(87 days)
No
The 510(k) summary describes sterilization cases and their intended use for holding and sterilizing dental instruments. There is no mention of AI or ML capabilities in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a kit case intended to enclose other medical devices for sterilization, not to provide therapy itself.
No
The device, Zirconia and Nuvo CF Guided Surgery Kit Cases, are reusable rigid containers intended to hold, organize, sterilize, and protect dental instruments. Their function is to facilitate sterilization and storage, not to diagnose any medical condition or disease.
No
The device is described as reusable rigid containers made of autoclavable polymer, intended to hold and sterilize dental instruments. This description clearly indicates a physical hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are "intended to be used to enclose other medical devices that are to be sterilized by a health care provider" and "intended to allow sterilization of the enclosed medical devices." This describes a device used in the process of sterilizing other medical instruments, not a device used to perform a diagnostic test on a biological sample.
- Device Description: The device is described as "reusable rigid containers... indicated to hold various dental instruments... in order to organize, sterilize and protect them." This further reinforces its role as a sterilization and organization tool for other medical devices.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition
- Using reagents or assays
The device's function is purely related to the sterilization and organization of other medical instruments.
N/A
Intended Use / Indications for Use
Zirconia Guided Surgery Kit Cases:
Zirconia Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Zirconia Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Zirconia Guided Surgery Kit Cases requre the use of FDA-cleared wrap 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 one of the following cycles: Dynamic Air Removal (pre-vacuum) – Exposure at 132°C for 4 minutes, 20-minute dry time. Gravity displacement – Exposure at 132°C for 15 minute dry time. Ziroonia Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The Zirconia Guided Surgery Kit Case and the associated instruments is 342.2 g. The weight of the empty Kit is 236.8 grams. Zirconia Guided Surgery Kit Case are recommended not to be stacked during sterilization.
Nuvo CF Guided Surgery Kit Cases:
Nuvo CF Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Nuvo CF Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo CF Guided Surgery Kit Cases 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): exposure at 132°C for 4 minutes, drying for 20 minutes. Gravity displacement: exposure at 132°C for 15 minutes, drying for 30 minutes. Nuvo CF Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Nuvo CF Guided Surgery Kit Cases and the associated instruments is approximately 693 g. The weight of the empty case is 487 grams. Nuvo CF Guided Surgery Kit Cases are not recommended to be stacked during sterilization.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The Zirconia and Nuvo CF Guided Surgery Kit Cases subject to this submission are reusable rigid containers, composed by a case bottom, a removable inner tray and a lid, which are made of autoclavable polymer. They are indicated to hold various dental instruments (not subject of this submission) in order to organize, sterilize and protect them. Sterilization via moist heat (steam) is performed by the healthcare provider.
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)
Non-Clinical Performance Data:
- Steam sterilization validation (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2): All Biological Indicators must be incubated for at least 7 days at 55-60°C. All positive controls for SAL testing must show characteristic growth of the indicator organism. Results: Passed.
- Manual cleaning validation (AAMI TIR 30:2011): Visual Inspection: No visible soil; Hemoglobin Test:
§ 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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 23, 2024
JJGC Indústria e Comércio de Materiais Dentários S.A. % Jennifer Jackson Sr. Director, Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K241492
Trade/Device Name: Zirconia and Nuvo CF Guided Surgery Kit Cases Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: Mav 28, 2024 Received: May 28, 2024
Dear Jennifer Jackson:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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"
1
(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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Image /page/1/Picture/6 description: This image shows a digital signature and contact information. The signature is from Stephen A. Anisko -S, and it was signed on August 23, 2024, at 12:50:29 -04'00'. The contact information is for Christopher Dugard, Assistant Director at the Division of Infection Control Devices, Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality, and Center for Devices and Radiological Health.
