(266 days)
No
The device description and intended use clearly define the device as a tray system for organizing and sterilizing surgical instruments, with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
No.
The device is intended to store and organize surgical instruments during sterilization and treatments, not to provide therapy itself.
No
The device is described as trays intended to store and organize surgical instruments, insertion tools, drill stops, and prosthetic instruments during steam sterilization and treatments. Its function is organizational and for sterilization, not diagnostic.
No
The device description clearly outlines physical components made of polyphenylsulfone and silicone rubber, indicating it is a hardware device for organizing surgical instruments. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are for storing and organizing surgical instruments during sterilization and implant/prosthetic treatments. This is a function related to the handling and preparation of surgical tools, not the diagnosis of a disease or condition using in vitro methods.
- Device Description: The description details the physical components of the trays and their purpose in holding and organizing instruments. There is no mention of reagents, samples, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is a surgical instrument tray designed for sterilization and organization, which falls under the category of medical devices used in surgical procedures.
N/A
Intended Use / Indications for Use
BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® DSTr 58356, BEGO SEMA-DOS® PKTr 58357 are intended to store and organize the BEGO Semados® surgical instruments, insertion tools, drill stops and prosthetic instruments during both steam sterilization in an autoclave and implant/ prosthetic treatments.
BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® DSTr 58356, BEGO SEMA-DOS® PKTr 58357 are not intended on its own to maintain sterility; it is intended to be used with a legally marketed, validated, FDA-cleared sterilization pouch.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
BEGO SEMADOS® Tr 58350
BEGO SEMADOS® Tr 58350 is composed of three main components: a tray cover, a tray container and a tray insert, all made of polyphenylsulfone. The tray container and the tray insert have additional silicone rubber grommets to store and organize the BEGO Semados® surgical instruments and insertion tools. The tray container and tray insert are printed to indicate the surgical workflow and the position of the above mentioned instruments within the tray for reprocessing and implant/ prosthetic treatments.
BEGO SEMADOS® Tr 58350 is supplied without BEGO Semados® surgical instruments and insertion tools.
BEGO SEMADOS® RS/RSX-LINE TRAY PLUS is supplied as a kit with BEGO SEMADOS® Tr 58350 and BEGO Semados® surgical instruments and insertion tools.
BEGO Semados® Tr 58349
BEGO Semados® Tr 58349 is composed of three main components: a tray cover, a tray container and a tray insert, all made of polyphenylsulfone. The tray container and the tray insert have additional silicone rubber grommets to store and organize the BEGO Semados® surgical instruments and insertion tools. The tray container and tray insert are printed to indicate the surgical workflow and the position of the above mentioned instruments within the tray for reprocessing and implant/ prosthetic treatments.
BEGO Semados® Tr 58349 is supplied without BEGO Semados® surgical instruments and insertion tools.
BEGO Semados® Tr 58348 is supplied as a kit with BEGO Semados® Tr 58349 and BEGO Semados® surgical instruments and insertion tools.
BEGO Semados® DSTr 58356
BEGO Semados® DSTr 58356 is composed of two main components: a tray cover made of polyphenylsulfone and a tray container made of polypropylene. The tray container has inserts to store and organize the drill stops. The tray container is printed to indicate the position of the drill stops within the tray for reprocessing and implant treatments.
BEGO Semados® DSTr 58356 is supplied without drill stops.
DRILL STOP TRAY PLUS (RS/RSX-Line) is supplied as a kit with BEGO Semados® DSTr 58356 and drill stops.
BEGO SEMADOS® PKTr 58357
BEGO SEMADOS® PKTr 58357 is composed of two main components: a tray cover made of polyphenylsulfone and a tray container made of polypropylene. The tray container has inserts to store and organize the BEGO Semados® insertion tools and prosthetic instruments. The tray container is printed to indicate the position of the above mentioned instruments within the tray for reprocessing and implant/prosthetic treatments.
BEGO SEMADOS® PKTr 58357 is supplied without BEGO Semados® insertion tools and prosthetic instruments.
