(397 days)
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.
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.
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.
The provided document is a 510(k) premarket notification for a medical device (Kit Boxes) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance acceptance criteria for a diagnostic or AI-driven system.
The document does not contain the information requested in points 1-9 regarding acceptance criteria and study details for a device's performance, especially in the context of an AI/diagnostic system. The "performance data" section (Section VII) refers to sterilization validation, shelf-life, and biocompatibility testing, which are relevant for a sterilization device but not for a diagnostic or AI product.
Therefore, I cannot extract the requested information from this document. The document describes a medical device used for organizing, sterilizing, transporting, and storing other medical devices, and the review is for its substantial equivalence to similar existing products, not for its performance in a clinical diagnostic or AI-assisted context.
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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
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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
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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 theOverkill Approach | 2 minutes(half-cycle) | 7.5 minutes(half-cycle) |
| 1.5 minutes(half cycle) | ||
| Minimum drying timesvalidated | 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)
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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. ●
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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.
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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 theOverkill Approach | 2 minutes(half-cycle) | 7.5 minutes(half-cycle) |
| Minimum drying timesvalidated | 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 ●
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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.
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| Kit Boxes | PRIMARY PREDICATEMedtronic Transportation / SterilizationCassettes(K152241) | REFERENCE DEVICERestore Modular Sterilization Tray System(K131455) | |
|---|---|---|---|
| Design | A base, inserted plate, support(stand) and alid | A base, a lid with a locking latch andindividual 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), Polymerand Silicon | Thermoplastic polymer, aluminum andstainless steel | Thermoplastic polymer, aluminum andstainless steel |
| PerfectPerforation | Evenly distributed hole pattern | Evenly distributed hole pattern | Evenly distributed hold pattern |
| SterilizationMethod | Pre-VacuumGravity Displacement | Pre-VacuumGravity Displacement | High Vacuum Steam |
| SterilantPenetration | Yes | Yes | Yes |
| Microbial BarrierProperties | To be used with an FDA clearedsterilization wrap/pouch | To be used with an FDA clearedsterilization wrap | To be used with an FDA clearedsterilization wrap |
| Reusable | Yes | Yes | Yes |
| MaterialCompatibilitywith SterilizationMethod | Yes | Yes | Yes |
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| Kit Boxes | PRIMARY PREDICATEMedtronic Transportation / SterilizationCassettes(K152241) | REFERENCE DEVICERestore Modular Sterilization Tray System(K131455) | ||||
|---|---|---|---|---|---|---|
| SterilizationParameters | Pre-Vacuum:Temp 270° FExposure Time 4 minutesPre-vacuum: 3 times < 60 mbarDrying Time: 30 minutesCooling Time: 10 minutes at roomtemperature | Cycle | Tempe-rature | Exposuretime | Minimumdry time | High Vacuum (pre-vacuum, three pulse,standard): Temp: 270° FExposure Time: 4 minutesCycle Dry Time (wrapped): 20 minutes(minimum)Cool Time: Varies according to load contents |
| Gravity:Temp 270° FExposure Time: 15 minutesPre-vacuum: N/A DryingTime: 30 minutesCooling Time: 10 minutes at roomtemperature | GravityDisplace-ment | 250° F(121° C) | 30Minutes | 30Minutes | ||
| GravityDisplace-ment | 270° F(132° C) | 15Minutes | 30Minutes | |||
| GravityDisplace-ment | 275° F(135° C) | 10Minutes | 30Minutes | |||
| Dynamic-Air-Removal | 270° F(132° C) | 4Minutes | 30Minutes | |||
| Dynamic-Air-Removal | 275° F(135° C) | 3Minutes | 30Minutes |
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| Kit Boxes | PRIMARY PREDICATEMedtronic Transportation / SterilizationCassettes(K152241) | REFERENCE DEVICERestore Modular Sterilization Tray System(K131455) | ||
|---|---|---|---|---|
