(407 days)
Not Found
No
The device is a physical instrument kit for organizing and sterilizing dental tools. The description focuses on materials, dimensions, sterilization parameters, and validation studies related to cleaning and sterilization, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
This device is a cassette designed to hold surgical instruments for sterilization and storage; it does not directly treat or diagnose a medical condition.
No
The device is described as an instrument kit/cassette designed to organize, steam sterilize, and protect dental surgical drills and tools. Its function is to facilitate sterilization, not to diagnose medical conditions or diseases.
No
The device is a physical instrument kit (cassette) made of materials like Radel and silicone, designed to hold and organize surgical tools for sterilization. It is not software.
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, and protecting dental surgical drills and tools for steam sterilization. This is a function related to the preparation and handling of surgical instruments, not the diagnosis of disease or other conditions.
- Device Description: The device is described as a cassette for enclosing and holding surgical instruments during sterilization and storage. This aligns with the intended use and does not involve any diagnostic function.
- Lack of Diagnostic Elements: There is no mention of the device being used with biological samples, reagents, or any process related to analyzing or testing for medical conditions.
- Performance Studies: The performance studies focus on cleaning, sterilization, cytotoxicity, and material compatibility, which are relevant to the safety and efficacy of a surgical instrument sterilization container, not an IVD.
- Predicate Device: The predicate device (K142519, InterActive Complete Surgical Tray) is also a surgical instrument tray, further supporting that this device falls under the category of surgical instrument handling rather than IVD.
In summary, the device's function is to facilitate the sterilization and organization of surgical instruments, which is a critical step in surgical procedures but does not involve in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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 cycle of sterilization is:
Pre-vacuum steam: 134 °C during 3 minutes with 16 minutes drying time
Anthogyr does not make any lumen claims for the instrument kits.
The Axiom range surgery kit represents the worst case validated load due to the number of components (34 instruments).
The cassettes are not intended to be stacked during sterilization process.
Product codes
KCT
Device Description
Instrument kits are cassettes used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage. The cassettes by themselves do not maintain sterility. They are to be used with an FDA cleared steam sterilizable pouch.
The cassette is available in only one size (129x156x47.5 mm) marketed in different variations, including different number of tools.
The tools included in the kits are class I exempt or already have class II pre-market notification clearance.
The cassettes are reusable and made of the same materials as the predicate device (Radel R-5000 and R-5100 for tray and lid and medical grade silicone for circular brackets holding the tools).
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)
Performance characteristics of the device are supported by cleaning validation, sterilization validation and cytotoxicity tests. No clinical tests were conducted.
Cleaning validations were conducted as per AAMI TIR 30, AAMI TIR 12, ISO 17665 for both manual and automatic cleaning.
Sterilization validation was performed with a legally marketed pouch on the most complete instrument kit, taking into account worst case scenarios. Steam sterilization validations were conducted as per ISO 17665.
Drying time was validated in steam sterilization report according to ISO 17665.
Cytotoxicity tests were conducted as per ISO 10993-5.
Material compatibility information was obtained from Radel technical data sheet.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 27, 2017
Anthogyr Therese Candau Regulatory Affairs Manager 2237 Avenue Andre Lasquin Sallanches. 74700 FR
Re: K160730
Trade/Device Name: Instrument Kits Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: March 20, 2017 Received: March 24, 2017
Dear Therese Candau:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160730
Device Name Instrument kits
Indications for Use (Describe)
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 cycle of sterilization is:
Pre-vacuum steam: 134 °C during 3 minutes with 16 minutes drying time
Anthogyr does not make any lumen claims for the instrument kits.
The Axiom range surgery kit represents the worst case validated load due to the number of components (34 instruments).
