(219 days)
Not Found
No
The device description and intended use are solely focused on a physical tray for organizing and sterilizing dental instruments. There is no mention of any software, data processing, or intelligent capabilities.
No.
The device is a sterilization tray used to organize and sterilize dental surgical drills and tools, not to provide therapy directly to a patient.
No
Explanation: The device is described as a reusable rigid sterilization container or organizing tray designed to hold various dental surgical drills and tools for organization, steam sterilization, and transport. Its function is to facilitate the sterilization of instruments, not to diagnose medical conditions or provide diagnostic information.
No
The device is a physical surgical tray made of polymer resin and silicone, designed to hold and sterilize dental instruments. It is clearly described as a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as holding, organizing, steam sterilizing, and transporting dental surgical drills and tools. This is a function related to the preparation and handling of medical devices, not the in vitro examination of specimens derived from the human body.
- Device Description: The description details a reusable rigid sterilization container made of specific materials, designed to hold instruments for sterilization. This aligns with a medical device used in a healthcare setting for instrument management.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in the body, or providing information for diagnosis, monitoring, or treatment based on in vitro testing.
The device falls under the category of a medical device used for the sterilization and organization of other medical devices. The performance studies mentioned (Steam Sterilization validations, Cytotoxicity tests, Cleaning validations, and Distribution studies) are also typical for sterilization containers, not IVDs.
N/A
Intended Use / Indications for Use
The InterActive Complete Surgical Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared sterilizable wrap and sterilized in an FDA cleared sterilizer for one of the following cycles:
- (1) Prevaccum Steam At 132℃ for 4 minutes with a 20 minutes dry time.
- (2) Gravity Steam At 132% for 15 minutes with a 30 minutes dry time.
- The trays are intended for sterilization of non-porous loads.
- The trays are recommended not to be stacked during sterilization.
- The Complete Surgical Tray represents the worst case validated load due to the number of components) and the weight of 608.05 grams.
- Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Interactive Complete Surgical Tray.
- The tray will be marketed in following variations.
| Device Model Name | Max no. of Instruments | Weight of each tray with instruments (gms.) |
|---|---|---|
| CST | 45 | 608.05 |
| ICST | 34 | 467.26 |
| IBST | 18 | 453.59 |
| IST | 0 | 404.37 |
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The InterActive Complete Surgical Tray is a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization. Each tray consists of three components - a base tray, a lid, and an internal individualized insert tray. All of the three components are perforated for steam penetration. The internal insert tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and ratchet. The tray is available in only one size of approximately 7.2 inches X 5.6 inches X 2.4 inches and will be marketed in four different variations – (1) InterActive Complete Surgical Tray (ICST) containing 34 instruments, (2) InterActive Basic Surgical Tray (IBST) containing almost half the number of instruments as ICST, (3) InterActive Surgical Tray (IST), empty tray containing no instruments, and (4) Complete Surgical Tray (CST), containing 45 instruments.
The rigid multi-piece tray holds dental device apparatus and accessories before, during, and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared sterilization wrap must be used for sterilization purposes to maintain the sterility of the contents.
The trays are reusable and the tray material allows repeated sterilization cycles. The lid, base, and insert are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC, and is identical to the Radel used in predicate device cleared under K052992 and K012105. Radel R 5000 CL 301 is used for the lid, and Radel R 5100 NT15 is used for base and insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain the drills and the tool holder with cradle on the base tray are made of medical grade silicone material which has been manufactured to meet FDA CFR 177.2600. These brackets and holders are used to secure the instruments during transport, sterilization, and storage. Although these trays are reusable they will not be serviced or repaired.
The instruments to be sterilized in the proposed tray are all non-porous devices and include dental surgical drills and tools. The tools are class I exempt and the drills have Class II pre-market notification clearance.
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
health care 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)
The performance testing of the proposed device complies with a special control: 21 CFR 880.6850 - Class II Special Controls Guidance Document for sterilization wrap (pack, sterilization wrapper, bag, and accessories. The performance characteristics of the device are supported by Steam Sterilization validations, Cytotoxicity tests, Cleaning validations, and Distribution studies conducted on the Complete Surgical Tray taking worst case scenarios into account. No clinical tests were conducted.
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.
K052992, K012105, K990761, K980065
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15, 2015
Implant Direct Sybron Manufacturing LLC Debleena Sinha, M.S. Regulatory Affairs Specialist 3050 East Hillcrest Drive Thousand Oaks, CA 91362
Re: K142519
Trade/Device Name: InterActive Complete Surgical Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: March 20, 2015 Received: March 23, 2015
Dear Ms. Sinha:
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.
