(300 days)
Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the enclosed medical devices. Neodent 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, 20 minute dry time
Gravity displacement - Exposure at 132 °C for 15 minutes, 20 minute dry time
Neodent Instrument Kits are intended for sterilization of non-porous loads.
The GM/WS Surgical Kit Case maximum load weight is 125 grams.
The GM Surgical Kit Case maximum load weight is 113 grams.
Neodent Instrument Kits are recommended not to be stacked during sterilization.
The subject device kits are reusable rigid containers, comprising a case bottom (or base), a removable inner tray base (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 includes two (2) kits in one size and two (2) inner tray configurations. The lids are manufactured from injection molded polyphenylsulfone, the tray base and case bottoms are manufactured from injection molded polysulfone, and holders of various geometries to position items in the trays are manufactured from molded silicone. The subject device kits are provided nonsterile to the end-user.
The provided text is a 510(k) summary for the Neodent Instrument Kits (K171713), which are sterilization containers. The document does not describe a study that uses AI or reports on acceptance criteria and performance data in the context of an AI-powered device.
Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, and ground truth for training set) are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (sterilization kits) and not an AI/ML medical device.
However, I can provide available information regarding the non-clinical performance data and acceptance relevant to the sterilization kits themselves:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not explicitly present a "table of acceptance criteria and reported device performance" in the format typically used for AI/ML device evaluations (e.g., accuracy, sensitivity, specificity). Instead, it states that various validations were performed to demonstrate substantial equivalence to the predicate device.
| Category | Acceptance Criteria (Implied by Validation) | Reported Device Performance/Validation |
|---|---|---|
| Cleaning | Effective removal of contaminants (microbiological, protein, hemoglobin). | Manual cleaning instructions were validated using microbiological, protein, and hemoglobin assays. |
| Sterilization | Sterilant penetration and adequate drying time. | Sterilization validation (sterilant penetration and drying time) performed according to AAMI/ANSI/ISO 17665-1 and ISO TS 17665-2. |
| Life Cycle/Durability | Maintenance of visual integrity, component dimensional fit, and functional closure over repeated uses. | Life cycle (simulated usage) testing performed, including visual inspection, component dimensional fit verification, and functional closure (lid-bottom latch) verification. |
| Biocompatibility | Biologically safe for intended use. | Biocompatibility testing performed using methods described in AAMI/ANSI/ISO 10993-5 and ISO 10993-12. |
| Load Weight | Maximum recommended load not to be exceeded. | GM/WS Surgical Kit Case maximum load weight is 125 grams. GM Surgical Kit Case maximum load weight is 113 grams. |
| Stacking | Not to be stacked during sterilization. | Neodent Instrument Kits are recommended not to be stacked during sterilization. |
2. Sample size used for the test set and the data provenance: Not applicable. This document describes validation studies for a physical sterilization device, not an AI/ML algorithm with a "test set" of data. The studies performed were laboratory-based validations of cleaning, sterilization, durability, and biocompatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would relate to the successful execution of validation protocols by qualified personnel, rather than expert consensus on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical performance studies would be defined by the results of standardized testing methods and international standards:
* Cleaning: Successful removal of biological and chemical contaminants per established assays.
* Sterilization: Achievement of sterility assurance level (SAL) and proper drying per AAMI/ANSI/ISO 17665-1 and ISO TS 17665-2.
* Life Cycle: Maintenance of functional and structural integrity after simulated use cycles.
* Biocompatibility: Absence of adverse biological reactions per AAMI/ANSI/ISO 10993-5 and ISO 10993-12.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
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April 5, 2018
JJGC Industria e Comercio de Materiais Dentarios S.A. % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K171713
Trade/Device Name: Neodent Instrument Kits Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: March 15. 2018 Received: March 16, 2018
Dear Kevin Thomas:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
| Sincerely, |
|---|
| Geeta K. |
| Pamidimukkala -S |
| for Tina Kiang, Ph.D. |
| Acting Director |
| Division of Anesthesiology, |
| General Hospital, Respiratory, |
| Infection Control, and Dental Devices |
| Office of Device Evaluation |
| Center for Devices and Radiological Health |
Enclosure
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Indications for Use
510(k) Number (if known)
K171713
Device Name
Neodent Instrument Kits
Indications for Use (Describe)
Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the enclosed medical devices. Neodent 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, 20 minute dry time
Gravity displacement - Exposure at 132 °C for 15 minutes, 20 minute dry time
Neodent Instrument Kits are intended for sterilization of non-porous loads.
