SteriTite rigid reusable sterilization container with MediTray Products

K240898 · Case Medical · KCT · Jul 31, 2024 · General Hospital

Device Facts

• Record ID: K240898
• Device Name: SteriTite rigid reusable sterilization container with MediTray Products
• Applicant: Case Medical
• Product Code: KCT · General Hospital
• Decision Date: Jul 31, 2024
• 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. The solid and perforated bottom container configurations are compatible for use with the following low temperature sterilizers and cycles identified below: - STERIS V-Pro 60: Flexible and Lumen cycle (Solid and perforated bottom container) - STERIS V-Pro s2: Flexible and Lumen cycle (Solid and perforated bottom container) - STERIS V-Pro maX 2: Lumen, Non-Lumen and Flexible cycle (Solid and perforated bottom container) - STERIS V-Pro maX: Lumen, Non-Lumen and Flexible cycle (Solid and perforated bottom container)

Device Story

Rigid reusable sterilization container system; consists of anodized aluminum lid/base, passivated stainless-steel hardware, and platinum-cured silicone gaskets. Used by healthcare providers in clinical settings to enclose medical instruments during sterilization, transport, and storage. Input: medical devices placed inside container with MediTray inserts. Operation: container utilizes perforated lid vents with single-use polypropylene filters to allow sterilant penetration while maintaining microbial barrier; solid base design reduces potential microbial ingression points compared to perforated-base predicates. Output: sterilized, protected medical instruments. Healthcare providers use the system to maintain sterility until point of use; tamper-evident seals provide visual confirmation of container integrity. Benefits: provides durable, reusable packaging that ensures sterility maintenance and protects instruments from damage during handling.

Clinical Evidence

Bench testing only. Testing conducted in accordance with ANSI/AAMI ST77, AAMI TIR 12, and ANSI/AAMI ST-79. Validated using the 'overkill method' with G. stearothermophilus biological indicators. Endpoints included sterility maintenance, whole package microbial challenge, biocompatibility (ISO 10993-1), material compatibility, and sterilization efficacy in V-Pro cycles. All tests passed.

Technological Characteristics

Materials: Anodized aluminum (lid/base), passivated stainless steel (hardware), platinum-cured silicone (gaskets), polypropylene (single-use filters). Design: Rigid container with gasketed lid-to-base seal, tamper-evident latching, and filter retention plates. Sterilization: Low-temperature vaporized hydrogen peroxide (V-Pro cycles) and pre-vacuum steam. 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 STERIS V-Pro low-temperature 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 products (K212711)

Reference Devices

• Steris V-Pro maX (K112904)
• Steris V-Pro maX 2 (K221492)
• Steris V-Pro s2 (K221492)
• Steris V-Pro 60 (K221492)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 31, 2024

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

Re: K240898/S001
Trade/Device Name: SteriTite rigid reusable sterilization container with MediTray Products
Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization Wrap
Regulatory Class: Class II
Product Code: KCT
Dated: March 25, 2024
Received: April 1, 2024

Dear Marcia Frieze:

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

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

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

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

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K240898 - Marcia Frieze
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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.

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

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

Sincerely,

Christopher K. Dugard -S

Christopher K. Dugard, MS
Assistant Director
Center for Devices and Radiological Health
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K240898

Device Name
SteriTite rigid reusable sterilization 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. The solid and perforated bottom container configurations are compatible for use with the following low temperature sterilizers and cycles identified below:

- STERIS V-Pro 60: Flexible and Lumen cycle (Solid and perforated bottom container)
- STERIS V-Pro s2: Flexible and Lumen cycle (Solid and perforated bottom container)
- STERIS V-Pro maX 2: Lumen, Non-Lumen and Flexible cycle (Solid and perforated bottom container)
- STERIS V-Pro maX: Lumen, Non-Lumen and Flexible cycle (Solid and perforated bottom container)

☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)

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.**

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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The following tables (1-3) identify the sterilizer maximum load weight recommendations with the SteriTite containers in V-Pro sterilization cycles as well as lumen claims per cycle.

