NUVO Implant System – NUVO Instrument Kit Cases

K202515 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · KCT · Nov 24, 2020 · General Hospital

Device Facts

• Record ID: K202515
• Device Name: NUVO Implant System – NUVO Instrument Kit Cases
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
• Product Code: KCT · General Hospital
• Decision Date: Nov 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Instrument Kits are intended to allow sterilization of the enclosed medical devices. Instrument Kits require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The Kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat using one of the following cycles: Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minute dry time Gravity displacement -Exposure at 132 °C for 15 minutes, 30-minute dry time. Instrument Kits are intended for sterilization of nonporous loads. The combined weight of the Kit and the associated instruments is 194.90 grams. The weight of the 189.12 grams. Instrument Kits are recommended not to be stacked during sterilization.

Device Story

Reusable rigid container system; comprises polymer base, removable inner tray, and lid; includes polyphenylsulfone retention grommets. Used by healthcare providers to organize, protect, and sterilize dental surgical instruments. Provided non-sterile; requires FDA-cleared sterilization wrap. Operates via moist heat (steam) sterilization (fractionated vacuum or gravity displacement cycles). Protects instruments during processing; facilitates sterilization of nonporous loads; ensures organized storage for clinical use.

Clinical Evidence

Bench testing only. Validated manual cleaning (blood soil removal), sterilization efficacy (sterilant penetration/drying time per ISO 17665-1/2), life cycle testing (100 cycles of cleaning/sterilization), and biocompatibility (cytotoxicity per ISO 10993-5).

Technological Characteristics

Materials: Polysulfone (base/tray), polyphenylsulfone (lid/grommets). Design: Rigid, perforated container. Sterilization: Moist heat (steam) via fractionated vacuum or gravity displacement. Reusable (up to 100 cycles). Biocompatibility: ISO 10993-1/5 compliant.

Indications for Use

Indicated for use by healthcare providers to enclose and sterilize nonporous medical device loads via moist heat (steam) sterilization. Requires use of FDA-cleared sterilization wrap. Not for stacking during sterilization.

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

• Neodent Instrument Kit Cases (K192670)

Reference Devices

• Neodent Instrument Kits (K182865)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 24, 2020

JJGC Industria e Comercio de Materiais Dentarios S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K202515

Trade/Device Name: NUVO Implant System - NUVO Instrument Kit Cases Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 1, 2020 Received: September 1, 2020

Dear Jennifer Jackson:

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

{1}------------------------------------------------

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray, III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

### K202515

## Device Name

NUVO Implant System - NUVO Instrument Kits Cases

Indications for Use (Describe)

Indications for Use for Drill Stop Pre-Mounted Kit and Drill Stop Kit

IInstrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Instrument Kits are intended to allow sterilization of the enclosed medical devices. Instrument Kits require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The Kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat using one of the following cycles: Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minute dry time Gravity displacement -Exposure at 132 °C for 15 minutes, 30-minute dry time.

Instrument Kits are intended for sterilization of nonporous loads.

The combined weight of the Kit and the associated instruments is 194.90 grams. The weight of the 189.12 grams. Instrument Kits are recommended not to be stacked during sterilization.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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}------------------------------------------------

## K202515 510(K) Summary

## ADMINISTRATIVE INFORMATION

| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA<br>(dba Neodent)<br>Av. Juscelino Kubitschek de Oliveira, 3291<br>Curitiba, Parana, Brazil 81270-200<br>Registration No.: 3008261720<br>Owner/Operator No.: 10031702 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs,<br>Straumann USA<br>E-mail: [e-mail]<br>Telephone [phone] |
| Date Prepared | 24/Nov/2020 |
| Preparer / Alternate<br>Contact | Mariana Soares Hartmann<br>Regulatory Affairs Analyst<br>JJGC Indústria e Comércio de Materiais Dentários SA<br>E-mail: [e-mail] |

