Who is the manufacturer of PureSet Tray?

Nobel Biocare AB filed the 510(k) submission for PureSet Tray (K181075).

What is the FDA product code for PureSet Tray?

KCT. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for PureSet Tray?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PureSet Tray?

Nobel Biocare - Kit Boxes and Kit Plates (K163600); Medtronic Sofamor Danek - Medtronic Transportation/Sterilization Cassettes (K152241).

Who can help prepare an FDA 510(k) submission like PureSet Tray?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PureSet Tray

K181075 · Nobel Biocare AB · KCT · Sep 27, 2018 · General Hospital

Device Facts

Record ID	K181075
Device Name	PureSet Tray
Applicant	Nobel Biocare AB
Product Code	KCT · General Hospital
Decision Date	Sep 27, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

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.

Device Story

PureSet Tray is a reusable surgical tray system for organizing and storing Nobel Biocare instruments during cleaning, sterilization, and surgical procedures. The device consists of perforated stainless steel bases, lids, PEEK grommets/sleeves, and silicone feet; some models include anodized aluminum plates. It is used in hospitals and healthcare facilities by clinical staff. The tray is not a sterile barrier; it must be enclosed in an FDA-cleared sterilization wrap or pouch before steam sterilization in standard autoclaves. The device protects instruments during transport and storage. By organizing tools, it facilitates efficient surgical workflows and ensures instruments are properly processed. The tray's design allows for sterilant penetration via an evenly distributed hole pattern. It is intended for repeated reprocessing cycles.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993), sterilization validation (AAMI/ANSI ST79, ISO 14937), handle durability (DIN 58952-3), repeated reprocessing, and shipping simulation (ASTM D4169-16).

Technological Characteristics

Materials: Stainless steel, PEEK (grommets, sleeves, locks), silicone elastomer (feet), anodized aluminum (plates). Design: Perforated base/lid, one or two-level configurations. Sterilization: Steam (pre-vacuum and gravity displacement). Connectivity: None. Software: None. Standards: AAMI/ANSI ST79, ISO 10993, ASTM D4169-16, DIN 58952-3.

Indications for Use

Indicated for use in healthcare facilities to store and organize Nobel Biocare surgical instruments and components during cleaning, sterilization, and implant/prosthetic treatment. Intended for use with an FDA-cleared sterilization wrap or pouch. Validated for specific surgical instruments including torque wrenches, implant drivers, direction indicators, drills, screw taps, screw drivers, and irrigation needles, with maximum load capacities of 1635g, 1082g, or 945g depending on the tray model.

Regulatory Classification

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.

Predicate Devices

Nobel Biocare - Kit Boxes and Kit Plates (K163600)
Medtronic Sofamor Danek - Medtronic Transportation/Sterilization Cassettes (K152241)

Submission Summary (Full Text)

{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) 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 Druq 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}------------------------------------------------ # 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) | |…

PureSet Tray

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

PureSet Tray

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps

Welcome

Check your email

Welcome!