(79 days)
No
The device description and intended use focus on physical components for sterilization and organization, with no mention of AI or ML capabilities.
No
Explanation: The device is intended to enclose and allow sterilization of other medical devices, and to assist in the installation of implants. It does not directly provide therapy.
No
The device, KLOCKNER KITS, is intended to enclose and sterilize other medical devices and assist in the installation of implants. Its function is not to diagnose medical conditions.
No
The device description clearly states that the device is comprised of physical components made from injection molded polysulfone and AISI 316L stainless steel, and silicone holders. It is a physical tray designed to hold and sterilize other medical devices.
Based on the provided text, the KLOCKNER KITS are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is defined as a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. These tests are performed outside of the body (in vitro).
- Intended Use of KLOCKNER KITS: The intended use of the KLOCKNER KITS is clearly stated as being used to enclose other medical devices for sterilization by a healthcare provider. They are designed to facilitate the sterilization process and maintain the sterility of the enclosed devices.
- No mention of testing or analysis of biological samples: The provided text does not mention any use of the KLOCKNER KITS for testing, analyzing, or examining biological samples. Their function is purely related to the physical process of sterilization and organization of surgical instruments.
Therefore, the KLOCKNER KITS fall under the category of devices used in the preparation and handling of other medical devices, rather than devices used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared 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 the following cycle: Dynamic air removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The KIT WT SNIPER is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers.
The KIT WT SNIPER JSI is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers.
The KIT WT INTERNA is exclusively indicated to assist in the installation of implants of both the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.
The KIT WT VEGA is exclusively indicated to assist in the installation of the VEGA® family and is not compatible with other lines and systems of other manufacturers.
The KIT WT ESSENTIAL is exclusively indicated to assist in the installation of implants of the ESSENTIAL® CONE family and is not compatible with other lines and systems of other manufacturers.
The KIT MEDGUIDE® is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.
Product codes
KCT
Device Description
The subject device trays are designed to hold various dental surgical drills and tools to organize and protect the instruments that are sterilized in the tray by the healthcare provider. The base, inner trav, and lid components are designed to be integrated into a single unit (the complete trav) which contains and protects the interior components during sterilization. The lid latches to the base to secure the tray into a single unit. The base, inner tray, and lid components are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam) sterilization and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polysulfone and AISI 316L stainless steel. Holders of various geometries to position instruments in the kits are manufactured from silicone. The subject device trays are summarized in the following table Summary of Tray Dimensions and 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
health care 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)
Manual Cleaning Validation: The purpose of this test is to validate that the cleaning instructions provided in the Instructions for Use appropriately clean the tray, and to ensure the sterilization cycle will be effective. Results: Cleaning instructions were validated and demonstrated that the subject devices could be visually and quantifiably cleaned. Pass.
Sterilization Validation including sterilant penetration and dry time validation: The purpose of this test is to validate that the sterilization instructions listed in the Instructions for Use appropriately sterilize the tray and contents. Results: 3 consecutive half-cycles performed for each of 4 configurations of trays demonstrate complete inactivation of all biologic indicators; A minimum SAL of 10-6 is achieved if the Instructions for Use are followed. Pass.
Dry time: The purpose of this test is to validate that the sterilization instructions listed in the Instructions for Use appropriately dry the wrapped tray for storage. Results: Using pre-cycle and post-cycle weights, the weight gain after drying will be
§ 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 shows 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 logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
December 18, 2024
Soadco, S.L. % Rebecca Kattan Regulatory Specialist PaxMed International, LLC 12264 El Camino Real Suite 400 San Diego, California 92130
Re: K243128
Trade/Device Name: Klockner Kits Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 29, 2024 Received: September 30, 2024
Dear Rebecca Kattan:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
2
assistance/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).
Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Stephen A. Anisko -S" in bold black font on the left side of the image. On the right side of the image, there is a digital signature by Stephen A. Anisko -S. The date of the signature is 2024.12.18 17:36:15-05'00'.
for: Christopher K. Dugard Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243128
Device Name KLOCKNER KITS
Indications for Use (Describe)
Indications for Use for the KIT WT SNIPER
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterlity 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 the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT SNIPER and the associated instruments is 820 grams.
The weight of the empty KIT WT SNIPER is 620 grams.
The KIT WT SNIPER is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT SNIPER JSI
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared 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 the following cycle: Dynamic air removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT SNIPER JSI and the associated instruments is 920 grams.
The weight of the empty KIT WT SNIPER JSI is 620 grams.
The KIT WT SNIPER JSI is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT INTERNA
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared 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 the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT INTERNA and the associated instruments is 840 grams.
4
The KIT WT INTERNA is exclusively indicated to assist in the installation of implants of both the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT VEGA
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared 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 the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT VEGA and the associated instruments is 820 grams.
The weight of the empty KIT WT VEGA is 620 grams.
The KIT WT VEGA is exclusively indicated to assist in the installation of the VEGA® family and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT ESSENTIAL
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterlization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 ℃ for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT ESSENTIAL and the associated instruments is 800 grams.
The weight of the empty KIT WT ESSENTIAL is 620 grams.
The KIT WT ESSENTIAL is exclusively indicated to assist in the installation of implants of the ESSENTIAL® CONE family and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT MEDGUIDE®
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared 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 the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT MEDGUIDE® and the associated instruments is 240 grams.
The weight of the empty KIT MEDGUIDE® is 160 grams.
The KIT MEDGUIDE® is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.
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)
5
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6
510(k) Summary K243128 SOADCO, S.L. KLOCKNER KITS
December 12, 2024
ADMINISTRATIVE INFORMATION
| Manufacturer Name | SOADCO, S.L.
Av. Pessebre, 76-82, Baixos
AD700 Escaldes-Engordany, Andorra [AD]
Telephone: +37 (6) 800-590 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Mercedes Roldan, General Manager |
| Representative/Consultant | Rebecca E. Kattan, PhD
Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone: +1 858-792-1235
Email: rkattan@paxmed.com
kthomas@paxmed.com
flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Device Name | KLOCKNER KITS |
|---|---|
| Common Name | Instrument sterilization trays |
| Regulation Number | 21 CFR 880.6850 |
| Regulation Name | Sterilization Wrap |
| Regulatory Class | Class II |
| Product Code | KCT |
| Classification Panel | General Hospital |
| Reviewing Office | Office of Health Technology 4 |
| (OHT 4: Office of Surgical and Infection Control Devices) | |
| Reviewing Division | Division of Health Technology 4C |
| (Infection Control Devices) |
PREDICATE DEVICE INFORMATION
K173642, KLOCKNER Surgical Box, SOADCO, S.L. K212068, Biotech Dental Kits, Biotech Dental SAS
The primary predicate device is K173642. The reference device is K212068.
7
SUBJECT DEVICE INDICATIONS FOR USE STATEMENT
Indications for Use for the KIT WT SNIPER
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared 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 the following cycle: Dynamic air removal steam sterilization -Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT SNIPER and the associated instruments is 820 grams. The weight of the empty KIT WT SNIPER is 620 grams.
The KIT WT SNIPER is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT SNIPER JSI
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared 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 the following cycle: Dynamic air removal steam sterilization -Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT SNIPER JSI and the associated instruments is 920 grams. The weight of the empty KIT WT SNIPER JSI is 620 grams.
The KIT WT SNIPER JSI is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT INTERNA
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared 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 the following cycle: Dynamic air removal steam sterilization -Exposure at 134 ℃ for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT INTERNA and the associated instruments is 840 grams. The weight of the empty KIT WT INTERNA is 620 grams.
8
The KIT WT INTERNA is exclusively indicated to assist in the installation of implants of both the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT VEGA
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared 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 cvcles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization -Exposure at 134 ℃ for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT VEGA and the associated instruments is 820 grams. The weight of the empty KIT WT VEGA is 620 grams.
