Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are focused on physical organization and sterilization of dental instruments, with no mention of AI or ML capabilities.

Therapeutic

No.
The device is described as a cassette designed to organize, sterilize, and protect dental surgical instruments. It does not directly diagnose, treat, or prevent disease.

Diagnostic

No

Explanation: The device, Anthogyr Surgical Cassettes, is described as a reusable rigid container designed to hold and organize dental surgical drills and tools for steam sterilization. Its function is to facilitate the organization, sterilization, and protection of instruments, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device is a physical medical device (surgical cassettes) designed to hold and organize dental instruments for sterilization. It is not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is designed to hold, organize, sterilize, and protect dental surgical drills and tools. This is a function related to the preparation and handling of surgical instruments, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
Device Description: The description details a reusable rigid container for holding dental instruments. It focuses on the physical structure and features for organizing and securing instruments during surgical procedures and sterilization.
Lack of IVD Characteristics: There is no mention of the device being used with biological specimens, reagents, or for the purpose of obtaining diagnostic information.

Therefore, the Anthogyr Surgical Cassettes fall under the category of surgical instrument accessories, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 ℃ (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.

Product codes (comma separated list FDA assigned to the subject device)

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 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission.

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 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.

Key results from performance testing: All tests passed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Hemoglobin Test:

Regulation Number and Section

§ 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).

Summary

0

July 11, 2023

Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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

2

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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3

Anthogyr Surgical Cassettes

510(k) Summary

Submitter's Contact Information

| 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, RAC
Senior Director, Regulatory Affairs & 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: | 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

4

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

5

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

6

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.

7

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 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 Surgical Cassettes:

INMODOPS3, INMODOPS3V, INMODOPS3L,
INMODOPS3LV, INMODOPP3, INMODOPP3V:
130x155x47 mm
INMODIGM, INMODIGMV: 76x155x47 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. | Indications for Use for GM EasyGuide
Surgical Kit Case Narrow/Regular Diam
Implants:
Neodent Instrument Kits are intended to be
used to enclose other medical devices that are
to be sterilized by a health care provider.
Neodent Instrument Kits are intended to allow
sterilization
of the enclosed medical devices. Neodent
Instrument Kits require the use of FDA-cleared
wrap to maintain the sterility of the enclosed
devices.
The Kits are to be enclosed in a sterilization
wrap that is FDA-cleared for the indicated
cycles, and moist heat (steam) sterilized using
one of the following cycles:
Fractionated vacuum (pre-vacuum) – Exposure
at 132 °C for 4 minutes, 20-minute dry time.
Gravity displacement - Exposure at 132 °C for
15 minutes, 20-minute dry time.
Neodent Instrument Kits are intended for
sterilization of non-porous loads.
The combined weight of the GM EasyGuide
Surgical Kit Case Narrow/Regular Diam
Implants
and the associated instruments is 310,18 g. The
weight of the empty Kit Case is 263,63 g.
Neodent GM EasyGuide Kit Cases should not
be stacked during sterilization
Indications for Use for GM EasyGuide
Surgical Kit Case Regular/Large Diam
Implants:
Neodent Instrument Kits are intended to be
used to enclose other medical devices that are
to be sterilized by a health care provider.
Neodent Instrument Kits are intended to allow | Identical
The subject devices have
the same indications for use
as the primary predicate.
More detail regarding the
indication like weight and
sterilization condition were
added. |
| | 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 the
enclosed devices. The Kits are to be enclosed
in a sterilization wrap that is FDA-cleared for the
indicated cycles, and moist heat (steam)
sterilized using one of the following cycles:

Fractionated vacuum (pre-vacuum) - Exposure
at 132 °C for 4 minutes, 20-minute dry time.

Gravity displacement - Exposure at 132 °C for
15 minutes, 45-minute dry time.

Neodent Instrument Kits are intended for
sterilization of non-porous loads.
The combined weight of the GM EasyGuide
Surgical Kit Case Regular/Large Diam Implants | |
| | | | and the associated instruments is 346,45 g. The
weight of the empty Kit Case is 264,12g.
Neodent EasyGuide Kit Cases should not be
stacked during sterilization. | |
| Product code | KCT | KCT | KCT | Identical
The subject devices have
the same product code as
the primary predicate and
reference devices. |
| Design | Plastic tray with locking lid and silicone
containments brackets | Plastic tray with locking lid and silicone
containments brackets | Rigid base and removable inner tray with a lid.
Retention grommets. | Identical
The subject devices have
the same design as the
primary predicate. |
| Dimensions | INMODOPS3, INMODOPS3V, INMODOPS3L,
INMODOPS3LV, INMODOPP3, INMODOPP3V:
130x155x47 mm
INMODIGM, INMODIGMV:
76x155x47 mm | 130x155x47 mm
76x155x47 mm | 195x90x 64 mm | Identical
The subject devices have
the same dimensions as the
primary 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 silicone
Stainless steel | Polyphenylsulfone (Radel R-5000)
Polyphenylsulfone (Radel R-5100)
Medical grade silicone
Stainless steel | Polysulfone polymer
Polyphenylsulfone
Medical grade silicone | Identical
The subject devices have
the same materials as the
primary predicate. |
| Materials
compatible with
sterilization
Method | Yes | Yes | Yes | Identical
The subject devices have
the same materials
compatible with sterilization
method as the primary
predicate and reference
devices. |
| Perforated | Yes; allows moist heat (steam) penetration to
achieve sterilization | Yes; allows moist heat (steam) penetration to
achieve sterilization | Yes; allows moist heat (steam) penetration to
achieve sterilization | Identical
The subject devices have
the same perforated as the
primary predicate. |
| Reusable | Yes, up to 250x | Yes, up to 250x | Yes, up to 100x | Identical
The subject devices have
the same reusable life as
the primary predicate. |
| Sterilization
Method | 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 | Identical
The subject devices have
the same sterilization
method as the primary
predicate and reference
devices. |
| Cycles | Pre-Vacuum Steam Sterilization | Fractionated vacuum (pre-vacuum) | Fractionated vacuum (pre-vacuum) | Identical
The subject devices have
the same cycle as the
primary predicate and
reference 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-Vacuum
Sterilization temperature: 132 °C
Sterilization time: 4 minutes.
Drying time: 20 minutes. | Identical
The subject devices have
the parameter of
sterilization as the reference
devices. |
| 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 indicated
method and cycles | Sterilization wrap, FDA-cleared for indicated
method and cycles | Sterilization wrap, FDA-cleared for indicated
method and cycles | Identical
The subject devices have
the same sterile barrier as
the primary predicate and
reference devices. |
| 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. | 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 devices have
the same biocompatibility as
the primary predicate and
reference devices. |

8

Anthogyr Surgical Cassettes

510(k) Summary

9

Anthogyr Surgical Cassettes

510(k) Summary

10

Anthogyr Surgical Cassettes

510(k) Summary

Table 2 – Technological Characteristics Comparison of subject device versus predicate devices

11

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 and
Protein	Visual Inspection: No Visible Soil
Hemoglobin Test: