(22 days)
Not Found
No
The device description explicitly states that the device is not programmable and has no software to be concerned with, which is inconsistent with the implementation of AI/ML.
No
The device measures patient entrance skin dose but does not provide any therapeutic intervention or treatment.
No
The device measures patient entrance skin dose during imaging procedures. While measuring dose is important for patient safety and procedure optimization, it does not diagnose a medical condition or disease. It provides information about the radiation exposure received, not the patient's health status.
No
The device description explicitly states that the PSD consists of sensors on cables connected to a display unit, and that it is not programmable, indicating it is a hardware-based device with no software component.
Based on the provided information, the Unfors Patient Skin Dosimeter (PSD) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- PSD Function: The Unfors PSD measures patient entrance skin dose in real-time during medical procedures (fluoroscopy/CT). It measures radiation exposure directly on the patient's skin.
- Lack of Specimen Analysis: The PSD does not analyze any biological specimens taken from the patient.
Therefore, the Unfors Patient Skin Dosimeter falls under the category of a radiation measurement device used in a clinical setting, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Unfors Patient Skin Dosimeter (PSD) is a skin dosimeter to measure patient entrance skin dose in real time during fluoroscopy / computerized tomography (CT) procedures. The PSD can be equipped with 1-4 sensors.
Measure patient entrance skin dose in real time during fluoroscopy / computerized tomography (CT) procedures. It can be equipped with 1-4 sensors.
Product codes
JAA
Device Description
The Unfors Patient Skin Dosimeter (PSD) is a skin dosimeter to measure patient entrance skin dose in real time during fluoroscopy / computerized tomography (CT) procedures. The PSD can be equipped with 1-4 sensors.
The PSD consists of several small (1-4) sensors on cables connected to a display unit. The sensors can be placed anywhere on the body and will leave a minimal footprint on the X-Ray image.
The 1-4 sensors can independently measure dose. The PSD has two keys, ON/OFF and SELECT. The SELECT key is used to step through measured values and to enter software menus. An audio-visual 4 level warning system indicates to the user when specific dose levels are reached.
The PSD is provided non-sterile and is not programmable. Thus, there is no software to be concerned with.
Accessories that can/may accompany the PSD are an aluminum holder to hold the PSD to a patient side rail and a hard case to protect the PSD during shipping and storage. These are the only two accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Real-time fluoroscopy / computerized tomography (CT) procedures.
Anatomical Site
Anywhere on the body.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the word "unfors" in a stylized, italicized font, followed by a stylized letter "U". The letter "U" is made up of several horizontal lines stacked on top of each other, creating a unique and modern design. The text and the letter are both in black, contrasting with the white background.
OCT 2 2 2004
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information
| 1. | Submitter's Name: | Unfors Instruments, Inc. |
|---|---|---|
| 2. | Address: | 123 Litchfield Road |
| New Milford, CT 06776 | ||
| 3. | Telephone: | 860-355-2588 |
| 4. | Contact Person: | Patrick R. Pyers |
| 5. | Date Prepared: | September 28, 2004 |
| 6. | Registration Number: | 3004099922 |
| B. Device | ||
| 1. | Name: | Unfors PSD |
| 2. | Trade Name: | Patient Skin Dosimeter |
| 3. | Common Name: | Patient Skin Dosimeter |
| 4. | Classification Name: | System, X-Ray, Fluoroscopic, Image-Intensified |
| 5. | Product Code: | JAA |
| 6. | Class: | II |
| 7. | Regulation Number: | 892.1650 |
C. Identification of Legally Marketed Devices
- Skin Dose Monitor (SDM) 1. Name: K961105 2. K Number: September 5, 1996 3. Date Cleared:
UNFORS INSTRUMENTS, Inc. 123 Litchfield Road New Milford, CT 06776, USA Phone: (866) 4UNFORS, (860) 355-2588 Fax: (860) 350-2664 E-mail: info@unfors.com, www.unfors.com THE UNFORS CONCEPT
10 s TO LEARN
Image /page/0/Picture/10 description: The image shows a black and white target with an arrow hitting the bullseye. The target consists of concentric circles, alternating between black and white. The arrow is black and is pointing directly at the center of the target. The image is simple and conveys the idea of accuracy and achieving a goal.
POCKET SIZED
ACCURATE RESULT
1
Image /page/1/Picture/1 description: The image shows the word "unfors" in a stylized, bold, sans-serif font. To the right of the word is a large letter "U" that is also in a bold, sans-serif font. The letter "U" is filled with horizontal lines.