Table 1. SteriTite Container in V-Pro s2 and V-Pro 60 including Weight of Container

| Part Number | Total Load Weight in V-Pro s2/60 Non-Lumen Cycle | Total Load Weight in V-Pro s2/60 Flexible Cycle |
| --- | --- | --- |
| SC02M | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC03M | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC04M | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC02N | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC03N | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC03NL | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC04NL | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC05NL | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC04H | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC05H | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC04Q | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC05Q | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC04F | 25 lbs/11.3kg | 11 lbs/4.9kg |

Table 2. SteriTite Container Maximum Load Weight in V-Pro maX/maX 2 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 |
| --- | --- | --- | --- |
| SC02M | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC03M | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC04M | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC02N | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC03N | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC03NL | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC04NL | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50 lbs/22.6kg |
| SC05NL | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50 lbs/22.6kg |
| SC04H | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50 lbs/22.6kg |
| SC05H | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50 lbs/22.6kg |
| SC06H | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50 lbs/22.6kg |
| SC08H | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50 lbs/22.6kg |
| SC04Q | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50 lbs/22.6kg |
| SC05Q | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50lbs/22.6kg |
| SC06Q | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50lbs/22.6kg |
| SC08Q | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50lbs/22.6kg |
| SC04F | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50lbs/22.6kg |
| SC05F | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50lbs/22.6kg |
| SC06F | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50lbs/22.6kg |
| SC08F | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50lbs/22.6kg |
| SC04L | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50lbs/22.6kg |
| SC06L | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50lbs/22.6kg |
| SC08L | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50lbs/22.6kg |
| SC05W | 19.65 lbs/ 8.9kg | 24lbs/11kg | 50lbs/22.6kg |

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Table 3. Sterilant penetration for channel lumens using solid bottom container in STERIS V-Pro sterilization

| Sterilizer | Cycle | Lumen Sterilization Claims (I.D. x Length) |
| --- | --- | --- |
| STERIS V-Pro 60 | Flexible | ≥1mm x ≤990mm: Single or Dual Lumen (Solid Bottom)* |
| STERIS V-Pro 60 | Lumen | ≥0.77mm x ≤527mm: Dual Channel (Solid Bottom)** |
| STERIS V-Pro s2 | Flexible | ≥1mm x ≤990mm: Single or Dual Lumen (Solid Bottom) |
| STERIS V-Pro s2 | Lumen | ≥0.77mm x ≤527mm: Dual Channel (Solid Bottom) |
| STERIS V-Pro maX 2 | Flexible | ≥1mm x ≤1050mm: Single Lumen (Solid Bottom) |
| STERIS V-Pro maX 2 | Lumen | ≥0.77mm x ≤527mm: Dual Channel (Solid Bottom) |
| STERIS V-Pro maX | Flexible | ≥1mm x ≤1050mm: Single Lumen (Solid Bottom) |
| STERIS V-Pro maX | Lumen | ≥0.77mm x ≤527mm: Dual Channel (Solid Bottom) |

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Confidential Information
Page 1 of 8
K240898

# 510K Summary K240898

## SteriTite rigid reusable sterilization container with MediTray Products

**Date Prepared**: 03/25/2024
**Company Name**: Case Medical, Inc
50 West Street
Bloomfield NJ 07003

**Contact**: Marcia Frieze
**Email**: [e-mail]
**Office**: 201-313-1999 x 225
**Fax**: 201-373-9090

**Trade Name**: SteriTite Container System with MediTray Products
**Common Name**: SteriTite Universal Container System
**Class of Device**: Class II
**Product Code**: KCT
**Review Panel**: General Hospital
**Establishment Registration Number**: 2248608
**Predicate Device**: K212711 -SteriTite Rigid Container Sterilization System with and MediTray products

## Description of Device

The SteriTite® Universal Container system consists of a family of rigid reusable containers and inserts that provide an effective reusable sterilization packaging system for operating room instruments. The SteriTite container, as previously cleared, is available with solid or perforated base. The container is made of anodized aluminum with passivated stainless-steel hardware and silicone gaskets, disposable single use filter, tamper evident seal, and perforated vents for sterilant penetration and air removal.

## 10.3 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. The solid and perforated bottom container configurations are compatible for use with the following low temperature sterilizers and cycles identified below:

- STERIS V-Pro 60: Flexible and Lumen cycle (Solid and perforated bottom container)
- STERIS V-Pro s2: Flexible and Lumen cycle (Solid and perforated bottom container)
- STERIS V-Pro maX 2: Lumen, Non-Lumen and Flexible cycle (Solid and perforated bottom container)
- STERIS V-Pro maX: Lumen, Non-Lumen and Flexible cycle (Solid and perforated bottom container)

Case Medical, Inc | 50 West St. Bloomfield NJ 07003 | 201-313-1999 | www.casemed.com

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Confidential Information

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K240898

The following table (Table 1) displays the SteriTite part numbers and the sterilizers they are compatible with:

Table 1. SteriTite Solid Bottom Container Compatibility with Low Temperature and Pre vacuum Steam Sterilizers.