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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3
510(k) SUMMARY K160730
SUBMITTER'S CONTACT INFORMATION 5.1
ANTHOGYR SAS
2237, avenue André Lasquin SALLANCHES, FRANCE 74700 Registration Number: 8020776 Phone number: (33) (0)4 50 58 02 37 Fax number: (33) (0)4 50 93 78 60 Contact person: Thérèse CANDAU (m.candau@anthogyr.com) Preparation date: 04/12/2017
DEVICE 5.2
Trade name: Instrument kits Classification name: STERILIZATION CASSETTE Class II Product Code: KCT CFR Section: 21CFR 880.6850 Device panel: GENERAL HOSPITAL
5.3 PREDICATE DEVICE
InterActive Complete Surgical Tray (K142519), manufactured by Implant Direct
DEVICE DESCRIPTION 5.4
Instrument kits are cassettes used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage. The cassettes by themselves do not maintain sterility. They are to be used with an FDA cleared steam sterilizable pouch.
The cassette is available in only one size (129x156x47.5 mm) marketed in different variations, including different number of tools.
The tools included in the kits are class I exempt or already have class II pre-market notification clearance.
The cassettes are reusable and made of the same materials as the predicate device (Radel R-5000 and R-5100 for tray and lid and medical grade silicone for circular brackets holding the tools).
4
5.5 INTENDED USE
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 cycle of sterilization is:
Pre-vacuum steam: 134 °C during 3 minutes with 16 minutes drying time Anthogyr does not make any lumen claims for the instrument kits.
The Axiom range surgery kit represents the worst case validated load due to the number of components (34 instruments).
The cassettes are not intended to be stacked during sterilization process.
| | ANTHOGYR (K160730)
Surgical kits | Implant Direct
(K142519)
InterActive Complete
Surgical Tray | Comparison |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 21CFR | 880.6850 | | Same part section |
| Indications
for use | 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 InterActive
Complete Surgical Tray
is designed to hold
various dental surgical
drills and tools in order
to organize, steam
sterilize, and transport
the instruments between
uses. The tray is to be
enclosed in an FDA
cleared steam
sterilizable wrap and
sterilized in an FDA
cleared sterilizer. | Same indications for
use |
| Raw material | Radel R5000
Radel R5100
Medical grade silicone
Stainless steel | Polymer resin Radel-
5000
Biomedical grade silicone | Some materials are
common.
Radel R5100 meets
USP class VI
requirements and
compatibility testing
demonstrated safety
and efficacy |
| Design | Plastic tray with locking lid and silicone containments
brackets | | Same design |
| Sterilization
method | Pre-vacuum steam | | Same sterilization
method |
| Reusable | Yes | | Both are reusable
devices |
TECHNOLOGICAL CHARACTERISTICS 5.6
5
| Material
compatibility
with
sterilization
process | Yes | | Both devices
demonstrate material
compatibility with
sterilization process |
|---------------------------------------------------------------|-------------------------------------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Microbial
barrier
properties | To be used in conjunction with an approved
sterilization pouch | | Both are used with an
approved sterilization
pouch to maintain
sterility |
| Vent/volume
ratio | $0.049 \frac{in^2}{in^3}$ | $0.184 \frac{in^2}{in^3}$ | The vent to volume
ratio is lower for the
candidate device, but
sterilant penetration
testing demonstrates
safety and efficacy |
5.7 PERFORMANCE TESTING
Performance characteristics of the device are supported by cleaning validation, sterilization validation and cytotoxicity tests.
No clinical tests were conducted.
Cleaning instructions for reusable devices
Cleaning validations were conducted as per AAMI TIR 30, AAMI TIR 12, ISO 17665 for both manual and automatic cleaning.
Sterilization validation
Sterilization validation was performed with a legally marketed pouch on the most complete instrument kit, taking into account worst case scenarios. Steam sterilization validations were conducted as per ISO 17665
Drying time
Validated in steam sterilization report according to ISO 17665
Toxicological properties
Cytotoxicity tests were conducted as per ISO 10993-5
Material compatibility
Radel technical data sheet
6
5.8 CONCLUSION
ANTHOGYR INSTRUMENT KITS are substantially equivalent to their predicate devices in terms of intended use, material, design, mechanical properties and function.
All the kits have the same vent to volume ratio, so the most challenging container to achieve sterilization is the most loaded one.
Non clinical performance testing (sterilization and cleaning validation, cytotoxicity test) according to special control demonstrate that ANTHOGYR INSTRUMENT KITS are as safe, as effective, and perform as safely and effectively as their predicate device.