(312 days)
No
The device description and intended use are solely focused on physical sterilization cassettes and their function in organizing and sterilizing surgical instruments. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI/ML.
No
Explanation: The device is a sterilization cassette designed to organize, steam sterilize, and transport dental surgical instruments. Its function is to facilitate the sterilization process of other medical devices, not to provide therapy directly to a patient.
No
No
The device description clearly states it is a set of sterilization cassettes, which are physical hardware components used to hold and organize surgical instruments for sterilization. There is no mention of any software component.
Based on the provided text, the Klockner Surgical Box is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "hold various dental surgical drills, instruments and/or tools in order to organize, steam sterilize and transport the instruments between uses." This describes a device used for the preparation and handling of surgical instruments, not for testing samples taken from the human body.
- Device Description: The description reinforces this by calling it a "reusable rigid sterilization cassette or organizing tray intended for the purpose of containing reusable (and in some cases, non-reusable) devices for sterilization."
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls
The Klockner Surgical Box is a device used in the process of sterilizing and managing surgical instruments, which falls under the category of medical devices used in a clinical setting, but not specifically IVD devices.
N/A
Intended Use / Indications for Use
Klockner Surgical Box is a set of sterilization cassettes (thirteen different models between injection molding and machining sterilization cassettes). They all are designed to hold various dental surgical drills, instruments and/or tools in order to organize, steam sterilize and transport the instruments between uses. Their use and handling are intended for physicians and dental professionals in health care or equivalent facilities. The sterilization cassettes have to be enclosed in an FDA-cleared steam sterilizable wrap and sterilized in an FDA-cleared sterilizer according to the following cycle:
Pre-vacuum Steam at 134 degrees Celsius for 4 minutes with 15 minutes drying time.
The trays are intended for sterilization of metal and thermoplastic loads.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
Klockner Surgical Box is a reusable rigid sterilization cassette or organizing tray intended for the purpose of containing reusable (and in some cases, non-reusable) devices for sterliization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization.
Under the device trade name "Klockner Surgical Box", two different sets of sterliization surgical boxes are presented: (Both sets differ in the way the plastic is molded).
- Injection molding sterilization cassettes
- Machined sterilization cassettes
Injection molding Klockner Surgical Box: Dimensions: 11.3 in x 6.93 in x 2.2 in
Each box consists of three components, a boking lid and an internal individualized insert tray. The internal insert tray has the ability to hold individualized pieces and accessories which include dental tools, drills and ratchet. A single box design is available with a size of approximately 11.3 in x 6.93 in x 2.2 inches and it will be marketed in six different kits:
KIT KLOCKNER - containing 80 instruments
KIT INTERNA - containing 60 instruments
KIT VEGA - containing 53 instruments
KIT ESSENTIAL - containing 38 instruments
KIT EXTERNA - containing 35 instruments
KIT 20 06 00 ESS - containing 62 instruments
The id, base and insert tray are made of Radel R PPSU (polyphenylsulfone), Radel R-5800 (violet color) is used R-5100 GY1037 (gray color) is used for the insert tray in two out of the six possible configurations of the surgical box, and Rade R-5100 BK937 (black color) is used for the base of all configurations and for the surgical box variations. the instruments contained in the injection molding Klockner Surgical Box (dental tools, drills and ratchet), are placed in small circular brackets (grommets) located throughout the insert tray. Brackets and holders, are made of medical The lid is locked to the trays with 304 stainless steel latches and both the lid and the trays are silkscreened in white ink with the trade name to to facilitate the user's use.
The instruments to be sterilized in the injection cassettes are all non-porous devices and include dental surgical drills and tools.
Machined Klockner Surgical Box:
Dimensions: 4.72 in x 2.95 in x 1.79 in and 1.02 in
Each container consists of two parts, a base and a linsert tray in this type of surgical box. Depending on the dental tools and instruments comprised in each kit/variation, there are seven different box designs intended to be commercialized:
KIT 10 00 02 - containing 35 instruments
KIT 10 00 03 - containing oc instruments
KIT 10 00 04 - containing 26 instruments
KIT 10 00 05 - containing 7 instruments
KIT 10 00 06 - containing 14 instruments
KIT 10 00 07 - containing 31 instruments
KIT 10 00 08 - containing 19 instruments
These seven machined sterlization boxes are available in two sizes depending on the Plengomaxilar Box Kit and the Prosthetic Box Kit which are marketed in a size of 4.72 in the five remaining marketed kits measure 4.72 in x 2.95 in x 1.02 in.
