Straumann BLX Surgical Cassette

K180791 · Institut Straumann AG · KCT · Jun 21, 2018 · General Hospital

Device Facts

• Record ID: K180791
• Device Name: Straumann BLX Surgical Cassette
• Applicant: Institut Straumann AG
• Product Code: KCT · General Hospital
• Decision Date: Jun 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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.

Device Story

BLX Surgical Cassette is a reusable container system for organizing and sterilizing dental surgical/prosthetic instruments. Components include lid, base, and tray made of polyphenylsulfone (Radel R5000) with silicone rubber grommets for instrument retention. Base and tray feature printed surgical workflow guides. Used in healthcare facilities; operated by clinical staff. Device holds instruments during manual or automated cleaning and steam sterilization cycles. Output is a sterilized, organized instrument set for surgical use. Benefits include standardized instrument management and protection during reprocessing. Requires use of external, validated sterilization wrap to maintain sterility post-process.

Clinical Evidence

No clinical data. Bench testing only. Validated cleaning (manual/automated) and sterilization (pre-vacuum steam 132°C for 4 minutes, 20 minutes drying) per ANSI/AAMI/ISO 17665-1 and AAMI TIR12:2010. Biocompatibility testing (cytotoxicity, chemical characterization) performed per ISO 10993-1, ISO 10993-5, and ISO 10993-18.

Technological Characteristics

Materials: Polyphenylsulfone (Radel R5000), silicone. Design: Perforated plastic tray/lid with silicone grommets. Sterilization: Moist heat (steam), pre-vacuum cycle (132°C, 4 min exposure, 20 min dry). Vent/volume ratio: 0.054 in²/in³. Reusable. No software or electronics.

Indications for Use

Indicated for use in healthcare facilities to organize, enclose, clean, sterilize, transport, and store medical devices between surgical uses. Not intended to maintain sterility; must be used with a validated sterilization wrap. Validated for a maximum load of 300 grams.

Regulatory Classification

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.

Predicate Devices

• Kit Boxes and Kit Plates (K163600)

Reference Devices

• Instrument kits (K160730)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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 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.

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*)

| <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|------------------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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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

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.

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 | K163600<br>Kit Boxes and Kit Plates | K160730<br>Instrument Kits |
| Intended Use | The Straumann BLX Cassette is used in<br>healthcare facilities to organize,<br>enclose, cleaning, sterilize, transport,<br>and store medical devices between<br>surgical uses. The BLX Cassette is not<br>intended to maintain sterility; it is<br>intended to be used in conjunction with<br>a legally marketed, validated<br>sterilization wrap. | The Nobel Biocare Kit Boxes are used<br>in healthcare facilities to organize,<br>enclose, sterilize, transport, and store<br>medical devices between surgical uses.<br>The Nobel Biocare Kit Boxes are not<br>intended on their own to maintain<br>sterility; it is intended to be used in<br>conjunction with a legally marketed,<br>validated, FDA-cleared sterilization<br>wrap. | The instrument kits are designed to hold<br>various dental surgical drills and tools in<br>order to organize, steam sterilize, and<br>protect the instruments that are<br>sterilized by healthcare provider. The<br>cassette is to be enclosed in an FDA<br>cleared steam sterilizable pouch. The<br>cassettes are not intended on their own<br>to maintain sterility. |
| Product Code | KCT | KCT | KCT |
| Design | Plastic tray and lid | Kit Box - Plastic tray and lid<br>Kit Plate - Silicone grommets and tool<br>holders | Plastic tray and lid |
| Materials | Polyphenylsulfone (Radel R5000)Silicon | AluminumPolymerSilicon | Polyphenylsulfone (Radel R5000,<br>Radel R5100)Medical grade siliconeStainless steel |
| Materials compatible<br>with<br>Sterilization Method | Yes | Yes | Yes |
| Perforated | Yes; allows moist heat (steam)<br>penetration to achieve sterilization | Yes; allows moist heat (steam)<br>penetration to achieve sterilization | Yes; allows moist heat (steam)<br>penetration to achieve sterilization |
| Enclosing feature | Silicone grommets | Silicone grommets | Silicone grommets |
| Reusable | Yes | Yes | Yes |
| Sterilization<br>Method | Moist heat (steam) | Moist heat (steam) | Moist heat (steam) |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE |
| | Subject Device | K163600<br>Kit Boxes and Kit Plates | K160730<br>Instrument Kits |
| Cycles | Pre-vacuum | Gravity-Displacement<br>Pre-vacuum | Pre-vacuum |
| Parameters | Pre-Vacuum:<br>132° C (270° F) for 4 minutes;<br>20 minutes drying time | Pre-Vacuum:<br>Temp 270° F<br>Exposure Time: 4 min<br>Pre-vacuum: 3 times < 60 mbar<br>Drying Time: 30 min<br>Cooling Time: 10 minutes at room<br>Temperature<br>Gravity:<br>Temp 270° F<br>Exposure Time: 15 min<br>Drying Time: 30 min<br>Cooling Time: 10 minutes at room<br>temperature | Pre-Vacuum:<br>134 °C during 3 min,<br>16 minutes drying time |
| Sterile Barrier | FDA cleared sterilization pouch | FDA cleared sterilization wrap/pouch | FDA cleared sterilization pouch |
| Vent/volume<br>ratio | 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.