| Part Number | Description | V-Pro maX/maX 2 | V-Pro s2/60 |
| --- | --- | --- | --- |
| SC02M | 2” High Mini-Size Solid Base | Yes | Yes |
| SCO3M | 3” High Mini-Size Solid Base | Yes | Yes |
| SCO4M | 4” High Mini-Size Solid Base | Yes | Yes |
| SC02N | 2” High Narrow-Size Solid Base | Yes | Yes |
| SC03N | 3” High Narrow-Size Solid Base | Yes | Yes |
| SC03NL | 3” High Narrow Long-Size Solid Base | Yes | Yes |
| SC04NL | 4” High Narrow Long-Size Solid Base | Yes | Yes |
| SC05NL | 5” High Narrow Long -Size Solid Base | Yes | Yes |
| SC04H | 4” High Half-Size w/ Solid Base | Yes | Yes |
| SC05H | 5” High Half-size w/ Solid Base | Yes | Yes |
| SC06H | 6” High Half-Size w/ Solid Base | Yes | N/A |
| SC08H | 8” High Half-Size w/ Solid Base | Yes | N/A |
| SC04Q | 4” High 3/4 Size w/ Solid Base | Yes | Yes |
| SC05Q | 5” High 3/4 Size w/ Solid Base | Yes | Yes |
| SC06Q | 6” High 3/4 Size w/ Solid Base | Yes | N/A |
| SC08Q | 8” High 3/4 Size w/ Solid Base | Yes | N/A |
| SC04F | 4” High Full-size w/ Solid Base | Yes | Yes |
| SC05F | 5” High Full-size w/ Solid Base | Yes | N/A |
| SC06F | 6” High Full-size w/ Solid Base | Yes | N/A |
| SC08F | 8” High Full-size w/ Solid Base | Yes | N/A |
| SC04L | 4” High Long-size w/ Solid Base | Yes | N/A |
| SC06L | 6” High Long-size w/ Solid Base | Yes | N/A |
| SC08L | 8” High Long-size w/ Solid Base | Yes | N/A |
| SC05W | 5” High Long Size w/ Solid Base | Yes | N/A |

The following table (Table 2) identifies which MediTray products are compatible with low temperature sterilizers and steam sterilization:

Table 2. MediTray Compatibility with Low Temp. Sterilizers & Steam Containerized and Wrapped

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

Case Medical, Inc | 50 West St. Bloomfield NJ 07003 | 201-313-1999 | www.casemed.com

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K240898

The following table (Table 3) identifies which SteriTite accessories are compatible with low temperature sterilization:

Table 3. SteriTite Consumables for Low Temperature

| SteriTite Disposables | Steris V-Pro maX/maX2 | V-Pro s2/60 |
| --- | --- | --- |
| SCF02 Round Polypro* filter | Yes | Yes |
| SCFM02 Rectangular Polypro* filter | Yes | Yes |
| SCS01W Tamper Evident Seal White | Yes | Yes |
| SCLH2O23 Load Card Large | Yes | Yes |
| SCLH2O24 Load Card Small | Yes | Yes |

*PolyPro is a non-woven polypropylene filter material that must be used for vaporized hydrogen peroxide and gas plasma. It may be used for steam sterilization. Use round filters for standard container sizes, rectangular filters for mini, narrow, and narrow long containers.

The following tables (4-5) identify the sterilizer maximum load weight recommendations with the SteriTite containers in Low temperature sterilization:

Table 4. SteriTite Container in V-Pro s2 and V-Pro 60 including Weight of Container

| Part Number | Total Load Weight in V-Pro s2/60 Non-Lumen Cycle | Total Load Weight in V-Pro s2/60 Flexible Cycle |
| --- | --- | --- |
| SC02M | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC03M | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC04M | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC02N | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC03N | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC03NL | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC04NL | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC05NL | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC04H | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC05H | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC04Q | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC05Q | 25 lbs/11.3kg | 11 lbs/4.9kg |
| SC04F | 25 lbs/11.3kg | 11 lbs/4.9kg |

Case Medical, Inc | 50 West St. Bloomfield NJ 07003 | 201-313-1999 | www.casemed.com

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K240898

Table 5. SteriTite Container Maximum Load Weight in V-Pro maX/maX 2 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 |
| --- | --- | --- | --- |
| SC02M | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC03M | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC04M | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC02N | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC03N | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC03NL | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC04NL | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC05NL | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC04H | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC05H | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC06H | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC08H | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC04Q | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC05Q | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC06Q | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC08Q | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC04F | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC05F | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC06F | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC08F | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC04L | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC06L | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC08L | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |
| SC05W | 19.65 lbs/ 8.9kg | 24 lbs/11kg | 50 lbs/22.6kg |