PROSTHETIC KIT is supplied as a kit with BEGO SEMADOS® PKTr 58357 and BEGO Semados® insertion tools and prosthetic instruments.
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)
Summary of non-clinical testing
The non-clinical testing performed demonstrated that the subject device non-clinical test results met the acceptance criteria of the standards.
Test/Methodology: AAMI TIR30:2011 Automated Cleaning Validation – Protein Analysis
Purpose: Verify cleaning instructions provided are efficacious for removing gross amounts of soil to a residual protein level of 6.4 µg protein/cm².
Results: The automated cleaning validation of BEGO Semados® Trays concluded that the manufacturer's cleaning instructions are efficacious for removing gross amounts of soil to a residual protein level of 6.4 µg protein/cm².
Test/Methodology: AAMI TIR30:2011 Automated Cleaning Validation - Organic Carbon Analysis
Purpose: Verify cleaning instructions provided are efficacious for removing gross amounts of soil to a total organic carbon (TOC) content of 3.1 µg of C/cm².
Results: The automated cleaning validation of BEGO Semados® Trays concluded that the manufacturer's cleaning instructions are efficacious for removing gross amounts of soil to a total organic carbon (TOC) con- tent of 3.1 µg of C/cm2.
Test/Methodology: ISO 10993-5:2009 Cell Growth Analysis via XTT-Staining
Purpose: Verify the device does not have a cytotoxic potential. An inhibition of cell growth (ICG) of more than 30% is considered as cytotoxic effect.
Results: The cytotoxicity testing concluded that test devices met the requirements of the test and are not considered to have a cy- totoxic potential.
Test/Methodology: ISO 17665-1:2006-08 ISO TS 17665-2:2009-01 ANSI/AAMI ST77:2013 Sterilization validation
Purpose: Verify the device and cycle parameters achieve a Sterility Assurance Level (SAL) of 10-6.
Results: The tested devices achieved a SAL of 10-6 after processing in pre-vacuum steam sterilization cycle at 132°C for 4 minutes.
Test/Methodology: AAMI TIR12:2010 Drying Time testing
Purpose: Verify the device is properly dried using the specified cycle parameters.
Results: The BEGO Semados® Trays are considered properly dried following processing in pre-vacuum steam sterilization cycle at 132°C for 4 minutes, and drying time of 20 minutes.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 18, 2021
BEGO Implant Systems GmbH & Co. KG Bertrand Lecointe Regulatory Affairs Manager Wilhelm-Herbst-Str. 1 Bremen, 28359 De
Re: K201412
Trade/Device Name: BEGO SEMADOS Tr 58350, BEGO Semados Tr 58349, BEGO Semados DSTr 58356, BEGO SEMADOS PKTr 58357 Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: January 19, 2021 Received: January 25, 2021
Dear Bertrand Lecointe:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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,
Clarence Murray III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® DSTr 58356, BEGO SEMADOS® PKTr 58357
Indications for Use (Describe)
3
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 Drug 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."
4
510(k) Summary K201412
| Submitter Information: | BEGO Implant Systems GmbH & Co. KG
Wilhelm-Herbst-Str. 1
28359 Bremen, Germany
Phone: +49 (0) 421 2028-246
Fax: +49 (0) 421 2028-265
Establishment Registration Number: 3008252251
Owner/Operator Number: 10028/893 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Kathleen Al-Kaissy, Regulatory Affairs Manager
BEGO Implant Systems GmbH & Co. KG
Phone: +49 (0) 421 2028-338
E-Mail: IM-RA@bego.com |
| Application Correspondent: | Bertrand Lecointe, Regulatory Affairs Manager
BEGO Implant Systems GmbH & Co. KG
Phone: +49 (0) 421 2028-230
E-Mail: IM-RA@bego.com |
| Date Prepared: | 2/17/2021 |
| 510(k) No.: | K201412 |
| Name of Device: | BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Se-
mados® DSTr 58356, BEGO SEMADOS® PKTr 58357 |
| Common name: | BEGO Semados® Trays |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Product Code: | KCT |
| C.F.R. Section: | 21 CFR 880.6850 |
| Classification Panel: | General Hospital |
| Regulation Class: | Class II |
Predicate Device Information
Primary Predicate
| Device Trade Name: | Straumann BLX Surgical Cassette |
|---|---|
| Applicant: | Institut Straumann AG |
| 510(k) No.: | K180791 |
| Reference Device | |
| Device Trade Name: | PureSet Tray |
| Applicant: | Nobel Biocare AB |
| 510(k) No.: | K181075 |
5
Device(s) Identification
Subject of this submission are the BEGO Semados® Trays (58350, 58349, 58356, 58357) that are parts of BEGO Semados® implant/ prosthetic treatment sets/ kits. The below table specifies the devices that are subject of this submission. The empty trays are highlighted in bold in all tables of this submission for identification purposes.
