(163 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 include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices which meet national or international specifications. 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 design consists of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, sterilization, and storage. These components consist of: an outer base, internal individual trays with or without lids, caddies and an outer locking lid. The components of the Medtronic Transportation/Sterilization Cassettes are fabricated from intrinsically stable metals and thermoplastic polymers. All of the components of the Medtronic Transportation/Sterilization Cassettes are perforated with an evenly distributed hole pattern, and are designed to be used for sterilization via steam sterilization. Since the Medtronic Transportation/Sterilization Cassettes are perforated, an FDA cleared wrap must be used for sterilization purposes and to maintain the sterility of the contents. The Medtronic Transportation/Sterilization Cassettes are designed to be used with standard autoclaves used in hospitals and healthcare facilities. Thus allowing the Medtronic Transportation/Sterilization Cassettes to be effective for sterilization and are designed such that they withstand the environment of repeated steam sterilization cycles.
The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation. They are not intended to maintain sterility on their own but are to be used with an FDA-cleared sterilization wrap. The device was evaluated for its ability to withstand the distribution environment, achieve sterility, and for biocompatibility.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Performance (Sterilization Adherence) | The Medtronic Transportation/Sterilization Cassettes achieved a Sterility Assurance Level (SAL) of $10^{-6}$ at the validated sterilization parameters. This was confirmed through testing conducted in accordance with AAMI TIR39, AAMI TIR30, AAMI TIR17, AAMI TIR12, ANSI/AAMI ST81, ANSI/AAMI ST79, ANSI/AAMI/ISO TIR17665-2, ANSI/AAMI/ISO 17665-1, ISO 17664, ANSI/AAMI/ISO 14161, and ANSI/AAMI/ISO 11737-2. Specifically, the following sterilization parameters were validated for the worst-case cassette configuration (22.75 x 11.26 x 5.5 inches, 28.4 lbs total weight, specific lumen dimensions: 363 x 1.575mm and 247.5 x 4.1mm):Gravity Displacement:- 250°F (121°C) for 30 minutes, 30 minutes dry time- 270°F (132°C) for 15 minutes, 30 minutes dry time- 275°F (135°C) for 10 minutes, 30 minutes dry timeDynamic-Air-Removal (4 Pre-conditioning pulses):- 270°F (132°C) for 4 minutes, 30 minutes dry time- 275°F (135°C) for 3 minutes, 30 minutes dry time |
| Durability (Distribution Environment) | The Medtronic Transportation/Sterilization Cassettes were able to withstand the distribution environment. Testing was conducted in accordance with ASTM D4169: 2009 – "Standard Practice for Performance Testing of Shipping Containers and Systems". |
| Biocompatibility | Materials used in the Medtronic Transportation/Sterilization Cassettes are biocompatible, including thermoplastic polymers, aluminum, and stainless steel. An assessment based on ISO 10993-1:2009 "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process" concluded that if substances were to transfer, they would not present a chemical hazard. The device does not have direct patient contact. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify a distinct "test set" sample size for the performance validation in the way a clinical trial would. Instead, the validation involved a "worst case" Medtronic Transportation/Sterilization Cassette configuration. This configuration was described as:
- Dimensions: 22.75 x 11.26 x 5.5 inches
- Total Weight: 28.4 lbs (including implants and common surgical instruments)
- Lumen Dimensions (worst case): 363 x 1.575mm and 247.5 x 4.1mm
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, based on the context of a 510(k) submission, the testing was prospective and conducted by the manufacturer, Medtronic Sofamor Danek, likely in the USA where the company is located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable. The ground truth for sterilization validation is established through recognized and standardized microbiological and physical testing methods (e.g., biological indicators, chemical indicators, physical monitoring) designed to demonstrate a specific Sterility Assurance Level (SAL). It does not involve human expert consensus in the same way a diagnostic imaging study would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments. The performance testing for this device (sterilization validation, durability, biocompatibility) relies on objective, standardized laboratory measurements and methodologies.
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:
No. A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. This type of study is used for diagnostic AI devices where human readers interpret medical images or data. The Medtronic Transportation/Sterilization Cassettes are physical medical device accessories for sterilization and transportation, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the performance testing was effectively "standalone" in that the device's ability to maintain sterility, withstand distribution, and its biocompatibility were evaluated directly through standardized physical and microbiological tests. There is no "algorithm" or "human-in-the-loop" component to the function of this medical device. The validation confirmed the device's inherent design capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for the performance evaluation was established through adherence to recognized industry standards and scientific principles for sterilization, durability, and biocompatibility.
- For Sterilization: The ground truth for sterility was defined by achieving a Sterility Assurance Level (SAL) of $10^{-6}$, which is a universally accepted standard for terminally sterilized medical devices. This is demonstrated through biological indicator (BI) and physical parameter monitoring as per AAMI and ISO standards.
- For Durability: The ground truth for durability was the successful completion of distribution testing as per ASTM D4169: 2009, indicating the device's ability to withstand simulated shipping environments without damage affecting its function.
- For Biocompatibility: The ground truth for biocompatibility was compliance with ISO 10993-1:2009, demonstrating that the materials are suitable for their intended use and do not pose a chemical hazard.
8. The sample size for the training set:
This information is not applicable. The device is a physical medical device accessory, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no "training set" for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2016
Medtronic Sofamor Danek Ms. Victoria Scheitlin Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
Re: K152241
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: December 18, 2015 Received: December 21, 2015
Dear Ms. Scheitlin:
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. 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
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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152241
Device Name Medtronic Transportation/Sterilization Cassettes
Indications for Use (Describe)
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.
Sterilization validations for the worst case Medtronic Transportation 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 x 4.1mm
Device List:
1850060 Case - Triple Generic Outer Base (22.74 x 11.260 x 5.040 inches) 1850064 Lid - Generic Outer Lid (22.75 x 11.260 x 0.470 inches) 7022101L Tray Lid (21 x 10.13 x 0.075 inches) P1850061 Tray 1 (20.75 x 9.79 x 1.32 inches) P1850062 Tray 2 (21 x 10.13 x 1.69 inches) P1850063 Tray 3 (21 x 10.13 x 1.38 inches) 7059532 Large Caddy (9.47 x 6.37 x 1.3 inches) 7059532L Large Lid (5.85 x 4.725 x 0.095 inches) P9213018 Small Caddy (2 x 1.5 x 1.025 inches) P9213018 Small Lid (2 x 1.29 x 0.095 inches)
Sterilization Parameters:
| Cycle | Temperature | Exposure time | Minimum dry time |
|---|---|---|---|
| Gravity Displacement | 250°F (121°C) | 30 Minutes | 30 Minutes |
| Gravity Displacement | 270°F (132°C) | 15 Minutes | 30 Minutes |
| Gravity Displacement | 275°F (135°C) | 10 Minutes | 30 Minutes |
| Dynamic-Air-Removal(4 Pre-conditioning pulses) | 270°F (132°C) | 4 Minutes | 30 Minutes |
| Dynamic-Air-Removal(4 Pre-conditioning pulses) | 275°F (135°C) | 3 Minutes | 30 Minutes |
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY
MEDTRONIC Sofamor Danek Medtronic Transportation/Sterilization Cassettes January 19, 2015
| Company: | Medtronic Sofamor Danek1800 Pyramid PlaceMemphis, Tennessee 38132(800) 876-3133 |
|---|---|
| Contact: | Victoria ScheitlinRegulatory Affairs SpecialistTelephone: (901) 344-0706 |
| Date Prepared: | Fax: (901) 346-9738January 19, 2015 |
| Device: | |
| Name of Device: | Medtronic Transportation/Sterilization Cassettes |
| 510(k) Number: | K152241 |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (21 CFR 880.6850) |
| Class: | II |
| Product Code: | KCT |
| Predicate Devices: | K131455 (Primary Predicate) – Restore Modular Sterilization Tray System (S.E. 08/30/2013)K033222 – Olympus Sterilization Trays (S.E. 08/02/2004)K993535 – Metapak Multi-Purpose Instrument Tray (S.E. 12/07/2001)K120947 – THS Sterilization Tray |
- K120947 THS Sterilization Tray . (S.E. 10/17/2012)
Additionally, this submission contains a reference device K130720 -Synthes Reusable Sterilization Container Systems (S.E. 08/14/2014). The Synthes Reusable Sterilization Container Systems are fabricated from similar materials to those used in the Medtronic Transportation/Sterilization Cassettes, specifically nylon and polypropylene. The reference device also has a similar sterilization method, design configuration options and sizes. The predicates have not been subject to a design related recall that
Medtronic is aware.
