(266 days)
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.
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 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 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 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.
The provided text is a 510(k) Summary for a medical device (BEGO Semados® Trays), which outlines non-clinical testing performed to demonstrate substantial equivalence to a predicate device. This type of document is not an academic study or research paper that involves AI algorithms or complex statistical analysis with human readers. Therefore, several of the requested categories are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test/Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| AAMI TIR30:2011 (Automated Cleaning - Protein) | Verify cleaning instructions are efficacious for removing gross amounts of soil to a residual protein level | Residual protein level of 6.4 µg protein/cm² | 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 - TOC) | Verify cleaning instructions are efficacious for removing gross amounts of soil to a total organic carbon content | Total organic carbon (TOC) content of 3.1 µg of C/cm² | The manufacturer's cleaning instructions are efficacious for removing gross amounts of soil to a total organic carbon (TOC) content of 3.1 µg of C/cm². |
| ISO 10993-5:2009 (Cell Growth Analysis) | Verify the device does not have a cytotoxic potential | Inhibition of cell growth (ICG) of more than 30% is considered as cytotoxic effect (i.e., less than or equal to 30% inhibition is acceptable) | The cytotoxicity testing concluded that test devices met the requirements of the test and are not considered to have a cytotoxic 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 Assurance Level (SAL) | 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 parameters | "Properly dried" (specific quantitative criteria for "properly dried" are not explicitly stated in the provided text, but it implies complete dryness with no visible moisture) | 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. (Note: Comparison table mentions 20-30 minutes for Drying time) |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical laboratory testing, not a clinical study with patient data. Therefore, the concept of a "test set" in the context of patient data, data provenance (country of origin, retrospective/prospective), and related terms are not applicable. The "test set" for these evaluations would be the physical devices and associated laboratory samples (e.g., inoculated materials for sterilization, cultured cells for cytotoxicity). The sample sizes for each specific test (e.g., number of devices tested for cleaning, number of biological indicators for sterilization) are not explicitly detailed in this summary, but implied to be sufficient for standard validation protocols of these benchmarks. The testing was conducted by BEGO Implant Systems GmbH & Co. KG, located in Bremen, Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the ground truth for these non-clinical tests is established by standardized laboratory methods and scientific principles, not by expert human graders or consensus on medical images/diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as there is no human adjudication for these types of non-clinical, objective laboratory tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a sterilization tray, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device (sterilization tray), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical tests described:
- Cleaning Validation (Protein & TOC): Ground truth is established by quantitative laboratory measurements of residual protein and total organic carbon using standardized assays.
- Cytotoxicity: Ground truth is established by cell culture assays measuring cell viability and proliferation, comparing effects of device extracts to controls.
- Sterilization Validation: Ground truth is established by biological indicators (BIs) that contain a known population of resistant microorganisms, and physical/chemical indicators, demonstrating the kill of all microorganisms to a specified probability (SAL).
- Drying Time Testing: Ground truth is established by visual inspection and/or quantitative measurement of residual moisture following sterilization cycles according to industry standards.
8. The sample size for the training set:
This is not applicable as the text describes non-clinical laboratory validation for a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above.
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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
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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)
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| 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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510(k) Summary K201412
| Submitter Information: | BEGO Implant Systems GmbH & Co. KGWilhelm-Herbst-Str. 128359 Bremen, GermanyPhone: +49 (0) 421 2028-246Fax: +49 (0) 421 2028-265Establishment Registration Number: 3008252251Owner/Operator Number: 10028/893 |
|---|---|
| Official Correspondent: | Kathleen Al-Kaissy, Regulatory Affairs ManagerBEGO Implant Systems GmbH & Co. KGPhone: +49 (0) 421 2028-338E-Mail: IM-RA@bego.com |
| Application Correspondent: | Bertrand Lecointe, Regulatory Affairs ManagerBEGO Implant Systems GmbH & Co. KGPhone: +49 (0) 421 2028-230E-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 |
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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 | Modelnumber | Product Code | |
|---|---|---|---|
| 1 | BEGO SEMADOS® Tr 58350 | 58350 | KCT |
| BEGO SEMADOS® RS/RSX-LINE TRAY PLUS | 57949 | Kit containingdevice KCT | |
| 2 | BEGO Semados® Tr 58349 | 58349 | KCT |
| BEGO Semados® Tr 58348 | 58348 | Kit containingdevice KCT | |
| 3 | BEGO Semados® DSTr 58356 | 58356 | KCT |
| DRILL STOP TRAY PLUS (RS/RSX-LINE) | 57483 | Kit containingdevice KCT | |
| 4 | BEGO SEMADOS® PKTr 58357 | 58357 | KCT |
| PROSTHETIC KIT | 55826 | Kit containingdevice 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.