The base is made of PROPYLUX HS2 heat-stabilized plastic, and the lid is manufactured using TECASON P VF polyphenylsulfone (PPSU) Smoke. Bases of all seven boxes are laser silkscreened with the trademark and useful information for the user. The system that enables to lock the lid to the box is based on the ability of the lid to slip through two guides that have a burr.
The instruments and dental tools to be sterilized in the machined sterilization cassettes are all non-porous devices.
All the cassettes of Klockner Surgical Box are reusable and the materials allow repeated sterliization wrap must be used for sterilization purposes to maintain the sterility contents.
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
physicians and dental professionals in health care or equivalent facilities.
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)
Validation test for steam sterilization, validation of manual cleaning and limit of reuse test for the Klockner Surgical Box (Surgical Box Kit Klockner and Bone Space Maintainers Box Kit are the containers that represent worst cases) have been carried out as the results are shown by test reports. All tests demonstrated compliance with both safety and effectiveness requirements that apply to the device, in terms of sterilization performance, maintenance of sterility and reusability.
Summary of Performance Test results:
- Cleaning validation: Cleaning instructions were validated and demonstrated that the subject device could be visually and quantifiably cleaned.
- Steam sterilization validation (Half cycle validation: 2' at 134 degrees Celsius): No growth at half cycle.
- Limits of reuse (Biocompatibility included): the kits were challenged with 101 reprocessing cycles. Both types of sterilization boxes met inspection and performance criteria after 101 reuses.
- Drying Time: Worst-case loads were determined to be visually and quantifiably dry after exposure to the sterilization cycle and claimed dry time.
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.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.
October 2, 2018
Soadco, S.L. Maria Mitjaneta Quality Manager Avgda. Fiter I Rossell, 4 Bis- Local 2 Escaldes-Engordany, AD700 Ad
Re: K173642
Trade/Device Name: Klockner Surgical Box Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: July 30, 2018 Received: September 5, 2018
Dear Maria Mitjaneta:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray lii III -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
Image /page/2/Picture/0 description: The image shows the logo for SOAD for KLOCKNER. The logo is in black and white, with the letters "SOAD" in a bold, sans-serif font. The "O" in SOAD is replaced by a globe. Below the logo, the words "for KLOCKNER" are written in a smaller font. The logo is simple and modern, and it is likely used to represent a company or organization.
INDICATIONS FOR USE
K173642 510(k) Number (if known):
Device Name: Klockner Surgical Box
Indications for Use:
Klockner Surgical Box is a set of sterilization cassettes (thirteen different models between injection molding and machining sterilization cassettes). They all are designed to hold various dental surgical drills, instruments and/or tools in order to orqanize, steam sterilize and transport the instruments between uses. Their use and handling are intended for physicians and dental professionals in health care or equivalent facilities. The sterilization cassettes have to be enclosed in an FDAcleared steam sterilizable wrap and sterilized in an FDA-cleared sterilizer according to the following cycle:
- o Pre-vacuum Steam at 134℃ for 4 minutes with 15 minutes drying time.
The trays are intended for sterilization of metal and thermoplastic loads.
Klockner Surgical Box includes the following variations of each type of cassette:
| Type of
cassette | Reference (Ref.) | Device Model Name | Maximum number of
instruments / Weight
of each container* |
|----------------------|------------------|--------------------------------|-----------------------------------------------------------------|
| Injection
molding | KIT KLOCKNER | Surgical Box Kit Klockner | 80 / 1200 gr. |
| | KIT INTERNA | Surgical Box Kit Internal® | 60 / 1160 gr. |
| | KIT VEGA | Surgical Box Kit Vega | 53 / 1160 gr. |
| | KIT ESSENTIAL | Surgical Box Kit Essential® | 38 / 1120 gr. |
| | KIT EXTERNA | Surgical Box Kit External® | 35/ 1120 gr. |
| | KIT 20 06 00 ESS | Essential® Guide System Kit | 62 / 1180 gr. |
| Machined | KIT 10 00 02 | Drill Stop Box Kit | 35 / 180 gr. |
| | KIT 10 00 03 | Expansion Box Kit | 8 / 200 gr. |
| | KIT 10 00 04 | Regeneration Box Kit | 26 / 180 gr. |
| | KIT 10 00 05 | Bone Space Maintainers Box Kit | 7 / 180 gr. |
| | KIT 10 00 06 | Pterigomaxilar Box Kit | 14 / 216 gr. |
| | KIT 10 00 07 | MedLocate Box Kit | 31 / 181 gr. |
| | KIT 10 00 08 | Prosthetic Box Kit | 19 / 256 gr. |
*Weight of the final product of the Klockner Surgical Box. Full container with all the possible instruments included, wrapped in plastic and included in a corporate carton box which is also wrapped in plastic.
