(86 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, sterilization, and organization functions of the trays, with no mention of AI or ML.
No
The device is described as reusable trays for storing and organizing surgical/prosthetic instruments and components during cleaning/sterilization and treatment, not for directly treating a patient's condition.
No
Explanation: The device is a tray used to store and organize surgical instruments during cleaning, sterilization, and treatment. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (base, plate, lid) and their function in organizing and protecting surgical instruments during sterilization and use. There is no mention of software as a component or function of the device.
Based on the provided text, 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 treatment. This is a function related to surgical procedures and instrument management, not the examination of specimens derived from the human body for diagnostic purposes.
- Device Description: The description focuses on the physical characteristics of the trays, their components, and their use in sterilization and organization of surgical tools. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Detecting or measuring specific substances in specimens.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a reusable tray designed to facilitate the handling and sterilization of surgical instruments. This falls under the category of surgical accessories or instrument management devices, not IVDs.
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. The Nobel Biocare PureSet Trays are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterilization wap. Sterlization validations for the worstcase PureSet Tray included surgical/prosthetic instruments such as torque wrenches, implant drivers, drills, screw taps, screw driver and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 grams (Trefoil PureSet Tray), 1082 grams (NobelParallel CC PureSet Tray), 945 grams (NobelReplace CC PureSet Tray), 454 grams (Nobel Biocare N1™ PureSet) and 486 grams (Prosthetic PureSet).
| Method | Steam Sterilization (Moist Heat Sterilization) | |
|---|---|---|
| Cycle | Dynamic-Air-Removal (fractionated vacuum) | Gravity- Displacement |
| Temperature | 132°C (270°F) | 132°C (270°F) |
| Exposure time for a single-use pouched device | 4 minutes (full-cycle) | 15 minutes (full-cycle) |
| Minimum drying times | 20 minutes | 30 minutes |
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The PureSet Trays are reusable trays to be used in combination with Nobel Biocare surgical/prosthetic instruments and components. The PureSet Trays are used to store and organize the instruments and components during both the surgical, restorative and reprocessing procedures. The PureSet Trays are not intended to maintain sterility on their own. They are intended to be used in conjunction with an FDA cleared sterilization wrap/pouch.
Each PureSet Tray consists of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, and storage. All the components of the PureSet Tray are perforated with an evenly distributed hold pattern, and are designed to be used for sterilization via steam sterilization. Since the PureSet Trays are perforated, an FDA cleared wrap or pouch must be used for sterilization purposes and to maintain the sterility of the contents. The PureSet Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities.
The PureSet Tray consists of three parts: 1) a base with holders to accommodate the different surgical/prosthetic instruments, 2) a removable PureSet Plate (spare part) to indicate the surgical workflow (in case of the surgical tray) and the position of the instruments and components within the tray, and 3) a lid to securely contain the instruments and components during reprocessing and transportation
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)
Nobel Biocare completed a number of nonclinical performance tests in accordance with internal requirements, international standards and FDA-recognized consensus standards.
Tests included Biocompatibility Test (Cytotoxicity) which passed based on ISO 10993-1 and ISO 10993-5.
Cleaning/Disinfection/Sterilization Testing (Manual and Automated Cleaning Validation, Manual Disinfection Validation, Steam Sterilization Validation (prevacuum and gravity cycle)) passed based on AAMI TIR 30, ISO 17665-1, AAMI ST79, AAMI TIR 12 with achievement of SAL 10-6.
Repeated Reprocessing (Legibility PureSet Tray and Repeated Plate Reprocessing) passed; laser markings readable after 500 reprocessing cycles, plate information readable after 250 cycles.
Tool Movement During Tray Transport (In-House Transportation) passed, instruments stayed in designated location and assembled during transport.
Shipping Simulation (Packaging-System Performance Testing) passed based on ASTM D4169-16, maintaining integrity and legibility.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 24, 2019
Nobel Biocare AB % Elena Cavallini Senior Regulatory Affairs Manager Nobel Biocare Services AG Balz Zimmermann-Strasse 7 Kloten Zurich, 8302 Ch
Re: K191475
Trade/Device Name: Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 3, 2019 Received: June 4, 2019
Dear Elena Cavallini:
This letter corrects our substantially equivalent letter of August 29, 2019.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray lii III -S
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K191475
Device Name
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Tray, Prosthetic PureSet Tray, Prosthetic PureSet Plate
Indications for Use (Describe)
The Nobel Biocare PureSet Trays are used in healthcare facilities to store and organize Nobel Biocare surgical/prosthetic instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The Nobel Biocare PureSet Trays are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterilization wap. Sterlization validations for the worstcase PureSet Tray included surgical/prosthetic instruments such as torque wrenches, implant drivers, drills, screw taps, screw driver and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 grams (Trefoil PureSet Tray), 1082 grams (NobelParallel CC PureSet Tray), 945 grams (NobelReplace CC PureSet Tray), 454 grams (Nobel Biocare N1™ PureSet) and 486 grams (Prosthetic PureSet).