1
Page 2 - Debleena Sinha,M.S.
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 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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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)
Device Name
InterActive Complete Surgical Tray
Indications for Use (Describe)
The InterActive Complete Surgical Tray is designed to hold various dental surgical drills and tools in order to organize. steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared sterilizable wrap and sterilized in an FDA cleared sterilizer for one of the following cycles:
- (1) Prevaccum Steam At 132℃ for 4 minutes with a 20 minutes dry time.
- (2) Gravity Steam At 132% for 15 minutes with a 30 minutes dry time.
- The trays are intended for sterilization of non-porous loads.
- The trays are recommended not to be stacked during sterilization.
- The Complete Surgical Tray represents the worst case validated load due to the number of components) and the weight of 608.05 grams.
- Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Interactive Complete Surgical Tray.
- The tray will be marketed in following variations.
| Device Model Name | Max no. of Instruments | Weight of each tray
with instruments (gms.) |
|-------------------|------------------------|------------------------------------------------|
| CST | 45 | 608.05 |
| ICST | 34 | 467.26 |
| IBST | 18 | 453.59 |
| IST | 0 | 404.37 |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Traditional 510(K) Submission
510 (K) Summary (21CFR 807.92(a)(1))
1. Submitter Information
| 510 K Sponsor | Implant Direct Sybron Manufacturing LLC |
|---|---|
| Address | 3050 East Hillcrest Drive |
| Thousand Oaks, CA 91362 | |
| Registration Number | 3001617766 |
| Correspondence Contact | Debleena Sinha, M.S |
| Specialist, Regulatory Affairs | |
| Ph: 818-444-3306 | |
| Fax: 818-444-3406 | |
| Email: debleena.sinha@implantdirect.com | |
| Date Summary Prepared | April 6, 2015 |
2. Device Name and Classification
| Trade Name | InterActive Complete Surgical Tray |
|---|---|
| Classification Name | Sterilization Wrap Containers, Trays, Cassettes, and other Accessories |
| Common Name | Instrument Sterilization Tray |
| Regulation Number | 21 CFR 880.6850 |
| Product Code | KCT |
| Regulatory Class | II |
4
Image /page/4/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo is set on an orange background and features the company name in blue, with a blue curved line above the name. Below the company name, the words "simply smarter." are written in a smaller, white font. At the bottom of the logo, the words "Sybron Dental Specialties" are written in a smaller, blue font.
Traditional 510(K) Submission
3. Predicate Devices
Conmed Linvatech Instrument Sterilization Tray (K052992) Polyvac Inc. Surgical Instrument Delivery Tray (K012105) Tuttnauer USA Co Ltd. Cassette Container (K990761) C/T Medical Systems Sterilization Cassettes (K980065)
4. Description of Device
The InterActive Complete Surgical Tray is a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization. Each tray consists of three components - a base tray, a lid, and an internal individualized insert tray. All of the three components are perforated for steam penetration. The internal insert tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and ratchet. The tray is available in only one size of approximately 7.2 inches X 5.6 inches X 2.4 inches and will be marketed in four different variations – (1) InterActive Complete Surgical Tray (ICST) containing 34 instruments, (2) InterActive Basic Surgical Tray (IBST) containing almost half the number of instruments as ICST, (3) InterActive
5
Image /page/5/Picture/0 description: The image is a logo for Implant Direct, a Sybron Dental Specialties company. The logo is set against an orange background. The words "Implant Direct" are in blue, with a blue arc above them. Below that, the words "simply smarter" are in white, and below that, the words "Sybron Dental Specialties" are in gray.
Surgical Tray (IST), empty tray containing no instruments, and (4) Complete Surgical Tray (CST), containing 45 instruments.
The rigid multi-piece tray holds dental device apparatus and accessories before, during, and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared sterilization wrap must be used for sterilization purposes to maintain the sterility of the contents.
The trays are reusable and the tray material allows repeated sterilization cycles. The lid, base, and insert are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC, and is identical to the Radel used in predicate device cleared under K052992 and K012105. Radel R 5000 CL 301 is used for the lid, and Radel R 5100 NT15 is used for base and insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain the drills and the tool holder with cradle on the base tray are made of medical grade silicone material which has been manufactured to meet FDA CFR 177.2600. These brackets and holders are used to secure the
6
instruments during transport, sterilization, and storage. Although these trays are reusable they will not be serviced or repaired.
The instruments to be sterilized in the proposed tray are all non-porous devices and include dental surgical drills and tools. The tools are class I exempt and the drills have Class II pre-market notification clearance.
