(94 days)
Not Found
No
The device description and intended use clearly define the device as a physical tray for organizing and sterilizing surgical instruments. There is no mention of software, algorithms, or any functionality that would involve AI or ML. The performance studies focus on physical durability and reprocessing effectiveness.
No
The device is a tray used to organize and store surgical instruments during cleaning, sterilization, and treatment, not to deliver therapy itself.
No
Explanation: The Nobel Biocare PureSet Trays are described as reusable surgical trays used to store and organize instruments during cleaning/sterilization and treatment. Their function is to facilitate the handling and sterilization of other medical instruments; they do not perform any diagnostic function to identify diseases or conditions.
No
The device is a physical tray used for organizing and sterilizing surgical instruments, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to store and organize surgical/prosthetic instruments and components during cleaning/sterilization and treatment. This is a function related to the handling and preparation of surgical tools, not the testing of biological samples for diagnostic purposes.
- Device Description: The device is described as reusable surgical trays used to organize and protect instruments. This aligns with the intended use and does not involve any diagnostic testing.
- Principle of Operation: The principle of operation is based on organizing and protecting instruments, not on analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), reagents, or any process that would lead to a diagnosis or provide information about a patient's health status.
The device is clearly intended for use in surgical procedures and the associated reprocessing of instruments, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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).
| 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 surqical 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)
Non-Clinical Test Data:
- Durability of Tray Handle and Closing Mechanism: The handle and closing mechanism of a representative PureSet tray were able to withstand 250N of force (25 kq of weight) without any permanent distortion, cracking or other evidence of failure to the handle or closing mechanism, which exceeded the 4x weight criteria prescribed in ANSI/AAMI ST77:2013. All test criteria passed.
- Packaging Performance: Distribution conditioning testing was performed on a representative PureSet tray according to ASTM D4169-16 and the test results verified the product was damage free and labeling was legible. All test criteria passed.
- Simulated Intrafacility Transportation: The subject PUR0900 PureSet tray retained all instruments in their designated holders, and the assembled multi-piece torque wrench remained assembled, during simulated transport of a fully-loaded tray throughout a typical healthcare facility. All test criteria passed.
- Repeated Reprocessing: The testing demonstrated that the plates and trays can withstand at least 250 and 500 reprocessing cycles, respectively, without any loss of functionality or legibility of the markings. There furthermore were no cytotoxic effects observed per EN ISO 10993-1 in any of the tested samples. All test criteria passed.
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, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
December 18, 2021
Nobel Biocare Services AG Nick Lewis Senior Regulatory Affairs Manager BOX 5190, SE-402 26, Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Re: K212932
Trade/Device Name: Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: November 19, 2021 Received: November 19, 2021
Dear Nick Lewis:
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
1
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 (OS) 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 mediation-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, III, PhD Assistant Director 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
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace SelectTM TC PureSet™ Trav
Indications for Use (Describe)
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 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 / Brânemark System® Mk III TiUnite / Replace SelectTM TC PureSet™ Tray).
| Method | Steam Sterilization (Moist Heat Sterilization)
for Wrapped Instruments | |
|--------------------------------------------------|---------------------------------------------------------------------------|-------------------------|
| Cycle | Dynamic-Air-Removal
(fractionated vacuum) | Gravity-Displacement |
| Temperature | 132°C (270°F) | 132°C (270°F) |
| Exposure time for a single-use
pouched device | 4 minutes (full-cycle) | 15 minutes (full-cycle) |
| Minimum drying times | 20 minutes | 30 minutes |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized "N" inside it, followed by the words "Nobel Biocare" in black text. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
510(k) Summary K212932
Nobel Biocare NobelSpeedy®Groovy / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray
-
- Submitter Information:
Submitter:
- Submitter Information:
| Nobel Biocare AB | |
|---|---|
| P.O. Box 5190, 402 26 | |
| Västra Hamngatan 1 | |
| Goteborg, SE-411 17 | |
| Sweden |
Submitted By:
| Nobel Biocare Services AG | |
|---|---|
| Balz Zimmermann-Str. 7 | |
| 8302 Kloten | |
| Switzerland | |
| Contact Person: | Nick Lewis, M.Sc. |
| E-Mail: | regulatory affairs@nobelbi |
| E-Mail: | regulatory.affairs@nobelbiocare.com |
|---|---|
| Telephone Number: | (+41) 79 941 68 17 |
| Fax Number: | (+41) 43 211 42 42 |
Date Prepared: November 18, 2021
- Device Name: 2.
