 days | Immediate Use | Same as
predicate
device |

The subject device and predicate device have the same sterilization cycle parameters and have similar size ranges and materials. The subject device and predicate device have the same 365-day event related storage period.

The predicate device has additional modalities that are not included with the subject device and has a slightly different drying time.

The subject device is the identical device as the reference device with the main differences being related to dry time and 365-day event related storage period.

The subject device and predicate have the same
- steam sterilization cycle parameters
- 365-day event related storage period

The subject device and predicate have the similar
- size ranges and materials
- drying times

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The differences are determined to be minor and have no impact on safety and effectiveness based on performance testing and compliance to consensus standards.

# 7. NONCLINICAL TESTS

The following nonclinical test were performed and summarized in the table below:

| Test Name | Method and/or Standard | Acceptance Criteria | Results (Pass / Fail) |
| --- | --- | --- | --- |
| Sterilization Efficacy | ANSI / AAMI ST77:2013 ANSI/AAMI TIR12:2010 ISO 17665-1 Sterilization of Healthcare Products – Moist Heat Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices. | A sterility assurance level of 10-6will be achieved post sterilization using the BI overkill method and half cycle validation. Biological indicators must be negative for growth after incubation period. | Pass |
| Dry Time | ANSI / AAMI ST77:2013 ANSI/AAMI TIR12:2010 ISO 17665-1 Sterilization of Healthcare Products – Moist Heat Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices. | The system shall demonstrate an average pre and post sterilization weight difference of less than 0.2% within five 15 minute cycle completion using final validated parameters and be free of visible moisture. | Pass |
| Microbial Aerosol Challenge | ANSI / AAMI ST77:2013 ANSI/AAMI TIR12:2010 | The container load maintains sterility after exposure to a defined amount of aerosol microorganisms. No presence of growth after incubation period. | Pass |
| Material Compatibility | AAMI ST98:2022 ANSI/AAMI TIR12:2020 | No impact to functionality at the completion of multiple cleaning and sterilization cycles. | Pass |
| Cytotoxicity | ISO 10993-5:2009 | Demonstrate no significant cytotoxic reaction after | Pass |
| | | exposure to a specific chemical substance. | |

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| | | exposure to sterilant. Using the ISO Elution Method, the response to the article is not greater than 2 (mild reactivity) | |
| --- | --- | --- | --- |
| Sterility Maintenance | AAMI ST98:2022
ANSI/AAMI TIR12:2020 | Sterility of container contents is maintained after processing for 365 days under conditions which simulate hospital sterile package handling and storage conditions. Biological indicators must be negative for growth after incubation period. | Pass |

The subject device was subjected to testing and validations including:

- Shelf Life Study: 365 Day Event Related Shelf Life Study
- Microbial Aerosol Challenge following Pre-Vacuum Steam Sterilization
- Biocompatibility (Cytotoxicity)
- Mechanical Cleaning Validation – Total Organic Carbon (TOC) Analysis
- Mechanical Cleaning Validation – Protein Analysis
- Sterilization Efficacy Study – Half Cycle
- Thermal Profile

The following guidance documents were utilized for the preparation of this submission and decision making regarding testing:

- FDA Guidance- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
- AAMI ST77 (FDA recognized consensus standard)

# 8. CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that the subject device in 510(k) submission K250029, ONE TRAY® Sealed Sterilization Container, is as safe, as effective, and performs as well as or better than the identified legally marketed predicate device cleared in K214041.

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