(120 days)
The Anthogyr Surgical 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 is:
INMODOPS3, INMODOPS3L, INMODOPP3, INMODIGM, INMODOPS3V, INMODOPS3LV, INMODOPP3V,
INMODIGMV: Pre-vacuum steam: 132 ℃ (270°F) during 4 minutes with 20 minutes drying time
The Anthogyr Surgical Cassettes have been validated for a maximum load of with the associated instruments: The worst-case recommended load is 412g.
The device dimensions are listed below for Anthogyr Surgical Cassettes:
-
INMODOPS3, INMODOPS3V, INMODOPS3L, INMODOPS3LV, INMODOPP3V: 130x155x47 mm
-
INMODIGM, INMODIGMV: 76x155x47 mm
The cassettes are not intended to be stacked during sterilization process.
Anthogyr Surgical 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 and prosthetic instruments of the Anthogyr Dental Implant System intended to be placed in the Anthogyr Surgical 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 Anthogyr Surgical Cassettes are designed to organize, steam sterilize, and protect dental surgical instruments. They are intended for healthcare providers and must be enclosed in an FDA-cleared steam sterilizable pouch.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visual Inspection (after cleaning): No Visible Soil | Passed |
| Hemoglobin Test (after cleaning): <2.2 µg/cm² | Passed |
| Protein Test (after cleaning): <6.4 µg/cm² | Passed |
| Sterilization Validation: 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 |
| Life Cycle (Simulate Usage) Testing: Withstand 250 cycles of use (cleaning, sterilization, and functional tests) without compromising functionalities. | Passed |
| Cytotoxicity Testing: Less than 30% cell proliferation inhibition | Passed |
2. Sample size used for the test set and the data provenance:
The document describes "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." Specific sample sizes for each test are not explicitly stated beyond this general description.
The data provenance is from non-clinical testing performed with the subject device. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective, as this is a non-clinical device performance study rather than a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the described studies are non-clinical performance tests (e.g., cleaning, sterilization, life cycle, cytotoxicity). Ground truth for these types of tests is established by objective measurements against predefined criteria, not by expert consensus.
4. Adjudication method for the test set:
This information is not applicable for non-clinical performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers or experts are involved in interpreting results or making diagnoses.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The Anthogyr Surgical Cassettes are a medical device for organizing, sterilizing, and protecting dental instruments. They do not incorporate AI, nor are they interpreted by human readers in a diagnostic capacity, hence no MRMC comparative effectiveness study involving AI assistance would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a surgical cassette, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The type of ground truth used:
For the non-clinical tests, the ground truth is established by:
- Objective measurements and scientific standards: For cleaning validation, this involves quantitative measurements of hemoglobin and protein residuals against established thresholds, and visual inspection.
- Compliance with validated methods and standards: For sterilization validation, this involves adherence to ISO 17665-1 and observation of biological indicator growth/non-growth.
- Predefined performance criteria: For life cycle testing, the ground truth is the ability to withstand 250 cycles without functional compromise.
- Laboratory test results: For cytotoxicity testing, the ground truth is based on the measured cell proliferation inhibition percentage against a set threshold.
8. The sample size for the training set:
This information is not applicable. As a non-AI medical device, there is no "training set" in the context of machine learning. The studies described are validation tests for the physical device.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as in point 8.
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July 11, 2023
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Anthogyr % Jennifer Jackson Senior Director, Regulatory & Quality NAM Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K230680
Trade/Device Name: Anthogyr Surgical Cassettes Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 9, 2023 Received: June 9, 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 (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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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 medical devices and radiation-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).
Sincerelv.
Image /page/1/Picture/5 description: The image shows a digital signature for Eileen Cadel. The signature includes the name "Eileen Cadel" on the left side of the image. On the right side, it states that the signature is "Digitally signed by Eileen Cadel" and includes the date and time of the signature: "2023.07.11 14:44:58 -04'00'".
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K230680
Device Name Anthogyr Surgical Cassettes
Indications for Use (Describe)
The Anthogyr Surgical 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 is:
INMODOPS3, INMODOPS3L, INMODOPP3, INMODIGM, INMODOPS3V, INMODOPS3LV, INMODOPP3V,
INMODIGMV: Pre-vacuum steam: 132 ℃ (270°F) during 4 minutes with 20 minutes drying time
The Anthogyr Surgical Cassettes have been validated for a maximum load of with the associated instruments: The worst-case recommended load is 412g.