| | Trade or Proprietary or Model Name for This Device | Model
number | Product Code |
|---|----------------------------------------------------|-----------------|------------------------------|
| 1 | BEGO SEMADOS® Tr 58350 | 58350 | KCT |
| | BEGO SEMADOS® RS/RSX-LINE TRAY PLUS | 57949 | Kit containing
device KCT |
| 2 | BEGO Semados® Tr 58349 | 58349 | KCT |
| | BEGO Semados® Tr 58348 | 58348 | Kit containing
device KCT |
| 3 | BEGO Semados® DSTr 58356 | 58356 | KCT |
| | DRILL STOP TRAY PLUS (RS/RSX-LINE) | 57483 | Kit containing
device KCT |
| 4 | BEGO SEMADOS® PKTr 58357 | 58357 | KCT |
| | PROSTHETIC KIT | 55826 | Kit containing
device KCT |
Overview BEGO Semados® Trays
Note: The instruments and accessory devices that are intended to be sterilized and stored in the subject Trays, are not subject to this submission.
6
Indications for use
BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® DSTr 58356, BEGO SEMA-DOS® PKTr 58357 are intended to store and organize the BEGO Semados® surgical instruments, insertion tools, drill stops and prosthetic instruments during both steam sterilization in an autoclave and implant/ prosthetic treatments.
BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® DSTr 58356, BEGO SEMA-DOS® PKTr 58357 are not intended on its own to maintain sterility; it is intended to be used with a legally marketed, validated, FDA-cleared sterilization pouch.
| Cycle | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Fractioned pre-vacuum | |||
| steam | 132°C (270°F) | 4 min | 20 min |
Sterilization validations included the worst-case load configurations and has the maximum load including instruments for the following device models:
| Device Model | Maximum load (wt),
including instruments | Type of Instruments |
|--------------------------|---------------------------------------------|-----------------------------------------|
| BEGO SEMADOS® Tr 58350 | 476 g | Surgical instruments, insertion tools |
| BEGO Semados® Tr 58349 | 261 g | Surgical instruments, insertion tools |
| BEGO Semados® DSTr 58356 | 137 g | Drill stops |
| BEGO SEMADOS® PKTr 58357 | 220 g | Insertion tools, prosthetic instruments |
Healthcare facilities should not exceed 25 pounds (BEGO Semados® Trays containment device + sterile pouch + surgical instruments/insertion tools/drill stop/prosthetic instruments).
Sterilization validations included the worst-case load configurations of following lumen sizes and dimensions and has the maximum load for the following device models:
| Device Model | Type of Lumen | Number of lumens | Sizes & Dimensions [mm] |
|---|---|---|---|
| BEGO SEMADOS® Tr 58350 | Drill holes | 8 | Ø1.2, L2.4 / Ø 1.2, L 6.8 / Ø 2.4-2.9, L 22.5/14.6 / Ø1.2, L6.8 |
| Oval hole | 1 | 2.3 x 2.0 | |
| BEGO Semados® Tr 58349 | Drill holes | 4 | Ø1.2, L2.4 / Ø2.4, L16 |
| Oval hole | 1 | 2.3x2.0 | |
| BEGO Semados® DSTr 58356 | Drill holes | 25 | Ø 2.6-5.1, L 6-12 |
| BEGO SEMADOS® PKTr 58357 | Drill holes | 5 | Ø 2.4, L16 / Ø 1.2, L 6.8 |
BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® DSTr 58356, BEGO SEMA-DOS® PKTr 58357 are offered in the following sizes:
| Device Model | Dimensions [mm] |
|---|---|
| BEGO SEMADOS® Tr 58350 | 188.1 x 138.7 x 61.5 |
| BEGO Semados® Tr 58349 | 142.7 x 99.6 x 61 |
| BEGO Semados® DSTr 58356 | 80 x 85 x 28 |
| BEGO SEMADOS® PKTr 58357 | 140 x 80 x 25 |
7
Device Description
BEGO SEMADOS® Tr 58350
BEGO SEMADOS® Tr 58350 is composed of three main components: a tray cover, a tray container and a tray insert, all made of polyphenylsulfone. The tray container and the tray insert have additional silicone rubber grommets to store and organize the BEGO Semados® surgical instruments and insertion tools. The tray container and tray insert are printed to indicate the surgical workflow and the position of the above mentioned instruments within the tray for reprocessing and implant/ prosthetic treatments.
BEGO SEMADOS® Tr 58350 is supplied without BEGO Semados® surgical instruments and insertion tools.
BEGO SEMADOS® RS/RSX-LINE TRAY PLUS is supplied as a kit with BEGO SEMADOS® Tr 58350 and BEGO Semados® surgical instruments and insertion tools.
BEGO Semados® Tr 58349
BEGO Semados® Tr 58349 is composed of three main components: a tray cover, a tray container and a tray insert, all made of polyphenylsulfone. The tray container and the tray insert have additional silicone rubber grommets to store and organize the BEGO Semados® surgical instruments and insertion tools. The tray container and tray insert are printed to indicate the surgical workflow and the position of the above mentioned instruments within the tray for reprocessing and implant/ prosthetic treatments.
BEGO Semados® Tr 58349 is supplied without BEGO Semados® surgical instruments and insertion tools.
BEGO Semados® Tr 58348 is supplied as a kit with BEGO Semados® Tr 58349 and BEGO Semados® surgical instruments and insertion tools.
BEGO Semados® DSTr 58356
BEGO Semados® DSTr 58356 is composed of two main components: a tray cover made of polyphenylsulfone and a tray container made of polypropylene. The tray container has inserts to store and organize the drill stops. The tray container is printed to indicate the position of the drill stops within the tray for reprocessing and implant treatments.
BEGO Semados® DSTr 58356 is supplied without drill stops.
DRILL STOP TRAY PLUS (RS/RSX-Line) is supplied as a kit with BEGO Semados® DSTr 58356 and drill stops.
BEGO SEMADOS® PKTr 58357
BEGO SEMADOS® PKTr 58357 is composed of two main components: a tray cover made of polyphenylsulfone and a tray container made of polypropylene. The tray container has inserts to store
8
and organize the BEGO Semados® insertion tools and prosthetic instruments. The tray container is printed to indicate the position of the above mentioned instruments within the tray for reprocessing and implant/prosthetic treatments.
BEGO SEMADOS® PKTr 58357 is supplied without BEGO Semados® insertion tools and prosthetic instruments.
PROSTHETIC KIT is supplied as a kit with BEGO SEMADOS® PKTr 58357 and BEGO Semados® insertion tools and prosthetic instruments.
Intended Use:
BEGO Semados® Trays are intended to store and organize the BEGO Semados® medical devices during both steam sterilization in an autoclave and implant/ prosthetic treatments.
BEGO Semados® Trays are not intended on their own to maintain sterility; they are intended to be used with a legally marketed, validated, FDA-cleared sterilization pouch.
9
Summary of technological characteristics
The below table presents the comparison of functions and parameters of the identified Predicate Device and the BEGO Semados® Trays.