| Indications forUse Statement | The Nobel Biocare Kit Boxes are used inhealthcare facilities to organize, enclose,sterilize, transport, and store medical devicesbetween surgical uses. The Nobel Biocare KitBoxes are not intended on their own tomaintain sterility; it is intended to be used inconjunction with a legally marketed,validated, FDA-cleared sterilization wrap.Sterilization validations for the worst-case KitBox included surgical instruments such astorque wrenches, implant drivers, directionindicators, drills, screw taps, screw driver andirrigation needles. The Kit Boxes werevalidated for a maximum load of 469 gramsincluding kit box and instruments. | The Medtronic Transportation/SterilizationCassettes are intended for use in healthcarefacilities to organize, enclose, sterilize,transport, and store medical devices and otherinstrumentation between surgical and othermedical uses. The Medtronic Transportation/Sterilization Cassettes are not intended ontheir own to maintain sterility; it is intendedto be used in conjunction with a legallymarketed, validated, FDA-clearedsterilization wrap.Sterilization validations for the worst caseMedtronic Transportation/SterilizationCassette (22.75 x 11.26 x 5.5 inches)included implants and common surgicalinstruments such as rasps, dirvers, trials,handles, inserters, porbes, drills, etc. Thevalidated total weight was 28.4 lbs. Thevalidated worst case loading configurationsof the Medtronic Tranportation/ SterilziationCassette included the following worst caselumen dimensions.-363 x 1.575 mm-247.5 x 4.1 mm | The Restore Modular Sterilization TraySystem is intended for use in healthcarefacilities to organize, enclose, sterilize,transport, and store medical devices and otherinstrumentation between surgical and othermedical uses when used in conjunction with aFDA cleared sterilization wrap.The Modular Sterilization Tray System maybe used with common surgical instrumentssuch as hammers, rasps, drivers, chisels,ringed-handled instruments, rongeurs,pickups, including but not limited to short-lumened devices etc. The validated totalweight for tray and contents was 20 pounds. | |
| Reusable Medical Device ChallengeConditions | ||||
| MinimumInnerDiameter | MaximumLength | Number oflumens | ||
| 1.8 mm | 4 inches | 2 | ||
| High Vacuum (pre-vacuum, three pulse, |
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| Kit Boxes | PRIMARY PREDICATEMedtronic Transportation / SterilizationCassettes(K152241) | REFERENCE DEVICERestore Modular Sterilization Tray System(K131455) |
|---|---|---|
| Device List: | standard): | |
| 1850060 Case- Triple Generic Outer Base | Temp: 270° F | |
| (22.74 x 11.260 x 5.040 inches) | Exposure Time: 4 Minutes | |
| 1850064 Lid- Generic Outer Lid (22.75 x | Cycle Cry Time (wrapped): 20 minutes | |
| 11.260 x 0.470 inches) | (minimum) | |
| 7022101L Tray Lid (21 x 10.075 x 0.075 | Cool Time: Varies according to load contents | |
| inches) | ||
| P1850061 Tray 1 (20.75 x 9.79 x 1.32 inches) | Note: Cool drafts from air ducts or other air | |
| P1850062 Tray 2 (21 x 10.13 x 1.69 inches) | currents should be avoided during the cooling | |
| P1850063 Tray 3 (21 x 10.13 x 1.38 inches) | phase to avoid post-sterilization moisture | |
| 7059532 Large Caddy (9.47 x 6.37 x 1.3 | caused by rapid cooling syndrome. | |
| inches) | ||
| 7059532L Large Lid (5.85 x 4.725 x 0.095 | ||
| inches) | ||
| P213018 Small Caddy (2 x 1.5 x 1.025 | ||
| inches) | ||
| P9213018 Small Lid (2 x 1.29 x 0.095 | ||
| inches) |
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Discussion
As seen above, the differences between the subject and predicate devices are the design and dimensions of the kit box/plates. 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.
VII. Performance Data
Kit Boxes are intended for storing and organizing instruments used during implant/ prosthetic/retrieval treatment with NobelBiocare implants. The following performance data is being provided or relied upon in support of the substantial equivalence determination. Additionally, due to the intended use of the subject device, the Kit Boxes and Kit Plates are not exposed to mechanical stress. No additional performance testing is required.
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
Kit Boxes a are considered accessories for medical devices, which do not come in to direct contact with the human body; however, they are intended for storing and subsequently sterilizing the respective medical devices and should be evaluated according to AAMI/ANSI/ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.
Surgical and restorative kit boxes pose a potential risk of contaminating the respective biocompatible medical devices with leachable substances released during the sterilization process. Therefore, 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.
VIII. Conclusion
Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, subject Kit Boxes and Kit Plates are substantially equivalent to, and are as safe and as effective as, the legally marketed predicate device, cleared under K152241 under regulation 21 CFR 880.6850, product code KCT.
§ 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).