PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0

K020436 · Sedecal., Sa. · IZL · Feb 22, 2002 · Radiology

Device Facts

• Record ID: K020436
• Device Name: PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0
• Applicant: Sedecal., Sa.
• Product Code: IZL · Radiology
• Decision Date: Feb 22, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Models SP-HF-2.8 and SP-HF-4.0 are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Device Story

Portable X-ray units (SP-HF-2.8 and SP-HF-4.0) designed for diagnostic imaging; utilizes high-frequency inverter technology; operates on 90-285 VAC power. Device is portable, mountable on tripods/support arms, or handheld. Operated by qualified physicians or technicians in clinical settings. Input: electrical power; Output: diagnostic X-ray exposures. User interface features pushbuttons for kVp and mAs selection with LED indicators. Healthcare providers use X-ray output to visualize internal anatomy for diagnostic purposes, facilitating clinical decision-making for various body parts. Benefits include portability for point-of-care imaging.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through comparison of technical specifications and performance testing against the predicate device.

Technological Characteristics

Portable X-ray system; high-frequency inverter; 90-285 VAC power input. Dimensions: 8.7"H x 10.4"W x 16.5"D; Weight: 33 lbs. User interface: pushbuttons for kVp/mAs. Compliance: 21 CFR 1020.30, UL 2601, IEC 60601-1. kVp range: 110-115 kVp. Exposure times: 0.001-10 seconds.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic exposures of the skull, spine, chest, abdomen, and extremities. Used by qualified physicians or technicians with patients in sitting, standing, prone, or supine positions.

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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## FEB 2 2 2002

K020436
Page 142

EXHIBIT 2 510(k) Summary of Safety and Effectiveness

| SEDECAL SA | SEDECAL USA, Inc. |
|--------------------------------------|----------------------------------|
| Pelaya 9- Poligono Industrial Rio De | 2910 N. Arlington Heights Rd. |
| Janeiro | Arlington Heights Illinois 60006 |
| 28110-Algete | Tel [phone] |
| Madrid Spain | Fax [phone] |
| Tel [phone] | (Initial Importer) |
| Fax [phone] | Contact: Gary Fromberg |
| (Foreign Manufacturer) | |

February 5, 2002

510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: Models SP-HF-2.8 and SP-HF-4.0 Portable X-ray Units Classification Name: Mobile X-ray system, Product Code 90 IZL Common/Usual Name: Portable general purpose diagnostic X-ray Unit.
- 2. Equivalent legally marketed devices: This product is similar in function to the MinXray HF100H (a pre-amendments device)
- 3. Indications for Use (intended use) Models SP-HF-2.8 and SP-HF-4.0 are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
- 4. Description of the Device: Models SP-HF-2.8 and SP-HF-4.0 are a portable units which operate from 120 V 50-60~ AC. The unit utilizes a newly designed high frequency inverter and can be either mounted to a tripod or support arm or can be hand held. The usual safety precautions regarding the use of x-rays must be observed by the operator.
- 5. Safety and Effectiveness, comparison to predicate device. The results of 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 | Models SP-HF-2.8 | Model SP-HF-4.0 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Intended Use: | Potable general<br>purpose diagnostic<br>X-ray unit | SAME | SAME |
| Physical<br>characteristics: | | | |
| Size | 8.75"H x 9.5" W x<br>15.35" D. | 8.7 H x 10.4" W x<br>16.5" D | 8.7 H x 10.4" W x<br>16.5" D |
| Weight | 40.9 lbs | 33 lb | 33 lb |
| Energy Source: | 120 v 50-60~ AC | 90 to 285 VAC (50-<br>60 Hz) | 90 to 285 VAC (50-<br>60 Hz) |
| User Interface | Up-Down<br>pushbuttons for<br>three kVp selections<br>and exposure time<br>selections with LED<br>indicators | Up-Down<br>pushbuttons for kVp<br>and mAs. kVp<br>adjustable in 1 kVp<br>steps | Up-Down<br>pushbuttons for kVp<br>and mAs. kVp<br>adjustable in 1 kVp<br>steps |
| Exposure times | 0.08-2.00 Sec. In<br>192 steps | 0.002-10 sec 38<br>steps | 0.001-10 sec 41<br>steps |
| Ma. | 20 mA | 5, 6.4, 8, 10, 12.5,<br>16, 20, 25, 32, 40,<br>50 | 5, 6.4, 8, 10, 12.5,<br>16, 20, 25, 32, 40,<br>50, 64, 80, 100 |
| KvP | 100 KvP | 110 KvP | 115 KvP |
| Standards and<br>Safety<br>characteristics: | | | |
| Performance<br>Standard | 21 CFR 1020.30 | SAME | SAME |
| Electrical safety: | UL 2601, IEC<br>60601-1 | SAME | SAME |

Chart, Models SP-HE-2 8 and SP-HF-4.0

## 7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of Sedecal that the Models SP-HF-2.8 and SP-HF-4.0 are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a black and white seal. The seal is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2002

SEDECAL USA, Inc. % Mr. Daniel Kamm, P.E. Kamm & Associates PO Box 7007 DEERFIELD IL 60015

Re: K020436

Trade/Device Name: Models SP-HF-2.8 and SP-HF-4.0 Portable X-ray Unit Regulation Number: 21 CFR 892.1720 Regulation Name: Mobil x-ray system Regulatory Class: II Product Code: 90 IZL Dated: February 6, 2002 Received: February 8, 2002

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 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 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 If you desire specific at one of the following numbers, based on the regulation number at the top of this 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 Additionally, relate at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on by received to premained from the Division of Small Manufacturers, Jour responsiblements assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours,

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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j) Indications for Use

510(k) Number KD204366

Device Name: Models SP-HF-2.8 and SP-HF-4.0 Portable X-ray Units

Indications for Use: Models SP-HF-2.8 and SP-HF-4.0 Portable X-ray Units are intended financills for Soor Meaned physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓ OR

Over the Counter Use (Per 21 CFR 801.109)

Nancy Srogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020436