(156 days)
No
The device description and performance studies focus on the physical properties, sterilization, and durability of a surgical instrument tray, with no mention of AI or ML capabilities.
No
The device is described as a reusable surgical tray used to store and organize instruments during cleaning/sterilization and treatment, but it does not directly provide a therapeutic effect to a patient.
No
This device is a surgical tray used for storing and organizing instruments during cleaning/sterilization and treatment, not for diagnosing medical conditions.
No
The device description clearly states it is a "reusable surgical tray" and describes physical components and materials, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Nobel Biocare PureSet Tray is used to store and organize surgical instruments and components during cleaning/sterilization and implant/prosthetic treatment. This is a function related to the handling and preparation of surgical tools, not the examination of specimens derived from the human body for diagnostic purposes.
- Device Description: The description reinforces its role as a reusable surgical tray for organizing instruments during surgical and reprocessing procedures.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples, reagents, or for the purpose of providing information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to diagnose diseases, monitor health, or determine treatment. The PureSet Tray's function is entirely focused on the handling and sterilization of surgical instruments used in vivo (within the body).
N/A
Intended Use / Indications for Use
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 wrap. Sterilization validations for the worst-case PureSet Tray included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, 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) and 945 grams (NobelReplace CC PureSet Tray).
Method: Steam Sterilization (Moist Heat Sterilization)
Cycle: Dynamic-Air-Removal (fractionated vacuum) Temperature: 132°C (270°F) Exposure time for a single-use pouched device: 4 minutes (full-cycle) Minimum drying times: 20 minutes
Method: Steam Sterilization (Moist Heat Sterilization)
Cycle: Gravity-Displacement Temperature: 132°C (270°F) Exposure time for a single-use pouched device: 15 minutes (full-cycle) Minimum drying times: 30 minutes
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The PureSet Tray is a reusable surgical tray to be used in combination with Nobel Biocare surgical instruments and components. The PureSet Tray is used to store and organize the instruments and components during both the surgical 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 consist 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.
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)
Summary of Non-Clinical Testing:
Biocompatibility Testing
PureSet Trays do not come in direct contact with the patient. However, they are intended for storage, organization and reprocessing of reusable surgical instruments and tools. Therefore, categorization as a surgical instruments and tools from ISO 10993 is applicable. Surgical instruments and tools in contact with tissue/bone/dentin are categorized as external communicating devices. They are used during surgery only, therefore the contact duration is limited and ≤24h. The biocompatibility of the PureSet Tray was validated accordingly. The following standards were used during the validation process.
- AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
- AAMI/ANSI/ISO 10993-5:2009 Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity
- ISO 10993-12 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials
Cleaning/Disinfection/Sterilization Testing
The PureSet Trays are supplied non-sterile and required processing through cleaning/disinfection and sterilization at the health care facility by the end user. Validation testing confirmed the methods and parameters of these processes as specified in the device labeling.
Sterilization validations for the heaviest 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 and other tools/devices needed for intended use or implant/prosthetic treatment. Worst-case validation testing was used for the PureSet Tray. The following standards were used during the validation process.
- AAMI/ANSI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- AAMI/ANSI/ISO 14161:2009 Sterilization of Health Care Products-Biological Indicators-Guidance for the selection, use and interpretation of results
- ANSI/AAMI ST8:2013 Hospital steam sterilizers
- EN 285:2015 Sterilization -Steam sterilizers- Large sterilizers
- ANSI/AAMI ST77:2013 Containment devices for reusable medical device sterilization
- ISO/TS 15883-5: 2005 Washer disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
- ANSI/AAMI/ISO 11737-2:2009 Sterilization of medical devices – Microbiology methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ANSI/AAMI ST81:2004/(R)2010 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
- ANSI/AAMI/ISO 14937:2009/(R) 2013 Sterilization of Health Care Products-General Requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
- AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
- AAMI TIR30:2011 A compendium of processes, materials, test methods, acceptance criteria for cleaning reusable medical devices
- AAMI TIR39:2009 Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
- ISO/NP 15883-1:2006 Washer disinfectors Part 1: General requirements, terms and definitions and tests
Performance Testing
- Handle Durability: The ability of the lid handle and lid to base connection to withstand typical forces has been validated. Validation of this characteristic was done following acceptance criteria defined in DIN 58952-3 - Sterilization transport baskets for sterile barrier systems - Part 3: Instrument travs for sterilizing goods made of metal. The validation verified the ability of the PureSet Tray's closing system and handle to withstand the anticipated forces.
