(156 days)
The Nobel Biocare PureSet Tray is used in healthcare facilities to store and organize Nobel Biocare surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The Nobel Biocare PureSet Trays 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 pouch or sterilization wrap. Sterilization validations for the worst-case PureSet Tray included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screw driver and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 grams (Trefoil PureSet Tray), 1082 grams (NobelActive/NobelParallel CC PureSet Tray) and 945 grams (NobelReplace CC PureSet Tray).
The PureSet Tray is a reusable surgical tray to be used in combination with Nobel Biocare surgical instruments and components. The PureSet Tray is used to store and organize the instruments and components during both the surgical and reprocessing procedures. The PureSet Trays are not intended to maintain sterility on their own. They are intended to be used in conjunction with an FDA cleared sterilization wrap/pouch.
Each PureSet Tray consist of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, and storage. All the components of the PureSet Tray are perforated with an evenly distributed hold pattern and are designed to be used for sterilization via steam sterilization. Since the PureSet Trays are perforated, an FDA cleared wrap or pouch must be used for sterilization purposes and to maintain the sterility of the contents. The PureSet Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities.
This document is a 510(k) premarket notification for the Nobel Biocare PureSet Tray, a Class II medical device. It's not a study proving the device meets acceptance criteria for an AI/ML product or diagnostic tool. Instead, it demonstrates the substantial equivalence of the PureSet Tray to legally marketed predicate devices, primarily regarding its function as a sterilization tray for surgical instruments.
Therefore, the requested information (acceptance criteria for an AI/ML product, study design for AI/ML performance, ground truth establishment for a diagnostic AI, etc.) cannot be extracted from this document because it pertains to a different type of medical device entirely. The document focuses on performance data related to material compatibility, sterilization effectiveness (for the tray itself, not its contents' sterility), durability, and reprocessing, which are relevant to a physical medical device like a surgical tray.
Here's why the specific questions cannot be answered based on this document:
- Table of acceptance criteria and reported device performance (for an AI/ML product): This document references acceptance criteria for physical and sterilization performance (e.g., handle durability, cleaning/sterilization effectiveness for the tray), not for AI/ML model performance metrics like sensitivity, specificity, AUC, etc.
- Sample size for the test set and data provenance: No "test set" in the context of AI/ML is mentioned. The testing involves physical prototypes of the tray.
- Number of experts used to establish ground truth and qualifications: "Ground truth" in the AI/ML sense (e.g., diagnosed diseases) is not applicable here. Ground truth concerns the physical properties and performance of the tray.
- Adjudication method for the test set: Not applicable to a physical device's performance testing.
- MRMC comparative effectiveness study: Not applicable to a physical device. There are no "human readers" or "AI assistance" in this context.
- Standalone (algorithm only) performance: Not applicable. This is a physical device, not an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" used for this device would be established by physical testing standards and validated sterilization methods, not medical expert consensus on diagnostic images or pathology.
- Sample size for the training set: Not applicable. There is no AI/ML model being trained.
- How ground truth for the training set was established: Not applicable. There is no AI/ML model being trained.
In summary: The provided document is a 510(k) premarket notification for a physical medical device (sterilization tray), not an AI/ML-based device. Therefore, the specific questions related to AI/ML product acceptance criteria and study design cannot be answered from this content.
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September 27, 2018
Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887
Re: K181075
Trade/Device Name: PureSet Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: August 27, 2018 Received: August 29, 2018
Dear Charlemagne Chua:
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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting 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) K181075
Device Name PureSet Tray
Indications for Use (Describe)
The Nobel Biocare PureSet Tray is used in healthcare facilities to store and organize Nobel Biocare surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The Nobel Biocare PureSet Trays 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 PureSet Tray included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw driver and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 grams (Trefoil PureSet Tray), 1082 grams (NobelActive/NobelParallel CC PureSet Tray) and 945 grams (NobelReplace CC PureSet Tray).
| Method | Steam Sterilization(Moist Heat Sterilization) | |
|---|---|---|
| Cycle | Dynamic-Air-Removal(fractionated vacuum) | Gravity-Displacement |
| Temperature | 132°C(270°F) | 132°C(270°F) |
| Exposure time for a single-use pouched device | 4 minutes(full-cycle) | 15 minutes(full-cycle) |
| Minimum drying times | 20 minutes | 30 minutes |
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
മ Over-The-Counter Use (21 CFR 801 Subpart C)
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I. SUBMITTER
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Submitted by Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348
Date Prepared: September 25, 2018
II. DEVICE
Name of Device: PureSet Tray Common or Usual Name: Sterilization Tray Classification Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (21 CFR 880.6850) Regulatory Class: II Primary Product Code: KCT
III. PREDICATE DEVICE
Primary predicate: Nobel Biocare - Kit Boxes and Kit Plates (K163600) This predicate has not been subject to a design-related recall.
