(84 days)
Not Found
No
The device is a physical container for organizing and sterilizing dental instruments. The description focuses on its physical properties, materials, and sterilization validation, with no mention of software, algorithms, or data processing.
No
The device is described as a reusable rigid container designed for organizing, sterilizing, and protecting dental surgical instruments, not for providing therapy directly to a patient.
No
The device is a non-diagnostic medical device designed to organize, steam sterilize, and protect dental surgical instruments. Its function is to facilitate the sterilization process and instrument management, not to diagnose medical conditions.
No
The device is a reusable rigid container designed to hold and sterilize dental instruments. The description focuses on physical components, materials, and sterilization validation, with no mention of software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as holding, organizing, steam sterilizing, and protecting dental surgical drills and tools. This is a function related to the preparation and handling of surgical instruments, not the diagnosis of a disease or condition.
- Device Description: The description details a reusable rigid container with trays and brackets for holding instruments. This aligns with a surgical instrument management system, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or provide information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on cleaning, sterilization, life cycle, and cytotoxicity – all related to the physical properties and reprocessing of a medical device, not its diagnostic accuracy.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
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. Anthogyr cassettes are intended to organize instruments, and secure instruments during the sterilization phase.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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 subject devices.
Study type: Manual cleaning validation
Acceptance Criteria: Visual Inspection: No Visible Soil; Hemoglobin Test: less than 2.2 micrograms/cm2; Protein Test: less than 6.4 micrograms/cm2.
Results: Passed
Study type: Automated cleaning validation
Acceptance Criteria: Visual Inspection: No Visible Soil; Hemoglobin Test: less than 2.2 micrograms/cm2; Protein Test: less than 6.4 micrograms/cm2.
Results: Passed
Study type: Sterilization validation, including sterilant penetration and drying time
Acceptance Criteria: All Biological Indicators must be incubated for at least 7 days at 55-60 degrees C. All positive controls for SAL testing must show characteristic growth of the indicator organism.
Results: Passed
Study type: Life cycle (simulate usage) testing
Acceptance Criteria: The tested samples must withstand 100 cycles of use (cleaning, sterilization, and functional tests) without compromising their functionalities.
Results: Passed
Study type: Cytotoxicity testing
Acceptance Criteria: Less than 30% cell proliferation inhibition
Results: Passed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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).
2
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
3
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
4
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 Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052
On the behalf of:
Anthogyr
2237 Av. André Lasquin,
74700 Sallanches, France |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS
Sr Dir, Regulatory & Quality NAM
Phone Number: +1 978 747-2509
Fax Number: +1 978 747-0023 |
| Prepared By &
Alternate Contact: | Aude GOULET
Regulatory Affairs Project Manager
Anthogyr
Phone 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 |
5
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.
6
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:
7
Anthogyr INTEGRAL Guided Surgery Cassettes
510(k) Summary K233264
| Dimensions | Max weight loaded | |
|---|---|---|
| Primary Predicate | ||
| Device | ||
| K203753 | 290mm x 176mm x 60mm | 1005g |
| Integral guided surgery | ||
| cassettes subject | ||
| 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 | |||
| Cassettes | Straumann Surgical Cassettes | Equivalence | |
| discussion | |||
| 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. 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. | The instrument kits 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 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 | Identical | ||
| The subject cassette | |||
| devices have the | |||
| same indication of use | |||
| as the primary | |||
| predicate. | |||
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICES | ||
| K23XXXX | K203753 | ||
| Anthogyr INTEGRAL Guided Surgery | |||
| Cassettes | Straumann Surgical Cassettes | Equivalence | |
| discussion | |||
| Product code | KCT | KCT | Identical |
| The subject cassette | |||
| devices have the | |||
| same product code as | |||
| the primary predicate | |||
| and the reference | |||
| predicate. | |||
| 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). | Identical | ||
| The subject cassettes | |||
| have the same design | |||
| as the primary | |||
| predicate device. | |||
| Dimensions | 290x176x62 mm | 290mm x 76mm x 60mm | |
| 290.10mmx174.50mmx53 mm | |||
| 130mmx118mmx25mm | |||
| 68.5mmx46.5mmx 22.2mm | Identical | ||
| The subject cassette | |||
| devices have the | |||
| same dimensions as | |||
| the primary predicate. | |||
| Materials | Polyphenylsulfone (Radel R-5000) | ||
| Polyphenylsulfone (Radel R-5100) | |||
| Medical grade silicone | |||
| Stainless steel | Polyphenylsulfone (Radel R-5000) | ||
| Silicone | |||
| Stainless Steel | Equivalent | ||
| The subject cassettes | |||
| have equivalent | |||
| materials as the | |||
| primary predicate | |||
| device. Because the | |||
| difference between | |||
| the R-5000 et R-5100 | |||
| is the color. | |||
| Materials | |||
| compatible with | |||
| sterilization | |||
| Method | Yes | Yes | Identical |
| The subject cassettes | |||
| have the same | |||
| materials compatible | |||
| with sterilization | |||
| method as the primary | |||
| predicate device. | |||
| Perforated | Yes; allows moist heat (steam) | ||
| penetration to achieve sterilization | Yes; allows moist heat (steam) | ||
| penetration to achieve sterilization | Identical | ||
| The subject cassettes | |||
| have the same | |||
| perforated as the | |||
| primary predicate | |||
| device. | |||
| Reusable | Yes, up to 100x | Yes, up to 100x | Identical |
| The subject cassettes | |||
| have the same | |||
| resusable life as the | |||
| primary predicate | |||
| device. | |||
| Sterilization | |||
| Method | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | Identical |
| The subject cassettes | |||
| have the same | |||
| sterilization method as | |||
| the primary predicate | |||
| device | |||
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICES | ||
| K23XXXXX | K203753 | ||
| Anthogyr INTEGRAL Guided Surgery | |||
| Cassettes | Straumann Surgical Cassettes | Equivalence | |
| discussion | |||
| Cycles | Pre-Vacuum Steam Sterilization | Fractionated vacuum (pre-vacuum) | Identical |
| The subject cassettes | |||
| have the same cycle | |||
| as the primary | |||
| predicate 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. | Identical | ||
| The subject cassette | |||
| have the parameter of | |||
| sterilization as the | |||
| primary predicate | |||
| device. | |||
| Sterile Barrier | Sterilization wrap, FDA-cleared for | ||
| indicated method and cycles | Sterilization wrap, FDA-cleared for | ||
| indicated method and cycles | Identical | ||
| The subject cassettes | |||
| have the same sterile | |||
| barrier as the primary | |||
| predicate device. | |||
| 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. | Identical | ||
| The subject cassettes | |||
| have the same | |||
| biocompatibility as the | |||
| primary predicate | |||
| device. |
8
Anthogyr INTEGRAL Guided Surgery Cassettes
510(k) Summary K233264
9
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 .
10
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
Method | Purpose of the
Testing | Acceptance Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Custom | • Test Soil: Blood Soil
(BLSO)
• Cleaning Method:
Manual
• Residuals Tested:
Hemoglobin and
Protein | Visual Inspection: No
Visible Soil
Hemoglobin Test: