K Number

Device Name

SteriTite Container System with MediTray Parts

Manufacturer

Case Medical, Inc.

Date Cleared

2022-10-07

(137 days)

Product Code

KCT

Regulation Number

880.6850

Intended 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. This container system is compatible for use with the following low temperature sterilizers and cycles identified below: - STERIS V-Pro 60 (Flexible and Lumen cycle) - - -STERIS V-Pro s2 (Flexible and Lumen cycle) - STERIS V-Pro maX 2 (Lumen, Non-Lumen and Flexible cycle) - - -STERIS V-Pro maX (Lumen, Non-Lumen and Flexible cycle) - STERRAD 100NX ALLCLEAR (Standard, Flexible,DUO and Express cycle) - - -Sterizone VP4 (Cycle 1) Refer to the specific Sterilizer user manual and vendor provided information regarding of appropriate devices and device type. See the following pages for tables of compatible devices and description of the validated loads. The following table (Table 1) identifies the validated lumen claims of the SteriTite container with MediTray parts in low temperature and pre-vacuum steam sterilizers: Table 1. SteriTite Container System with MediTray Parts Lumen Claims: | Sterilizer | Cycle | Lumen Sterilization Claims (I.D. x Length) | |--------------------|----------|---------------------------------------------------------------------------| | STERIS V-Pro 60 | Flexible | ≥1mm x ≤990mm (Single or Dual Lumen) | | STERIS V-Pro 60 | Lumen | ≥0.77mm x ≤527mm (Dual Channel) | | STERIS V-Pro s2 | Flexible | ≥1mm x ≤990mm (Single or Dual Lumen) | | STERIS V-Pro s2 | Lumen | ≥0.77mm x ≤527mm (Dual Channel) | | STERIS V-Pro maX 2 | Flexible | ≥1mm x ≤1050mm (Single Lumen) | | STERIS V-Pro maX 2 | Lumen | ≥0.77mm x ≤527mm (Dual Channel) | | STERIS V-Pro maX | Flexible | ≥1mm x ≤1050mm (Single Lumen) | | STERIS V-Pro maX | Lumen | ≥0.77mm x ≤527mm (Dual Channel) | | STERRAD 100NX | DUO | ≥1mm x ≤875mm (Single Lumen) | | Sterizone VP4 | Cycle 1 | ≥1.2mm x ≤1955mm (Flexible Lumens) | | Sterizone VP4 | Cycle 1 | ≥1.45mm x ≤3500mm (Flexible Lumens) | | Steam | Pre-Vac | ≥2mm x ≤400mm (Stainless Steel Lumen)<br>≥1.2mm x ≤400mm (Flexible Lumen) |

Device Description

The SteriTite® Universal Container is a rigid, reusable, sealed sterilization packaging system that is compatible with steam, hydrogen peroxide, ethylene oxide, and ozone sterilizers. The SteriTite® container system consists of a family of rigid reusable containers and inserts that provide an effective reusable sterilization packaging system for operating room instruments. The SteriTite® container as previously cleared is available with solid or perforated base. The container is made of anodized aluminum with passivated stainless-steel hardware and silicone gaskets. Each filter retention plate with gaskets and off set vent pattern secures a disposable filter for bacterial barrier filtration. Filter retention plates in lid and base are interchangeable for universal use. A recessed gasket contributes to a knife edge fit between lid and base. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions, and racks provide instrument protection and secure devices for sterilization within the container.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K212711

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on the physical properties and sterilization capabilities of a reusable container system. There is no mention of AI or ML technology.

Therapeutic

No
The device is a reusable sterilization container system used to sterilize, transport, and store other medical devices, not to provide therapy directly to a patient.

Diagnostic

The device is a reusable sterilization container system designed to enclose other medical devices for sterilization, transport, and storage. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

The device is a physical sterilization container system made of aluminum and stainless steel, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is 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." This describes a device used in the sterilization and handling of medical instruments, not for performing diagnostic tests on biological samples.
Device Description: The description details a "rigid, reusable, sealed sterilization packaging system" made of materials like aluminum and stainless steel, designed to hold instruments for sterilization. This aligns with the intended use and does not suggest any diagnostic function.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on biological sample analysis
- Reagents, calibrators, or controls used in diagnostic tests

The device's purpose is to facilitate the sterilization and storage of other medical devices, which is a crucial part of healthcare but is not an in vitro diagnostic activity.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

STERIS V-Pro 60 (Flexible and Lumen cycle)
-STERIS V-Pro s2 (Flexible and Lumen cycle)
STERIS V-Pro maX 2 (Lumen, Non-Lumen and Flexible cycle)
-STERIS V-Pro maX (Lumen, Non-Lumen and Flexible cycle)
STERRAD 100NX ALLCLEAR (Standard, Flexible,DUO and Express cycle)
-Sterizone VP4 (Cycle 1)

Refer to the specific Sterilizer user manual and vendor provided information regarding of appropriate devices and device type. See the following pages for tables of compatible devices and description of the validated loads.

The following table (Table 1) identifies the validated lumen claims of the SteriTite container with MediTray parts in low temperature and pre-vacuum steam sterilizers:

Table 1. SteriTite Container System with MediTray Parts Lumen Claims:

Sterilizer	Cycle	Lumen Sterilization Claims (I.D. x Length)
STERIS V-Pro 60	Flexible	>=1mm x =0.77mm x =1mm x =0.77mm x =1mm x =0.77mm x =1mm x =0.77mm x =1mm x =1.2mm x =1.45mm x =2mm x =1.2mm 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).

Summary

October 7, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Case Medical, Inc. Michael Polozani Regulatory Affairs 50 West Street Bloomfield, New Jersey 07003

Re: K221492

Trade/Device Name: SteriTite Container System with MediTray Parts Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: May 20, 2022 Received: May 23, 2022

Dear Michael Polozani:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K221492

Device Name

SteriTite Container with MediTray Products

Indications for Use (Describe)

STERIS V-Pro 60 (Flexible and Lumen cycle) -
-STERIS V-Pro s2 (Flexible and Lumen cycle)
STERIS V-Pro maX 2 (Lumen, Non-Lumen and Flexible cycle) -
-STERIS V-Pro maX (Lumen, Non-Lumen and Flexible cycle)
STERRAD 100NX ALLCLEAR (Standard, Flexible,DUO and Express cycle) -
-Sterizone VP4 (Cycle 1)

The following table (Table 1) identifies the validated lumen claims of the SteriTite container with MediTray parts in low temperature and pre-vacuum steam sterilizers:

Table 1. SteriTite Container System with MediTray Parts Lumen Claims:

Sterilizer	Cycle	Lumen Sterilization Claims (I.D. x Length)
STERIS V-Pro 60	Flexible	≥1mm x ≤990mm (Single or Dual Lumen)
STERIS V-Pro 60	Lumen	≥0.77mm x ≤527mm (Dual Channel)
STERIS V-Pro s2	Flexible	≥1mm x ≤990mm (Single or Dual Lumen)
STERIS V-Pro s2	Lumen	≥0.77mm x ≤527mm (Dual Channel)
STERIS V-Pro maX 2	Flexible	≥1mm x ≤1050mm (Single Lumen)
STERIS V-Pro maX 2	Lumen	≥0.77mm x ≤527mm (Dual Channel)
STERIS V-Pro maX	Flexible	≥1mm x ≤1050mm (Single Lumen)
STERIS V-Pro maX	Lumen	≥0.77mm x ≤527mm (Dual Channel)
STERRAD 100NX	DUO	≥1mm x ≤875mm (Single Lumen)
Sterizone VP4	Cycle 1	≥1.2mm x ≤1955mm (Flexible Lumens)
Sterizone VP4	Cycle 1	≥1.45mm x ≤3500mm (Flexible Lumens)
Steam	Pre-Vac	≥2mm x ≤400mm (Stainless Steel Lumen)
≥1.2mm x ≤400mm (Flexible Lumen)

The following table (Table 2) displays the SteriTite part numbers and the sterilizers they are compatible with.

V-Pro s2/60	V-Pro 1	V-Pro maX/2	Sterizone VP4	STERRAD 100NX
Lumen	Lumen Cycle	Lumen	Cycle 1	Standard,Flex
SC02MG	SC02MG	SC02MG	SC02M(G)*	SC02MG
SC03MG	SC03MG	SC03MG	SC03M(G)*	SC03MG
SC04MG	SC02NG	SC04MG	SC04M(G)*	SC04MG
SC02NG	SC03NG	SC02NG	SC02N(G)*	SC02NG
SC03NG	SC04FG	SC03NG	SC03N(G)*	SC03NG
SC04NLG	SC05FG	SC04NLG	SC04NL(G)*	SC04NLG
SC05NLG	SC06FG	SC05NLG	SC05NL(G)*	SC05NLG
SC04HG	SC08FG	SC04HG	SC04H(G)*	SC04HG
SC05HG	SC04HG	SC05HG	SC05H(G)*	SC05HG
SC04QG	SC05HG	SC06HG	SC06H(G)*	SC06HG
SC05QG	SC06HG	SC08HG	SC08H(G)*	SC08HG
SC04FG	SC08HG	SC04QG	SC04Q(G)*	SC04QG
	SC04QG	SC05QG	SC05Q(G)*	SC05QG
	SC05QG	SC06QG	SC06Q(G)*	SC06QG
	SC06QG	SC08QG	SC08Q(G)*	SC08QG
	SC08QG	SC04FG	SC04F(G)*	SC04FG
	SC04LG	SC05FG	SC04L(G)*	SC05FG
	SC06LG	SC06FG	SC06L(G)*	SC06FG
	SC05WG	SC08FG		SC08FG
		SC04LG		SC04LG
		SC06LG		SC06LG
		SC05WG		SC05WG

Table 2. SteriTite Container Compatibility with Low Temperature and Steam Sterilizers

STERRAD 100NX

DUO, Express Cycle

SC02MG SC03MG SC04MG SC02NG SC03NG SC04NLG SC05NLG SC04HG SC05HG SC06HG SC08HG SC04QG SC05QG SC06QG SC04FG SC05FG SC06FG SC08FG SC04LG

*Please note that the SteriTite perforated bottom containers are compatible with the Sterizone VP4 Sterilizer.

