Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate

Q: Who is the manufacturer of Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate?

Nobel Biocare AB filed the 510(k) submission for Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate (K191475).

Q: What is the FDA product code for Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate?

KCT. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

Q: What is the regulatory pathway for Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K191475 · Nobel Biocare AB · KCT · Aug 29, 2019 · General Hospital

Device Facts

Record ID	K191475
Device Name	Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
Applicant	Nobel Biocare AB
Product Code	KCT · General Hospital
Decision Date	Aug 29, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Intended Use

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 validations for the worst-case 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).

Device Story

Reusable sterilization trays for Nobel Biocare surgical/prosthetic instruments; used in healthcare facilities. Trays consist of perforated base, removable plate for workflow/positioning, and lid. Instruments (e.g., torque wrenches, drills, drivers) are placed in designated holders. Device is not a sterile barrier; requires use of FDA-cleared sterilization wrap/pouch. Used in standard hospital autoclaves (steam sterilization). Protects instruments during transport, cleaning, and storage. Benefits include organized instrument management and standardized reprocessing workflows.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing: biocompatibility (ISO 10993), cleaning/disinfection/sterilization validation (AAMI TIR 30, ISO 17665-1, AAMI ST79), repeated reprocessing (ANSI/AAMI ST77), transport simulation, and packaging performance (ASTM D4169-16).

Technological Characteristics

Materials: Stainless steel (1.4301, 1.4303, 1.4310, 1.4024), PEEK grommets/sleeves/locks, silicone elastomer feet, anodized aluminum plates. Perforated design for steam sterilization (pre-vacuum or gravity displacement). Dimensions vary by model. Reusable. No software/electronics.

Indications for Use

Indicated for use in healthcare facilities to store and organize Nobel Biocare surgical/prosthetic instruments and components during cleaning, sterilization, and implant/prosthetic treatment. Not intended to maintain sterility independently; must be used with an FDA-cleared sterilization wrap or pouch.

Regulatory Classification

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.

Predicate Devices

PureSet Tray (K181075)

