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

• K Number: K020436
• Device Name: PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0
• Manufacturer: SEDECAL S.A.
• Date Cleared: 2002-02-22 ( 14 days)
• Product Code: IZL
• Regulation Number: 892.1720
• Type: Abbreviated
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: K103522

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 Description

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.

AI/ML Overview

The provided document describes the safety and effectiveness summary for two portable X-ray units, Models SP-HF-2.8 and SP-HF-4.0. The study's acceptance criteria are implicitly defined by demonstrating substantial equivalence to a predicate device, the MinXray HF100H.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally understood to be that the new devices (Models SP-HF-2.8 and SP-HF-4.0) perform as safely and effectively as the predicate device (MinXray HF100H) and present no new indications for use or significant technological differences that would raise new questions of safety or effectiveness. The document achieves this by comparing technical specifications and intended use.

Characteristic	Acceptance Criteria (Predicate Device: MinXray HF100H)	Reported Device Performance (Models SP-HF-2.8 & SP-HF-4.0)	Meets Acceptance Criteria?
Intended Use	Portable general purpose diagnostic X-ray unit	SAME (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.)	Yes
Physical Characteristics:
Size	8.75"H x 9.5" W x 15.35" D.	8.7"H x 10.4" W x 16.5" D	Yes*
Weight	40.9 lbs	33 lb	Yes*
Energy Source	120 V 50-60~ AC	90 to 285 VAC (50-60 Hz)	Yes*
User Interface	Up-Down pushbuttons for three kVp selections and exposure time selections with LED indicators	Up-Down pushbuttons for kVp and mAs. kVp adjustable in 1 kVp steps	Yes*
Exposure times	0.08-2.00 Sec. In 192 steps	SP-HF-2.8: 0.002-10 sec 38 stepsSP-HF-4.0: 0.001-10 sec 41 steps	Yes*
Ma.	20 mA	SP-HF-2.8: 5, 6.4, 8, 10, 12.5, 16, 20, 25, 32, 40, 50SP-HF-4.0: 5, 6.4, 8, 10, 12.5, 16, 20, 25, 32, 40, 50, 64, 80, 100	Yes*
KvP	100 KvP	SP-HF-2.8: 110 KvPSP-HF-4.0: 115 KvP	Yes*
Standards & Safety Characteristics:
Performance Standard	21 CFR 1020.30	SAME	Yes
Electrical safety	UL 2601, IEC 60601-1	SAME	Yes
Overall Safety and Effectiveness	"as safe and effective as the predicate device"	"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."	Yes

Note: For the physical and operational characteristics (Size, Weight, Energy Source, User Interface, Exposure times, Ma., KvP), the acceptance criteria are not explicitly stated as strict numerical equivalence. Instead, "substantial equivalence" is being claimed, meaning the differences are not considered to raise new questions of safety or effectiveness. The new devices often show improvements (e.g., wider range of mAs/kVp, lower weight) or minor variations that are deemed acceptable and within the scope of the predicate device's intended use.

2. Sample size used for the test set and the data provenance

The document states that "bench and user testing" was performed. However, there is no specific sample size provided for the test set. The data provenance (country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document mentions "user testing" but does not specify the number or qualifications of experts used to establish ground truth. Given the nature of the device (portable X-ray unit) and the era of the submission, "user testing" likely refers to evaluations by technicians or qualified medical personnel regarding the device's operational aspects and image acquisition capabilities rather than diagnostic interpretation.

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

The document does not describe any adjudication method for establishing ground truth from the "user testing."

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

No MRMC comparative effectiveness study was done or reported. This device is a portable X-ray unit, not an AI-powered diagnostic tool. The comparison is between the new X-ray unit and a predicate X-ray unit, focusing on technical specifications and overall safety/effectiveness in producing images, not on human reader performance or AI assistance.

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

No standalone algorithm performance study was done or reported. This is a hardware device for image acquisition, not a software algorithm.

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

The concept of a "ground truth" as typically applied to diagnostic performance studies (e.g., pathology, expert consensus on disease presence) is not applicable or described in this 510(k) summary. The "ground truth" for this submission revolves around the technical performance metrics of the X-ray unit (e.g., kVp, mA, exposure times, safety standards) and whether it can produce diagnostic-quality images, implicitly judged during "user testing." The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate device based on its technical specifications and intended use.

8. The sample size for the training set

Not applicable. This submission is for a medical device (X-ray unit) that does not involve machine learning or AI algorithms requiring a training set in the typical sense.

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

Not applicable. As stated above, this device does not utilize a training set.

Summary

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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 generalpurpose diagnosticX-ray unit	SAME	SAME
Physicalcharacteristics:
Size	8.75"H x 9.5" W x15.35" D.	8.7 H x 10.4" W x16.5" D	8.7 H x 10.4" W x16.5" D
Weight	40.9 lbs	33 lb	33 lb
Energy Source:	120 v 50-60~ AC	90 to 285 VAC (50-60 Hz)	90 to 285 VAC (50-60 Hz)
User Interface	Up-Downpushbuttons forthree kVp selectionsand exposure timeselections with LEDindicators	Up-Downpushbuttons for kVpand mAs. kVpadjustable in 1 kVpsteps	Up-Downpushbuttons for kVpand mAs. kVpadjustable in 1 kVpsteps
Exposure times	0.08-2.00 Sec. In192 steps	0.002-10 sec 38steps	0.001-10 sec 41steps
Ma.	20 mA	5, 6.4, 8, 10, 12.5,16, 20, 25, 32, 40,50	5, 6.4, 8, 10, 12.5,16, 20, 25, 32, 40,50, 64, 80, 100
KvP	100 KvP	110 KvP	115 KvP
Standards andSafetycharacteristics:
PerformanceStandard	21 CFR 1020.30	SAME	SAME
Electrical safety:	UL 2601, IEC60601-1	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

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
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.(b)
Classification. Class II.