Reference predicate: Medtronic Sofamor Danek - Medtronic Transportation/Sterilization Cassettes (K152241)
IV. DEVICE DESCRIPTION
The PureSet Tray is a reusable surgical tray to be used in combination with Nobel Biocare surgical instruments and components. The PureSet Tray is used to store and organize the instruments and components during both the surgical and reprocessing procedures. The PureSet Trays are not intended to maintain sterility on their own. They are intended to be used in conjunction with an FDA cleared sterilization wrap/pouch.
Each PureSet Tray consist of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, and storage. All the components of the PureSet Tray are perforated with an evenly distributed
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hold pattern and are designed to be used for sterilization via steam sterilization. Since the PureSet Trays are perforated, an FDA cleared wrap or pouch must be used for sterilization purposes and to maintain the sterility of the contents. The PureSet Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities.
V. INDICATIONS FOR USE
The Nobel Biocare PureSet Tray is used in healthcare facilities to store and organize Nobel Biocare surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The Nobel Biocare PureSet Trays 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 pouch or sterilization wrap. Sterilization validations for the worst-case PureSet Tray included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screw driver and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 gram (Trefoil PureSet Tray), 1082 grams (NobelActive/NobelParallel CC PureSet Tray) and 945 grams (NobelReplace CC PureSet Tray).
| Method | Steam Sterilization(Moist Heat Sterilization) | |
|---|---|---|
| Cycle | Dynamic-Air-Removal(fractionated vacuum) | Gravity-Displacement |
| Temperature | 132°C(270°F) | 132°C(270°F) |
| Exposure time for asingle-use poucheddevice | 4 minutes(full-cycle) | 15 minutes(full-cycle) |
| Minimum dryingtimes | 20 minutes | 30 minutes |
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VI. Comparison of Technological Characteristics
Comparison of intended use and indication for use statement
| Technologicalcharacteristics | Subject Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|---|
| Intended use | PureSet Tray | Kit Boxes and Kit Plates (K163600) | Medtronic Transportation/ SterilizationCassettes (K152241) | |
| The Nobel Biocare PureSet Tray isintended for use in healthcare facilities tostore and organize Nobel Biocaresurgical instruments and componentsduring cleaning/sterilization and duringimplant/prosthetic treatment. The NobelBiocare PureSet Trays are not intendedon their own to maintain sterility; it isintended to be used in conjunction with alegally marketed, validated, FDA-clearedsterilization pouch or sterilization wrap. | The Nobel Biocare Kit Boxes are intendedfor use in healthcare facilities to organize,enclose, sterilize, transport, and storemedical devices between surgical uses.The Nobel Biocare Kit Boxes are notintended on their own to maintain sterility;it is intended to be used in conjunction witha legally marketed, validated, FDA-clearedsterilization wrap. Sterilization validationsfor the worst-case Nobel Biocare Kit Box(170 mm x 145 mm x 57) included surgicalinstruments such as torque wrenches,implant drivers, direction indicators, drills,etc. | The Medtronic Transportation/SterilizationCassettes are intended for use in healthcarefacilities to organize, enclose, sterilize,transport, and store medical devices andother instrumentation between surgical andother medical uses. The MedtronicTransportation/Sterilization Cassettes are notintended on their own to maintain sterility; itis intended to be used in conjunction with alegally marketed, validated, FDA-clearedsterilization wrap. | ||
| Technologicalcharacteristics | Subject Device | Primary Predicate | Reference Predicate | |