Subject Device Predicate Device Feature BEGO Semados® Trays (K201412) Straumann BLX Surgical Cassette Comparison (K180791) BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® The Straumann BLX Cassette is used in DSTr 58356, BEGO SEMADOS® PKTr 58357 are intended to store and healthcare facilities to organize, enclose, sterorganize the BEGO Semados® surgical instruments, insertion tools, ilize, transport, and store medical devices bedrill stops and prosthetic instruments during both steam sterilizatween surgical uses. The BLX Cassette is not tion in an autoclave and implant/ prosthetic treatments. intended to maintain sterility; it is intended to BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® conjunction with a legally marketed, validated DSTr 58356, BEGO SEMADOS® PKTr 58357 are not intended on its own sterilization wrap. to maintain sterility; it is intended to be used with a legally mar-The BLX Cassette has been validated for a keted, validated, FDA-cleared sterilization pouch. maximum load of 300 grams, including cas-Cycle Temperature Exposure Drying sette and instruments. Time Time Fractioned pre-132°C (270°F) 4 min 20 min Sterilization parameters: Pre-vacuum steam: Indications for Use vacuum steam Similar 132°C (270°F) for 4 minutes with 20 minutes drying time. Sterilization validations included the worst-case load configurations and has the maximum load including instruments for the following device models: Device Model Maximum load Type of Instruments (wt), including instruments BEGO SEMADOS® Tr Surgical instruments, in-476 g 58350 sertion tools BEGO Semados® Tr Surgical instruments, in-261 g 58349 sertion tools BEGO Semados® 137 g Drill stops DSTr 58356
Comparison between Subject and Predicate Device
10
| Subject Device | Predicate Device | |||||
|---|---|---|---|---|---|---|
| Feature | BEGO Semados® Trays (K201412) | Straumann BLX Surgical Cassette | ||||
| (K180791) | Comparison | |||||
| BEGO SEMADOS® | ||||||
| PKTr 58357 | 220 g | Insertion tools, pros- | ||||
| thetic instruments | ||||||
| Healthcare facilities should not exceed 25 pounds (BEGO Semados® | ||||||
| Trays containment device + sterile pouch + surgical instruments/inser- | ||||||
| tion tools/drill stop/prosthetic instruments). | ||||||
| Sterilization validations included the worst-case load configurations of | ||||||
| following lumen sizes and dimensions and has the maximum load for | ||||||
| the following device models: | ||||||
| Device Model | Type of | |||||
| Lumen | Number | |||||
| of lu- | ||||||
| men | Sizes & Dimensions | |||||
| [mm] | ||||||
| BEGO SEMADOS® | ||||||
| Tr 58350 | Drill holes | 8 | $Ø$ 1.2, L2.4 / $Ø$ 1.2, | |||
| L 6.8 / $Ø$ 2.4-2.9, | ||||||
| L 22.5/14.6 / $Ø$ 1.2, | ||||||
| L6.8 | ||||||
| Oval hole | 1 | 2.3 x 2.0 | ||||
| BEGO Semados® | Drill holes | 4 | $Ø$ 1.2, L2.4 / $Ø$ 2.4, L16 | |||
| Tr 58349 | Oval hole | 1 | 2.3x2.0 | |||
| BEGO Semados® | ||||||
| DSTr 58356 | Drill holes | 25 | $Ø$ 2.6-5.1, L 6-12 | |||
| BEGO SEMADOS® | ||||||
| PKTr 58357 | Drill holes | 5 | $Ø$ 2.4, L16 / $Ø$ 1.2, L | |||
| 6.8 | ||||||
| BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® | ||||||
| DSTr 58356, BEGO SEMADOS® PKTr 58357 are offered in the following | ||||||
| sizes: | ||||||
| Device Model | Dimensions [mm] | |||||
| BEGO SEMADOS® Tr 58350 | 188.1 x 138.7 x 61.5 | |||||
| BEGO Semados® Tr 58349 | 142.7 x 99.6 x 61 | |||||
| BEGO Semados® DSTr 58356 | 80 x 85 x 28 | |||||
| BEGO SEMADOS® PKTr 58357 | 140 x 80 x 25 |
11
| Subject Device | Predicate Device | |||
|---|---|---|---|---|
| Feature | BEGO Semados® Trays (K201412) | Straumann BLX Surgical Cassette | ||
| (K180791) | Comparison | |||
