Who is the manufacturer of Straumann Surgical Cassettes?

Straumann USA, LLC filed the 510(k) submission for Straumann Surgical Cassettes (K203753).

What is the FDA product code for Straumann Surgical Cassettes?

KCT. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Straumann Surgical Cassettes?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Straumann Surgical Cassettes?

Straumann BLX Surgical Cassette (K180791).

Who can help prepare an FDA 510(k) submission like Straumann Surgical Cassettes?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Straumann Surgical Cassettes

K203753 · Straumann USA, LLC · KCT · Jul 29, 2021 · General Hospital

Device Facts

Record ID	K203753
Device Name	Straumann Surgical Cassettes
Applicant	Straumann USA, LLC
Product Code	KCT · General Hospital
Decision Date	Jul 29, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Intended Use

The Straumann Cassettes are intended to store, organize and reprocess surgical instruments and auxiliaries of the Straumann® Dental Implant System during implant/prosthetic treatment and sterilization.

Device Story

Reusable rigid containers; base, inner tray, and lid; designed to hold dental surgical drills/tools. Perforated design allows steam penetration; requires FDA-cleared sterilization pouches for sterility maintenance. Used in healthcare facilities by professionals; organizes instruments for sterilization and transport. Trays feature pictograms/color-coded workflows for instrument positioning. Protects instruments during sterilization and storage; facilitates efficient surgical workflows; ensures sterility of dental implant system components.

Clinical Evidence

Bench testing only. Validated per AAMI TIR 30:2011 for manual and automated cleaning (protein/hemoglobin residue limits met). Sterilization validated per ISO 17665-1:2006/(R)2013 (SAL ≤10⁻⁶). Life-cycle testing confirmed functionality after 100 cleaning/sterilization cycles. Biocompatibility confirmed per ISO 10993-1 and ISO 10993-5 (non-cytotoxic).

Technological Characteristics

Reusable rigid containers made of Polyphenylsulfone (Radel 5000), Tecapro MT, Propylux, EUROPLEX PPSU, and PP HS2. Stainless steel used for lid hinges. Perforated design for steam sterilization. Dimensions/form factor vary by cassette type. No electronic components or software.

Indications for Use

Indicated for healthcare professionals in healthcare facilities to organize, sterilize, and transport surgical instruments and auxiliaries. Must be enclosed in two layers of FDA-cleared sterilization pouches. Validated for pre-vacuum steam sterilization at 132°C for 4 minutes with 30 minutes drying time. Maximum load limits: 1005g (Surgical), 2007g (Osteotome), 283g (Bone Block Fixation), 65g (Screw Container).

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

Straumann BLX Surgical Cassette (K180791)

Reference Devices

Straumann Modular Surgical Cassette (K191522)

