EZ-TRAX Containment Device

K192487 · K1 Medical, LLC · KCT · Dec 23, 2019 · General Hospital

Device Facts

• Record ID: K192487
• Device Name: EZ-TRAX Containment Device
• Applicant: K1 Medical, LLC
• Product Code: KCT · General Hospital
• Decision Date: Dec 23, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The EZ-TRAX™ Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store medical devices between surgical and other medical uses. The EZ-TRAX™ Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.

Device Story

The EZ-TRAX™ Containment Device is a reusable sterilization cassette used in healthcare facilities to organize and protect medical instruments during reprocessing, transport, and storage. It consists of perforated anodized aluminum bases and lids with stainless steel handles and thermoplastic polymer posts. The device is used in conjunction with an FDA-cleared sterile barrier system (e.g., sterilization wrap) to maintain sterility. It is designed for dynamic air removal steam sterilization cycles (270°F/132°C for 4 minutes). The device protects instruments—including cannulated devices, forceps, and retractors—from damage during handling. Healthcare providers use the device to manage instrument sets, ensuring they remain organized and protected throughout the sterilization and transport workflow. It benefits patients by ensuring that surgical instruments are properly processed and maintained in a sterile state until use.

Clinical Evidence

No clinical data were included in this submission. Performance was established through bench testing, including cleaning validation (hemoglobin and protein assays), sterilization validation (SAL 10^-6), thermal profile studies, drying time verification, and mechanical strength testing (handle load testing). Biocompatibility was confirmed via cytotoxicity testing per ISO 10993-5.

Technological Characteristics

Materials: Anodized aluminum, stainless steel, medical-grade thermoplastic polymers. Design: Perforated base/lid assembly with locking latches and dividers. Sterilization: Dynamic air removal steam (270°F/132°C). Standards: ANSI/AAMI/ISO 17665-2, AAMI ST77, AAMI ST79, ISO 10993-5. Connectivity: None (mechanical device).

Indications for Use

Indicated for use in healthcare facilities to organize, enclose, reprocess, transport, and store medical devices between surgical and other medical uses. Used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system. Not intended to maintain sterility on its own.

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

• Medtronic Transportation / Sterilization Cassettes (K152241)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 23, 2019

K1 Medical LLC % Joseph Azary Regulatory Consultant K1 Medical Technologies 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K192487

Trade/Device Name: EZ-TRAX™ Containment Device Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: November 24, 2019 Received: November 27, 2019

Dear Joseph Azary:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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.

{1}------------------------------------------------

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 mediation-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.

CAPT. Elizabeth Claverie Williams, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (if known) K192487

Device Name

## EZ-TRAX™ Containment Device

Indications for Use (Describe)

The EZ-TRAXIM Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store medical devices between surgical and other medical uses. The EZ-TRAX™ Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.

# Validated Cycle Times for Dynamic Air Removal Steam Sterilization Cycles

| Cycle | Temperature | Exposure Time | Drying Time |
|------------------------|----------------|---------------|-------------|
| Dynamic Air<br>Removal | 270° F/ 132° C | 4 minutes | 10 minutes |

Sterilization validations included a worst case EZ-TRAX™ Containment Device and a medical device challenge set comprising of:

- Lumen dimensions (3) 1mm x 500mm -
- -Conjoined/mated surfaces: forceps, clamps, bending pliers, ratchet handles, retractors
- -Cannulated: drill bits, taps, guides, screwdrivers, cannulated screws
- -A total weight of 42 lbs comprising of (EZ-TRAX" " Containment Device + sterile barrier system + medical device load) as a worst case challenge to the system. Healthcare facilities should not exceed 25 pounds (EZ-TRAXIM Containment Device + sterile barrier system + medical device load).

The EZ-TRAX™ is offered in the following sizes:

| Brand Name | Model | Dimensions |
|------------|------------------------|---------------------------------|
| EZ-TRAXTM | BASE.ASSY.AL.24.12.2 | (L) 22.97" (W) 11.18" (H) 2.04" |
| EZ-TRAXTM | BASE.ASSY.AL.24.12.2.4 | (L) 22.97" (W) 11.18" (H) 2.44" |

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

_ Prescription Use (Part 21 CFR 801 Subpart D)

ZOver-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and

FORM FDA 3881 (8/14)

{3}------------------------------------------------

complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number

{4}------------------------------------------------

### 510(K) SUMMARY

# K1 Medical LLC's EZ-TRAX'M Containment Device K192487

#### Submitter

K1 Medical LLC 56 Newton Road Woodbridge, CT 06525 Contact Person: Joseph Azary, Regulatory Consultant

Phone: [phone]

Date Prepared: December 21, 2019

Name of Device: EZ-TRAXTM Containment Device

Common or Usual Name: Sterilization Cassette

Classification Name: Sterilization Wrap

Regulatory Class: Class II, 21 CFR 880.6850

Product Code: KCT

Predicate Device: Medtronic Transportation / Sterilization Cassettes (K152241)

#### Intended Use / Indications for Use

The EZ-TRAX™ Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store medical devices between surgical and other medical uses. The EZ-TRAX™ Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.

