(63 days)
Not Found
Not Found
No
The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks any description of training or test sets, performance studies, or key metrics typically associated with AI/ML devices.
No
The device is an intra oral camera, which is used for observation and imaging, not for treating a condition.
No
Explanation: The "Intended Use / Indications for Use" states "Allow introl of the manation and observator," which does not indicate a diagnostic purpose.
No
The device description explicitly states "S595 Intra Oral Camera," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Allow introl of the manation and observator". While this phrasing is a bit unclear, it suggests a function related to control and observation, likely within the oral cavity. This does not align with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: It's described as an "S595 Intra Oral Camera". Intra oral cameras are used to visualize the inside of the mouth, not to analyze biological samples.
- Input Imaging Modality: The input is an "Intra Oral Camera", which captures images of the oral cavity directly, not from a biological specimen.
- Lack of IVD-related information: There is no mention of analyzing biological samples, processing specimens, or providing diagnostic information based on laboratory tests.
Therefore, the S595 Intra Oral Camera, as described, functions as a visualization tool for the oral cavity and does not meet the criteria for an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Allow introl of the manation and observator
Product codes
EIA
Device Description
Not Found
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
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
OCT - 5 2001
Exhibit 9.
510(k) Summary
SOPRO feels the S595 Intra Oral Camera is substantially equivalent to the many marketed devices already in commercial distribution. The legally marketed devices already in commercial distribution are : Air Techniques, Cygnus, Schick just to name a few.
KO12505
The design of the S595 is virtually identical to the comparative devices, which are listed and displayed in Exhibit 2 and 3. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same, SOPRO feels that these minor differences have no impact on the safe use and/or effectiveness of the device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the body and wings. The eagle is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 5 2001
Mr. Pierre Montillot CEO Sopro Place Street Christophe Les Accates-La Valentine Marseilla, FRANCE
Re: K012505
Trade/Device Name: Sopro 595 Intra Oral Camera Regulation Number: 872.6640 Regulation Name: Laparoscope and Accessories, General & Plastic Regulatory Class: I Product Code: EIA Dated: July 30, 2001 Received: August 3, 2001
Dear Mr. Montillot:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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
2
Page 2 - Mr. Montillot
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Snoer Ruano
A Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
3
| 510(k) Number (if known): | And Comments of the Children Comments of the Children Comments of the Children of the Children of the Children of the Children of the Children of the Children of the Children |
|---|---|
| --------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Page_ 0125
Device Name: State 595 Tate Ord Camod
Indications For Use:
Allow introl of the manation and observator
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
ນັ້ນ:ນວັດ:program ປຣູຊ (Per 2) CERR 801 109
ਂ ਵ
Over !:--Counter Use _
:Optional Format 1-2-96)
Susan Rury
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Det 510(k) Number