UNFORS PATIENT SKIN DOSIMETER (PSD)

K042698 · Unfors, Inc. · JAA · Oct 22, 2004 · Radiology

Device Facts

• Record ID: K042698
• Device Name: UNFORS PATIENT SKIN DOSIMETER (PSD)
• Applicant: Unfors, Inc.
• Product Code: JAA · Radiology
• Decision Date: Oct 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended 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.

Device Story

Unfors Patient Skin Dosimeter (PSD) measures patient entrance skin dose during fluoroscopy and CT procedures. Device consists of 1-4 sensors connected via cables to a display unit. Sensors placed on patient body; minimal footprint on X-ray image. User interface includes ON/OFF and SELECT keys; audio-visual 4-level warning system alerts user when specific dose levels are reached. Used in clinical settings (fluoroscopy/CT suites) by healthcare professionals. Provides real-time dose data to assist clinicians in monitoring patient radiation exposure, potentially benefiting patients by enabling informed clinical decision-making regarding radiation dose management. Device is battery-powered and non-sterile.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-powered, non-sterile, multi-use dosimeter. Consists of 1-4 sensors connected to a display unit. Includes mounting bracket and hard case. No software or programmable components.

Indications for Use

Indicated for real-time measurement of patient entrance skin dose during fluoroscopy and computerized tomography (CT) procedures. Prescription use only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Skin Dose Monitor (SDM) (K961105)

Submission Summary (Full Text)

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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.

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 Road<br>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, [phone] Fax: [phone] E-mail: [e-mail], www.unfors.com THE UNFORS CONCEPT

10 s TO LEARN

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POCKET SIZED

ACCURATE RESULT

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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 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, [phone] Fax: [phone] E-mail: [e-mail], www.unfors.com

THE UNFORS CONCEPT

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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

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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, [phone] Fax: [phone] E-mail: [e-mail], 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

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### 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.

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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 [phone] or [phone] 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

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#### 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 _

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