Who is the manufacturer of NobelZygoma PureSet Tray?

Nobel Biocare Services AG filed the 510(k) submission for NobelZygoma PureSet Tray (K231219).

What is the FDA product code for NobelZygoma PureSet Tray?

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

What is the regulatory pathway for NobelZygoma PureSet Tray?

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

Who can help prepare an FDA 510(k) submission like NobelZygoma PureSet Tray?

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.

NobelZygoma PureSet Tray

K231219 · Nobel Biocare Services AG · KCT · Jun 27, 2023 · General Hospital

Device Facts

Record ID	K231219
Device Name	NobelZygoma PureSet Tray
Applicant	Nobel Biocare Services AG
Product Code	KCT · General Hospital
Decision Date	Jun 27, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

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; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization container, sterilization pouch or sterilization wrap. Sterilization validations for the worst-case Nobel Biocare PureSet Tray (276.1 mm x 176 mm x 78.1 mm) included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, etc.

Device Story

Reusable surgical tray system; stores/organizes Nobel Biocare surgical/prosthetic instruments during cleaning, sterilization, and treatment. Components: tray base, lid, plate; perforated design for steam sterilant penetration. Used in hospitals/healthcare facilities; operated by clinical staff. Requires external FDA-cleared sterilization container, pouch, or wrap to maintain sterility. Protects instruments during transport/reprocessing. Benefits: ensures organized, sterile-ready instrument sets for implant procedures.

Clinical Evidence

Bench testing only. Validated for cleaning and steam sterilization (dynamic-air-removal and gravity-displacement cycles). Testing included biocompatibility (ISO 10993-1, -5, -12), repeated reprocessing durability, instrument retention, and mechanical strength of handles/closures (ANSI/AAMI ST77).

Technological Characteristics

Materials: Stainless steel tray/closures, PEEK/stainless steel grommets, silicone elastomer feet, anodized aluminum plate. Perforated design for steam sterilization. Dimensions: 276.1mm x 176mm x 58.9mm. 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 FDA-cleared sterilization containers, pouches, or wraps.

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

NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite/Replace Select™ TC PureSet™ Tray (K212932)
Trefoil PureSet™ Tray (K181075)

