Medtronic Transportation / Sterilization Cassettes

K190840 · Medtronic Sofamor Danek USA, Inc. · KCT · Oct 15, 2019 · General Hospital

Device Facts

• Record ID: K190840
• Device Name: Medtronic Transportation / Sterilization Cassettes
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Oct 15, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation Sterilization Cassettes are intended for transport of non-sterile loads.

Device Story

Medtronic Transportation/Sterilization Cassettes are reusable containers, trays, and lids used in healthcare facilities to organize and protect orthopedic or neurological surgical instruments during sterilization and transport. The system consists of perforated bases, lids, and nested inserts fabricated from Radel, SANTOPRENE, silicone, aluminum, nylon, polypropylene, and stainless steel. The device does not maintain sterility independently; it must be used with a validated, FDA-cleared sterilization wrap. The system is processed via dynamic-air-removal steam sterilization. Healthcare staff load instruments into the cassettes, wrap them, and subject them to steam cycles. The cassettes protect instruments from damage during distribution and handling. The device benefits patients by ensuring surgical instruments are organized, protected, and properly sterilized before use in surgical procedures.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included distribution simulation per ASTM D4169-14 to verify structural integrity and fit/function post-testing. Sterilization validation per ANSI/AAMI ISO 17665-1 confirmed the system achieves a sterility assurance level (SAL) of 10^-6 using dynamic-air-removal steam cycles.

Technological Characteristics

Materials: Radel, SANTOPRENE, silicone, aluminum, nylon, polypropylene, stainless steel. Design: Perforated base, lid with locking latch, nested inserts. Sterilization: Dynamic-air-removal steam (132°C/4 min or 135°C/3 min). Dimensions: 22.75 x 11.26 x 5.51 inches. Connectivity: None (mechanical).

Indications for Use

Indicated for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and surgical instrumentation. Intended for use with FDA-cleared sterilization wrap for non-sterile loads.

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)

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October 15, 2019

Medtronic Sofamor Danek USA, INC. Elizabeth Hamilton Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K190840

Trade/Device Name: Medtronic Transportation / Sterilization Cassettes Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 12, 2019 Received: September 17, 2019

Dear Elizabeth Hamilton:

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

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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 (OS) 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,

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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

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## Indications for Use

510(k) Number (if known) K190840

### Device Name

Medtronic Transportation/ Sterilization Cassettes

### Indications for Use (Describe)

The Medtronic Transportation/Sterilization Cassettes are intenthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/Sterilization Cassettes are not intended on their sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation Sterilization Cassettes are intended for transport of non-sterile loads.

Sterilization validations for the worst case Medtronic Transportation/Sterilization Cassettes (22.75 x 11.26 x 5.5 inches) included implants and common surgical instruments such as rasps, drivers, trials, handles, inserters, probes, drills, etc. The validated total weight was 28.6lbs. The validated worst case loading configurations of the Medtronic Transportation/ Sterilization Cassettes included the following worst case lumen dimensions:

- · 363 x 1.575mm
- 247.5 x 4.1mm
- Device list:
- · P1850078 Generic Triple Outer Base (22.74×11.26×5.04 inches)
- · P1850079 Generic Outer Lid (22.75×1 1.26×.470 inches)
- · 7022101L Tray Lid (21.00×10.13×.075 inches)
- · P1850010 Tray 1 (20.71×9.82×4.4 inches)
- P1850011 Tray 2 (18.81×9.50×2.8 inches)
- P1850012 Tray 3 (18.30×9.20×.840 inches)
- · P1850013 Large Caddy (9.4×5.3×1.49 inches)
- · P1850014 Large Lid (9.40×5.045×.095 inches)
- · P1850015 Small Caddy (2.00×1.50×1.025 inches)
- · P1850016 Small Lid (2.0xl.245x.095 inches)

### Sterilization Parameters

| Cycle | Temperature | Exposure time |
|---------------------|---------------|---------------|
| Dynamic-air-removal | 270°F (132°C) | 4 Minutes |
| Dynamic-air-removal | 275°F (135°C) | 3 Minutes |

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)

