Neodent Implant System-Helix NGM Compact Surgical Kit Cases

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. April 13, 2022 JJGC Indústria e Comércio de Materiais Dentários S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810 Re: K214051 Trade/Device Name: Neodent Implant System-Helix NGM Compact Surgical Kit Cases Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: March 18, 2022 Received: March 23, 2022 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K214051 #### Device Name Neodent Implant System - Helix NGM Compact Surgical Kit Cases Indications for Use (Describe) Helix NGM Compact Surgical Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. 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. 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, 20-minute dry time. Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time. Neodent 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 268.0 g. The weight of the empty Kit Case is 208.15 grams. Neodent Instrument Kit Cases should not be stacked during sterilization. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><span style="font-size:20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### 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}------------------------------------------------ ## 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: jennifer.jackson@straumann.com<br>Telephone (978) 747-2509 | | Date Prepared | 5/Apr/2022 | | Preparer / Alternate Contact | Mariana Hartmann<br>Regulatory Affairs Analyst<br>JJGC Indústria e Comércio de Materiais Dentários SA<br>E-mail: mariana.hartmann@neodent.com | ## DEVICE NAME AND CLASSIFICATION | Trade/ Proprietary Name | Neodent Implant System – Helix NGM Compact Surgical 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<br>Comércio de Materiais Dentários S.A | {4}------------------------------------------------ #### INDICATIONS FOR USE #### Indications for Use for Helix NGM Compact Surgical Kit Case and Pre-Mounted Helix NGM Compact Surgical Kit Case: Helix NGM Compact Surgical Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. 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. 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, 20-minute dry time. Gravity displacement – Exposure at 132 °C for 15 minutes, 20-minute dry time. Neodent 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 268.0 g. The weight of the empty Kit Case is 208.15 grams. Neodent Instrument Kit Cases should not 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 autoclavable polymer. The design of the subject devices include grommets manufactured from medical grade silicone that retain the instruments within the tray. They also presents markings that guide instrument use during procedures. 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<br>Kit Case<br>Dimension<br>(L x W x H) | Component<br>Number | Component Dimension<br>(L x W x H) | |-----------------------|----------------------------------------------------|---------------------------------------------------|---------------------|------------------------------------| | 110.315 | Helix NGM Compact<br>Surgical Kit Case | 195 x 90 x<br>54 mm | 212.293 (Lid) | 195 x 90 x 36 mm | | | | | 704346 (Tray) | 180 x 76 x 16.5 mm | | | | | 704345 (Base) | 188 x 84 x 32 mm | | 110.316 | Pre-Mounted Helix NGM<br>Compact Surgical Kit Case | 195 x 90 x<br>54 mm | 212.293 (Lid) | 195 x 90 x 36 mm | | | | | 704346 (Tray) | 180 x 76 x 16.5 mm | | | | | 704345 (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 TABLE | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | Helix NGM Compact Surgical 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 | | Indications for<br>Use Statement | Indications for Use for Helix NGM Compact<br>Surgical Kit Case<br>Helix NGM Compact Surgical Kit Cases are<br>indicated for organization of surgical and/or<br>prosthetic instruments during sterilization,<br>storage and transport. The use of this<br>product facilitates storage and organization<br>of instruments during and after surgical<br>procedures.<br>Neodent Instrument Kit Cases are intended<br>to allow sterilization of the enclosed medical<br>devices. Neodent Instrument Kit Cases<br>require the use of FDA cleared wrap to<br>maintain the sterility of the enclosed devices.<br>The kits are to be enclosed in a sterilization<br>wrap that is FDA-cleared for the indicated<br>cycles, and moist heat (steam) sterilized<br>using one of the following cycles:<br>Fractionated vacuum (pre-vacuum)<br>Exposure at 132 °C for 4 minutes, 20-minute<br>dry time.<br>Gravity displacement — Exposure at 132 °C<br>for 15 minutes, 20-minute dry time.<br>Neodent Instrument Kit Cases are intended<br>for sterilization of non-porous loads.<br>The combined weight of the GM Surgical Kit<br>Case and the associated instruments is 268.0<br>g. The weight of the empty Kit Case is 208.15<br>grams. Neodent Instrument Kit Cases should<br>not be stacked during sterilization.