Related Devices

K212932 — Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray · Nobel Biocare Services AG · Dec 18, 2021
K191475 — Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate · Nobel Biocare AB · Aug 29, 2019
K181075 — PureSet Tray · Nobel Biocare AB · Sep 27, 2018
K202268 — CrossRoads Tray System · Crossroads Extremity Systems, LLC · Dec 30, 2020
K241050 — CrossRoads Modular Tray System · Crossroads Extremity Systems · Jul 16, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health and Human Services seal. The right side of the logo features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. June 27, 2023 Nobel Biocare Services AG Bernice Jim Head of RA Product Development and Marketed Products Balz Zimmermann-Str. 7 Kloten. Zurich 8302 Switzerland ### Re: K231219 Trade/Device Name: NobelZygoma PureSet™ Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: April 28, 2023 Received: April 28, 2023 ### Dear Bernice Jim: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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, Eileen Digitally signed by Eileen Cadel - S Cadel -S Date: 2023.06.27 12:15:40-04'00' for Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) #### K231219 Device Name NobelZygoma PureSet™ Tray #### 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. Nobel Biocare PureSet™ Travs are not inteir own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization container, sterilization pouch or sterilization wrap. Sterlization validations for the worst-case PureSet™ Tray included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screwdrivers, and irrigation needles. The PureSet™ Trays were validated for a maximum load of 1635 grams (Trefoil™ Tray), 1122 grams (NobelActive® / NobelParallel™ CC PureSet™ Tray), 1063 grams (NobelReplace® CC PureSet™ Tray), 454 grams (Nobel Biocare N1™ PureSet™ Tray), 486 grams (Prosthetic PureSet™ Tray), 1143 grams (NobelActive® Guided PureSet™ Tray), 1146 grams (NobelParallel™ CC Guided PureSet™ Tray), 1176 grams (NobelReplace® CC Guided PureSet™ Tray), and 1035 grams (NobelSpeedy® Groovy® / Brånemark System® Mk III TiUnite / Replace SelectTM TC PureSet™ Tray) and 1202 grams (NobelZygoma PureSet™ Tray). | Method | Steam Sterilization (Moist Heat Sterilization) for Wrapped Instruments | | |-----------------------------------------------|------------------------------------------------------------------------|-------------------------| | 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) |X | 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized "N" inside it. To the right of the square is the text "Nobel Biocare" in black font, with the "TM" symbol in superscript. # 510(K) Summary ## NobelZygoma PureSet™ Tray ### 1. Submitter Information | Submitter: | Nobel Biocare AB Vastra Hamngatan 1 Goteborg 411 17 Sweden | |------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By: | Nobel Biocare Services AG Balz-Zimmerman-Strasse 7 8302 Kloten Switzerland | | Contact Person: E-Mail: Telephone Number: Prepared By: Date Prepared | Bernice Jim, Ph.D. regulatory.affairs.nb@envistaco.com +41 43 211 42 00 Ana Sala Roca, Ph.D. April 28, 2023 | | 2. Device Name | | | Proprietary name: Manufacturer: Common Name: Classification Name: Regulation Number: Device Class: Product Code: | NobelZygoma PureSet™ Tray Nobel Biocare AB Sterilization Wrap Sterilization Wrap containers, Trays, Cassettes & Other Accessories 21 CFR 880.6850 II KCT | {4}------------------------------------------------ ### 3. Predicate Device ### Primary Predicate device | Proprietary name: | NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite/Replace Select™ TC PureSet™ Tray (K212932) | |----------------------|------------------------------------------------------------------------------------------------------| | Manufacturer: | Nobel Biocare AB | | Common Name: | Sterilization Wrap | | Classification Name: | Sterilization Wrap containers, Trays, Cassettes & Other Accessories | | Regulation Number: | 21 CFR 880.6850 | | Device Class: | II | | Product Code: | KCT | | Predicate device #2 | | | Proprietary name: | Trefoil PureSet™ Tray (K181075) | | Manufacturer: | Nobel Biocare AB | | Common Name: | Sterilization Wrap | | Classification Name: | Sterilization Wrap containers, Trays, Cassettes & Other Accessories | | Regulation Number: | 21 CFR 880.6850 | | Device Class: | II | | Product Code: | KCT | ### 4. Device Description PureSet Trays are reusable surgical trays to be used in combination with Nobel Biocare surgical instruments and components. PureSet Trays are used to organize and store the instruments and components during both surgical and reprocessing procedures. 