(87 days)
Zirconia Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Zirconia Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Zirconia Guided Surgery Kit Cases requre the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterlization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Dynamic Air Removal (pre-vacuum) – Exposure at 132°C for 4 minutes, 20-minute dry time. Gravity displacement – Exposure at 132°C for 15 minute dry time. Ziroonia Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The Zirconia Guided Surgery Kit Case and the associated instruments is 342.2 g. The weight of the empty Kit is 236.8 grams. Zirconia Guided Surgery Kit Case are recommended not to be stacked during sterilization.
Nuvo CF Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Nuvo CF Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo CF Guided Surgery 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): exposure at 132°C for 4 minutes, drying for 20 minutes. Gravity displacement: exposure at 132°C for 15 minutes, drying for 30 minutes. Nuvo CF Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Nuvo CF Guided Surgery Kit Cases and the associated instruments is approximately 693 g. The weight of the empty case is 487 grams. Nuvo CF Guided Surgery Kit Cases are not recommended to be stacked during sterilization.
The Zirconia and Nuvo CF Guided Surgery Kit Cases subject to this submission are reusable rigid containers, composed by a case bottom, a removable inner tray and a lid, which are made of autoclavable polymer. They are indicated to hold various dental instruments (not subject of this submission) in order to organize, sterilize and protect them. Sterilization via moist heat (steam) is performed by the healthcare provider.
This document is a 510(k) Summary for the Zirconia and Nuvo CF Guided Surgery Kit Cases. It describes the non-clinical performance data used to evaluate the device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Standard or Test Method | Purpose of the Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ANSI/AAMI/ISO 17665-1ANSI/AAMI/ISO 17665-2 | Steam sterilization validation, including sterilant penetration and drying time | All Biological Indicators must be incubated for at least 7 days at 55-60°C. All positive controls for SAL testing must show characteristic growth of the indicator organism. | Passed |
| AAMI TIR 30:2011 | Manual cleaning validation• Test Soil: Blood Soil (BLSO)• Cleaning Method: Manual• Residuals Tested: Hemoglobin and Protein | • Visual Inspection: No visible soil• Hemoglobin Test: < 2.2 µg/cm²• Protein Test: < 6.4 µg/cm² | Passed |
| Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff (Life cycle testing) | Life cycle (simulate usage) testing | The tested samples must withstand 100 cycles of use (cleaning, sterilization and functional tests) without compromising their functionalities. | Passed |
| ANSI/AAMI/ISO 10993-5 | Biocompatibility of subject devices via cytotoxicity testing | Less than 30% cell proliferation inhibition | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each test set (e.g., number of kit cases tested for sterilization, cleaning, or life cycle). It mentions "representative samples" for biocompatibility.
The data provenance is not explicitly stated in terms of country of origin but is from the manufacturer (JJGC Indústria e Comércio de Materiais Dentários S.A. dba Neodent, Brazil, and Straumann USA, LLC). The studies appear to be prospective, specifically designed to validate the new devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This document describes non-clinical performance data involving laboratory testing against established standards. Therefore, it does not involve "experts" in the sense of clinicians establishing ground truth for diagnostic accuracy. The ground truth is defined by the technical specifications and performance requirements established by the listed ISO and AAMI standards.
4. Adjudication Method for the Test Set:
Not applicable, as this is laboratory testing against objective criteria defined by standards, not subjective evaluation by human experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a study assessing the effectiveness of an AI or diagnostic device with human reader interaction. It relates to the sterilization and reprocessing of medical device cases.
6. Standalone Performance Study:
Yes, the studies described are standalone performance studies of the device itself (the Zirconia and Nuvo CF Guided Surgery Kit Cases). The tests evaluate characteristics like sterilization effectiveness, cleaning efficacy, durability over multiple cycles, and biocompatibility, without human-in-the-loop performance being a factor.