Related Devices

K142519 — InterActive Complete Surgical Tray · Implant Direct Sybron Manufacturing, LLC · Apr 15, 2015
K191566 — Avinent Surgical Tray · Avinent Implant System S.L.U. · Mar 6, 2020
K203618 — Neodent EasyGuide Kit Cases · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Mar 9, 2021
K214051 — Neodent Implant System-Helix NGM Compact Surgical Kit Cases · JJGC Indústria e Comércio de Materiais Dentários S.A. · Apr 13, 2022
K210923 — Southern Implants Instrument Trays · Southern Implants (Pty), Ltd. · Mar 2, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 29, 2021 Straumann USA, LLC Jennifer Jackson Director, Regulatory Affairs 60 Minuteman Rd Andover, Massachusetts 01810 Re: K203753 Trade/Device Name: Straumann Surgical Cassettes Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 25, 2021 Received: June 28, 2021 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. 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, for Clarence W. Murray, III, PhD 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) K203753 Device Name Straumann® Surgical Cassettes #### Indications for Use (Describe) The Straumann Cassettes are used to organize, sterilize and transport surgical instruments and auxiliaries between and during surgical uses. They are indicated to be used in healthcare facilities by healthcare professionals. The Straumann Cassettes are to be enclosed in FDA cleared sterilization pouches in two layers to maintain the sterility of the enclosed devices using the following sterilization parameters: pre-vacuum steam exposure at 132°C (270° F) for 4 minutes, 30 minutes drying time. The Straumann Cassettes have been validated for a maximum load of 1005 grams for the Surgical Cassettes, 2007 grams for the Osteotome Cassettes, 283 grams for the Bone Block Fixation Cassette and 65 grams for the Screw Container, including cassette and instruments. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| Residential Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | | 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." {3}------------------------------------------------ # Straumann® Surgical Cassettes 510(k) Summary ## 510(k) Summary ### Submitter's Contact Information | Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810 Registration No.: 1222315 Owner/Operator No.: 9005052 | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jennifer M. Jackson, MS Director of Regulatory Affairs and Quality Phone Number: +1 978 747-2509 Fax Number: +1 978 747-0023 | | Prepared By & Alternate Contact: | Chanrasmey White, MS Regulatory Affairs Specialist Straumann, USA, LLC | | Date of Submission: | July 29, 2021 | #### Name of the Device | Trade Names: | Straumann® Surgical Cassettes | |------------------------|------------------------------------------------------------------------| | Common Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | | Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | | Regulation Number: | §880.6850 | | Device Classification: | II | | Product Code(s): | KCT | | Classification Panel: | General Hospital | ### Predicate Device(s) Primary Predicate: - . K180791 – Straumann BLX Surgical Cassette (Institut Straumann AG) {4}------------------------------------------------ ### Straumann® Surgical Cassettes 510(k) Summary Reference Devices: - K191522 Straumann Modular Surgical Cassette (Institut Straumann AG) . #### Device Description Straumann® Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, sterilize and protect the instruments that are sterilized by the healthcare provider. The subject devices consist of reusable rigid containers, comprising of a case bottom (base), a removable inner tray base (tray), and tray lid (lid). The case base, tray base, and tray lid are designed to be integrated into a single unit which contains and protects the interior components during sterilization and subsequent storage. The tray lid latches to the case bottom is designed to secure the kit into a single unit. The kits are perforated to allow for penetration of the moist heat (steam) sterilant and require the use of an FDA-cleared wrap to maintain sterility. To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays and modules have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical and prosthetic instruments of the Straumann® Dental Implant System intended to be placed in the Straumann® Surgical Cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Straumann® Dental Implant System. These devices are all Class I exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission. In addition, the Straumann Screw Container is included in this submission. The Straumann Screw Container is used for storing and sterilizing closure screws and healing caps. All the closure screws and healing caps that may be contained in the Screw Container are cleared Class II devices according to 21 CFR 872.3630 (Endosseous dental implant abutment) and are not subject devices of this submission. #### Intended Use The Straumann Cassettes are intended to store, organize and reprocess surgical instruments and auxiliaries of the Straumann® Dental Implant System during implant/prosthetic treatment and sterilization. {5}------------------------------------------------ ### Straumann® Surgical Cassettes 510(k) Summary #### Indications for Use The Straumann Cassettes are used to organize, sterilize and transport surgical instruments and auxiliaries between and during surgical uses. They are indicated to be used in healthcare facilities by healthcare professionals. The Straumann Cassettes are to be enclosed in FDA cleared sterilization pouches in two layers to maintain the sterility of the enclosed devices using the following sterilization parameters: prevacuum steam exposure at 132°C (270° F) for 4 minutes, 30 minutes drying time. The Straumann Cassettes have been validated for a maximum load of 1005 grams for the Surgical Cassettes, 2007 grams for the Osteotome Cassettes, 283 grams for the Bone Block Fixation Cassette and 65 grams for the Screw Container, including cassette and instruments. #### Technological Characteristic Comparison The subject and predicate device share the following characteristics: - Equivalent indications for use . - . Equivalent design - ldentical sterilization method . - . Equivalent sterilization parameters - . Reusable The subject device is technologically different from the predicate device as follows: - . Materials (the only part of the cassette made out of stainless steel is the lid hinge) - Vent-to-Volume ratio . - . Drying time The technological characteristics of the subject devices are compared to the predicate devices in Table 