5. Intended Use
The InterActive Complete Surgical Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA cleared sterilizer for one of the following cycles:
(1) Prevaccum Steam – At 132ºC for 4 minutes with a 20 minutes dry time.
(2) Gravity Steam - At 132ºC for 15 minutes with a 30 minutes dry time.
- -The trays are intended for sterilization of non-porous loads.
- -The trays are recommended not to be stacked during sterilization.
- -The Complete Surgical Tray represents the worst case validated load due to the number of components (45 instruments) and the weight of 608.05 grams.
7
Image /page/7/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo is set on an orange background and features the company name in blue, with a blue arc above the name. Below the company name is the tagline "simply smarter." in a smaller font. At the bottom of the logo is the text "Sybron Dental Specialties".
-
Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the -
InterActive Complete Surgical Tray. -
-The tray will be marketed in following variations.
| Device Model
Name | Max no. of Instruments | Weight of each tray
with instruments (gms.) |
|----------------------|------------------------|------------------------------------------------|
| CST | 45 | 608.05 |
| ICST | 34 | 467.26 |
| IBST | 18 | 453.59 |
| IST | 0 | 404.37 |
6. Substantial Equivalence
The tables below shows that the InterActive Complete Surgical Tray compared against 510(K) cleared products. The comparison analysis consists of the products' intended use, technological characteristics and performance testing to support the substantial equivalency to their corresponding predicate devices.
8
Image /page/8/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo is set on an orange background and features a blue swoosh above the company name. Below the company name is the tagline "simply smarter" in a smaller, white font. The logo also includes the text "Sybron Dental Specialties" in a smaller font.
TABLE1: Substantial Equivalence: Comparison of Proposed Device with Predicates on Technological Considerations
| Manufacturer | Implant Direct | ConMed
Linvatech | PolyVac Inc. | Tuttnauer
USA Co Ltd | C/TMedical
Systems |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed Device | Predicate | Predicate | Predicate | Predicate |
| 510 (K) | K142519 | K052992 | K012105 | K990761 | K980065 |
| Trade Name | InterActive
Complete Surgical
Tray | Instrument
Sterilization
Tray | Surgical
Instrument
Delivery
System | Mini
Container
Cassette;
Standard
Cassette
Container | Sterilization
cassettes |
| Product Code | KCT | FRG | KCT | FRG | KCT |
| Intended Use | Perforated
instrument
cassette system
to hold dental
instruments in
place during
transport, steam
sterilization, and
storage | Perforated trays
with lids to hold
surgical
instruments in
place during
transport,
steam
sterilization,
and storage | Perforated
trays with lids
to hold surgical
instruments in
place during
transport,
steam
sterilization,
and storage | Dental
instrument
cassette
system to
hold
instruments
in place
during
transport,
steam
sterilization,
and storage | Dental
instrument
cassette
system to
hold
instruments
in place
during
transport,
steam
sterilization,
and storage |
| Material
Composition | Polymer Resin
Radel-5000,
biomedical grade
silicone | Polymer Resin
Radel-5000,
biomedical
grade silicone | Radel-5000
plastic,
Biomedical
grade silicone,
and Aluminum,
300 series
stainless steel | Plastic
Polymer,
biomedical
grade silicone | Plastic,
Metal, and
Stainless
Steel
container |
| Manufacturer | Implant Direct | ConMed
Linvatech | PolyVac Inc. | Tuttnauer
USA Co Ltd | C/TMedical
Systems |
| Design | Plastic tray with
locking lid and
silicone
containment
brackets | Plastic tray with
stainless steel
latch and
silicone
containment
brackets | Tray made of
plastic or metal
base with lid | Small to
medium tray
with silicone
mat inserts | Trays and
cassettes
made of
metal and
plastic. Latch
made of
stainless
steel. |
| Sterilization by | | | | | |
| (1) Gravity
Steam | Yes | Yes | Yes | Yes | Yes |
| (2) Pre Vaccum
Steam | Yes | Yes | Yes | Yes | Yes |
| Air Permeance | Yes | Yes | Yes | Yes | Assume |
| Locking system to
hold lid in place | Yes | Yes | Yes | Yes | Yes |
| Reusable | Yes | Yes | Yes | Yes | Yes |
| Material
compatibility
with sterilization
process | Yes | Yes | Yes | Yes | Yes |
9
Image /page/9/Picture/0 description: The image is a logo for Implant Direct, a Sybron Dental Specialties company. The logo is set against an orange background. Above the company name is a blue curved line. Below the company name is the tagline "simply smarter."