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, or container. All components of the PureSet Tray are perforated with an evenly-distributed hole pattern and are designed to be used for sterilization via steam sterilization. Because the PureSet Trays are perforated, an FDA-cleared sterilization wrap, pouch, or container must be used during sterilization and storage to maintain the sterility of the contents. PureSet Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities. {5}------------------------------------------------ ### Principle of Operation / Mechanism of Action PureSet™ Trays consist of multiple components (tray base, lid, and plate) integrated into a single unit which is used to organize instruments during surgical procedures and to protect the instruments during transportation, reprocessing, and storage. ### Compatible Devices and accessories: The NobelZygoma PureSet™ Tray is intended to be used with the following exempt devices from Nobel Biocare (See Table-1). {6}------------------------------------------------ Table-1: NobelZygoma PureSet™ Tray Device/Accessory compatibility overview | | a) List of Devices to be cleaned and sterilized in the subject NobelZygoma PureSet™Tray | | |--|------------------------------------------------------------------------------------------|--| | | | | | Component | Article Number | Device Class | Regulation Number | Product Code | 510(k) | |------------------------------------------|----------------|--------------|----------------------|--------------|--------| | Zygoma Handle | 37786 | Class I | 872.3980 | NDP | Exempt | | Zygoma Drill Guard | 37787 | Class I | 872.3980 | NDP | Exempt | | Zygoma Drill Guard Short | 37788 | Class I | 872.3980 | NDP | Exempt | | Zygoma Depth Indicator Straight | 37789 | Class I | 872.3980 | NDP | Exempt | | Zygoma Depth Indicator Angled | 37790 | Class I | 872.3980 | NDP | Exempt | | Connection to Handpiece | 29081 | Class I | 872.3980 | NDP | Exempt | | Screwdriver Manual Unigrip 28mm | 29149 | Class I | 872.3980 | NDP | Exempt | | Screwdriver Machine Unigrip 25mm | 29152 | Class I | 872.3980 | NDP | Exempt | | Cover Screw Driver Bmk Syst Hexagon | DIB 097-0 | Class I | 872.3980 | NDP | Exempt | | Screwdriver Machine Multi-Unit 21 mm | 29158 | Class I | 872.3980 | NDP | Exempt | | Manual Torque Wrench Prosthetic | 29165 | Class I | 872.3980 | NDP | Exempt | | Manual Torque Wrench Adapter Prosthetic | 29167 | Class I | 872.3980 | NDP | Exempt | | Implant Driver Bmk Syst RP 21 mm | 29129 | Class I | 872.3980 | NDP | Exempt | | Impl Driver Wrench Adap Bmk Syst RP 12mm | 29132 | Class I | 872.3980 | NDP | Exempt | - b) List of Devices that can be stored in the NobelZgyoma PureSet™ Tray that are not intended in the subject NobelZygoma PureSet™Tray. | Component | Article Number | Device Class | Regulation Number | Product Code | 510(k) | |-----------------------------------------|----------------|--------------|----------------------|--------------|--------| | Brånemark System Zygoma Round Bur | DIA 578-0 | Class I | 872.3980 | NDP | Exempt | | NobelZygoma 0° Twist Drill 2.9mm | 377661 | Class I | 872.3980 | NDP | Exempt | | Bmk Syst Zygoma Twist Drill 2.9mm | 326281 | Class I | 872.3980 | NDP | Exempt | | NobelZygoma 0° Twist Drill 2.9mm Short | 377672 | Class I | 872.3980 | NDP | Exempt | | Bmk Syst Zygoma Twist Drill 2.9mm Short | 326292 | Class I | 872.3980 | NDP | Exempt | | Bmk Syst Zygoma Pilot Drill 3.5mm | 32630 | Class I | 872.3980 | NDP | Exempt | {7}------------------------------------------------ | Component | Article Number | Device Class | Regulation Number | Product Code | 510(k) | |-----------------------------------------|----------------|--------------|----------------------|--------------|--------| | Bmk Syst Zygoma Pilot Drill 3.5mm short | 32791 | Class I | 872.3980 | NDP | Exempt | | NobelZygoma 0° Twist Drill 3.5mm | 377683 | Class I | 872.3980 | NDP | Exempt | | Bmk Syst Zygoma Twist Drill 3.5mm | 326313 | Class I | 872.3980 | NDP | Exempt | | NobelZygoma 0° Twist Drill 3.5mm Short | 377694 | Class I | 872.3980 | NDP | Exempt | | Bmk Syst Zygoma Twist Drill 3.5mm Short | 326324 | Class I | 872.3980 | NDP | Exempt | | NobelZygoma 0° Twist Drill 4.0mm | 37770 | Class I | 872.3980 | NDP | Exempt | | NobelZygoma 0° Twist Drill 4.0mm Short | 37771 | Class I | 872.3980 | NDP | Exempt | | NobelZygoma 0° Twist Drill 4.4mm | 37772 | Class I | 872.3980 | NDP | Exempt | | NobelZygoma 0° Twist Drill 4.4mm Short | 37773 | Class I | 872.3980 | NDP | Exempt | 1, 2, 3,4 Two alternative articles available. There is only space for one in the Subject device. {8}------------------------------------------------ ## 5. Indication for 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. 