Table 2 (Continued). SteriTite Container Compatibility with Low Temperature and Steam Sterilizers

STERRAD 100S/200	NX	Steam
Standard	Standard	Pre-Vac
	Advanced	Gravity
		IUSS
SC02MG	SC02MG	SC02MG
SC03MG	SC03MG	SC03MG
SC04MG	SC04MG	SC04MG
SC02NG	SC02NG	SC02NG
SC03NG	SC03NG	SC03NG
SC04NLG	SC04HG	SC04NLG
SC05NLG	SC05HG	SC05NLG
SC04HG	SC04QG	SC04HG
SC05HG	SC05QG	SC05HG
SC06HG	SC04FG	SC06HG
SC08HG		SC08HG
SC04QG		SC04QG
SC05QG		SC05QG
SC06QG		SC06QG
SC08QG		SC08QG
SC04FG		SC04FG
SC05FG		SC05FG
SC06FG		SC06FG
SC08FG		SC08FG
		SC04LG
		SC06LG
		SC08LG
		SC05WG

The following table identifies which MediTray products are compatible with low temperature sterilizers and steam sterilization:

| MediTray Product | V-Pro
maX/2 | V-Pro 1 | V-Pro
s2/60 | STERRAD
100NX | STERRAD
100s/200 | STERRAD
NX | STERIZONE
VP4 | STEAM |
|------------------|----------------|---------|----------------|------------------|---------------------|---------------|------------------|-------|
| Baskets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Trays | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Insert Boxes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |

Metal Brackets	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Metal Partitions	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Posts	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Silicone Brackets	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Racks	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Stringers	Yes	Yes	Yes	Yes	Yes	Yes	Yes

The following table (Table 4)identifies which SteriTite accessories are compatible with low temperature sterilizers and steam sterilization:

Table 4. SteriTite Accessories Sterilizer Compatibility Table

| SteriTite Accessories | V-Pro
maX/2 | V-Pro 1 | V-Pro
s2/60 | STERRAD
100NX | STERRAD
100s/200 | STERRAD
NX | STERIZONE
VP4 | Steam |
|-----------------------|----------------|---------|----------------|------------------|---------------------|---------------|------------------|-------|
| Baskets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Trays | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Insert Boxes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Metal Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Metal Partitions | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Posts | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Silicone Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Racks | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Stringers | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |

The following tables (5-11) identify the sterilizer maximum load weight recommendations with the SteriTite containers:

Table 5. SteriTite Container in V-Pro 60 Maximum Load Weight Recommendations Including Weight of Container

| Part Number | Total Load Weight in
V-Pro s2/60
Lumen Cycle | Total Load Weight in
V-Pro s2/60
Flexible Cycle |
|-------------|----------------------------------------------------|-------------------------------------------------------|
| SC02MG | 25 lbs | 11 lbs |
| SC03MG | 25 lbs | 11 lbs |
| SC04MG | 25 lbs | 11 lbs |
| SC02NG | 25 lbs | 11 lbs |
| SC03NG | 25 lbs | 11 lbs |
| SC04NLG | 25 lbs | 11 lbs |
| SC05NLG | 25 lbs | 11 lbs |
| SC04HG | 25 lbs | 11 lbs |
| SC05HG | 25 lbs | 11 lbs |
| SC04QG | 25 lbs | 11 lbs |
| SC05QG | 25 lbs | 11 lbs |
| SC04FG | 25 lbs | 11 lbs |

Table 6. SteriTite Container in STERRAD NX Maximum Load Weight Recommendations Including Weight of Container

| Part Number | Total Load Weight in
NX Standard Cycle | Total Load Weight in
NX Advanced Cycle |
|-------------|-------------------------------------------|-------------------------------------------|
| SC02MG | 10.7 lbs | 10.7 lbs |
| SC03MG | 10.7 lbs | 10.7 lbs |
| SC04MG | 10.7 lbs | 10.7 lbs |
| SC02NG | 10.7 lbs | 10.7 lbs |
| SC03NG | 10.7 lbs | 10.7 lbs |
| SC04HG | 10.7 lbs | 10.7 lbs |
| SC05HG | 10.7 lbs | 10.7 lbs |
| SC04QG | 10.7 lbs | 10.7 lbs |
| SC05QG | 10.7 lbs | 10.7 lbs |
| SC04FG | 10.7 lbs | 10.7 lbs |

