(106 days)
Not Found
No
The device description and intended use clearly define the product as a physical storage case for surgical instruments, with no mention of software, data processing, or any capabilities that would involve AI or ML.
No
The device is described as an instrument kit case for organizing and sterilizing surgical/prosthetic instruments, not for directly treating a condition.
No
The device is described as a storage case for surgical and/or prosthetic instruments, intended for organization, sterilization, storage, and transport of instruments, not for diagnosing medical conditions.
No
The device description clearly states the device is made of "autoclavable polymer" and has "silicone holders," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic products are those used to examine specimens, such as blood, urine, or tissue, taken from the human body to help diagnose diseases or conditions.
- Device Function: The described device, the Neodent and Nuvo Complement Kit Cases, is designed for the organization, sterilization, storage, and transport of surgical and prosthetic instruments. It is a container and organizational tool for medical devices used during procedures, not for analyzing biological samples outside the body.
- Intended Use: The "Indications for Use" clearly state its purpose is for handling instruments, not for diagnostic testing.
- Device Description: The description focuses on its physical characteristics as a storage case with silicone holders.
- Performance Studies: The performance studies described (manual cleaning validation, sterilization validation, life cycle validation, biocompatibility) are all related to the device's ability to safely and effectively handle and sterilize instruments, not to its diagnostic accuracy or performance with biological samples.
Therefore, the Neodent and Nuvo Complement Kit Cases fall under the category of medical devices used in surgical and clinical settings, but they are not IVDs.
N/A
Intended Use / Indications for Use
Indications for Use for Neodent Complement Kit Cases:
Neodent Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat using one of the following cycles:
Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-minute dry time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.
Neodent Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Complement Case and the associated instruments is 75,7 g. The weight of the empty Kit Case is 53.62 grams.
Neodent Instrument Kit Cases should not be stacked during sterilization.
Indications for Use for Nuvo Complement Kit Cases:
Nuvo™ Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. Nuvo™ Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo™ 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 using one of the following cycles:
Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-minute dry time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.
Nuvo™ Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Complement Case and the associated instruments is 75.7 g. The weight of the empty Kit Case is 52.72 grams.
Nuvo™ Instrument Kit Cases should not be stacked during sterilization.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The subject devices Complement Kit Cases consist of a storage case for Neodent and Nuvo instruments set. They are made of autoclavable polymer, the case has silicone holders to store and hold each instrument securely during sanitization and surgical procedures. The case can be equipped according to the procedure.
The dimensions for each part of the model and the overall dimensions are presented in the table below:
Assembled Kit Case: 110.335; Description: Complement Case (model 2); Assembled Kit Case Dimension (L x W x H): 81 x 67 x 60 mm; Component Number: 212.304 (Lid); Component Dimension (L x W x H): 50 x 80 x 30 mm; - (empty row) -; Component Number: 212.087 (Base); Component Dimension (L x W x H): 59 x 81 x 35 mm.
Assembled Kit Case: CD1099002; Description: Complement Case (model 2); Assembled Kit Case Dimension (L x W x H): 81 x 67 x 60 mm; Component Number: 702989 (Lid); Component Dimension (L x W x H): 58 x 80 x 30 mm; - (empty row) -; Component Number: 212.087 (Base); Component Dimension (L x W x H): 59 x 81 x 35 mm.
Note: The instrument and accessory devices that are sterilized and stored within the subject Kit Cases are provided separately and they are not subject devices of this submission.
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
Not Found
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)
Non-clinical performance data were provided, including:
- Manual cleaning validation: Tests performed using AAMI TIR30:2011 involving 6 simulated use cycles (contamination, cleaning, sterilization). Visual inspection and residual levels criteria were met.
- Sterilization validation: Validated according to ISO 17665 – 1, demonstrating a Sterility Assurance Level (SAL) of 1 x 10^-6 for moist heat (steam) sterilization.
- Life cycle validation: Tested to withstand 100 cycles of use (cleaning, sterilization, functional tests) without compromising functionality, validating manufacturer recommendations in IFU.
- Biocompatibility: Assessed per ISO 10993-1:2018 and FDA Guidance. No new biocompatibility issues raised, no additional testing required.
Results: All tests passed. The proposed device is as safe, as effective, and performs as well as or better than the predicate device K182865.
