(145 days)
Not Found
No
The document describes a standard portable dental X-ray system and its software for operation and configuration. There is no mention of AI, ML, image processing, or any data sets used for training or testing algorithms, which are typical indicators of AI/ML technology in medical devices.
No
The device is used for capturing radiographic images for dental diagnosis, which is an imaging function, not a therapeutic one. It helps diagnose, but does not treat.
Yes
Explanation: The "Intended Use" clearly states that the device captures radiographic images for "dental diagnosis." The "Device Description" also mentions that the N1 is "a product designed to diagnose the conditions of teeth through X-irradiation."
No
The device description explicitly states it is a "portable dental X-ray imaging device" with hardware components like an X-ray generator, tube, control unit, user interface, collimator, shielding glass, and remote irradiation switch. While software is included for operation, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis. The description of the N1 clearly states it is an X-ray imaging system that captures images of teeth, jaws, and other oral structures within the body.
- The device description focuses on generating X-rays and capturing images, not on analyzing biological samples.
- The intended use is for dental diagnosis using radiographic images, not laboratory testing of specimens.
The N1 is a medical imaging device, specifically a dental X-ray system.
N/A
Intended Use / Indications for Use
N1 is a dental portable X-ray imaging system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use N1 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.
Product codes (comma separated list FDA assigned to the subject device)
EHD
Device Description
N1 is a portable dental X-ray imaging device powered by a rechargeable lithium polymer battery pack. It generates X-rays optimized for dental examinations (on teeth, etc.). The N1's X-ray generator equipped with an X-ray tube consists of control unit, user interface, X-ray aperture (collimator), a back-scatter shielding glass, and remote irradiation switch. The x-ray detectors (digital detectors or analog film) are not accessories for use with the N1. N1 is a product designed to diagnose the conditions of teeth through X-irradiation using its intraoral imaging sensors. Software is included for operation and configuration of the N1. It is of Moderate level of concern and it's not based on the predicate software.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray imaging
Anatomical Site
teeth, jaws, and/or other oral structures
Indicated Patient Age Range
adults and children
Intended User / Care Setting
trained and qualified dental practitioner or radiologist / Dental Clinic
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)
Software validation and verification test, EMC/Electrical Safety tests, and performance tests were conducted and the test results support that the subject device is substantially equivalent to the predicate device.
Non-Clinical Performance Data: Applicable non-clinical tests in the FDA guidance document for solid state x-ray detectors were performed. The digital detectors used for testing are not part of the subject device.
Software Verification and Validation Testing: Software was designed and developed according to a software development process. Also, Software verification and validation test were conducted and documented in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices, on May 11, 2005". The software for this device contains "Moderate" level of concern software.
Safety, EMC and Performance Data: N1 complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC60601-1, IEC60601-1-2, IEC 60601-2-65. The N1 battery has been tested following the standards IEC 62133-2. This successful test results indicate that the lithium battery that operates the N1 system is effective and safe.
No clinical studies are submitted.
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
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
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November 28, 2023
Osstem Implant Co., Ltd. % Peter Lee QA/RA Manager Hiossen Inc. 85 Ben Fairless Dr. FAIRLESS HILLS PA 19030
Re: K232012
Trade/Device Name: N1 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: EHD Dated: October 25, 2023 Received: October 25, 2023
Dear Mr. Lee:
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.
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).
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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 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 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).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K232012
Device Name N1
Indications for Use (Describe)
N is a dental portable X-ray imaging system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use N1 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.
| 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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Dsstem Implant Co., Ltd 2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea Tel: +82 70 4871 0191 Fax: +82 70 4015 0508 www.osstem.com
510(k) Summary - K232012
Date: November 26, 2023
1. Company and Correspondent making the submission
| - Submitter's Name | : Osstem Implant Co., Ltd. |
|---|---|
| - Address | : 2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si |
| Gyeonggi-do, 15079, Republic of Korea | |
| - Contact | : Miss. Jimin hyun |
| - Phone | : +82-70-4871-0191 |
| - Correspondent's Name | : Hiossen Inc. |
| - Address | : 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - Contact | : Mr. Peter Lee |
- +1-267-759-7031 Phone -
2. Proposed Device
| - Trade or (Proprietary) Name | : N1 |
|---|---|
| - Classification Name | : Extraoral source x-ray system |
| - Regulation Number | : 21 CFR872.1800 |
| - Devce Classification | : Class II |
| - Classification Product Code | : EHD |
| - 510(K) number | : K232012 |
3. Predicate Device
| - | Trade or (Proprietary) Name | : NOMAD DENTAL X-RAY SYSTEM |
|---|---|---|
| - | Classification Name | : Extraoral source x-ray system |
| - | Regulation Number | : 21 CFR872.1800 |
| - | Device Classification | : Class II |
| - | Classification Product Code | : EHD |
| - | 510(k) number | : K051795 |
4. Description
- N1 is a portable dental X-ray imaging device powered by a rechargeable lithium polymer battery pack. It generates X-rays optimized for dental examinations (on teeth, etc.). The N1's X-ray generator equipped with an X-ray tube consists of control unit, user interface, X-ray aperture (collimator), a back-scatter shielding glass, and remote irradiation switch. The x-ray detectors (digital detectors or analog film) are not accessories for use with the N1. N1 is a product designed to diagnose the conditions of teeth through X-irradiation using its intraoral imaging sensors. Software is included for operation and configuration of the N1. It is of Moderate level of concern and it's not based on the predicate software.
