MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT

K973712 · Minxray, Inc. · IZL · Dec 12, 1997 · Radiology

Device Facts

• Record ID: K973712
• Device Name: MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT
• Applicant: Minxray, Inc.
• Product Code: IZL · Radiology
• Decision Date: Dec 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2

Intended Use

The MinXray HF100H will be initially marketed for portable and mobile general purpose diagnostic medical radiography. Because of its compact size and high output to weight ratio, we anticipate that the initial uses will be in field, home care, and nursing home diagnostic radiographic applicatons. These uses are typical of the predicate device, the MinXray HF80H. We believe that the safety and effectiveness of the two models are substantially equivalent. Experience in the market with the HF100H may make us aware of other possible This unit may be eventually married with stands for permanent or applications. semi-permanent installation for intra-operative use, hand and/or foot radiography, or other medical diagnostic applications. MinXray will make some stands available as accessory items for use with the HF100H. Other manufacturers may make stands compatible with various portable X-ray units, and we anticipate that some end users will purchase a MinXray HF100H to be used with some other stand of their choice.

Device Story

The MinXray HF100H is a portable, self-contained high-frequency diagnostic X-ray unit. It consists of a control unit, X-ray generator, and beam-limiting device. The operator manually selects tube voltage (40-100 kV) and exposure time; tube current is fixed at 20 mA. The device is used in field, home care, nursing home, or clinical settings for general radiography. It is operated by healthcare professionals. The device produces X-ray images for diagnostic purposes, aiding clinical decision-making. It is designed for mobility, with a compact form factor and high output-to-weight ratio, and can be used with optional stands for semi-permanent or intra-operative applications.

Clinical Evidence

Bench testing only. Preproduction testing compared radiographs of the same patient produced on the subject device and the predicate device, finding them to be essentially identical.

Technological Characteristics

High-frequency (60 kHz) constant potential X-ray generator; full-wave rectified. Tube voltage: 40-100 kV (2 kV steps). Fixed tube current: 20 mA. Timer: 0.08-2.00 sec. Filtration: 3.2 mm Al equivalent. Focal spot: 1.2 mm. Includes thermal overload protection. Digital control display. Complies with 21 CFR 1020.30. Not software controlled.

Indications for Use

Indicated for portable and mobile general purpose diagnostic medical radiography in field, home care, nursing home, intra-operative, and extremity (hand/foot) settings.

Regulatory Classification

Identification

A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• MinXray HF80H High Frequency Diagnostic X-ray Unit (K945707)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo for MINXRAY INC. The logo is in black and white and features the company name in a bold, stylized font. The letters are closely spaced and slightly overlapping, creating a sense of unity and strength. The "INC" is smaller and placed to the right of the main name.

## EXHIBIT A

# 510(k) Summary of Safety and Effectiveness

DEC 1 2 1997

### Identification of the Device 1.

Classification Name: 90 IZL per 21 CFR 892.1720

Common/Usual Name: Portable general purpose diagnostic X-ray unit.

Proprietary Trade Name: MinXray HF100H High Frequency Diagnostic X-ray Unit

### Equivalent legally marketed device 2.

This product is similar in design and function to the MinXray HF80H High Frequency Diagnostic X-ray Unit (K945707).

## 3. Indications for Use (intended use)

The MinXray HF100H will be initially marketed for portable and mobile general purpose diagnostic medical radiography. Because of its compact size and high output to weight ratio, we anticipate that the initial uses will be in field, home care, and nursing home diagnostic radiographic applicatons. These uses are typical of the predicate device, the MinXray HF80H. We believe that the safety and effectiveness of the two models are substantially equivalent.

Experience in the market with the HF100H may make us aware of other possible This unit may be eventually married with stands for permanent or applications. semi-permanent installation for intra-operative use, hand and/or foot radiography, or other medical diagnostic applications. MinXray will make some stands available as accessory items for use with the HF100H. Other manufacturers may make stands compatible with various portable X-ray units, and we anticipate that some end users will purchase a MinXray HF100H to be used with some other stand of their choice.

#### Description of the device 4.

The MinXray HF100H is a compact, self-contained high frequency X-ray unit consisting of the control, X-ray generator, and beam limiting device. Tube voltage (KV) and exposure time are variable and selected by the operator. Tube current is fixed at 20 mA.

#### Safety and Effectiveness, comparison to predicate device 5.

The MinXray HF100H is substantially equivalent to the MinXray HF80H in safety and effectiveness. Preproduction testing showed that radiographs of the same patient produced on either device were essentially identical. The following chart compares the new and predicate devices.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for MINXRAY Inc. The logo is in black and white and features a stylized font. The letters are bold and slightly overlapping.

## 6. Substantial Equivalence Chart

| Feature | MinXray HF100H (new device) | MinXray HF80H (predicate) |
|-------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| X-ray output | 20 mA @ 40-100 kV<br>in 2 kV steps | 10 mA @ 50-80 kV<br>in 5 kV steps |
| Timer | 0.08-2.00 sec.<br>192 steps | 0.08-3.98 sec.<br>195 steps |
| X-ray generator | Constant potential, 60 kHz<br>Full-wave rectified | Constant potential, 45 kHz<br>Full-wave rectified |
| Line voltage adjustment | Automatic, dynamic | Automatic, dynamic |
| X-ray tube | Toshiba D-124K or equiv. | Toshiba D-102 or equiv. |
| Focal spot size | 1.2 mm | 1.0 mm |
| Total filtration | 3.2 mm Al equivalent | 3.2 mm Al equivalent |
| Collimator | Advantech R-70ET or equiv. | Advantech R-70ET or equiv. |
| Exposure cord | 8 feet (2.44 meters) | 8 feet (2.44 meters) |
| Exposure switch | Two-stage, deadman type | Two-stage, deadman type |
| Power cord | 10 feet (3.05 meters) | 10 feet (3.05 meters) |
| Overload protection | Thermal, built-in | Thermal, built-in |
| Size (tubehead/control) | 9.5" (24.1 cm) W,<br>8.75" (22.2 cm) H,<br>15.35" (39 cm) L<br>+ skin guards | 6.5" (16.5 cm) W,<br>7.5" (19 cm) H,<br>14.5" (27.94 cm) L<br>+ skin guards |
| Weight | 40.9 lbs (18.6 kgs) | 27.5 lbs (12.5 kgs) |
| Control display | Digital | Digital |

# 7. Conclusion

Since there are no new indications for use, nor are there any new potential hazards, and preproduction testing showed that radiographs of the same patient produced on either device were essentially identical, MinXray is of the opinion that the devices are substantially equivalent.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for MINXRAY INC. The logo is in black and white and features the company name in a bold, sans-serif font. The "X" in MINXRAY is stylized with the left side of the X being thicker than the right side. The letters "INC" are smaller and located to the right of the word MINXRAY.

### Manufacturer's Statement of Substantial Equivalence 8.

STATEMENT OF INDICATIONS FOR USE:

The MinXray HF100H will be initially marketed for portable and mobile general purpose diagnostic medical radiography. These uses are typical of the predicate device, the MinXray HF80H.

CLAIMS REGARDING DEVICE FEATURES, PERFORMANCE, OR SAFETY:

This product is similar in design and function to the MinXray HF80H high frequency diagnostic X-ray unit (K945707).

This notification contains all of the information required by 21 CFR 807.87. A completed copy of the "DRAERD Premarket Notification 510(k) Screening Checklist" is attached.

The subject device conforms to the following mandatory standards:

Performance Standard: 21 CFR 1020.30 Diagnostic X-ray Systems

The subject device has the same technological characteristics as a legally marketed predicate device. Specifically, the features, specifications, materials, and mode of action are equivalent. If the subject device is a kit, all of the contents of the kit are either pre-Amendment devices or have been cleared for marketing through previous 510(k)s. The kit contains no drug or biologic product.

The subject device is not software controlled.

TRUTHFUL AND ACCURATE STATEMENT (as required by 21 CFR 807.87(j)):

I certify that, in my capacity as President of MinXray, Inc., I believe, to the best of my knowledge, that the above statements and all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted.

Keith R. Krettenhir

Keith R. Kretchmer President

4/26/97
Data

Date

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 1997

Keith R. Kretchmer President MinXRay, Inc. 3611 Commercial Avenue Northbrook, IL 60062-1822 Re: K973712 MinXray HF100H High Frequency Diagnostic X-Ray Unit Dated: December 5, 1997 Received: December 8, 1997 Regulatory Class: II 21 CFR 892.1720/Procode: 90 IZL

Dear Mr. Kretchmer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 80) and additionally 809.10 for in vitr' diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]- Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for MINXRAY INC. The logo is in black and white and features the company name in a bold, sans-serif font. The "X" in MINXRAY is stylized with the left side of the "X" being thicker than the right side. The "INC" is in a smaller font size and is located to the right of the word "MINXRAY".

### EXHIBIT B

# Indications for Use (intended use)

The MinXray HF100H will be initially marketed for portable and mobile general purpose diagnostic medical radiography. Because of its compact size and high output to weight ratio, we anticipate that the initial uses will be in field, home care, and nursing home diagnostic radiographic applicatons. These uses are typical of the predicate device, the diagnotic rational depice that the safety and effectiveness of the two models are substantially equivalent.

Experience in the market with the HF100H may make us aware of other possible This unit may be eventually married with stands for permanent or applications. semi-permanent installation for intra-operative use, hand and/or foot radiography, or other medical diagnostic applications. MinXray will make some stands available as accessory items for use the HF100H. Other manufacturers may make stands compatible with various portable X-ray units, and we anticipate that some end users will purchase a MinXray HF100H to be used with some other stand of their choice.

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)