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 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, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
JJGC Indústria e Comércio de Materiais Dentários S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K230804
Trade/Device Name: Complement Kit Cases Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 5, 2023 Received: June 5, 2023
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 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
July 7, 2023
1
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,
Eileen
Digitally signed by
Eileen Cadel -S
Date: 2023.07.07
Cadel -S 12:15:20-04'00'
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230804
Device Name Complement Kit Cases
Indications for Use (Describe)
Indications for Use for Neodent Complement Kit Cases:
Neodent Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat using one of the following cycles:
Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-minute dry time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.
Neodent Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Complement Case and the associated instruments is 75,7 g. The weight of the empty Kit Case is 53.62 grams.
Neodent Instrument Kit Cases should not be stacked during sterilization.
Indications for Use for Nuvo Complement Kit Cases:
Nuvo™ Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. Nuvo™ Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo™ 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 using one of the following cycles:
Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-minute dry time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.
Nuvo™ Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Complement Case and the associated instruments is 75.7 g. The weight of the empty Kit Case is 52.72 grams.
Nuvo™ Instrument Kit Cases should not 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(K) Summary
ADMINISTRATIVE INFORMATION
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA
(dba Neodent)
Av. Juscelino Kubitschek de Oliveira, 3291
Curitiba, Parana, Brazil 81270-200
Registration No.: 3008261720
Owner/Operator No.: 10031702 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jennifer M. Jackson, MS
Director of Regulatory Affairs,
Straumann USA
E-mail: jennifer.jackson@straumann.com
Telephone (978) 747-2509 |
| Date Prepared | 7 July 2023 |
| Preparer / Alternate
Contact | Bárbara Uzae
Regulatory Affairs Analyst
JJGC Indústria e Comércio de Materiais Dentários SA
E-mail: barbara.uzae@neodent.com |
DEVICE NAME AND CLASSIFICATION
Product Code
| Trade/ Proprietary Name | Complement 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 | K182865 – Neodent Instrument Kit Cases, JJGC Indústria e |
Comércio de Materiais Dentários S.A Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other 21 CFR 880.6850, Class II Classification Regulation
КСТ
5
INDICATIONS FOR USE
Indications for Use for Neodent Complement Kit Cases:
Neodent Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Dynamic Air Removal (pre-vacuum)- Exposure at 132 °C for 4 minutes, 30-minute dry time. Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.
Neodent Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Complement Case and the associated instruments is 75.7 g. The weight of the empty Kit Case is 53.62 grams.
Neodent Instrument Kit Cases should not be stacked during sterilization.
Indications for Use for Nuvo Complement Kit Cases:
Nuvo™ Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. Nuvo™ Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo™ 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:
Dynamic Air Removal (pre-vacuum)- Exposure at 132 °C for 4 minutes, 30-minute dry time. Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.
Nuvo™ Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Complement Case and the associated instruments is 75.7 g. The weight of the empty Kit Case is 52.72 grams.
Nuvo™ Instrument Kit Cases should not be stacked during sterilization.
SUBJECT DEVICE DESCRIPTION
The subject devices Complement Kit Cases consist of a storage case for Neodent and Nuvo instruments set. They are made of autoclavable polymer, the case has silicone holders to store and hold each instrument securely during sanitization and surgical procedures. The case can be equipped according to the procedure.
The dimensions for each part of the model and the overall dimensions are presented in the table below:
| Assembled
Kit Case | Description | Assembled Kit
Case Dimension
(L x W x H) | Component
Number | Component
Dimension
(L x W x H) |
|-----------------------|------------------------------|------------------------------------------------|---------------------|---------------------------------------|
| 110.335 | Complement Case
(model 2) | 81 x 67 x 60 mm | 212.304 (Lid) | 50 x 80 x 30 mm |
| | | | 212.087 (Base) | 59 x 81 x 35 mm |
| CD1099002 | Complement Case
(model 2) | 81 x 67 x 60 mm | 702989 (Lid) | 58 x 80 x 30 mm |
| | | | 212.087 (Base) | 59 x 81 x 35 mm |
Note: The instrument and accessory devices that are sterilized and stored within the subject Kit Cases are provided separately and they are not subject devices of this submission.
