MINXRAY, MODEL HF120/60H POWERPLUS

K040046 · Minxray, Inc. · IZL · Feb 2, 2004 · Radiology

Device Facts

• Record ID: K040046
• Device Name: MINXRAY, MODEL HF120/60H POWERPLUS
• Applicant: Minxray, Inc.
• Product Code: IZL · Radiology
• Decision Date: Feb 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The MinXray HF120/60H PowerPlus™ is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.

Device Story

MinXray HF120/60H PowerPlus™ is a portable high-frequency diagnostic X-ray unit; operates on 120V AC; mounts to tripod or support arm. Device utilizes high-frequency inverter to generate X-rays for diagnostic imaging. Operator (physician or technician) selects kVp and exposure time via pushbuttons with LED indicators; mAs indicator provided. Used in clinical settings for adult and pediatric patients. Output is diagnostic X-ray exposure; assists clinicians in diagnostic decision-making. Benefits include portability for general purpose diagnostic imaging.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and user testing comparing performance characteristics to the predicate device.

Technological Characteristics

Portable high-frequency diagnostic X-ray unit; 120V 50-60Hz AC power; high-frequency inverter; 406 x 221 x 240 mm; 20 kg. User interface: pushbuttons for kVp/exposure time, LED indicators. Performance: 40-120 kVp, 20-30 mA. Safety: 21 CFR 1020.30, UL 2601, IEC 60601-1, UL listed.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic x-rays. Intended for use by qualified/trained physicians or technicians.

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 HF100H

Submission Summary (Full Text)

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EXHIBIT 2

K040046

Mikasa X-Ray Co., LTD. (Manufacturer) 13-2, Hongo 3-chome Bunkvo-Ku. Tokyo 113-0033 Japan Tel [phone] Fax [phone]

MinXray, Inc (Initial Distributor) 3611 Commercial Ave. Northbrook, IL 60062 Tel [phone] Fax [phone] Contact: Keith Kretchmer

## January 6, 2004

## 510(k) Summary

- 1. Identification of the Device: Proprietary-Trade Name: MinXray HF120/60H PowerPlus™ High Frequency Diagnostic X-Ray Unit" Classification Name: Mobile X-ray system, Product Code 90 IZL Common/Usual Name: Portable general purpose diagnostic X-ray Unit.
- Equivalent legally marketed devices This product is similar in function to the 2. MinXray HF100H (a pre-amendments device)
- Indications for Use (intended use) The MinXray HF120/60H PowerPlus™ is 3. intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.
- Description of the Device: MinXray HF120/60H PowerPlus™ is a portable unit 4. which operates from 120 V 50-60~ AC. The unit utilizes a newly designed high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator.
- Safety and Effectiveness, comparison to predicate device. The results of న్న bench and user testing indicates that the new device is as safe and effective as the predicate device.

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| Characteristic | MinXray HF100H<br>(Pre-amendments device) | MinXray HF120/60H<br>PowerPlus™ |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Intended for use by a qualified/trained<br>physician or technician on both adult and<br>pediatric subjects for taking diagnostic x-<br>rays. | SAME |
| Physical characteristics: | | |
| Size/weight | 406 x 222 x 241 mm 18.6 kg | 406 x 221 x 240 mm, 20 kg. |
| Energy Source: | 120 v 50-60~ AC | SAME |
| User Interface | Up-Down pushbuttons for three kVp<br>selections and exposure time selections with<br>LED indicators | Up-Down pushbuttons for kVp<br>selections and exposure time<br>selections with LED indicators<br>mAs indicator |
| Exposure times | 199 (in 0.01 sec. Steps)<br>0.08 - 4.00 sec. | (0.01 - 0.2 sec ) (in 0.01 sec. Step) ,<br>(0.2 - 0.4 sec ) (in 0.02 sec.<br>Step)<br>(0.4 - 1.0 sec ) (in 0.05 sec. Step),<br>(1.0 - 5.0 sec ) (in 0.1 sec. Step) |
| Ma. | 20 mA constant | 30 mA( 40-60kV)<br>25mA(62-80kV)<br>20mA(82-100kV) |
| KvP | 40-100 KvP | Max. 120 KvP |
| Standards and Safety<br>characteristics: | | |
| Performance<br>Standard | 21 CFR 1020.30 | SAME |
| Electrical<br>safety | UL 2601, IEC 60601-1 | SAME, plus UL listed |

## 6. Substantial Equivalence Chart, MinXray HF120/60H PowerPlus™

## 7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of MinXray that the MinXray HF120/60H PowerPlus™ is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. Safety is further assured by Underwriters Laboratories testing and listing.

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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 eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 2004

MinXray, Inc. % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

Re: K040046

Trade/Device Name: MinXray HF120/60H PowerPlus™ Regulation Number: 21 CFR 892.1720 Regulation Name: Mobil x-ray system Regulatory Class: II Product Code: 90 IZL Dated: January 6, 2004 Received: January 13, 2004

Dear Mr. Kamm:

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 either class II (Special Controls) or class III (PMA), 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 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brydon

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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j) Indications for Use

510(k) Number K040046

Device Name: MinXray HF120/60H PowerPlus™

Indications for Use: The MinXray IIF120/60H PowerPlus™ is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.

Concurrence of CDRH, Office of Device Evaluation (ODF)

Prescription Use X ાર

Over the Counter Use (Per 21 CFR 801.109)

David A. Syner

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number