(86 days)
The Nobel Biocare PureSet Trays are used in healthcare facilities to store and organize Nobel Biocare surgical/prosthetic 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; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterilization wap. Sterlization validations for the worstcase PureSet Tray included surgical/prosthetic instruments such as torque wrenches, implant drivers, 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 (NobelParallel CC PureSet Tray), 945 grams (NobelReplace CC PureSet Tray), 454 grams (Nobel Biocare N1™ PureSet) and 486 grams (Prosthetic PureSet).
The PureSet Trays are reusable trays to be used in combination with Nobel Biocare surgical/prosthetic instruments and components. The PureSet Trays are used to store and organize the instruments and components during both the surgical, restorative 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 consists 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. The PureSet Tray consists of three parts: 1) a base with holders to accommodate the different surgical/prosthetic instruments, 2) a removable PureSet Plate (spare part) to indicate the surgical workflow (in case of the surgical tray) and the position of the instruments and components within the tray, and 3) a lid to securely contain the instruments and components during reprocessing and transportation
The Nobel Biocare PureSet Trays underwent several non-clinical performance tests to demonstrate substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Safety and Performance Aspects | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Acceptance criteria are defined per ISO 10993-1 and ISO 10993-5. | Pass |
| Cleaning/Disinfection/Sterilization | For Cleaning Validation: Acceptance criteria defined as per AAMI TIR 30. For Steam Sterilization Validation: Acceptance criteria defined in ISO 17665-1; AAMI ST79; AAMI TIR 12. Achievement of a SAL 10-6. | Pass |
| Repeated Reprocessing (Legibility) | Each laser marking is human readable in an office environment after 500 reprocessing cycles, despite expected fading compared to non-processed Trays. | Pass |
| Repeated Reprocessing (Plate) | The information on the plate is still readable after 250 cycles of cleaning and sterilization. | Pass |
| Tool Movement During Tray Transport | The instruments stay in the designated location within the tray. The assembled instruments do not disassemble during transport. | Pass |
| Shipping Simulation | Visual Inspection of the shipping box Acceptance criteria based on ASTM4169-16. Inspection of label legibility Labels are present and legible. Abrasion and smudge are acceptable as long as information is human legible. | Pass |
| Risk Analysis | N/A (Risk analysis performed in accordance with ISO 14971, which implies that identified risks are mitigated to an acceptable level, but specific quantitative acceptance criteria are not provided in this table for the risk analysis itself beyond its completion.) | N/A (Risk analysis performed) |
2. Sample Size and Data Provenance:
- Test Set Sample Size: The document does not explicitly state a specific "sample size" in terms of number of devices for each test. However, it mentions quantities in the context of repeated reprocessing:
- Legibility: 500 cleaning and sterilization cycles.
- Plate Reprocessing: 250 cycles of cleaning and sterilization.
- Worst-case product was used for shipping simulation.
- Data Provenance: The tests were conducted by Nobel Biocare AB, presumably in a laboratory setting, to evaluate the device's performance against established standards. The document does not specify the country of origin of the data beyond Nobel Biocare's location. The testing appears to be prospective as it was performed specifically for this submission.
3. Number of Experts and Qualifications for Ground Truth:
- This device is a sterilization tray, and the testing focuses on its physical and functional performance (biocompatibility, cleaning efficacy, sterilization efficacy, durability, transport integrity, packaging). These tests typically rely on standardized methods and laboratory measurements rather than human expert opinion to establish ground truth. Therefore, the concept of "experts used to establish ground truth" as it would apply to diagnostic AI is not directly relevant here. The ground truth is established by the objective measures defined by the standards (e.g., SAL 10-6 for sterilization).
4. Adjudication Method:
- Not applicable. As described in point 3, the evaluation of a sterilization tray's performance against physical and biological standards does not involve expert adjudication in the way diagnostic image review might.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This device is a medical accessory (sterilization tray), not an AI-powered diagnostic tool. Therefore, an MRMC study to compare human reader performance with and without AI assistance is irrelevant.