6
TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |||
|---|---|---|---|---|
| Complement Kit Cases | ||||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K182865 | |||
| Neodent Instrument Kit Cases | ||||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | COMPARISON | |||
| Indications for | ||||
| Use Statement | Indications for Use for Neodent Complement Kit Cases: | |||
| Neodent Instrument Kit Cases are indicated for organization of surgical and/or | ||||
| prosthetic instruments during sterilization, storage and transport. The use of | ||||
| this product facilitates storage and organization of instruments during and | ||||
| after surgical procedures. Neodent Instrument Kit Cases are intended to allow | ||||
| sterilization of the enclosed medical devices. Neodent Instrument Kit Cases | ||||
| require the use of FDA cleared wrap to maintain the sterility of the enclosed | ||||
| devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared | ||||
| for the indicated cycles, and moist heat (steam) sterilized using one of the | ||||
| following cycles: | ||||
| Dynamic Air Removal (pre-vacuum) - Exposure at 132 °C for 4 minutes, 30- | ||||
| minute dry time. | ||||
| Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time. | ||||
| Neodent Instrument Kit Cases are intended for sterilization of non-porous | ||||
| loads. The combined weight of the Complement Case and the associated | ||||
| instruments is 75.7 g. The weight of the empty Kit Case is 53.62 grams. | ||||
| Neodent Instrument Kit Cases should not be stacked during sterilization. |
Indications for Use for Nuvo Complement Kit Cases:
Nuvo™ Instrument Kit Cases are indicated for organization of surgical and/or
prosthetic instruments during sterilization, storage and transport. The use of
this product facilitates storage and organization of instruments during and
after surgical procedures. Nuvo™ Instrument Kit Cases are intended to allow
sterilization of the enclosed medical devices. Nuvo™ 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:
Dynamic Air Removal (pre-vacuum)- Exposure at 132 °C for 4 minutes, 30-
minute dry time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.
Nuvo™ Instrument Kit Cases are intended for sterilization of non-porous loads.
The combined weight of the Complement Case and the associated
instruments is 75.7 g. The weight of the empty Kit Case is 52.72 grams.
Nuvo™ Instrument Kit Cases should not be stacked during sterilization. | Indications for Use for GM/WS Surgical Kit Case:
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 combined
weight of the GM/WS Surgical Kit Case and the associated instruments is 674.5 g. The
weight of the empty Kit Case is 507 grams. Neodent Instrument Kits are recommended not
to be stacked during sterilization.
Indications for Use for GM Prosthetic Kit Case:
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 Prosthetic Kit Case maximum load weight is 50 grams. Neodent Instrument Kits
are recommended not to be stacked during sterilization.
Indications for Use for GM Try-In Kit Case:
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 require the use of
FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be
enclosed in a sterilizable 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 ºC for 15 minutes, 20-minute dry time.
Neodent Instrument Kits are intended for sterilization of non-porous loads. The combined
weight of the GM Try-In Kit Case and the associated instruments is 212.6 g. The weight of
the empty Kit Case is 195 grams. Neodent Instrument Kits are recommended not to be
stacked during sterilization. | Equivalent
Although the language is
slightly different, the
indications for use are
equivalent. Both subject and
predicate devices are
intended to allow
organization and sterilization
of the enclosed medical
devices. The difference in the
text is specific due to the
weight of each device in their
maximum load configuration. | |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | | |
| | Complement Kit Cases
JJGC Indústria e Comércio de Materiais Dentários S.A. | K182865
Neodent Instrument Kit Cases
JJGC Indústria e Comércio de Materiais Dentários S.A. | COMPARISON | |
| Indications for
Use Statement | | Indications for Use for GM Guided Surgery Kit Case:
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, 40-minute dry time. Neodent
Instrument Kits are intended for sterilization of non-porous loads. The combined weight
of the GM Guided Surgery Surgical Kit Case and the associated instruments is 728.4 g. The
weight of the empty Kit Case is 567 grams. Neodent Instrument Kits are recommended not
to be stacked during sterilization. | Equivalent
Although the language is
slightly different , the
indications for use are
equivalent. Both subject and
predicate devices are
intended to allow
organization and sterilization
of the enclosed medical
devices. The difference in the
text is specific due to the
weight of each device in their
maximum load configuration. | |
| Intended Use | This product is intended to hold and store surgical and/or prosthetic
instruments during their use and sterilization. Use of this product streamlines
the storage and organization od instruments during and after the dental
procedure. | 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. | Equivalent
Subject and predicate
device are intended to safe
storage surgical instruments
and provide support during
sterilization. | |
| Device
Classification | Class II | Class II | Identical | |
| Classification
Name | Sterilization Wrap Containers, Trays, Cassettes & Other | Sterilization Wrap Containers, Trays, Cassettes & Other | Identical | |
| Product Code | NHA | NHA | Identical | |
| Design | Rigid polysulfone polymer base and removable inner tray with a
polyphenylsulfone lid.
Retention grommets of medical grade silicone. | Rigid polysulfone polymer base and removable inner tray with a polyphenylsulfone lid.