The device dimensions are listed below for Anthogyr Surgical Cassettes:
-
INMODOPS3, INMODOPS3V, INMODOPS3L, INMODOPS3LV, INMODOPP3V: 130x155x47 mm
-
INMODIGM, INMODIGMV: 76x155x47 mm
The cassettes are not intended to be stacked during sterilization process.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Anthogyr Surgical Cassettes
510(k) Summary
510(k) Summary
Submitter's Contact Information
| 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, MS, RACSenior Director, Regulatory Affairs & 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: | July 10, 2023 |
Name of the Device
| Trade Names: | Anthogyr Surgical Cassettes |
|---|---|
| Common Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Regulation Number: | 21 CFR 880.6850 |
| Device Classification: | II |
| Product Code(s): | KCT |
| Classification Panel: | General Hospital |
| Proprietary Name | Anthogyr Surgical Cassettes |
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Anthogyr Surgical Cassettes
510(k) Summary
Predicate Device(s)
Primary Predicate:
- K160730 Instrument Kits (Anthogyr) .
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
|---|---|
| Regulation Number: | 21 CFR 880.6850 |
| Device Classification: | II |
| Product Code(s): | KCT |
Reference Devices:
- K203618 Neodent EasyGuide Kit Cases (JJGC Indústria e Comércio de Materiais .
Dentários SA)
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
|---|---|
| Regulation Number: | 21 CFR 880.6850 |
| Device Classification: | II |
| Product Code(s): | KCT |
Device Description
Anthogyr Surgical 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 and prosthetic instruments of the Anthogyr Dental Implant System intended to be placed in the Anthogyr Surgical 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
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Anthogyr Surgical Cassettes
510(k) Summary
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.
Indications for Use
The Anthogyr Surgical 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 is:
INMODOPS3, INMODOPS3L, INMODOPP3, INMODIGM, INMODOPS3V, INMODOPS3LV, INMODOPP3V, INMODIGMV: Pre-vacuum steam: 132 °C (270° F) during 4 minutes with 20 minutes drying time
The Anthogyr Surgical Cassettes have been validated for a maximum load of with the associated instruments:
The worst-case recommended load is 412g.
The device dimensions are listed below for Anthogyr Surqical Cassettes:
- INMODOPS3, INMODOPS3V, INMODOPS3L, INMODOPS3LV, INMODOPP3,
INMODOPP3V: 130x155x47 mm
- INMODIGM, INMODIGMV: 76x155x47 mm
The cassettes are not intended to be stacked during sterilization process.
Technological Characteristics
The subject devices and predicate devices K160730 and K203618 share the following characteristics:
- . ldentical indications for use
- ldentical Product code .
- . Identical Design
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Anthogyr Surgical Cassettes
510(k) Summary
- Identical Material ●
- Identical Materials compatible with sterilization method .
- . Identical Perforated
- Identical Reusable ●
- . Identical Sterilization Method
- . Identical Cycles
- Identical Parameters
- ldentical Sterile Barrier ●
- . Identical Biocompability
- . Equivalent vent to volume
The difference between the primary predicate device with the Anthogyr Surgical Cassettes subject devices are in the Table 1:
| Number of brackets in the cassette | |
|---|---|
| Primary Predicate Device:(K160730) | 33 |
| Subject devices:INMODOPS3L/ INMODOPS3LV | 37 |
| Subject devices:INMODOPS3/ INMODOPS3V | 37 |
| Subject devices:INMODOPP3/ INMODOPP3V | 21 |
| Subject devices:INMODIGM/ INMODIGMV | 12 |
Table 1 – Difference between the primary predicate device with the Anthogyr Surgical Cassettes subject devices
The technological characteristics of the subject devices are compared to the primary predicate and reference device in the Table 2.
