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.

Device Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the Unfors Patient Skin Dosimeter (PSD). It describes the device, its intended use, and compares it to a legally marketed predicate device (Skin Dose Monitor, SDM). However, the document does not contain information about acceptance criteria, detailed study design, or performance metrics that would typically be found in a study demonstrating the device meets specific acceptance criteria. This summary is primarily focused on establishing substantial equivalence to a predicate device for regulatory clearance.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

Cannot be provided. The document does not specify any quantitative acceptance criteria for device performance (e.g., accuracy, precision, error margins) or report specific performance values from a study against such criteria. The submission is a 510(k) summary, which generally focuses on substantial equivalence rather than detailed performance study results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not describe any specific test set, its sample size, or data provenance. It mentions "The PSD is provided non-sterile and is not programmable. Thus, there is no software to be concerned with," and focuses on comparison to a predicate device. There is no performance study described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. No ground truth establishment is described as there is no performance study detailed in this summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No adjudication method is described as there is no performance study detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. This device is a passive dosimeter, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Cannot be provided. This device is a hardware dosimeter, not an algorithm, so a standalone algorithm performance study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. No ground truth is described. Performance for dosimeters is typically evaluated against calibrated radiation sources or reference dosimetry standards, rather than expert consensus, pathology, or outcomes data. However, the details of such testing are not in this summary.

8. The sample size for the training set

Cannot be provided. This device is a hardware dosimeter developed by Unfors Instruments, Inc., not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Cannot be provided. Not applicable, as detailed above.

Summary

{0}------------------------------------------------

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.

K042698

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 RoadNew 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}------------------------------------------------

K042698

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 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 PSD is provided non-sterile and is not programmable. Thus, there is no software to be concerned with.

E. Intended Use Statement

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

K042698

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 _

Page 1 of 1

Regulation Number and Section

§ 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.