OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM

• K Number: K012546
• Device Name: OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM
• Manufacturer: SEDECAL USA, INC.
• Date Cleared: 2001-11-02 ( 87 days)
• Product Code: KPR
• Regulation Number: 892.1680
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K001201
• Predicate For: K042876 , K062335 , K071193 , K072659 , K082261 , K141192

Intended Use

The "Optima URS" Universal Radiographic System is 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

The "Optima URS" is a stationary unit which operates from 120 V 50-60~ AC. Optima URS is a universal swivel arm X-ray system. It is easy to operate and permits a swift radiographic procedure, a feature which applies to all conventional exposure techniques on all parts of the body. The system is composed of a floor-to wall column and a turnable arm with variable high center. It allows one to take exposures of patients in standing, sitting or laying position. Owing to its compact design Optima URS is a low-cost radiography system which takes up little space and is quick to install.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Optima URS" Universal Radiographic System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance acceptance criteria through a detailed study on diagnostic accuracy or clinical outcomes.

The "study" that proves the device meets its "acceptance criteria" here is the bench and user testing conducted to show substantial equivalence to the predicate device, the Siemens Multix Stationary X-Ray System (K001201). The acceptance criteria are primarily related to safety, operational performance, and intended use as compared to this predicate.

Here's an analysis based on the information provided:

---

Description of Acceptance Criteria and Device Performance

The acceptance criteria for the "Optima URS" Universal Radiographic System are defined by its substantial equivalence to the Siemens Multix Stationary X-Ray System (K001201). The key deemed "acceptance criteria" and the device's reported performance are summarized below:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (aligned with Predicate)	Optima URS Performance (Reported as "SAME")
Intended Use: 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.	SAME
Performance Standard: 21 CFR 1020.30	SAME
Electrical Safety: Electrical Safety per Underwriters Laboratories Standard UL-2601 (IEC-60601) and IEC 60601, Underwriters Laboratories Standard UL187: UL Standard for Safety for X-Ray Equipment, CE Marking Requirements, ISO 9001.	SAME, plus EMC: EN50081-1 Residential commercial, light industry general - EMC emission EN50082-1 Residential, commercial, light industry general - EMC immunity, EN60950 Safety of IT and electrical business equipment
Technological Differences: Few technological differences compared to the predicate device.	Few technological differences reported.
New Indications for Use: No new indications for use compared to the predicate device.	No new indications for use reported.

Conclusion from the Submission: "After analyzing both bench and user testing data, it is the conclusion of Sedecal USA that the 'Optima URS' Universal Radiographic System 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."

---

Study Details to Prove Acceptance

The provided document describes a 510(k) submission, which primarily relies on demonstrating substantial equivalence. The "study" referenced in the document is "bench and user testing."

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not specify a numerical sample size for either the "bench" or "user testing." This type of submission typically involves engineering evaluations and potentially limited clinical feedback rather than large-scale clinical trials with specific patient sample sizes.
   • Data Provenance: Not explicitly stated, but the manufacturer is SEDECAL SA (Spain) with an initial importer in the USA. The "bench testing" likely occurred at the manufacturer's facility. "User testing" could imply testing by qualified personnel in a simulated or real clinical environment, but details are not provided. The data is retrospective in the sense that it supports a premarket notification for an existing design.

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

   • The document does not mention a ground truth established by experts for a test set in the context of diagnostic accuracy. The "user testing" likely evaluated system usability, functionality, and image quality from a technical perspective, not diagnostic performance tied to a "ground truth" of disease presence/absence.

3. Adjudication method for the test set:

   • Not applicable as there is no mention of a diagnostic accuracy test set requiring adjudication of findings.

4. 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. This is an X-ray system, not an AI-powered diagnostic tool. MRMC studies or AI assistance effect sizes are not relevant to this submission.

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

   • No. This is an X-ray system, not an algorithm. Standalone algorithm performance is not applicable.