- Proprietary Name: Nobel Biocare NobelSpeedy® Groovy / Brånemark System® Mk III ● TiUnite / Replace SelectTM TC PureSet™ Tray
- Common Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories .
- Manufacturer: Nobel Biocare Services AG ●
- CFR Number: 880.6850 ●
- Classification Name: Sterilization Wrap
- Device Class: II
- Product Code: KCT ●
4
3. Predicate Device
Primary Predicate Device:
- Proprietary Name: NobelActive / NobelParallel CC PureSet Trav (K181075) ●
- Common Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories .
- Manufacturer: Nobel Biocare Services AG .
- CFR Number: 880.6850 ●
- Classification Name: Sterilization Wrap
- Device Class: II
- Product Code: KCT
Predicate Device #2:
- . Proprietary Name: Nobel Biocare N1 ™ PureSet Tray (K191475)
- Common Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories .
- Manufacturer: Nobel Biocare Services AG .
- CFR Number: 880.6850 .
- Classification Name: Sterilization Wrap ●
- Device Class: II ●
- Product Code: KCT ●
-
- Description of Device:
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 surqical 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.
5
Accessories:
There are no accessories for the subject PureSet tray.
-
- Indications for Use:
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.
- Indications for Use:
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).
| 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 Predicate Devices:
The similarities between the NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray (Subject Device), the Primary Predicate Device NobelActive / NobelParallel CC PureSet Tray (K181075), and Predicate Device #2 Nobel Biocare N1™ PureSet Tray (K191475) as described in Table 5.1 are as follows:
- The Intended Use statement, design aspects including tray perforation, sterilant . penetration, tray configuration, and reusability, the materials of construction, the
6
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 identical for the subject device and both predicate devices.
- The macro design of the subject device is identical 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, and they have an identical volume to vent ratio.
Details of the Differences Between the Subject and Predicate Devices:
There are no significant differences between the subject and predicate devices but there are minor differences as follows:
- The Indications for Use for the subject device is similar but not identical to both predicate . devices. It differs from the statement for the primary predicate because it includes the subject device, as well as three trays that were referenced in the Indications statement for predicate device #2. It differs from the statement for predicate device #2 because it includes the subject device, as well as minor updates to the maximum validated load for several of the referenced trays as follows:
- NobelActive / NobelParallel CC PureSet Tray (PUR0200): 1122 grams instead of O 1082 grams
- NobelReplace CC PureSet Tray (PUR0300): 1063 grams instead of 945 grams O
- NobelActive Guided PureSet Tray (PUR0600): 1143 grams instead of 1117 grams O
- NobelParallel CC Guided PureSet Tray (PUR0700): 1146 grams instead of 1120 O grams
- NobelReplace CC Guided PureSet Tray (PUR0800): 1176 grams instead of 1156 O grams
- The macro design of the subject device is similar but not identical to predicate device #2. ● Both trays are single level trays, but the subject tray has an integrated handle whereas predicate device #2 does not.
- . The dimensions of the subject device are greater than predicate device #2 due to the larger assortment of instruments used with the subject tray. As a result, the volume to vent ratio for the subject device also is greater than predicate device #2.
Table 5.1 presents a comparison of the subject device, primary predicate device, and predicate device #2 with regard to their indications for use, technology, and performance specifications.