| Intended Use | BEGO Semados® Trays are intended to store and organize the BEGO | |||
| Semados® medical devices during both steam sterilization in an au- | ||||
| toclave and implant/ prosthetic treatments. | ||||
| BEGO Semados® Trays are not intended on their own to maintain | ||||
| sterility; they are intended to be used with a legally marketed, vali- | ||||
| dated, FDA-cleared sterilization pouch. | The Straumann BLX Cassette is used in | |||
| healthcare facilities to organize, enclose, ster- | ||||
| ilize, transport, and store medical devices be- | ||||
| tween surgical uses. The BLX Cassette is not | ||||
| intended to maintain sterility; it is intended to | ||||
| conjunction with a legally marketed, validated | ||||
| sterilization wrap. | Identical | |||
| Product Code | KCT | KCT | Identical | |
| Reusable | Yes | Yes | Identical | |
| Sterilization | ||||
| Method | Moist Heat (Steam) | Moist Heat (Steam) | Identical | |
| Cycle | Dynamic-Air-Removal (fractionated vacuum) | Pre-vacuum | Identical | |
| Temperature | 132°C (270°F) | 132°C (270°F) | Identical | |
| Exposure time | 4 minutes | 4 minutes | Identical | |
| Drying time | 20-30 minutes | 20 minutes | Similar | |
| Sterile Barrier | FDA-cleared sterilization pouch | FDA-cleared sterilization wrap | Different | |
| Maximum Load | Device Model | Maximum load (wt), including instruments | 300g, including cassette and instruments | Different |
| BEGO SEMADOS® Tr 58350 | 476 g | |||
| BEGO Semados® Tr 58349 | 261 g | |||
| BEGO Semados® DSTr 58356 | ||||
| BEGO SEMADOS® PKTr 58357 | 137 g | |||
| 220 g | ||||
| Vent to volume ratio | Device Model | V-to-V ratio | 0.054 in 2/in3 | Different |
| BEGO SEMADOS® Tr 58350 | 0.084 in2/in3 | |||
| Subject Device | Predicate Device | |||
| Feature | BEGO Semados® Trays (K201412) | Straumann BLX Surgical Cassette (K180791) | Comparison | |
| BEGO Semados® Tr 58349 0.072 in²/in³ | ||||
| BEGO Semados® DSTr 58356 0.601 in²/in³ | ||||
| BEGO SEMADOS® PKTr 58357 0.241 in²/in³ | ||||
| Device Construction | BEGO SEMADOS® Tr 58350/ BEGO Semados® Tr 58349: | |||
| Plastic tray, lid and insert | ||||
| BEGO Semados® DSTr 58356/ | ||||
| BEGO SEMADOS® PKTr 58357: | ||||
| Plastic tray and lid | Plastic tray and lid | Similar | ||
| Perforated | Yes, allows moist heat (steam) penetration to achieve sterilization | Yes, allows moist heat (steam) penetration to achieve sterilization | Identical | |
| Material Composition | BEGO SEMADOS® Tr 58350/ BEGO Semados® Tr 58349: |
- Polyphenylsulfone (PPSU Radel® R5000)
- Silicone/ Polydimethylsiloxane
BEGO Semados® DSTr 58356/
BEGO SEMADOS® PKTr 58357: - Polyphenylsulfone (PPSU Radel® R5000
- Polypropylene Heat Stabilized (PP-HS) | Polyphenylsulfone (Radel® R5000)
Silicone | Similar | |
| Material compatibility with sterilization process | Yes | Yes | Identical | |
| Enclosing feature | BEGO SEMADOS® Tr 58350/ BEGO Semados® Tr 58349: Silicone rubber grommets | Silicone grommets | Similar | |
| | | Subject Device | Predicate Device | |
| Feature | | BEGO Semados® Trays (K201412) | Straumann BLX Surgical Cassette
(K180791) | Comparison |
| | | BEGO Semados® DSTr 58356/ BEGO SEMADOS® PKTr 58357: None | | |
| Dimension | Device Model | Dimension [mm] | | |
| | BEGO SEMADOS® Tr 58350 | 188.1 x 138.7 x 61.5 | | Different |
| | BEGO Semados® Tr 58349 | 142.7 x 99.6 x 61 | 143 mm x 100 mm x 61 mm | |
| | BEGO Semados® DSTr 58356 | 80 x 85 x 28 | | |
| | BEGO SEMADOS® PKTr 58357 | 140 x 80 x 25 | | |
12
13
14
Summary of non-clinical testing
Provided below is a summary table of the non-clinical testing that were performed using the subject device. The result demonstrated that the subject device non-clinical test results met the acceptance criteria of the standards.