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Anthogyr Surgical Cassettes
510(k) Summary
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | ||
|---|---|---|---|---|
| FEATURE | K230680 | K160730 | K203618 | Equivalence discussion |
| Anthogyr Surgical Cassettes | Instrument Kits | Neodent EasyGuide Kit Cases | ||
| Indications forUse | The Anthogyr Surgical Cassettes are designedto hold various dental surgical drills and tools inorder to organize, steam sterilize, and protectthe instruments that are sterilized by healthcareprovider. The cassette is to be enclosed in anFDA cleared steam sterilizable pouch. Thecassettes are not intended on their own tomaintain sterility.The cycle of sterilization is:INMODOPS3, INMODOPS3L, INMODOPP3,INMODIGM, INMODOPS3V, INMODOPS3LV,INMODOPP3V, INMODIGMV: Pre-vacuumsteam: 132 °C (270° F) during 4 minutes with 20minutes drying timeThe Anthogyr Surgical Cassettes have beenvalidated for a maximum load of with theassociated instruments:The worst-case recommended load is 412g.The device dimensions are listed below forAnthogyr Surgical Cassettes:- INMODOPS3, INMODOPS3V, INMODOPS3L,INMODOPS3LV, INMODOPP3, INMODOPP3V:130x155x47 mm- INMODIGM, INMODIGMV: 76x155x47 mmThe cassettes are not intended to be stackedduring sterilization process. | The instrument kits are designed to hold variousdental surgical drills and tools in order toorganize, steam sterilize, and protect theinstruments that are sterilized by healthcareprovider. The cassette is to be enclosed in anFDA cleared steam sterilizable pouch. Thecassettes are not intended on their own tomaintain sterility. | Indications for Use for GM EasyGuideSurgical Kit Case Narrow/Regular DiamImplants:Neodent Instrument Kits are intended to beused to enclose other medical devices that areto be sterilized by a health care provider.Neodent Instrument Kits are intended to allowsterilizationof the enclosed medical devices. NeodentInstrument Kits require the use of FDA-clearedwrap to maintain the sterility of the encloseddevices.The Kits are to be enclosed in a sterilizationwrap that is FDA-cleared for the indicatedcycles, and moist heat (steam) sterilized usingone of the following cycles:Fractionated vacuum (pre-vacuum) – Exposureat 132 °C for 4 minutes, 20-minute dry time.Gravity displacement - Exposure at 132 °C for15 minutes, 20-minute dry time.Neodent Instrument Kits are intended forsterilization of non-porous loads.The combined weight of the GM EasyGuideSurgical Kit Case Narrow/Regular DiamImplantsand the associated instruments is 310,18 g. Theweight of the empty Kit Case is 263,63 g.Neodent GM EasyGuide Kit Cases should notbe stacked during sterilizationIndications for Use for GM EasyGuideSurgical Kit Case Regular/Large DiamImplants:Neodent Instrument Kits are intended to beused to enclose other medical devices that areto be sterilized by a health care provider.Neodent Instrument Kits are intended to allow | IdenticalThe subject devices havethe same indications for useas the primary predicate.More detail regarding theindication like weight andsterilization condition wereadded. |
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | ||
| FEATURE | K230680 | K160730 | K203618 | Equivalence discussion |
| Anthogyr Surgical Cassettes | Instrument Kits | Neodent EasyGuide Kit Cases | ||
| sterilization of the enclosed medical devices.Neodent Instrument Kits require the use of FDA-cleared wrap to maintain the sterility of theenclosed devices. The Kits are to be enclosedin a sterilization wrap that is FDA-cleared for theindicated cycles, and moist heat (steam)sterilized using one of the following cycles:Fractionated vacuum (pre-vacuum) - Exposureat 132 °C for 4 minutes, 20-minute dry time.Gravity displacement - Exposure at 132 °C for15 minutes, 45-minute dry time.Neodent Instrument Kits are intended forsterilization of non-porous loads.The combined weight of the GM EasyGuideSurgical Kit Case Regular/Large Diam Implants | ||||
| and the associated instruments is 346,45 g. Theweight of the empty Kit Case is 264,12g.Neodent EasyGuide Kit Cases should not bestacked during sterilization. | ||||
| Product code | KCT | KCT | KCT | IdenticalThe subject devices havethe same product code asthe primary predicate andreference devices. |
| Design | Plastic tray with locking lid and siliconecontainments brackets | Plastic tray with locking lid and siliconecontainments brackets | Rigid base and removable inner tray with a lid.Retention grommets. | IdenticalThe subject devices havethe same design as theprimary predicate. |
| Dimensions | INMODOPS3, INMODOPS3V, INMODOPS3L,INMODOPS3LV, INMODOPP3, INMODOPP3V:130x155x47 mmINMODIGM, INMODIGMV:76x155x47 mm | 130x155x47 mm76x155x47 mm | 195x90x 64 mm | IdenticalThe subject devices havethe same dimensions as theprimary predicate. |
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | Equivalence discussion | |
| FEATURE | K230680 | K160730 | K203618 | |
| Anthogyr Surgical Cassettes | Instrument Kits | Neodent EasyGuide Kit Cases | ||
| Materials | Polyphenylsulfone (Radel R-5000)Polyphenylsulfone (Radel R-5100)Medical grade siliconeStainless steel | Polyphenylsulfone (Radel R-5000)Polyphenylsulfone (Radel R-5100)Medical grade siliconeStainless steel | Polysulfone polymerPolyphenylsulfoneMedical grade silicone | IdenticalThe subject devices havethe same materials as theprimary predicate. |