Table 7. SteriTite Container in V-Pro 1 Maximum Load Weight Recommendations Including Weight of Container

Part Number	Total Load Weight in
	V-Pro 1 Lumen Cycle
SC02MG	19.65 lbs
SC03MG	19.65 lbs
SC02NG	19.65 lbs
SC03NG	19.65 lbs
SC04FG	19.65 lbs
SC05FG	19.65 lbs
SC06FG	19.65 lbs
SC08FG	19.65 lbs
SC04HG	19.65 lbs
SC05HG	19.65 lbs
SC06HG	19.65 lbs
SC08HG	19.65 lbs
SC04QG	19.65 lbs
SC05QG	19.65 lbs
SC06QG	19.65 lbs
SC08QG	19.65 lbs
SC04LG	19.65 lbs
SC06LG	19.65 lbs
SC08LG	19.65 lbs
SC05WG	19.65 lbs

Table 8. SteriTite Container in STERRAD 100s/200 Maximum Load Weight Recommendations Including Weight of Container

| Part Number | Total Load Weight in the
STERRAD 100s/200 Standard Cycle |
|-------------|-------------------------------------------------------------|
| SC02MG | 22 lbs |
| SC03MG | 22 lbs |
| SC04MG | 22 lbs |
| SC02NG | 22 lbs |
| SC03NG | 22 lbs |
| SC04NLG | 22 lbs |
| SC05NLG | 22 lbs |
| SC04HG | 22 lbs |

SC05HG	22 lbs
SC06HG	22 lbs
SC08HG	22 lbs
SC04QG	22 lbs
SC05QG	22 lbs
SC06QG	22 lbs
SC08QG	22 lbs
SC04FG	22 lbs
SC05FG	22 lbs
SC06FG	22 lbs
SC08FG	22 lbs

Table 9. SteriTite Container in 100NX Maximum Load Weight Recommendations Including Weight of Container.

| Part Number | 100NX Standard 100NX Flex Cycle 100NX DUO Cycle |
|-------------|--------- | SC02MG | 21.4 lbs | SC03MG | 21.4 lbs | SC04MG | 21.4 lbs | SC02NG | 21.4 lbs | SC03NG | 21.4 lbs | SC04NLG | 21.4 lbs | SC05NLG | 21.4 lbs | SC04HG | 21.4 lbs | SC05HG | 21.4 lbs | SC06HG | 21.4 lbs | SC08HG | 21.4 lbs | SC04QG | 21.4 lbs | SC05QG | 21.4 lbs | SC06QG | 21.4 lbs | SC08QG | 21.4 lbs | SC04FG | 21.4 lbs | SC05FG | 21.4 lbs | SC06FG | 21.4 lbs | SC08FG | 21.4 lbs | SC04LG | 21.4 lbs | SC06LG | 21.4 lbs | SC05WG | 21.4 lbs Total Load Weight in
Cycle | Total Load Weight in
| Total Load Weight in
-------------------------------------|------------------------------------------|-----------------------------------------|
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | Not Compatible |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |
| 21.4 lbs | 13.2 lbs |

Total Load Weight in 100NX Express Cycle

SC02MG	10.7lbs
SC03MG	10.7lbs
SC04MG	10.7lbs
SC02NG	10.7lbs
SC03NG	10.7lbs
SC04NLG	10.7lbs
SC05NLG	10.7lbs
SC04HG	10.7lbs
SC05HG	10.7lbs
SC06HG	10.7lbs

SC08HG	10.7lbs
SC04QG	10.7lbs
SC05QG	10.7lbs
SC06QG	10.7lbs
SC08QG	Not Compatible
SC04FG	10.7lbs
SC05FG	10.7lbs
SC06FG	10.7lbs
SC08FG	10.7lbs
SC04LG	10.7lbs
SC06LG	10.7lbs
SC05WG	10.7lbs

Table 10. SteriTite Container in V-Pro maX/maX 2 Maximum Load Weight Recommendations Including Weight of Container

| Part Number | Total Load Weight in V-Pro
maX/maX 2 Lumen Cycle | Total Load Weight in V-Pro
maX/maX 2 Flex Cycle | Total Load Weight in V-Pro
maX/maX 2 Non-Lumen Cycle |
|-------------|-----------------------------------------------------|----------------------------------------------------|---------------------------------------------------------|
| SC02MG | 19.65 lbs | 24 lbs | 50 lbs |
| SC03MG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04MG | 19.65 lbs | 24 lbs | 50 lbs |
| SC02NG | 19.65 lbs | 24 lbs | 50 lbs |
| SC03NG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04NLG | 19.65 lbs | 24 lbs | 50 lbs |
| SC05NLG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04HG | 19.65 lbs | 24 lbs | 50 lbs |
| SC05HG | 19.65 lbs | 24 lbs | 50 lbs |
| SC06HG | 19.65 lbs | 24 lbs | 50 lbs |
| SC08HG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04QG | 19.65 lbs | 24 lbs | 50 lbs |
| SC05QG | 19.65 lbs | 24 lbs | 50 lbs |
| SC06QG | 19.65 lbs | 24 lbs | 50 lbs |
| SC08QG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04FG | 19.65 lbs | 24 lbs | 50 lbs |
| SC05FG | 19.65 lbs | 24 lbs | 50 lbs |
| SC06FG | 19.65 lbs | 24 lbs | 50 lbs |
| SC08FG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04LG | 19.65 lbs | 24 lbs | 50 lbs |
| SC06LG | 19.65 lbs | 24 lbs | 50 lbs |
| SC08LG | 19.65 lbs | 24 lbs | 50 lbs |
| SC05WG | 19.65 lbs | 24 lbs | 50 lbs |