| PureSet Tray | Kit Boxes and Kit Plates (K163600) | Medtronic Transportation/ SterilizationCassettes (K152241) | ||
| Indication foruse statement | The Nobel Biocare PureSet Tray is usedin healthcare facilities to store andorganize Nobel Biocare surgicalinstruments and components duringcleaning/sterilization and duringimplant/prosthetic treatment. The NobelBiocare PureSet Trays are not intendedon their own to maintain sterility; it isintended to be used in conjunction with alegally marketed, validated, FDA-clearedsterilization pouch or sterilization wrap.Sterilization validations for the worst-case PureSet Tray included surgicalinstruments such as torque wrenches,implant drivers, direction indicators,drills, screw taps, screw driver andirrigation needles. The PureSet Trayswere validated for a maximum load of1635 grams (Trefoil PureSet Tray), 1082grams (NobelActive/NobelParallel CCPureSet Tray) and 945 grams(NobelReplace CC PureSet Tray). | The Nobel Biocare Kit Boxes are used inhealthcare facilities to organize, enclose,sterilize, transport, and store medicaldevices between surgical uses. The NobelBiocare Kit Boxes are not intended on theirown to maintain sterility; it is intended to beused in conjunction with a legallymarketed, validated, FDA-clearedsterilization wrap. Sterilization validationsfor the worst-case Nobel Biocare Kit Box(170 mm x 145 mm x 57mm) includedsurgical instruments such as torquewrenches, implant drivers, directionindicators, drills, etc. The Kit Boxes werevalidated for a maximum load of 469grams including kit box and instruments. | Cycle Tempe-rature Exposuretime Minimumdry time | |
| MethodSteam Sterilization(Moist Heat Sterilization) | GravityDisplace-ment 250° F(121°C) 30Minutes 30Minutes | |||
| Cycle Dynamic-Air-Removal(fractionatedvacuum) Dynamic-Air-Removal(fractionatedvacuum) Gravity-Displacement | GravityDisplace-ment 270° F(132°C) 15Minutes 30Minutes | |||
| GravityDisplace-ment 275° F(135°C) 10Minutes 30Minutes | ||||
| Dynamic-Air-Removal 270º F(132°C) 4Minutes 30Minutes | ||||
| MethodSteam Sterilization(Moist Heat Sterilization) | Dynamic-Air-Removal 275° F(135° C 3Minutes 30Minutes | |||
| Temperature 132°C(270°F) 134°C(270°F) 132°C(270°F) | The Medtronic Transportation/ SterilizationCassettes are intended for use in healthcarefacilities to organize, enclose, sterilize,transport, and store medical devices andother instrumentation between surgical andother medical uses. The MedtronicTransportation/ Sterilization Cassettes arenot intended on their own to maintain sterility;it is intended to be used in conjunction with alegally marketed, validated, FDA-clearedsterilization wrap. | |||
| Cycle Dynamic-Air-Removal(fractionat | Sterilization validations for the worst-caseMedtronic Transportation/Sterilization | |||
| Gravity-Displacement | ||||
| Exposuretime for asingle-use 4 minutes(full-cycle) 3 minutes(full-cycle) 15minutes(full-cycle) | ||||
| Technologicalcharacteristics | Subject Device | Primary Predicate | Reference Predicate | |
| PureSet Tray | Kit Boxes and Kit Plates (K163600) | Medtronic Transportation/ SterilizationCassettes (K152241) | ||
| edvacuum) | poucheddevice | Cassette (22.75 x 11.26 x 5.5 inches)included implants and common surgicalinstruments such as rasps, drivers, trials,handles, inserters, probes, drills, etc. Thevalidated total weight was 28.4 lbs. Thevalidated worst-case loading configurationsof the Medtronic Transportation/ SterilizationCassette included the following worst-caselumen dimensions. | ||
| Temperature | 132°C(270°F) | Exposretime fortheOverkillApproach | ||
| 132°C(270°F) | 2 minutes(halfcycle) | -363 x 1.575 mm-247.5 x 4.1 mmDevice List:1850060 Case- Triple Generic Outer Base(22.74 x 11.260 x 5.040 inches) | ||
| Exposuretime for asingle-usepoucheddevice | 4 minutes(full-cycle) | 1.5minutes(halfcycle) | 1850064 Lid- Generic Outer Lid (22.75 x11.260 x 0.470 inches)7022101L Tray Lid (21 x 10.13 x 0.075inches)P1850061 Tray 1 (20.75 x 9.79 x 1.32inches) | |