- Repeated Reprocessing: The PureSet Tray is intended to be reprocessed. PureSet Trays were subject to repeated multiple cleaning and sterilization cycles as described in the device labelling. After processing the trays were inspected for laser marking legibility and coloration. The laser markings remained legible and there was no degradation to the plate coloring found.
- Tool Movement During Tray Transport: The PureSet Trays are intended to hold specialized tooling in specific locations during intra-clinical transportation after surgery, through processing, storage, and eventually back to surgery. Therefore, the ability of the tray to hold the tooling properly during transport was validated by simulating typical transportation method.
- Shipping Simulation: The subject device was validated using ASTM D4169-16 titled Standard Practice for Performance Testing of Shipping Containers and Systems. The testing demonstrates that the trays can be boxed and transported internationally.
No Clinical data was used in making the substantially equivalence decision.
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.
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized depiction of a human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
September 27, 2018
Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887
Re: K181075
Trade/Device Name: PureSet Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: August 27, 2018 Received: August 29, 2018
Dear Charlemagne Chua:
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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181075
Device Name PureSet Tray
Indications for Use (Describe)
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 wrap. Sterilization validations for the worst-case PureSet Tray included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, 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) and 945 grams (NobelReplace CC PureSet Tray).
| 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)
മ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
I. SUBMITTER
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Submitted by Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348
Date Prepared: September 25, 2018
II. DEVICE
Name of Device: PureSet Tray Common or Usual Name: Sterilization Tray Classification Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (21 CFR 880.6850) Regulatory Class: II Primary Product Code: KCT
III. PREDICATE DEVICE
Primary predicate: Nobel Biocare - Kit Boxes and Kit Plates (K163600) This predicate has not been subject to a design-related recall.
Reference predicate: Medtronic Sofamor Danek - Medtronic Transportation/Sterilization Cassettes (K152241)
IV. DEVICE DESCRIPTION
The PureSet Tray is a reusable surgical tray to be used in combination with Nobel Biocare surgical instruments and components. The PureSet Tray is used to store and organize the instruments and components during both the surgical 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 consist 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
4
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.
V. INDICATIONS FOR USE
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, screw driver and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 gram (Trefoil PureSet Tray), 1082 grams (NobelActive/NobelParallel CC PureSet Tray) and 945 grams (NobelReplace CC PureSet Tray).
