(24 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the description of features and testing focuses on standard imaging and reconstruction techniques.
No.
The device is described as an "extraoral system intended to produce two-dimensional digital X-ray images... as diagnostic support," which indicates it is an imaging device used for diagnosis, not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended to produce two-dimensional digital X-ray images... as diagnostic support". The "Device Description" also reiterates that the images are for "diagnostic support". Additionally, the "Summary of Performance Studies" mentions that the images are of "clinically usable diagnostic quality".
No
The device description explicitly states that the CS 9600 is an "extraoral system" and a "cone-beam computed tomography (CBCT) x-ray system," which are hardware components. The summary also describes testing of the "system as a whole," indicating it includes more than just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body. This typically involves things like blood, urine, tissue samples, etc., and the tests are performed in vitro (outside the body).
- The CS 9600 is an imaging system. It produces images of the patient's anatomy in vivo (within the body) using X-rays. It does not analyze biological specimens.
The description clearly states that the device produces "two-dimensional digital X-ray images" and "reconstruct a two or a three-dimensional (3D) image" of various anatomical regions of the patient. This is the function of a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The CS 9600 is extraoral system intended to produce two-dimensional digital X-ray images of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
CS 9600 is an extraoral system intended to produce two-dimensional digital X-ray images of the dento-maxilofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
CS 9600 is cone-beam computed tomography (CBCT) x-ray system. It means CS 9600 rotates around the patient, capturing data using a cone-shaped x-ray beam. These data are used to reconstruct a two or a three-dimensional (3D) image of the following regions of the patient's anatomy: dental (teeth); oral and maxillofacial region (mouth, jaw and neck); ears, nose and throat region (ENT); cervical spine or wrist region.
Additional features such as low dose mode, scout image, metal artifact reduction are also provided by the CS 9600.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, Cone-beam computed tomography (CBCT)
Anatomical Site
dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
healthcare professionals
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
The performance testing for imaging applications was carried out taking clinical images representative of the range of the different radiological exams available. The images were reviewed by a qualified expert and were evaluated to be of acceptable clinical effectiveness for the proposed indications for use. The CS 9600 set of images were deemed to be of a clinically usable diagnostic quality.
Non clinical and bench testing was conducted as part of design control to ensure the substantial equivalence of CS 9600 with the predicate device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
The performance testing for imaging applications was carried out taking clinical images representative of the range of the different radiological exams available. The images were reviewed by a qualified expert and were evaluated to be of acceptable clinical effectiveness for the proposed indications for use. The CS 9600 set of images were deemed to be of a clinically usable diagnostic quality.
Non clinical and bench testing was conducted as part of design control to ensure the substantial equivalence of CS 9600 with the predicate device. The substantial equivalence for the proposed indication for use is substantiated through verification and validation testing of CS 9600 as a conebeam computed tomography x-ray system that is capable of providing digital two-dimensional and three-dimensional digital x-ray images of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients. CS 9600 has been tested to ensure that the system as a whole operated in a safe and effective manner that is substantially equivalent to the primary predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 24, 2018
Trophy % Marie-Pierre Labat-Camy Global Regulatory Affairs Senior Manager 4 Rue F. Pelloutier - Croissy Beaubourg 77435 Marne la Vallee Cedex 2 FRANCE
Re: K181136 Trade/Device Name: CS 9600 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: April 27, 2018 Received: April 30, 2018
Dear Marie-Pierre Labat-Camy:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hsl 2. Nils
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
CS 9600
Indications for Use (Describe)
The CS 9600 is extraoral system intended to produce two-dimensional digital X-ray images of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
| 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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Image /page/3/Picture/0 description: The image shows the Carestream Dental logo. The logo consists of a stylized triangle pointing to the right, with the left side of the triangle being gray and the right side being yellow. To the right of the triangle is the word "Carestream" in black, and below that is the word "DENTAL" in gray.
