The Straumann BLX Cassette is used in healthcare facilities to organize, cleaning, sterilize, transport, and store medical devices between surgical uses. The BLX Cassette is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated sterilization wrap.

Device Description

The BLX Surgical Cassette is a container composed of three main components: a lid, a cassette base and a tray, all made of polyphenylsulfone (Radel R5000). The base and the tray have silicone rubber grommets to hold the instruments. The base and tray are printed to indicate the surgical workflow and the position of the instruments within the cassette.

AI/ML Overview

This is a 510(k) summary for a medical device (Straumann BLX Surgical Cassette), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria in terms of an AI algorithm's performance.

Therefore, many of the requested sections about AI algorithm performance, sample sizes for test/training sets, expert consensus, and MRMC studies are not applicable or cannot be extracted from this document. The document describes non-clinical testing for the cassette's cleaning, sterilization, and biocompatibility.

I will fill in the applicable information based on the provided text, and mark sections as "N/A" (Not Applicable) when the information pertains to AI algorithm studies which are not relevant to this document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Study Focus)	Reported Device Performance (Summary)
Cleaning Validation:	Demonstrated effectiveness of recommended manual and automated cleaning processes.
Sterilization Validation:	Achieved a Sterility Assurance Level (SAL) of ≥10⁻⁶ using the biological indicator (BI) overkill method. Dry times were validated.
Biocompatibility:	Biocompatible for its intended use, based on in vitro cytotoxicity and chemical characterization studies.

2. Sample size used for the test set and the data provenance

N/A. This document describes non-clinical laboratory testing of a physical medical device (a surgical cassette) for its cleaning, sterilization, and biocompatibility, not an AI algorithm. Therefore, "test set" and "data provenance" (in the context of AI data) are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. Ground truth in the context of expert consensus for AI interpretation is not relevant here. The ground truth for the cleaning was determined by assays measuring residual soil, sterilization by BI overkill method for SAL, and biocompatibility by standard in-vitro and chemical characterization. These are standard laboratory methods, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

N/A. Adjudication methods (e.g., 2+1) are typically used for establishing ground truth in AI studies. This document discusses laboratory testing, not human judgment for a test set.

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

N/A. MRMC studies are used to evaluate diagnostic performance of AI or human readers, which is not relevant for this device (a surgical cassette).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This document pertains to a physical medical device, not a standalone AI algorithm.

7. The type of ground truth used

The ground truth or validation methods used were:

Cleaning: Efficacy evaluated through laboratory methods demonstrating the removal of simulated soil on the device.
Sterilization: Sterility Assurance Level (SAL) of ≥10⁻⁶ was validated using the biological indicator (BI) overkill method according to ANSI/AAMI/ISO 17665-1. Dry times were validated according to AAMI TIR12:2010.
Biocompatibility: Evaluated based on ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1) and FDA guidance, including in vitro cytotoxicity according to ISO 10993-12 and ISO 10993-5, and chemical characterization according to ISO 10993-12 and 10993-18.

8. The sample size for the training set

N/A. There is no AI algorithm training set for this medical device.

9. How the ground truth for the training set was established

N/A. Not applicable as there is no AI algorithm training set.

Summary

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Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs & Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K180791

Trade/Device Name: Straumann BLX Surgical Cassette Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: March 27, 2018 Received: March 27, 2018

Dear Jennifer Jackson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 W. Murray lii III -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180791

Device Name Straumann BLX Surgical Cassette

Indications for Use (Describe)

The BLX Cassette has been validated for a maximum load of 300 grams, including cassette and instruments.

Sterilization parameters: Pre-vacuum steam: 132°C (270° F) for 4 minutes with 20 minutes drying time.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Straumann® BLX Surgical Cassette

510(k) Summary

1 510(k) Summary

Submitter's Contact Information 1.1

Straumann USA, LLC (on behalf of Institut Straumann AG)

60 Minuteman Road

Andover, MA 01810

Phone Number:	1-978-747-2509
Fax Number:	1-978-747-0023
Contact Person:	Jennifer M. Jackson, MS
Preparer / Alternate Contact:	Ana Carolina Martins Vianna
Preparer / Alternate Contact:	Viviana Horhoiu
Date of Submission:	June 20, 2018

Name of the Device 1.2

Trade Names:	Straumann® BLX Surgical Cassette
Common Name:	BLX Surgical Cassette
Classification Name:	Sterilization wrap
Regulation Number:	21 CFR 880.6850
Classification:	Class II
Product Codes:	КСТ

1.3 Predicate Device(s)

Primary Predicate:

K163600 Kit Boxes and Kit Plates, Nobel Biocare AB .
Reference Devices:
K160730 Instrument kits, Anthogyr .

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Straumann® BLX Surgical Cassette

510(k) Summary

1.4 Device Description

New surgical and prosthetic instruments have been developed to accommodate the new Straumann® BLX Implant System, a line of endosseous dental implants and abutments that are not subject devices to this submission. These new instruments are used for implant bed preparation and abutment removal (if necessary after placement). These devices are all Class I exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices to this submission. The cassette, along with a complete load of instruments, weights 300 g.

1.5 Indications for Use

The Straumann BLX Cassette is used in healthcare facilities to organize, enclose, cleaning, sterilize, transport, and store medical devices between surgical uses. The BLX Cassette is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated sterilization wrap.

The BLX Cassette has been validated for a maximum load of 300 grams, including cassette and instruments.