6. The type of ground truth used:

   • Not applicable for diagnostic accuracy. The "ground truth" in this context relates to meeting engineering specifications, safety standards, and functional equivalence to the predicate device.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

---

Summary of the "Study" and its limitations for diagnostic claims:

The "study" consists of "bench and user testing." This testing was sufficient to conclude that the "Optima URS" is "as safe and effective as the predicate device" in terms of its mechanical, electrical, and radiation generation aspects. The acceptance criteria here are functional and safety equivalency to a legally marketed device, not specific quantitative diagnostic performance metrics like sensitivity, specificity, or AUC against a clinical "ground truth." The 510(k) pathway specifically seeks to avoid the need for extensive clinical trials when substantial equivalence can be demonstrated.

Summary

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

EXHIBIT 2

K012546 Page 1 of 2

SEDECAL SA Pelaya 9- Poligono Industrial Rio De Janeiro 28110 -Algete Madrid Spain Tel [phone] Fax [phone] (Foreign Manufacturer)

SEDECAL USA. Inc. 2910 N. Arlington Heights Rd. Arlington Heights Illinois 60006 Tel [phone] Fax [phone] (Initial Importer)

August 2, 2001 Contact: Gary Fromberg, Official Correspondent 510(k) Summary of Safety and Effectiveness

• 1. Identification of the Device: Proprietary-Trade Name: "Optima URS" Universal Radiographic System Classification Name: Stationary X-Ray System, Product Code 90 KPR Common/Usual Name: Stationary X-Ray System
• 2. Equivalent legally marketed devices This product is similar in function to the Siemens Multix Stationary X-Ray System (K001201)
• 3. Indications for Use (intended use) The "Optima URS" Universal Radiographic System is 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: The "Optima URS" is a stationary unit which operates from 120 V 50-60~ AC. Optima URS is a universal swivel arm X-ray system. It is easy to operate and permits a swift radiographic procedure, a feature which applies to all conventional exposure techniques on all parts of the body. The system is composed of a floor-to wall column and a turnable arm with variable high center. It allows one to take exposures of patients in standing, sitting or laying position. Owing to its compact design Optima URS is a low-cost radiography system which takes up little space and is quick to install.
• 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 devices.

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

K012596
page 2 of 2

Characteristic	Siemens MultixStationary X-RaySystem (K001201)	"Optima URS"UniversalRadiographicSystem
Intended Use:	Intended for use by aqualified/trained doctor ortechnician on both adult andpediatric subjects for takingdiagnostic radiographicexposures of the skull, spinalcolumn, chest, abdomen,extremities, and other bodyparts. Applications can beperformed with the patientsitting, standing, or lying inthe prone or supine position.	SAME
PerformanceStandard	21 CFR 1020.30	SAME
Electrical safety	Electrical Safety perUnderwriters LaboratoriesStandard UL-2601(IEC-60601) and IEC 60601,Underwriters LaboratoriesStandard UL187: ULStandard for Safety for X-Ray Equipment, CEMarking Requirements, ISO9001.	SAME, plus EMC:EN50081-1 Residentialcommercial, lightindustry general - EMCemission EN50082-1Residential, commercial,light industry general -EMC immunity,EN60950 Safety of ITand electrical businessequipment

6. Substantial Equivalence Chart, "Optima URS"

7. · Conclusion

After analyzing both bench and user testing data, it is the conclusion of Sedecal USA that the "Optima URS" Universal Radiographic System 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.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three curved lines representing wings or streams.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 2 2001

Sedecal USA. Inc. % Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015 Re: K012546

Trade/Device Name: Optima URS Universal Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 KPR Dated: August 6, 2001 Received: August 7, 2001

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. Iisting 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.

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

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 contact the Office of Compliance 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

NOV 0222001

K012546

i) Indications for Use

510(k) Number KO12546

Device Name: "Optima URS" Universal Radiographic System

Indications for Use: The "Optima URS" Universal Radiographic System is 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over the Counter Use (Per 21 CFR 801.109)

Nancyc Brozdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012546

OR

7

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.