510K SUMMARY
Date 510(k) Summary prepared: May 16, 2018
Submitter information:
Trophy 4 Rue F. Pelloutier - Croissy-Beaubourg 77435 Marne La Vallée, Cedex 2 France Phone: +33 1 64 80 85 26 Fax: + 33 1 64 80 84 93 Contact person: Ms. Marie-Pierre LABAT-CAMY
United Stated Sales Representative (U.S. Designated Agent):
Carestream Dental LLC 1765 The Exchange Atlanta, GA 30339, USA Phone: 585-627-6985 Fax: 678-802-0976 Contact: John Riggi
Device name and classification:
Trade name: CS 9600 Regulation number: 892.1750 Regulation name (classification name): Computed tomography x-ray system Common name: Cone-beam computed tomography system Device Class: II Product Code: OAS
Predicate device:
We consider the CS 9600 to be similar in design, composition and function to the following device introduced into commercial distribution after May 28, 1976:
Trade/Device Name: Planmeca ProMax 3D Max, Planmeca Maximity 510(k) Number: K160506 Date of clearance: May 20, 2016 Regulation number: 892.1750 Regulation name (classification name): Computed tomography x-ray system Common name: Cone-beam computed tomography system Device Class: II Product Code: OAS
Device Description:
CS 9600 is an extraoral system intended to produce two-dimensional digital X-ray images of the dento-maxilofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
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Image /page/4/Picture/0 description: The image shows the Carestream Dental logo. The logo features a stylized arrow pointing to the right, with the left side of the arrow in gray and the right side in yellow. To the right of the arrow is the word "Carestream" in black, with the word "DENTAL" in gray underneath.
CS 9600 is cone-beam computed tomography (CBCT) x-ray system. It means CS 9600 rotates around the patient, capturing data using a cone-shaped x-ray beam. These data are used to reconstruct a two or a three-dimensional (3D) image of the following regions of the patient's anatomy: dental (teeth); oral and maxillofacial region (mouth, jaw and neck); ears, nose and throat region (ENT); cervical spine or wrist region.
Additional features such as low dose mode, scout image, metal artifact reduction are also provided by the CS 9600.
Intended use:
CS 9600 is an extraoral system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxilofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
Substantial Equivalence:
The following table provides the summary of the technological characteristics of CS 9600 compared to the predicate device.
| COMPANY
NAME
MODEL NAME | Trophy
CS 9600 | Planmeca Oy
Planmeca ProMax 3D Max, Planmeca Maximity |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | | K160506 |
| Indication for
use | The CS 9600 is an extraoral system intended to
produce two-dimensional and three-dimensional
digital X-ray images of the dento-maxillofacial,
ENT (Ear, Nose and Throat), cervical spine and
wrist regions at the direction of healthcare
professionals as diagnostic support for pediatric
and adult patients. | The Planmeca ProMax 3D Max or Maximity is
a system intended to produce two-dimensional
(2D) and three-dimensional (3D) digital X-ray
images of the dento-maxillofacial, cervical spine
and ENT (Ear, Nose and Throat) regions at the
direction of healthcare professionals as
diagnostic support for pediatric and adult
patients. |
| GENERAL SPECIFICATIONS | | |
| Performance
specification | · Panoramic modality
· 3D modality | · Panoramic modality
· 3D modality |
| Rated line
voltage | 100-240 Vac - 50/60 Hz | 100-240 Vac - 50/60 Hz |