## DEVICE NAME AND CLASSIFICATION

| Trade/ Proprietary Name | NUVO Implant System - NUVO Instrument Kit Cases |
|------------------------------|---------------------------------------------------------|
| Common Name | Instrument Sterilization Trays |
| Classification Name | Sterilization Wrap Containers, Trays, Cassettes & Other |
| Classification Regulations | 21 CFR 880.6850, Class II |
| Product Code | KCT |
| Classification Panel | General Hospital |
| Reviewing Branch | Infection Control Devices Branch |
| PREDICATE DEVICE INFORMATION | |

#### Primary Predicate Device K192670 – Neodent Instrument Kit Cases, JJGC Indústria e Comércio de Materiais Dentários S.A Reference Predicate K182865 - Neodent Instrument Kits, JJGC Indústria e Comércio Device de Materiais Dentários S.A

{4}------------------------------------------------

## INDICATIONS FOR USE

## Indications for Use for Drill Stop Pre-Mounted Kit and Drill Stop Kit:

Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Instrument Kits are intended to allow sterilization of the enclosed medical devices. Instrument Kits require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices.

The Kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:

Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 30-minute dry time Gravity displacement - Exposure at 132 °C for 15 minutes, 30-minute dry time.

Instrument Kits are intended for sterilization of nonporous loads.

The combined weight of the Kit and the associated instruments is 194,90 grams. The weight of the empty Kit is 189,12 grams.

Instrument Kits are recommended not to be stacked during sterilization.

## SUBJECT DEVICE DESCRIPTION

The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject kit cases are manufactured in polymer. The design of the subject devices include grommets manufactured from polyphenylsulfone that retain the instruments within the tray. The subject device kit cases are provided nonsterile to the end-user.

The dimensions for each part of the model and the overall dimensions are presented in the table below:

| Assembled<br>Kit Case | Description | Assembled Kit<br>Case<br>Dimension<br>(L x W x H) | Component<br>Number | Component<br>Dimension<br>(L x W x H) |
|-----------------------|--------------------------------|---------------------------------------------------|---------------------|---------------------------------------|
| CD1030001 | Drill Stop Pre-<br>Mounted Kit | 195 x 90 x 34,<br>mm | 703279 (Lid) | 195 x 90 x 16 mm |
| | | | 703278 (Tray) | 180 x 76 x 23 mm |
| | | | 212.197 (Base) | 188 x 84 x 32 mm |
| CD1030002 | Drill Stop Kit | 195 x 90 x 34,<br>mm | 703279 (Lid) | 195 x 90 x 16 mm |
| | | | 703278 (Tray) | 180 x 76 x 23 mm |
| | | | 212.197 (Base) | 188 x 84 x 32 mm |

Note: The instrument and accessory devices that are sterilized and stored within the subject Kit Cases are not themselves subject devices of this submission.