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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-vacuumsteam | 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 |
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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
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| 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 offollowing lumen sizes and dimensions and has the maximum load forthe following device models: | ||||||
| Device Model | Type ofLumen | Numberof 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, L6.8 | |||
| BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados®DSTr 58356, BEGO SEMADOS® PKTr 58357 are offered in the followingsizes: | ||||||
| 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 |
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| 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 BEGOSemados® medical devices during both steam sterilization in an au-toclave and implant/ prosthetic treatments.BEGO Semados® Trays are not intended on their own to maintainsterility; they are intended to be used with a legally marketed, vali-dated, FDA-cleared sterilization pouch. | The Straumann BLX Cassette is used inhealthcare facilities to organize, enclose, ster-ilize, transport, and store medical devices be-tween surgical uses. The BLX Cassette is notintended to maintain sterility; it is intended toconjunction with a legally marketed, validatedsterilization wrap. | Identical | |
| Product Code | KCT | KCT | Identical | |
| Reusable | Yes | Yes | Identical | |
| SterilizationMethod | 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 58356BEGO SEMADOS® PKTr 58357 | 137 g220 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/in³BEGO Semados® DSTr 58356 0.601 in²/in³BEGO SEMADOS® PKTr 58357 0.241 in²/in³ | ||||
| Device Construction | BEGO SEMADOS® Tr 58350/ BEGO Semados® Tr 58349:Plastic tray, lid and insertBEGO 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/ PolydimethylsiloxaneBEGO 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 |
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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 CleaningValidation – ProteinAnalysis | Verify cleaning instruc-tions provided are effi-cacious for removinggross amounts of soil toa residual protein levelof 6.4 µg protein/cm² | The automated cleaning validation ofBEGO Semados® Trays concluded that themanufacturer's cleaning instructions areefficacious for removing gross amounts ofsoil to a residual protein level of 6.4 µgprotein/cm². |
| AAMI TIR30:2011 | Automated CleaningValidation - OrganicCarbon Analysis | Verify cleaning instruc-tions provided are effi-cacious for removinggross amounts of soil toa total organic carbon(TOC) content of 3.1 µgof C/cm² | The automated cleaning validation ofBEGO Semados® Trays concluded that themanufacturer's cleaning instructions areefficacious for removing gross amounts ofsoil to a total organic carbon (TOC) con-tent of 3.1 µg of C/cm2. |
| ISO 10993-5:2009 | Cell Growth Analysisvia XTT-Staining | Verify the device doesnot have a cytotoxic po-tential. An inhibition ofcell growth (ICG) ofmore than 30% is con-sidered as cytotoxic ef-fect. | The cytotoxicity testing concluded thattest devices met the requirements of thetest and are not considered to have a cy-totoxic potential. |
| ISO 17665-1:2006-08ISO TS 17665-2:2009-01ANSI/AAMIST77:2013 | Sterilization validation | Verify the device andcycle parametersachieve a Sterility As-surance Level (SAL) of10-6. | The tested devices achieved a SAL of 10-6after processing in pre-vacuum steamsterilization cycle at 132°C for 4 minutes. |
| AAMI TIR12:2010 | Drying Time testing | Verify the device isproperly dried using thespecified cycle parame-ters. | The BEGO Semados® Trays are consideredproperly dried following processing inpre-vacuum steam sterilization cycle at132°C for 4 minutes, and drying time of20 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.
§ 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).