| X-ray tube
voltage | 60-90 KV
60-120 kV (in option) | 60-96 KV
60-120 kV (in option) |
| X-ray tube
current | 2-15 mA | 1-14 mA |
| X-ray tube | Toshiba DF-071G or CEI OX/120-0307 | Toshiba D-067SB or Toshiba D-059SBR or
SXR 130-10-0.5 SC |
| Tube focal
spot | 0.3 or 0.7 mm | 0.5 or 0.6 mm |
| Patient sizes | 4 patients sizes:
child, small adult, medium adult, large adult | 5 patients sizes:
child, small adult, medium adult, large adult,
extra large adult |
| Sensor
technology | CMOS | Amorphous silicon |
| Sensor model | CGF81 | 2520D |
| Sensor active
area (mm) | 120 x 140 | 193 x 242 |
| Pixel size
(um) | 100 x 100 | 127 x 127 |
| Sensor
resolution | 1200 x 1400 pixels | 1536 x 1920 pixels |
| Gray scale | 16384 - 14 bits | 32768 - 15 bits |
| Limiting
resolution | 5 lp/mm | 3.94 lp/mm |
| MTF, X-ray (%)
at 1 lp/mm, Typical | 60 | ≥48 |
| DQE, X-ray (%) at 0
lp/mm, Typical | 60 | 70 |
| Unit
dimensions
(mm) | 1284 (L) x 1669 (D) x 2526 (H) | 1280(L) x 1430 (D) x 2390 (H) |
| | Two-dimensional modality: PANORAMIC | |
| | • Full panoramic | • Standard panoramic |
| Radiological
Exams | • Segmented panoramic
• Bitewing
• Maxillary sinus
• Lateral TMJ x2 and Lateral TMJx4
• Sinus AP / PA / Lateral
• Orthogonal panoramic | • Horizontal and vertical segmenting panoramic
• Bitewing
• PA linear sinus
• Lateral TMJ (closed & open)
• Sinus: AP / PA / Lateral
• Orthogonal panoramic |
| Magnification | 1.28 | 1.2 |
| Exposure time | 2-14 seconds | 2.7-16 seconds |
| Dose
Estimation for
Full Panoramic
(DAP)
(mGy.cm²) | • Child: 68 kV - 6.3 mA – 10.9 s = 58.5
• Adult Small: 72 kV - 6.3 mA - 11.6 s = 87.8
• Adult Medium: 73 kV - 8 mA - 12.3 s = 122
• Adult Large: 76 kV - 8 mA - 13 s = 139 | • Child: 72 kV - 16 mA - 8.6 s = 55
• Adult Small: 76 kV - 16 mA - 9.9 s = 92
• Adult Medium: 80 kV - 16 mA - 9.9 s = 111
• Adult Large: 84 kV - 16 mA - 10.2 s = 136 |
| | Three-dimensional modality: 3D | |
| Radiological
Exams | • Tooth/Teeth
• Jaw (full, upper or lower)
• TMJ
• Face
• ENT
• Upper cervical spine
• Wrist | • Tooth/Teeth
• Jaw (full, upper or lower)
• Temporal bone
• Face
• Skull
• ENT
• Vertebrae |
| Magnification | 1.4 | 1.4 |
| Voxel size (µm) | 75, 150, 300 and 400 | 75, 100, 150, 200, 400 and 600 |
| Field of View
(cm)
diameter x
height | 4 x 4
5 x 5 (child 4 x 4)
5 x 8
6 x 6
8 x 5
8 x 8
10 x 5 (child 8 x 5)
10 x 10* (child 8 x 8)
12 x 5
12 x 10*
16 x 6
16 x 10*
16 x 12*
16 x 17*
- with tip of the volume | 5 x 5 (child 4.2 x 5)
10 x 5.5 (child 8.5 x 5)
10 x 9 (child 8.5 x 7.5)
10 x 13 (child 8.5 x 11)
13 x 5.5 (child 11 x 5)
13 x 9 (child 11 x 7.5)
13 x 10
13 x 13 (child 11 x 11)
13 x 16 (child 11 x 13.6)
23 x 6
23 x 10
23 x 16 (max without stitching)
23 x 26 (max with vertical stitching = two vertical
image volumes) |
| Exposure time | 3-20 seconds | 2.8-18 seconds |
| Dose
Estimation for
Field of View 5
x 5 cm | • Child: 80 kV – 2.5 mA – 15 s = 211
• Adult Small: 90 kV - 2 mA - 15 s = 220
• Adult Medium: 90 kV - 4 mA - 15 s = 440
• Adult Large: 90 kV - 5 mA – 15 s = 550 | • Child: 96 kV – 4.5 mA – 12 s = 288
• Adult Small: 96 kV - 5.6 mA - 12 s = 472
• Adult Medium: 96 kV - 7.1 mA - 12 s = 598
• Adult Large: 96 kV - 9 mA - 12 s = 758 |
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Image /page/5/Picture/0 description: The image shows the Carestream Dental logo. The logo features a stylized triangle shape in yellow and gray on the left side. To the right of the triangle is the word "Carestream" in a bold, sans-serif font, with the word "Dental" in a smaller font below it.