2
K241492 - Jennifer Jackson
Enclosure
3
Indications for Use
510(k) Number (if known) K241492
Device Name
Zirconia and Nuvo CF Guided Surgery Kit Cases
Indications for Use (Describe)
Zirconia Guided Surgery Kit Cases:
Zirconia Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Zirconia Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Zirconia Guided Surgery Kit Cases requre the use of FDA-cleared wrap 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 one of the following cycles: Dynamic Air Removal (pre-vacuum) – Exposure at 132°C for 4 minutes, 20-minute dry time. Gravity displacement – Exposure at 132°C for 15 minute dry time. Ziroonia Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The Zirconia Guided Surgery Kit Case and the associated instruments is 342.2 g. The weight of the empty Kit is 236.8 grams. Zirconia Guided Surgery Kit Case are recommended not to be stacked during sterilization.
Nuvo CF Guided Surgery Kit Cases:
Nuvo CF Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Nuvo CF Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo CF Guided Surgery Kit Cases 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): exposure at 132°C for 4 minutes, drying for 20 minutes. Gravity displacement: exposure at 132°C for 15 minutes, drying for 30 minutes. Nuvo CF Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Nuvo CF Guided Surgery Kit Cases and the associated instruments is approximately 693 g. The weight of the empty case is 487 grams. Nuvo CF Guided Surgery Kit Cases are not recommended to be stacked during sterilization.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
510(k) Summary 1
Submitter's Contact Information
| Submitter: | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810, USA
Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | On the behalf of: |
| | JJGC Indústria e Comércio de Materiais Dentários S.A. (dba Neodent
Av. Juscelino Kubitschek de Oliveira, 3291 - CIC
Curitiba, Paraná, Brazil 81270-200
Registration No.: 3008261720
Owner/Operator No.: 10031702 |
| Contact Person: | Jennifer M. Jackson, MS, RAC
Sr. Director, Regulatory Affairs and Quality
Email: jennifer.jackson@straumann.com
Phone Number: +1 978 747-2509
Fax Number: +1 978 747-0023 |
| Prepared By &
Alternate Contact: | Leticia Milani
Regulatory Affairs Analyst
JJGC Indústria e Comércio de Materiais Dentários SA
E-mail: leticia.milani@neodent.com
Phone Number: +55 41 216-9485 |
| Date Prepared: | August 22, 2024 |
Name of the Device
| Trade Names: | Zirconia and Nuvo CF Guided Surgery Kit Cases |
|---|---|
| Common Name: | Instrument Sterilization Trays |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other |
| Regulation Number: | 21 CFR 880.6850, Class II, Sterilization wrap |
| Device Classification: | II |
| Product Code(s): | KCT |
| Classification Panel: | General Hospital |
5
Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
Predicate Device(s)
Primary Predicate:
- K203618 Neodent EasyGuide Kit Cases (JJGC Indústria e Comércio de Materiais . Dentários S.A)
Reference Devices:
- K182865 Neodent Instrument Kits (JJGC Indústria e Comércio de Materiais Dentários S.A) .
- . K223662 – Neodent Implant System – Helix Short Surgical Kit Cases (JJGC Indústria e Comércio de Materiais Dentários S.A)
Device Description
The Zirconia and Nuvo CF Guided Surgery Kit Cases subject to this submission are reusable rigid containers, composed by a case bottom, a removable inner tray and a lid, which are made of autoclavable polymer. They are indicated to hold various dental instruments (not subject of this submission) in order to organize, sterilize and protect them. Sterilization via moist heat (steam) is performed by the healthcare provider.
Intended Use
The Zirconia and Nuvo CF Guided Surgery Kit Cases are used to safe storage and securing of instruments during sanitization and surgical procedures. The Zirconia Guided Surgery Kit Cases are designed for storing the instruments used to install Bone Level (BL) ceramic implants. The Nuvo CF Guided Surgery Kit Cases are intended for the installation of Nuvo CF implants.