OCT 2 2 2004
D. Description of the Device
The Unfors Patient Skin Dosimeter (PSD) is a skin dosimeter to measure patient entrance skin dose in real time during fluoroscopy / computerized tomography (CT) procedures. The PSD can be equipped with 1-4 sensors.
The PSD consists of several small (1-4) sensors on cables connected to a display unit. The sensors can be placed anywhere on the body and will leave a minimal footprint on the X-Ray image.
The 1-4 sensors can independently measure dose. The PSD has two keys, ON/OFF and SELECT. The SELECT key is used to step through measured values and to enter software menus. An audio-visual 4 level warning system indicates to the user when specific dose levels are reached.
The PSD is provided non-sterile and is not programmable. Thus, there is no software to be concerned with.
Accessories that can/may accompany the PSD are an aluminum holder to hold the PSD to a patient side rail and a hard case to protect the PSD during shipping and storage. These are the only two accessories.
E. Intended Use Statement
The Unfors Patient Skin Dosimeter (PSD) is a skin dosimeter to measure patient entrance skin dose in real time during fluoroscopy / computerized tomography (CT) procedures. The PSD can be equipped with 1-4 sensors.
F. Technological Characteristics Summary
Similarities between both devices are the following:
- Mounting Bracket .
- Indications for Use .
- . Prescription Device
- ◆ Multi-Use
- . Non-Sterile
- Environment (X-Ray Procedures)
- Sensors .
UNFORS INSTRUMENTS, Inc. 123 Litchfield Road New Milford, CT 06776, USA Phone: (866) 4UNFORS, (860) 355-2588 Fax: (860) 350-2664 E-mail: info@unfors.com, www.unfors.com
THE UNFORS CONCEPT
Image /page/1/Picture/22 description: The image contains a simple, high-contrast graphic. A single, stylized eye is positioned on the left side of the frame. The eye is depicted with a large, solid black pupil and a white surrounding area, creating a stark visual contrast. The rest of the image is blank and white.
Image /page/1/Picture/25 description: The image shows a black and white circular target. The target has alternating black and white rings. The center of the target is black.
POCKET SIZED
2
unfors U
- Cables .
- . Read-out Instrument
- Diagnostic Purposes ●
- Battery Powered .
Differences are the PSD has 1-4 sensors, whereas the SDM has one sensor. SDM uses a fiber optic cable which is prone to mechanical stress. The life-time of the SDM Sensor is a few examinations and then disposed.
The differences are considered minor and do not raise safety concerns.
UNFORS INSTRUMENTS, Inc. 123 Litchfield Road New Milford, CT 06776, USA Phone: (866) 4UNFORS, (860) 355-2588 Fax: (860) 350-2664 E-mail: info@unfors.com, www.unfors.com THE UNFORS CONCEPT
10 s TO
Image /page/2/Picture/9 description: The image shows a target with concentric circles. The target has alternating black and white rings. An arrow is pointing towards the center of the target, indicating a successful hit.
POCKET SIZED
ACCURATE RESULT
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2004
Mr. Patrick R. Pyers President Unfors Instruments, Inc. 123 Litchfield Road :NEW MILFORD, CT 06776 Re: K042698
Trade/Device Name: Patient Skin Dosimeter Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system
Regulatory Class: II Product Code: 90 JAA Dated: September 28, 2004 Received: September 30, 2004
›Dear Mr. Pyers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave reviewed your becaled is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the enerosate) to regally manned date of the Medical Device Amendments, or to devices that have been May 20, 1770, the chance 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 do not require approval controls provisions of the Act. The general controls provisions of the Act de nee, subjoct to the general 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 (Premarket n your de revels to such additional controls. Existing major regulations affecting your Applo rary, it the 90 colors 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 statues and regulations administered by other Federal agencies. You must comply with all the roderal states and roganing, 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) (21 CFR Part 801), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
4
This Ictter will allow you to begin marketing your device as described in your Section 510(k) I ms letter witi anow you to ough finding of substantial equivalence of your device to a legally prematics notification: "The sition 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), please If you desire specifice at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsmaldsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): To be determined
Device Name: Patient Skin Dosimeter
Indications for Use:
- Measure patient entrance skin dose in real time during fluoroscopy / computerized . tomography (CT) procedures. It can be equipped with 1-4 sensors.
Prescription Use X
AND/OR
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
David R. Legum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
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