(90 days)
Not Found
No
The description focuses on digital signal processing and data collection/display techniques, with no mention of AI, ML, or related concepts.
No
The device is described as a "digital imaging system designed for Digital Videography" intended to "acquire, record, review and distribute a digital image from a x-ray image intensifiers in diagnostic imaging chains" and function by "converting an optical (analog) image to a digital image having sufficient diagnostic properties as to assist the physician in establishing a diagnosis." This indicates a diagnostic rather than therapeutic purpose.
Yes
The document explicitly states that the device is intended for use in diagnostic imaging chains, is described as a Class II diagnostic system, and functions by producing diagnostic images to assist physicians in establishing a diagnosis.
No
The device description explicitly states it is composed of software, proprietary hardware and software, and a CCD Camera, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PS 3000 Digital PhotoSpot System works by acquiring, recording, and displaying digital images derived from x-ray image intensifiers. This is an imaging modality that captures images of the internal structures of the body, not by analyzing samples taken from the body.
- Intended Use: The intended use is to assist trained healthcare professionals in producing a diagnostic image from x-ray procedures. This is a function of medical imaging equipment, not IVD.
The device is clearly described as a digital imaging system used in conjunction with x-ray equipment for diagnostic imaging procedures. This falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The PS 3000 Digital PhotoSpot System " is a high resolution, digital imaging system designed for Digital Videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy and angiography or cardiac imaging procedures are performed.
The PS 3000 Digital PhotoSpot System " is indicated for use when it is necessary for a trained health care professional (for example an Radiologist) to acquire, record, review and distribute a digital image from a x-ray image intensifiers in diagnostic imaging chains.
The PS 3000 Digital PhotoSpot System " is a prescription device. The labeling, instructions and user operations are designed for trained professionals.
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA
Device Description
This device can be described as a Class II diagnostic system that receives an image from an image intensifier tube and acquire, record, display and publish diagnostic images using proprietary techniques. This device is composed of:
- software {that runs in a qualified, ancillary computer}, .
- proprietary hardware and software, and a ●
- CCD Camera that receives the image. .
All ancillary equipment, which works with this device, is identified as a configured item and tested to formal procedures. This device will only be used with specific ancillary equipment, which is tested and qualified to work with PS 3000 Digital PhotoSpot System ***.
The scientific concept on which this device is based that by monitoring images from the image intensified tube a valid diagnostic image can be derived and reproduced.
This device functions by converting an optical (analog) image to a digital image having sufficient diagnostic properties as to assist the physician in establishing a diagnosis.
The intended use of this device is for a trained health care professional to produce a diagnostic inage. The PS 3000 Digital PhotoSpot System " uses sophisticated digital signal processing and data collection/display techniques to offer the physician or trained health care provider, a reliable, simple tool.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained health care professional (for example an Radiologist)
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)
A series of factory adjustments/calibration tests are conducted to verify the device is accurate can maintain calibration over its useful life. The PS 3000 Digital PhotoSpot System ™ has benefited from design, development, testing and production procedures that conform to Quality Systems.
This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy. Precise Optics/PME, Inc. continues to research all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.
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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Exhibit 19 Summary of Safety & Effectiveness
KO30061
APR 0 7 2003
19 December 2002
The PS 3000 Digital PhotoSpot System " , Picture archiving and communications system is designed for clinical applications to allow health care providers to acquire, record, display and publish diagnostic images. As such, this device is a Class II device, having Regulation Number: 21 CFR part 892-2050, Classification Number: LLZ. JAA, OWB 892.1650
This summary is submitted in behalf of: Precise Optics/PME, Inc. 239 South Fehr Way, Bay Shore NY 11706 Voice phone number-631 242 6600 Fax phone number- 631 242 4421
This summary is submitted by: Richard Keen Compliance Consultants 1151 Hope Street Stamford, Connecticut, 06907 voice phone number (203) 329 2700) fax phone number (203) 329 2345.
