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

Intended 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)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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<br>(Moist Heat Sterilization) | |
|---------------------------------------------------|---------------------------------------------------|----------------------------|
| Cycle | Dynamic-Air-Removal<br>(fractionated vacuum) | Gravity-Displacement |
| Temperature | 132°C<br>(270°F) | 132°C<br>(270°F) |
| Exposure time for a single-<br>use pouched device | 4 minutes<br>(full-cycle) | 15 minutes<br>(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)

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# 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: [phone] x 7830 Fax: [phone]

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

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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<br>(Moist Heat Sterilization) | |
|-----------------------------------------------------|---------------------------------------------------|----------------------------|
| Cycle | Dynamic-Air-Removal<br>(fractionated vacuum) | Gravity-Displacement |
| Temperature | 132°C<br>(270°F) | 132°C<br>(270°F) |
| Exposure time for a<br>single-use pouched<br>device | 4 minutes<br>(full-cycle) | 15 minutes<br>(full-cycle) |
| Minimum drying<br>times | 20 minutes | 30 minutes |

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#### VI. Comparison of Technological Characteristics

# Comparison of intended use and indication for use statement

| Technological<br>characteristics | Subject Device | Primary Predicate | Reference Predicate | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | PureSet Tray | Kit Boxes and Kit Plates (K163600) | Medtronic Transportation/ Sterilization<br>Cassettes (K152241) | |
| | The Nobel Biocare PureSet Tray is<br>intended for use in healthcare facilities to<br>store and organize Nobel Biocare<br>surgical instruments and components<br>during cleaning/sterilization and during<br>implant/prosthetic treatment. The Nobel<br>Biocare PureSet Trays are not intended<br>on their own to maintain sterility; it is<br>intended to be used in conjunction with a<br>legally marketed, validated, FDA-cleared<br>sterilization pouch or sterilization wrap. | The Nobel Biocare Kit Boxes are intended<br>for use in healthcare facilities to organize,<br>enclose, sterilize, transport, and store<br>medical devices between surgical uses.<br>The Nobel Biocare Kit Boxes are not<br>intended on their own to maintain sterility;<br>it is intended to be used in conjunction with<br>a legally marketed, validated, FDA-cleared<br>sterilization wrap. Sterilization validations<br>for the worst-case Nobel Biocare Kit Box<br>(170 mm x 145 mm x 57) included surgical<br>instruments such as torque wrenches,<br>implant drivers, direction indicators, drills,<br>etc. | The Medtronic Transportation/Sterilization<br>Cassettes are intended for use in healthcare<br>facilities to organize, enclose, sterilize,<br>transport, and store medical devices and<br>other instrumentation between surgical and<br>other medical uses. The Medtronic<br>Transportation/Sterilization Cassettes are not<br>intended on their own to maintain sterility; it<br>is intended to be used in conjunction with a<br>legally marketed, validated, FDA-cleared<br>sterilization wrap. | |
| Technological<br>characteristics | Subject Device | Primary Predicate | Reference Predicate | |
| | PureSet Tray | Kit Boxes and Kit Plates (K163600) | Medtronic Transportation/ Sterilization<br>Cassettes (K152241) | |
| Indication for<br>use statement | The Nobel Biocare PureSet Tray is used<br>in healthcare facilities to store and<br>organize Nobel Biocare surgical<br>instruments and components during<br>cleaning/sterilization and during<br>implant/prosthetic treatment. The Nobel<br>Biocare PureSet Trays are not intended<br>on their own to maintain sterility; it is<br>intended to be used in conjunction with a<br>legally marketed, validated, FDA-cleared<br>sterilization pouch or sterilization wrap.