| 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 |
5
VI. Comparison of Technological Characteristics
Comparison of intended use and indication for use statement
| Technological
| characteristics | Subject Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|---|
| Intended use | PureSet Tray | Kit Boxes and Kit Plates (K163600) | Medtronic Transportation/ Sterilization | |
| Cassettes (K152241) | ||||
| 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. | The Nobel Biocare Kit Boxes are intended | |||
| for use in healthcare facilities to organize, | ||||
| enclose, sterilize, transport, and store | ||||
| medical devices between surgical uses. | ||||
| The Nobel Biocare Kit Boxes 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 wrap. Sterilization validations | ||||
| for the worst-case Nobel Biocare Kit Box | ||||
| (170 mm x 145 mm x 57) included surgical | ||||
| instruments such as torque wrenches, | ||||
| implant drivers, direction indicators, drills, | ||||
| etc. | The Medtronic Transportation/Sterilization | |||
| Cassettes are intended for use in healthcare | ||||
| facilities to organize, enclose, sterilize, | ||||
| transport, and store medical devices and | ||||
| other instrumentation between surgical and | ||||
| other medical uses. The Medtronic | ||||
| Transportation/Sterilization Cassettes 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 wrap. | ||||
| Technological | ||||
| characteristics | Subject Device | Primary Predicate | Reference Predicate | |
| PureSet Tray | Kit Boxes and Kit Plates (K163600) | Medtronic Transportation/ Sterilization | ||
| Cassettes (K152241) | ||||
| Indication for | ||||
| use statement | 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, 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) and 945 grams | ||||
| (NobelReplace CC PureSet Tray). | The Nobel Biocare Kit Boxes are used in | |||
| healthcare facilities to organize, enclose, | ||||
| sterilize, transport, and store medical | ||||
| devices between surgical uses. The Nobel | ||||
| Biocare Kit Boxes 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 wrap. Sterilization validations | ||||
| for the worst-case Nobel Biocare Kit Box | ||||
| (170 mm x 145 mm x 57mm) included | ||||
| surgical instruments such as torque | ||||
| wrenches, implant drivers, direction | ||||
| indicators, drills, etc. The Kit Boxes were | ||||
| validated for a maximum load of 469 | ||||
| grams including kit box and instruments. | Cycle Tempe- | |||
| rature Exposure | ||||
| time Minimum | ||||
| dry time | ||||
| Method | ||||
| Steam Sterilization | ||||
| (Moist Heat Sterilization) | Gravity | |||
| Displace- | ||||
| ment 250° F | ||||
| (121° | ||||
| C) 30 | ||||
| Minutes 30 | ||||
| Minutes | ||||
| Cycle Dynamic- | ||||
| Air- | ||||
| Removal | ||||
| (fractionat | ||||
| ed | ||||
| vacuum) Dynamic- | ||||
| Air- | ||||
| Removal | ||||
| (fractionat | ||||
| ed | ||||
| vacuum) Gravity- | ||||
| Displacem | ||||
| ent | Gravity | |||
| Displace- | ||||
| ment 270° F | ||||
| (132° | ||||
| C) 15 | ||||
| Minutes 30 | ||||
| Minutes | ||||
| Gravity | ||||
| Displace- | ||||
| ment 275° F | ||||
| (135° | ||||
| C) 10 | ||||
| Minutes 30 | ||||
| Minutes | ||||
| Dynamic- | ||||
| Air- | ||||
| Removal 270º F | ||||
| (132° | ||||
| C) 4 | ||||
| Minutes 30 | ||||
| Minutes | ||||
| Method | ||||
| Steam Sterilization | ||||
| (Moist Heat Sterilization) | Dynamic- | |||
| Air- | ||||
| Removal 275° F | ||||
| (135° C 3 | ||||
| Minutes 30 | ||||
| Minutes | ||||
| Temperat | ||||
| ure 132°C | ||||
| (270°F) 134°C | ||||
| (270°F) 132°C | ||||
| (270°F) | The Medtronic Transportation/ Sterilization | |||
| Cassettes are intended for use in healthcare | ||||
| facilities to organize, enclose, sterilize, | ||||
| transport, and store medical devices and | ||||
| other instrumentation between surgical and | ||||
| other medical uses. The Medtronic | ||||
| Transportation/ Sterilization Cassettes 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 wrap. | ||||
| Cycle Dynamic- | ||||
| Air- | ||||
| Removal | ||||
| (fractionat | Sterilization validations for the worst-case | |||
| Medtronic Transportation/Sterilization | ||||