The KIT WT VEGA is exclusively indicated to assist in the installation of implants of the VEGA® family and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT ESSENTIAL
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared 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 the following cycle: Dynamic air removal steam sterilization -Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT ESSENTIAL and the associated instruments is 800 grams. The weight of the empty KIT WT ESSENTIAL is 620 grams.
The KIT WT ESSENTIAL is exclusively indicated to assist in the installation of implants of the ESSENTIAL® CONE family and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT MEDGUIDE®
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared 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 the following cycle: Dynamic air removal steam sterilization -Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
9
The combined weight of the KIT MEDGUIDE® and the associated instruments is 240 grams. The weight of the empty KIT MEDGUIDE® is 160 grams.
The KIT MEDGUIDE® is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.
SUBJECT DEVICE DESCRIPTION
The subject device trays are designed to hold various dental surgical drills and tools to organize and protect the instruments that are sterilized in the tray by the healthcare provider . The base, inner trav, and lid components are designed to be integrated into a single unit (the complete trav) which contains and protects the interior components during sterilization. The lid latches to the base to secure the tray into a single unit. The base, inner tray, and lid components are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam) sterilization and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polysulfone and AISI 316L stainless steel. Holders of various geometries to position instruments in the kits are manufactured from silicone. The subject device trays are summarized in the following table Summary of Tray Dimensions and Contents.
| [Tray Part Number]/
[Kit Part Number] | Number of
items (in Kit) | Enclosed
Volume | Total Vent
Area | Vent to volume
ratio |
|------------------------------------------|-----------------------------|--------------------|--------------------|-------------------------|
| [20 06 32]/ [KIT WT
SNIPER] | 69 | 185.239 in3 | 93.41 in2 | 0.504 in2/ in3 |
| [20 06 33]/ [KIT WT
SNIPER JSI] | 104 | 185.239 in3 | 93.41 in2 | 0.504 in2/ in3 |
| [10 06 23]/ [KIT WT
INTERNA] | 36 | 185.239 in3 | 93.41 in2 | 0.504 in2/ in3 |
| [10 06 23]/ [KIT WT
VEGA] | 31 | 185.239 in3 | 93.41 in2 | 0.504 in2/ in3 |
| [10 06 23]/ [KIT WT
ESSENTIAL] | 22 | 185.239 in3 | 93.41 in2 | 0.504 in2/ in3 |
| [10 00 09]/ [KIT
MEDGUIDE®] | 16 | 14.280 in3 | 2.656 in2 | 0.181 in2/ in3 |
Summary of Tray Dimensions and Contents
TECHNOLOGICAL CHARACTERISTICS COMPARISION DISCUSSION
The subject device and the predicate device K173642 have the same intended use, the same product classification and product code (KCT) and have similar Indications for Use statements. The subject device and the predicate device K173642 are reusable rigid containers used to organize and protect the instruments that are sterilized by the healthcare provider. The subject device and the predicate device K173642 are to be sterilized by moist heat (steam) and require the use of an FDA cleared wrap to maintain sterility. The Indications for Use Statement (IFUs) for the subject device is similar to that of the predicate device K173642 and reference device K212068; slight differences in language of the IFUs do not affect the intended use.
The subject device is provided in 2 sizes and 6 configurations; the predicate device K173642 is provided in 1 size and 1 configuration. The subject device and the predicate device have
10
similar overall dimensions, enclose similar volumes, and have similar vent to volume ratios. Differences in the dimensions and vent to volume ratios between the subject device and the predicate device are mitigated by the sterilization validation performed.
The reference device, K212068, is provided in 10 sizes and 11 configurations. The subject device and the reference device have very similar overall dimensions, enclose very similar volumes, and have very similar vent to volume ratios. Differences in the dimensions and vent to volume ratios between the subject device and the predicate device are mitigated by the sterilization validation performed.