<br>Sterilization validations for the worst-<br>case PureSet Tray included surgical<br>instruments such as torque wrenches,<br>implant drivers, direction indicators,<br>drills, screw taps, screw driver and<br>irrigation needles. The PureSet Trays<br>were validated for a maximum load of<br>1635 grams (Trefoil PureSet Tray), 1082<br>grams (NobelActive/NobelParallel CC<br>PureSet Tray) and 945 grams<br>(NobelReplace CC PureSet Tray). | The Nobel Biocare Kit Boxes are used in<br>healthcare facilities to organize, enclose,<br>sterilize, transport, and store medical<br>devices between surgical uses. The Nobel<br>Biocare Kit Boxes are not intended on their<br>own to maintain sterility; it is intended to be<br>used in conjunction with a legally<br>marketed, validated, FDA-cleared<br>sterilization wrap. Sterilization validations<br>for the worst-case Nobel Biocare Kit Box<br>(170 mm x 145 mm x 57mm) included<br>surgical instruments such as torque<br>wrenches, implant drivers, direction<br>indicators, drills, etc. The Kit Boxes were<br>validated for a maximum load of 469<br>grams including kit box and instruments. | Cycle Tempe-<br>rature Exposure<br>time Minimum<br>dry time | |
| | | Method<br>Steam Sterilization<br>(Moist Heat Sterilization) | Gravity<br>Displace-<br>ment 250° F<br>(121°<br>C) 30<br>Minutes 30<br>Minutes | |
| | | Cycle Dynamic-<br>Air-<br>Removal<br>(fractionat<br>ed<br>vacuum) Dynamic-<br>Air-<br>Removal<br>(fractionat<br>ed<br>vacuum) Gravity-<br>Displacem<br>ent | Gravity<br>Displace-<br>ment 270° F<br>(132°<br>C) 15<br>Minutes 30<br>Minutes | |
| | | | Gravity<br>Displace-<br>ment 275° F<br>(135°<br>C) 10<br>Minutes 30<br>Minutes | |
| | | | Dynamic-<br>Air-<br>Removal 270º F<br>(132°<br>C) 4<br>Minutes 30<br>Minutes | |
| | | Method<br>Steam Sterilization<br>(Moist Heat Sterilization) | Dynamic-<br>Air-<br>Removal 275° F<br>(135° C 3<br>Minutes 30<br>Minutes | |
| | | Temperat<br>ure 132°C<br>(270°F) 134°C<br>(270°F) 132°C<br>(270°F) | The Medtronic Transportation/ Sterilization<br>Cassettes are intended for use in healthcare<br>facilities to organize, enclose, sterilize,<br>transport, and store medical devices and<br>other instrumentation between surgical and<br>other medical uses. The Medtronic<br>Transportation/ Sterilization Cassettes are<br>not intended on their own to maintain sterility;<br>it is intended to be used in conjunction with a<br>legally marketed, validated, FDA-cleared<br>sterilization wrap. | |
| | | Cycle Dynamic-<br>Air-<br>Removal<br>(fractionat | Sterilization validations for the worst-case<br>Medtronic Transportation/Sterilization | |
| | | Gravity-<br>Displacement | | |
| | | Exposure<br>time for a<br>single-<br>use 4 minutes<br>(full-<br>cycle) 3 minutes<br>(full-cycle) 15<br>minutes<br>(full-cycle) | | |
| Technological<br>characteristics | Subject Device | | Primary Predicate | Reference Predicate |
| | PureSet Tray | | Kit Boxes and Kit Plates (K163600) | Medtronic Transportation/ Sterilization<br>Cassettes (K152241) |
| | ed<br>vacuum) | | pouched<br>device | Cassette (22.75 x 11.26 x 5.5 inches)<br>included implants and common surgical<br>instruments such as rasps, drivers, trials,<br>handles, inserters, probes, drills, etc. The<br>validated total weight was 28.4 lbs. The<br>validated worst-case loading configurations<br>of the Medtronic Transportation/ Sterilization<br>Cassette included the following worst-case<br>lumen dimensions. |
| | Temperature | 132°C<br>(270°F) | Exposre<br>time for<br>the<br>Overkill<br>Approach | |
| | | 132°C<br>(270°F) | 2 minutes<br>(half<br>cycle) | -363 x 1.575 mm<br>-247.5 x 4.1 mm<br>Device List:<br>1850060 Case- Triple Generic Outer Base<br>(22.74 x 11.260 x 5.040 inches) |
| | Exposure<br>time for a<br>single-use<br>pouched<br>device | 4 minutes<br>(full-cycle) | 1.5<br>minutes<br>(half<br>cycle) | 1850064 Lid- Generic Outer Lid (22.75 x<br>11.260 x 0.470 inches)<br>7022101L Tray Lid (21 x 10.13 x 0.075<br>inches)<br>P1850061 Tray 1 (20.75 x 9.79 x 1.32<br>inches) |
| | | 15 minutes<br>(full-cycle) | 7.5<br>minutes<br>(half<br>cycle) | P1850062 Tray 2 (21 x 10.13x 1.69 inches)<br>P1850063 Tray 3 (21 x 10.13 x 1.38 inches)<br>7059532 Large Caddy (9.47 x 6.37 x 1.3<br>inches) |
| | Minimum<br>drying times | 20<br>minutes | Minimum<br>drying<br>times | 7059532L Large Lid (5.85 x 4.725 x 0.095<br>inches) |
| | | 30 minutes | 20<br>minutes | P213018 Small Caddy (2 x 1.5 x 1.025<br>inches) |
| | | | 10<br>minutes | P9213018 Small Lid (2 x 1.29 x 0.095<br>inches) |
| | | | 30<br>minutes | |

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Nobel Biocare Traditional 510(k) Notification (K181075) PureSet Tray September 2018

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| Technological | Subject Device | Primary Predicate | Reference Predicate | | | |
|-----------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------|-----------------------------------|--------------------------------------|
| characteristics | PureSet Tray | Kit Boxes and Kit Plates (K163600) | Medtronic Transportation/ Sterilization<br>Cassettes (K152241) | |…