| Gravity- | ||||
| Displacement | ||||
| Exposure | ||||
| time for a | ||||
| single- | ||||
| use 4 minutes | ||||
| (full- | ||||
| cycle) 3 minutes | ||||
| (full-cycle) 15 | ||||
| minutes | ||||
| (full-cycle) | ||||
| Technological | ||||
| characteristics | Subject Device | Primary Predicate | Reference Predicate | |
| PureSet Tray | Kit Boxes and Kit Plates (K163600) | Medtronic Transportation/ Sterilization | ||
| Cassettes (K152241) | ||||
| ed | ||||
| vacuum) | pouched | |||
| device | Cassette (22.75 x 11.26 x 5.5 inches) | |||
| included implants and common surgical | ||||
| instruments such as rasps, drivers, trials, | ||||
| handles, inserters, probes, drills, etc. The | ||||
| validated total weight was 28.4 lbs. The | ||||
| validated worst-case loading configurations | ||||
| of the Medtronic Transportation/ Sterilization | ||||
| Cassette included the following worst-case | ||||
| lumen dimensions. | ||||
| Temperature | 132°C | |||
| (270°F) | Exposre | |||
| time for | ||||
| the | ||||
| Overkill | ||||
| Approach | ||||
| 132°C | ||||
| (270°F) | 2 minutes | |||
| (half | ||||
| cycle) | -363 x 1.575 mm | |||
| -247.5 x 4.1 mm | ||||
| Device List: | ||||
| 1850060 Case- Triple Generic Outer Base | ||||
| (22.74 x 11.260 x 5.040 inches) | ||||
| Exposure | ||||
| time for a | ||||
| single-use | ||||
| pouched | ||||
| device | 4 minutes | |||
| (full-cycle) | 1.5 | |||
| minutes | ||||
| (half | ||||
| cycle) | 1850064 Lid- Generic Outer Lid (22.75 x | |||
| 11.260 x 0.470 inches) | ||||
| 7022101L Tray Lid (21 x 10.13 x 0.075 | ||||
| inches) | ||||
| P1850061 Tray 1 (20.75 x 9.79 x 1.32 | ||||
| inches) | ||||
| 15 minutes | ||||
| (full-cycle) | 7.5 | |||
| minutes | ||||
| (half | ||||
| cycle) | P1850062 Tray 2 (21 x 10.13x 1.69 inches) | |||
| P1850063 Tray 3 (21 x 10.13 x 1.38 inches) | ||||
| 7059532 Large Caddy (9.47 x 6.37 x 1.3 | ||||
| inches) | ||||
| Minimum | ||||
| drying times | 20 | |||
| minutes | Minimum | |||
| drying | ||||
| times | 7059532L Large Lid (5.85 x 4.725 x 0.095 | |||
| inches) | ||||
| 30 minutes | 20 | |||
| minutes | P213018 Small Caddy (2 x 1.5 x 1.025 | |||
| inches) | ||||
| 10 | ||||
| minutes | P9213018 Small Lid (2 x 1.29 x 0.095 | |||
| inches) | ||||
| 30 | ||||
| minutes |
6
Nobel Biocare Traditional 510(k) Notification (K181075) PureSet Tray September 2018
7
8
| Technological | Subject Device | Primary Predicate | Reference Predicate | |||
|---|---|---|---|---|---|---|
| characteristics | PureSet Tray | Kit Boxes and Kit Plates (K163600) | Medtronic Transportation/ Sterilization | |||
| Cassettes (K152241) | ||||||
| Cycle | ||||||
| Gravity | ||||||
| Displace- | ||||||
| ment | Tempe- | |||||
| rature | ||||||
| 250° F | ||||||
| (121° C) | Exposure | |||||
| time | ||||||
| 30 | ||||||
| Minutes | Minimum | |||||
| dry time | ||||||
| 30 | ||||||
| Minutes | ||||||
| Gravity | ||||||
| Displace- | ||||||
| ment | 270° F | |||||
| (132° C) | 15 | |||||
| Minutes | 30 | |||||
| Minutes | ||||||
| Gravity | ||||||
| Displace- | ||||||
| ment | 275° F | |||||
| (135° C) | 10 | |||||
| Minutes | 30 | |||||
| Minutes | ||||||
| Dynamic- | ||||||
| Air- | ||||||
| Removal | 270° F | |||||
| (132° C) | 4 | |||||
| Minutes | 30 | |||||
| Minutes | ||||||
| Dynamic- | ||||||
| Air- | ||||||
| Removal | 275° F | |||||
| (135° C) | 3 | |||||
| Minutes | 30 | |||||
| Minutes | ||||||
| Comparison of Intended use/Indications for Use: The intended use of the PureSet Tray is the same as the primary predicate Kit Boxes and Kit Plates (K163600). Both |
9
Comparison of Technological Characteristics
| | Candidate
PureSet Tray | Primary PREDICATE
Kit Boxes and Kit Plates
(K163600) | PREDICATE
Medtronic Transportation /
Sterilization Cassettes
(K152241) | Comparison |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Trefoil PureSet Tray
- Two levels (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 with
grommets and a basket
for holding tooling in
specific locations and
covering lid with
integrated handle. | A base, inserted plate,
support(stand) and a lid | A base, a lid with a locking latch
and individual inserts | The PureSet Tray
and primary
predicate each
have a base, insert,
and lid.