7. Type of Ground Truth Used:
The ground truth used is based on established international and national medical device standards (ISO 17665-1, ISO 17665-2, AAMI TIR 30:2011, ISO 10993-5) and regulatory guidance documents (FDA Guidance document for ISO 10993-1). These standards define objective criteria for successful performance (e.g., specific microbial reduction, acceptable residual levels, physical integrity over cycles, cytotoxicity limits).
8. Sample Size for the Training Set:
Not applicable. These are non-clinical validation studies for physical devices, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set involved. The "ground truth" for the device's performance is established by its compliance with the specified performance standards in the validation testing.
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Image /page/0/Picture/0 description: The image shows 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 the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 23, 2024
JJGC Indústria e Comércio de Materiais Dentários S.A. % Jennifer Jackson Sr. Director, Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K241492
Trade/Device Name: Zirconia and Nuvo CF Guided Surgery Kit Cases Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: Mav 28, 2024 Received: May 28, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
Image /page/1/Picture/6 description: This image shows a digital signature and contact information. The signature is from Stephen A. Anisko -S, and it was signed on August 23, 2024, at 12:50:29 -04'00'. The contact information is for Christopher Dugard, Assistant Director at the Division of Infection Control Devices, Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality, and Center for Devices and Radiological Health.
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K241492 - Jennifer Jackson
Enclosure
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Indications for Use
510(k) Number (if known) K241492
Device Name
Zirconia and Nuvo CF Guided Surgery Kit Cases
Indications for Use (Describe)
Zirconia Guided Surgery Kit Cases:
Zirconia Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Zirconia Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Zirconia Guided Surgery Kit Cases requre the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterlization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Dynamic Air Removal (pre-vacuum) – Exposure at 132°C for 4 minutes, 20-minute dry time. Gravity displacement – Exposure at 132°C for 15 minute dry time. Ziroonia Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The Zirconia Guided Surgery Kit Case and the associated instruments is 342.2 g. The weight of the empty Kit is 236.8 grams. Zirconia Guided Surgery Kit Case are recommended not to be stacked during sterilization.
Nuvo CF Guided Surgery Kit Cases:
Nuvo CF Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Nuvo CF Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo CF Guided Surgery 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): exposure at 132°C for 4 minutes, drying for 20 minutes. Gravity displacement: exposure at 132°C for 15 minutes, drying for 30 minutes. Nuvo CF Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Nuvo CF Guided Surgery Kit Cases and the associated instruments is approximately 693 g. The weight of the empty case is 487 grams. Nuvo CF Guided Surgery Kit Cases are not recommended to be stacked during sterilization.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
510(k) Summary 1
Submitter's Contact Information
| Submitter: | Straumann USA, LLC60 Minuteman RoadAndover, MA 01810, USARegistration No.: 1222315 Owner/Operator No.: 9005052 |
|---|---|
| On the behalf of: | |
| JJGC Indústria e Comércio de Materiais Dentários S.A. (dba NeodentAv. Juscelino Kubitschek de Oliveira, 3291 - CICCuritiba, Paraná, Brazil 81270-200Registration No.: 3008261720Owner/Operator No.: 10031702 | |
| Contact Person: | Jennifer M. Jackson, MS, RACSr. Director, Regulatory Affairs and QualityEmail: jennifer.jackson@straumann.comPhone Number: +1 978 747-2509Fax Number: +1 978 747-0023 |
| Prepared By &Alternate Contact: | Leticia MilaniRegulatory Affairs AnalystJJGC Indústria e Comércio de Materiais Dentários SAE-mail: leticia.milani@neodent.comPhone Number: +55 41 216-9485 |
| Date Prepared: | August 22, 2024 |
Name of the Device
| Trade Names: | Zirconia and Nuvo CF Guided Surgery Kit Cases |
|---|---|
| Common Name: | Instrument Sterilization Trays |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other |
| Regulation Number: | 21 CFR 880.6850, Class II, Sterilization wrap |
| Device Classification: | II |
| Product Code(s): | KCT |
| Classification Panel: | General Hospital |
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Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
Predicate Device(s)
Primary Predicate:
- K203618 Neodent EasyGuide Kit Cases (JJGC Indústria e Comércio de Materiais . Dentários S.A)
Reference Devices:
- K182865 Neodent Instrument Kits (JJGC Indústria e Comércio de Materiais Dentários S.A) .