{5}------------------------------------------------

# TECHNOLOGICAL CHARACTERISTIC COMPARISON

| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | NUVO Instrument Kit Cases<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K192670<br>Neodent Instrument Kit Cases JJGC<br>Indústria e Comércio de Materiais<br>Dentários S.A. | COMPARISON |
| Indications<br>for Use<br>Statement | Indications for Use for Drill Stop Pre-Mounted Kit and Drill Stop Kit:<br>Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices.<br>The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:<br>Fractionated vacuum (pre-vacuum) — Exposure at 132 °C for 4 minutes, 20-minute dry time.<br>Gravity displacement — Exposure at 132 °C for 15 minutes, 45-minute dry time.<br>Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the GM Surgical Kit Case and the associated instruments is 613.1 g. The weight of the empty Kit Case is 510 grams.<br>Instrument Kit Cases should not to be stacked during sterilization. | Indications for Use for GM Surgical Kit Case:<br>Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices.<br>The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:<br>Fractionated vacuum (pre-vacuum) — Exposure at 132 °C for 4 minutes, 20-minute dry time.<br>Gravity displacement — Exposure at 132 °C for 15 minutes, 40-minute dry time.<br>Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.<br>The combined weight of the GM Surgical Kit Case and the associated instruments is 613.1 g. The weight of the empty Kit Case is 510 grams. Neodent Instrument Kit Cases should not to be stacked during sterilization.<br>Indications for Use for GM Helix Compact Surgical Kit Case:<br>Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices.<br>The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:<br>Fractionated vacuum (pre-vacuum) — Exposure at 132 °C for 4 minutes, 20-minute dry time<br>Gravity displacement — Exposure at 132 °C for 15 minutes, 20-minute dry time.<br>Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.<br>The combined weight of the GM Helix Compact Surgical Kit Case and the associated instruments is 308.2 g. The weight of the empty Kit Case is 231 grams. Neodent Instrument Kit Cases should not to be stacked during sterilization. | Similar |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
| | NUVO Instrument Kit Cases<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K192670<br>Neodent Instrument Kit Cases<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | COMPARISON |
| Intended<br>Use | The kit is used for the safe storage of<br>surgical instruments, as well as for support<br>during sterilization. | The GM Helix Compact Surgical Kit Case is<br>suitable for safe storage of surgical and<br>prosthetic<br>instruments, organizing<br>the<br>instruments in the sequence in which they will<br>be used, as well as for sterilization of such<br>instruments. | Similar |
| Design | Rigid polysulfone polymer base and<br>removable inner tray with a<br>polyphenylsulfone lid.<br>Retention grommets of polyphenylsulfone. | Rigid polysulfone polymer base and<br>removable inner tray with a<br>polyphenylsulfone lid.<br>Retention grommets of medical grade<br>silicone. | Similar |
| Perforated | Yes; allows moist heat (steam) penetration<br>to achieve sterilization | Yes; allows moist heat (steam) penetration<br>to achieve sterilization | Identical |
| Reusable | Yes | Yes | Identical |
| Overall<br>dimensions | CD1030001: 195 L x 90 W x 34 H, mm | 110.288: 264 L x 163 W x 54 H, mm | Similar |
| | CD1030002: 195 L x 90 W x 34 H, mm | 110.297: 195 L x 90 W x 64 H, mm | |
| Volume to<br>Vent Ratio | CD1030001: 46.8 cm³/ cm² (18.4 in³/in²) | 110.288: 98.04 cm³/cm² (38.6 in³/in²) | Similar |
| | CD1030002: 46.8 cm³/ cm² (18.4 in³/in²) | 110.297: 63.5 cm³/cm² (25.0 in³/in²) | |
| Useful Life | Yes, reusable up to 100 cycles | Yes, reusable up to 100 cycles | Identical |
| Biocompatibility | The assessment to Biocompatibility was<br>performed per ISO 10993-1 and testing was<br>performed using methods described in<br>AAMI/ANSI/ISO<br>10993-5.<br>The<br>results<br>indicate that the subject devices are<br>biocompatible. | The assessment to Biocompatibility was<br>performed per ISO 10993-1 and testing was<br>performed using methods described in<br>AAMI/ANSI/ISO 10993-5. The results indicate<br>that the subject devices are biocompatible. | Identical |
| Sterilization<br>Method | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | Identical |
| Cycles | Gravity displacement | Gravity displacement | Identical |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
| | Neodent Instrument Kit Cases<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K192670<br>Neodent Instrument Kit Cases<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | COMPARISON |
| Parameters | Gravity<br>Sterilization temperature: 132 °C<br>Sterilization time: 15 minutes;<br>Drying time: 45 minutes<br>Pre-Vacuum<br>Sterilization temperature: 132 °C<br>Sterilization time: 4 minutes;<br>Drying time: 20 minutes. | Gravity<br>Sterilization temperature: 132 °C<br>Sterilization time: 15 minutes;<br>Drying time: 40 minutes (model number<br>110.288) or 20 minutes (model number<br>110.297)<br>Pre-Vacuum<br>Sterilization temperature: 132 °C<br>Sterilization time: 4 minutes;<br>Drying time: 20 minutes.…