(84 days)
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 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.
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 provided text describes the acceptance criteria and the study conducted for the NUVO Implant System - NUVO Instrument Kit Cases, a device intended for sterilizing other medical devices.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Manual cleaning validation: | |
| Visual Inspection: No Visible Soil | Passed |
| Hemoglobin Test: < 2.2 µg/cm² | Passed |
| Protein Test: < 6.4 µg/cm² | Passed |
| Sterilization validation (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2): | |
| All Biological Indicators must be incubated for at least 7 days at 55-60°C. | Passed |
| Positive controls for SAL testing must show characteristic growth of the indicator organism. | Passed |
| Life cycle (simulate usage) testing (Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance): | |
| The tested samples must withstand 100 cycles of use (cleaning, sterilization and functional testes) without compromising their functionalities. | Passed |
| Cytotoxicity testing (ANSI/AAMI/ISO 10993-5): | |
| Less than 30% cell proliferation inhibition | Passed |
2. Sample sized used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "The tested samples" for life cycle testing and "All Biological Indicators" for sterilization validation, without specifying the number.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information (number and qualifications of experts for ground truth establishment) is not applicable to the non-clinical performance data presented in the document. The tests performed are objective laboratory tests with defined acceptance criteria, not subjective interpretations requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods are not applicable to the types of non-clinical, objective tests described in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. This device is an instrument kit case for sterilization, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is not an algorithm or AI system. The tests evaluate the physical and functional performance of the instrument kit case itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed is based on established scientific and regulatory standards and objective measurements. For example:
- Manual cleaning validation: Objective measurements of residual hemoglobin and protein, and visual inspection against a "no visible soil" criterion.
- Sterilization validation: Growth or non-growth of biological indicators, indicating successful sterilization (achieving a sterility assurance level (SAL) of 10⁻⁶).
- Life cycle testing: Ability to withstand a specified number of cycles (100) without functional degradation.
- Cytotoxicity testing: Measured cell proliferation inhibition against a set threshold.
8. The sample size for the training set
This is not applicable as the device is not an AI/ML model which requires a training set. The tests are for the physical device.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/ML model and therefore does not have a training set or associated ground truth.
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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
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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, 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
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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)
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K202515 510(K) Summary
ADMINISTRATIVE INFORMATION
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA(dba Neodent)Av. Juscelino Kubitschek de Oliveira, 3291Curitiba, Parana, Brazil 81270-200Registration No.: 3008261720Owner/Operator No.: 10031702 |
|---|---|
| Contact Person | Jennifer M. Jackson, MSDirector of Regulatory Affairs,Straumann USAE-mail: jennifer.jackson@straumann.comTelephone (978) 747-2509 |
| Date Prepared | 24/Nov/2020 |
| Preparer / AlternateContact | Mariana Soares HartmannRegulatory Affairs AnalystJJGC Indústria e Comércio de Materiais Dentários SAE-mail: mariana.hartmann@neodent.com |
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
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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:
| AssembledKit Case | Description | Assembled KitCaseDimension(L x W x H) | ComponentNumber | ComponentDimension(L x W x H) |
|---|---|---|---|---|
| CD1030001 | Drill Stop Pre-Mounted Kit | 195 x 90 x 34,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,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.
