(60 days)
Not Found
No
The device is a physical tray for organizing and sterilizing surgical instruments. The description focuses on its physical properties, sterilization methods, and validation studies related to reprocessing and material properties. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
No
This device is a surgical tray used for organizing and sterilizing instruments, not for providing medical therapy directly to a patient.
No
The device is a tray used to store and organize surgical instruments during cleaning, sterilization, and treatment, not to diagnose a condition.
No
The device described is a physical tray used for organizing and sterilizing surgical instruments. It is a hardware device, not software.
Based on the provided information, the Nobel Biocare PureSet™ Trays are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as storing and organizing surgical/prosthetic instruments and components during cleaning/sterilization and during implant/prosthetic treatment. This is a function related to the handling and preparation of medical devices used in vivo (within the body), not for testing samples in vitro (in a test tube or lab setting).
- Device Description: The description reinforces the intended use as reusable surgical trays for organizing and storing instruments during surgical and reprocessing procedures.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or calibrators
The device's function is purely related to the physical management and sterilization of surgical instruments, which are used directly on patients. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
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 |
Product codes (comma separated list FDA assigned to the subject device)
KCT
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical tests were performed:
- 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. (Result: PASS)
- Repeated reprocessing on representative worst-case per relevant requirements of ISO 17664-1 and ANSI/AAMI ST77. (Result: PASS)
- Biocompatibility evaluation. Testing on representative worst-case in accordance with ISO 10993-1, ISO 10993-5 and ISO 10993-12. (Result: PASS)
- Assessment of instrument retention features of the Subject NobelZygoma Tray after reprocessing. (Result: PASS: The retention ability of the instrument retention features in the Subject NobelZygoma PureSet™ Tray during reprocessing was assessed. Testing on the Subject device demonstrated that instruments are not dislodged after reprocessing. There was no sign of protrusion of sharp edges or components from the tray.)
- 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. (Result: PASS)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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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 |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| 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