(275 days)
No
The summary describes a traditional plate and screw system for maxillofacial fixation and reconstruction, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No.
The device is a maxillofacial plate and screw system intended for osteotomy, stabilization, and rigid fixation of maxillofacial/midface fractures and reconstruction, which are surgical interventions rather than therapeutic treatments.
No
The device is described as a plate and screw system intended for osteotomy, stabilization, and rigid fixation of maxillofacial fractures and reconstruction. This indicates a therapeutic or surgical function rather than a diagnostic one.
No
The device description clearly states it consists of physical plates and screws made from titanium, which are hardware components.
Based on the provided information, the Tandry CMF System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "Maxillofacial plate and screw system intended for osteotomy, stabilization and rigid fixation of maxillofacial/midface fractures and reconstruction". This describes a surgical implant used directly on the patient's body for structural support and repair.
- Device Description: The description details physical components (plates and screws) made of titanium, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The Tandry CMF System is an implantable medical device used inside the body for surgical treatment.
N/A
Intended Use / Indications for Use
The Tandry CMF System is a Maxillofacial plate and screw system intended for osteotomy, stabilization and rigid fixation of maxillofacial/midface fractures and reconstruction including infraorbital area and maxillofacial, and mandibular and maxillary correction surgery.
Each plate is indicated to be used in the following anatomic regions:
- · 1.2mm upper-face plates Orbital floor region, zygomatic region, and dento-alveolar region
- · 1.5mm mid-face plates Zygomatic region, orbital floor region, and maxilla
- · 2.0 mm mini plates Orthognathics midface/mandible
- · 2.0/2.3mm mandible plates Mandibular
Product codes
JEY, DZL
Device Description
The Tandry CMF Plate System consists of various sized plates and screws. The plates and screws are fabricated from pure titanium and Ti-6Al-4V. The plates are designed to distribute for respective anatomical and indicated areas, besides, they can be used with self-tapping, self-drilling, emergency self-tapping and locking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillofacial/midface, infraorbital area, zygomatic area, mandibular, maxillary, Orbital floor region, dento-alveolar region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
-
Biomechanical Test
The biomechanical tests ASTM F543 and F382 were performed to determine substantial equivalence for the Tandry CMF Plate System including the performance of plate and screw. -
Biocompatibility
Representative samples of each of the subject devices was subjected to the following: "Biocompatibility sample preparation was made according to ISO 10993-12. Biological Safety Assessment guided by ISO 10993-1. Cytotoxicity testing was performed per ISO 10993-5. -
Reprocessing and sterilization
Since the material, manufacturing process, geometry & physico-chemical, body/ fluid contact and sterilization process of the proposed device is the same as Tandry Locking Plate System K171904, the performance and testing result of the predicate can be utilized in the proposed device. The testing results support the proposed device to meet the validation requirement.
The steam sterilization instructions are validated to a sterility assurance level (SAL) of 10-6 using the biological indicator overkill method. The sterilization test is performed in accordance with ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937. The subject device is a single-use device.
- The Tandry CMF Plate System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the Tandry CMF Plate System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
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11/10/22
Microware Precision Co., Ltd. Harrison Du General Manager No. 12, Keyuan 2nd Rd., Situn District Taichung, 40763 TAIWAN
Re: K220360
Trade/Device Name: Tandry CMF Plate System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZL Dated: October 11, 2022 Received: October 12, 2022
Dear Harrison Du:
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220360
Device Name Tandry CMF Plate System
The Tandry CMF System is a Maxillofacial plate and screw system intended for osteotomy, stabilization and rigid fixation of maxillofacial/midface fractures and reconstruction including infraorbital area and maxillofacial, and mandibular and maxillary correction surgery.