- . K223662 – Neodent Implant System – Helix Short Surgical Kit Cases (JJGC Indústria e Comércio de Materiais Dentários S.A)
Device Description
The Zirconia and Nuvo CF Guided Surgery Kit Cases subject to this submission are reusable rigid containers, composed by a case bottom, a removable inner tray and a lid, which are made of autoclavable polymer. They are indicated to hold various dental instruments (not subject of this submission) in order to organize, sterilize and protect them. Sterilization via moist heat (steam) is performed by the healthcare provider.
Intended Use
The Zirconia and Nuvo CF Guided Surgery Kit Cases are used to safe storage and securing of instruments during sanitization and surgical procedures. The Zirconia Guided Surgery Kit Cases are designed for storing the instruments used to install Bone Level (BL) ceramic implants. The Nuvo CF Guided Surgery Kit Cases are intended for the installation of Nuvo CF implants.
Indications for Use
Zirconia Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Zirconia Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Zirconia Guided Surgery 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: Dynamic Air Removal (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. Zirconia Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Zirconia Guided Surgery Kit Case and the associated instruments is 342.2
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Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
g. The weight of the empty Kit is 236.8 grams. Zirconia Guided Surgery Kit Case are recommended not to be stacked during sterilization.
Nuvo CF Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Nuvo CF Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo CF Guided Surgery 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, drying for 20 minutes. Gravity displacement: exposure at 132°C for 15 minutes, drying for 30 minutes. Nuvo CF Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Nuvo CF Guided Surgery Kit Cases and the associated instruments is approximately 693 g. The weight of the empty case is 487 grams. Nuvo CF Guided Surgery Kit Cases are not recommended to be stacked during sterilization.
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Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables:
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
|---|---|---|---|---|
| K Number | K241492Zirconia Guided Surgery Kit Cases | K203618Neodent EasyGuide Kit Cases | K223662Helix Short Surgical Kit Cases | |
| Indications forUse Statement | Zirconia Guided Surgery Kit Cases areintended to be used to enclose othermedical devices that are to be sterilizedby a health care provider. ZirconiaGuided Surgery Kit Cases are intendedto allow sterilization of the enclosedmedical devices. Zirconia GuidedSurgery Kit Cases require the use ofFDA-cleared wrap to maintain thesterility of the enclosed devices. Thekits are to be enclosed in a sterilizationwrap that is FDA-cleared for theindicated cycles, and moist heat(steam) sterilized using one of thefollowing cycles: Dynamic Air Removal(pre-vacuum) - Exposure at 132°C for4 minutes, 20-minute dry time. Gravitydisplacement - Exposure at 132°C for15 minutes, 20-minute dry time.Zirconia Guided Surgery Kit Cases areintended for sterilization of non-porousloads. The combined weight of theZirconia Guided Surgery Kit Case andthe associated instruments is 342.2 g.The weight of the empty Kit is 236.8grams. Zirconia Guided Surgery KitCase are recommended not to bestacked during sterilization. | Neodent Instrument Kits are intended tobe used to enclose other medicaldevices that are to be sterilized by ahealth care provider. NeodentInstrument Kits are intended to allowsterilization of the enclosed medicaldevices. Neodent Instrument Kitsrequire the use of FDA-cleared wrap tomaintain the sterility of the encloseddevices. The Kits are to be enclosed ina sterilization wrap that is FDA-clearedfor the indicated cycles, and moist heat(steam) sterilized using one of thefollowing cycles: Fractionated vacuum(pre-vacuum) - Exposure at 132 °C for4 minutes, 20-minute dry time. Gravitydisplacement - Exposure at 132 °C for15 minutes, 20-minute dry time.Neodent Instrument Kits are intendedfor sterilization of non-porous loads. Thecombined weight