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 container, 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, screwdrivers, and irrigation needles. The PureSet™ Trays were validated for a maximum load of 1635 grams (Trefoil™ PureSet™ Tray), 1122 grams (NobelActive® / NobelParallel™ CC PureSet™ Tray), 1063 grams (NobelReplace® CC PureSet™ Tray), 454 grams (Nobel Biocare N1™ PureSet™ Tray), 486 grams (Prosthetic PureSet™ Tray), 1143 grams (NobelActive® Guided PureSet™ Tray), 1146 grams (NobelParallel™ CC Guided PureSet™ Tray), 1176 grams (NobelReplace® CC Guided PureSet™ Tray), and 1035 grams (NobelSpeedy® Groovy® / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray) and 1202 grams (NobelZygoma PureSet™ Tray). | Method | Steam Sterilization (Moist Heat Sterilization) for Wrapped Instruments | | |--------------------------------------------------|---------------------------------------------------------------------------|----------------------------| | 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 | ## 6. Technological Characteristic Comparison: Details of the Similarities Between the Subject and the Predicate devices The similarities between the NobelZygoma PureSet™ Tray (Subject Device), the Primary Predicate device NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite/Replace SelectTM TC PureSet™ Tray (K212932) and the Predicate device #2 Trefoil PureSet™ Tray (K181075) are as follow: - The Intended Use statement of the subject device is identical to the Primary . Predicate device and similar to the Predicate device #2. - The Indications for Use for the subject device are the same to the Predicate devices. - . The design aspects including tray perforation, sterilant penetration, tray configuration, and reusability, the materials of construction, the sterilization methods, and parameters for reprocessing (including the microbial barriers to be used), the compatibility of the tray materials with the prescribed sterilization methods, and the approach to non-clinical performance testing are all the same for the subject device and both Predicate devices. - The macro design of the subject device is similar to the Primary Predicate device. ● Both the subject device and the Primary Predicate device are single level trays which have an integrated handle. The dimensions of the Subject and Primary Predicate devices are identical in width and length. The volume to vent ratio of the {9}------------------------------------------------ Subject Device is within range of the volume to vent ratio of the Predicate device #2. ### Details of the Differences Between the Subject and Predicate No. 2 device There are no significant differences between the subject and Predicate devices but there are minor differences as follows: - . The design layout of the subject device is different to the Predicate devices. Each tray is designed to accommodate the instruments of the respective Nobel Biocare System. Since the assortment of instruments used with each tray is different, the instrument retention features (e.g., grommets, holders, mini baskets/drill holder, metal brackets) are adapted to the needs of each PureSet System Tray. Because of the differences on the design layout, the height of the subject is different to the Predicate devices as well as the volume to vent ratio (V-to-V), maximum validation load. However, these values are within range of the Predicate devices. The Subject device does not represent a greater challenge to cleaning and sterilization validations of the Predicate devices. These minor differences do not raise new concerns of substantial equivalence. The comparison below (Table-2) for the Subject device, Primary Predicate device and Predicate device #2 demonstrates that the Subject device is substantially equivalent to the Predicate devices with regards to their Indications for use, technology, and performance specifications. The Subject device furthermore does not introduce a fundamentally new scientific technology. The Design control activities described in this submission supports the conclusion that the Subject device performs as well as the Predicate devices for its intended use. {10}------------------------------------------------ ### Table-2: NobelZygoma PureSet™ Tray comparison table | Descriptive Information | Subject Device NobelZygoma PureSet Tray | Primary Predicate device NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray - K212932 | Predicate device #2 Trefoil PureSet Tray - K181075 | Comparison | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Pictorial Representation | Image: NobelZygoma PureSet Tray | Image: NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray - K212932 | Image: Trefoil PureSet Tray - K181075 | N/A | | 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; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization container, sterilization pouch or sterilization wrap. Sterilization