Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are focused on physical cassettes for organizing and sterilizing medical devices, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

No
This device is a transportation and sterilization cassette for medical devices, not a therapeutic device. It is intended to organize, enclose, sterilize, transport, and store other medical devices.

Diagnostic

No

The device is a transportation and sterilization cassette for medical devices, not a tool for diagnosing medical conditions. Its function is to organize, enclose, sterilize, transport, and store medical devices.

SaMD (Software as a Medical Device)

No

The device description clearly states it includes physical components like cases, trays, lids, caddies, modules, or brackets fabricated from various materials. It is a physical medical device used for transportation and sterilization, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the device is for organizing, enclosing, sterilizing, transporting, and storing medical devices and other instrumentation. This is a function related to the handling and preparation of medical devices, not for performing tests on samples taken from the human body to diagnose conditions.
Device Description: The description reinforces the intended use, focusing on the physical characteristics and purpose of the cassettes for containing and protecting medical devices.
Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), reagents, or for the purpose of providing diagnostic information about a patient's health status.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 247.5 X4.1 mm Device List P1850078 Generic Triple Outer Base (22.74 X 11.26 X 5.04 inches) P1850079 Generic Outer Lid (22.75 X 11.26 X .470 inches) 7022101L Tray Lid (21.00 X 10.13 X .075 inches) P1850010 Tray 1 (20.71 X 9.82 X 4.4 inches) P1850011 Tray 2 (18.81 X 9.50 X 2.8 inches) P1850012 Tray 3 (18.30 X 9.20 X .840 inches) P1850013 Large Caddy (9.4 X 5.3X 1.49 inches) P1850014 Large Lid (9.40 X 5.045 X .095 inches) P1850015 Small Caddy (2.00 X 1.50 X 1.025 inches) P1850016 Small Lid (2.0 X 1.245 X .095 inches)

Product codes

KCT

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical Performance Testing:

Distribution Simulation Validation For the New Outercase Per ASTM D4169-14:
- Purpose: The objective of this project was to evaluate the ability of the new outer case for Medtronic to withstand the distribution environment.
- Acceptance criteria: Outer cases and inner trays will be visually inspected after each distribution cycle for obvious damages. Outer cases will fail the test protocol if there is obvious Fit and function of devices were evaluated post distribution testing to show devices within the brackets still meet the surgical intent.
- Results: Pass
Biocompatibility Testing per ISO 10993:
- Purpose: Evaluate patient contact and harm associated to materials.
- Acceptance criteria: Not applicable to subject devices; as device does not have direct patient contact. However medical devices that are used in conjunction with sterilization cassettes are tested.
- Results: Pass
ANSI/AMMI ISO 17665-1:
- Purpose: The objective of this study is to demonstrate that steam sterilization processes achieves a sterility assurance level (SAL) of 10-6.
- Acceptance criteria: (SAL) of 10-6
- Results: Pass

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K152241

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.6850 Sterilization wrap.

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

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133
Fax: (901) 346-9738 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Elizabeth Hamilton
Regulatory Affairs Specialist
Direct Telephone: (901) 399-3395 |
| 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
247.5 X4.1 mm
Device List
P1850078 Generic Triple Outer Base (22.74 X 11.26 X 5.04 inches)
P1850079 Generic Outer Lid (22.75 X 11.26 X .470 inches)
7022101L Tray Lid (21.00 X 10.13 X .075 inches)
P1850010 Tray 1 (20.71 X 9.82 X 4.4 inches)
P1850011 Tray 2 (18.81 X 9.50 X 2.8 inches)
P1850012 Tray 3 (18.30 X 9.20 X .840 inches)
P1850013 Large Caddy (9.4 X 5.3X 1.49 inches)
P1850014 Large Lid (9.40 X 5.045 X .095 inches)
P1850015 Small Caddy (2.00 X 1.50 X 1.025 inches)
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:
Shown below is a comparison of the subject device with the predicate device.
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
Image: Nested Capability of the Individual Trays within the Medtronic Transportation/Sterilization Cassettes	Image: Medtronic Transportation/Sterilization Cassettes
Image: Stacking capability of Individual Trays	similar
Trade Name	Medtronic Transportation/Sterilization Cassettes	Medtronic Transportation/Sterilization Cassettes	identical
Fundamental
Scientific
Technology	Sterilization Cassette	Sterilization Cassette	identical
Intended use	The Medtronic
Transportation/
Sterilization Cassettes are
intended for use in health
care facilities to organize,
enclose, sterilize, transport
and store medical devices
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.	The Medtronic
Transportation/
Sterilization Cassettes are
intended for use in health
care facilities to organize,
enclose, sterilize, transport
and store medical devices
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	identical
Product Code	KCT	KCT	identical
Material
Composition	Radel®,
SANTOPRENE™,
Silicone, Aluminum,
Nylon, Polypropylene and
Stainless Steel	Radel®,
SANTOPRENE™,
Silicone, Aluminum,
Nylon, Polypropylene and
Stainless Steel	identical
Device
Design	A base, a lid with a locking
latch and individual inserts
in nested design	A base a lid with a locking
latch and individual inserts
stacked	similar
Dimensions	22.750×(W)11.26
×(H)5.51 (outer case)
The inserts are offered in
different sizes	22.750×(W)11.26
×(H)5.51 (outer case)
The inserts are offered in
different sizes	identical
Weight	28.6lbs	28.4lbs	different
Configuration	Perforated bases, lids and
inserts	Perforated bases, lids and
inserts	identical
Percent
perforation	1.304% greatest challenge
component	4.73% greatest challenge
component	different
Sterilization
Method	Pre- Vacuum (Steam)	Pre-Vacuum(Steam)
Gravity Displacement
(Steam)	similar
Sterilization
Parameters	¹Dynamic- Air Removal
(4 Pre-conditioning pulses)
132°C(270°F)
4 minutes135°C(275°F)
3 minutes134°C(273°F)
3 minutes	Gravity Displacement
Minimum Dry Time: 30
mins
121°C(250°F)
30 minutes132°C(270°F)
15 minutes135°C(275°F)
10 minutes
Pre-Vacuum
Minimum Dry Time: 30
mins
132°C(270°F)
4 minutes134°C(273°F)
4 minutes135°C(275°F)
3 minutes	similar
	¹ Note "Dynamic Air Removal" is also commonly referred to as "Pre-vacuum"
Reusable	Yes	Yes	same

7

8

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

Conclusion	The conclusion drawn from the nonclinical tests demonstrate that the, Medtronic
Transportation/Sterilization Cassette devices, is as safe, as effective, and performs as well as or
better than legally marketed predicate device (K152241).

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