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K181075 — PureSet Tray · Nobel Biocare AB · Sep 27, 2018
K203753 — Straumann Surgical Cassettes · Straumann USA, LLC · Jul 29, 2021
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Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ # 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-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) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate | |--------------------------|------------------------------------------------------------------------------------------------------------------------| | Common or Usual Name: | Sterilization wrap containers, trays, cassettes & other accessories | | Classification Name: | Sterilization Wrap | | Regulation Number: | 21 CFR 880.6850 | | Product Code: | KCT | | Device Classification | Class II | | Classification Panel | Dental Devices Panel | {4}------------------------------------------------ #### 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 {5}------------------------------------------------ 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-use pouched 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. {6}------------------------------------------------ | Technological characteristics | Subject Device PureSet Tray | Predicate Device PureSet 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 intended for use 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; 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 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, etc. | The Nobel Biocare PureSet Tray is intended for use in healthcare facilities to store and organize Nobel Biocare surgical instruments and components during cleaning/sterilization and during implant/proshetic 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 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, etc. | Same | Table 1: Comparison of PureSet Tray Characteristics. {7}------------------------------------------------ {8}------------------------------------------------ | Method | Steam Sterilization (Moist Heat Sterilization) | | Method | Steam Sterilization (Moist Heat Sterilization) | | | | |-----------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|----------------------------|--| | | Cycle | Dynamic-Air- Removal (fractionated vacuum) | Gravity- Displacement | Cycle | Dynamic-Air- Removal (fractionated vacuum) | Gravity- Displacement | | | | Temperature | 132°C (270°F) | 132°C (270°F) | 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) | Exposure time for a single-use pouched device | 4 minutes (full-cycle) | 15 minutes (full-cycle) | | | | Minimum drying times | 20 minutes | 30 minutes | Minimum drying times | 20 minutes | 30 minutes | | | Design Features | Macro Design | Nobel Biocare N1™ and Prosthetic PureSet Trays Single level tray with grommets and a basket for holding tooling in specific locations and covering lid (without handle). | | Trefoil PureSet Tray - Two levels tray (upper level with grommets, lower level with holders and baskets) for holding tooling in specific locations and covering lid with integrated handle. NobelActive/NobelParallel CC PureSet Tray and NobelReplace CC PureSet Tray Single level tray with grommets and a basket for holding tooling in specific locations and covering lid with integrated handle. | | Differs | | {9}------------------------------------------------ | Material | PureSet Tray - Stainless steel construction (1.4301 1.4303, 1.4310, 1.4024) - PEEK grommets and storage sleeves - PEEK mini tray locks - Silicone elastomer feet PureSet Tray Plate Aluminum construction with anodization | PureSet Tray - Stainless steel construction (1.4301 1.4303, 1.4310) - PEEK grommets and storage sleeves - PEEK mini tray locks - Silicone elastomer feet PureSet Tray Plate Aluminum construction with anodization | Same (except for 1.4024 Stainless Steel) | |----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------| | | Nobel Biocare N1™ and Prosthetic PureSet Trays | 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 mm NobelReplace CC PureSet 276.1 mm x 176 mm x 51.1 mm | Differs | | Configuration | Perforated bases, lids and PEEK Luvocom grommets | Perforated bases, lids and PEEK Luvocom grommets | Same | | Perforation | Evenly distributed hole pattern | Evenly distributed hole pattern | Same | | Sterilization Method | Pre-Vacuum (wrap or pouch) Gravity Displacement (wrap or pouch) | Pre-Vacuum (wrap or pouch) Gravity Displacement (wrap or pouch) | Same | | Sterilant Penetration | Yes | Yes | Same | | Microbial Barrier Properties | To be used with an FDA approved sterilization wrap/pouch | To be used with an FDA approved sterilization wrap/pouch | Same | | Reusable | Yes | Yes | Same | | Material Compatibility with Sterilization | Yes | Yes | Same | {10}------------------------------------------------ | | Method | | | | |-----------------------------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Sterilization Parameters | | Pre-Vacuum: Temp 132°C (270° F) Exposure Time 4 minutes Pre-vacuum: 4 times < 60 mbar Drying Time: 20 minutes Cooling Time: 30 minutes total | Pre-Vacuum: Temp 132°C (270° F) Exposure Time 4 minutes Pre-vacuum: 4 times < 60 mbar Drying Time: 20 minutes Cooling Time: 30 minutes total | Same | | | | | | | | | | | | | | | | | | | | | | Gravity: Temp 132°C (270° F) Exposure Time: 15 minutes Pre-vacuum: N/A Drying Time: 30 minutes Cooling Time: 30 minutes total | Gravity: Temp 132°C (270° F) Exposure Time: 15 minutes Pre-vacuum: N/A Drying Time: 30 minutes Cooling Time: 30 minutes total | | | | | | | | | | | | | | | | | | | | {11}------------------------------------------------ # 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: {12}------------------------------------------------ | Safety and performance aspects | Test Name | Test Purpose | Acceptance Criteria | Results | Comment | |--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility | Biocompatibility Test (Cytotoxicity) | Provide a biological evaluation of the subject device. | Acceptance criteria are defined per ISO 10993-1 and ISO 10993-5. | Pass | The PureSet Tray was successfully tested for biocompatibility testing in accordance with ISO 10993. | | Cleaning/ Disinfection/ Sterilization Testing | 1.Manual and Automated Cleaning Validation 2.Manual Disinfection Validation 3.Steam Sterilization Validation (prevacuum and gravity cycle) | Validation of the instructions for use for cleaning and 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 | The subject PureSet Tray is supplied non- sterile and required processing through cleaning/disinfection and sterilization at the health care facility by the end user. | | Repeated Reprocessing | 1.Repeated Reprocessing Legibility PureSet Tray 2.Repeated Plate Reprocessing | 1.Validate that the laser markings on the PureSet Tray are readable for the reuse life of 500 cleaning and sterilization cycles. | 1.Each laser marking is human readable in an office environment after 500 reprocessing cycles, despite expected fading compared to non-processed Trays. | Pass | The subject PureSet Tray is intended to be reprocessed multiple times. An analysis was performed according to ANSI/AAMI ST77:2013 and AAMI TIR12:2010. As a | | | | 2.Evaluate the resistance to cleaning and sterilization methods recommended by Nobel Biocare of the PureSet Plates. | 2.The information on the plate is still readable after 250 cycles of cleaning and sterilization. | | result, it was concluded that no additional tests are necessary to validate the subject device in terms of repeated reprocessing compared to the predicate device (K181075). | | Tool Movement During Tray Transport | In-House Transportation | Verify that the tray keeps the content in its designated location and assembled 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 is 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 | Packaging-System Performance Testing | Verify that this non- sterile packaging configuration, represented by a worst-case product of a family of comparable products using the same packaging, maintains integrity of packaging system and provides physical protection to the product following climate conditioning and distribution 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 | 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. | | Risk Analysis | N/A | N/A | N/A | N/A | Risk analysis for PureSet Tray was performed in accordance with the ISO 14971 | Table 2: Overview of safety and performance data . {13}------------------------------------------------ {14}------------------------------------------------ # 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.