This device can be described as a Class II diagnostic system that receives an image from an image intensifier tube and acquire, record, display and publish diagnostic images using proprietary techniques. This device is composed of:
- software {that runs in a qualified, ancillary computer}, .
- proprietary hardware and software, and a ●
- CCD Camera that receives the image. .
All ancillary equipment, which works with this device, is identified as a configured item and tested to formal procedures. This device will only be used with specific ancillary equipment, which is tested and qualified to work with PS 3000 Digital PhotoSpot System ***.
The scientific concept on which this device is based that by monitoring images from the image intensified tube a valid diagnostic image can be derived and reproduced.
This device functions by converting an optical (analog) image to a digital image having sufficient diagnostic properties as to assist the physician in establishing a diagnosis.
The intended use of this device is for a trained health care professional to produce a diagnostic inage. The PS 3000 Digital PhotoSpot System " uses sophisticated digital signal processing and data collection/display techniques to offer the physician or trained health care provider, a reliable, simple tool.
The PS 3000 Digital PhotoSpot System " is a high resolution, digital imaging system designed for Digital Videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy and angiography or cardiac imaging procedures are performed.
The PS 3000 Digital PhotoSpot System " is indicated for use when it is necessary for a trained health care professional (for example an Radiologist) to acquire, record, review and distribute a digital image from a x-ray image intensifiers in diagnostic imaging chains.
1
Exhibit 19 Summary of Safety & Effectiveness
The PS 3000 Digital PhotoSpot System "" is a prescription device. The labeling, instructions and user operations are designed for trained professionals.
Precise Optics/PME, Inc. has determined that the PS 3000 Digital PhotoSpot System™ is substantially equivalent to the performance of a an existing medical device:
Patriot, now Gold One, manufactured by Infimed, Inc. of Liverpool, NY 13088 (K963037). The differences between these systems are incidental and not significant. Both devices use a similar technology and principles.
Precise Optics/PME, Inc. has determined that this device is substantially equivalent to the predicate device and has these similar technological characteristics:
both devices use computers and software having analog/digital processing, both devices produce diagnostic images, and both use computer processing to acquire, store, display and publish diagnose images.
A series of factory adjustments/calibration tests are conducted to verify the device is accurate can maintain calibration over its useful life. The PS 3000 Digital PhotoSpot System ™ has benefited from design, development, testing and production procedures that conform to Quality Systems.
This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy. Precise Optics/PME, Inc. continues to research all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.
CERTIFICATION:
I hereby certify this Summary of Safety and Effectiveness applies for the above indicated device.
Llena Corr
Mr. Glen Corso President Precise Optics/PME, Inc. 239 South Fehr Way, Bay Shore NY 11706 Voice 631 242 6600 631 242 4421 Fax
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and head. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY - 7 2012
Precise Optics/PME, Inc. % Mr. Richard Keen Compliance Consultants 1151 Hope St. STAMFORD CT 06907
Re: K030061
Trade/Device Name: PS 3000 Digital Photospot System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: December 19, 2002 Received: January 7, 2003
Dear Mr. Keen:
This letter corrects our substantially equivalent letter of April 7, 2003.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Exhibit 2 510(K) Number (If known):K63x6 no 510(K) number assigned Device Name: PS 3000 Digital PhotoSpot System "
Indications for Use
The PS 3000 Digital PhotoSpot System " is a high resolution, digital imaging system designed for Digital Videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy and angiography or cardiac imaging procedures are performed.
The PS 3000 Digital PhotoSpot System " is indicated for use when it is necessary for a trained health care professional (for example an Radiologist) to acquire, record, review and distribute a digital image from a x-ray image intensifiers in diagnostic imaging chains.
The PS 3000 Digital PhotoSpot System " is a prescription device. The labeling, instructions and user operations are designed for trained professionals.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030041
or Over - The Counter Use XXX
(Optional Format 1-2-96)
Prescription Use
(Per 21 CFR 801.109)
Sheet 1 of 1