Indications for Use
Zirconia Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Zirconia Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Zirconia Guided Surgery Kit Cases 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: Dynamic Air Removal (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. Zirconia Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Zirconia Guided Surgery Kit Case and the associated instruments is 342.2
6
Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
g. The weight of the empty Kit is 236.8 grams. Zirconia Guided Surgery Kit Case are recommended not to be stacked during sterilization.
Nuvo CF Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Nuvo CF Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo CF Guided Surgery Kit Cases 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, drying for 20 minutes. Gravity displacement: exposure at 132°C for 15 minutes, drying for 30 minutes. Nuvo CF Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Nuvo CF Guided Surgery Kit Cases and the associated instruments is approximately 693 g. The weight of the empty case is 487 grams. Nuvo CF Guided Surgery Kit Cases are not recommended to be stacked during sterilization.
7
Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables:
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
|---|---|---|---|---|
| K Number | K241492 | |||
| Zirconia Guided Surgery Kit Cases | K203618 | |||
| Neodent EasyGuide Kit Cases | K223662 | |||
| Helix Short Surgical Kit Cases | ||||
| Indications for | ||||
| Use Statement | Zirconia Guided Surgery Kit Cases are | |||
| intended to be used to enclose other | ||||
| medical devices that are to be sterilized | ||||
| by a health care provider. Zirconia | ||||
| Guided Surgery Kit Cases are intended | ||||
| to allow sterilization of the enclosed | ||||
| medical devices. Zirconia Guided | ||||
| Surgery Kit Cases 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: Dynamic Air Removal | ||||
| (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. | ||||
| Zirconia Guided Surgery Kit Cases are | ||||
| intended for sterilization of non-porous | ||||
| loads. The combined weight of the | ||||
| Zirconia Guided Surgery Kit Case and | ||||
| the associated instruments is 342.2 g. | ||||
| The weight of the empty Kit is 236.8 | ||||
| grams. Zirconia Guided Surgery Kit | ||||
| Case are recommended not to be | ||||
| stacked during sterilization. | 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 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. | HS Surgical Kit Cases are indicated for the | |||
| organization of surgical and/or prosthetic | ||||
| instruments during sterilization, storage, | ||||
| and transport. Use of this product facilitates | ||||
| the storage and organization of instruments | ||||
| during and after surgical procedures. | ||||
| Neodent instrument kit cases are intended | ||||
| to allow sterilization of the medical devices | ||||
| included. Neodent instrument kit cases | ||||
| must be wrapped in FDA-approved | ||||
| materials to maintain the sterility of the | ||||
| devices included. The kits should be placed | ||||
| in an FDA-approved sterilization wrap for | ||||
| the indicated cycles and sterilized by moist | ||||
| heat (steam) using one of the following | ||||
| cycles: Dynamic Air Removal (pre-vacuum): | ||||
| exposure at 132°C for 4 minutes, drying for | ||||
| 30 minutes. Gravity displacement: exposure | ||||
| at 132°C for 15 minutes, drying for 50 | ||||
| minutes. Neodent instrument kit cases are | ||||
| intended for sterilization of non-porous | ||||
| fillers. The combined weight of the HS | ||||
| Surgical Kit case and associated | ||||
| instruments is 302.88 grams. The weight of | ||||
| the empty case is approximately 214.85 | ||||
| grams. Neodent instrument kit cases should | ||||
| not be stacked during sterilization. | Similar | |||
| The subject and primary predicate | ||||
| devices present the same indications | ||||
| for use, being both intended to allow | ||||
| sterilization of the enclosed medical | ||||
| devices. The reference predicate | ||||
| device has a slightly different language, | ||||
| but the indications for use are similar. | ||||
| All devices are intended to enclose | ||||
| other medical devices that are to be | ||||
| sterilized by a health care provider. | ||||
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number | K241492 | |||
| Zirconia Guided Surgery Kit Cases | K203618 | |||
| Neodent EasyGuide Kit Cases | K223662 | |||
| Helix Short Surgical Kit Cases | EQUIVALENCE DISCUSSION | |||
| Material and | ||||
| design | Rigid polyphenylsulfone (PPSU) polymer base and removable inner tray with a polyphenylsulfone (PPSU) lid. | |||
| Retention grommets of medical grade silicone. | Rigid polysulfone (PSU) polymer base and removable inner tray with a polyphenylsulfone (PPSU) lid. Retention grommets of medical grade silicone. | Rigid polysulfone (PSU) polymer base and removable inner tray with a polyphenylsulfone (PPSU) lid. Retention grommets of medical grade silicone. | Similar | |
| The subject and predicate devices are made of the same material. Despite the subject devices presenting a difference in base and tray composition, the PPSU material has already been used before in devices cleared by FDA. Furthermore, this material change does not interfere with the biocompatibility and performance of the new products. | ||||
| Perforated | Yes | Yes | Yes | Same |
| Overall | ||||
| dimensions | 195 L x 90 W x 67 H, mm | 195 L x 90 W x 64 H, mm | 195 L x 90 W x 67 H, mm | Similar |
| The subject, primary predicate and reference devices have the same dimensions. The small difference between the height of subject and primary predicate device does not compromise safety and efficacy as is better discussed along this submission. | ||||
| Reusable | Yes, reusable up to 100 cycles | Yes, reusable up to 100 cycles | Yes, reusable up to 100 cycles | Same |
| Volume to Vento | ||||
| Ratio | 64.8 cm³/ cm² (25.5 in³/ in²) | 63.5 cm³/ cm² (25.0 in³/ in²) | 64.8 cm³/ cm² (25.5 in³/ in²) | Similar |
| The subject and primary predicate device have a slight difference in volume to vent rate, which does not compromise safety and efficacy, as is proved by the presented sterilization validation. | ||||
| 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 | Same |
| Cycles and | ||||
| parameters | Fractionated vacuum (pre-vacuum): | |||
| Sterilization temperature: 132 °C; | ||||
| Sterilization time: 4 minutes; | ||||
| Drying time: 20 minutes. | ||||
| Gravity displacement: | ||||
| Sterilization temperature: 132 °C; | ||||
| Sterilization time: 15 minutes; | ||||
| Drying time: 20 minutes. | Fractionated vacuum (pre-vacuum): | |||
| Sterilization temperature: 132 °C; | ||||
| Sterilization time: 4 minutes; | ||||
| Drying time: 20 minutes. | ||||
| Gravity displacement: | ||||
| Sterilization temperature: 132 °C; | ||||
| Sterilization time: 15 minutes; | ||||
| Drying time: 20 minutes. | Fractionated vacuum (pre-vacuum): | |||
| Sterilization temperature: 132 °C; | ||||
| Sterilization time: 4 minutes; | ||||
| Drying time: 30 minutes. | ||||
| Gravity displacement: | ||||
| Sterilization temperature: 132 °C; | ||||
| Sterilization time: 15 minutes; | ||||
| Drying time: 50 minutes. | Similar | |||
| The subject devices have the same cycle parameters already cleared for the predicate devices, however the reference predicate device requires a longer drying cycle. | ||||
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number | K241492 | |||
| Zirconia Guided Surgery Kit Cases | K203618 | |||
| Neodent EasyGuide Kit Cases | K223662 | |||
| Helix Short Surgical Kit Cases | EQUIVALENCE DISCUSSION | |||
| 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 | Same | |||
| Biocompatibility | The assessment to Biocompatibility | |||
| was performed per ISO 10993-1 and | ||||