| Non-Clinical Performance Testing Table | ||
|---|---|---|
| -- | -- | ---------------------------------------- |
| Test/ Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| AAMI TIR30:2011 | Automated Cleaning | ||
| Validation – Protein | |||
| Analysis | Verify cleaning instruc- | ||
| tions provided are effi- | |||
| cacious for removing | |||
| gross amounts of soil to | |||
| a residual protein level | |||
| of 6.4 µg protein/cm² | The automated cleaning validation of | ||
| BEGO Semados® Trays concluded that the | |||
| manufacturer's cleaning instructions are | |||
| efficacious for removing gross amounts of | |||
| soil to a residual protein level of 6.4 µg | |||
| protein/cm². | |||
| AAMI TIR30:2011 | Automated Cleaning | ||
| Validation - Organic | |||
| Carbon Analysis | Verify cleaning instruc- | ||
| tions provided are effi- | |||
| cacious for removing | |||
| gross amounts of soil to | |||
| a total organic carbon | |||
| (TOC) content of 3.1 µg | |||
| of C/cm² | The automated cleaning validation of | ||
| BEGO Semados® Trays concluded that the | |||
| manufacturer's cleaning instructions are | |||
| efficacious for removing gross amounts of | |||
| soil to a total organic carbon (TOC) con- | |||
| tent of 3.1 µg of C/cm2. | |||
| ISO 10993-5:2009 | Cell Growth Analysis | ||
| via XTT-Staining | Verify the device does | ||
| not have a cytotoxic po- | |||
| tential. An inhibition of | |||
| cell growth (ICG) of | |||
| more than 30% is con- | |||
| sidered as cytotoxic ef- | |||
| fect. | The cytotoxicity testing concluded that | ||
| test devices met the requirements of the | |||
| test and are not considered to have a cy- | |||
| totoxic potential. | |||
| ISO 17665-1:2006- | |||
| 08 | |||
| ISO TS 17665- | |||
| 2:2009-01 | |||
| ANSI/AAMI | |||
| ST77:2013 | Sterilization validation | Verify the device and | |
| cycle parameters | |||
| achieve a Sterility As- | |||
| surance Level (SAL) of | |||
| 10-6. | The tested devices achieved a SAL of 10-6 | ||
| after processing in pre-vacuum steam | |||
| sterilization cycle at 132°C for 4 minutes. | |||
| AAMI TIR12:2010 | Drying Time testing | Verify the device is | |
| properly dried using the | |||
| specified cycle parame- | |||
| ters. | The BEGO Semados® Trays are considered | ||
| properly dried following processing in | |||
| pre-vacuum steam sterilization cycle at | |||
| 132°C for 4 minutes, and drying time of | |||
| 20 minutes. |
Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® DSTr 58356, BEGO SEMADOS® PKTr 58357 Device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Straumann BLX Surgical Cassette.