of the GM EasyGuideSurgical Kit Case Narrow/Regular andthe associated instruments is 310,18 g.The weight of the empty Kit Case is263,63 g. Neodent GM EasyGuide KitCases should not be stacked duringsterilization. | HS Surgical Kit Cases are indicated for theorganization of surgical and/or prostheticinstruments during sterilization, storage,and transport. Use of this product facilitatesthe storage and organization of instrumentsduring and after surgical procedures.Neodent instrument kit cases are intendedto allow sterilization of the medical devicesincluded. Neodent instrument kit casesmust be wrapped in FDA-approvedmaterials to maintain the sterility of thedevices included. The kits should be placedin an FDA-approved sterilization wrap forthe indicated cycles and sterilized by moistheat (steam) using one of the followingcycles: Dynamic Air Removal (pre-vacuum):exposure at 132°C for 4 minutes, drying for30 minutes. Gravity displacement: exposureat 132°C for 15 minutes, drying for 50minutes. Neodent instrument kit cases areintended for sterilization of non-porousfillers. The combined weight of the HSSurgical Kit case and associatedinstruments is 302.88 grams. The weight ofthe empty case is approximately 214.85grams. Neodent instrument kit cases shouldnot be stacked during sterilization. | SimilarThe subject and primary predicatedevices present the same indicationsfor use, being both intended to allowsterilization of the enclosed medicaldevices. The reference predicatedevice has a slightly different language,but the indications for use are similar.All devices are intended to encloseother medical devices that are to besterilized by a health care provider. |
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number | K241492Zirconia Guided Surgery Kit Cases | K203618Neodent EasyGuide Kit Cases | K223662Helix Short Surgical Kit Cases | EQUIVALENCE DISCUSSION |
| Material anddesign | Rigid polyphenylsulfone (PPSU) polymer base and removable inner tray with a polyphenylsulfone (PPSU) lid.Retention grommets of medical grade silicone. | Rigid polysulfone (PSU) polymer base and removable inner tray with a polyphenylsulfone (PPSU) lid. Retention grommets of medical grade silicone. | Rigid polysulfone (PSU) polymer base and removable inner tray with a polyphenylsulfone (PPSU) lid. Retention grommets of medical grade silicone. | SimilarThe subject and predicate devices are made of the same material. Despite the subject devices presenting a difference in base and tray composition, the PPSU material has already been used before in devices cleared by FDA. Furthermore, this material change does not interfere with the biocompatibility and performance of the new products. |
| Perforated | Yes | Yes | Yes | Same |
| Overalldimensions | 195 L x 90 W x 67 H, mm | 195 L x 90 W x 64 H, mm | 195 L x 90 W x 67 H, mm | SimilarThe subject, primary predicate and reference devices have the same dimensions. The small difference between the height of subject and primary predicate device does not compromise safety and efficacy as is better discussed along this submission. |
| Reusable | Yes, reusable up to 100 cycles | Yes, reusable up to 100 cycles | Yes, reusable up to 100 cycles | Same |
| Volume to VentoRatio | 64.8 cm³/ cm² (25.5 in³/ in²) | 63.5 cm³/ cm² (25.0 in³/ in²) | 64.8 cm³/ cm² (25.5 in³/ in²) | SimilarThe subject and primary predicate device have a slight difference in volume to vent rate, which does not compromise safety and efficacy, as is proved by the presented sterilization validation. |
| SterilizationMethod | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | Same |
| Cycles andparameters | Fractionated vacuum (pre-vacuum):Sterilization temperature: 132 °C;Sterilization time: 4 minutes;Drying time: 20 minutes.Gravity displacement:Sterilization temperature: 132 °C;Sterilization time: 15 minutes;Drying time: 20 minutes. | Fractionated vacuum (pre-vacuum):Sterilization temperature: 132 °C;Sterilization time: 4 minutes;Drying time: 20 minutes.Gravity displacement:Sterilization temperature: 132 °C;Sterilization time: 15 minutes;Drying time: 20 minutes. | Fractionated vacuum (pre-vacuum):Sterilization temperature: 132 °C;Sterilization time: 4 minutes;Drying time: 30 minutes.Gravity displacement:Sterilization temperature: 132 °C;Sterilization time: 15 minutes;Drying time: 50 minutes. | SimilarThe subject devices have the same cycle parameters already cleared for the predicate devices, however the reference predicate device requires a longer drying cycle. |
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number | K241492Zirconia Guided Surgery Kit Cases | K203618Neodent EasyGuide Kit Cases | K223662Helix Short Surgical Kit Cases | EQUIVALENCE DISCUSSION |
| Sterile Barrier | Sterilization wrap, FDA-clearedforindicated method and cycles | Sterilization wrap, FDA-cleared forindicated method and cycles | Sterilization wrap,FDA-clearedforindicated method and cycles | Same |
| Biocompatibility | The assessment to Biocompatibilitywas performed per ISO 10993-1 andtesting was performed using methodsdescribed in AAMI/ANSI/ISO 10993-5.Results indicate that the subjectdevices are biocompatible. | The assessment to Biocompatibility wasperformed per ISO 10993-1 and testingperformed using methodsdescribed in AAMI/ANSI/ISO 10993-5.Results indicate that the subject devicesare biocompatible. | The assessment to Biocompatibility wasperformed per ISO 10993-1 and testing wasperformed using methods described inAAMI/ANSI/ISO 10993-5. Results indicatethat the subject devices are biocompatible. | Same |
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number | K241492Nuvo CF Guided Surgery Kit Cases | K203618Neodent EasyGuide Kit Cases | K182865Neodent Instrument Kits | |
| Indications forUse Statement | Nuvo CF Guided Surgery Kit Cases areintended to be used to enclose othermedical devices that are to be sterilizedby a health care provider. Nuvo CFGuided Surgery Kit Cases are intended toallow sterilization of the enclosed medicaldevices. Nuvo CF Guided Surgery KitCases require the use of FDA-clearedwrap to maintain the sterility of theenclosed devices. The kits are to beenclosed in a sterilization wrap that isFDA-cleared for the indicated cycles, andmoist heat (steam) sterilized using one ofthe following cycles: Fractionatedvacuum (pre-vacuum): exposure at132°C for 4 minutes, drying for 20minutes. Gravity displacement: exposureat 132°C for 15 minutes, drying for 30minutes. Nuvo CF Guided Surgery KitCases are intended for sterilization ofnon-porous loads. The combined weightof the Nuvo CF Guided Surgery Kit Casesand the associated instruments isapproximately 693 g. The weight of theempty case is 487 grams. Nuvo CFGuided Surgery Kit Cases are notrecommended to be stacked duringsterilization. | Neodent Instrument Kits are intended tobe used to enclose other medical devicesthat are to be sterilized by a health careprovider. Neodent Instrument Kits areintended to allow sterilization of theenclosed medical devices. NeodentInstrument Kits require the use of FDA-cleared wrap to maintain the sterility ofthe enclosed devices. The Kits are to beenclosed in a sterilization wrap that isFDA-cleared for the indicated cycles, andmoist heat (steam) sterilized using one ofthe following cycles: Fractionatedvacuum (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 Kits are intended forsterilization of non-porous loads. Thecombined weight of the GM EasyGuideSurgical Kit Case Narrow/Regular andthe associated instruments is 310,18 g.The weight of the empty Kit Case is263,63 g. Neodent GM EasyGuide KitCases should not be stacked duringsterilization. | Neodent Instrument Kits are intended tobe used to enclose other medical devicesthat are to be sterilized by a health careprovider. Neodent Instrument Kits areintended to allow sterilization of theenclosed medical devices. NeodentInstrument Kits require the use of FDA-cleared wrap to maintain the sterility ofthe enclosed devices. The kits are to beenclosed in a sterilization wrap that isFDA-cleared for the indicated cycles, andmoist heat (steam) sterilized using one ofthe following cycles: Fractionatedvacuum (pre-vacuum) – Exposure at 132°C for 4 minutes, 40-minute dry time.Gravity displacement – Exposure at 132°C for 15 minutes, 40-minute dry time.Neodent Instrument Kits are intended forsterilization of non-porous loads. Thecombined weight of the GM GuidedSurgery Surgical Kit Case and theassociated instruments is 728.4 g. Theweight of the empty Kit Case is 567grams. Neodent Instrument Kits arerecommended not to be stacked duringsterilization. | SimilarAlthough the language in theindications for use of the subject andprimary predicate devices is slightlydifferent, the indications for use aresimilar in that they are used to encloseinstruments to be sterilized by thehealth care provider. |
