(60 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.
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
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.
This is a 510(k) Pre-Market Notification for a medical device called the "NobelZygoma PureSet™ Tray," a type of sterilization wrap. The document is primarily concerned with demonstrating "substantial equivalence" to previously cleared predicate devices, rather than presenting a groundbreaking study with novel acceptance criteria and deep dives into AI performance statistics.
However, I can extract the relevant information regarding acceptance criteria and the types of studies performed, as described in the provided text, recognizing that these are not clinical studies in the typical sense for AI devices.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like the NobelZygoma PureSet™ Tray (a sterilization tray), acceptance criteria are typically related to its functionality in terms of cleaning, sterilization, biocompatibility, and durability, ensuring it performs as intended and is safe for patient contact.
| Acceptance Criteria Category | Specific Criteria/Standard (as implied or stated) | Reported Device Performance |
|---|---|---|
| Cleaning & Sterilization | Validation according to AAMI TIR12, AAMI TIR 30, ISO 15883-1, ISO 15883-5, ISO 10993-5, AAMI ST79, AAMI ST77, ISO 17665-1, ISO14161, ISO14937, AAMI ST8, ISO 11737-2, AAMI TIR17, and FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. (Ensuring effective removal of contaminants and sterilization of instruments within the tray, including worst-case scenarios). | Cleaning and sterilization validation testing on representative worst-case devices was performed according to the listed standards. Result: PASS |
| Biocompatibility | Evaluation and testing in accordance with ISO 10993-1, ISO 10993-5, and ISO 10993-12. | Biocompatibility testing on representative worst-case devices demonstrated that the Subject device is biocompatible.Result: PASS |
| Repeated Reprocessing | Withstand repeated reprocessing cycles as described in ANSI/AAMI ST77 and ISO 17664. | Testing on representative worst-case devices demonstrated that the Subject device can withstand repeated reprocessing cycles.Result: PASS |
| Instrument Retention | Retention ability of instrument features during reprocessing; no dislodgment of instruments; no protrusion of sharp edges/components from the tray after reprocessing. | The retention ability of the instrument retention features in the Subject NobelZygoma PureSet™ Tray during reprocessing was assessed. Testing demonstrated that instruments are not dislodged after reprocessing. There was no sign of protrusion of sharp edges or components from the tray.Result: PASS |
| Durability (Handle & Closing Mechanism) | Withstand at least 4 times the maximum weight of a full loaded tray. (Acceptance criteria fulfilling ANSI/AAMI ST77 requirements). | Testing on representative worst-case device demonstrated that the tray handle and the closing mechanism can withstand at least 4 times the maximum weight of a full loaded tray.Result: PASS |
| Maximum Load Support | Specific maximum load capacities were validated for various PureSet™ Trays (e.g., 1202 grams for NobelZygoma PureSet™ Tray). | The PureSet™ Trays were validated for a maximum load of 1202 grams (NobelZygoma PureSet™ Tray). This specific value is presented as a validated performance characteristic rather than a distinct "test result" in the summary table, but it's an inherent part of the device's acceptable performance.Result: Met (implied) |
2. Sample Size Used for the Test Set and Data Provenance
This document describes validations for a physical medical device, not an AI/ML model for diagnostic or prognostic purposes involving patient data. Therefore, the concept of a "test set" and "data provenance" in the context of country of origin or retrospective/prospective data as it applies to software or AI is not directly applicable here.
- Sample Size for Testing: The document refers to "representative worst-case devices" for all non-clinical tests. It doesn't specify a numerical sample size (e.g., N=3, N=50) for these physical device tests. The selection of "worst-case" implies that a specific configuration or condition that would pose the greatest challenge to cleaning, sterilization, or durability was chosen for testing.
