(397 days)
No
The device description and intended use focus on physical organization, sterilization, and storage of instruments, with no mention of computational or analytical capabilities that would involve AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a kit box for organizing, sterilizing, and storing medical devices, not for treating a disease or condition itself.
No
The device is described as a system for organizing, enclosing, sterilizing, transporting, and storing medical devices, not for diagnosing conditions.
No
The device description clearly details physical components made of plastic and silicone, designed for organizing, enclosing, sterilizing, transporting, and storing medical devices. There is no mention of software as part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Nobel Biocare Kit Boxes are designed for organizing, sterilizing, transporting, and storing surgical instruments used in dental implant procedures. They are physical containers and organizers for medical devices.
- Intended Use: The intended use clearly states their purpose in handling surgical instruments, not in analyzing biological samples.
- Device Description: The description focuses on the physical components and how they hold and organize instruments.
- Performance Studies: The performance studies relate to sterilization, shelf-life, and biocompatibility of the materials, all relevant to a reusable surgical instrument container, not an IVD.
The device's function and intended use are entirely focused on the handling and preparation of surgical instruments, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Nobel Biocare Kit Boxes are used in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices between surgical uses. The Nobel Biocare Kit Boxes are not intended on their own to maintain sterility, it is intended to be used in conjunction with a legally marketed, FDA-cleared sterilization wrap. Sterilization validations for the worst-case Kit Box included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screw driver and irrigation needles. The Kit Boxes were validated for a maximum load of 469 grams including kit box and instruments.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The Kit Boxes are a module-based kit system that can be organized in different ways according to the user's needs. A Module is composed by a Kit Box and an inserted Kit Plate. The Module can be used as a cleaning and sterilization container. Additionally, it is used for presentation and storage of products. These products are sold as standalone articles (Drills, Screw Taps, Depth Gauge, Implant Drivers, Torque Wrench etc.) and are available in a variety of combinations for different implant systems.
The Modules are intended for storing, organizing and sterilizing the instruments used during implant/prosthetic/retrieval treatment with Nobel Biocare implants.
The Module have 2 different sizes: The Main Module, and the Sub-Module.
Main Module
The Main Module measures 170 mm x 145 mm x 57 mm in size and consists of a Kit Box and a Kit Plate to be inserted. The Kit Box consists of a base with support (stand) and a removable transparent plastic lid. The base is made of silicone over molded on a grey or red plastic base. The inserted Kit Plate snaps into the base of the Kit Box and consists of a pattern of silicone Grommets and tool holders for instruments.
To accommodate the different systems, the Kit Plate is available with unique patterns, different color printing, different size of Grommets and different size tool-holders to meet the end user's needs.
Sub-Module
The Sub-Module (smaller Module) measures 170 mm x 57 mm and consists of Kit Box and a Kit Plate to be inserted. The Kit Box consists of a base with support (stand) and a removable transparent plastic lid. The base is made of silicone over molded on a grey or red plastic base. The inserted Kit Plate snaps into the base of the Kit Box and consists of a pattern of silicone Grommets and tool holders for instruments.
To accommodate the different systems, the Kit Plate is available with unique patterns, different color printing, different size of Grommets and different size tool-holders to meet the end user's needs.
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 facilities
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)
Sterilization: The Kit Boxes are supplied non-sterilized at the health care facility by the enduser. The testing validation confirmed the parameters for temperature, exposure time, dry time and cool time.
Shelf-Life: The Kit Boxes are reusable, non-sterile devices, there is no expiration date identified.
Biocompatibility Testing: Cytotoxicity testing in accordance with AAMI/ANSI/ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity was performed and confirmed that no toxic leachable substances in a water-based environment were transferred to the medical device.
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2018
Charlemagne Chua Sr. Regulatory Affairs Manager Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Re: K163600
Trade/Device Name: Kit Boxes Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: December 20, 2017 Received: December 21, 2017
Dear Charlemagne Chua:
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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -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) K163600
Device Name Kit Boxes
Indications for Use (Describe)
The Nobel Biocare Kit Boxes are used in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices between surgical uses. The Nobel Biocare Kit Boxes are not intended on their own to maintain sterility, it is intended to be used in conjunction with a legally marketed, FDA-cleared sterilization wrap. Sterilization validations for the worst-case Kit Box included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screw driver and irrigation needles. The Kit Boxes were validated for a maximum load of 469 grams including kit box and instruments.
Sterilization Parameters
| Method | Steam Sterilization
(Moist Heat Sterilization) | |
|---------------------------------------------------|---------------------------------------------------|-----------------------------|
| Cycle | Dynamic-Air-Removal
(fractionated vacuum) | Gravity-Displacement |
| Temperature | 132°C (270°F) | 132°C (270°F) |
| Exposure time for a single-
use pouched device | 4 minutes
(full-cycle) | 15 minutes
(full-cycle) |
| | 134°C (273.2 °F) | |
| Exposure time for the
Overkill Approach | 2 minutes
(half-cycle) | 7.5 minutes
(half-cycle) |
| | 1.5 minutes
(half cycle) | |
| Minimum drying times
validated | 20 minutes | 30 minutes |
| | 10 minutes | |
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
K163600
I. Submitter
Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x7830 Fax: (714) 998-9348
Submitted for: Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Date Prepared : January 22, 2018
II. Device
| Device Proprietary Name: | Kit Boxes |
|---|---|
| Common or Usual Name: | Sterilization Tray |
| Classification Name: | Sterilization Wraps |
| Regulation Number: | 21 CFR 880.6850 |
| Product Code: | KCT |
| Device Classification: | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary Predicate
-
. Medtronic Transportation/Sterilization Cassettes, K152241, Medtronic Sofamor Danek USA, Inc.