The basis for the belief of SOADCO, S.L. that the subject device is similar to the predicate device and reference device is summarized in the following Table of Technological Characteristics Comparison.
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Table of Technological Characteristics Comparison
| Subject Device | Primary Predicate Device | Refence Predicate Device | Similarity | |
|---|---|---|---|---|
| K243128 | ||||
| KLOCKNER KITS | ||||
| SOADCO, S.L. | K173642 | |||
| KLOCKNER Surgical Box | ||||
| SOADCO, S.L. | K212068 | |||
| Biotech Dental Kits | ||||
| Biotech Dental | ||||
| Product Code | KCT | KCT | KCT | Same |
| Intended Use | organize and protect the devices, instruments, and accessories that are | |||
| sterilized by health care provider | organize and protect the devices, instruments, and accessories that are sterilized by health | |||
| care provider | organize and protect the devices, instruments, and accessories that are | |||
| sterilized by health care provider | Same | |||
| Design | 2-piece plastic trays |
- Rigid polymer base and lid
3-piece plastic trays
- Rigid polymer base, lid, and removable inner tray | 3-piece plastic trays
- Rigid polymer base, lid, and removable inner tray | 2-piece plastic trays
- Rigid polymer base and lid
3-piece plastic trays
- Rigid polymer base, lid, and removable inner tray
2-piece metal trays
- Rigid metal base, lid, and inner tray. | Similar |
| Materials | 2-piece plastic trays
Polyphenylsulfone (PPSU) [lid/base]
3-piece plastic trays
Polyphenylsulfone (PPSU) [lid, base]
Polyphenylsulfone (PPSU) + Silicone SE-PX [inner tray] | 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 | 2-piece plastic trays
Polyphenylsulfone (PPSU) (Radel R5000) [lid]
Polypropylene (PPHS) [base]
3-piece plastic trays
Polyphenylsulfone (Radel R5000) [lid, base, insert]
Medical grade silicone [grommets]
2-piece metal trays
Stainless Steel AISI 304L
Medical grade silicone [grommets] | Same |
| Materials Compatible with
Sterilization Method | Yes | Yes | Yes | Same |
| 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 | Same |
| Number of Overall Sizes | 2 | 1 | 10 | Similar |
| Number of Configurations | 6 | 1 | 11 | Similar |
| | Length x Width x Height | Length x Width x Height | Length x Width x Height | |
| | Vent to Volume Ratio | Vent to Volume Ratio | Vent to Volume Ratio | |
| Overall Dimensions and
Vent to Volume Ratio | 251mm x 156mm x 60.7mm
0.1984 cm²/cm³ (0.504 in²/ in³) | 287.02 mm x 176.02 mm x 55.8 mm (11.3 in x 6.93 in x 2.2 in)
(0.181 in²/ in³) | 150 mm x 65 mm x 25 mm
0.2260 cm²/cm³ | Similar |
| | 251mm x 156mm x 60.7mm
0.1984 cm²/cm³ (0.504 in²/ in³) | | 150 mm x 65 mm x 25 mm
0.1472 cm²/cm³ | Similar |
| | 251mm x 156mm x 60.7mm
0.1984 cm²/cm³ (0.504 in²/ in³) | | 150 mm x 65 mm x 25 mm
0.3694 cm²/cm³ | Similar |
| | 251mm x 156mm x 60.7mm
0.1984 cm²/cm³ (0.504 in²/ in³) | | 150 mm x 65 mm x 25 mm
0.3932 cm²/cm³ | Similar |
| | 251mm x 156mm x 60.7mm
0.1984 cm²/cm³ (0.504 in²/ in³) | | 125 mm x 127 mm x 24.5 mm
0.1224 cm²/cm³ | Similar |
| | 120mm x 75mm x 26mm
0.0713 cm²/cm³ (0.181 in²/ in³) | | 125 mm x 127 mm x 36.5 mm
0.0346 cm²/cm³ | Similar |
| | | | 125 mm x 127 mm x 32.5 mm
0.0567 cm²/cm³ | Similar |
| | | | 162.2 mm x 170 mm x 55 mm
0.0049 cm²/cm³ | Similar |
| | Subject Device | Primary Predicate Device | Refence Predicate Device | Similarity |
| | K243128
KLOCKNER KITS
SOADCO, S.L. | K173642
KLOCKNER Surgical Box
SOADCO, S.L. | K212068
Biotech Dental Kits
Biotech Dental | |
| | | | 162.2 mm x 170 mm x 55 mm
0.0049 cm²/cm³ | |
| | | | 162.2 mm x 170 mm x 65 mm
0.0041 cm²/cm³ | |
| | | | 40 mm x 50 mm x 20 mm
0.9500 cm²/cm³ | |
| Reusable | Yes | Yes | Yes | Same |
| Use Life Testing | Reusable up to 20 cycles
Assembled, sterilized
Visual inspection
Functional closure (lid-base latch) verification | Reusable up to 101 cycles.