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TECHNOLOGICAL CHARACTERISTIC COMPARISON
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | ||
|---|---|---|---|
| NUVO Instrument Kit CasesJJGC Indústria e Comércio de MateriaisDentários S.A. | K192670Neodent Instrument Kit Cases JJGCIndústria e Comércio de MateriaisDentários S.A. | COMPARISON | |
| Indicationsfor UseStatement | Indications for Use for Drill Stop Pre-Mounted Kit and Drill Stop Kit: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.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, 45-minute dry time.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.Instrument Kit Cases should not to be stacked during sterilization. | Indications for Use for GM Surgical Kit Case: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.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, 40-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 613.1 g. The weight of the empty Kit Case is 510 grams. Neodent Instrument Kit Cases should not to be stacked during sterilization.Indications for Use for GM Helix Compact Surgical Kit Case: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.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 timeGravity 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 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 CasesJJGC Indústria e Comércio de MateriaisDentários S.A. | K192670Neodent Instrument Kit CasesJJGC Indústria e Comércio de MateriaisDentários S.A. | COMPARISON | |
| IntendedUse | The kit is used for the safe storage ofsurgical instruments, as well as for supportduring sterilization. | The GM Helix Compact Surgical Kit Case issuitable for safe storage of surgical andprostheticinstruments, organizingtheinstruments in the sequence in which they willbe used, as well as for sterilization of suchinstruments. | Similar |
| Design | Rigid polysulfone polymer base andremovable inner tray with apolyphenylsulfone lid.Retention grommets of polyphenylsulfone. | Rigid polysulfone polymer base andremovable inner tray with apolyphenylsulfone lid.Retention grommets of medical gradesilicone. | Similar |
| Perforated | Yes; allows moist heat (steam) penetrationto achieve sterilization | Yes; allows moist heat (steam) penetrationto achieve sterilization | Identical |
| Reusable | Yes | Yes | Identical |
| Overalldimensions | 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 toVent 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 wasperformed per ISO 10993-1 and testing wasperformed using methods described inAAMI/ANSI/ISO10993-5.Theresultsindicate that the subject devices arebiocompatible. | The assessment to Biocompatibility wasperformed per ISO 10993-1 and testing wasperformed using methods described inAAMI/ANSI/ISO 10993-5. The results indicatethat the subject devices are biocompatible. | Identical |
| SterilizationMethod | 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 CasesJJGC Indústria e Comércio de MateriaisDentários S.A. | K192670Neodent Instrument Kit CasesJJGC Indústria e Comércio de MateriaisDentários S.A. | COMPARISON | |
| Parameters | GravitySterilization temperature: 132 °CSterilization time: 15 minutes;Drying time: 45 minutesPre-VacuumSterilization temperature: 132 °CSterilization time: 4 minutes;Drying time: 20 minutes. | GravitySterilization temperature: 132 °CSterilization time: 15 minutes;Drying time: 40 minutes (model number110.288) or 20 minutes (model number110.297)Pre-VacuumSterilization temperature: 132 °CSterilization time: 4 minutes;Drying time: 20 minutes. | Similar |
| Sterile Barrier | Sterilization wrap, FDA-cleared forindicated method and cycles | Sterilization pouch, FDA-cleared for indicatedmethod and cycles | Identical |
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The subject devices and the primary predicate device per K192670 have the same intended use and have similar Indications for Use Statements. The subject devices and the primary predicate devices are reusable rigid containers used to organize and protect dental surgical instruments that are sterilized by the healthcare provider. The subject device and the primary predicate device components are perforated to allow for penetration of the moist heat (steam) sterilant and require the use of an FDA-cleared wrap or pouch to maintain sterility.
The subject devices and the primary predicate device include components manufactured from polyphenylsulfone and polysulfone. The subject device is provided in two different configurations and same size, whereas the primary predicate device is provided in four two different size and configurations. The overall dimensions of the subject device are similar to the range of overall dimensions cleared for the predicate devices. The subject device and the predicate devices are to be used according to the validated labeling (sterilization processes and cycles).
SUMMARY OF NON-CLINICAL PERFORMANCE DATA
| Standard or Test Method | Purpose of the Testing | Acceptance Criteria | Results |
|---|---|---|---|
| Custom | 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 |
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| ANSI/AAMI/ISO17665-1ANSI/AAMI/ISO17665-2 | Sterilization validation,including sterilantpenetration and dryingtime | All Biological Indicatorsmust be incubated for atleast 7 days ate 55-60°C.the positive controls forSAL testing must showcharacteristic growth ofthe indicator organism. | Passed |
|---|---|---|---|
| Reprocessing MedicalDevices in Health CareSettings: ValidationMethods and Labeling Guidance forIndustry and Food and DrugAdministration Staff | Life cycle (simulate usage)testing | The tested samples mustwithstand 100 cycles ofuse (cleaning, sterilizationand functional testes)without compromisingtheir functionalities | Passed |
| ANSI/AAMI/ISO 10993-5(Cytotoxicity) | Cytotoxicity testing | Less than 30% cellproliferation inhibition | Passed |
CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the NUVO Instrument Kit Cases are as safe, as effective, and performs as well as or better than the legally marketed device Neodent Instrument Kit Cases (K192670).
§ 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).