1. {6}------------------------------------------------ # Straumann® Surgical Cassettes 510(k) Summary | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | COMPARISON | |---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------| | K Number | K203753 | K180791 | K191522 | | | Indications for Use | The Straumann Cassettes are used to organize, store, sterilize and transport surgical instruments and auxiliaries between and during surgical uses. They are indicated to be used in healthcare facilities by healthcare professionals. The Straumann Cassettes are to be enclosed in FDA cleared sterilization pouches in two layers to maintain the sterility of the enclosed devices using the following sterilization parameters: pre-vacuum steam exposure at 132°C (270° F) for 4 minutes, 30 minutes drying time. The Straumann Cassettes have been validated for a maximum load of 1005 grams for the Surgical Cassettes, 2007 grams for the Osteotome Cassettes, 283 grams for the Bone Block Fixation Cassette and 65 grams for the Screw Container, including cassette and instruments. | 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. | Straumann® Modular Cassette is used in healthcare facilities to organize, enclose, sterilize, transport and store Straumann instruments between surgical uses. Straumann® Modular Cassette is not intended to maintain sterility on its own, but is intended to be used in conjunction with a legally marketed, validated sterilization double pouch to maintain the sterility of the enclosed devices. The Straumann® Modular Cassette has been validated for the following maximum loads: Module A 400gBCC Maximum permissible stack BCC 611gThe A module is intended to be sterilized individually, without stacking with other modules. The B and C module are intended to be sterilized individually, or by stacking the B module on top of C module bases. The maximum permissible stack for sterilization is one B module on top of two C module bases. The B module lid and C module lid could be used to enclose an ultrasonic mat (Art. No. 041.774) for ultrasonic bath cleaning used instruments. Only use the following sterilization parameters: Fractionated vacuum: 132°C (270 °F) for 4 minutes with 30 minutes drying time | Similar | | Product Code | KCT | KCT | KCT | Same | | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | COMPARISON | | K Number | K203753 | K180791 | K191522 | | | Design | Reusable rigid container, case bottom (base), a removable inner tray base (tray), and tray lid (lid). | Plastic tray and lid | Plastic modules, trays and lids | Similar | | Materials | Polyphenylsulfone (Radel 5000) Tecapro MT, Propylux Silicone Stainless Steel EUROPLEX® PPSU 99050 GT, grey PP HS2 WHV200 WM, white | Polyphenylsulfone (Radel R5000) Silicone | Polyphenylsulfone Silicone Stainless Steel | Similar | | Materials compatible with sterilization Method | Yes | Yes | Yes | Same | | 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 | Same | | Reusable | Yes, up to 100x | Yes, up to 100x | Yes, up to 100x | Same | | Sterilization method | Moist heat (steam) | Moist heat (steam) | Moist heat (steam) | Same | | Cycles | Pre-vacuum | Pre-vacuum | Fractionated vacuum | Same as K180791 | | Parameters | Pre-Vacuum: 132º C (270º F) for 4 minutes; 30 minutes drying time | Pre-Vacuum: 132º C (270º F) for 4 minutes; 20 minutes drying time | Fractionated vacuum: 132°C (270 °F) for 4 minutes; 30 minutes drying time | Same as K180791 | | Sterile barrier | FDA cleared sterilization pouch | FDA cleared sterilization pouch | FDA cleared sterilization pouch | Same | | Biocompatibility | The Biocompatibility assessment was performed per ISO 10993-1 and testing was performed using methods described in ISO 10993-5. The results indicate that the subject devices are non-cytotoxic. | The Biocompatibility assessment was performed per ISO 10993-1 and testing was performed using methods described in ISO 10993-5. The results indicate that the subject devices are non-cytotoxic. | The Biocompatibility assessment was performed per ISO 10993-1 and testing was performed using methods described in ISO 10993-5. The results indicate that the subject devices are non-cytotoxic. | Same | {7}------------------------------------------------ # Straumann® Surgical Cassettes 510(k) Summary Table 1 – Comparison Matrix {8}------------------------------------------------ ### Traditional 510(k) Submission ## Straumann® Surgical Cassettes 510(k) Summary ### Performance Testing The performance during multiple reprocessing steps for the Straumann® Surgical Cassettes, 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". The worst-case cassettes were tested for performance based on critical impact factors including weight, vent to volume ratio and worstcase instruments to be contained. The summary of testing performed is provided in Table 2. | Type of Testing | Purpose | Acceptance Criteria | Result | |----------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Manual Cleaning Validation (AAMI TIR 30:2011) | Evaluate and validate the manual cleaning of the subject devices | • No visible soil • Amount of protein per sample <100 µg • Amount of protein/cm² <3.0 µg/cm² • Amount of hemoglobin/cm² <2.2 µg/cm² | Pass | | Automated Cleaning Validation (AAMI TIR 30:2011) | Evaluate and validate the automated cleaning of the subject devices | • No visible soil • Amount of protein per sample <100 µg • Amount of protein/cm² <3.0 µg/cm² • Amount of hemoglobin/cm² <2.2 µg/cm² | Pass | | Sterilization Validation (ISO 17665- 1:2006/(R)2013) | Validate a sterilization cycle and drying time of the subject devices | • SAL ≤10⁻⁶ using the biological indicator (BI) overkill method | Pass | | Reprocessing of Medical Devices in a Health Care Setting | Life Cycle (simulated use) testing after 100 cleaning and sterilization cycles | • Test samples must withstand 100 cycles of use (cleaning, sterilization, and functional tests) without compromising function | Pass | {9}------------------------------------------------ # Traditional 510(k) Submission # Straumann® Surgical Cassettes 510(k) Summary | Biocompatibility (ISO 10993-5) | Cytotoxicity Testing | • Viability of cultures treated with test extracts >70% | Pass | |-----------------------------------|----------------------|---------------------------------------------------------------|------| |-----------------------------------|----------------------|---------------------------------------------------------------|------| #### Table 2 – Performance testing summary ### Conclusion The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K203753, Straumann Surgical Cassettes, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K180791 and K191522.