# Indications For Use Comparison

The device has no different indication for use than the predicate (K212711). The SteriTite rigid reusable sealed container system with solid base is equivalent to the SteriTite container with perforated base (predicate) previously cleared for compatibility with Steris V-Pro Sterilizers, including Steris V-Pro maX (K112904), V-Pro maX 2, V-Pro s2, V-Pro 60 (K221492, K212711). Case Medical adheres to the overkill principle for sterilization validation testing. As a worst-case scenario, half cycles are utilized, as are end of shelf-life concentrations of hydrogen peroxide for low temperature sterilization validation. The SteriTite container system has also been previously cleared for compatibility with other various low temperature sterilizers as well as steam sterilization. All functional and design characteristics are the same as the predicate previously cleared and show equivalent performance characteristics. The SteriTite container system with MediTray products presented in the current submission shares the same technological characteristics as the previously cleared SteriTite container and MediTray products. This includes anodized lid and base, passivated stainless steel hardware, gasketed seal between lid and base, platinum cured silicone gaskets, perforated vent pattern on the lid, utilizing polypropylene filters (polypropylene filters specified for H2O2 sterilizers), tamper evident latching mechanism, and one year shelf life (365 days) for sterility maintenance

Case Medical, Inc | 50 West St. Bloomfield NJ 07003 | 201-313-1999 | www.casemed.com

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# Technological Comparison

Table 6. Technological Characteristics of Predicate and Subject Device

| Technological Characteristics | Predicate | Subject Device |
| --- | --- | --- |
| Anodized aluminum lid and base | Same | Same |
| Passivated stainless steel hardware | Same | Same |
| Platinum cured silicone gaskets | Same | Same |
| Perforated vent pattern on lid | Same | Same |
| Perforated vent pattern on base | Yes | Different |
| Interchangeable filter retention plate | Same | Same |
| Polypropylene single use filters | Same | Same |
| Tamper evident latching mechanism | Same | Same |
| One year shelf-life sterility maintenance | Same | Same |
| Pre-Vacuum Steam Sterilization | Same | Same |
| Low Temperature Sterilization (V-Pro) | Same | Same |

The following tables (6a-6d) list the substantial equivalence of the previously cleared perforated bottom SteriTite container with MediTray products (predicate) K212711 and the solid base SteriTite container system and MediTray products (subject device).

Table 6a Indications for Use

| INDICATIONS FOR USE: | Predicate | Subject Device |
| --- | --- | --- |
| Intended to enclose medical devices | Same | Same |
| Intended for holding instruments to be sterilized, transported, and stored | Same | Same |
| Intended to be reused | Same | Same |
| Protect instruments from damage | Same | Same |
| Maintain the sterility of enclosed medical devices | Same | Same |
| Provide a barrier to microorganisms | Same | Same |

Table 6b Device Design

| DESIGN: | Predicate | Subject Device |
| --- | --- | --- |
| Rectangular anodized aluminum container consisting of lid and base | Same | Same |
| Recessed gasket seal between lid and base | Same | Same |
| Filter system to permit entry of sterilant agent and exit | Same | Same |
| Off set retention plate | Same | Same |
| Microbial barrier migration | Same | Same |
| Interchangeable filter retention plates with gasket | Same | Same |
| Latching mechanism to secure lid and base | Same | Same |
| Tamper-proof locking mechanisms | Same | Same |
| Handles for ease of transport | Same | Same |
| Passivated stainless-steel hardware | Same | Same |
| A knife edge fit between lid and base. | Same | Same |
| Various instrument trays to correspond with container | Same | Same |
| Organizational inserts | Same | Same |
| Internal and external stacking | Same | Same |
| Aseptic presentation of contents | Same | Same |

Case Medical, Inc | 50 West St. Bloomfield NJ 07003 | 201-313-1999 | www.casemed.com

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Table 6c Performance Standards/Specifications
| PERFORMANCE STANDARDS/ SPECIFICATIONS: | Predicate | Subject Device |
| --- | --- | --- |
| Sterile barrier system | Same | Same |
| Secure transport of sterilized contents to point of use | Same | Same |
| Shelf life 365 days/ 1year of sterility maintenance | Same | Same |
| Dry outcome in all methods of sterilizations | Same | Same |
| Corrosion resistant seal | Same | Same |
| Inspection Instructions included in labeling | Same | Same |
| Durable construction for long use life | Same | Same |
| User responsibilities listed in labeling | Same | Same |
| Remain sealed until opened | Same | Same |
| The filter retention plates audibly click to lock into place | Same | Same |
| Tamper evident seals on latches provide visual evidence of sterility breach | Same | Same |
| Lid and bottom are made of anodized aluminum making them lightweight | Same | Same |

