SteriTite Container System with MediTray Parts

K221492 · Case Medical, Inc. · KCT · Oct 7, 2022 · General Hospital

Device Facts

• Record ID: K221492
• Device Name: SteriTite Container System with MediTray Parts
• Applicant: Case Medical, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Oct 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

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)

Device Story

Reusable rigid sterilization container system; consists of anodized aluminum containers with passivated stainless-steel hardware and silicone gaskets. Features filter retention plates with disposable bacterial barrier filters. Used in clinical settings (hospitals/ORs) by healthcare providers to house surgical instruments during sterilization, transport, and storage. Protects instruments via internal baskets, trays, inserts, brackets, and racks. Compatible with various low-temperature (hydrogen peroxide gas plasma/vapor) and steam sterilization cycles. Ensures sterility maintenance until point of use. Benefits include standardized, durable, and validated protection for surgical instrumentation.

Clinical Evidence

Bench testing only. Validated per ANSI/AAMI ST77, AAMI TIR 12, and ANSI/AAMI ST-79. Testing included sterility maintenance, whole package microbial challenge, biocompatibility (ISO 10993-1), material compatibility, and sterilization efficacy (ISO 14937) using G. stearothermophilus biological indicators.

Technological Characteristics

Materials: Anodized aluminum, passivated stainless-steel hardware, silicone gaskets. Design: Rigid, reusable container with filter retention plates and disposable filters. Compatibility: Low-temperature (V-Pro, STERRAD, Sterizone) and steam sterilization. Standards: ANSI/AAMI ST77, ISO 10993-1, ISO 14937.

Indications for Use

Indicated for use by healthcare providers to enclose, sterilize, transport, and store medical devices. Compatible with specific low-temperature (V-Pro, STERRAD, Sterizone) and steam sterilization cycles.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• SteriTite Rigid Container Sterilization System with and MediTray Parts (K212711)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## Indications for Use

510(k) Number (if known) K221492

#### Device Name

SteriTite Container with MediTray Products

#### Indications for Use (Describe)

The SteriTite container and MediTray products are a reusable sterilization container system to be used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. It is intended to allow sterilization of the enclosed devices and maintain sterility of the enclosed 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) |

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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

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*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<br>maX/2 | V-Pro 1 | V-Pro<br>s2/60 | STERRAD<br>100NX | STERRAD<br>100s/200 | STERRAD<br>NX | STERIZONE<br>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 |

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| 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<br>maX/2 | V-Pro 1 | V-Pro<br>s2/60 | STERRAD<br>100NX | STERRAD<br>100s/200 | STERRAD<br>NX | STERIZONE<br>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<br>V-Pro s2/60<br>Lumen Cycle | Total Load Weight in<br>V-Pro s2/60<br>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

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| Part Number | Total Load Weight in<br>NX Standard Cycle | Total Load Weight in<br>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<br>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 |

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

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| 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<br>maX/maX 2 Lumen Cycle | Total Load Weight in V-Pro<br>maX/maX 2 Flex Cycle | Total Load Weight in V-Pro<br>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<br>Steam Sterilization Pre-Vacuum Cycle | Total Load Weight in<br>Steam Sterilization Gravity Cycle |
|-------------|--------------------------------------------------------------|-----------------------------------------------------------|
| SC02MG | 35 lbs | 35 lbs |
| SC03MG | 35 lbs | 35 lbs |

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| 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<br>50 West Street<br>Bloomfield NJ 07003 |
| Contact:<br>Email<br>Office<br>Fax | Michael Polozani<br>[e-mail]<br>201-313-1999 x 633<br>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<br>Registration Number | 2248608 |
| Predicate Device | K212711 -SteriTite Rigid Container Sterilization System with and MediTray<br>Parts |
| Description of Device | The SteriTite® Universal Container is a rigid, reusable, sealed sterilization<br>packaging system that is compatible with steam, hydrogen peroxide, ethylene<br>oxide, and ozone sterilizers. The SteriTite® container system consists of a family<br>of rigid reusable containers and inserts that provide an effective reusable<br>sterilization packaging system for operating room instruments. The SteriTite®<br>container as previously cleared is available with solid or perforated base. The<br>container is made of anodized aluminum with passivated stainless-steel<br>hardware and silicone gaskets. Each filter retention plate with gaskets and off<br>set vent pattern secures a disposable filter for bacterial barrier filtration. Filter<br>retention plates in lid and base are interchangeable for universal use. A<br>recessed gasket contributes to a knife edge fit between lid and base. Various<br>instrument trays as well as stacked baskets and inserts including insert boxes,<br>brackets, posts, partitions, and racks provide instrument protection and secure<br>devices for sterilization within the container. |

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### 2. Indications for Use Summary

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 sterilizer and cycle identified below:

- -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<br>Lumen<br>Flex | V-Pro 1<br>Lumen | V-Pro<br>max/maX2<br>Lumen<br>Flex<br>Non-Lumen | Sterizone<br>VP4<br>Cycle 1 | 100NX<br>Standard<br>Flex | 100NX<br>DUO<br>Express** | 100S/200<br>Standard | NX<br>Advanced<br>Standard | Steam<br>Pre-vac<br>Gravity<br>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

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### K221492

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

| MediTray Product | V-Pro<br>maX/2 | V-Pro 1 | V-Pro<br>s2/60 | STERRAD<br>100NX | STERRAD<br>100S/200 | STERRAD<br>NX | STERIZONE<br>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<br>maX/2 | V-Pro 1 | V-Pro<br>s2/60 | STERRAD<br>100NX | STERRAD<br>100S/200 | STERRAD<br>NX | STERIZONE<br>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<br>Number | Total Load Weight in V-Pro<br>s2/60 Lumen Cycle | Total Load Weight in V-Pro<br>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 |

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| Part<br>Number | Total Load Weight<br>in NX<br>Standard Cycle | Total Load Weight<br>in NX<br>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<br>Number | Total Load Weight in V-Pro 1<br>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<br>the STERRAD 100s/200<br>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 |

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

| Part | Total Weight in 100NX<br>Standard Cycle | Total Weight in 100NX<br>Flexible Cycle | Total Weight in 100NX<br>DUO Cycle | Total Weight in 100NX<br>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<br>Number | Total Load Weight in<br>V-Pro maX/maX2<br>Lumen Cycle | Total Load Weight in<br>V-Pro maX/maX2 Flex<br>Cycle | Total Load Weight in V-<br>Pro maX/maX2 Non-<br>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 |

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| Part<br>Number | Total Load Weight in<br>Steam Sterilization<br>Pre-Vacuum Cycle | Total Load Weight in<br>Steam Sterilization<br>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.

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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…