3
Image /page/3/Picture/1 description: The image shows a logo with the text "SOADC" in bold, black letters. The letters are stylized and interconnected. The logo also includes a globe graphic, and the text "for KLOCKNER" is written in a smaller font below the globe. The entire logo is set against a gray background.
Prescription Use (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use ✓ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4
510(k) SUMMARY
| Date of Preparation: | 9-28-2018 |
|---|---|
| Submitter name: | SOADCO, S.L. |
| Submitter address: | Avgda. Fiter i Rossell, 4bis - Local 2 |
| ESCALDES - ENGORDANY | |
| AD-700 (ANDORRA) | |
| Contact person: | Maria Mitjaneta |
| Phone: | +376 800 590 |
| Fax: | +376 800 594 |
| E-mail: | calidad@soadco.com |
| Device Trade Name: | KlocknerSurgical box |
| Common Name: | Instrument Sterilization Tray |
| Classification Name: | Sterilization Wrap |
| Regulation Number: | 21 CFR 880.6850 |
| Class: | Class II |
| Product code: | KCT |
Legally Marketed (Predicate) Device:
| Primary Predicate
device
| 510(k) Number | Device Trade Name | Manufacturer | |
|---|---|---|---|
| K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron | |
| Manufacturing LLC | |||
| Reference | |||
| devices | 510(k) | ||
| Number | Device Trade Name | Manufacturer |
5
| 1 | K012105 | PolyVac Surgical Instruments Delivery
System | Symmetry Medical Inc. |
|---|---------|------------------------------------------------------------------|-----------------------------------|
| 2 | K162063 | Steri-Cassette and Steri-Cage
Sterilization Packaging Systems | Sybron Dental Specialties
Inc. |
| 3 | K120947 | THS sterilization Tray | Hologic, Inc. |
Device Description:
Klockner Surgical Box is a reusable rigid sterilization cassette or organizing tray intended for the purpose of containing reusable (and in some cases, non-reusable) devices for sterliization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization.
Under the device trade name "Klockner Surgical Box", two different sets of sterliization surgical boxes are presented: (Both sets differ in the way the plastic is molded).
- Injection molding sterilization cassettes ●
- Machined sterilization cassettes ●
Injection molding Klockner Surgical Box: Dimensions: 11.3 in x 6.93 in x 2.2 in
Each box consists of three components, a boking lid and an internal individualized insert tray. The internal insert tray has the ability to hold individualized pieces and accessories which include dental tools, drills and ratchet. A single box design is available with a size of approximately 11.3 in x 6.93 in x 2.2 inches and it will be marketed in six different kits:
| Reference (Ref.) | Device Model Name | ||
|---|---|---|---|
| KIT KLOCKNER | Surgical Box Kit Klockner | - containing | 80 instruments* |
6
| KIT INTERNA | Surgical Box Kit Internal® | - containing | 60 | instruments* |
|---|---|---|---|---|
| KIT VEGA | Surgical Box Kit Vega | - containing | 53 | instruments* |
| KIT ESSENTIAL | Surgical Box Kit Essential® | - containing | 38 | instruments* |
| KIT EXTERNA | Surgical Box Kit External® | - containing | 35 | instruments* |
| KIT 20 06 00 ESS | Essential® Guide System Kit | - containing | 62 | instruments* |
*Maximum number of instruments each kit can contain
The id, base and insert tray are made of Radel® R PPSU (polyphenylsulfone), Radel® R-5800 (violet color) is used® R-5100 GY1037 (gray color) is used for the insert tray in two out of the six possible configurations of the surgical box, and Rade® R-5100 BK937 (black color) is used for the base of all configurations and for the surgical box variations. the instruments contained in the injection molding Klockner Surgical Box (dental tools, drills and ratchet), are placed in small circular brackets (grommets) located throughout the insert tray. Brackets and holders, are made of medical The lid is locked to the trays with 304 stainless steel latches and both the lid and the trays are silkscreened in white ink with the trade name to to facilitate the user's use.