Table 11. SteriTite Container in Steam Sterilization/IUSS Maximum Load Weight Recommendations Including Weight of Container.

| Part Number | Total Load Weight in
Steam Sterilization Pre-Vacuum Cycle | Total Load Weight in
Steam Sterilization Gravity Cycle |
|-------------|--------------------------------------------------------------|-----------------------------------------------------------|
| SC02MG | 35 lbs | 35 lbs |
| SC03MG | 35 lbs | 35 lbs |

SC04MG	35 lbs	35 lbs
SC02NG	35 lbs	35 lbs
SC03NG	35 lbs	35 lbs
SC04NLG	35 lbs	35 lbs
SC05NLG	35 lbs	35 lbs
SC04HG	35 lbs	35 lbs
SC05HG	35 lbs	35 lbs
SC06HG	35 lbs	35 lbs
SC08HG	35 lbs	35 lbs
SC04QG	35 lbs	35 lbs
SC05QG	35 lbs	35 lbs
SC06QG	35 lbs	35 lbs
SC08QG	35 lbs	35 lbs
SC04FG	35 lbs	35 lbs
SC05FG	35 lbs	35 lbs
SC06FG	35 lbs	35 lbs
SC08FG	35 lbs	35 lbs

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

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

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1. 510K Summary

SteriTite Container System with MediTray Parts

Date Prepared :	10/4/2022
Company Name :	Case Medical, Inc
50 West Street
Bloomfield NJ 07003
Contact:
Email
Office
Fax	Michael Polozani
MPolozani@casemed.com
201-313-1999 x 633
201-373-9090
Trade Name	SteriTite Container System with MediTray Parts
Common Name	Sterilization Wrap Containers, Trays, Cassettes, and Other Accessories
Class of Device	Class II
Regulation Number	21 CFR 880.6850 - Sterilization Wrap
Product Code	кст,
Review Panel	General Hospital
Establishment
Registration Number	2248608
Predicate Device	K212711 -SteriTite Rigid Container Sterilization System with and MediTray
Parts
Description of Device	The SteriTite® Universal Container is a rigid, reusable, sealed sterilization
packaging system that is compatible with steam, hydrogen peroxide, ethylene
oxide, and ozone sterilizers. The SteriTite® container system consists of a family
of rigid reusable containers and inserts that provide an effective reusable
sterilization packaging system for operating room instruments. The SteriTite®
container as previously cleared is available with solid or perforated base. The
container is made of anodized aluminum with passivated stainless-steel
hardware and silicone gaskets. Each filter retention plate with gaskets and off
set vent pattern secures a disposable filter for bacterial barrier filtration. Filter
retention plates in lid and base are interchangeable for universal use. A
recessed gasket contributes to a knife edge fit between lid and base. Various
instrument trays as well as stacked baskets and inserts including insert boxes,
brackets, posts, partitions, and racks provide instrument protection and secure
devices for sterilization within the container.

2. Indications for Use Summary

-STERRAD 100NX ALLCLEAR-Express Cycle
The following table (Table 1) displays the SteriTite part numbers and the sterilizers they are compatible with:

| V-Pro s2/60
Lumen
Flex | V-Pro 1
Lumen | V-Pro
max/maX2
Lumen
Flex
Non-Lumen | Sterizone
VP4
Cycle 1 | 100NX
Standard
Flex | 100NX
DUO
Express** | 100S/200
Standard | NX
Advanced
Standard | Steam
Pre-vac
Gravity
IUSS |
|------------------------------|------------------|-------------------------------------------------|-----------------------------|---------------------------|---------------------------|----------------------|----------------------------|-------------------------------------|
| SC02MG | SC02MG | SC02MG | SC02M(G)* | SC02MG | SC02MG | SC02MG | SC02MG | SC02MG |
| SC03MG | SC03MG | SC03MG | SC03M(G)* | SC03MG | SC03MG | SC03MG | SC03MG | SC03MG |
| SC04MG | SC02NG | SC04MG | SC04M(G)* | SC04MG | SC04MG | SC04MG | SC04MG | SC04MG |
| SC02NG | SC03NG | SC02NG | SC02N(G)* | SC02NG | SC02NG | SC02NG | SC02NG | SC02NG |
| SC03NG | SC04NLG | SC03NG | SC03N(G)* | SC03NG | SC03NG | SC03NG | SC03NG | SC03NG |
| SC04NLG | SC05NLG | SC04NLG | SC04NL(G)* | SC04NLG | SC04NLG | SC04NLG | SC04NLG | SC04NLG |
| SC05NLG | SC04FG | SC05NLG | SC05NL(G)* | SC05NLG | SC05NLG | SC05NLG | SC05NLG | SC05NLG |
| SC04HG | SC05FG | SC04HG | SC04H(G)* | SC04HG | SC04HG | SC04HG | SC04HG | SC04HG |
| SC05HG | SC06FG | SC05HG | SC05H(G)* | SC05HG | SC05HG | SC05HG | SC05HG | SC05HG |
| SC04QG | SC08FG | SC06HG | SC06H(G)* | SC06HG | SC06HG | SC06HG | SC04QG | SC06HG |
| SC05QG | SC04HG | SC08HG | SC08H(G)* | SC08HG | SC08HG | SC08HG | SC05QG | SC08HG |
| SC04FG | SC05HG | SC04QG | SC04Q(G)* | SC04QG | SC04QG | SC04QG | SC04FG | SC04QG |
| | SC06HG | SC05QG | SC05Q(G)* | SC05QG | SC05QG | SC05QG | | SC05QG |
| | SC08HG | SC06QG | SC06Q(G)* | SC06QG | SC06QG | SC06QG | | SC06QG |
| | SC04QG | SC08QG | SC08Q(G)* | SC08QG | SC04FG | SC08QG | | SC08QG |
| | SC05QG | SC04FG | SC04F(G)* | SC04FG | SC05FG | SC04FG | | SC04FG |
| | SC06QG | SC05FG | SC04L(G)* | SC05FG | SC06FG | SC05FG | | SC05FG |
| | SC08QG | SC06FG | SC06L(G)* | SC06FG | SC08FG | SC06FG | | SC06FG |
| | SC04LG | SC08FG | SC08L(G)* | SC08FG | SC04LG | SC08FG | | SC08FG |
| | SC06LG | SC04LG | | SC04LG | SC06LG | SC04LG | | SC04LG |
| | SC05WG | SC06LG | | SC06LG | SC05WG | SC06LG | | SC06LG |
| | | SC05WG | | SC05WG | | SC05WG | | SC08LG |
| | | | | | | | | SC05WG |

Table 1. SteriTite Container Compatibility Table with Low Temperature and Steam Sterilizers

*Please note that the SteriTite perforated bottom containers are compatible with the Sterizone VP4 Sterilizer. **The Express cycle would be added to the Compatibility Table in the Case Medical IFU

K221492

The following table identifies which MediTray products are compatible with ow temperature sterilizers and steam sterilization:

| MediTray Product | V-Pro
maX/2 | V-Pro 1 | V-Pro
s2/60 | STERRAD
100NX | STERRAD
100S/200 | STERRAD
NX | STERIZONE
VP4 | Steam |
|-------------------|----------------|---------|----------------|------------------|---------------------|---------------|------------------|-------|
| Baskets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Trays | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Insert Boxes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Metal Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Metal Partitions | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Posts | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Silicone Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Racks | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Stringers | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |

Table 3. MediTray Products Sterilizer Compatibility Table

The following table identifies which SteriTite accessories are compatible with low temperature sterilizers and steam sterilization:

Table 4. SteriTite Accessories Sterilizer Compatibility Table

| SteriTite Accessories | V-Pro
maX/2 | V-Pro 1 | V-Pro
s2/60 | STERRAD
100NX | STERRAD
100S/200 | STERRAD
NX | STERIZONE
VP4 | Steam |
|-----------------------------|----------------|---------|----------------|------------------|---------------------|---------------|------------------|-------|
| SCF02 Round filter | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| SCFM02 Rectangular filter | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| SCS01W Tamper Evident Seals | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| SCLH2O23 Load Card Large | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| SCLH2O24 Load Card Small | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |

The following tables (5-11) identify the sterilizer maximum load weight recommendations with the SteriTite containers:

Table 5. SteriTite Container in V-Pro 60 Manufacturer's Maximum Load Weight Recommendations Including Weight of Container

| Part
Number | Total Load Weight in V-Pro
s2/60 Lumen Cycle | Total Load Weight in V-Pro
s2/60 Flexible Cycle |
|----------------|-------------------------------------------------|----------------------------------------------------|
| SC02MG | 25lbs | 11lbs |
| SC03MG | 25lbs | 11lbs |
| SC04MG | 25lbs | 11lbs |
| SC02NG | 25lbs | 11lbs |
| SC03NG | 25lbs | 11lbs |
| SC04NLG | 25lbs | 11lbs |
| SC05NLG | 25lbs | 11lbs |
| SC04HG | 25lbs | 11lbs |
| SC05HG | 25lbs | 11lbs |
| SC04QG | 25lbs | 11lbs |
| SC05QG | 25lbs | 11lbs |
| SC04FG | 25lbs | 11lbs |