- Data Provenance: Not applicable in the context of clinical/patient data for AI. The tests are laboratory-based, non-clinical evaluations of the device itself.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not explicitly provided in the document. For physical device validations like these, "ground truth" is established through adherence to recognized international and national consensus standards (e.g., ISO, AAMI) and testing protocols, rather than expert consensus on diagnostic images or pathology. The testing laboratories performing these validations would employ qualified personnel, but their specific roles or number are not detailed.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective, laboratory-based validations against predefined physical/mechanical and microbiological criteria defined by recognized standards. There isn't a need for expert adjudication in the way it's used for interpreting ambiguous clinical data or establishing ground truth for AI model outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance for diagnostic tasks, usually involving medical images or clinical data. The NobelZygoma PureSet™ Tray is a physical sterilization tray, not an AI/ML diagnostic or therapeutic device.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone study in the context of an "algorithm only" or AI performance was not done. This device is not an algorithm. The non-clinical tests described were "standalone" in the sense that they evaluated the device's intrinsic characteristics (cleaning, sterilization, durability) without human intervention in the performance of the device itself, but not in the AI-specific meaning.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by adherence to and successful completion of recognized international and national consensus standards for sterilization, cleaning, biocompatibility, and durability. These standards incorporate scientific principles and validated methodologies to empirically determine if a device meets safety and effectiveness requirements.
- Examples of such standards cited: AAMI TIR12, AAMI TIR 30, ISO 15883-1, ISO 15883-5, ISO 10993-1, ISO 10993-5, ISO 10993-12, AAMI ST79, AAMI ST77, ISO 17665-1, ISO14161, ISO14937, AAMI ST8, ISO 11737-2, AAMI TIR17, FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, ISO 17664-1, ANSI/AAMI ST77.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
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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
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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
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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)
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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 ABVastra Hamngatan 1Goteborg 411 17Sweden |
|---|---|
| Submitted By: | Nobel Biocare Services AGBalz-Zimmerman-Strasse 78302 KlotenSwitzerland |
| Contact Person:E-Mail:Telephone Number:Prepared By:Date Prepared | Bernice Jim, Ph.D.regulatory.affairs.nb@envistaco.com+41 43 211 42 00Ana 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™ TrayNobel Biocare ABSterilization WrapSterilization Wrap containers, Trays, Cassettes & OtherAccessories21 CFR 880.6850IIKCT |
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3. Predicate Device
Primary Predicate device
| Proprietary name: | NobelSpeedy® Groovy / Brånemark System® Mk IIITiUnite/Replace Select™ TC PureSet™ Tray (K212932) |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Sterilization Wrap |
| Classification Name: | Sterilization Wrap containers, Trays, Cassettes & OtherAccessories |
| 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 & OtherAccessories |
| 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.
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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).
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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 | RegulationNumber | 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 | RegulationNumber | 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 |
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| Component | Article Number | Device Class | RegulationNumber | 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.
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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-usepouched 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
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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.
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Table-2: NobelZygoma PureSet™ Tray comparison table