The GM/WS Surgical Kit Case maximum load weight is 125 grams.
The GM Surgical Kit Case maximum load weight is 113 grams.
Neodent Instrument Kits are recommended not to be stacked during sterilization.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K171713 Neodent Instrument Kits JJGC Indústria e Comércio de Materiais Dentários S.A.
March 23, 2018
ADMINISTRATIVEINFORMATION
| Manufacturer Name | JJGC Indústria e Comércio de Materiais Dentários S.A.Av. Juscelino Kubitschek de Oliveira, 3291 – CICCuritiba, Paraná, 81270-200, Brazil | |
|---|---|---|
| Telephone: | +55 41 2169 4058 | |
| Fax: | +55 41 2169 4061 | |
| Official Contact | Julianne de Oliveira Capucho LechechemRegulatory Affairs Manager | |
| Representative/Consultant | Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130 | |
| Telephone: | +1-858-792-1235 | |
| Fax: | +1-858-792-1236 | |
| Email: | kthomas@paxmed.comflarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Neodent Instrument Kits |
|---|---|
| Common Name | Instrument sterilization trays |
| Classification Name | Sterilization wrap containers, trays, cassettes, and other accessories |
| Classification Regulations | 21 CFR 880.6850, Class II |
| Product Code | KCT |
| Classification Panel | General Hospital |
| Reviewing Branch | General Hospital |
PREDICATE DEVICE INFORMATION
The primary predicate device is K160730, Instrument Kits, Anthogyr.
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INDICATIONS FOR USE
Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the enclosed medical devices. Neodent 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, 20 minute dry time Gravity displacement - Exposure at 132 °C for 15 minutes, 20 minute dry time Neodent Instrument Kits are intended for sterilization of non-porous loads. The GM/WS Surgical Kit Case maximum load weight is 125 grams. The GM Surgical Kit Case maximum load weight is 113 grams. Neodent Instrument Kits are recommended not to be stacked during sterilization.
SUBJECT DEVICE DESCRIPTION
The subject device kits are reusable rigid containers, comprising a case bottom (or base), a removable inner tray base (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 device includes two (2) kits in one size and two (2) inner tray configurations. The lids are manufactured from injection molded polyphenylsulfone, the tray base and case bottoms are manufactured from injection molded polysulfone, and holders of various geometries to position items in the trays are manufactured from molded silicone. The subject device kits are provided nonsterile to the end-user.
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| Subject Device | Primary Predicate Device | ||
|---|---|---|---|
| K171713Neodent Instrument KitsJJGC Indústria e Comércio de MateriaisDentários S.A. | K160730Instrument KitsAnthogyr | Comparison | |
| Indications for UseStatement | Neodent Instrument Kits are intended to be usedto enclose other medical devices that are to besterilized by a health care provider. NeodentInstrument Kits are intended to allow sterilizationof the enclosed medical devices. NeodentInstrument Kits require the use of FDA clearedwrap to maintain the sterility of the encloseddevices.The kits are to be enclosed in a sterilization wrapthat is FDA-cleared for the indicated cycles, andmoist heat (steam) sterilized using one of thefollowing cycles:Fractionated vacuum (pre-vacuum) – Exposure at132 °C for 4 minutes, 20 minute dry timeGravity displacement - Exposure at 132 °C for 15minutes, 20 minute dry timeNeodent Instrument Kits are intended forsterilization of non-porous loads.The GM/WS Surgical Kit Case maximum loadweight is 125 grams.The GM Surgical Kit Case maximum load weightis 113 grams.Neodent Instrument Kits are recommended not tobe stacked during sterilization. | The instrument kits are designed to hold variousdental surgical drills and tools in order to organize,steam sterilize, and protect the instruments that aresterilized by healthcare provider. The cassette is tobe enclosed in an FDA cleared steam sterilizablepouch. The cassettes are not intended on their ownto maintain sterility.The cycle of sterilization is:Pre-vacuum steam: 134 ℃ during 3 minutes with16 minutes drying timeAnthogyr does not make any lumen claims for theinstrument kits.The Axiom range surgery kit represents the worstcase validated load due to the number ofcomponents (34 instruments).The cassettes are not intended to be stacked duringsterilization process. | Similar |
| Product Code | KCT | KCT | Same |
| Design | Rigid polymer bottom, lid, and removable innertray | Plastic tray and lid | Similar |
| Materials | PolysulfonePolyphenylsulfone (Radel R5000)Medical grade silicone | Polyphenylsulfone (Radel R5000, Radel R5100)Medical grade siliconeStainless steel | Similar |
| Materials compatiblewith SterilizationMethod | Yes | Yes | Same |
| Perforated | Yes; allows moist heat (steam) penetration toachieve sterilization | Yes; allows moist heat (steam) penetration toachieve sterilization | Same |
| Reusable | Yes | Yes | Same |
| Overall dimensions | 264 mm L x 163 mm W x 54 mm H | 156 mm L x 129 mm W x 47.5 mm H | Similar |
| Volume to vent ratio | 98.04 cm3 / cm2 = 38.6 in3 / in2 | 20.41 in3 / in2(Reported as vent to volume ratio = 0.049 in2 / in3) | Similar |
| Vent to volume ratio | 0.0102 cm2 / cm3 (0.0259 in2 / in3) | 0.049 in2 / in3 | Similar |
| SterilizationMethod | Moist heat (steam) | Moist heat (steam) | Same |
| Cycles | Gravity displacementFractionated vacuum (pre-vacuum) | Pre-vacuum | Same |
| Sterile Barrier | Sterilization wrap, FDA-cleared for indicatedmethod and cycles | Sterilization pouch, FDA-cleared for indicatedmethod and cycles | Same |
The subject device and the primary predicate device K160730 have the same intended use, the same product classification and product code (KCT), and have similar Indications for Use statements. The subject device and the primary predicate device K160730 are reusable rigid containers used to organize and protect the instruments that are sterilized by the healthcare provider. The subject device and the
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predicate K160730 components are perforated to allow for penetration of the sterilant, and are to be used with moist heat (steam) sterilization, and require the use of a FDA-cleared wrap or pouch to maintain sterility. Although the subject device and the primary predicate device K160730 have slightly different Indications for Use language, this difference in language does not change the intended use.
The subject device and the primary predicate K160730 include components manufactured from polyphenylsulfone and silicone.; The subject device and primary predicate device K160730 are provided in one (1) size and two (2) configurations. The subject device and the predicate devices are manufactured from materials with a history biocompatibility and clinical use for the cleared indications. The subject device and the predicate devices are to be used according to the validated labeling (sterilization processes and cycles).
SUMMARY OF NON-CLINCAL PERFORMANCE DATA
Manual cleaning instructions were validated using microbiological, protein, and hemoglobin assays. Sterilization validation, including sterilant penetration and drying time, was performed according to AAMI/ANSI/ISO 17665-1 and ISO TS 17665-2. Life cycle (simulated usage) testing was performed, which included visual inspection, component dimensional fit verification, and functional closure (lidbottom latch) verification. Biocompatibility testing was performed using methods described in AAMI/ANSI/ISO 10993-5 and ISO 10993-12. No clinical data were included in this submission.
CONCLUSION
The subject device K171713 and the predicate device K160730 have the same intended use, have similar designs and technological characteristics, and are made of similar materials. The data included in this submission demonstrate that the subject device is as safe and as effective as the predicate device.
§ 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).