| Part
Number | Total Load Weight
in NX
Standard Cycle | Total Load Weight
in NX
Advanced Cycle |
|----------------|----------------------------------------------|----------------------------------------------|
| SC02MG | 10.7lbs | 10.7lbs |
| SC03MG | 10.7lbs | 10.7lbs |
| SC04MG | 10.7lbs | 10.7lbs |
| SC02NG | 10.7lbs | 10.7lbs |
| SC03NG | 10.7lbs | 10.7lbs |
| SC04HG | 10.7lbs | 10.7lbs |
| SC05HG | 10.7lbs | 10.7lbs |
| SC04QG | 10.7lbs | 10.7lbs |
| SC05QG | 10.7lbs | 10.7lbs |
| SC04FG | 10.7lbs | 10.7lbs |

Table 6. SteriTite Container in STERRAD NX Manufacturer's Maximum Load Weight Recommendations Including Weight of Container

Table 7. SteriTite Container in V-Pro 1 Maximum Load Weight Recommendations Including Weight of Container

| Part
Number | Total Load Weight in V-Pro 1
Lumen Cycle |
|----------------|---------------------------------------------|
| SC02MG | 19.65lbs |
| SC03MG | 19.65lbs |
| SC02NG | 19.65lbs |
| SC03NG | 19.65lbs |
| SC04FG | 19.65lbs |
| SC05FG | 19.65lbs |
| SC06FG | 19.65lbs |
| SC08FG | 19.65lbs |
| SC04HG | 19.65lbs |
| SC05HG | 19.65lbs |
| SC06HG | 19.65lbs |
| SC08HG | 19.65lbs |
| SC04QG | 19.65lbs |
| SC05QG | 19.65lbs |
| SC06QG | 19.65lbs |
| SC08QG | 19.65lbs |
| SC04LG | 19.65lbs |
| SC06LG | 19.65lbs |
| SC08LG | 19.65lbs |
| SC05WG | 19.65lbs |

Table 8. SteriTite Container in STERRAD 100s/200 Maximum Load Weight Recommendations Including Weight of Container

| Part Number | Total Load Weight in
the STERRAD 100s/200
Standard Cycle |
|-------------|----------------------------------------------------------------|
| SC02MG | 22lbs |
| SC03MG | 22lbs |
| SC04MG | 22lbs |
| SC02NG | 22lbs |
| SC03NG | 22lbs |
| SC04NLG | 22lbs |
| SC05NLG | 22lbs |
| SC04HG | 22lbs |
| SC05HG | 22lbs |
| SC06HG | 22lbs |
| SC08HG | 22lbs |
| SC04QG | 22lbs |
| SC05QG | 22lbs |
| SC06QG | 22lbs |
| SC08QG | 22lbs |
| SC04FG | 22lbs |
| SC05FG | 22lbs |
| SC06FG | 22lbs |
| SC08FG | 22lbs |

Table 9. SteriTite Container in 100NX Maximum Load Weight Recommendations Including Weight of Container

| Part | Total Weight in 100NX
Standard Cycle | Total Weight in 100NX
Flexible Cycle | Total Weight in 100NX
DUO Cycle | Total Weight in 100NX
Express Cycle |
|---------|-----------------------------------------|-----------------------------------------|------------------------------------|----------------------------------------|
| Number | | | | |
| SC02MG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC03MG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC04MG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC02NG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC03NG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC04NLG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC05NLG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC04HG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC05HG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC06HG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC08HG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC04QG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC05QG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC06QG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC08QG | 21.4lbs | 21.4lbs | Not Compatible | Not Compatible |
| SC04FG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC05FG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC06FG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC08FG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC04LG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC06LG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |
| SC05WG | 21.4lbs | 21.4lbs | 13.2lbs | 10.7lbs |

Table 10. SteriTite Container in V-Pro maX/maX 2 Maximum Load Weight Recommendations Including Weight of Container