| DescriptiveInformation | Subject DeviceNobelZygoma PureSet Tray | Primary Predicate deviceNobelSpeedy® Groovy / Brånemark System® Mk IIITiUnite / Replace Select™ TC PureSet™ Tray -K212932 | Predicate device #2Trefoil PureSet Tray - K181075 | Comparison |
|---|---|---|---|---|
| PictorialRepresentation | 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 usein healthcare facilities to store and organize NobelBiocare surgical / prosthetic instruments andcomponents during cleaning/sterilization and duringimplant / prosthetic treatment.The Nobel Biocare PureSet Trays are not intended ontheir own to maintain sterility; they are intended to beused in conjunction with a legally marketed, validated,FDA-cleared sterilization container, sterilization pouchor sterilization wrap.Sterilization validations for the worst-case NobelBiocare 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 usein healthcare facilities to store and organize NobelBiocare surgical instruments/prosthetic andcomponents during cleaning/sterilization and duringimplant / prosthetic treatment.The Nobel Biocare PureSet Trays are not intended ontheir own to maintain sterility; they are intended to beused in conjunction with a legally marketed, validated,FDA-cleared sterilization container, sterilization pouchor sterilization wrap.Sterilization validations for the worst-case NobelBiocare PureSet Tray (276.1 mm x 176 mm x 78 mm)included surgical instruments such as torquewrenches, implant drivers, direction indicators, drills,etc. | The Nobel Biocare PureSet Trays are intended foruse in healthcare facilities to store and organizeNobel Biocare surgical instruments andcomponents during cleaning/sterilization and duringimplant / prosthetic treatment.The Nobel Biocare PureSet Trays are not intendedon their own to maintain sterility; they are intendedto be used in conjunction with a legally marketed,validated, FDA-cleared sterilization pouch orsterilization wrap. | Same |
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| Indications forUse | The Nobel Biocare PureSet™ Trays are used inhealthcare facilities to store and organize Nobel Biocaresurgical/prosthetic instruments and components duringcleaning/sterilization and during implant/prosthetictreatment. The Nobel Biocare PureSet™ Trays are notintended on their own to maintain sterility; they areintended to be used in conjunction with a legallymarketed, validated, FDA-cleared sterilization container,sterilization pouch, or sterilization wrap. Sterilizationvalidations for the worst-case PureSet™ Tray includedsurgical instruments such as torque wrenches, implantdrivers, direction indicators, drills, screw taps,screwdriver, and irrigation needles. The PureSet™Trays were validated for a maximum load of 1635grams (Trefoil PureSet™ Tray), 1122 grams(NobelActive®/ NobelParallel™ CC PureSet™ Tray),1063 grams (NobelReplace® CC PureSet™ Tray), 454grams (Nobel Biocare N1™ PureSet™ Tray), 486grams (Prosthetic PureSet™ Tray), 1143 grams(NobelActive® Guided PureSet™ Tray), 1146 grams(NobelParallel™ CC Guided PureSet™ Tray), 1176grams (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 healthcarefacilities to store and organize Nobel Biocaresurgical/prosthetic instruments and components duringcleaning/sterilization and during implant/prosthetictreatment. Nobel Biocare PureSet Trays are notintended on their own to maintain sterility; they areintended to be used in conjunction with a legallymarketed, validated, FDA cleared sterilizationcontainer, sterilization pouch, or sterilization wrap.Sterilization validations for the worst-case PureSetTray included surgical instruments such as torquewrenches, implant drivers, direction indicators, drills,screw taps, screwdrivers, and irrigation needles.The PureSet Trays were validated for a maximum loadof 1635 grams (Trefoil PureSet Tray), 1122 grams(NobelActive / NobelParallel CC PureSet Tray),1063 grams (NobelReplace CC PureSet Tray), 454grams (Nobel Biocare N1™ PureSet Tray), 486 grams(Prosthetic PureSet Tray), 1143 grams (NobelActiveGuided PureSet Tray), 1146 grams (NobelParallel CCGuided PureSet Tray), 1176 grams (NobelReplace CCGuided PureSet Tray), and 1035 grams(NobelSpeedy® Groovy / Brånemark System® Mk IIITiUnite / Replace Select™ TC PureSet™ Tray). | Nobel Biocare PureSet Trays are used inhealthcare facilities to store and organize NobelBiocare surgical instruments and componentsduring cleaning/sterilization and duringimplant/prosthetic treatment. Nobel BiocarePureSet Trays are not intended on their own tomaintain sterility; they are intended to be used inconjunction with a legally marketed, validated, FDAcleared sterilization pouch, or sterilization wrap.Sterilization validations for the worst-case PureSetTray included surgical instruments such as torquewrenches, implant drivers, direction indicators,drills, screw taps, screwdrivers, and irrigationneedles.The PureSet Trays were validated for a maximumload of 1635 grams (Trefoil PureSet Tray), 1082grams (NobelActive/NobelParallel CC PureSetTray) and 945 grams (NobelReplace CC PureSetTray). | Same | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Method | Steam Sterilization (Moist HeatSterilization) for wrapped Instruments | Cycle | Dynamic-Air-Removal(fractionated vacuum) | Gravity-Displacement | Method | Steam Sterilization (Moist HeatSterilization) for wrapped InstrumentsDynamic-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 asingle-use poucheddevice | 4 minutes (full-cycle) | 15 minutes (full-cycle) | Exposure time for asingle-use pouched device | 4 minutes(full-cycle) | 15 minutes (full- cycle) | |||