| 15 minutes(full-cycle) | 7.5minutes(halfcycle) | P1850062 Tray 2 (21 x 10.13x 1.69 inches)P1850063 Tray 3 (21 x 10.13 x 1.38 inches)7059532 Large Caddy (9.47 x 6.37 x 1.3inches) | ||
| Minimumdrying times | 20minutes | Minimumdryingtimes | 7059532L Large Lid (5.85 x 4.725 x 0.095inches) | |
| 30 minutes | 20minutes | P213018 Small Caddy (2 x 1.5 x 1.025inches) | ||
| 10minutes | P9213018 Small Lid (2 x 1.29 x 0.095inches) | |||
| 30minutes |
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Nobel Biocare Traditional 510(k) Notification (K181075) PureSet Tray September 2018
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| Technological | Subject Device | Primary Predicate | Reference Predicate | |||
|---|---|---|---|---|---|---|
| characteristics | PureSet Tray | Kit Boxes and Kit Plates (K163600) | Medtronic Transportation/ SterilizationCassettes (K152241) | |||
| CycleGravityDisplace-ment | Tempe-rature250° F(121° C) | Exposuretime30Minutes | Minimumdry time30Minutes | |||
| GravityDisplace-ment | 270° F(132° C) | 15Minutes | 30Minutes | |||
| GravityDisplace-ment | 275° F(135° C) | 10Minutes | 30Minutes | |||
| Dynamic-Air-Removal | 270° F(132° C) | 4Minutes | 30Minutes | |||
| Dynamic-Air-Removal | 275° F(135° C) | 3Minutes | 30Minutes | |||
| Comparison of Intended use/Indications for Use: The intended use of the PureSet Tray is the same as the primary predicate Kit Boxes and Kit Plates (K163600). Both |
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Comparison of Technological Characteristics
| CandidatePureSet Tray | Primary PREDICATEKit Boxes and Kit Plates(K163600) | PREDICATEMedtronic Transportation /Sterilization Cassettes(K152241) | Comparison | |
|---|---|---|---|---|
| Design | Trefoil PureSet Tray- Two levels (upper levelwith grommets, lowerlevel with holders andbaskets) for holdingtooling in specificlocations and coveringlid with integratedhandle.NobelActive/NobelParallelCC PureSet Tray andNobelReplace CC PureSetTray– Single level withgrommets and a basketfor holding tooling inspecific locations andcovering lid withintegrated handle. | A base, inserted plate,support(stand) and a lid | A base, a lid with a locking latchand individual inserts | The PureSet Trayand primarypredicate eachhave a base, insert,and lid.The PureSet Trayhas either a one ortwo-level design.The two-leveldesign is not usedin the predicate.This change indesign wassuccessfullyvalidated. |
| Dimensions | Trefoil PureSet- 276.1 mm x 176 mm x78.1 mmNobelActive/NobelParallelCC PureSet- 276.1 mm x 176 mm x63.1 mm | 170 mm x 145 mm x 57mm (main)170 mm x 70 mm x 57mm (sub)310 mm x 180 mm x 70mm (kit organizer) | 22.75 in. x 11.26 in. x 5.51 in. | The dimensionsand volume of thePureSet Tray isbetween theprimary predicateand referencedevice. |
| CandidatePureSet Tray | Primary PREDICATEKit Boxes and Kit Plates(K163600) | PREDICATEMedtronic Transportation /Sterilization Cassettes(K152241) | Comparison | |
| NobelReplace CC PureSet- 276.1 mm x 176 mm x51.1 mm | ||||
| Configuration | Perforated bases, lids andPEEK Luvocom grommets | Perforated bases, lidsand silicone grommets | Perforated bases, lids, andinserts | The PureSet Tray,primary predicate,and referencedevice all utilize aperforated design. |
| Device Material | PureSet Tray- Stainless steelconstruction- PEEK grommets andstorage sleeves- PEEK mini tray locks- Silicone elastomer feetPureSet Tray Plate- Aluminum constructionwith anodization | Aluminum (Drill StopBox only), Polymer andSilicon | Thermoplastic polymer,aluminum and stainless steel | The PureSet Trayuses materials notincluded in thepredicate. ThePureSet Tray hassuccessfully beenvalidated. |
| Perforation | Evenly distributed holepattern | Evenly distributed holepattern | Unknown | Same as primary |
| Vent to VolumeRatio | Trefoil PureSet: 43.5NobelActive PureSet/NobelParallel CC PureSet:40.3NobelReplace CC PureSet:35.8 | 65 | Unknown | The PureSet Trayshave a lowervolume to vent ratioallowing easiersterilantpenetration. |
