(115 days)
No.
The device description and specifications indicate it is a passive sterilization container made of metal and silicone, designed to physically enclose and protect medical devices during steam sterilization. There is no mention of any electronic components, software, data processing, or intelligent functions that would typically be associated with an AI model. Its function is purely mechanical and physical.
No.
The device is a sterilization container intended to sterilize other reusable medical devices, not to provide therapy directly.
No
Explanation: The device is a sterilization container used to enclose medical devices for steam sterilization and maintain their sterility. It does not perform any diagnostic function.
No
The device is a physical, reusable sterilization container made of anodized aluminum, silicone, and stainless steel, explicitly designed to enclose medical devices for steam sterilization and maintain sterility. It performs a physical function and does not describe any software components or functionality.
No.
This device is a reusable rigid sterilization container for medical devices. It does not perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / 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.
Product codes
KCT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider, Healthcare Facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
FDA 510(k) Clearance Letter - ONE TRAY® Sealed Sterilization Container System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 1, 2025
Innovative Sterilization Technologies
℅ Joseph Azary
Regulatory Consultant
Aztech Regulatory & 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.
Page 2
K250029 - Joseph Azary Page 2
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-
Page 3
K250029 - Joseph Azary Page 3
assistance/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,
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
Page 4
FORM FDA 3881 (6/20) Page 1 of 2
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 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.
| 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.
Page 5
FORM FDA 3881 (6/20) Page 2 of 2
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
PRAStaff@fda.hhs.gov
"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."
Page 6
K250029
Page 1 of 12
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: woko@ISTsterilization.com
Telephone: (937) 619-0138
Date: April 16, 2025
Prepared By: Joseph Azary / Aztech Regulatory & 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
Page 7
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.
![Device Components Diagram showing Latching Mechanisms (2x), Lid, Deck Plate, Filter Covers, Base, and Handles (2x)]
Page 2 of 12
Page 8
K250029
Page 3 of 12
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.
Page 9
FIGURE 1
[Steam flow diagram showing container cross-section with arrows indicating steam flow patterns]
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.
Page 4 of 12
Page 10
K250029
Page 5 of 12
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" |
Page 11
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) | ||
| Exposure Time: minimum 4 minutes | |||
| Dry Time Cycle: 15 minutes | |||
| Stacking Not Permitted |