The instruments to be sterilized in the injection cassettes are all non-porous devices and include dental surgical drills and tools.
Machined Klockner Surgical Box:
Dimensions: 4.72 in x 2.95 in x 1.79 in and 1.02 in
Each container consists of two parts, a base and a linsert tray in this type of surgical box. Depending on the dental tools and instruments comprised in each kit/variation, there are seven different box designs intended to be commercialized:
| Reference (Ref.) | Device Model Name | |||
|---|---|---|---|---|
| KIT 10 00 02 | Drill Stop Box Kit | — containing | 35 instruments | |
| KIT 10 00 03 | Expansion Box Kit | - containing | oc | instruments |
| KIT 10 00 04 | Regeneration Box Kit | - containing | 26 instruments | |
| KIT 10 00 05 | Bone Space Maintainers Box Kit - containing | 7 | instruments |
7
| KIT 10 00 06 | Pterigomaxilar Box Kit | - containing | 14 | instruments |
|---|---|---|---|---|
| KIT 10 00 07 | MedLocate Box Kit | - containing | 31 | instruments |
| KIT 10 00 08 | Prosthetic Box Kit | - containing | 19 | instruments |
These seven machined sterlization boxes are available in two sizes depending on the Plengomaxilar Box Kit and the Prosthetic Box Kit which are marketed in a size of 4.72 in the five remaining marketed kits measure 4.72 in x 2.95 in x 1.02 in.
The base is made of PROPYLUX® HS2 heat-stabilized plastic, and the lid is manufactured using TECASON® P VF polyphenylsulfone (PPSU) Smoke. Bases of all seven boxes are laser silkscreened with the trademark and useful information for the user. The system that enables to lock the lid to the box is based on the ability of the lid to slip through two guides that have a burr.
The instruments and dental tools to be sterilized in the machined sterilization cassettes are all non-porous devices.
All the cassettes of Klockner Surgical Box are reusable and the materials allow repeated sterliization wrap must be used for sterilization purposes to maintain the sterility contents.
Intended Use / Indications for Use:
Klockner Surgical Box is a set of sterlization cassettes (thitteent models between injection molding and machining sterlization cassettes). They all are designed to hold surgical drills, instruments and/or tools in order to organize, steam sterilize and transport the instruments between uses. Their use and handling are intended for physicians in health care or equivalent facilities. The sterilization cassettes must be enclosed in an FDA- cleared sterlized wap and sterlized in an FDA-cleared sterilizer according to the following cycle:
Pre-vacuum Steam at 134ºC for 4 minutes drying time. The trays are intended for sterlization of metal and ● thermoplastic loads.
Klockner Surgical Box includes the following variations of each type of cassette:
| Type of
cassette | Reference (Ref.) | Device Model Name | Maximum number of
instruments / Weight
of each container* |
|----------------------|------------------|----------------------------|-----------------------------------------------------------------|
| Injection
molding | KIT KLOCKNER | Surgical Box Kit Klockner | 80 / 1200 gr. |
| Injection
molding | KIT INTERNA | Surgical Box Kit Internal® | 60 / 1160 gr. |
| Injection
molding | KIT VEGA | Surgical Box Kit Vega | 53 / 1160 gr. |
8
| Type of
cassette | Reference (Ref.) | Device Model Name | Maximum number of
instruments / Weight
of each container* |
|---------------------|------------------|--------------------------------|-----------------------------------------------------------------|
| | KIT ESSENTIAL | Surgical Box Kit Essential® | 38 / 1120 gr. |
| | KIT EXTERNA | Surgical Box Kit External® | 35 / 1120 gr. |
| | KIT 20 06 00 ESS | Essential® Guide System Kit | 62 / 1180 gr. |
| Machined | KIT 10 00 02 | Drill Stop Box Kit | 35 / 180 gr. |
| | KIT 10 00 03 | Expansion Box Kit | 8 / 200 gr. |
| | KIT 10 00 04 | Regeneration Box Kit | 26 / 180 gr. |
| | KIT 10 00 05 | Bone Space Maintainers Box Kit | 7 / 180 gr. |
| | KIT 10 00 06 | Pterigomaxilar Box Kit | 14 / 216 gr. |
| | KIT 10 00 07 | MedLocate Box Kit | 31 / 181 gr. |
*Weight of the final product of the Klockner Surgical Box. Full container with all the possible instruments included, wrapped in plastic and included in a corporate carton box which is also wrapped in plastic.
