(300 days)
Not Found
No
The document describes a reusable rigid container for sterilizing medical devices and does not mention any AI or ML components or functionalities.
No
The device is a reusable rigid container designed for organizing, protecting, and sterilizing other medical instruments, not for direct therapeutic treatment of a patient.
No
The device description indicates that Neodent Instrument Kits are rigid containers to organize and protect instruments for sterilization, not for diagnostic purposes.
No
The device description clearly states the device is comprised of physical components (case bottom, inner tray base, tray lid, holders) made from materials like polyphenylsulfone, polysulfone, and silicone. It is a reusable rigid container for organizing and protecting instruments during sterilization, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Neodent Instrument Kits are "intended to be used to enclose other medical devices that are to be sterilized by a health care provider." and "intended to allow sterilization of the enclosed medical devices." This describes a device used in the process of sterilizing other medical devices, not a device used to perform tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The description details a reusable rigid container for organizing and protecting instruments during sterilization. This aligns with the intended use and does not suggest any diagnostic function.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Measurement of analytes
- Diagnostic or monitoring purposes
The device's function is purely related to the sterilization and organization of other medical instruments.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
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
1
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
2
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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3
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 – CIC
Curitiba, Paraná, 81270-200, Brazil | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| | Telephone: | +55 41 2169 4058 |
| | Fax: | +55 41 2169 4061 |
| Official Contact | Julianne de Oliveira Capucho Lechechem
Regulatory Affairs Manager | |
| Representative/Consultant | Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130 | |
| | Telephone: | +1-858-792-1235 |
| | Fax: | +1-858-792-1236 |
| | Email: | kthomas@paxmed.com
flarson@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.
4
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.
5
| Subject Device | Primary Predicate Device | ||
|---|---|---|---|
| K171713 | |||
| Neodent Instrument Kits | |||
| JJGC Indústria e Comércio de Materiais | |||
| Dentários S.A. | K160730 | ||
| Instrument Kits | |||
| Anthogyr | Comparison | ||
| Indications for Use | |||
| Statement | 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 instrument kits are designed to hold various | ||
| dental surgical drills and tools in order to organize, | |||
| steam sterilize, and protect the instruments that are | |||
| sterilized by healthcare provider. The cassette is to | |||
| be enclosed in an FDA cleared steam sterilizable | |||
| pouch. The cassettes are not intended on their own | |||
| to maintain sterility. | |||
| The cycle of sterilization is: | |||
| Pre-vacuum steam: 134 ℃ during 3 minutes with | |||
| 16 minutes drying time | |||
| Anthogyr does not make any lumen claims for the | |||
| instrument kits. | |||
| The Axiom range surgery kit represents the worst | |||
| case validated load due to the number of | |||
| components (34 instruments). | |||
| The cassettes are not intended to be stacked during | |||
| sterilization process. | Similar | ||
| Product Code | KCT | KCT | Same |
| Design | Rigid polymer bottom, lid, and removable inner | ||
| tray | Plastic tray and lid | Similar | |
| Materials | Polysulfone | ||
| Polyphenylsulfone (Radel R5000) | |||
| Medical grade silicone | Polyphenylsulfone (Radel R5000, Radel R5100) | ||
| Medical grade silicone | |||
| Stainless steel | Similar | ||
| Materials compatible | |||
| with Sterilization | |||
| Method | Yes | Yes | Same |
| Perforated | Yes; allows moist heat (steam) penetration to | ||
| achieve sterilization | Yes; allows moist heat (steam) penetration to | ||
| achieve 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 |
| Sterilization | |||
| Method | Moist heat (steam) | Moist heat (steam) | Same |
| Cycles | Gravity displacement | ||
| Fractionated vacuum (pre-vacuum) | Pre-vacuum | Same | |
| Sterile Barrier | Sterilization wrap, FDA-cleared for indicated | ||
| method and cycles | Sterilization pouch, FDA-cleared for indicated | ||
| method 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
6
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.