Sterilization parameters:

Pre-vacuum steam: 132°C (270° F) for 4 minutes with 20 minutes drying time.

Comparison of Technological Characteristics 1.6

The subject and primary predicate devices share the following characteristics:

. Intended Use
Design ●
Sterilization Method and Parameters ●
Reusable

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Straumann® BLX Surgical Cassette

510(k) Summary

The subject devices are technologically different from the primary predicate devices as follows:

. Material
Vent / volume ratio .

Nevertheless, the technological characteristics were evaluated through non-clinical testing.

Table 1 provides a comparison matrix of the features of primary predicate, reference and subject devices:

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Straumann® BLX Surgical Cassette

510(k) Summary

The technological characteristics of the subject device are compared to the primary predicate and reference device in the following:

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE
	Subject Device	K163600Kit Boxes and Kit Plates	K160730Instrument Kits
Intended Use	The Straumann BLX Cassette is used inhealthcare facilities to organize,enclose, cleaning, sterilize, transport,and store medical devices betweensurgical uses. The BLX Cassette is notintended to maintain sterility; it isintended to be used in conjunction witha legally marketed, validatedsterilization wrap.	The Nobel Biocare Kit Boxes are usedin healthcare facilities to organize,enclose, sterilize, transport, and storemedical devices between surgical uses.The Nobel Biocare Kit Boxes are notintended on their own to maintainsterility; it is intended to be used inconjunction with a legally marketed,validated, FDA-cleared sterilizationwrap.	The instrument kits are designed to holdvarious dental surgical drills and tools inorder to organize, steam sterilize, andprotect the instruments that aresterilized by healthcare provider. Thecassette is to be enclosed in an FDAcleared steam sterilizable pouch. Thecassettes are not intended on their ownto maintain sterility.
Product Code	KCT	KCT	KCT
Design	Plastic tray and lid	Kit Box - Plastic tray and lidKit Plate - Silicone grommets and toolholders	Plastic tray and lid
Materials	Polyphenylsulfone (Radel R5000)Silicon	AluminumPolymerSilicon	Polyphenylsulfone (Radel R5000,Radel R5100)Medical grade siliconeStainless steel
Materials compatiblewithSterilization Method	Yes	Yes	Yes
Perforated	Yes; allows moist heat (steam)penetration to achieve sterilization	Yes; allows moist heat (steam)penetration to achieve sterilization	Yes; allows moist heat (steam)penetration to achieve sterilization
Enclosing feature	Silicone grommets	Silicone grommets	Silicone grommets
Reusable	Yes	Yes	Yes
SterilizationMethod	Moist heat (steam)	Moist heat (steam)	Moist heat (steam)
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE
	Subject Device	K163600Kit Boxes and Kit Plates	K160730Instrument Kits
Cycles	Pre-vacuum	Gravity-DisplacementPre-vacuum	Pre-vacuum
Parameters	Pre-Vacuum:132° C (270° F) for 4 minutes;20 minutes drying time	Pre-Vacuum:Temp 270° FExposure Time: 4 minPre-vacuum: 3 times < 60 mbarDrying Time: 30 minCooling Time: 10 minutes at roomTemperatureGravity:Temp 270° FExposure Time: 15 minDrying Time: 30 minCooling Time: 10 minutes at roomtemperature	Pre-Vacuum:134 °C during 3 min,16 minutes drying time
Sterile Barrier	FDA cleared sterilization pouch	FDA cleared sterilization wrap/pouch	FDA cleared sterilization pouch
Vent/volumeratio	0.054 in²/in³	Information not available.	0.049 in²/in³

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Straumann® BLX Surgical Cassette

510(k) Summary

Table 1 – Comparison of subject device versus predicate device

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Straumann® BLX Surgical Cassette

510(k) Summary

Non-Clinical Testing 1.7

The performance during multiple reprocessing steps for the Straumann BLX Surgical Cassette, as recommended in the labeling, was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".

Cleaning and Sterilization Validation

The subject device is a multiple-use device provided non-sterile which needs to be end user sterilized. The cleaning and sterilization procedures reflect the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".

Both manual and automated cleaning methods were validated and demonstrated the effectiveness of the recommended manual and automated cleaning processes.

Sterilization Validation

The sterilization parameters have been validated to a sterility assurance level (SAL) of ≥10° using the biological indicator (BI) overkill method according to ANSI/AAMI/ISO 17665-1 "Sterilization of health care products - Moist heat - Part1: Requirements for the development, validation, and routine control of a sterilization process for medical devices". In addition to the SAL validation, dry times were validated using full cycle parameters according to AAMI TIR12:2010 "Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers".

Biocompatibility

The biological assessment of the BLX Cassette was performed according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and the biocompatibility evaluation flow chart according to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016".

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Straumann® BLX Surgical Cassette

510(k) Summary

The following biocompatibility studies were conducted:

In vitro cytotoxicity according to ISO 10993-12 and ISO 10993-5 .
. Chemical characterization according to ISO 10993-12 and 10993-18

Results of conducted studies based upon the biological safety profile of the BLX surgical cassette show that they are biocompatible for their intended use.

1.8 Conclusion

Based on the intended use, technological characteristics, performance data, and nonclinical tests performed are substantially equivalent to, and are as safe and as effective as, the legally marketed predicate device, cleared under K163600 under regulation 21 CFR 880.6850, product code KCT.

Regulation Number and Section

§ 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).