Traditional 510(K) Submission
7. Non-Clinical Performance Testing
The performance testing of the proposed device complies with a special control: 21 CFR 880.6850 - Class II Special Controls Guidance Document for sterilization wrap (pack, sterilization wrapper, bag, and accessories. The performance characteristics of the device are supported by Steam Sterilization validations, Cytotoxicity tests,
10
Image /page/10/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo is set on an orange background. The words "Implant Direct" are written in blue, with a blue arc above the words. Below the company name, the words "simply smarter" are written in white, and below that, the words "Sybron Dental Specialties" are written in gray.
Cleaning validations, and Distribution studies conducted on the Complete Surgical
Tray taking worst case scenarios into account.
TABLE 2: Substantial Equivalence: Comparison with Predicates on Performance Testing
| Manufacturer | Implant Direct | ConMed
Linvatech | PolyVac Inc. | Tuttnauer
USA Co Ltd | C/T Medical
Systems |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------|
| Proposed Device | Predicate | Predicate | Predicate | Predicate | Predicate |
| Manufacturer | Implant Direct | ConMed
Linvatech | PolyVac Inc. | Tuttnauer
USA Co Ltd | C/T Medical
Systems |
| 510 (K) | K142519 | K052992 | K012105 | K990761 | K980065 |
| Sterilant
Penetration
Studies | Yes
Steam
Sterilization
Validations
conducted as per
AAMI/ANSI/ISO
17665;
AAMI TIR 12 | Yes | Yes | Yes | Yes |
| Toxicological
Properties
(biocompatibilty) | Yes
Cytotoxicity
Tests conducted
as per
ISO 10993 - 5;
ISO 10993 -12 | Yes
Brackets and
containment
mats made
from
Biomedical
grade silicone | Yes
Biocomapatibilty
tested to USP
requirements | Yes
Cassette
inserts
made from
biomedical
grade
silicone | Not stated
in summary |
| Transportation
studies
(Packaging
Integrity) | Yes
Distribution
Studies
conducted as per
ASTM D4169 | Not stated in
summary | Not stated in
summary | Not stated in
summary | Not stated
in summary |
| Cleaning
Instructions for
Reusable devices | Yes
Cleaning
Validations
conducted as per
AAMI TIR 30;
AAMI TIR 12 | Not stated in
summary | Not stated in
summary | Not stated in
summary | Yes |
| Material
Compatibility
(repeat
sterilization) | Yes
Radel Technical
Data Sheet | Yes
Radel | Yes
Radel | Not stated
in summary | Not stated
in summary |
| Manufacturer | Implant Direct | ConMed
Linvatech | PolyVac Inc. | Tuttnauer
USA Co Ltd | C/T Medical
Systems |
| Drying Time | Yes
Validated in
Steam
Sterilization
report
AAMI/ANSI/ISO
17665;
AAMI TIR 12 | Not stated in
summary | Not stated in
summary | Not stated
in summary | Yes
Drying time
in labeling |
| Vent/Volume
Ratio | All proposed
trays are
$0.184 in^2/in^3$ | Not stated in
summary | $0.02276 in^2/in^3$ | Not stated
in summary | Not stated
in summary |
11
Image /page/11/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo features the company name in blue, with the words "simply smarter" in a smaller font below. The text "Sybron Dental Specialties" is at the bottom of the logo. The background is orange.
Traditional 510(K) Submission
12
Image /page/12/Picture/0 description: The image is a logo for Implant Direct. The logo is set on an orange background. The words "Implant Direct" are in blue, with a blue arc above them. Below that, in a smaller font, it says "simply smarter" and "Sybron Dental Specialties".
Traditional 510(K) Submission
The proposed devices have high vent to volume ratio, allowing easier sterilant penetration than the predicate device.
The Complete Surgical Tray (CST) container represents the worst case vent to volume
ratio for the Surgical Tray System making this container the most challenging
container to achieve sterilization.
8. Clinical Testing
No clinical tests were conducted.
9. Summary and Conclusion
13
Image /page/13/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo is set on an orange background and features a blue arc above the company name. Below the company name, in smaller letters, is the tagline "simply smarter." The text "Sybron Dental Specialties" is at the bottom of the logo.
Traditional 510(K) Submission
A comparison of the intended use, technological characteristics, and performance studies conducted on the InterActive Complete Surgical Tray demonstrate that the device is substantially equivalent to its predicate devices K052992 (ConMed Linvatech Instrument Sterilization Tray), K012105 (Polyvac Surgical Instrument Delivery System), K990761 (Tuttnauer USA Co Ltd. Cassette Container), and K980065 (C/T Medical Systems Sterilization Cassettes).