Assembled, sterilized
Visual inspection | Reusable up to 100 cycles
Assembled, sterilized
Visual inspection
Component dimensional fit verification
Functional closure (lid-base latch) verification | Similar |
| Sterilant | Moist heat (steam) | Moist heat (steam) | Moist heat (steam) | Same |
| Cycles | Pre-vacuum Steam at 134°C for 4 minutes with 16 minutes drying time. | Pre-vacuum Steam at 134°C for 4 minutes with 15 minutes drying time. | Fractionated vacuum (pre-vacuum)
Exposure at 132 °C (270 °F) for 4 minutes with 20 minutes drying time. | Similar |
| Sterile Barrier | Sterilization wrap or pouch, FDA cleared for indicated method and cycle | Sterilization wrap or pouch, FDA cleared for indicated method and cycle | Sterilization wrap or pouch, FDA cleared for indicated method and
cycle | Same |
12
13
SUMMARY OF NONCLINICAL TESTING
Provided below are the nonclinical test methodologies performed to demonstrate the subject devices met the acceptance criteria of the standard.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Manual Cleaning Validation | |||
| FDA Guidance | |||
| Reprocessing Medical Devices in | |||
| Health Care Settings: Validation | |||
| Methods and Labeling (issued | |||
| March 2015) | |||
| ANSI AAMI ST8:2013/(R)2018 | The purpose of this test is to | ||
| validate that the cleaning | |||
| instructions provided in the | |||
| Instructions for Use | |||
| appropriately clean the tray, and | |||
| to ensure the sterilization cycle | |||
| will be effective. | Cleaning instructions were | ||
| validated and demonstrated that | |||
| the subject devices could be | |||
| visually and quantifiably cleaned. | Pass | ||
| Sterilization Validation | |||
| including sterilant penetration | |||
| and dry time validation | |||
| ANSI/AAMI/ISO 17665- | |||
| 1:2006/(R)2013 | |||
| ANSI/AAMI/ISO 17665-2:2009 | The purpose of this test is to | ||
| validate that the sterilization | |||
| instructions listed in the | |||
| Instructions for Use | |||
| appropriately sterilize the tray | |||
| and contents. | 3 consecutive half-cycles | ||
| performed for each of 4 | |||
| configurations of trays | |||
| demonstrate complete inactivation | |||
| of all biologic indicators; A | |||
| minimum SAL of 10-6 is achieved | |||
| if the Instructions for Use are | |||
| followed. | Pass | ||
| Dry time | |||
| Validated in Drying Time | |||
| Validation Report | |||
| AAMI TIR12: 2020 | |||
| ANSI/AAMI/ISO 17665-2:2009 | The purpose of this test is to | ||
| validate that the sterilization | |||
| instructions listed in the | |||
| Instructions for Use | |||
| appropriately dry the wrapped | |||
| tray for storage. | Using pre-cycle and post-cycle | ||
| weights, the weight gain after | |||
| drying will be |