| Part
Number | Total Load Weight in
V-Pro maX/maX2
Lumen Cycle | Total Load Weight in
V-Pro maX/maX2 Flex
Cycle | Total Load Weight in V-
Pro maX/maX2 Non-
Lumen Cycle |
|----------------|-------------------------------------------------------|------------------------------------------------------|-------------------------------------------------------------|
| SC02MG | 19.65lbs | 24lbs | 50lbs |
| SC03MG | 19.65lbs | 24lbs | 50lbs |
| SC04MG | 19.65lbs | 24lbs | 50lbs |
| SC02NG | 19.65lbs | 24lbs | 50lbs |
| SC03NG | 19.65lbs | 24lbs | 50lbs |
| SC04NLG | 19.65lbs | 24lbs | 50lbs |
| SC05NLG | 19.65lbs | 24lbs | 50lbs |
| SC04HG | 19.65lbs | 24lbs | 50lbs |
| SC05HG | 19.65lbs | 24lbs | 50lbs |
| SC06HG | 19.65lbs | 24lbs | 50lbs |
| SC08HG | 19.65lbs | 24lbs | 50lbs |
| SC04QG | 19.65lbs | 24lbs | 50lbs |
| SC05QG | 19.65lbs | 24lbs | 50lbs |
| SC06QG | 19.65lbs | 24lbs | 50lbs |
| SC08QG | 19.65lbs | 24lbs | 50lbs |
| SC04FG | 19.65lbs | 24lbs | 50lbs |
| SC05FG | 19.65lbs | 24lbs | 50lbs |
| SC06FG | 19.65lbs | 24lbs | 50lbs |
| SC08FG | 19.65lbs | 24lbs | 50lbs |
| SC04LG | 19.65lbs | 24lbs | 50lbs |
| SC06LG | 19.65lbs | 24lbs | 50lbs |
| SC08LG | 19.65lbs | 24lbs | 50lbs |
| SC05WG | 19.65lbs | 24lbs | 50lbs |

| Part
Number | Total Load Weight in
Steam Sterilization
Pre-Vacuum Cycle | Total Load Weight in
Steam Sterilization
Gravity Cycle |
|----------------|-----------------------------------------------------------------|--------------------------------------------------------------|
| SC02MG | 35lbs | 35lbs |
| SC03MG | 35lbs | 35lbs |
| SC04MG | 35lbs | 35lbs |
| SC02NG | 35lbs | 35lbs |
| SC03NG | 35lbs | 35lbs |
| SC04NLG | 35lbs | 35lbs |
| SC05NLG | 35lbs | 35lbs |
| SC04HG | 35lbs | 35lbs |
| SC05HG | 35lbs | 35lbs |
| SC06HG | 35lbs | 35lbs |
| SC08HG | 35lbs | 35lbs |
| SC04QG | 35lbs | 35lbs |
| SC05QG | 35lbs | 35lbs |
| SC06QG | 35lbs | 35lbs |
| SC08QG | 35lbs | 35lbs |
| SC04FG | 35lbs | 35lbs |
| SC05FG | 35lbs | 35lbs |
| SC06FG | 35lbs | 35lbs |
| SC08FG | 35lbs | 35lbs |
| SC04LG | 35lbs | 35lbs |
| SC06LG | 35lbs | 35lbs |
| SC08LG | 35lbs | 35lbs |
| SC05WG | 35lbs | 35lbs |

Table 11. SteriTite Container in Steam Sterilization/IUSS Maximum Load Weight Recommendations Including Weight of Container

Technological Comparison

All functional and design characteristics are the same as the previously cleared in K212711 and show equivalent performance characteristics. The SteriTite container system is the same container system previously cleared and demonstrated the same technical and performance characteristics previously. Sterilization efficacy testing has been conducted to support new indications.

Non-Clinical Performance Testing

Case Medical, Inc. follows the "overkill method" of sterility assurance to show an elimination of a biological challenge. All SteriTite containers were tested with inner baskets or trays representative of the of products. Testing was designed to simulate worst-case scenarios with half cycles utilized with end of shelf-life concentrations of hydrogen peroxide for low temperature sterilization. The bacterial strain G. stearothermophilus was used in all testing due to its resistance to moist heat and hydrogen peroxide. The validation testing was conducted at qualified independent laboratories in accordance with FDA guidance and available ANSI/AAMI standards such as ANSI/AAMI ST77, AAMI TIR 12 and ANSI/AMMI ST-79.

Based on the testing performed on the SteriTite container and MediTray parts, the device has demonstrated compatibility with the sterilizers indicated above. Results are summarized in Table 12 below.

Table 12. Summary of Performance Testing

Performance Testing	Standard	Purpose	Results
Sterility Maintenance	ANSI/AAMI ST77:2013
(R)2018	Demonstrate the integrity of the
container to maintain sterility of contents
over time and with multiple handling
events after sterilization.	Pass
Whole Package
Microbial Challenge	ANSI/AAMI ST77:2013
(R)2018	Demonstration of whole package integrity
following exposure to aerosolized
bacteria spores.	Pass
Biocompatibility	ANSI AAMI ISO10993-
1	Acute systemic toxicity, primary irritation
and sensitization of the subject device.	Pass
Material
Compatibility / Re-
Use Testing	ANSI/AAMI ST77:2013
(R)2018	Demonstration that the subject device
materials are compatible with the
intended sterilization cycles.	Pass
Simulated Use
Testing/Sterilization
Efficacy	ANSI AAMI ISO
14937:2009/(R)2013	Testing was completed to demonstrate
sterilization efficacy of the subject device
for processing of medical devices with
the indicated claims using the identified
sterilization processes.	Pass

Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission for the SteriTite Universal Container System and MediTray Products, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K212711.