6. Standalone Performance Study:
- Yes, a standalone performance study was conducted. The non-clinical performance tests mentioned in the table (biocompatibility, cleaning/sterilization, repeated reprocessing, tool movement during transport, shipping simulation) represent the standalone performance evaluation of the Nobel Biocare PureSet Tray itself, without human intervention in the primary function being tested (beyond, for example, loading/unloading for cleaning/sterilization tests).
7. Type of Ground Truth Used:
- The ground truth used for these tests is based on objective, standardized measurements and criteria defined by consensus standards (e.g., ISO 10993-1, ISO 10993-5, AAMI TIR 30, ISO 17665-1, AAMI ST79, AAMI TIR 12, ASTM D4169-16, ISO 14971). For example, achieving a Sterility Assurance Level (SAL) of 10-6 in sterilization validation is an objective ground truth.
8. Sample Size for the Training Set:
- Not applicable. This device is a physical medical accessory, not an AI/machine learning algorithm. Therefore, there is no "training set."
9. How Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this type of medical 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 & 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.
September 24, 2019
Nobel Biocare AB % Elena Cavallini Senior Regulatory Affairs Manager Nobel Biocare Services AG Balz Zimmermann-Strasse 7 Kloten Zurich, 8302 Ch
Re: K191475
Trade/Device Name: Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 3, 2019 Received: June 4, 2019
Dear Elena Cavallini:
This letter corrects our substantially equivalent letter of August 29, 2019.
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
{1}------------------------------------------------
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 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 (QS) 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 medical devices and radiation-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,
Clarence W. Murray lii III -S
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
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Indications for Use
510(k) Number (if known) K191475
Device Name
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Tray, Prosthetic PureSet Tray, Prosthetic PureSet Plate
Indications for Use (Describe)
The Nobel Biocare PureSet Trays are used in healthcare facilities to store and organize Nobel Biocare surgical/prosthetic 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; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterilization wap. Sterlization validations for the worstcase PureSet Tray included surgical/prosthetic instruments such as torque wrenches, implant drivers, 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 (NobelParallel CC PureSet Tray), 945 grams (NobelReplace CC PureSet Tray), 454 grams (Nobel Biocare N1™ PureSet) and 486 grams (Prosthetic PureSet).
| 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-usepouched 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K191475 510(k) Summary
l. Submitter
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Submitted by:
Nobel Biocare Services AG Balz Zimmermann-Strasse 7 8302 Kloten, Switzerland
Contact Person: Elena Cavallini, Senior Regulatory Affairs Manager E-mail: elena.cavallini@nobelbiocare.com Phone: (+41) 79 571 82 46 Fax: (+41) 43 211 42 42
Date Prepared: August 28, 2019
II. Device
| Device Proprietary Name: | Nobel Biocare N1 PureSet Tray, Nobel Biocare N1PureSet Plate, Prosthetic PureSet Tray, ProstheticPureSet Plate |
|---|---|
| Common or Usual Name: | Sterilization wrap containers, trays, cassettes & otheraccessories |
| Classification Name: | Sterilization Wrap |
| Regulation Number: | 21 CFR 880.6850 |
| Product Code: | KCT |
| Device Classification | Class II |
| Classification Panel | Dental Devices Panel |
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lll. Predicate Device
Predicate Nobel Biocare - PureSet Tray (K181075)
The following device are referenced in the Substantial Equivalence Discussion:
| Device Name | Applicant | 510(k) number | |
|---|---|---|---|
| Predicate | PureSet Tray | Nobel Biocare AB | K181075 |
IV. Device Description
The PureSet Trays are reusable trays to be used in combination with Nobel Biocare surgical/prosthetic instruments and components. The PureSet Trays are used to store and organize the instruments and components during both the surgical, restorative 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 consists 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.