IV. Description:
The Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a
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variety of materials commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices which meet national or international specifications. 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 design consists of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, sterilization, and storage. These components consist of: an outer base, internal individual trays with or without lids, caddies and an outer locking lid. The components of the Medtronic Transportation/Sterilization Cassettes are fabricated from intrinsically stable metals and thermoplastic polymers. All of the components of the Medtronic Transportation/Sterilization Cassettes are perforated with an evenly distributed hole pattern, and are designed to be used for sterilization via steam sterilization. Since the Medtronic Transportation/Sterilization Cassettes are perforated, an FDA cleared wrap must be used for sterilization purposes and to maintain the sterility of the contents. The Medtronic Transportation/Sterilization Cassettes are designed to be used with standard autoclaves used in hospitals and healthcare facilities. Thus allowing the Medtronic Transportation/Sterilization Cassettes to be effective for sterilization and are designed such that they withstand the environment of repeated steam sterilization cycles.
V. 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.
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 x 4.1mm
Device List: 1850060 Case - Triple Generic Outer Base (22.74 x 11.260 x 5.040 inches) 1850064 Lid - Generic Outer Lid (22.75 x 11.260 x 0.470 inches)
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7022101L Tray Lid (21 x 10.13 x 0.075 inches) P1850061 Tray 1 (20.75 x 9.79 x 1.32 inches) P1850062 Tray 2 (21 x 10.13 x 1.69 inches) P1850063 Tray 3 (21 x 10.13 x 1.38 inches) 7059532 Large Caddy (9.47 x 6.37 x 1.3 inches) 7059532L Large Lid (5.85 x 4.725 x 0.095 inches) P9213018 Small Caddy (2 x 1.5 x 1.025 inches) P9213018 Small Lid (2 x 1.29 x 0.095 inches)
Sterilization Parameters:
| Cycle | Temperature | Exposure time | Minimum dry time |
|---|---|---|---|
| GravityDisplacement | 250°F (121°C) | 30 Minutes | 30 Minutes |
| GravityDisplacement | 270°F (132°C) | 15 Minutes | 30 Minutes |
| GravityDisplacement | 275°F (135°C) | 10 Minutes | 30 Minutes |
| Dynamic-Air-Removal(4 Pre-conditioningpulses) | 270°F (132°C) | 4 Minutes | 30 Minutes |
| Dynamic-Air-Removal(4 Pre-conditioningpulses) | 275°F (135°C) | 3 Minutes | 30 Minutes |
VI. Comparison of Technological Characteristics and Performance Data with the Predicate Devices:
Table 2 and Table 3 display the comparison of the Medtronic Transportation/Sterilization Cassettes compared against the predicates. The comparison analysis was performed to support the substantial equivalence of the Medtronic Transportation/Sterilization Cassettes and trays to the listed predicates.