Each plate is indicated to be used in the following anatomic regions:
- · 1.2mm upper-face plates Orbital floor region, zygomatic region, and dento-alveolar region
- · 1.5mm mid-face plates Zygomatic region, orbital floor region, and maxilla
- · 2.0 mm mini plates Orthognathics midface/mandible
- · 2.0/2.3mm mandible plates Mandibular
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Microware
K220360
510(K) Summary
Submitter's Name: Microware Precision Co., Ltd. Address: No. 12, Keyuan 2nd Rd., Situn District, Taichung City 40763, Taiwan Tel: +886-4-24636275 # 100 Fax: +886-4-24636276
Contact Name: Harrison Du
Preparation date: Nov. 10. 2022
Registration Number: 3007738812
Device Name: Tandry CMF Plate System
Common Name: Bone Plate and Bone Screw
Classification Name: Class II, 21 CFR 872.4760
Product Code: JEY and DZL
Predicate Device Information:
Primary device: Stryker Leibinger Universal CMF System (K022185) Reference device: MCI - CMF System (K182758) Tandry Locking Plate System (K171904) Synthes Midfacial System (K953806)
Device Description:
The Tandry CMF Plate System consists of various sized plates and screws. The plates and screws are fabricated from pure titanium and Ti-6Al-4V. The plates are designed to distribute for respective anatomical and indicated areas, besides, they can be used with self-tapping, self-drilling, emergency self-tapping and locking screws.
Indication for use:
The Tandry CMF System is a Maxillofacial plate and screw system intended for osteotomy, stabilization and rigid fixation of maxillofacial/midface fractures and reconstruction including infraorbital area, zygomatic area and maxillofacial, and maxillary correction surgery.
Each plate is indicated to be used in the following anatomic regions:
- 1.2mm upper-face plates Orbital floor region, zygomatic region, and dento-alveolar region .
4
Microware
- · 1.5mm mid-face plates Zygomatic region, orbital floor region, and maxilla
- · 2.0 mm mini plates Orthognathics midface/mandible
- 2.0/2.3mm mandible plates Mandibular
Technological Characteristics:
The Tandry CMF Plate System is fabricated from titanium alloy per ASTM F136 and unalloyed titanium per ASTM F67. The screws are made of titanium alloy conforming to ASTM F136 and its surfaces are colored-anodized. The plates are manufactured in commercially pure titanium conforming to ASTM F67 and its surfaces are colored-anodized and type 2-anodized. The design feature for the Tandry CMF Plate System is similar to the predicate devices including dimensions, shape and sizes as following Table 1.
Summary of Performance Data (Nonclinical and/or Clinical)
Clinical Test
Clinical studies are not required to support substantially equivalent.
Non-Clinical Test
-
Biomechanical Test
The biomechanical tests ASTM F543 and F382 were performed to determine substantial equivalence for the Tandry CMF Plate System including the performance of plate and screw. -
Biocompatibility
Representative samples of each of the subject devices was subjected to the following: "Biocompatibility sample preparation was made according to ISO 10993-12. Biological Safety Assessment guided by ISO 10993-1. Cytotoxicity testing was performed per ISO 10993-5. -
Reprocessing and sterilization
Since the material, manufacturing process, geometry & physico-chemical, body/ fluid contact and sterilization process of the proposed device is the same as Tandry Locking Plate System K171904, the performance and testing result of the predicate can be utilized in the proposed device. The testing results support the proposed device to meet the validation requirement.
The steam sterilization instructions are validated to a sterility assurance level (SAL) of 10-6 using the biological indicator overkill method. The sterilization test is performed in accordance with ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937. The subject device is a single-use device.
- The Tandry CMF Plate System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the Tandry CMF Plate System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
5
Summary of Substantial Equivalence:
The Tandry CMF Plate System is substantially equivalent to the predicated devices. Result of non-clinical tests and the similarities with the legally marketed predicate device have demonstrated substantial equivalence.
6
| Device
Item | Proposed device | Primary predicate device | Reference device 1 | Reference device 2 | Reference device 3 | SE
? |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Tandry CMF Plate System | Stryker Leibinger
Universal CMF System | MCI - CMF System | Synthes Midfacial System | Tandry Locking Plate
System | NA |
| 510K Number | K220360 | K022185 | K182758 | K953806 | K171904 | NA |
| Trade Name | Tandry | Stryker | MCI | Synthes | Tandry | NA |
| Indication for Use | The Tandry CMF System is
a Maxillofacial plate and
screw system intended for
osteotomy, stabilization and
rigid fixation of
maxillofacial/midface
fractures and reconstruction
including infraorbital area,
zygomatic area and
maxillofacial,
mandibular and maxillary
correction surgery.