Minimum dry time

30 Minutes

30 Minutes

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(k) SUMMARY

# MEDTRONIC

# Medtronic Transportation / Sterilization Cassettes

| Submitter: | Medtronic Sofamor Danek, USA Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: [phone]<br>Fax: [phone] |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Elizabeth Hamilton<br>Regulatory Affairs Specialist<br>Direct Telephone: [phone] |
| Date Prepared | September 27, 2019 |
| Name of Device | Medtronic Transportation/ Sterilization Cassettes |
| 510(k) Number | K190840 |
| Common Name | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Classification Name | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (21 CFR 880.6850) |
| Classification | Class II |
| Product Codes | KCT |
| Predicate Device | Medtronic Transportation /Sterilization Cassettes (K152241, S.E. 1/20/2016) |
| Description of Device | The Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials which meet national or international specifications and are commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. |

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| Indications for Use | The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/ Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation Sterilization Cassettes are intended for transport of non-sterile loads. Sterilization validations for the worst-case Medtronic Transportation/ Sterilization Cassette (22.75 X 11.26 X 5.5 inches) included implants and common surgical instruments such as rasps, drivers, trials, handles, inserters, probes, drills etc. The validated total weight was 28.4lbs. The validated worst-case loading configurations of the Medtronic Transportation / Sterilization Cassette included the following worst-case lumen dimensions. 363 X 1.575mm<br>247.5 X4.1 mm<br>Device List<br>P1850078 Generic Triple Outer Base (22.74 X 11.26 X 5.04 inches)<br>P1850079 Generic Outer Lid (22.75 X 11.26 X .470 inches)<br>7022101L Tray Lid (21.00 X 10.13 X .075 inches)<br>P1850010 Tray 1 (20.71 X 9.82 X 4.4 inches)<br>P1850011 Tray 2 (18.81 X 9.50 X 2.8 inches)<br>P1850012 Tray 3 (18.30 X 9.20 X .840 inches)<br>P1850013 Large Caddy (9.4 X 5.3X 1.49 inches)<br>P1850014 Large Lid (9.40 X 5.045 X .095 inches)<br>P1850015 Small Caddy (2.00 X 1.50 X 1.025 inches)<br>P1850016 Small Lid (2.0 X 1.245 X .095 inches) | | | |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|---------------|------------------|
| Sterilization Parameters | | | | |
| | Cycle | Temperature | Exposure Time | Minimum Dry Time |
| | Dynamic-air-removal | 270°F (132°C) | 4 Minutes | 30 Minutes |
| | Dynamic-air-removal | 275°F (135°C) | 3 Minutes | 30 Minutes |
| Technological Characteristics | Technological Characteristics Comparison Table:<br>Shown below is a comparison of the subject device with the predicate device.<br>Table 2: Comparison of Technological Characteristics of Medtronic Transportation/ Sterilization Cassettes with Brodicato | | | |