Reference Devices: -
Restore Modular Sterilization Tray System, K131455, Restore Medical Solutions, Inc. ●
4
IV. Device Description
The Kit Boxes are a module-based kit system that can be organized in different ways according to the user's needs. A Module is composed by a Kit Box and an inserted Kit Plate. The Module can be used as a cleaning and sterilization container. Additionally, it is used for presentation and storage of products. These products are sold as standalone articles (Drills, Screw Taps, Depth Gauge, Implant Drivers, Torque Wrench etc.) and are available in a variety of combinations for different implant systems.
The Modules are intended for storing, organizing and sterilizing the instruments used during implant/prosthetic/retrieval treatment with Nobel Biocare implants.
The Module have 2 different sizes: The Main Module, and the Sub-Module.
Main Module
The Main Module measures 170 mm x 145 mm x 57 mm in size and consists of a Kit Box and a Kit Plate to be inserted. The Kit Box consists of a base with support (stand) and a removable transparent plastic lid. The base is made of silicone over molded on a grey or red plastic base. The inserted Kit Plate snaps into the base of the Kit Box and consists of a pattern of silicone Grommets and tool holders for instruments.
To accommodate the different systems, the Kit Plate is available with unique patterns, different color printing, different size of Grommets and different size tool-holders to meet the end user's needs.
Sub-Module
The Sub-Module (smaller Module) measures 170 mm x 57 mm and consists of Kit Box and a Kit Plate to be inserted. The Kit Box consists of a base with support (stand) and a removable transparent plastic lid. The base is made of silicone over molded on a grey or red plastic base. The inserted Kit Plate snaps into the base of the Kit Box and consists of a pattern of silicone Grommets and tool holders for instruments.
To accommodate the different systems, the Kit Plate is available with unique patterns, different color printing, different size of Grommets and different size tool-holders to meet the end user's needs.
5
V. Indications for Use
The Nobel Biocare Kit Boxes are used in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices between surgical uses. The Nobel Biocare Kit Boxes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterilizations for the worst-case Kit Box included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screw driver and irrigation needles. The Kit Boxes were validated for a maximum load of 469 grams including kit box and instruments.
| Method | Steam Sterilization
(Moist Heat Sterilization) | |
|---------------------------------------------------|---------------------------------------------------|-----------------------------|
| Cycle | Dynamic-Air-Removal
(fractionated vacuum) | Gravity-Displacement |
| Temperature | 132°C (270°F) | 132°C (270°F) |
| Exposure time for a single-
use pouched device | 4 minutes
(full-cycle) | 15 minutes
(full-cycle) |
| Exposure time for the
Overkill Approach | 2 minutes
(half-cycle) | 7.5 minutes
(half-cycle) |
| Minimum drying times
validated | 20 minutes | 30 minutes |
Sterilization Parameters
VI. Comparison of Technological Characteristics
The subject and primary predicate devices share the following characteristics:
- . Similar Indications for Use
- Similar materials of construction
- Configuration
- Sterilization Methods
- Sterilization Parameters
- Reusable
- Microbial Barrier Properties ●
6
Discussion
The Indications for Use statement between the subject and predicate devices is similar and does not differ. Both the subject and predicate devices are intended to organize, enclose, sterilize, transport and store medical devices and other instrumentation between surgical and other medical uses.
The subject devices are technologically different from the predicate devices as follows:
- Dimension .
- Design .
A comparison of the subject and predicate devices is provided in the table below.
7
| | Kit Boxes | PRIMARY PREDICATE
Medtronic Transportation / Sterilization
Cassettes
(K152241) | REFERENCE DEVICE
Restore Modular Sterilization Tray System
(K131455) |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Design | A base, inserted plate, support(stand) and a
lid | A base, a lid with a locking latch and
individual inserts | A base, a lid and individual inserts |
| Dimensions | 170 mm x 145 mm x 57 mm (main)
170 mm x 70 mm x 57 mm (sub)
310 mm x 180 mm x 70 mm (kit organizer) | 22.75 in. x 11.26 in. x 5.51 in. | 10 in. x 20 in. x 4 in.
10 in. x 10 in. x 4 in. |
| Configuration | Perforated bases, lids and silicone grommets | Perforated bases, lids, and inserts | Perforated bases, lids, and inserts |
| Device Material | Aluminum (Drill Stop Box only), Polymer
and Silicon | Thermoplastic polymer, aluminum and
stainless steel | Thermoplastic polymer, aluminum and
stainless steel |
| Perfect
Perforation | Evenly distributed hole pattern | Evenly distributed hole pattern | Evenly distributed hold pattern |
| Sterilization
Method | Pre-Vacuum
Gravity Displacement | Pre-Vacuum
Gravity Displacement | High Vacuum Steam |
| Sterilant
Penetration | Yes | Yes | Yes |
| Microbial Barrier
Properties | To be used with an FDA cleared
sterilization wrap/pouch | To be used with an FDA cleared
sterilization wrap | To be used with an FDA cleared
sterilization wrap |
| Reusable | Yes | Yes | Yes |
| Material
Compatibility
with Sterilization
Method | Yes | Yes | Yes |
8
| | Kit Boxes | | | PRIMARY PREDICATE
Medtronic Transportation / Sterilization
Cassettes
(K152241) | | REFERENCE DEVICE
Restore Modular Sterilization Tray System
(K131455) |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------------------|-----------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization
Parameters | Pre-Vacuum:
Temp 270° F
Exposure Time 4 minutes
Pre-vacuum: 3 times