(84 days)
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.
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.
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.
The provided text is a 510(k) Summary for the Anthogyr INTEGRAL Guided Surgery Cassettes. It does not describe a study involving an AI/software device that requires establishing ground truth by experts or evaluating human reader performance. Instead, it focuses on demonstrating substantial equivalence of a medical device (sterilization cassettes) to a predicate device through non-clinical performance testing.
Therefore, many of the requested criteria, such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "standalone (i.e. algorithm only) performance" are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance for the non-clinical tests mentioned.
Here's a breakdown of the requested information based on the provided text, indicating "Not Applicable" (N/A) for criteria that do not fit the nature of this submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Standard or Test Method | Purpose of the Testing | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Custom | • Test Soil: Blood Soil (BLSO) • Cleaning Method: Manual • Residuals Tested: Hemoglobin and Protein | Visual Inspection: No Visible Soil Hemoglobin Test: <2.2 µg/cm2 Protein Test: <6.4 µg/cm2 | Passed |
| Custom | • Test Soil: Blood Soil (BLSO) • Cleaning Method: Automated • Residuals Tested: Hemoglobin and Protein | Visual Inspection: No Visible Soil Hemoglobin Test: <2.2 µg/cm2 Protein Test: <6.4 µg/cm2 | Passed |
| ISO 17665-1 | Sterilization validation, including sterilant penetration and drying time | All Biological Indicators must be incubated for at least 7 days at 55-60°C. All positive controls for SAL testing must show characteristic growth of the indicator organism. | Passed |
| Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff | Life cycle (simulate usage) testing | The tested samples must withstand 100 cycles of use (cleaning, sterilization, and functional tests) without compromising their functionalities | Passed |
| ISO 10993-5 (Cytotoxicity) | Cytotoxicity testing | Less than 30% cell proliferation inhibition | Passed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "The worst-case cassettes were tested for performance." However, it does not specify an exact number of cassettes or samples used for each test.
- Data Provenance: The tests are non-clinical (laboratory/bench-top), not derived from patient data. The manufacturer is Anthogyr, located in Sallanches, France, and the submission is by Straumann USA, LLC.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- N/A. Ground truth in this context refers to the defined acceptance criteria for engineering and materials performance, not expert consensus on medical images or diagnoses. The 'experts' would be the engineers and quality control personnel performing and evaluating the tests against established industry standards and internal protocols.
4. Adjudication Method for the Test Set
- N/A. Adjudication is typically for resolving discrepancies in human expert labeling or diagnoses. For non-clinical bench testing, the results are objectively measured against pre-defined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- N/A. This is a medical device (sterilization cassette), not an AI/software device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A. This is a hardware medical device, not an algorithm.
7. The Type of Ground Truth Used
- The ground truth for this device's performance is based on pre-defined acceptance criteria derived from:
- Applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
- International standards like ISO 17665-1 and ISO 10993-5.
- Internal custom test protocols developed for cleaning and residual testing.
- Functional requirements for the cassette's intended use.
8. The Sample Size for the Training Set
- N/A. This is not an AI/software device where a "training set" of data would be used to train a model. The "training set" concept is irrelevant here.
9. How the Ground Truth for the Training Set Was Established
- N/A. As explained above, there is no training set or AI model involved in the context of this device's submission.
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Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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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FORM FDA 3881 (6/20)
Page 1 of 1
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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)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052On the behalf of:Anthogyr2237 Av. André Lasquin,74700 Sallanches, France |
|---|---|
| Contact Person: | Jennifer M. Jackson, MSSr Dir, Regulatory & Quality NAMPhone Number: +1 978 747-2509Fax Number: +1 978 747-0023 |
| Prepared By &Alternate Contact: | Aude GOULETRegulatory Affairs Project ManagerAnthogyrPhone number: +33450580237 |
| 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 PredicateDeviceK203753 | 290mm x 176mm x 60mm | 1005g |
| Integral guided surgerycassettes subjectdevices | 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 SurgeryCassettes | Straumann Surgical Cassettes | Equivalencediscussion | |