| testing was performed using methods | ||||
| described in AAMI/ANSI/ISO 10993-5. | ||||
| Results indicate that the subject | ||||
| devices are biocompatible. | The assessment to Biocompatibility was | |||
| performed per ISO 10993-1 and testing | ||||
| performed using methods | ||||
| described in AAMI/ANSI/ISO 10993-5. | ||||
| Results indicate that the subject devices | ||||
| are biocompatible. | The assessment to Biocompatibility was | |||
| performed per ISO 10993-1 and testing was | ||||
| performed using methods described in | ||||
| AAMI/ANSI/ISO 10993-5. Results indicate | ||||
| that the subject devices are biocompatible. | Same | |||
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number | K241492 | |||
| Nuvo CF Guided Surgery Kit Cases | K203618 | |||
| Neodent EasyGuide Kit Cases | K182865 | |||
| Neodent Instrument Kits | ||||
| Indications for | ||||
| Use Statement | Nuvo CF Guided Surgery Kit Cases are | |||
| intended to be used to enclose other | ||||
| medical devices that are to be sterilized | ||||
| by a health care provider. Nuvo CF | ||||
| Guided Surgery Kit Cases are intended to | ||||
| allow sterilization of the enclosed medical | ||||
| devices. Nuvo CF Guided Surgery Kit | ||||
| Cases 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, drying for 20 | ||||
| minutes. Gravity displacement: exposure | ||||
| at 132°C for 15 minutes, drying for 30 | ||||
| minutes. Nuvo CF Guided Surgery Kit | ||||
| Cases are intended for sterilization of | ||||
| non-porous loads. The combined weight | ||||
| of the Nuvo CF Guided Surgery Kit Cases | ||||
| and the associated instruments is | ||||
| approximately 693 g. The weight of the | ||||
| empty case is 487 grams. Nuvo CF | ||||
| Guided Surgery Kit Cases are not | ||||
| recommended to be stacked during | ||||
| sterilization. | 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 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. | 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, 40-minute dry time. | ||||
| Gravity displacement – Exposure at 132 | ||||
| °C for 15 minutes, 40-minute dry time. | ||||
| Neodent Instrument Kits are intended for | ||||
| sterilization of non-porous loads. The | ||||
| combined weight of the GM Guided | ||||
| Surgery Surgical Kit Case and the | ||||
| associated instruments is 728.4 g. The | ||||
| weight of the empty Kit Case is 567 | ||||
| grams. Neodent Instrument Kits are | ||||
| recommended not to be stacked during | ||||
| sterilization. | Similar | |||
| Although the language in the | ||||
| indications for use of the subject and | ||||
| primary predicate devices is slightly | ||||
| different, the indications for use are | ||||
| similar in that they are used to enclose | ||||
| instruments to be sterilized by the | ||||
| health care provider. | ||||
| Material and | ||||
| design | Rigid polyphenylsulfone (PPSU) polymer | |||
| base and removable inner tray with a | ||||
| polyphenylsulfone (PPSU) lid. Retention | ||||
| grommets of medical grade silicone. | Rigid polysulfone (PSU) polymer base | |||
| and removable inner tray with a | ||||
| polyphenylsulfone (PPSU) lid. Retention | ||||
| grommets of medical grade silicone. | Rigid polysulfone (PSU) polymer base | |||
| and removable inner tray with a | ||||
| polyphenylsulfone (PPSU) lid. Retention | ||||
| grommets of medical grade silicone. | Similar | |||
| The subject, primary predicate and | ||||
| reference devices are made of the | ||||
| same material. Despite the subject | ||||
| devices presenting a difference in base | ||||
| and tray composition, the PPSU | ||||
| material has already been used before | ||||
| in devices cleared by FDA. | ||||
| Furthermore, this material change does | ||||
| not interfere with the biocompatibility | ||||
| and performance of the new products. | ||||
| Perforated | Yes | Yes | Yes | Same |
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number | K241492 | |||