| Exposure time for asingle-use poucheddevice | 4 minutes (full-cycle) | 15 minutes (full-cycle) | Minimum dryingtimes | 20 minutes | 30 minutes | Minimum dryingtimes | 20 minutes | 30 minutes | |||
| Minimum dryingtimes | 20 minutes | 30 minutes |
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| DescriptiveInformation | Subject DeviceNobelZygoma PureSet Tray | Primary Predicate deviceNobelSpeedy® Groovy / Brånemark System® Mk IIITiUnite / Replace Select™ TC PureSet™ Tray -K212932 | Predicate device #2Trefoil PureSet Tray - K181075 | Comparison |
|---|---|---|---|---|
| Macro Design | Single level tray with grommets and instruments holders(including a drill holder) with a covering lid withintegrated handle. | Single level tray with grommets, a mini-basket andinstruments holders with a covering lid with integratedhandle. | Two levels tray for holding the tooling in specificlocations.The upper level is designed with grommets whilethe lower level is designed with holders andbaskets. The Trefoil PureSet Tray includes acovering lid with an integrated handle. | Same |
| Design Layout | The subject device features a bottom tray with a sheetmetal containing holes used to fasten the grommetswhich hold the instruments as well as metal bracketsthat hold the larger instruments. The base tray isdesigned with a drill holder. | The tray features a bottom tray, a mini basket and asheet metal containing holes used to fasten thegrommets which hold the instruments. | The bottom tray (or lower level) includes two minibaskets and sheet metal brackets for holding largerinstruments.The second layer (or upper level) is designed withsheet metal containing holes used to fasten thegrommets and with sheet metal brackets. | Differs-withinrange |
| Dimensions(LxWxH) | The overall dimensions of the tray and lid assembly are276.1mm x 176mm x 58.9mm.Plate outer dimensions (LxW): 83x97mm | The overall dimensions and lid assembly are 276.1mmx 176mm x 47mm.Plate outer dimensions (LxW): 260x165mm | The overall dimensions of the tray and lid assemblyare 276.1x176x73.6mmPlate 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 Luvocomgrommets | Same |
| Sterilization atsupply | Non-sterile | Non-sterile | Non-sterile | Same |
| Reusable | Yes | Yes | Yes | Same |
| SterilantPenetration | Yes | Yes | Yes | Same |
| DescriptiveInformation | Subject DeviceNobelZygoma PureSet Tray | Primary Predicate deviceNobelSpeedy® Groovy / Brånemark System® Mk IIITiUnite / Replace Select™ TC PureSet™ Tray -K212932 | Predicate device #2Trefoil 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 5002inks 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 5002inks 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, Dynacolor5002 inks print | Same |
| Microbial BarrierProperties | 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 |
| SterilizationMethod | The candidate tray and the combination of the tray withthe instruments can be steam sterilized. Steamsterilization methods:• Pre-vacuum (sterilization wrap or sterilizationpouch or sterilization container)• Gravity Displacement (sterilization wrap orsterilization pouch) | The candidate tray and the combination of the tray withthe instruments can be steam sterilized. Steamsterilization methods:• Pre-vacuum (sterilization wrap or sterilizationpouch or sterilization container)• Gravity Displacement (sterilization wrap orsterilization pouch) | The candidate tray and the combination of the traywith the instruments can be steam sterilized. Steamsterilization methods:• Pre-vacuum (sterilization wrap or sterilizationpouch or sterilization container)• Gravity Displacement (sterilization wrap orsterilization pouch) | Same |
| SterilizationParameters | • Pre-Vacuum:o Temp 132°C (270°F)o Exposure Time 4 minuteso Pre-vacuum: 4 times < 60 mbaro Drying Time: 20 minuteso Cooling Time: 30 minutes total• Gravity Displacement:o Temp 132°C (270° F)o Exposure Time: 15 minuteso Pre-vacuum: N/Ao Drying Time: 30 minuteso Cooling Time: 30 minutes total | • Pre-Vacuum:o Temp 132°C (270° F)o Exposure Time 4 minuteso Pre-vacuum: 4 times < 60 mbaro Drying Time: 20 minuteso Cooling Time: 30 minutes total• Gravity Displacement:o Temp 132°C (270° F)o Exposure Time: 15 minuteso Pre-vacuum: N/Ao Drying Time: 30 minuteso Cooling Time: 30 minutes total | • Pre-Vacuum:o Temp 132°C (270° F)o Exposure Time 4 minuteso Pre-vacuum: 4 times < 60 mbaro Drying Time: 20 minuteso Cooling Time: 30 minutes total• Gravity Displacement:o Temp 132°C (270° F)o Exposure Time: 15 minuteso Pre-vacuum: N/Ao Drying Time: 30 minuteso Cooling Time: 30 minutes total | Same |