The Medtronic Transportation/Sterilization Cassettes were validated to be the greatest challenge (worst case). The Medtronic Transportation/Sterilization Cassettes described within this submission were determined to be the worst case configuration for sterilization and reprocessing due to the weight, percent perforation, and the number of trays and caddies included within the final configuration in the entirety.
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| Feature | Subject Device | K131455(PrimaryPredicate) | K033222 | K993535 | K120947 | |
|---|---|---|---|---|---|---|
| 1. Trade Name | Medtronic Transportation/Sterilization Cassettes | Restore™ModularSterilizationTray System | OlympusSterilizationTrays | MetapakMulti-PurposeInstrumentTray | THSSterilizationTray | |
| 2. | FundamentalScientificTechnology | Sterilization Cassette | Same | Same | Same | Same |
| 2. | Intended Use | The Medtronic Transportation/Sterilization Cassettesare intended for use in healthcare facilities to organize,enclose, sterilize, transport, and store medical devicesand other instrumentation between surgical and othermedical uses. The MedtronicTransportation/Sterilization Cassettes are not intendedon their own to maintain sterility; it is intended to beused in conjunction with a legally marketed, validated,FDA-cleared sterilization wrap. | The Restore™ModularSterilizationTray System isintended foruse inhealthcarefacilities toorganize,enclose,sterilize,transport, andstore medicaldevices andotherinstrumentationbetweensurgical andother medicaluses whenused Inconjunctionwith a FDAclearedsterilizationwrap. | The Olympussterilizationtrays areintended tobe used toencloseOlympusmedicaldevicesincludinghandinstruments,trocars,cameraheads,adapter, andendoscopesto besterilized by ahealth careprovider. It isintended toallow steamsterilization ofthe enclosedmedical | The RileyMetapakMulti-PurposeInstrumentTray is usedfor loadingsurgicalinstruments inorder toconvenientlyorganize,sterilizes,transportsand store theinstrumentsbetween use.The RileyMetapakMulti-PurposeInstrumentTray can beused in pre-vacuumsteam andethyleneoxide | The THSSterilizationTray is usedto enclose,protect, andorganize theTHS scopes,diagnosticsheath, andassociatedaccessorycomponents,and tofacilitate thesterilizationprocess byallowingsterilantpenetrationand airremoval whenused inconjunctionwith anapprovedsterilization |
| Feature | Subject Device | K131455(PrimaryPredicate) | K033222 | K993535 | K120947 | |
| device. | sterilization | wrap. | ||||
| 3. | Product Code | KCT | KCT | KCT | KCT | KCT |
| 4. | MaterialComposition | Thermoplastic polymers, aluminum, and stainless steel | Thermoplasticpolymers,aluminum, andstainless steel | Thermoplastic polymersand stainlesssteel | Thermoplastic polymers,aluminum,and stainlesssteel | Thermoplastic polymers,aluminum,and stainlesssteel |
| 5. | Design | A base, a lid with a locking latch, and individual inserts | A base, a lid,and individualinserts | A bottom, alid withlocking tabs,and individualinserts | A base, a lidwith latches,and individualinserts | A base, a lid,and individualinserts |
| 6. | Dimensions | The greatest challenge dimension was assessed to be:22.75 x 11.26 x 5.51 inchesThe inserts are offered in different sizes | 10 x 20 x 4inches ora 10 x 10 x 4inches tray witha lid.The insertsare offered indifferent sizes(not specifiedin summary.) | A wide varietyof dimensionsandconfigurationsranging from:405 x 95 x200mm (16 x4 x 8 inches)to665 x 52 x204mm (26 x2 x 8 inches) | Bases andlids areoffered in 3sizes:• 22 x 10 x 6inches• 22 x 10 x 4inches• 26 x 10 x 6inchesInsert traysare offered in2 sizes:• 21 x 9.5 x2.5 inches• 10 x 9.5 x2.5 inchesThe insertsare offeredin differentsizes (notspecified insummary.) | The "base"tray is17.3 x 7.25 x4 inchesThe insertsare offered indifferent sizes(not specifiedin summary.) |