| Materialscompatible withsterilizationMethod | Yes | Yes | Yes | IdenticalThe subject devices havethe same materialscompatible with sterilizationmethod as the primarypredicate and referencedevices. |
| Perforated | Yes; allows moist heat (steam) penetration toachieve sterilization | Yes; allows moist heat (steam) penetration toachieve sterilization | Yes; allows moist heat (steam) penetration toachieve sterilization | IdenticalThe subject devices havethe same perforated as theprimary predicate. |
| Reusable | Yes, up to 250x | Yes, up to 250x | Yes, up to 100x | IdenticalThe subject devices havethe same reusable life asthe primary predicate. |
| SterilizationMethod | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | IdenticalThe subject devices havethe same sterilizationmethod as the primarypredicate and referencedevices. |
| Cycles | Pre-Vacuum Steam Sterilization | Fractionated vacuum (pre-vacuum) | Fractionated vacuum (pre-vacuum) | IdenticalThe subject devices havethe same cycle as theprimary predicate andreference devices. |
| Parameters | Pre-Vacuum:Sterilization temperature: 132° C (270° F).Sterilization time: 4 minutes.Drying time: 20 minutes. | Pre-Vacuum:Sterilization temperature: 134° C (270° F).Sterilization time: 3 minutes.Drying time: 16 minutes. | Pre-VacuumSterilization temperature: 132 °CSterilization time: 4 minutes.Drying time: 20 minutes. | IdenticalThe subject devices havethe parameter ofsterilization as the referencedevices. |
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | Equivalence discussion |
| K230680 | K160730 | K203618 | ||
| Anthogyr Surgical Cassettes | Instrument Kits | Neodent EasyGuide Kit Cases | ||
| Sterile Barrier | Sterilization wrap, FDA-cleared for indicatedmethod and cycles | Sterilization wrap, FDA-cleared for indicatedmethod and cycles | Sterilization wrap, FDA-cleared for indicatedmethod and cycles | IdenticalThe subject devices havethe same sterile barrier asthe primary predicate andreference devices. |
| Biocompatibility | The Biocompatibility assessment wasperformed per ISO 10993-1 and testing wasperformed using methods described in ISO10993-5.The results indicate that the subject devices arenon-cytotoxic. | The Biocompatibility assessment wasperformed per ISO 10993-1 and testing wasperformed using methods described in ISO10993-5.The results indicate that the subject devices arenon-cytotoxic. | The Biocompatibility assessment wasperformed per ISO 10993-1 and testing wasperformed using methods described in ISO10993-5.The results indicate that the subject devices arenon-cytotoxic. | IdenticalThe subject devices havethe same biocompatibility asthe primary predicate andreference devices. |
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Anthogyr Surgical Cassettes
510(k) Summary
{9}------------------------------------------------
Anthogyr Surgical Cassettes
510(k) Summary
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Anthogyr Surgical Cassettes
510(k) Summary
Table 2 – Technological Characteristics Comparison of subject device versus predicate devices
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Anthogyr Surgical Cassettes
510(k) Summary
Non-Clinical Performance data
The performance during multiple reprocessing steps for the Anthogyr Axiom® 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 non-clinical testing performed with the subject device are listed below:
- Manual cleaning validation .
- . Automated cleaning validation
- . Sterilization validation, including sterilant penetration and drying time
- Life cycle (simulate usage) testing ●
- . Cytotoxicity testing
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 Anthogyr Surgical Cassettes.
| Standard or Test | Purpose of the | Acceptance Criteria | Results |
|---|---|---|---|
| Method | Testing | ||
| Custom | • Test Soil: Blood Soil(BLSO)• Cleaning Method:Manual• Residuals Tested:Hemoglobin andProtein | Visual Inspection: No Visible SoilHemoglobin Test: <2.2 $\mu$ g/cm2Protein Test: <6.4 $\mu$ g/cm2 | Passed |
| Custom | • Test Soil: Blood Soil(BLSO)• Cleaning Method:Automated• Residuals Tested:Hemoglobin andProtein | Visual Inspection: No Visible SoilHemoglobin Test: <2.2 $\mu$ g/cm2Protein Test: <6.4 $\mu$ g/cm2 | Passed |
| ISO 17665-1 | Sterilization validation,including sterilantpenetration and dryingtime | All Biological Indicators must beincubated for at least 7 days at 55-60°C. | Passed |
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Anthogyr Surgical Cassettes
510(k) Summary
| Standard or Test | Purpose of the | Acceptance Criteria | Results |
|---|---|---|---|
| Method | Testing | ||
| All positive controls for SALtesting must show characteristicgrowth of the indicator organism. | |||
| Reprocessing MedicalDevices in Health CareSettings: ValidationMethods and LabelingGuidance for Industryand Food and DrugAdministration Staff | Life cycle (simulateusage) testing | The tested samples mustwithstand 250 cycles of use(cleaning, sterilization, andfunctional tests) withoutcompromising their functionalities | Passed |
| ISO 10993-5(Cytotoxicity) | Cytotoxicity testing | Less than 30% cell proliferationinhibition | Passed |
Table 3 – Performance testing summary
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, Anthogyr Axiom® Surgery Cassettes, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K160730.
§ 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).