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| CandidatePureSet Tray | Primary PREDICATEKit Boxes and Kit Plates(K163600) | PREDICATEMedtronic Transportation /Sterilization Cassettes(K152241) | Comparison | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sterilization Method | Pre-Vacuum (wrap, pouch)Gravity Displacement (wrapor pouch) | Pre-VacuumGravity Displacement | Pre-VacuumGravity Displacement | Same | ||||||||||||||||||||
| Sterilant Penetration | Yes | Yes | Yes | Same | ||||||||||||||||||||
| Microbial BarrierProperties | To be used with an FDAapproved sterilizationwrap/pouch | To be used with an FDAapproved sterilizationwrap/pouch | To be used with an FDAapproved sterilization wrap | Same | ||||||||||||||||||||
| Reusable | Yes | Yes | Yes | Same | ||||||||||||||||||||
| MaterialCompatibility withSterilization Method | Yes | Yes | Yes | Same | ||||||||||||||||||||
| SterilizationParameters | Pre-Vacuum:Temp 132°C (270° F)Exposure Time 4 minutesPre-vacuum: 4 times < 60mbarDrying Time: 20 minutesCooling Time: 30 minutestotalGravity:Temp 132°C (270° F)Exposure Time: 15 minutesPre-vacuum: N/ADrying Time: 30 minutesCooling Time: 30 minutestotal | Pre-Vacuum:Temp 270° FExposure Time 4minutesPre-vacuum: 3 times <60 mbarDrying Time: 30 minutesCooling Time: 10minutes at roomtemperatureGravity:Temp 270° FExposure Time: 15minutesPre-vacuum: N/ADrying Time: 30 minutes | 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 270° F(132° C) 4 Minutes 30 Minutes | The PureSet Traysterilizationparameters areslightly from thepredicate devices.The PureSet Traysterilizationparameters havebeen successfullyvalidated. |
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| CandidatePureSet Tray | Primary PREDICATEKit Boxes and Kit Plates(K163600) | PREDICATEMedtronic Transportation /Sterilization Cassettes(K152241) | Comparison | ||||
|---|---|---|---|---|---|---|---|
| Cooling Time: 10minutes at roomtemperature | Dynamic-Air-Removal 275°F(135°C) 3Minutes 30Minutes |
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Analysis of Differences Between Subject Device and Predicate
Indications for use
The PureSet Travs have the same intended use as the primary and reference predicates. Both the subject and predicate devices are intended to orqanize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical uses.
Technological characteristics
Device Construction/Materials
The PureSet Trays and predicates are all designed to hold specific surgical tooling in specific locations and are constructed in a manner that would pose the minimum barrier to the moist heat sterilant. The PureSet Tray and predicates are made of materials that will withstand the repeated use as a sterilization tray. The differences in design and materials have been verified through use of biocompatibility testing and sterilization validation.
The size and weight of the PureSet Tray lies between the primary and reference predicate. This is primarily due to the surgical tooling that is intended to be held by the tray. Any differences in size have been verified as inconsequential to the intended use by sterilization validation.
Sterilization Method
The PureSet Trays and predicates are intended to be used with moist heat sterilization using both pre-vacuum (wraps, pouches and containers) and gravity cycles (wraps and pouches). Both the PureSet Trays and the primary predicate (K163600) are intended to be enclosed in an FDA cleared sterilization wrap or pouch. In addition, the PureSet Tray can be enclosed in an FDA cleared sterilization wrap or pouch when using the pre-vacuum cycle. The use of a sterilization wrap or pouch has been verified through sterilization. The weight of the loaded PureSet Tray is between the weight of the primary and reference predicates.
VII. PERFORMANCE DATA
Summary of Non-Clinical Testing:
The following performance data was provided or relied upon in support of the substantial equivalence determination.