| DescriptiveInformation | Subject DeviceNobelZygoma PureSet Tray | Primary Predicate deviceNobelSpeedy® Groovy / Brånemark System® Mk IIITiUnite / Replace Select™ TC PureSet™ Tray -K212932 | Predicate device #2Trefoil PureSet Tray - K181075 | Comparison |
| MaterialCompatibilitywith SterilizationMethod | Yes | Yes | Yes | Same |
| Volume to VentRatio (V-to-V) | 30.8 | 29.4 | 40.2 | Same -within range |
| Biocompatibility | Biocompatibility evaluation and testing performed onrepresentative worst-case device (Trefoil PureSet Tray;PUR0100).Testing on representative worst-case in accordancewith 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 accordancewith ISO 10993-1. ISO 10993-5 and ISO 10993-12. | Biocompatibility established via testing performedon representative worst-case device (TrefoilPureSet Tray; PUR0100).Testing on representative worst-case in accordancewith ISO 10993-1, ISO 10993-5 and ISO 10993-12. | Same |
| Cleaning andSterilizationValidations | Cleaning and sterilization method validated via testingperformed on representative worst-case devices | Cleaning and sterilization method validated via testingperformed on representative worst-case device | Cleaning and sterilization method validated viatesting performed on representative worst-casedevice | Same |
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7. Non-Clinical Test Data:
The following non-clinical tests were performed as described in Table-3 below:
- . End user cleaning and sterilization validation on representative worst-case PureSet Tray according to AAMI TIR12, AAMI TIR 30, ISO 15883-1, ISO 15883-5, ISO 10993-5, AAMI ST79, AAMI ST77, ISO 17665-1, ISO14161, ISO14937, AAMI ST8, ISO 11737-2, AAMI TIR17 and FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, where applicable.
- Repeated reprocessing on representative worst-case per relevant requirements of ISO 17664-1 and ANSI/AAMI ST77.
- . Biocompatibility evaluation. Testing on representative worst-case in accordance with ISO 10993-1, ISO 10993-5 and ISO 10993-12.
- Assessment of instrument retention features of the Subject NobelZygoma Tray after reprocessing.
- . The handle and closing mechanism of PureSet Trays withstands at least 4 times the maximum weight of a full loaded tray. Acceptance criteria fulfilling ANSI/AAMI ST77 requirements.
| Test | Result | Conclusion |
|---|---|---|
| Cleaning andsterilization | Cleaning and sterilization validation testing on representativeworst-case devices performed according to AAMI TIR12,AAMI TIR 30, ISO 15883-1, ISO 15883-5, ISO 10993-5,AAMI ST79, AAMI ST77, ISO 17665-1, ISO14161,ISO14937, AAMI ST8, ISO 11737-2, AAMI TIR17 and FDAGuidance Reprocessing Medical Devices in Health CareSettings: Validation Methods and Labeling, where applicable. | PASS |
| Biocompatiblity | Bicompatibility testing on representative worst-case deviceaccording to ISO 10993-1, ISO 10993-5 and ISO 10993-12demonstrating that the Subject device is biocompatible. | PASS |
| Repeatedreprocessing | Testing on representative worst-case devices as described inANSI/AAMI ST77 and ISO 17664 demonstrating that theSubject Device can withstand repeated reprocessing cycles | PASS |
| Verification ofinstrumentretention features | The retention ability of the instrument retention features inthe Subject NobelZygoma PureSet™ Tray duringreprocessing was assessed. Testing on the Subject devicedemonstrated that instruments are not dislodged afterreprocessing. There was no sign of protrusion of sharpedges or components from the tray. | PASS |
| Durability of trayhandle and closingmechanisms | Testing on representative worst-case device demonstratedthat the tray handle and the closing mechanism canwithstand at least 4 times the maximum weight of a full | PASS |
| Table- 3: Summary of Non-Clinical Test Data | ||
|---|---|---|
| --------------------------------------------- | -- | -- |
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| loaded tray. Acceptance criteria fulfilling ANSI/AAMI ST77 requirements. | |
|---|---|
| -------------------------------------------------------------------------- | -- |
8. Conclusion
Based on a comparison of intended use, indications, material composition, technological characteristics, principle of operation, features, and performance data, the Subject NobelZygoma PureSet™ Tray is deemed to be substantially equivalent to the Predicate devices.
§ 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).