The PureSet Tray consists of three parts: 1) a base with holders to accommodate the different surgical/prosthetic instruments, 2) a removable PureSet Plate (spare part) to indicate the surgical workflow (in case of the surgical tray) and the position of the instruments and components within the tray, and 3) a lid to securely contain the instruments and components during reprocessing and transportation
> Indications for Use
The Nobel Biocare PureSet Trays are used in healthcare facilities to store and organize Biocare surgical/prosthetic instruments and components Nobel during cleaning/sterilization and during implant/prosthetic treatment. The Nobel Biocare PureSet Trays are not intended on their own to maintain sterility; they are 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/prosthetic 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), 945 grams (NobelReplace CC
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PureSet Tray), 454 grams (Nobel Biocare N1™ PureSet) and 486 grams (Prosthetic PureSet).
| 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-usepouched device | 4 minutes (full-cycle) | 15 minutes (full-cycle) |
| Minimum drying times | 20 minutes | 30 minutes |
VI. Comparison of Technological Characteristics
Comparisons of the subject and predicate devices are provided in the following tables.
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| Technologicalcharacteristics | Subject DevicePureSet Tray | Predicate DevicePureSet Tray (K181075) | Comparison |
|---|---|---|---|
| Manufacturer | Nobel Biocare AB | Nobel Biocare AB | Same |
| Device Class | Class II | Class II | Same |
| Product Code | KCT | KCT | Same |
| Regulation number | 880.6850 | 880.6850 | Same |
| Intended Use | The Nobel Biocare PureSet Trays are intendedfor use in healthcare facilities to store andorganize Nobel Biocare surgical/prostheticinstruments and components duringcleaning/sterilization and duringimplant/prosthetic treatment. The Nobel BiocarePureSet Trays are not intended on their own tomaintain sterility; it is intended to be used inconjunction with a legally marketed, validated,FDA-cleared sterilization pouch or sterilizationwrap. Sterilization validations for the worst-caseNobel Biocare PureSet Tray (276.1 mm x 176mm x 78 mm) included surgical instrumentssuch as torque wrenches, implant drivers,direction indicators, drills, etc. | The Nobel Biocare PureSet Tray is intended for usein healthcare facilities to store and organize NobelBiocare surgical instruments and componentsduring cleaning/sterilization and duringimplant/proshetic treatment. The Nobel BiocarePureSet Trays are not intended on their own tomaintain sterility; it is intended to be used inconjunction with a legally marketed, validated, FDA-cleared sterilization pouch or sterilization wrap.Sterilization validations for the worst-case NobelBiocare PureSet Tray (276.1 mm x 176 mm x 78mm) included surgical instruments such as torquewrenches, implant drivers, direction indicators,drills, etc. | Same |
Table 1: Comparison of PureSet Tray Characteristics.
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| Method | Steam Sterilization(Moist Heat Sterilization) | Method | Steam Sterilization(Moist Heat Sterilization) | ||||
|---|---|---|---|---|---|---|---|
| Cycle | Dynamic-Air-Removal(fractionatedvacuum) | Gravity-Displacement | Cycle | Dynamic-Air-Removal(fractionatedvacuum) | Gravity-Displacement | ||
| Temperature | 132°C (270°F) | 132°C(270°F) | Temperature | 132°C (270°F) | 132°C (270°F) | ||
| Exposuretime for asingle-usepoucheddevice | 4 minutes(full-cycle) | 15 minutes(full-cycle) | Exposuretime for asingle-usepoucheddevice | 4 minutes(full-cycle) | 15 minutes(full-cycle) | ||
| Minimumdryingtimes | 20 minutes | 30 minutes | Minimumdrying times | 20 minutes | 30 minutes | ||