Table 2: Substantial Equivalence - Comparison of Medtronic Transportation/Sterilization Cassettes with Predicates on Technological Characteristics
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| Feature | Subject Device | K131455(PrimaryPredicate) | K033222 | K993535 | K120947 | |||
|---|---|---|---|---|---|---|---|---|
| 7. Configuration | Perforated bases, lids, and inserts | Perforatedbases, lids,and inserts | • Perforatedor SolidLids• PerforatedBottoms | Perforatedbases, lids,and inserts | Perforatedbases, lids,and inserts | |||
| 8. Air Permeance | Yes | Yes | Yes | Yes | Yes | |||
| 9. PercentPerforation | Evenly distributed hole pattern. | Evenlydistributed holepattern. | Evenlydistributedhole pattern. | Evenlydistributedhole pattern. | Evenlydistributedhole pattern. | |||
| 10. SterilizationMethod | • Pre-Vacuum• Gravity Displacement | High VacuumSteam | Pre-vacuumSteam | • Pre-vacuumSteam• EthyleneOxideSterilization | •Pre-Vacuum•GravityDisplacement | |||
| 11. SterilizationParameters | CycleGravityDisplacementGravityDisplacementGravityDisplacementDynamic-Air-Removal(4 Pre-conditioningpulses)Dynamic-Air-Removal(4 Pre-conditioningpulses) | Temperature250°F(121°C)270°F(132°C)275°F(135°C)270°F(132°C)275°F(135°C) | Exposuretime30Minutes15Minutes10Minutes4Minutes3Minutes | Minimumdry time30Minutes30Minutes30Minutes30Minutes30Minutes | High Vacuum(pre-vacuum,three pulse,standard):Temp: 270° FExposureTime: 4MinutesCycle Dry Time(wrapped):20 Minutes(minimum)Cool Time:Variesaccording toload contents | PrevacuumSteam: 132°C- 134°C5 minutesminimumDrying Time:10 –20minutes asneeded. | Not providedin 510(k)Summary | Pre-VacuumParameters:270°F for 4minutesPre-VacuumDry Time: 30minutesGravityParameters:250°F for 30minutesGravity DryTime: 30minutes |
| 12. Reusable | Yes | Yes | Yes | Yes | Yes |
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| Feature | Subject Device | K131455(PrimaryPredicate) | K033222 | K993535 | K120947 | |
|---|---|---|---|---|---|---|
| 1. | SterilantPenetration | Yes | Yes | Yes | Yes | Yes |
| 2. | MicrobialBarrierProperties | To be used with anFDA approvedsterilization wrap | To be used with anFDA approvedsterilization wrap | To be used with anFDA approvedsterilization wrap | No claims aremade in thesummary | No claims aremade in thesummary |
| 3. | MaterialCompatibilitywithSterilizationMethod | Materials arecompatible withsterilizationmethod | Yes | Compatible toSteam Sterilizationat 132°C | Yes | Yes |
| 4. | ToxicologicalProperties | Materials arebiocompatible | Materials arebiocompatible | Materials arebiocompatible | Not stated insummary | Not stated insummary |
Table 3: Substantial Equivalence - Comparison of Medtronic Transportation/Sterilization Cassettes with Predicates on Performance Data
No new issues of safety or effectiveness have been raised, based on the nonclinical tests performed. There are no differences between the subject and predicate devices. The subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate devices.
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VII. Performance Testing
The testing of the Medtronic Transportation/Sterilization Cassettes is supported by packaging testing, sterilization validations, and biocompatibility testing. . The performance testing performed on the Medtronic Transportation/Sterilization Cassettes was tested and validated to the greatest challenge (worst case).