#### Validated Cycle Times for Dynamic Air Removal Steam Sterilization Cycles

| Cycle | Temperature | Exposure Time | Drying Time |
|------------------------|----------------|---------------|-------------|
| Dynamic Air<br>Removal | 270° F/ 132° C | 4 minutes | 10 minutes |

Sterilization validations included a worst case EZ-TRAX™ Containment Device and a medical device challenge set comprising of:

- Lumen dimensions (3) 1mm x 500mm -
- Conjoined/mated surfaces: forceps, clamps, bending pliers, ratchet handles, retractors -
- Cannulated: drill bits, taps, guides, screwdrivers, cannulated screws -
- A total weight of 42 lbs comprising of (EZ-TRAXTM Containment Device + sterile barrier system + medical device load) as a worst case challenge to the system. Healthcare facilities should not exceed 25 pounds (EZ-TRAXTM Containment Device + sterile barrier system + medical device load).

{5}------------------------------------------------

## Device Description

The EZ-TRAXTM Containment Device includes bases with dividers, lids, and brackets fabricated from a variety of materials commonly used to enclose, protect, and organize non-sterile medical devices.

The subject device is not intended to maintain sterility, but it is intended to be used in conjunction with a legally marketed, validated, FDA cleared sterilization wrap.

The subject device protects the interior components during transportation, and storage.

The EZ-TRAX TM Containment Device is composed of intrinsically stable metals and thermoplastic polymers. The trays and lids are composed of anodized aluminum with stainless steel handles. The dividers are composed of Aluminum and the posts are composed of medical grade thermoplastic polymers.

The lids and bottom of bases are fully perforated with an evenly distributed hole pattern. The sides of the bases are partially perforated. The trays are used with locking lids.

The bases / lid assembly was designed to be used for sterilization via steam sterilization and used in standard autoclaves found in hospitals and healthcare facilities. The trays were designed in such a way to withstand repeated steam sterilization cycles.

The following EZ-TRAXTM models / sizes are offered:

| Brand Name | Model | Dimensions |
|------------|------------------------|---------------------------------|
| EZ TRAXTM | BASE.ASSY.AL.24.12.2 | (L) 22.97" (W) 11.18" (H) 2.04" |
| EZ TRAXTM | BASE.ASSY.AL.24.12.2.4 | (L) 22.97" (W) 11.18" (H) 2.44" |

The maximum load is 25 lbs and can be used with different types of medical devices including:

- Devices with lumens up to 500mm in length -
- -Conjoined/mated surfaces: forceps, clamps, bending pliers, ratchet handles, retractors
- -Cannulated: drill bits, taps, guides, screwdrivers, cannulated screws

{6}------------------------------------------------

| | Subject Device | Predicate Device | Comparison |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | K1 Medical LLC<br>EZ-TRAXTM Containment<br>Device K192487 | Medtronic Transportation /<br>Sterilization Cassettes K152241 | |
| Indications<br>for Use | The EZ-TRAXTM<br>Containment Device is<br>intended for use as an<br>accessory in healthcare<br>facilities to organize, enclose,<br>reprocess, transport, and store<br>medical devices between<br>surgical and other medical<br>uses. The EZ-TRAXTM<br>Containment Device is not<br>intended on its own to<br>maintain sterility; it is<br>intended to be used in<br>conjunction with a legally<br>marketed, validated, FDA-<br>cleared sterile barrier system.<br>The following parameters<br>and cycles have been<br>validated to attain sterility<br>assurance level (SAL) of<br>10-6.<br>Cycle Times for Dynamic Air<br>Removal Steam Sterilization<br>Cycles<br>Cycle: Dynamic Air<br>Removal Temperature:<br>270F / 132C Exposure<br>Time: 4 minutes Drying<br>Time: 10 minutes<br>Sterilization validations<br>included a worst case EZ-<br>TRAXTM Containment<br>Device and a medical device<br>challenge set comprising of:<br>- Lumen dimensions<br>(3) 1mm x 500mm<br>- Conjoined/mated<br>surfaces: forceps,<br>clamps, bending<br>pliers, ratchet<br>handles, retractors<br>- Cannulated: drill<br>bits, taps, guides,<br>screwdrivers,<br>cannulated screws<br>- A total weight of 42<br>lbs comprising of<br>(EZ-TRAXTM<br>Containment Device<br>+ sterile barrier | Intended for use in healthcare<br>facilities to organize, enclose,<br>sterilize, transport, and store<br>medical devices and other<br>instrumentation between surgical<br>and other medical uses. The system<br>is not intended on its own to<br>maintain sterility; it is intended to<br>be used in conjunction with a<br>legally marketed, validated, FDA-<br>cleared sterilization wrap.<br><br>Sterilization validations included<br>implants and common surgical<br>instruments such as rasps, drivers,<br>trials, handles, inserters, probes,<br>drills, etc. The validated total<br>weight of 28.4 lbs. The validated<br>worst case loading configuration<br>included the following worst case<br>lumen dimensions 363 x 1.575mm<br>and 247.5 x 4.1mm.<br><br>Cycle: Gravity Displacement<br>Temperature: 250F, 270F, and<br>275F Exposure Time: 30, 15, and<br>10 minutes Min Dry Time: 30<br>minutes<br><br>Cycle: Dynamic Air Removal<br>Temperature: 270F and 275F<br>Exposure Time: 4 and 3 minutes | Similar |
| | | | |
| | system + medical | | |
| | device load) as a | | |
| | worst case challenge | | |
| | to the system. | | |
| | Healthcare | | |
| | facilities should | | |
| | | | |
| | not exceed 25 | | |
| | pounds (EZ- | | |
| | TRAXTM | | |
| | Containment | | |
| | Device + sterile | | |
| | barrier system + | | |
| | medical device | | |
| | load). | | |
| Fundamental | Sterilization Cassette | Sterilization Cassette | Same |
| Scientific | | | |
| Technology | | | |
| Product Code | KCT | KCT | Same |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| |…