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| Feature | Subject Device (K190840) | Predicate Device (K152241) | Comparison |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Picture | Image: Medtronic Transportation/Sterilization Cassettes<br>Image: Nested Capability of the Individual Trays within the Medtronic Transportation/Sterilization Cassettes | Image: Medtronic Transportation/Sterilization Cassettes<br>Image: Stacking capability of Individual Trays | similar |
| Trade Name | Medtronic Transportation/Sterilization Cassettes | Medtronic Transportation/Sterilization Cassettes | identical |
| Fundamental<br>Scientific<br>Technology | Sterilization Cassette | Sterilization Cassette | identical |
| Intended use | The Medtronic<br>Transportation/<br>Sterilization Cassettes are<br>intended for use in health<br>care facilities to organize,<br>enclose, sterilize, transport<br>and store medical devices<br>and other medical uses.<br>The Medtronic<br>Transportation/Sterilization<br>Cassettes are not intended<br>on their own to maintain<br>sterility, it is intended to be<br>used in conjunction with a<br>legally marketed, validated<br>FDA-cleared sterilization<br>wrap. The Medtronic<br>Transportation Sterilization<br>Cassettes are intended for<br>transport of non-sterile<br>loads. | The Medtronic<br>Transportation/<br>Sterilization Cassettes are<br>intended for use in health<br>care facilities to organize,<br>enclose, sterilize, transport<br>and store medical devices<br>and other medical uses.<br>The Medtronic<br>Transportation/Sterilization<br>Cassettes are not intended<br>on their own to maintain<br>sterility, it is intended to be<br>used in conjunction with a<br>legally marketed, validated<br>FDA-cleared sterilization<br>wrap. The Medtronic<br>Transportation Sterilization<br>Cassettes are intended for<br>transport of non-sterile<br>loads | identical |
| Product Code | KCT | KCT | identical |
| Material<br>Composition | Radel®,<br>SANTOPRENE™,<br>Silicone, Aluminum,<br>Nylon, Polypropylene and<br>Stainless Steel | Radel®,<br>SANTOPRENE™,<br>Silicone, Aluminum,<br>Nylon, Polypropylene and<br>Stainless Steel | identical |
| Device<br>Design | A base, a lid with a locking<br>latch and individual inserts<br>in nested design | A base a lid with a locking<br>latch and individual inserts<br>stacked | similar |
| Dimensions | 22.750×(W)11.26<br>×(H)5.51 (outer case)<br>The inserts are offered in<br>different sizes | 22.750×(W)11.26<br>×(H)5.51 (outer case)<br>The inserts are offered in<br>different sizes | identical |
| Weight | 28.6lbs | 28.4lbs | different |
| Configuration | Perforated bases, lids and<br>inserts | Perforated bases, lids and<br>inserts | identical |
| Percent<br>perforation | 1.304% greatest challenge<br>component | 4.73% greatest challenge<br>component | different |
| Sterilization<br>Method | Pre- Vacuum (Steam) | Pre-Vacuum(Steam)<br>Gravity Displacement<br>(Steam) | similar |
| Sterilization<br>Parameters | ¹Dynamic- Air Removal<br>(4 Pre-conditioning pulses)<br>132°C(270°F)<br>4 minutes135°C(275°F)<br>3 minutes134°C(273°F)<br>3 minutes | Gravity Displacement<br>Minimum Dry Time: 30<br>mins<br>121°C(250°F)<br>30 minutes132°C(270°F)<br>15 minutes135°C(275°F)<br>10 minutes<br>Pre-Vacuum<br>Minimum Dry Time: 30<br>mins<br>132°C(270°F)<br>4 minutes134°C(273°F)<br>4 minutes135°C(275°F)<br>3 minutes | similar |
| | ¹ Note "Dynamic Air Removal" is also commonly referred to as "Pre-vacuum" | | |
| Reusable | Yes | Yes | same |

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| | The results from the comparison table demonstrate that the subject device and the predicate device have similar technological characteristics. | | | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Performance<br>Testing | Shown below is a description of the performance testing performed to demonstrate and verify that<br>the subject device meets the acceptance criteria found in the standard and test methodology.<br>Table 3: Nonclinical Performance Testing | | | |
| | Test Methodology | Purpose | Acceptance criteria | Results |
| | Distribution Simulation<br>Validation For the New<br>Outercase<br>Per ASTM D4169-14 | The objective of this<br>project was to<br>evaluate the ability<br>of the new outer<br>case for Medtronic<br>to withstand the<br>distribution<br>environment | Outer cases and inner<br>trays will be visually<br>inspected after each<br>distribution cycle for<br>obvious damages.<br>Outer cases will fail the<br>test protocol if there is<br>obvious<br>Fit and function of<br>devices were evaluated<br>post distribution testing to<br>show devices within the<br>brackets still meet the<br>surgical intent. | Pass |
| | Biocompatibility Testing<br>per ISO 10993 | Evaluate patient<br>contact and harm<br>associated to<br>materials | Not applicable to subject<br>devices; as device does<br>not have direct patient<br>contact. However medical<br>devices that are used in<br>conjunction with<br>sterilization cassettes are<br>tested | Pass |
| | ANSI/AMMI ISO<br>17665-1 | The objective of<br>this study is to<br>demonstrate that<br>steam sterilization<br>processes | $(SAL)$ of 10-6 | Pass |
| | achieves a sterility<br>assurance level<br>(SAL) of 10-6 | | | |
| | | | | |
| Conclusion | The conclusion drawn from the nonclinical tests demonstrate that the, Medtronic<br>Transportation/Sterilization Cassette devices, is as safe, as effective, and performs as well as or<br>better than legally marketed predicate device (K152241). | | | |

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