(197 days)
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.
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.
The document provided describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Medtronic Transportation/Sterilization Cassettes (K190840).
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Distribution Simulation Validation (Per ASTM D4169-14) | 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 damage. Fit and function of devices within the brackets must still meet surgical intent. | Pass |
| Biocompatibility Testing (Per ISO 10993) | Evaluate patient contact and harm associated with 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 (Steam Sterilization Validation) | Demonstrate that steam sterilization processes achieve a sterility assurance level (SAL). | Achieves a sterility assurance level (SAL) of 10^-6. | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of typical AI/ML medical devices (e.g., patient data). The testing performed seems to be for the physical characteristics and sterilization efficacy of the medical device (cassettes).
- Distribution Simulation Validation: The sample size for outer cases and inner trays is not explicitly mentioned, but the test involves subjecting these items to distribution cycles.
- Biocompatibility Testing: Not applicable to the cassettes themselves, but to the medical devices used in conjunction with them. No sample size for devices or data provenance (e.g., country of origin, retrospective/prospective) is provided for this aspect.
- ANSI/AMMI ISO 17665-1 (Sterilization Validation): The sample size refers to the "worst case" Medtronic Transportation/Sterilization Cassettes (22.75 x 11.26 x 5.5 inches), loaded with implants and common surgical instruments (total weight 28.6 lbs), including worst-case lumen dimensions. The number of cassettes or specific instruments tested is not quantified as a sample size.
Given the nature of the device (sterilization cassettes) and the tests conducted, the data provenance is likely from laboratory testing and engineering evaluations rather than clinical patient data. The document does not specify countries of origin or whether the data is retrospective or prospective, as these are not relevant to device performance for this type of product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document as the device is not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The ground truth for the performance testing is based on established industry standards (ASTM D4169-14, ISO 10993, ANSI/AAMI ISO 17665-1) and objective measurements.
4. Adjudication method for the test set
Not applicable, as this is not an AI/ML diagnostic device requiring expert adjudication of results. The "ground truth" is defined by the objective pass/fail criteria of the specified engineering and sterilization standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a physical sterilization cassette, not an AI/ML diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical sterilization cassette, not an algorithm.
7. The type of ground truth used
The ground truth for the performance testing is based on:
- Objective Visual Inspection: For distribution simulation, assessing obvious damages.
- Compliance with Standards: For biocompatibility (ISO 10993) and sterilization efficacy (ANSI/AAMI ISO 17665-1), meeting defined performance metrics like an SAL of 10^-6. These are scientific and engineering benchmarks rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device, and therefore, does not have a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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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
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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 (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
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 PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738 |
|---|---|
| Contact Person | Elizabeth HamiltonRegulatory Affairs SpecialistDirect 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 1.575mm247.5 X4.1 mmDevice ListP1850078 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 CassettesImage: Nested Capability of the Individual Trays within the Medtronic Transportation/Sterilization Cassettes | Image: Medtronic Transportation/Sterilization CassettesImage: Stacking capability of Individual Trays | similar |
| Trade Name | Medtronic Transportation/Sterilization Cassettes | Medtronic Transportation/Sterilization Cassettes | identical |
| FundamentalScientificTechnology | Sterilization Cassette | Sterilization Cassette | identical |
| Intended use | The MedtronicTransportation/Sterilization Cassettes areintended for use in healthcare facilities to organize,enclose, sterilize, transportand store medical devicesand other medical uses.The MedtronicTransportation/SterilizationCassettes are not intendedon their own to maintainsterility, it is intended to beused in conjunction with alegally marketed, validatedFDA-cleared sterilizationwrap. The MedtronicTransportation SterilizationCassettes are intended fortransport of non-sterileloads. | The MedtronicTransportation/Sterilization Cassettes areintended for use in healthcare facilities to organize,enclose, sterilize, transportand store medical devicesand other medical uses.The MedtronicTransportation/SterilizationCassettes are not intendedon their own to maintainsterility, it is intended to beused in conjunction with alegally marketed, validatedFDA-cleared sterilizationwrap. The MedtronicTransportation SterilizationCassettes are intended fortransport of non-sterileloads | identical |
| Product Code | KCT | KCT | identical |
| MaterialComposition | Radel®,SANTOPRENE™,Silicone, Aluminum,Nylon, Polypropylene andStainless Steel | Radel®,SANTOPRENE™,Silicone, Aluminum,Nylon, Polypropylene andStainless Steel | identical |
| DeviceDesign | A base, a lid with a lockinglatch and individual insertsin nested design | A base a lid with a lockinglatch and individual insertsstacked | similar |
| Dimensions | 22.750×(W)11.26×(H)5.51 (outer case)The inserts are offered indifferent sizes | 22.750×(W)11.26×(H)5.51 (outer case)The inserts are offered indifferent sizes | identical |
| Weight | 28.6lbs | 28.4lbs | different |
| Configuration | Perforated bases, lids andinserts | Perforated bases, lids andinserts | identical |
| Percentperforation | 1.304% greatest challengecomponent | 4.73% greatest challengecomponent | different |
| SterilizationMethod | Pre- Vacuum (Steam) | Pre-Vacuum(Steam)Gravity Displacement(Steam) | similar |
| SterilizationParameters | ¹Dynamic- Air Removal(4 Pre-conditioning pulses)132°C(270°F)4 minutes135°C(275°F)3 minutes134°C(273°F)3 minutes | Gravity DisplacementMinimum Dry Time: 30mins121°C(250°F)30 minutes132°C(270°F)15 minutes135°C(275°F)10 minutesPre-VacuumMinimum Dry Time: 30mins132°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 |
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| The results from the comparison table demonstrate that the subject device and the predicate device have similar technological characteristics. | ||||
|---|---|---|---|---|
| PerformanceTesting | Shown below is a description of the performance testing performed to demonstrate and verify thatthe 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 SimulationValidation For the NewOutercasePer ASTM D4169-14 | The objective of thisproject was toevaluate the abilityof the new outercase for Medtronicto withstand thedistributionenvironment | Outer cases and innertrays will be visuallyinspected after eachdistribution cycle forobvious damages.Outer cases will fail thetest protocol if there isobviousFit and function ofdevices were evaluatedpost distribution testing toshow devices within thebrackets still meet thesurgical intent. | Pass | |
| Biocompatibility Testingper ISO 10993 | Evaluate patientcontact and harmassociated tomaterials | Not applicable to subjectdevices; as device doesnot have direct patientcontact. However medicaldevices that are used inconjunction withsterilization cassettes aretested | Pass | |
| ANSI/AMMI ISO17665-1 | The objective ofthis study is todemonstrate thatsteam sterilizationprocesses | $(SAL)$ of 10-6 | Pass | |
| achieves a sterilityassurance level(SAL) of 10-6 | ||||
| Conclusion | The conclusion drawn from the nonclinical tests demonstrate that the, MedtronicTransportation/Sterilization Cassette devices, is as safe, as effective, and performs as well as orbetter than legally marketed predicate device (K152241). |
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§ 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).