(56 days)
The provided text does not contain any predicate device K/DEN numbers. The "Predicate Device(s)" section explicitly states "Not Found".
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description emphasizes its similarity to existing, non-AI/ML predicate devices.
No
The provided text does not contain information to determine if the device is therapeutic. It describes the device's design, intended use (which is stated as "the same" as comparative devices), and input imaging modality (Video Imaging), but lacks any mention of treatment, diagnosis, or health-improving functions.
No
There is no explicit mention of diagnosis in the "Intended Use / Indications for Use" section. The predicate devices listed (dental cameras) are typically for imaging and visualization, not necessarily diagnosis.
Unknown
The provided summary lacks sufficient detail about the device's components and how it interacts with the "Video Imaging" input and "practitioner's hands" intended user. It mentions the design is "virtually identical" to comparative devices, but without knowing the nature of those devices (hardware, software, or a combination), it's impossible to definitively determine if the S-53 is software-only. The absence of mentions of image processing, AI/ML, and performance studies further limits the ability to assess its software nature.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Lack of mention of biological samples: IVDs are designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information about a person's health. The description doesn't mention any interaction with biological samples.
- Input Modality: The input modality is "Video Imaging," which is typical for devices that capture visual information directly, not analyze biological samples.
- Intended User/Care Setting: The intended user is "practitioner's hands," suggesting a device used directly by a healthcare professional, likely for visual examination or procedures.
- Anatomical Site: While not explicitly stated, the lack of mention of specific anatomical sites often points away from devices that analyze internal biological processes.
- Predicate and Reference Devices: The listed predicate and reference devices (Fuji Optical Systems-Dentacam, New Image- Accucam, IDT, Welch Allyn, Dentsply, Air Technologies) are generally associated with medical imaging, dental equipment, or other non-IVD medical devices.
In summary, the information provided strongly suggests a device that uses video imaging for direct visual examination or procedures, which is not the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The design of the S-53 is virtually identical to the comparative devices which are listed and displayed in Exhibits 2 and 3. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same, DMS feels that thes minor differences have no impact on the safe use and/or effectiveness of the device.
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4130 Intraoral dental drill.
(a)
Identification. An intraoral dental drill is a rotary device intended to be attached to a dental handpiece to drill holes in teeth to secure cast or preformed pins to retain operative dental appliances.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Exhibit 9
510(k) Summary
DMS will provide a 510(k) Summary and allow for the "public" to request this information.
We have taken the terminology from the Reference Manual- Premarket Notification 510(k): Regulatory Requirements for Medical Devices" (FDA 92-4158).
Summary
Del Medical Systems feels the S-53 Video Imaging System is substantially equivalent tothe Fuji Optical Systems-Dentacam and the New Image- Accucam and also to many legally marketed devices already in commerical distribution such as: IDT, Welch Allyn, Dentsply and Air Tecghnologies, just to name a few.
The design of the S-53 is virtually identical to the comparative devices which are listed and displayed in Exhibits 2 and 3. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same, DMS feels that thes minor differences have no impact on the safe use and/or effectiveness of the device.
For information purposes and completeness, Del Medical Systems has also incorporated other legally marketed devices in this filing to illustrate the wide, general use of similar other devices. This wide use has led to the safe use of the device in many practitioner's hands.
SEP 2 5 1996