| Method | Steam Sterilization (Moist Heat Sterilization) | |
|---|---|---|
| Cycle | Dynamic-Air-Removal | |
| (fractionated vacuum) | Gravity- Displacement | |
| Temperature | 132°C (270°F) | 132°C (270°F) |
| Exposure time for a single-use | ||
| pouched device | 4 minutes (full-cycle) | 15 minutes (full-cycle) |
| Minimum drying times | 20 minutes | 30 minutes |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K191475 510(k) Summary
l. Submitter
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Submitted by:
Nobel Biocare Services AG Balz Zimmermann-Strasse 7 8302 Kloten, Switzerland
Contact Person: Elena Cavallini, Senior Regulatory Affairs Manager E-mail: elena.cavallini@nobelbiocare.com Phone: (+41) 79 571 82 46 Fax: (+41) 43 211 42 42
Date Prepared: August 28, 2019
II. Device
| Device Proprietary Name: | Nobel Biocare N1 PureSet Tray, Nobel Biocare N1
PureSet Plate, Prosthetic PureSet Tray, Prosthetic
PureSet Plate |
|--------------------------|------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Sterilization wrap containers, trays, cassettes & other
accessories |
| Classification Name: | Sterilization Wrap |
| Regulation Number: | 21 CFR 880.6850 |
| Product Code: | KCT |
| Device Classification | Class II |
| Classification Panel | Dental Devices Panel |
4
lll. Predicate Device
Predicate Nobel Biocare - PureSet Tray (K181075)
The following device are referenced in the Substantial Equivalence Discussion:
| Device Name | Applicant | 510(k) number | |
|---|---|---|---|
| Predicate | PureSet Tray | Nobel Biocare AB | K181075 |
IV. Device Description
The PureSet Trays are reusable trays to be used in combination with Nobel Biocare surgical/prosthetic instruments and components. The PureSet Trays are used to store and organize the instruments and components during both the surgical, restorative and reprocessing procedures. The PureSet Trays are not intended to maintain sterility on their own. They are intended to be used in conjunction with an FDA cleared sterilization wrap/pouch.
Each PureSet Tray consists of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, and storage. All the components of the PureSet Tray are perforated with an evenly distributed hold pattern, and are designed to be used for sterilization via steam sterilization. Since the PureSet Trays are perforated, an FDA cleared wrap or pouch must be used for sterilization purposes and to maintain the sterility of the contents. The PureSet Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities.
The PureSet Tray consists of three parts: 1) a base with holders to accommodate the different surgical/prosthetic instruments, 2) a removable PureSet Plate (spare part) to indicate the surgical workflow (in case of the surgical tray) and the position of the instruments and components within the tray, and 3) a lid to securely contain the instruments and components during reprocessing and transportation
> Indications for Use
The Nobel Biocare PureSet Trays are used in healthcare facilities to store and organize Biocare surgical/prosthetic instruments and components Nobel during cleaning/sterilization and during implant/prosthetic treatment. The Nobel Biocare PureSet Trays are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization pouch or sterilization wrap. Sterilization validations for the worst- case PureSet Tray included surgical/prosthetic instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screw driver and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 grams (Trefoil PureSet Tray), 1082 grams (NobelActive/NobelParallel CC PureSet Tray), 945 grams (NobelReplace CC
5
PureSet Tray), 454 grams (Nobel Biocare N1™ PureSet) and 486 grams (Prosthetic PureSet).
| Method | Steam Sterilization (Moist Heat Sterilization) | |
|---|---|---|
| Cycle | Dynamic-Air-Removal | |
| (fractionated vacuum) | Gravity- Displacement | |
| Temperature | 132°C (270°F) | 132°C (270°F) |
| Exposure time for a single-use | ||
| pouched device | 4 minutes (full-cycle) | 15 minutes (full-cycle) |
| Minimum drying times | 20 minutes | 30 minutes |
VI. Comparison of Technological Characteristics
Comparisons of the subject and predicate devices are provided in the following tables.
