Anthogyr INTEGRAL Guided Surgery Cassettes

K233264 · Anthogyr · KCT · Dec 22, 2023 · General Hospital

Device Facts

• Record ID: K233264
• Device Name: Anthogyr INTEGRAL Guided Surgery Cassettes
• Applicant: Anthogyr
• Product Code: KCT · General Hospital
• Decision Date: Dec 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Anthogyr Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.

Device Story

Anthogyr INTEGRAL Guided Surgery Cassettes are reusable rigid containers designed for organizing, protecting, and steam sterilizing dental surgical instruments. The device consists of a base, removable inner trays, and a lid. Trays feature medical-grade silicone brackets to secure instruments and include color-coded markings or pictograms to guide surgical workflows. Used in clinical settings by healthcare professionals, the cassettes are loaded with instruments and placed inside an FDA-cleared steam sterilizable pouch before undergoing a pre-vacuum steam sterilization cycle (132°C for 4 minutes, 30 minutes drying). The cassettes do not maintain sterility independently. By organizing instruments and facilitating standardized sterilization, the device supports efficient surgical procedures and ensures instrument protection during reprocessing.

Clinical Evidence

Bench testing only. Validation included manual and automated cleaning (blood soil residuals), sterilization efficacy (ISO 17665-1), life-cycle testing (100 cycles of use), and biocompatibility (ISO 10993-5 cytotoxicity). All tests met acceptance criteria.

Technological Characteristics

Materials: Polyphenylsulfone (Radel R-5000/R-5100), medical-grade silicone, stainless steel. Form factor: Reusable rigid container (290x176x62 mm). Sterilization: Pre-vacuum steam (132°C, 4 min exposure, 30 min dry). Perforated design for steam penetration. Biocompatibility: Non-cytotoxic per ISO 10993-5.

Indications for Use

Indicated for use by healthcare providers to organize, steam sterilize, and protect dental surgical drills and tools. The device is intended for use in a clinical setting and must be enclosed in an FDA-cleared steam sterilizable pouch to maintain sterility.

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 Surgical Cassettes (K203753)

Submission Summary (Full Text)

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December 22, 2023

Anthogyr % Jennifer Jackson Senior Director, Regulatory & Quality NAM The Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801

Re: K233264

Trade/Device Name: Anthogyr INTEGRAL Guided Surgery Cassettes Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 28, 2023 Received: September 29, 2023

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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)

K233264

Device Name

Anthogyr INTEGRAL Guided Surgery Cassettes

Indications for Use (Describe)

The Anthogyr Cassettes are designed to hold various derills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.

The cycle of sterilization, for Anthogyr INTEGRAL Gurgery Cassettes, uses pre-vacuum steam: 132 °C (270° F) during 4 minutes with 30 minutes drying time.

Anthogyr INTEGRAL Guided Surgery Cassettes have been validated for a maximum load of with the worstcase recommended load is: 886 g.

The device dimension of Anthogyr INTEGRAL Guided Surgery Cassettes is 290x176x62 mm.

The cassettes are not intended to be stacked during sterilization process.

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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## Anthogyr INTEGRAL Guided Surgery Cassettes

510(k) Summary K233264

#### 510(k) Summary - K233264 5

#### Submitter's Contact Information 5.1

| Submitter: | Straumann USA, LLC (on behalf of Anthogyr)<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315 Owner/Operator No.: 9005052<br>On the behalf of:<br>Anthogyr<br>2237 Av. André Lasquin,<br>74700 Sallanches, France |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS<br>Sr Dir, Regulatory & Quality NAM<br>Phone Number: [phone]<br>Fax Number: [phone] |
| Prepared By &<br>Alternate Contact: | Aude GOULET<br>Regulatory Affairs Project Manager<br>Anthogyr<br>Phone number: [phone] |
| Date of Submission: | 28/09/2023 |

#### Name of the Device 5.2

| Trade Names: | Anthogyr INTEGRAL Guided Surgery Cassettes |
|------------------------|---------------------------------------------------------------------|
| Common Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Classification Name: | Sterilization Wrap |
| Regulation Number: | 21 CFR 880.6850 |
| Device Classification: | II |
| Product Code(s): | KCT |
| Classification Panel: | General Hospital |
| Proprietary Name: | Anthogyr INTEGRAL Guided Surgery Cassettes |

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## Anthogyr INTEGRAL Guided Surgery Cassettes

510(k) Summary K233264

#### Predicate Device(s) 5.3 -

Primary Predicate:

- K203753 Straumann Surgical Cassettes .

| Product Code(s): | KCT |
|------------------------|--------------------|
| Device Classification: | II |
| Classification name | Sterilization Wrap |
| Regulation Number: | 21 CFR 880.6850 |

### 5.4 Device Description

Anthoqyr cassettes are reusable rigid containers, comprising a case bottom (base), one or more removable inner tray base (tray) and a tray lid (lid). The trays are composed of brackets made of medical grade silicone, namely brackets used to maintain the Anthogyr dental instruments in place during the surgical or prosthetic procedure and during sterilization. The base and trays have markings and/or colors code to indicate either the surgical workflow, or the position of the instruments in the kit. The lid holds all the instruments securely in place during treatment. To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical instruments of the Anthogyr Dental Implant System intended to be placed in the Anthogyr cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Anthogyr Dental Implant System. These devices are all Class I exempt or already have class II pre-market notification clearance as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission.

### Intended Use

Anthogyr cassettes are intended to organize instruments, and secure instruments during the sterilization phase.

#### 5.5 Indications for Use

The Anthogyr Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider.

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## Anthogyr INTEGRAL Guided Surgery Cassettes

### 510(k) Summary K233264

The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.

The cycle of sterilization, for Anthogyr INTEGRAL Guided Surgery Cassettes, uses pre-vacuum steam: 132 °C (270° F) during 4 minutes with 30 minutes drying time.

Anthogyr INTEGRAL Guided Surgery Cassettes have been validated for a maximum load of with the associated instrument. The worst-case recommended load is: 886 g.

The device dimension of Anthogyr INTEGRAL Guided Surgery Cassettes is 290x176x62 mm.

The cassettes are not intended to be stacked during sterilization process.

#### Technological Characteristics 5.6

The subject devices and primary predicate devices as K203753 share the following characteristics:

- o ldentical indications for use
- ldentical Product code o
- Identical Design
- o Equivalent Material
- Identical Materials compatible with sterilization method ●
- Identical Perforated o
- ldentical Reusable ●
- . Identical Sterilization Method
- . ldentical Cycles
- Identical Parameters ●
- o ldentical Sterile Barrier
- Identical Biocompability ●

The main differences between the primary predicate device (K203753) with the integral guided surgery cassettes subject devices are in the Table 1:

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## Anthogyr INTEGRAL Guided Surgery Cassettes

510(k) Summary K233264

| | Dimensions | Max weight loaded |
|---------------------------------------------------------|----------------------|-------------------|
| Primary Predicate<br>Device<br>K203753 | 290mm x 176mm x 60mm | 1005g |
| Integral guided surgery<br>cassettes subject<br>devices | 290mm x 176mm x 62mm | 886g |

### Table 1 – Differences between the primary predicate device with the integral guided surgery cassettes subject devices

The technological characteristics of the subject devices are compared to the primary predicate and primary predicate device in the Table 2.

| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICES | |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K23XXXX | K203753 | |
| | Anthogyr INTEGRAL Guided Surgery<br>Cassettes | Straumann Surgical Cassettes | Equivalence<br>discussion |
| Indications for<br>Use | The Anthogyr Cassettes are designed to<br>hold various dental surgical drills and<br>tools in order to organize, steam<br>sterilize, and protect the instruments<br>that are sterilized by healthcare<br>provider. The cassette is to be enclosed<br>in an FDA cleared steam sterilizable<br>pouch. The cassettes are not intended<br>on their own to maintain sterility.<br>The cycle of sterilization, for Anthogyr<br>INTEGRAL Guided Surgery Cassettes,<br>uses pre-vacuum steam: 132 °C (270°<br>F) during 4 minutes with 30 minutes<br>drying time.<br>Anthogyr INTEGRAL Guided Surgery<br>Cassettes have been validated for a<br>maximum load of with the associated<br>instrument. The worst-case<br>recommended load is: 886 g.<br>The device dimension of Anthogyr<br>INTEGRAL Guided Surgery Cassettes<br>is 290x176x62 mm.<br>The cassettes are not intended to be<br>stacked during sterilization process. | 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 sterilized<br>by healthcare provider. The cassette is<br>to be enclosed in an FDA cleared steam<br>sterilizable pouch. The cassettes are not<br>intended on their own to maintain sterility<br>The Straumann Cassettes are used to<br>organize, store, sterilize and transport<br>surgical instruments and auxiliaries<br>between and during surgical uses. They<br>are indicated to be used in healthcare<br>facilities by healthcare professionals.<br>The Straumann Cassettes are to be<br>enclosed in FDA cleared sterilization<br>pouches in two layers to maintain the<br>sterility of the enclosed devices using the<br>following sterilization parameters: pre-<br>vacuum steam exposure at 132°C (270°<br>F) for 4 minutes, 30 minutes drying time.<br>The Straumann Cassettes have<br>been validated for a maximum load of<br>1005 grams for the Surgical Cassettes,<br>2007 grams for the Osteotome<br>Cassettes, 283 grams for the Bone Block<br>Fixation Cassette and 65 grams for the<br>Screw Container, including cassette and<br>instruments | Identical<br>The subject cassette<br>devices have the<br>same indication of use<br>as the primary<br>predicate. |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICES | |
| | K23XXXX | K203753 | |
| | Anthogyr INTEGRAL Guided Surgery<br>Cassettes | Straumann Surgical Cassettes | Equivalence<br>discussion |
| Product code | KCT | KCT | Identical<br>The subject cassette<br>devices have the<br>same product code as<br>the primary predicate<br>and the reference<br>predicate. |
| Design | Reusable rigid container, case bottom<br>(base), a removable inner tray base<br>(tray), and tray lid (lid). | Reusable rigid container, case bottom<br>(base), a removable inner tray base<br>(tray), and tray lid (lid). | Identical<br>The subject cassettes<br>have the same design<br>as the primary<br>predicate device. |
| Dimensions | 290x176x62 mm | 290mm x 76mm x 60mm<br>290.10mmx174.50mmx53 mm<br>130mmx118mmx25mm<br>68.5mmx46.5mmx 22.2mm | Identical<br>The subject cassette<br>devices have the<br>same dimensions as<br>the primary predicate. |
| Materials | Polyphenylsulfone (Radel R-5000)<br>Polyphenylsulfone (Radel R-5100)<br>Medical grade silicone<br>Stainless steel | Polyphenylsulfone (Radel R-5000)<br>Silicone<br>Stainless Steel | Equivalent<br>The subject cassettes<br>have equivalent<br>materials as the<br>primary predicate<br>device. Because the<br>difference between<br>the R-5000 et R-5100<br>is the color. |
| Materials<br>compatible with<br>sterilization<br>Method | Yes | Yes | Identical<br>The subject cassettes<br>have the same<br>materials compatible<br>with sterilization<br>method as the primary<br>predicate device. |
| Perforated | Yes; allows moist heat (steam)<br>penetration to achieve sterilization | Yes; allows moist heat (steam)<br>penetration to achieve sterilization | Identical<br>The subject cassettes<br>have the same<br>perforated as the<br>primary predicate<br>device. |
| Reusable | Yes, up to 100x | Yes, up to 100x | Identical<br>The subject cassettes<br>have the same<br>resusable life as the<br>primary predicate<br>device. |
| Sterilization<br>Method | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | Identical<br>The subject cassettes<br>have the same<br>sterilization method as<br>the primary predicate<br>device |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICES | |
| | K23XXXXX | K203753 | |
| | Anthogyr INTEGRAL Guided Surgery<br>Cassettes | Straumann Surgical Cassettes | Equivalence<br>discussion |
| Cycles | Pre-Vacuum Steam Sterilization | Fractionated vacuum (pre-vacuum) | Identical<br>The subject cassettes<br>have the same cycle<br>as the primary<br>predicate device. |
| Parameters | Pre-Vacuum:<br>Sterilization temperature: 132° C (270°<br>F).<br>Sterilization time: 4 minutes.<br>Drying time: 30 minutes. | Pre-Vacuum:<br>Sterilization temperature: 132° C (270°<br>F).<br>Sterilization time: 4 minutes.<br>Drying time: 30 minutes. | Identical<br>The subject cassette<br>have the parameter of<br>sterilization as the<br>primary predicate<br>device. |
| Sterile Barrier | Sterilization wrap, FDA-cleared for<br>indicated method and cycles | Sterilization wrap, FDA-cleared for<br>indicated method and cycles | Identical<br>The subject cassettes<br>have the same sterile<br>barrier as the primary<br>predicate device. |
| Biocompatibility | The Biocompatibility assessment was<br>performed per ISO 10993-1 and testing<br>was performed using methods<br>described in ISO 10993-5.<br>The results indicate that the subject<br>devices are non-cytotoxic. | The Biocompatibility assessment was<br>performed per ISO 10993-1 and testing<br>was performed using methods described<br>in ISO 10993-5.<br>The results indicate that the subject<br>devices are non-cytotoxic. | Identical<br>The subject cassettes<br>have the same<br>biocompatibility as the<br>primary predicate<br>device. |