<br>Indications for Use for Pre-Mounted Helix<br>NGM Compact Surgical Kit Case<br>Product indicated for conditioning and safe<br>fastening surgical and/or prosthetic<br>instruments during their use and<br>sterilization. The use of this product<br>facilitates storage and organization of<br>instruments during and after surgical<br>procedures.<br>Neodent Instrument Kit Cases are intended<br>to allow sterilization of the enclosed medical<br>devices. Neodent Instrument Kit Cases<br>require the use of FDA cleared wrap to<br>maintain the sterility of the enclosed devices.<br>The kits are to be enclosed in a sterilization<br>wrap that is FDA-cleared for the indicated<br>cycles, and moist heat (steam) sterilized<br>using one of the following cycles:<br>Fractionated vacuum (pre-vacuum)<br>Exposure at 132 °C for 4 minutes, 20-minute<br>dry time.<br>Gravity displacement — Exposure at 132 °C<br>for 15 minutes, 20-minute dry time.<br>Neodent Instrument Kit Cases are intended<br>for sterilization of non-porous loads.<br>The combined weight of the GM Surgical Kit<br>Case and the associated instruments is 268.0<br>g. The weight of the empty Kit Case is 208.15<br>grams. Neodent Instrument Kit Cases should | Indications for Use for GM Surgical Kit Case:<br>Neodent Instrument Kit Cases are intended to<br>be used to enclose other medical devices that<br>are to be sterilized by a health care provider.<br>Neodent Instrument Kit Cases are intended to<br>allow sterilization of the enclosed medical<br>devices. Neodent Instrument Kit Cases require<br>the use of FDA cleared wrap to maintain the<br>sterility of the enclosed devices.<br>The kits are to be enclosed in a sterilization<br>wrap that is FDA-cleared for the indicated<br>cycles, and moist heat (steam) sterilized using<br>one of the following cycles:<br>Fractionated vacuum (pre-vacuum) — Exposure<br>at 132 °C for 4 minutes, 20-minute dry time.<br>Gravity displacement — Exposure at 132 °C for<br>15 minutes, 40-minute dry time.<br>Neodent Instrument Kit Cases are intended for<br>sterilization of non-porous loads.<br>The combined weight of the GM Surgical Kit<br>Case and the associated instruments is 613.1 g.<br>The weight of the empty Kit Case is 510 grams.<br>Neodent Instrument Kit Cases should not to be<br>stacked during sterilization.<br>Indications for Use for GM Helix Compact<br>Surgical Kit Case:<br>Neodent Instrument Kit Cases are intended to<br>be used to enclose other medical devices that<br>are to be sterilized by a health care provider.<br>Neodent Instrument Kit Cases are intended to<br>allow sterilization of the enclosed medical<br>devices. Neodent Instrument Kit Cases require<br>the use of FDA cleared wrap to maintain the<br>sterility of the enclosed devices.<br>The kits are to be enclosed in a sterilization<br>wrap that is FDA-cleared for the indicated<br>cycles, and moist heat (steam) sterilized using<br>one of the following cycles:<br>Fractionated vacuum (pre-vacuum) — Exposure<br>at 132 °C for 4 minutes, 20-minute dry time<br>Gravity displacement — Exposure at 132 °C for<br>15 minutes, 20-minute dry time.<br>Neodent Instrument Kit Cases are intended for<br>sterilization of non-porous loads.<br>The combined weight of the GM Helix Compact<br>Surgical Kit Case and the associated<br>instruments is 308.2 g. The weight of the empty<br>Kit Case is 231 grams. Neodent Instrument Kit<br>Cases should not to be stacked during<br>sterilization. | Similar | | | not be stacked during sterilization. | | | | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | | | | Helix NGM Compact Surgical 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 Use | The Helix Narrow GM Compact Surgical<br>Kit Cases is suitable for safe storage of<br>surgical and prosthetic instruments,<br>organizing the instruments in the<br>sequence in which they will be used, as<br>well as for sterilization of such<br>instruments. | The GM Helix Compact Surgical Kit Case is<br>suitable for safe storage of surgical and<br>prosthetic instruments, organizing the<br>instruments in the sequence in which they<br>will be used, as well as for sterilization of<br>such instruments. | Same | | Design | Rigid polysulfone polymer base and<br>removable inner tray with a<br>polyphenylsulfone lid.<br>Retention grommets of medical grade<br>silicone. | Rigid polysulfone polymer base and<br>removable inner tray with a<br>polyphenylsulfone lid.<br>Retention grommets of medical grade<br>silicone. | Identical | | Perforated | Yes; allows moist heat (steam)<br>penetration to achieve sterilization | Yes; allows moist heat (steam)<br>penetration to achieve sterilization | Identical | | Reusable | Yes | Yes | Identical | | Overall<br>dimensions | 110.315: 195 L x 90 W x 54 H, mm<br>110.316: 195 L x 90 W x 54 H, mm | 110.288: 264 L x 163 W x 54 H, mm<br>110.297: 195 L x 90 W x 64 H, mm | Similar | | Volume to Vent<br>Ratio | 110.315: 52.3 cm³/cm² (20.59 in³/in²)<br>110.316: 52.3 cm³/cm² (20.59 in³/in²) | 110.288: 98.04 cm³/cm² (38.6 in³/in²)<br>110.297: 63.5 cm³/cm² (25.0 in³/in²) | Similar | | Useful Life | Yes, reusable up to 100 cycles | Yes, reusable up to 100 cycles…