| Material anddesign | Rigid polyphenylsulfone (PPSU) polymerbase and removable inner tray with apolyphenylsulfone (PPSU) lid. Retentiongrommets of medical grade silicone. | Rigid polysulfone (PSU) polymer baseand removable inner tray with apolyphenylsulfone (PPSU) lid. Retentiongrommets of medical grade silicone. | Rigid polysulfone (PSU) polymer baseand removable inner tray with apolyphenylsulfone (PPSU) lid. Retentiongrommets of medical grade silicone. | SimilarThe subject, primary predicate andreference devices are made of thesame material. Despite the subjectdevices presenting a difference in baseand tray composition, the PPSUmaterial has already been used beforein devices cleared by FDA.Furthermore, this material change doesnot interfere with the biocompatibilityand performance of the new products. |
| Perforated | Yes | Yes | Yes | Same |
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number | K241492Nuvo CF Guided Surgery Kit Cases | K203618Neodent EasyGuide Kit Cases | K182865Neodent Instrument Kits | |
| Overalldimensions | 264 L x 163 W x 58 H, mm | 264 L x 163 W x 58 H, mm | Same | |
| Reusable | Yes, reusable up to 100 cycles | Yes, reusable up to 100 cycles | Yes, reusable up to 100 cycles | Same |
| Volume toVento Ratio | 107.5 cm³/ cm² (42.32 in³/ in²) | 107.5 cm³/ cm² (42.32 in³/ in²) | Same | |
| SterilizationMethod | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | Same |
| Cycles andparameters | Fractionated vacuum (pre-vacuum):Sterilization temperature: 132 °C:Sterilization time: 4 minutes;Drying time: 20 minutes.Gravity displacement:Sterilization temperature: 132 °C;Sterilization time: 15 minutes:Drying time: 30 minutes. | Fractionated vacuum (pre-vacuum):Sterilization temperature: 132 °C;Sterilization time: 4 minutes;Drying time: 20 minutes.Gravity displacement:Sterilization temperature: 132 °C;Sterilization time: 15 minutes:Drying time: 20 minutes. | Fractionated vacuum (pre-vacuum):Sterilization temperature: 132 °C;Sterilization time: 4 minutes;Drying time: 40 minutes.Gravity displacement:Sterilization temperature: 132 °C;Sterilization time: 15 minutes;Drying time: 40 minutes. | SimilarThe subject devices have the samecycle parameters already cleared forthe primary predicate and referencedevice.howeverthereferencepredicate device requires a longerdrying cycle. |
| Sterile Barrier | Sterilization wrap,FDA-clearedforindicated method and cycles | Sterilization wrap,FDA-clearedforindicated method and cycles | Sterilization wrap, FDA-clearedforindicated method and cycles | Same |
| Biocompatibility | The assessment to Biocompatibility wasperformed per ISO 10993-1 and testingwas performed using methods describedin AAMI/ANSI/ISO 10993-5. Resultsindicate that the subject devices arebiocompatible. | The assessment to Biocompatibility wasperformed per ISO 10993-1 and testingwas performed using methods describedin AAMI/ANSI/ISO 10993-5. Resultsindicate that the subject devices arebiocompatible. | The assessment to Biocompatibility wasperformed per ISO 10993-1 and testingwas performed using methods describedin AAMI/ANSI/ISO 10993-5. Resultsindicate that the subject devices arebiocompatible. | Same |
Table 1 – Comparison of subject device (Zirconia Guided Surgery Kit Cases) and predicate device
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Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
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Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
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Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
Table 2 – Comparison of subject device (Nuvo CF Guided Surgery Kit Cases) and predicate device
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Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
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Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
Non-Clinical Performance Data
To evaluate the performance of the subject kit cases, the tests described in the following table were performed.
| Standard or TestMethod | Purpose of the Testing | Acceptance Criteria | Results |
|---|---|---|---|
| ANSI/AAMI/ISO 17665-1ANSI/AAMI/ISO 17665-2 | Steam sterilization validation,including sterilant penetrationand drying time | All Biological Indicators mustbe incubated for at least 7 daysat 55-60°C. All positive controlsfor SAL testing must showcharacteristic growth of theindicator organism. | Passed |
| AAMI TIR 30:2011 | Manual cleaning validation• Test Soil:• Blood Soil (BLSO)• Cleaning Method:Manual• Residuals Tested:Hemoglobin and Protein | • Visual Inspection: Novisible soil• Hemoglobin Test: $<2.2$ µg/cm²• Protein Test: $<6.4$ µg/cm² | Passed |
| Reprocessing MedicalDevices in Health CareSettings: ValidationMethods and LabelingGuidance for Industryand Food and DrugAdministration Staff | Life cycle (simulate usage)testing | The tested samples mustwithstand 100 cycles of use(cleaning, sterilization andfunctional tests) withoutcompromising theirfunctionalities | Passed |
| ANSI/AAMI/ISO 10993-5 | Biocompatibility of subjectdevices via cytotoxicitytesting | Less than 30% cell proliferationinhibition | Passed |
Manual cleaning and sterilization validation
Manual cleaning of the subject kit cases following the manufacturer's recommended cleaning procedures has been validated according to AAMI TIR30:2011. Six simulated use cycles consisting of contamination, cleaning and sterilization were performed. All test method acceptance criteria were met for visual inspection and residuals levels.
Sterilization of the subject kit cases via steam process in autoclave has been validated according to ISO 17665 – 1 "Sterilization of Health Care Products – Moist Heat – Part 1: Requirements for the Development, Validation and Routine of a Sterilization Process for Medical Devices using the "Overkill" method to demonstrate the achievement of a sterility assurance level (SAL) of 10-9". A minimum Sterility Assurance Level (SAL) of 1 x 10 ° has been validated.
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Traditional 510(k) Submission Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
Life Cycle Testing
Life cycle testing of the subject kit cases was performed to validate the recommendations provided by the manufacturer in the Instructions for Use. The reference method consists of cleaning and sterilization cycles (simulated usage) interspersed with visual and functional analyzes. The tested worst case devices withstand 100 cycles of use without compromising their functionalities, validating the recommendations provided in the draft Instructions for Use.
Biocompatibility Testing
A biological assessment was performed according to ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff". Representative samples of the subject devices were subjected to the chemical characterization (ISO 10993-18) and cytotoxicity testing (ISO 10993-5).
The subject devices are similar in material and manufacturing processes to the primary predicate and reference devices, therefore, no new issues regarding biocompatibility were raised and no additional biocompatibility testing was required.
In summary, the nonclinical testing provided for the subject device met the acceptance criteria for each standard and test methodology used to evaluate the subject device as shown in the table above. No clinical data was included in this submission.
Conclusion
The conclusions drawn from the non-clinical tests submitted in this premarket notification demonstrate that the proposed devices are as safe, as effective, and performs as well as or better than the predicate device, K203618, Neodent EasyGuide Kit Cases.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).