6
| Technological
characteristics | Subject Device
PureSet Tray | Predicate Device
PureSet Tray (K181075) | Comparison |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Nobel Biocare AB | Nobel Biocare AB | Same |
| Device Class | Class II | Class II | Same |
| Product Code | KCT | KCT | Same |
| Regulation number | 880.6850 | 880.6850 | Same |
| Intended Use | The Nobel Biocare PureSet Trays are intended
for use in healthcare facilities to store and
organize Nobel Biocare surgical/prosthetic
instruments and components during
cleaning/sterilization and during
implant/prosthetic treatment. The Nobel Biocare
PureSet Trays are not intended on their own to
maintain sterility; it is intended to be used in
conjunction with a legally marketed, validated,
FDA-cleared sterilization pouch or sterilization
wrap. Sterilization validations for the worst-case
Nobel Biocare PureSet Tray (276.1 mm x 176
mm x 78 mm) included surgical instruments
such as torque wrenches, implant drivers,
direction indicators, drills, etc. | The Nobel Biocare PureSet Tray is intended for use
in healthcare facilities to store and organize Nobel
Biocare surgical instruments and components
during cleaning/sterilization and during
implant/proshetic treatment. The Nobel Biocare
PureSet Trays are not intended on their own to
maintain sterility; it is intended to be used in
conjunction with a legally marketed, validated, FDA-
cleared sterilization pouch or sterilization wrap.
Sterilization validations for the worst-case Nobel
Biocare PureSet Tray (276.1 mm x 176 mm x 78
mm) included surgical instruments such as torque
wrenches, implant drivers, direction indicators,
drills, etc. | Same |
Table 1: Comparison of PureSet Tray Characteristics.
7
8
| Method | Steam Sterilization
(Moist Heat Sterilization) | | Method | Steam Sterilization
(Moist Heat Sterilization) | | | |
|-----------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|----------------------------|--|
| | Cycle | Dynamic-Air-
Removal
(fractionated
vacuum) | Gravity-
Displacement | Cycle | Dynamic-Air-
Removal
(fractionated
vacuum) | Gravity-
Displacement | |
| | Temperature | 132°C (270°F) | 132°C
(270°F) | Temperature | 132°C (270°F) | 132°C (270°F) | |
| | Exposure
time for a
single-use
pouched
device | 4 minutes
(full-cycle) | 15 minutes
(full-cycle) | Exposure
time for a
single-use
pouched
device | 4 minutes
(full-cycle) | 15 minutes
(full-cycle) | |
| | Minimum
drying
times | 20 minutes | 30 minutes | Minimum
drying times | 20 minutes | 30 minutes | |
| Design Features | Macro
Design | Nobel Biocare N1™ and Prosthetic PureSet
Trays
Single level tray with grommets and a basket
for holding tooling in specific locations and
covering lid (without handle). | | Trefoil PureSet Tray
- Two levels tray (upper level with
grommets, lower level with holders and
baskets) for holding tooling in specific
locations and covering lid with integrated
handle.
NobelActive/NobelParallel CC PureSet Tray and
NobelReplace CC PureSet Tray
Single level tray with grommets and a basket for
holding tooling in specific locations and covering lid
with integrated handle. | | Differs | |
9
| Material | PureSet Tray
- Stainless steel construction (1.4301
1.4303, 1.4310, 1.4024) - PEEK grommets and storage sleeves
- PEEK mini tray locks
- Silicone elastomer feet
PureSet Tray Plate
Aluminum construction with anodization | PureSet Tray - Stainless steel construction (1.4301
1.4303, 1.4310) - PEEK grommets and storage sleeves
- PEEK mini tray locks
- Silicone elastomer feet
PureSet Tray Plate
Aluminum construction with anodization | Same
(except for
1.4024
Stainless
Steel) |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| | Nobel Biocare N1™ and Prosthetic PureSet
Trays | Trefoil PureSet - 276.1 mm x 176 mm x 78.1 mm | |
| Dimensions | 122.1x115x45.6mm | NobelActive/NobelParallel CC PureSet - 276.1 mm x 176 mm x 63.1 mm
NobelReplace CC PureSet
276.1 mm x 176 mm x 51.1 mm | Differs |
| Configuration | Perforated bases, lids and PEEK Luvocom
grommets | Perforated bases, lids and PEEK Luvocom
grommets | Same |
| Perforation | Evenly distributed hole pattern | Evenly distributed hole pattern | Same |
| Sterilization
Method | Pre-Vacuum (wrap or pouch)
Gravity Displacement (wrap or pouch) | Pre-Vacuum (wrap or pouch)
Gravity Displacement (wrap or pouch) | Same |
| Sterilant
Penetration | Yes | Yes | Same |
| Microbial
Barrier
Properties | To be used with an FDA approved sterilization
wrap/pouch | To be used with an FDA approved sterilization
wrap/pouch | Same |
| Reusable | Yes | Yes | Same |
| Material
Compatibility
with
Sterilization | Yes | Yes | Same |
10
| Method | ||||
|---|---|---|---|---|
| Sterilization | ||||
| Parameters | Pre-Vacuum: | |||
| Temp 132°C (270° F) | ||||
| Exposure Time 4 minutes | ||||
| Pre-vacuum: 4 times |