Each plate is indicated to
be used in the following
anatomic regions:
- 1.2mm upper-face
plates - Orbital floor
region, zygomatic
region, and
dento-alveolar region - 1.5mm mid-face plates -
Zygomatic region, | The Stryker Leibinger
Universal CMF System is a
Cranio-maxillofacial
(CMF) plate and screw
system intended for
osteotomy, stabilization and
rigid fixation of CMF
fractures and
reconstruction. | MCI - CMF System is
intended for use in
selective trauma of the
midface, maxillofacial
surgery, reconstructive
procedures, and selective
orthognathic surgery of
the maxilla, mandible and
chin. | The Synthes Midfacial
System is a plate and
screw system,
manufactured from
commercially pure (CP)
titanium, and is intended
for use in selective trauma
of the midface and
craniofacial skeleton;
craniofacial surgery;
reconstructive procedures;
and selective orthognathic
surgery of the maxilla and
chin. The plates are
available in a variety of
configurations to
accommodate various
fracture sites, and attach to
bone via 1.3mm or 1.7mm
self-tapping screws, with a
low plate/screw profile. | Tandry Locking Plate
System is intended to
provide fixation during
fractures, fusions, and
osteotomies for bones
including the clavicle,
pelvis, scapula and
calcaneal, small bones
including the metacarpals,
wrist, metatarsals, tarsals
and phalanges; long bones
including the radius, ulna,
humerus, olecranon, fibula,
femur, and tibia. | No substantial
differences
between subject
and reference
device.
Reference
device 3 is only
for evaluation of
biocompatibility
, reprocessing
and sterilization. |
| | | | | | | |
| | orbital floor region, and
maxilla - 2.0 mm mini plates -
Orthognathics
midface/mandible - 2.0/2.3mm mandible
plates - Mandibular | | | | | |
| Materials | Pure titanium: ASTM F67
Titanium Alloy: ASTM
F136 | Pure titanium: ASTM F67
Titanium Alloy: ASTM
F136 | Pure titanium: ASTM F67
Titanium Alloy: ASTM
F136 | Pure titanium: ASTM F67 | Pure Titanium: ASTM F67
Titanium Alloy: ASTM
F136
Stainless steel: ASTM
F138 and F139 | No substantial
differences
between subject
and reference
device. |
| Dimensions | Screw
Diameter: 1.2 to 2.7mm
Length: 3 to 20mm
Plate
Thickness: 0.4 to 2.8mm
Holes: 4 to 39 Holes | Screw
Diameter: 1.2 to 2.7mm
Length: 3 to 42mm
Plate
Thickness: 0.1 to 2.8mm
Holes: 4 to 29 Holes | Screw
Diameter: 1.5 to 2.3mm
Length: 4 to 20mm
Plate
Thickness: 0.6 to 1.0mm
Holes: 4 to 20 Holes | Screw
Diameter: 1.3 to 1.7mm
Length: 3 to 18mm
Plate
Thickness: 0.2 to 0.8mm
Holes: 4 to 39 Holes | Screw
Diameter: 1.5 to 4.5mm
Length: 6 to 160mm
Plate
Thickness: 1.1 to 6.25mm
Holes: 2 to 22 holes | No substantial
differences
between subject
and reference
device. |
| Surface | Colored-anodized and
type2-anodized | Colored-anodized | Colored-anodized | Colored-anodized | Colored-anodized for
titanium
Electrolytic polishing for
Stainless steel | No substantial
differences
between subject
and reference
device. |
| Sterilization | Non-sterilize. Steam
sterilization before use. | Non-sterilize. Steam
sterilization before use. | Non-sterilize. Steam
sterilization before use. | Non-sterilize. Steam
sterilization before use. | Non-sterilize. Steam
sterilization before use. | No substantial
differences
between subject
and reference
device. |
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