Table 6d Validation
| VALIDATION: | Predicate | Subject Device |
| --- | --- | --- |
| Half Cycle Test Conditions | Same | Same |
| Maximum Load Test | Same | Same |
| Microbial Barrier | Same | Same |
| Test Organism G. Stearothermophilus | Same | Same |
| Simulated Use Test | Same | Same |
| Inoculated blades | Same | Same |
| Inoculated lumens | Same | Same |
| Occlusion / matted surfaces | Same | Same |
| Sterilization of single and dual lumen devices | Same | Same |
| Testing in lumen, non-lumen, and flexible cycles | Same | Same |

Non-Clinical Performance Testing
Case Medical, Inc. follows the “overkill method” of sterility assurance to show an elimination of a biological challenge. All SteriTite containers were tested with inner baskets or trays representative of the MediTray line of products. Testing was designed to simulate worst-case scenarios with half cycles utilized with end of shelf-life concentrations of hydrogen peroxide for low temperature sterilization. The bacterial strain G. stearothermophilus was used in all testing due to its resistance to moist heat and hydrogen peroxide. The validation testing was conducted at qualified independent laboratories in accordance with FDA guidance and available ANSI/AAMI standards such as ANSI/AAMI ST77, AAMI TIR 12 and ANSI/AMMI ST-79. Results are summarized in Table 7 below.

Table 7. Summary of Performance Testing
The solid bottom container is substantially equivalent to the perforated bottom container. However, it has greater performance features for sterility maintenance and for maintaining a microbial barrier as there are no perforations or vents in the bottom of the container.

Case Medical, Inc | 50 West St. Bloomfield NJ 07003 | 201-313-1999 | www.casemed.com

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| 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 | Demonstrated sterilization efficacy of the subject device for processing medical devices using the identified sterilization processes. | Pass |

Table 8. Sterilant penetration

| Test Device | Predicate | Subject Device |
| --- | --- | --- |
| General instrumentation | Same | Same |
| Single/double channel flexible endoscopes | Same | Same |
| Single/double channel rigid endoscopes | Same | Same |
| Closed-end Cannula | N/A | Pass |

Table 9. Sterilant penetration for channel lumens using solid bottom container in low temperature sterilization and steam

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

Case Medical, Inc | 50 West St. Bloomfield NJ 07003 | 201-313-1999 | www.casemed.com

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*The validation study in the flexible cycle utilized lumens of 0.48 mm I.D x 100 mm L. Additional lumens in the load were 1.0mm I.D x 1050 mm L. (Attachment 013- Steris Lab Report 14463393.A) ** ≥ 0.8mm ID and ≤ 542 mm in length lumens have been shown to be equivalent to be equivalent for validation testing purposes to the predicate ≥0.77mm ID and ≤527mm in length (Attachment 011- Steris Lab report 14463391.A).

# Conclusion

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

The solid bottom container has been previously cleared in pre-vacuum steam, EO, VP4 sterilizer and received FDA 510k clearance. This submission is for compatibility of the SteriTite solid bottom container system in the V-Pro maX, V-Pro maX2, V-Pro s2 and the V-Pro 60 sterilizer. The solid bottom container is substantially equivalent to the perforated bottom container previously cleared. However, it has greater performance features for sterility maintenance and for maintaining a microbial barrier as there are no perforations or vents in the bottom of the container. 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.

All functional and design characteristics are the same as the predicate previously cleared in K212711 and show equivalent performance characteristics. The SteriTite container system with solid base for this submission is the same container system that has been previously cleared for steam and low temperature sterilization with perforated base. The solid base line of SteriTite container systems has only perforations on the lid compared to the predicate which has perforations in lid and base. Therefore, there are fewer inlets for microbial ingression. The solid bottom line of SteriTite container systems demonstrated the same technical and performance characteristics in the V-Pro maX, V-Pro maX 2, V-Pro s2, and V-Pro 60 as the predicate. The functional and design characteristics are the same as the predicate previously cleared and show equivalent performance characteristics.

Case Medical, Inc | 50 West St. Bloomfield NJ 07003 | 201-313-1999 | www.casemed.com