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## Anthogyr INTEGRAL Guided Surgery Cassettes

510(k) Summary K233264

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## Anthogyr INTEGRAL Guided Surgery Cassettes

510(k) Summary K233264

Table 2 – Comparison of subject device versus Primary predicate Device

#### Non-Clinical Performance data 5.7

The performance during multiple reprocessing steps for the Anthogyr INTEGRAL Guided Surgery 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 non-clinical testing performed with the subject device are listed below:

- . Manual cleaning validation
- Automated cleaning validation
- o Sterilization validation, including sterilant penetration and drying time
- Life cycle (simulate usage) testing ●
- Cytotoxicity testing .

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## Anthogyr INTEGRAL Guided Surgery Cassettes

### 510(k) Summary K233264

The worst-case cassettes were tested for performance based on critical impact factors including materials, vent to volume ratio, design complexity, weight of the loaded cassettes or the weight of the empty cassettes. The summary of testing performed is provided in Table 3 for subject devices.

| Standard or Test<br>Method | Purpose of the<br>Testing | Acceptance Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Custom | • Test Soil: Blood Soil<br>(BLSO)<br>• Cleaning Method:<br>Manual<br>• Residuals Tested:<br>Hemoglobin and<br>Protein | Visual Inspection: No<br>Visible Soil<br>Hemoglobin Test: <2.2 µg/cm2<br>Protein Test: <6.4 µg/cm2 | Passed |
| Custom | • Test Soil: Blood Soil<br>(BLSO)<br>• Cleaning Method:<br>Automated<br>• Residuals Tested:<br>Hemoglobin and<br>Protein | Visual Inspection: No<br>Visible Soil<br>Hemoglobin Test: <2.2 µg/cm2<br>Protein Test: <6.4 µg/cm2 | Passed |
| ISO 17665-1 | Sterilization validation,<br>including sterilant<br>penetration and drying<br>time | All Biological Indicators<br>must be incubated for at<br>least 7 days at 55-60°C.<br>All positive controls for<br>SAL testing must show<br>characteristic growth of the<br>indicator organism. | Passed |
| Reprocessing Medical<br>Devices in Health Care<br>Settings: Validation<br>Methods and Labeling<br>Guidance for Industry<br>and Food and Drug<br>Administration Staff | Life cycle (simulate<br>usage) testing | The tested samples must<br>withstand 100 cycles of<br>use (cleaning, sterilization,<br>and functional tests)<br>without compromising their<br>functionalities | Passed |
| ISO 10993-5<br>(Cytotoxicity) | Cytotoxicity testing | Less than 30% cell<br>proliferation inhibition | Passed |

| | | | | Table 3 - Performance testing summary (Anthogyr INTEGRAL Guided Surgery Cassettes) |
|--|--|--|--|------------------------------------------------------------------------------------|
|--|--|--|--|------------------------------------------------------------------------------------|

#### Conclusion 5.8

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, Anthogyr INTEGRAL Guided Surgery Cassettes, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K203753.