validations for the worst-case Nobel Biocare PureSet Tray (276.1 mm x 176 mm x 78.1 mm) included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, etc. | The Nobel Biocare PureSet Trays are intended for use in healthcare facilities to store and organize Nobel Biocare surgical instruments/prosthetic 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 container, 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 Trays are intended for use 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; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization pouch or sterilization wrap. | Same | {11}------------------------------------------------ | | Indications for 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 container, 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, screwdriver, and irrigation needles. The PureSet™ Trays were validated for a maximum load of 1635 grams (Trefoil PureSet™ Tray), 1122 grams (NobelActive®/ NobelParallel™ CC PureSet™ Tray), 1063 grams (NobelReplace® CC PureSet™ Tray), 454 grams (Nobel Biocare N1™ PureSet™ Tray), 486 grams (Prosthetic PureSet™ Tray), 1143 grams (NobelActive® Guided PureSet™ Tray), 1146 grams (NobelParallel™ CC Guided PureSet™ Tray), 1176 grams (NobelReplace® CC Guided PureSet™ Tray), 1035 grams (NobelSpeedy®/Brånemark System®/ Replace Select™ TC PureSet™ Tray) and 1202 grams (NobelZygoma PureSet™ Tray). | | | 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. 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 container, 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, screwdrivers, and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 grams (Trefoil PureSet Tray), 1122 grams (NobelActive / NobelParallel CC PureSet Tray), 1063 grams (NobelReplace CC PureSet Tray), 454 grams (Nobel Biocare N1™ PureSet Tray), 486 grams (Prosthetic PureSet Tray), 1143 grams (NobelActive Guided PureSet Tray), 1146 grams (NobelParallel CC Guided PureSet Tray), 1176 grams (NobelReplace CC Guided PureSet Tray), and 1035 grams (NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray). | | | Nobel Biocare PureSet Trays are used in healthcare facilities to store and organize Nobel Biocare surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. 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 instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screwdrivers, 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). | | | Same | |--|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|--|------| | | Method | Steam Sterilization (Moist Heat Sterilization) for wrapped Instruments | | Cycle | Dynamic-Air-Removal (fractionated vacuum) | Gravity- Displacement | Method | Steam Sterilization (Moist Heat Sterilization) for wrapped Instruments Dynamic-Air-Removal (fractionate d 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) | | | | | 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) | | | | | 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 | | | | | Minimum drying times | 20 minutes | 30 minutes | | | | | | | | | {12}------------------------------------------------ | Descriptive Information | Subject Device NobelZygoma PureSet Tray | Primary Predicate device NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray - K212932 | Predicate device #2 Trefoil PureSet Tray - K181075 | Comparison | 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| Macro Design | Single level tray with grommets and instruments holders (including a drill holder) with a covering lid with integrated handle. | Single level tray with grommets, a mini-basket and instruments holders with a covering lid with integrated handle. | Two levels tray for holding the tooling in specific locations. The upper level is designed with grommets while the lower level is designed with holders and baskets. The Trefoil PureSet Tray includes a covering lid with an integrated handle. | Same | | Design Layout | The subject device features a bottom tray with a sheet metal containing holes used to fasten the grommets which hold the instruments as well as metal brackets that hold the larger instruments. The base tray is designed with a drill holder. | The tray features a bottom tray, a mini basket and a sheet metal containing holes used to fasten the grommets which hold the instruments. | The bottom tray (or lower level) includes two mini baskets and sheet metal brackets for holding larger instruments. The second layer (or upper level) is designed with sheet metal containing holes used to fasten the grommets and with sheet metal brackets. | Differs-within range | | Dimensions (LxWxH) | The overall dimensions of the tray and lid assembly are 276.1mm x 176mm x 58.9mm. Plate outer dimensions (LxW): 83x97mm | The overall dimensions and lid assembly are 276.1mm x 176mm x 47mm. Plate outer