The PureSet Tray
has either a one or
two-level design.
The two-level
design is not used
in the predicate.
This change in
design was
successfully
validated. |
| Dimensions | Trefoil PureSet - 276.1 mm x 176 mm x
78.1 mm
NobelActive/NobelParallel
CC PureSet - 276.1 mm x 176 mm x
63.1 mm | 170 mm x 145 mm x 57
mm (main)
170 mm x 70 mm x 57
mm (sub)
310 mm x 180 mm x 70
mm (kit organizer) | 22.75 in. x 11.26 in. x 5.51 in. | The dimensions
and volume of the
PureSet Tray is
between the
primary predicate
and reference
device. |
| | Candidate
PureSet Tray | Primary PREDICATE
Kit Boxes and Kit Plates
(K163600) | PREDICATE
Medtronic Transportation /
Sterilization Cassettes
(K152241) | Comparison |
| | NobelReplace CC PureSet - 276.1 mm x 176 mm x
51.1 mm | | | |
| Configuration | Perforated bases, lids and
PEEK Luvocom grommets | Perforated bases, lids
and silicone grommets | Perforated bases, lids, and
inserts | The PureSet Tray,
primary predicate,
and reference
device all utilize a
perforated design. |
| Device Material | PureSet Tray - Stainless steel
construction - PEEK grommets and
storage sleeves - PEEK mini tray locks
- Silicone elastomer feet
PureSet Tray Plate
- Aluminum construction
with anodization | Aluminum (Drill Stop
Box only), Polymer and
Silicon | Thermoplastic polymer,
aluminum and stainless steel | The PureSet Tray
uses materials not
included in the
predicate. The
PureSet Tray has
successfully been
validated. |
| Perforation | Evenly distributed hole
pattern | Evenly distributed hole
pattern | Unknown | Same as primary |
| Vent to Volume
Ratio | Trefoil PureSet: 43.5
NobelActive PureSet/
NobelParallel CC PureSet:
40.3
NobelReplace CC PureSet:
35.8 | 65 | Unknown | The PureSet Trays
have a lower
volume to vent ratio
allowing easier
sterilant
penetration. |
10
11
| | Candidate
PureSet Tray | Primary PREDICATE
Kit Boxes and Kit Plates
(K163600) | PREDICATE
Medtronic Transportation /
Sterilization Cassettes
(K152241) | Comparison | | | | | | | | | | | | | | | | | | | | |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization Method | Pre-Vacuum (wrap, pouch)
Gravity Displacement (wrap
or pouch) | Pre-Vacuum
Gravity Displacement | Pre-Vacuum
Gravity Displacement | Same | | | | | | | | | | | | | | | | | | | | |
| Sterilant Penetration | Yes | 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 | To be used with an FDA
approved sterilization wrap | Same | | | | | | | | | | | | | | | | | | | | |
| Reusable | Yes | Yes | Yes | Same | | | | | | | | | | | | | | | | | | | | |
| Material
Compatibility with
Sterilization Method | Yes | Yes | Yes | Same | | | | | | | | | | | | | | | | | | | | |
| Sterilization
Parameters | Pre-Vacuum:
Temp 132°C (270° F)
Exposure Time 4 minutes
Pre-vacuum: 4 times