5. Substantial Equivalence Matrix
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Image /page/4/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, gray, sans-serif font. There is a small circle with the number 6 in the upper right corner of the logo.
Ossterm Implant Co., Ltd..
2 Floor, B-dong, S1, Mayu-ro 238beon-gil, Gibeung-si, Gyeonggi-do, 15079, Republic of Korea
Tel: +82 70 4871 0191 Fax: +82 70 4015 0508 www.osstem
| Proposed Devices | Predicate Devices | Remark | ||
|---|---|---|---|---|
| Device Name | N1 | NOMAD DENTAL X-RAY | ||
| SYSTEM | Different | |||
| 510(k) No. | Proposed | K051795 | Different | |
| Manufacturer | Osstem Implant Co., Ltd. | ARIBEX,INC. | Different | |
| Indications for Use | N1 is a dental portable X-ray | |||
| imaging system that captures | ||||
| radiographic images for dental | ||||
| diagnosis using intraoral | ||||
| imaging sensors. Only trained | ||||
| and qualified dental | ||||
| practitioner or radiologist shall | ||||
| use N1 to diagnose and treat | ||||
| diseases related to the teeth, | ||||
| jaws, and/or other oral | ||||
| structures in adults and | ||||
| children. | The NOMADTM Dental X-ray | |||
| System is intended to be used | ||||
| by trained dentists and dental | ||||
| technicians as an extraoral x-ray | ||||
| source for producing diagnostic | ||||
| x-ray images using intraoral | ||||
| image receptors. Its use is | ||||
| intended for both adult and | ||||
| pediatric subjects. | Same | |||
| Fixed structure | Handheld device | Handheld device | Same | |
| Remote switch | USB Type-C Cable | N/A | Different | |
| Power | 22.2V | 14.4V | Similar | |
| (included | ||||
| within | ||||
| range of | ||||
| predicate | ||||
| product) | ||||
| Battery | Rechargeable 22.2V DC | |||
| Li-ion Polymer Battery Pack | Rechargeable 14.4V DC | |||
| NiCd battery pack | Different | |||
| Tube voltage[kV] | 70kV | 70kV | Same | |
| Tube current[mA] | 3mA | 2.3mA | Similar | |
| (included | ||||
| within | ||||
| range of | ||||
| predicate | ||||
| product) | ||||
| Focus | 0.3mm | 0.4mm | Similar | |
| (included | ||||
| within | ||||
| range of | ||||
| predicate | ||||
| product) | ||||
| X-ray tube | Angle | 13' | 12' | Similar |
| (included | ||||
| within | ||||
| predicate | ||||
| product) | ||||
| Inherent | ||||
| Filtration | 0.5mm AI | 0.8mm AI | Similar | |
| (included | ||||
| within | ||||
| range of | ||||
| predicate | ||||
| product) | ||||
| X-ray | ||||
| Coverage | ||||
| (FOV) | 20 mm x 30 mm (600 mm²) | Φ 60 mm (2826 mm²) | Similar | |
| (included | ||||
| within | ||||
| 30 mm x 40 mm (1200 mm²) | range of | |||
| predicate | ||||
| product) | ||||
| Total filtration | 1.5mm Al | 1.5mm Al | Same | |
| User | Dentist or Radiologist | Dentist or Radiologist | Same | |
| Operation environment | Dental Clinic | Dental Clinic | Same | |
| Site of application | Tooth | Tooth | Same | |
| Contact area of patient | Buy a sterilized plastic bag at | |||
| the dental clinic and cover the | ||||
| product with a plastic bag when | ||||
| using | Buy a sterilized plastic bag at | |||
| the dental clinic and cover the | ||||
| product with a plastic bag when | ||||
| using | Same |
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Image /page/5/Picture/0 description: The image features the logo of OSSTEM IMPLANT. The logo is composed of the word "OSSTEM" in a bold, sans-serif font, with the letters in a bright orange color. Below "OSSTEM", the word "IMPLANT" is written in a smaller, gray, sans-serif font. The overall design is clean and modern, suggesting a professional and technologically advanced company.
Dsstem Implant Co., Ltd
Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea el: +82 70 4871 0191 Fax: +82 70 4015 0508 www.osstem.com
6. Indications for Use
- -N1 is a dental portable X-ray imaging system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use N1 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.
7. Summary of Non-clinical Performance Testing
Software validation and verification test, EMC/Electrical Safety tests, and performance tests were conducted and the test results support that the subject device is substantially equivalent to the predicate device
Non-Clinical Performance Data
We performed the applicable non-clinical tests in the FDA guidance document for solid state x-ray detectors. The digital detectors used for testing are not part of the subject device.
Software Verification and Validation Testing
Software was designed and developed according to a software development process. Also, Software verification and validation test were conducted and documented in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices, on May 11, 2005". The software for this device contains "Moderate" level of concern software.
Safety, EMC and Performance Data
N1 complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC60601-1, IEC60601-1-2, IEC 60601-2-65 The N1 battery has been tested following the standards IEC 62133-2. This successful test results indicate that the lithium battery that operates the N1 system is effective and safe.
8. Summary of Clnical Testing
No clinical studies are submitted.
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Image /page/6/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, with a small circle containing the number 6 in the upper right corner. Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.
9. Conclusion
There were some differences in some specifications, but there was no significant difference in the safety / performance of the product, and it was confirmed that the Portable dental X-ray imaging device had better performance than the equivalent device in some specifications.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this submission, we conclude that the subject device is safe and effective and substantially equivalent to the predicate device.