| Design Features | MacroDesign | Nobel Biocare N1™ and Prosthetic PureSetTraysSingle level tray with grommets and a basketfor holding tooling in specific locations andcovering lid (without handle). | Trefoil PureSet Tray- Two levels tray (upper level withgrommets, lower level with holders andbaskets) for holding tooling in specificlocations and covering lid with integratedhandle.NobelActive/NobelParallel CC PureSet Tray andNobelReplace CC PureSet TraySingle level tray with grommets and a basket forholding tooling in specific locations and covering lidwith integrated handle. | Differs |
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| Material | PureSet Tray- Stainless steel construction (1.43011.4303, 1.4310, 1.4024)- PEEK grommets and storage sleeves- PEEK mini tray locks- Silicone elastomer feetPureSet Tray PlateAluminum construction with anodization | PureSet Tray- Stainless steel construction (1.43011.4303, 1.4310)- PEEK grommets and storage sleeves- PEEK mini tray locks- Silicone elastomer feetPureSet Tray PlateAluminum construction with anodization | Same(except for1.4024StainlessSteel) |
|---|---|---|---|
| Nobel Biocare N1™ and Prosthetic PureSetTrays | Trefoil PureSet- 276.1 mm x 176 mm x 78.1 mm | ||
| Dimensions | 122.1x115x45.6mm | NobelActive/NobelParallel CC PureSet- 276.1 mm x 176 mm x 63.1 mmNobelReplace CC PureSet276.1 mm x 176 mm x 51.1 mm | Differs |
| Configuration | Perforated bases, lids and PEEK Luvocomgrommets | Perforated bases, lids and PEEK Luvocomgrommets | Same |
| Perforation | Evenly distributed hole pattern | Evenly distributed hole pattern | Same |
| SterilizationMethod | Pre-Vacuum (wrap or pouch)Gravity Displacement (wrap or pouch) | Pre-Vacuum (wrap or pouch)Gravity Displacement (wrap or pouch) | Same |
| SterilantPenetration | Yes | Yes | Same |
| MicrobialBarrierProperties | To be used with an FDA approved sterilizationwrap/pouch | To be used with an FDA approved sterilizationwrap/pouch | Same |
| Reusable | Yes | Yes | Same |
| MaterialCompatibilitywithSterilization | Yes | Yes | Same |
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| Method | ||||
|---|---|---|---|---|
| SterilizationParameters | Pre-Vacuum:Temp 132°C (270° F)Exposure Time 4 minutesPre-vacuum: 4 times < 60 mbarDrying Time: 20 minutesCooling Time: 30 minutes total | Pre-Vacuum:Temp 132°C (270° F)Exposure Time 4 minutesPre-vacuum: 4 times < 60 mbarDrying Time: 20 minutesCooling Time: 30 minutes total | Same | |
| Gravity:Temp 132°C (270° F)Exposure Time: 15 minutesPre-vacuum: N/ADrying Time: 30 minutesCooling Time: 30 minutes total | Gravity:Temp 132°C (270° F)Exposure Time: 15 minutesPre-vacuum: N/ADrying Time: 30 minutesCooling Time: 30 minutes total | |||
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Analysis of differences between Subject Device and Predicate
Indications for use
The PureSet Tray has the same intended use as the predicate device PureSet Tray (K181075). Both the subject and predicate device are intended to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical uses and/or prosthetic uses.
The differences in indications for use between the subject device and predicate relate to weight and size only and do not alter the intended use of the device.
Technological characteristics
Device Construction/Materials
The subject PureSet Tray and predicate PureSet Tray (K181075) are all designed to hold specific surgical and/or prosthetic tooling in specific locations and are constructed in a manner that would pose the minimum barrier to the moist heat sterilant. The subject PureSet Tray and predicate PureSet Tray (K181075) 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, sterilization and performance testing.
The size and weight of the subject PureSet Tray are lower compared to the predicate device (K181075). This is primarily due to the surgical tooling that is intended to be held by the tray. Any differences in size have been evaluated according to AAMI TIR12:2010 and been assessed as inconsequential to the intended use by sterilization validation.
VII. Performance Data
Summary of Non-Clinical Performance Data
Nobel Biocare completed a number of nonclinical performance tests in accordance with internal requirements, international standards and FDA-recognized consensus standards.
Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The non-clinical testing detailed in this submission supports the substantial equivalence of this device.
The following safety and performance data were provided in support of the substantial equivalence determination:
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| Safety andperformanceaspects | Test Name | Test Purpose | Acceptance Criteria | Results | Comment |
|---|---|---|---|---|---|
| Biocompatibility | BiocompatibilityTest(Cytotoxicity) | Provide a biologicalevaluation of thesubject device. | Acceptance criteria are definedper ISO 10993-1 and ISO10993-5. | Pass | The PureSet Tray wassuccessfully tested forbiocompatibility testingin accordance withISO 10993. |
| Cleaning/Disinfection/SterilizationTesting | 1.Manual andAutomated CleaningValidation2.Manual DisinfectionValidation3.Steam SterilizationValidation (prevacuumand gravity cycle) | Validation of theinstructions for usefor cleaning andsterilization. | For Cleaning Validation:Acceptance criteria defined asper AAMI TIR 30.For Steam SterilizationValidation:Acceptance criteria defined inISO 17665-1; AAMI ST79;AAMI TIR 12. Achievement ofa SAL 10-6. | Pass | The subject PureSetTray is supplied non-sterile and requiredprocessing throughcleaning/disinfectionand sterilization at thehealth care facility bythe end user. |
| RepeatedReprocessing | 1.RepeatedReprocessingLegibility PureSet Tray2.Repeated PlateReprocessing | 1.Validate that thelaser markings onthe PureSet Tray arereadable for thereuse life of 500cleaning andsterilization cycles. | 1.Each laser marking is humanreadable in an officeenvironment after 500reprocessing cycles, despiteexpected fading compared tonon-processed Trays. | Pass | The subject PureSetTray is intended to bereprocessed multipletimes.An analysis wasperformed accordingto ANSI/AAMIST77:2013 and AAMITIR12:2010. As a |
| 2.Evaluate theresistance tocleaning andsterilization methodsrecommended byNobel Biocare of thePureSet Plates. | 2.The information on the plateis still readable after 250cycles of cleaning andsterilization. | result, it wasconcluded that noadditional tests arenecessary tovalidate the subjectdevice in terms ofrepeated reprocessingcompared to thepredicate device(K181075). | |||
| Tool MovementDuring TrayTransport | In-HouseTransportation | Verify that the traykeeps the content inits designatedlocation andassembled during in-house transportation. | The instruments stay in the designated location within the tray. The assembled instruments do not disassemble during transport. | Pass | The PureSet Tray isintended to holdspecialized tooling inspecific locationsduring intra clinicaltransportation aftersurgery, throughprocessing, storage,and eventually back tosurgery. Therefore,theability of the tray tohold the toolingproperly duringtransport wasvalidated bysimulating typicaltransportation method. |
| ShippingSimulation | Packaging-SystemPerformance Testing | Verify that this non-sterilepackagingconfiguration,represented by aworst-case productof a family ofcomparableproducts using thesame packaging,maintains integrity ofpackaging systemand providesphysical protection tothe product followingclimate conditioningand distributionsimulation. | Visual Inspection of theshipping boxAcceptance criteria based onASTM4169-16.Inspection of label legibilityLabels are present and legible.Abrasion and smudge areacceptable as long asinformation is human legible. | Pass | The subject devicewas validated usingASTM D4169-16 titledStandard Practice forPerformance Testingof Shipping Containersand Systems. Thetesting demonstratesthat the trays can beboxed and transportedinternationally. |
| Risk Analysis | N/A | N/A | N/A | N/A | Risk analysis forPureSet Tray wasperformed inaccordance with theISO 14971 |
Table 2: Overview of safety and performance data
.
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Conclusions
The conclusions drawn from the noncinical tests demonstrate that the PureSet Tray is as safe, as effective, and performs as well as or better than the legally marketed device cleared 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).