Summary of Technological Characterics:
Proposed device intended use, indications for use and technological characteristics have been compared with those of the predicates devices (see next pages).
| ELEMENT | NEW DEVICE | PRIMARY
PREDICATE | REFERENCE
DEVICE 1 | REFERENCE
DEVICE 2 | REFERENCE
DEVICE 3 | Comparison: |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Klockner Surgical Box | InterActive Complete
Surgical Tray | PolyVac Surgical
Instruments Delivery
System | Steri-Cassette and Steri-
Cage Sterilization
Packaging System | THS sterilization Tray | Subject device
vs. |
| Manufacturer | SOADCO,S.L. | Implant Direct Sybron
Manufacturing LLC | Poly Vac Inc./ Symmetry
Medical Inc. | Sybron Dental Specialties
Inc. | Hologic, Inc. | Predicate
device /
Reference
devices |
| 510 (K) | | K142519 | K012105 | K162063 | K120947 | |
| Indications for
Use: | Klockner Surgical Box
is a set of sterilization | The InterActive
Complete Surgical | PolyVac's delivery
systems consist of | The Steri-Cassettes
and Steri-Cages are | The THS
Sterilization Tray is | Similiar |
| | | | | | | |
| Intended use | cassettes (thirteen
different models
between injection
molding and machining
sterilization cassettes).
They all are designed to
hold various dental
surgical drills,
instruments and/or tools
to organize, steam
sterilize and transport
the instruments
between uses. Their
use and handling are
intended for physicians
and dental professionals
in health care or
equivalent facilities.
The sterilization
cassettes have to be
enclosed in an FDA-
cleared steam
sterilizable wrap and
sterilized in an FDA-
cleared sterilizer
according to the
following cycle:
Pre-vacuum Steam at
134°C for 4 minutes with
15 minutes drying time.
The trays are intended
for sterilization of metal
and thermoplastic loads.
• and
thermoplastic loads. | 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 for
one of the following
cycles:
(1) Prevaccum Steam
– At 132 °C for 4
minutes with a 20
minutes dry time.
(2) Gravity Steam - At
132 °C for 15 minutes
with a 30 minutes dry
time. | perforated trays with
lids, which are intended
to enclose and protect
medical device
instrumentation, and to
facilitate the
sterilization process by
allowing steam
penetration and air
removal. When used in
conjunction with an
approved sterilization
wrap, sterility of the
enclosed medical device
is maintained until used.
PolyVac's delivery
systems are to be
sterilized in one of the
following cycles:
Prevacuum Steam :
132°C - 4 min
Gravity Steam: 132°C -
30 min
Gravity Steam: 121°C
- 55 minutes | intended to contain
dental intruments for
cleaning sterilization,
organization storage
and handling. The
Steri-Cassettes and
Steri-Cages are
suitable for prevacuum
and gravity
displacement steam
sterilization methods.
The cassettes and
cages are not intended
to maintain sterility;
they are intended to be
used in conjunction
with validated, FDA
cleared sterilization
wrap in order to
maintain sterility of
the enclosed devices. | used to enclose,
protect, and organize
the THS scopes,
diagnostic sheath,
and associated
accessory
components, and to
facilitate the
sterilization process
by allowing sterilant
penetration and air
removal when used
in conjunction with
an approved
sterilization wrap.
The THS Instrument
tray is not designed
to maintain sterility
by itself, but.when
used in conjunction
with an approved
sterilization wrap
sterility of the
enclosed medical
device is maintained
based on the specific
time that the
maintenance of
sterility for that
specific wrap as
cleared by the FDA. | |
| | Perforated instrument
cassette system to hold | Perforated
cassette system to hold | instrument Perforated trays with lids,
which are intended to | Perforated trays with lids, to hold | trays with
surgical lids, used to enclose, | Same |
| | dental instruments in place
during transport, steam
sterilization, and storage
when used in conjunction
with an approved
sterilization wrap. | dental instruments in
place during transport,
steam sterilization, and
storage. | enclose and protect medical
device instrumentation, and
to facilitate the sterilization
process by allowing steam
penetration and air removal.