Retention grommets of medical grade silicone.
Retention fixtures of titanium alloy. | Equivalent
Subject and primary
predicate devices have the
same materials. | |
| Perforated | Yes; allows moist heat (steam) penetration to achieve sterilization. | Yes; allows moist heat (steam) penetration to achieve sterilization | Identical | |
| Reusable | Yes | Yes | Identical | |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | | |
| | Complement Kit Cases
JJGC Indústria e Comércio de Materiais Dentários S.A. | K182865
Neodent Instrument Kit Cases
JJGC Indústria e Comércio de Materiais Dentários S.A. | COMPARISON | |
| Overall
dimensions | 110.335: 81 L x 67 W x 60 H, mm
CD1099002: 81 L x 67 W x 60 H, mm | For 110.295: 195 L x 90 W x 44 H, mm
For 110.294: 195 L x 90 W x 54 H, mm
For 110.287: 264 L x 163 W x 54 H, mm
For 110.296: 264 L x 163 W x 58 H, mm | Equivalent
Subject Kit Cases have
overall dimensions within
the overall dimensions of
the predicate devices, not
representing a critical case.
The difference between
them does not compromise
safety and efficacy as is
better discussed along this
submission. | |
| Volume to Vent
Ratio | 110.335: 27.4 cm³/cm² (10.78 in³/in²)
CD1099002: 27.4 cm³/cm² (10.78 in³/in²) | 110.296: 107.5 cm³ / cm² (42.32 in³/in²)
110.287: 98.04 cm³ / cm² (38.60 in³/in²)
110.294: 52.3 cm³ / cm² (20.59 in³/ in²)
110.295: 40.5 cm³ / cm² (15.94 in³/ in²) | Equivalent
The primary predicate
devices have volume to vent
ratio bigger than the subject
devices. Thus, the subject
devices do not represent
criticality for sterilization
procedure and the
difference between them
and predicate devices does
not compromise safety and
efficacy, as is proved by the
presented sterilization
validation. | |
| Useful Life | Yes, reusable up to 100 cycles | Yes, reusable up to 100 cycles | Identical | |
| Biocompatibility | The assessment to Biocompatibility was performed per ISO 10993-1 and
testing was performed using methods described in AAMI/ANSI/ISO 10993-5.
The results indicate that the subject devices are biocompatible. | The assessment to Biocompatibility was performed per ISO 10993-1 and testing was
performed using methods described in AAMI/ANSI/ISO 10993-5. The results indicate that
the subject devices are biocompatible. | Identical | |
| Sterilization
Method | Moist heat (steam) to a SAL of 10⁻⁶ | Moist heat (steam) to a SAL of 10⁻⁶ | Identical | |
| Cycles | Gravity displacement
Dynamic Air Removal (pre-vacuum) | Gravity displacement
Gravity displacement (pre-vacuum) | Identical | |
| SUBJECT DEVICE | | PRIMARY PREDICATE DEVICE | | COMPARISON |
| Complement Kit Cases
JJGC Indústria e Comércio de Materiais Dentários S.A. | | K182865
Neodent Instrument Kit Cases
JJGC Indústria e Comércio de Materiais Dentários S.A. | | |
| | Parameters | | Gravity | Equivalent |
| | | | Sterilization temperature: 132 °C | The subject devices have the |
| | | | Sterilization time: 15 minutes; | same cycle parameters already |
| | | | Drying time: 20 minutes. | cleared for the predicate
devices. |
| | | | | |
| | | | Pre-Vacuum | |
| | | | Sterilization temperature: 132 °C | |
| | | | Sterilization time: 4 minutes; | |
| | | | Drying time: 20 minutes. | |
| Sterile Barrier | Sterilization wrap, FDA-cleared for indicated method and cycles | | Sterilization pouch, FDA-cleared for indicated method and cycles | Identical |
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8
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The subject devices and the primary predicate devices cleared per K182865 have similar intended use and equivalent Indications for Use Statements. Both are reusable rigid containers used to organize and protect dental surgical instruments that are sterilized by the healthcare provider. The subject device and 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 primary predicate device include components manufactured from polyphenylsulfone and polysulfone. The subject devices have the same size, whereas the primary predicate device is provided in two different size and configurations. The overall dimensions of the subject device are equivalent to the range of overall dimensions cleared for the predicate devices. The subject device and the primary predicate device 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).
NON-CLINICAL PERFORMANCE DATA
To evaluate the performance of the subject kit cases, the tests described in the following table were performed.
| 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: |