dimensions (LxW): 260x165mm | The overall dimensions of the tray and lid assembly are 276.1x176x73.6mm Plate outer dimensions (LxW): 260x165mm | Same - within range | | Tray Perforation | Evenly distributed hole pattern | Evenly distributed hole pattern | Evenly distributed hole pattern | Same | | Configuration | Perforated bases, lids, and PEEK Luvocom grommets | Perforated bases, lids, and PEEK Luvocom grommets | Perforated bases, lids, and PEEK Luvocom grommets | Same | | Sterilization at supply | Non-sterile | Non-sterile | Non-sterile | Same | | Reusable | Yes | Yes | Yes | Same | | Sterilant Penetration | Yes | Yes | Yes | Same | | Descriptive Information | Subject Device NobelZygoma PureSet Tray | Primary Predicate device NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray - K212932 | Predicate device #2 Trefoil PureSet Tray - K181075 | Comparison | | Materials | PureSet Tray: • Tray: Stainless steel • Grommets: PEEK, Stainless steel • Tray closures: Stainless steel • Feet: Silicone elastomer (ST-EC-60-722) PureSet Plate: Anodized aluminum; Dynacolor 5002 inks print | PureSet Tray: • Tray: Stainless steel • Grommets: PEEK, Stainless steel • Tray / Basket Closures: Stainless steel /PEEK • Feet: Silicone elastomer (ST-EC-60-722) PureSet Plate: Anodized aluminum, Dynacolor 5002 inks print | PureSet Tray: • Tray: Stainless steel • Grommets: PEEK, Stainless steel • Tray / Basket Closures: Stainless steel /PEEK • Feet: Silicone elastomer (ST-EC-60-722) PureSet Plate: Anodized aluminum, Dynacolor 5002 inks print | Same | | Microbial Barrier Properties | FDA cleared sterilization container (only pre-vacuum) / sterilization wrap/ sterilization pouch | FDA cleared sterilization container (only pre-vacuum) / sterilization wrap/ sterilization pouch | FDA cleared sterilization container (only pre- vacuum) / sterilization wrap/ sterilization pouch | Same | | Sterilization Method | The candidate tray and the combination of the tray with the instruments can be steam sterilized. Steam sterilization methods: • Pre-vacuum (sterilization wrap or sterilization pouch or sterilization container) • Gravity Displacement (sterilization wrap or sterilization pouch) | The candidate tray and the combination of the tray with the instruments can be steam sterilized. Steam sterilization methods: • Pre-vacuum (sterilization wrap or sterilization pouch or sterilization container) • Gravity Displacement (sterilization wrap or sterilization pouch) | The candidate tray and the combination of the tray with the instruments can be steam sterilized. Steam sterilization methods: • Pre-vacuum (sterilization wrap or sterilization pouch or sterilization container) • Gravity Displacement (sterilization wrap or sterilization pouch) | Same | | Sterilization Parameters | • Pre-Vacuum: o Temp 132°C (270°F) o Exposure Time 4 minutes o Pre-vacuum: 4 times < 60 mbar o Drying Time: 20 minutes o Cooling Time: 30 minutes total • Gravity Displacement: o Temp 132°C (270° F) o Exposure Time: 15 minutes o Pre-vacuum: N/A o Drying Time: 30 minutes o Cooling Time: 30 minutes total | • Pre-Vacuum: o Temp 132°C (270° F) o Exposure Time 4 minutes o Pre-vacuum: 4 times < 60 mbar o Drying Time: 20 minutes o Cooling Time: 30 minutes total • Gravity Displacement: o Temp 132°C (270° F) o Exposure Time: 15 minutes o Pre-vacuum: N/A o Drying Time: 30 minutes o Cooling Time: 30 minutes total | • Pre-Vacuum: o Temp 132°C (270° F) o Exposure Time 4 minutes o Pre-vacuum: 4 times < 60 mbar o Drying Time: 20 minutes o Cooling Time: 30 minutes total • Gravity Displacement: o Temp 132°C (270° F) o Exposure Time: 15 minutes o Pre-vacuum: N/A o Drying Time: 30 minutes o Cooling Time: 30 minutes total | Same | | Descriptive Information | Subject Device NobelZygoma PureSet Tray | Primary Predicate device NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray - K212932 | Predicate device #2 Trefoil PureSet Tray - K181075 | Comparison | | Material Compatibility with Sterilization Method | Yes | Yes | Yes | Same | | Volume to Vent Ratio (V-to-V) | 30.8 | 29.4 | 40.2 | Same - within range | | Biocompatibility | Biocompatibility evaluation and testing performed on representative worst-case device (Trefoil PureSet Tray; PUR0100). Testing on representative worst-case in accordance with ISO 10993-1, ISO 10993-5 and ISO 10993-12. | Testing performed on representative worst-case device (Trefoil PureSet Tray: PUR0100). Testing on representative worst-case in accordance with ISO 10993-1. ISO 10993-5 and ISO 10993-12. | Biocompatibility established via testing performed on representative worst-case device (Trefoil PureSet Tray; PUR0100). Testing on representative worst-case in accordance with ISO 10993-1, ISO 10993-5 and ISO 10993-12. | Same | | Cleaning and Sterilization Validations…