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Image /page/6/Picture/0 description: The image shows the Carestream Dental logo. The logo consists of a stylized triangle shape on the left, with the word "Carestream" in bold, black letters to the right of the triangle. Below "Carestream" is the word "DENTAL" in smaller, gray letters.
| OTHER INFORMATION | ||
|---|---|---|
| Low dose | ||
| mode | Yes | Yes |
| Scout image | Yes | Yes |
| 3D Face Photo | Yes in option (CS Face Scan) | Yes in option (Planmeca ProFace) |
| Metal Artefact | ||
| Reduction | Yes in option (CS MAR) | Yes in option (Planmeca ARA) |
| Concerned | ||
| anatomical | ||
| sites | • Dento-maxillofacial area | |
| • ENT area | ||
| • Cervical spine | ||
| • Hand/wrist | • Dento-maxillofacial area | |
| • ENT area | ||
| • Cervical spine | ||
| • Hand/wrist (with cephalostat module available as an option) |
Two-dimensional and three-dimensional modalities, performances and imaging applications of the CS 9600 are similar to those of primary predicate device K160506.
CS 9600 and the predicate device K160506 share:
- equivalent general technological characteristics in terms of X-ray tube voltage, X-ray tube l current, tube focal spot or patient sizes;
- similar key imaging characteristics of the digital sensor;
- same two-dimensional panoramic and three-dimensional radiological programs;
- equivalent dose values on each modality. -
In addition, both CS 9600 and the predicate device K160506 provides the same additional features such as:
- Low dose mode to capture image with a minimal dose of radiation. ।
- -Scout image to capture 2D views to verify correct positioning to avoid risk of retake.
- 3D Face Photo to capture 3D facial picture to visualize soft tissue. ।
- Metal Artifact Reduction to remove shadows and streaks caused by metal restorations and root fillings.
Standards Conformance:
EMC and Electrical Safety testing were performed respectively by LCIE and UL laboratory and found to meet all the requirements in standards IEC 60601-1: 2005 with A1 2012 (AAMI/ANSI ES60601-1:2005/R(2012), IEC 60601-1-2: 2014, IEC 60601-1-3: 2008 with A1 2013, IEC 60601-2-63: 2012 and IEC 62304: 2006 with A1 2015.
CS 9600 meets the provisions of NEMA PS 3.1-3.20, Digital Imaging and Communications in Medicine (DICOM) Set.
Performance Testing:
The performance testing for imaging applications was carried out taking clinical images representative of the range of the different radiological exams available. The images were reviewed by a qualified expert and were evaluated to be of acceptable clinical effectiveness for the proposed indications for use. The CS 9600 set of images were deemed to be of a clinically usable diagnostic quality.
Non clinical and bench testing was conducted as part of design control to ensure the substantial equivalence of CS 9600 with the predicate device. The substantial equivalence for the proposed indication for use is substantiated through verification and validation testing of CS 9600 as a conebeam computed tomography x-ray system that is capable of providing digital two-dimensional and three-dimensional digital x-ray images of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients. CS 9600 has been tested to ensure that the system as a whole operated in a safe and effective manner that is substantially equivalent to the primary predicate device.
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Image /page/7/Picture/0 description: The image shows the Carestream Dental logo. The logo consists of a stylized arrow pointing to the right, with the left side of the arrow being gray and the right side being yellow. To the right of the arrow is the word "Carestream" in black, bold letters. Below "Carestream" is the word "DENTAL" in gray, smaller letters.
Conclusion:
The comparison of characteristics supports substantial equivalence. CS 9600 is as safe and effective as the predicate device K160506.
CS 9600 is considered substantially equivalent to the predicate device K160506 because the intended use of the subject device CS 9600 and the predicate device is identical. The compared technical features for imaging technology, Field of View, imaging parameters, resolution, and other basic characteristics are matching very closely. The differences are so small that they do not raise questions of safety and effectiveness and they do not have any effect on performance in practice.