| Nuvo CF Guided Surgery Kit Cases | K203618 | |||
| Neodent EasyGuide Kit Cases | K182865 | |||
| Neodent Instrument Kits | ||||
| Overall | ||||
| dimensions | 264 L x 163 W x 58 H, mm | 264 L x 163 W x 58 H, mm | Same | |
| Reusable | Yes, reusable up to 100 cycles | Yes, reusable up to 100 cycles | Yes, reusable up to 100 cycles | Same |
| Volume to | ||||
| Vento Ratio | 107.5 cm³/ cm² (42.32 in³/ in²) | 107.5 cm³/ cm² (42.32 in³/ in²) | Same | |
| 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 | Same |
| Cycles and | ||||
| parameters | Fractionated vacuum (pre-vacuum): | |||
| Sterilization temperature: 132 °C: | ||||
| Sterilization time: 4 minutes; | ||||
| Drying time: 20 minutes. | ||||
| Gravity displacement: | ||||
| Sterilization temperature: 132 °C; | ||||
| Sterilization time: 15 minutes: | ||||
| Drying time: 30 minutes. | Fractionated vacuum (pre-vacuum): | |||
| Sterilization temperature: 132 °C; | ||||
| Sterilization time: 4 minutes; | ||||
| Drying time: 20 minutes. | ||||
| Gravity displacement: | ||||
| Sterilization temperature: 132 °C; | ||||
| Sterilization time: 15 minutes: | ||||
| Drying time: 20 minutes. | Fractionated vacuum (pre-vacuum): | |||
| Sterilization temperature: 132 °C; | ||||
| Sterilization time: 4 minutes; | ||||
| Drying time: 40 minutes. | ||||
| Gravity displacement: | ||||
| Sterilization temperature: 132 °C; | ||||
| Sterilization time: 15 minutes; | ||||
| Drying time: 40 minutes. | Similar | |||
| The subject devices have the same | ||||
| cycle parameters already cleared for | ||||
| the primary predicate and reference | ||||
| device. | ||||
| however | ||||
| the | ||||
| reference | ||||
| predicate device requires a longer | ||||
| drying cycle. | ||||
| 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 | Same | |||
| Biocompatibility | The assessment to Biocompatibility was | |||
| performed per ISO 10993-1 and testing | ||||
| was performed using methods described | ||||
| in AAMI/ANSI/ISO 10993-5. Results | ||||
| indicate that the subject devices are | ||||
| biocompatible. | The assessment to Biocompatibility was | |||
| performed per ISO 10993-1 and testing | ||||
| was performed using methods described | ||||
| in AAMI/ANSI/ISO 10993-5. Results | ||||
| indicate that the subject devices are | ||||
| biocompatible. | The assessment to Biocompatibility was | |||
| performed per ISO 10993-1 and testing | ||||
| was performed using methods described | ||||
| in AAMI/ANSI/ISO 10993-5. Results | ||||
| indicate that the subject devices are | ||||
| biocompatible. | Same |
Table 1 – Comparison of subject device (Zirconia Guided Surgery Kit Cases) and predicate device
8
Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
9
Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
10
Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
Table 2 – Comparison of subject device (Nuvo CF Guided Surgery Kit Cases) and predicate device
11
Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
12
Zirconia and Nuvo CF Guided Surgery Kit Cases
510(k) Summary - K241492
Non-Clinical Performance Data
To evaluate the performance of the subject kit cases, the tests described in the following table were performed.
| Standard or Test
| Method | Purpose of the Testing | Acceptance Criteria | Results |
|---|---|---|---|
| ANSI/AAMI/ISO 17665-1 | |||
| ANSI/AAMI/ISO 17665-2 | Steam sterilization validation, | ||
| including sterilant penetration | |||
| and drying time | All Biological Indicators must | ||
| be incubated for at least 7 days | |||
| at 55-60°C. All positive controls | |||
| for SAL testing must show | |||
| characteristic growth of the | |||
| indicator organism. | Passed | ||
| AAMI TIR 30:2011 | Manual cleaning validation | ||
| • Test Soil: | |||
| • Blood Soil (BLSO) | |||
| • Cleaning Method: | |||
| Manual | |||
| • Residuals Tested: | |||
| Hemoglobin and Protein | • Visual Inspection: No | ||
| visible soil | |||
| • Hemoglobin Test: $ |