| Indications forUse | The Anthogyr Cassettes are designed tohold various dental surgical drills andtools in order to organize, steamsterilize, and protect the instrumentsthat are sterilized by healthcareprovider. The cassette is to be enclosedin an FDA cleared steam sterilizablepouch. The cassettes are not intendedon their own to maintain sterility.The cycle of sterilization, for AnthogyrINTEGRAL Guided Surgery Cassettes,uses pre-vacuum steam: 132 °C (270°F) during 4 minutes with 30 minutesdrying time.Anthogyr INTEGRAL Guided SurgeryCassettes have been validated for amaximum load of with the associatedinstrument. The worst-caserecommended load is: 886 g.The device dimension of AnthogyrINTEGRAL Guided Surgery Cassettesis 290x176x62 mm.The cassettes are not intended to bestacked during sterilization process. | The instrument kits are designed to holdvarious dental surgical drills and tools inorder to organize, steam sterilize, andprotect the instruments that are sterilizedby healthcare provider. The cassette isto be enclosed in an FDA cleared steamsterilizable pouch. The cassettes are notintended on their own to maintain sterilityThe Straumann Cassettes are used toorganize, store, sterilize and transportsurgical instruments and auxiliariesbetween and during surgical uses. Theyare indicated to be used in healthcarefacilities by healthcare professionals.The Straumann Cassettes are to beenclosed in FDA cleared sterilizationpouches in two layers to maintain thesterility of the enclosed devices using thefollowing sterilization parameters: pre-vacuum steam exposure at 132°C (270°F) for 4 minutes, 30 minutes drying time.The Straumann Cassettes havebeen validated for a maximum load of1005 grams for the Surgical Cassettes,2007 grams for the OsteotomeCassettes, 283 grams for the Bone BlockFixation Cassette and 65 grams for theScrew Container, including cassette andinstruments | IdenticalThe subject cassettedevices have thesame indication of useas the primarypredicate. |
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICES | ||
| K23XXXX | K203753 | ||
| Anthogyr INTEGRAL Guided SurgeryCassettes | Straumann Surgical Cassettes | Equivalencediscussion | |
| Product code | KCT | KCT | IdenticalThe subject cassettedevices have thesame product code asthe primary predicateand the referencepredicate. |
| Design | Reusable rigid container, case bottom(base), a removable inner tray base(tray), and tray lid (lid). | Reusable rigid container, case bottom(base), a removable inner tray base(tray), and tray lid (lid). | IdenticalThe subject cassetteshave the same designas the primarypredicate device. |
| Dimensions | 290x176x62 mm | 290mm x 76mm x 60mm290.10mmx174.50mmx53 mm130mmx118mmx25mm68.5mmx46.5mmx 22.2mm | IdenticalThe subject cassettedevices have thesame dimensions asthe primary predicate. |
| Materials | Polyphenylsulfone (Radel R-5000)Polyphenylsulfone (Radel R-5100)Medical grade siliconeStainless steel | Polyphenylsulfone (Radel R-5000)SiliconeStainless Steel | EquivalentThe subject cassetteshave equivalentmaterials as theprimary predicatedevice. Because thedifference betweenthe R-5000 et R-5100is the color. |
| Materialscompatible withsterilizationMethod | Yes | Yes | IdenticalThe subject cassetteshave the samematerials compatiblewith sterilizationmethod as the primarypredicate device. |
| Perforated | Yes; allows moist heat (steam)penetration to achieve sterilization | Yes; allows moist heat (steam)penetration to achieve sterilization | IdenticalThe subject cassetteshave the sameperforated as theprimary predicatedevice. |
| Reusable | Yes, up to 100x | Yes, up to 100x | IdenticalThe subject cassetteshave the sameresusable life as theprimary predicatedevice. |
| SterilizationMethod | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | IdenticalThe subject cassetteshave the samesterilization method asthe primary predicatedevice |
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICES | ||
| K23XXXXX | K203753 | ||
| Anthogyr INTEGRAL Guided SurgeryCassettes | Straumann Surgical Cassettes | Equivalencediscussion | |
| Cycles | Pre-Vacuum Steam Sterilization | Fractionated vacuum (pre-vacuum) | IdenticalThe subject cassetteshave the same cycleas the primarypredicate device. |
| Parameters | Pre-Vacuum:Sterilization temperature: 132° C (270°F).Sterilization time: 4 minutes.Drying time: 30 minutes. | Pre-Vacuum:Sterilization temperature: 132° C (270°F).Sterilization time: 4 minutes.Drying time: 30 minutes. | IdenticalThe subject cassettehave the parameter ofsterilization as theprimary predicatedevice. |
| Sterile Barrier | Sterilization wrap, FDA-cleared forindicated method and cycles | Sterilization wrap, FDA-cleared forindicated method and cycles | IdenticalThe subject cassetteshave the same sterilebarrier as the primarypredicate device. |
| Biocompatibility | The Biocompatibility assessment wasperformed per ISO 10993-1 and testingwas performed using methodsdescribed in ISO 10993-5.The results indicate that the subjectdevices are non-cytotoxic. | The Biocompatibility assessment wasperformed per ISO 10993-1 and testingwas performed using methods describedin ISO 10993-5.The results indicate that the subjectdevices are non-cytotoxic. | IdenticalThe subject cassetteshave the samebiocompatibility as theprimary predicatedevice. |
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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 TestMethod | Purpose of theTesting | Acceptance Criteria | Results |
|---|---|---|---|
| Custom | • Test Soil: Blood Soil(BLSO)• Cleaning Method:Manual• Residuals Tested:Hemoglobin andProtein | Visual Inspection: NoVisible SoilHemoglobin Test: <2.2 µg/cm2Protein Test: <6.4 µg/cm2 | Passed |
| Custom | • Test Soil: Blood Soil(BLSO)• Cleaning Method:Automated• Residuals Tested:Hemoglobin andProtein | Visual Inspection: NoVisible SoilHemoglobin Test: <2.2 µg/cm2Protein Test: <6.4 µg/cm2 | Passed |
| ISO 17665-1 | Sterilization validation,including sterilantpenetration and dryingtime | All Biological Indicatorsmust be incubated for atleast 7 days at 55-60°C.All positive controls forSAL testing must showcharacteristic growth of theindicator organism. | Passed |
| Reprocessing MedicalDevices in Health CareSettings: ValidationMethods and LabelingGuidance for Industryand Food and DrugAdministration Staff | Life cycle (simulateusage) testing | The tested samples mustwithstand 100 cycles ofuse (cleaning, sterilization,and functional tests)without compromising theirfunctionalities | Passed |
| ISO 10993-5(Cytotoxicity) | Cytotoxicity testing | Less than 30% cellproliferation 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.
§ 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).