Biocompatibility Testing
PureSet Trays do not come in direct contact with the patient. However, they are intended for storage, organization and reprocessing of reusable surgical instruments and tools. Therefore, categorization as a surgical instruments and tools from ISO 10993 is applicable. Surgical instruments and tools in contact with tissue/bone/dentin are categorized as external communicating devices. They are used during surgery only, therefore the contact duration is limited and ≤24h. The biocompatibility of the PureSet Tray was validated accordingly. The following standards were used during the validation process.
| Standard Reference | Standard Title |
|---|---|
| AAMI/ANSI/ISO 10993-1:2009 | Biological evaluation of medical devices—Part 1: Evaluationand testing within a risk management process |
| AAMI/ANSI/ISO 10993-5:2009 | Biological evaluation of medical devices—Part 5: Tests for invitro cytotoxicity |
| ISO 10993-12 | Biological evaluation of medical devices—Part 12: Samplepreparation and reference materials |
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Cleaning/Disinfection/Sterilization Testing
The PureSet Trays are supplied non-sterile and required processing through cleaning/disinfection and sterilization at the health care facility by the end user. Validation testing confirmed the methods and parameters of these processes as specified in the device labeling.
Sterilization validations for the heaviest worst-case Nobel Biocare PureSet Tray (276.1 mm x 176 mm x 78 mm) included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills and other tools/devices needed for intended use or implant/prosthetic treatment. Worst-case validation testing was used for the PureSet Tray. The following standards were used during the validation process.
| Internal and externalStandard | |
|---|---|
| Standard Reference | Standard Title |
| AAMI/ANSI ST79:2017 | Comprehensive guide to steam sterilization and sterility assurance in health care facilities |
| AAMI/ANSI/ISO14161:2009 | Sterilization of Health Care Products-Biological Indicators-Guidance for the selection, use and interpretation of results |
| ANSI/AAMI ST8:2013 | Hospital steam sterilizers |
| EN 285:2015 | Sterilization -Steam sterilizers- Large sterilizers |
| ANSI/AAMI ST77:2013 | Containment devices for reusable medical device sterilization |
| ISO/TS 15883-5: 2005 | Washer disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy |
| ANSI/AAMI/ISO11737-2:2009 | Sterilization of medical devices – Microbiology methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ANSI/AAMIST81:2004/(R)2010 | Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices |
| ANSI/AAMI/ISO14937:2009/(R) 2013 | Sterilization of Health Care Products-General Requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| AAMI TIR12:2010 | Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers |
| AAMI TIR30:2011 | A compendium of processes, materials, test methods, acceptance criteria for cleaning reusable medical devices |
| AAMI TIR39:2009 | Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices |
| External Standard | |
|---|---|
| Standard Reference | Standard Title |
| ISO/NP 15883-1:2006 | Washer disinfectors Part 1: General requirements, terms anddefinitions and tests |
Performance Testing
A number of validations were performed to ensure that the PureSet Tray will perform as intended. These are summarized below.
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Handle Durability
The ability of the lid handle and lid to base connection to withstand typical forces has been validated. Validation of this characteristic was done following acceptance criteria defined in DIN 58952-3 - Sterilization transport baskets for sterile barrier systems - Part 3: Instrument travs for sterilizing goods made of metal. The validation verified the ability of the PureSet Tray's closing system and handle to withstand the anticipated forces.
Repeated Reprocessing
The PureSet Tray is intended to be reprocessed. PureSet Trays were subject to repeated multiple cleaning and sterilization cycles as described in the device labelling. After processing the trays were inspected for laser marking legibility and coloration. The laser markings remained legible and there was no degradation to the plate coloring found.
Tool Movement During Tray Transport
The PureSet Trays are intended to hold specialized tooling in specific locations during intra-clinical transportation after surgery, through processing, storage, and eventually back to surgery. Therefore, the ability of the tray to hold the tooling properly during transport was validated by simulating typical transportation method.
Shipping Simulation
The subject device was validated using ASTM D4169-16 titled Standard Practice for Performance Testing of Shipping Containers and Systems. The testing demonstrates that the trays can be boxed and transported internationally.
No Clinical data was used in making the substantially equivalence decision.
VIII. CONCLUSIONS
Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, the subject PureSet Tray are as safe and as effective, and perform as well as the legally marketed predicate device, cleared under K163600 under regulation 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).