7
| Descriptive Information | Subject Device | Primary Predicate Device | Predicate Device #2 | Comparison of Subject to Predicate Devices |
|---|---|---|---|---|
| NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray | NobelActive / NobelParallel CC PureSet Tray (K181075) | Nobel Biocare N1 ™ PureSet Tray (K191475) | ||
| Indications for Use | Indications for Use | |||
| 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). | The Nobel Biocare PureSet Tray is used 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; 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 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), 1082 grams (NobelActive/NobelParallel CC PureSet Tray) and 945 grams (NobelReplace CC 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 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), 945 grams (NobelReplace CC PureSet Tray), 454 grams (Nobel Biocare N1 ™ PureSet), 486 grams (Prosthetic PureSet). | The Indications for Use for the subject device is similar to both predicate devices. | |||
| Method | ||||
| Cycle | ||||
| Temperature | ||||
| Exposure time for a single-use pouched device | ||||
| Minimum drying times | Steam Sterilization (Moist Heat Sterilization) | |||
| Dynamic-Air-Removal (fractionated vacuum) | ||||
| 132°C (270°F) | ||||
| 4 minutes (full-cycle) | ||||
| 20 minutes | Gravity-Displacement | |||
| 132°C (270°F) | ||||
| 15 minutes (full-cycle) | ||||
| 30 minutes | ||||
| Method | ||||
| Cycle | ||||
| Temperature | ||||
| Exposure time for a single-use pouched device | ||||
| Minimum drying times | Steam Sterilization (Moist Heat Sterilization) | |||
| Dynamic-Air-Removal (fractionated vacuum) | ||||
| 132°C (270°F) | ||||
| 4 minutes (full-cycle) | ||||
| 20 minutes | Gravity-Displacement | |||
| 132°C (270°F) | ||||
| 15 minutes (full-cycle) | ||||
| 30 minutes | ||||
| 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 | ||
| Descriptive Information | Subject Device | Primary Predicate Device | Predicate Device #2 | Comparison of Subject to Predicate Devices |
| Intended Use | NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray | |||
| 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/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 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. | NobelActive / NobelParallel CC PureSet Tray (K181075) | |||
| 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/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. | Nobel Biocare N1™ PureSet Tray (K191475) | |||
| 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/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 Intended Use for the subject device is identical to both predicate devices. | |||
| Device Design / Construction / Materials | ||||
| Representative Picture | Image: NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray | Image: NobelActive / NobelParallel CC PureSet Tray | Image: Nobel Biocare N1 PureSet Tray | The macro design of the subject device is identical to the primary predicate device. |
| Macro Design | Single level tray with grommets and a basket for holding tooling in specific locations and covering lid with integrated handle. | Single level tray with grommets and a basket for holding tooling in specific locations and covering lid with integrated handle. | Single level tray with grommets and a basket for holding tooling in specific locations and covering lid (without handle). | |
| Dimensions (LxWxH) | 276.1mm x 176mm x 47mm | 276.1mm x 176mm x 47mm* | 122.1mm x 115mm x 45.6mm | The dimensions of the subject device are identical to the primary predicate device. |
| Tray Perforation | Evenly distributed hole pattern | Evenly distributed hole pattern | Evenly distributed hole pattern | Subject device is identical to both predicate devices. |
| Volume to Vent Ratio | 29.4 | 29.4* | 11.4 | The volume to vent of the subject device is identical to the primary predicate device. |
| Configuration | Perforated bases, lids and PEEK Luvocom grommets | Perforated bases, lids and PEEK Luvocom grommets | Perforated bases, lids and PEEK Luvocom grommets | Subject device is identical to both predicate devices. |
| Reusable | Yes | Yes | Yes | Subject device is identical to both predicate devices. |
| Sterilization Method | • Pre-Vacuum (wrap or pouch) | |||
| • Gravity Displacement (wrap or pouch) | • Pre-Vacuum (wrap or pouch) | |||
| • Gravity Displacement (wrap or pouch) | • Pre-Vacuum (wrap or pouch) | |||
| • Gravity Displacement (wrap or pouch) | Subject device is identical to both predicate devices. | |||
| Descriptive Information | Subject Device | Primary Predicate Device | Predicate Device #2 | Comparison of Subject to |
| NobelSpeedy® Groovy / Brånemark System® Mk III | NobelActive / NobelParallel CC PureSet Tray (K181075) | Nobel Biocare N1™ PureSet Tray (K191475) | Predicate Devices | |
| TiUnite / Replace Select™ TC PureSet™ Tray | ||||
| Sterilization Parameters | • Pre-Vacuum: | |||
| o Temp 132°C (270° F) | ||||
| o Exposure Time 4 minutes | ||||
| o Pre-vacuum: 4 times |