Medtronic Transportation/Sterilization Cassettes were evaluated on the ability to withstand the distribution environment. The distribution testing concluded that the Medtronic Transportation/Sterilization Cassettes were able to with stand the distribution environment. The testing was conducting in accordance with ASTM D4169: 2009 – "Standard Practice for Performance Testing of Shipping Containers and Systems".
To establish substantial equivalence with a predicate device, the performance testing was conducted to confirm that SAL (10 %) sterility level was achieved at the validated sterilization parameters. The testing was conducting in accordance with the following standards:
- . AAMI TIR39: 2009 "Guidance On Selecting A Microbial Challenge And Inoculation Sites For Sterilization Validation Of Medical Devices"
- AAMI TIR30: 2011 "A Compendium Of Processes, Materials, Test ● Methods, And Acceptance Criteria For Cleaning Reusable Medical Devices"
- AAMI TIR17: 2008 "Compatibility Of Materials Subject To ● Sterilization"
- AAMI TIR12: 2010 "Designing, Testing, And Labeling Reusable . Medical Devices For Reprocessing In Health Care Facilities: A Guide For Medical Device Manufacturers"
- ANSI/AAMI ST81: 2004 "Sterilization Of Medical Devices-. Information To Be Provided By The Manufacturer For The Processing Of Resterilizable Medical Devices"
- ANSI/AAMI ST79: 2010 (R) 2014 "Comprehensive Guide To Steam ● Sterilization And Sterility Assurance In Health Care Facilities -Incorporates "
- ANSI/AAMI/ISO TIR17665-2: 2009 "Sterilization Of Health Care ● Products - Moist Heat - Part 2"
- ANSI/AAMI/ISO 17665-1: 2006 "Sterilization Of Health Care ● Products-Moist Heat-Part 1: Requirements For The Development, Validation, And Routine Control Of A Sterilization Process For Medical Devices"
- ISO 17664: 2004 "Sterilization Of Medical Devices Information To ● Be Provided By The Manufacturer For The Processing Of Resterilizable Medical Device"
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- ANSI/AAMI/ISO 14161: 2009 "Sterilization Of Health Care Products ● — Biological Indicators — Guidance For The Selection, Use And Interpretation Of Results "
- ANSI/AAMI/ISO 11737-2: 2009 "Sterilization Of Medical Devices ● Microbiological Methods — Part 2: Tests Of Sterility Performed In The Definition, Validation And Maintenance Of A Sterilization Process "
The Medtronic Transportation/Sterilization Cassettes do not have direct patient contact. The Medtronic Transportation/Sterilization Cassette components are fabricated from a variety of intrinsically stable metals and thermoplastics. Based on the testing performed, should substances transfer from the Medtronic Transportation/Sterilization Cassettes they would not present a chemical hazard. The assessment was conducted based on ISO 10993-1:2009 "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process".
VIII. Conclusion:
Results of performance testing, and the similarities with legally marketed predicate devices it can be concluded that the Medtronic Transportation/Sterilization Cassettes will perform to the intended use. Medtronic believes that the subject Transportation/Sterilization Cassettes is substantially equivalent to the following predicates:
- Predicate 1 Restore Modular Sterilization Tray System ● K131455 (S.E. 08/30/2013)
- Predicate 2 Olympus Sterilization Trays K033222 (S.E. ● 08/02/2004)
- Predicate 3 Metapak Multi-Purpose Instrument Tray . K993535 (S.E. 12/07/2001)
- Predicate 4 THS Sterilization Tray K120947 (S.E. ● 10/17/2012)
- Reference Device K130720 Synthes Reusable ● Sterilization Container Systems (S.E. 08/14/2014) for the fabrication of nylon and polypropylene as materials.
No new issues of safety or effectiveness have been raised, based on the nonclinical tests performed. The subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate devices. Therefore, the Medtronic Transportation/Sterilization Cassettes are considered to be substantially equivalent to the predicate devices, Class II (21 CFR 880.6850), Product code KCT.
§ 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).