When used in conjunction
with an approved
sterilization wrap, sterility
of the enclosed medical
device is maintained until
used. | instruments in
place during transport, steam
sterilization, and storage. | protect, and organize the
THS scopes, diagnostic
sheath, and associated
accessory components,
and to facilitate the
sterilization process by
allowing sterilant
penetration and air
removal when used in
conjunction with an
approved sterilization
wrap. | |
| Material
Composition | Injection molding surgical
box: - Radel® R-5100 and
- Radel® R-5800 polymer
resin (PPSU
Polyphenylsulfone) - Medical grade silicone
- 300 series stainless steel
Machined surgical box:
- Radel® R PPSU
polymer resin - Polypropylene heat-
stabilized plastic | - Radel® R-5000 and - Radel® R-5100
(polyphenylsulfone -
PPSU) - Medical grade silicone | - Radel® R-5000 plastic
- Medical grade silicone
- Aluminum
- 300 series stainless steel | Cassettes - High Heat: High-
Resistant Plastic - Ultem
Resin 1000 (proprietary
mixture with pigments)
(thermoplastic).
Cassettes - Standard
Heat and cages:
polypropylene with color
(proprietary mixture with
pigments)
(thermoplastic). | - Radel® R-5000
plastic grade
- Medical grade
silicone - 300 series stainless
steel | For injection
molding boxes
K142519 has
the same
material
composition.
For machined
boxes,
K162063 has
the same
material
composition. |
| Reusable | Yes | Yes | Yes | Yes | Yes | Same |
| Material
compatibility
with
sterilization
process | Yes | Yes | Yes | Yes | Yes | Same |
9
10
11
Image /page/11/Picture/0 description: The image shows the logo for SOAD for KLOCKNER. The logo is in black and white, and the letters are large and bold. The letters are arranged in a slightly curved line, and the word "for KLOCKNER" is written in smaller letters below the letters SOAD. The logo is simple and easy to read.
Summary discussion of non-clinical data:
Validation test for steam sterilization, validation of manual cleaning and limit of reuse test for the Klockner Surgical Box (Surgical Box Kit Klockner and Bone Space Maintainers Box Kit are the containers that represent worst cases) have been carried out as the results are shown by test reports. All tests demonstrated compliance with both safety and effectiveness requirements that apply to the device, in terms of sterilization performance, maintenance of sterility and reusability.
In the following table, Table 5.1, a summary of the different performance test carried out and the corresponding standards and results are described.
| Performance Test | Standard(s) used | Results |
|---|---|---|
| Cleaning validation | AAMI TIR30:2011 | |
| ISO/DIS 19277 / AFNOR-NF S94- | ||
| 091 | ||
| ISO 11737-1:2006 | ||
| ISO 9377-2:2000 | ||
| European Pharmacopoeia | ||
| ("Method D" from 2.6.14 chapter) | Cleaning instructions were | |
| validated and demonstrated that | ||
| the subject device could be | ||
| visually and quantifiably cleaned | ||
| Steam sterilization | ||
| validation (Half cycle | ||
| validation: 2' at 134°C) | ISO 17665-1:2006 | |
| ISO 17665-2:2009 | ||
| AAMI TIR12:2010 | ||
| ISO 11737-2:2009 | No growth at half cycle | |
| Limits of reuse | ||
| (Biocompatibility included) | FDA Guideline: Reprocessing | |
| Medical Devices in Health Care | ||
| Settings: Validation Methods and | ||
| Labeling (2011) | ||
| AAMI TIR12:2010 | ||
| AAMI TIR30:2011 | ||
| ISO 10993 | the kits were challenged with | |
| 101 reprocessing cycles. Both | ||
| types of sterilization boxes | ||
| met inspection and | ||
| performance criteria after 101 | ||
| reuses. | ||
| Drying Time | Validated in Drying Time Validation | |
| Report (ISO 17665; AAMI TIR12) | Worst-case loads were | |
| determined to be visually and | ||
| quantifiably dry after exposure | ||
| to the sterilization cycle and | ||
| claimed dry time. |
Table 5.1 Brief description of non-clinical performance testing
Summary Discussion of Clinical Data:
Not applicable.
Conclusions:
Based on the performed nonclinical tests, the device is as safe, as effective, and performs as well as the legally marketed predicate device, K142519.