The Spectre System is intended for use with compatible diagnostic x-ray systems in hospitals or outpatient facilities. The Spectre System is indicated for use as an accessory to provide input control to compatible x-ray systems. This accessory includes a wireless footswitch, a wireless hand switch, and a receiver. It is cleared for use for the particular indications of the x-ray system to which it is attached.

Device Description

The Spectre System is an alternate option to the existing cabled foot switch and hand switch for users of Xray systems. It consists of three parts-a footswitch/transmitter, a hands switch/transmitter, and a receiver. The Spectre system receiver connects to the x-ray system through the same connector as the current footswitch, and operates the x-ray system by exactly emulating the functionality of the current cabled footswitch and hand switch. There are no cables, therefore, no trip hazards, contamination hazards, or cable breakage hazards. The footswitch and hand switch are powered by batteries, eliminating shock hazards. The receiver is mounted on the predicate device, and is powered from the predicate device.

AI/ML Overview

Here's an analysis of the provided text regarding the Spectre Wireless Encrypted Footswitch and Hand switch System, outlining the acceptance criteria and the study that demonstrates its compliance:

The document describes the Spectre System as an alternative option to existing cabled footswitches and hand switches used with X-ray systems. It aims to eliminate trip hazards, contamination hazards, and cable breakage associated with traditional cabled devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Goal	Reported Device Performance (from "Non clinical testing in our facility")	Supporting Documentation
Functional Equivalence: The Spectre system must perform identically to the predicate cabled footswitch and hand switches.	"Test results showed in each individual condition that the Spectre system performed identically to the predicate devices."	Section VI. Rationale for Substantial Equivalence
Reliable Operation: The system must function reliably over time.	"Long term testing using the Spectre system over a period of weeks also produced reliable functionality results from the system. During these tests, no malfunction was recorded."	Section VI. Rationale for Substantial Equivalence
No Malfunctions during Iterative Testing: The system should not exhibit malfunctions during repeated signal configurations.	"100 iterations of each possible signal configuration were tested. There were no malfunctions noted during the tests."	Section VI. Rationale for Substantial Equivalence
Safety: Elimination of trip hazards, contamination hazards, and shock hazards.	"elimination the contamination hazards of cables as well as improving the overall performance record of the predicate device, thus making it a safer device by eliminating the cables."	Section VII. Safety and Effectiveness Information
Conformance to Electrical Safety Standards (IEC 60601-1): The device must meet general requirements for medical electrical equipment safety.	"All design, testing, manufacturing and documentation was performed in conformance with IEC 60601-1... Independent testing was conducted by Underwriter's Laboratories, Inc... These tests concluded that this system complies and conforms to all applicable sections of this standard."	Section VIII. Conformance to Standards
Conformance to EMC Standards (IEC 60601-1-2 and related): The device must meet electromagnetic compatibility requirements for medical devices.	"Additional testing by an independent Laboratory demonstrates compliance to the following standards: IEC 60601-1-2 Medical Device (ed 2.1) (2004) which includes IEC 61000-4-2... These tests concluded that the Spectre System is in conformance to FCC Standards, and all applicable sections of IEC 60606-1-1-2 Medical Device (ed 2.1) 2004."	Section VIII. Conformance to Standards

2. Sample Size Used for the Test Set and Data Provenance

Test Set: The primary functional testing involved 100 iterations of each possible signal configuration for the Spectre system. The number of unique signal configurations is not explicitly stated, but the "100 iterations" refers to repeated testing of each command.
Data Provenance: The document explicitly states, "Non clinical testing in our facility included the installation of the Spectre system onto the predicate devices listed, and conducting functional testing of the Spectre system..." This indicates the testing was retrospective and conducted in-house by TransAmerican Medical Imaging. Independent testing was also conducted by Underwriter's Laboratories, Inc. and "an independent Laboratory" for standards compliance. The country of origin for the functional testing data is likely the USA (Lindon, UT), where TransAmerican Medical Imaging is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for this type of device. The ground truth for functional equivalence was based on direct comparison to the "exact functionality of the current cabled footswitch and hand switch." The testing was technical in nature, verifying signal transmission and system response, rather than diagnostic interpretation requiring clinical experts.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the testing was non-clinical and focused on functional and electrical performance. There was no subjective assessment requiring multiple reviewers or a consensus process.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is typically relevant for diagnostic imaging devices where the performance of human readers (with and without AI assistance) is evaluated in interpreting medical images. The Spectre System is an accessory to X-ray systems, focused on control input, not diagnostic interpretation.

6. Standalone Performance Study

Yes, a standalone study was done in the context of the device's functional and standards compliance.

Functional Testing: "Non clinical testing in our facility included... conducting functional testing of the Spectre system to insure exact functional performance as compared to the predicate footswitch and hand switches." This demonstrates the algorithm-only performance in emulating the predicate device's signals.
Standards Compliance: Independent laboratories (UL and another unspecified independent lab) conducted testing solely on the Spectre System to ensure its conformance to electrical safety and EMC standards.

7. Type of Ground Truth Used

The ground truth used was primarily functional equivalence to established predicate devices.

For the functional testing, the "ground truth" was the expected and demonstrated behavior of the standard cabled footswitch and hand switch. The Spectre system was designed to "exactly emulat[e] the functionality" of these predicate devices.
For safety and EMC, the ground truth was defined by the requirements of international standards (IEC 60601-1, IEC 60601-1-2, etc.).

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. The Spectre System is a hardware accessory with embedded firmware designed to emulate existing hardware functionality. It does not use machine learning or AI algorithms that require a training set to "learn" patterns or make predictions. Its design and "knowledge" are hard-coded based on the existing functionality of cabled footswitches.

9. How the Ground Truth for the Training Set Was Established

As noted above, there was no training set for this device in the context of machine learning. The "ground truth" for its development was the pre-existing, well-understood functional specifications and electrical characteristics of standard cabled footswitches and hand switches used with X-ray systems. The device was engineered to meet these established specifications.

Summary

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965 WEST 325 NORTH LINDON, UTAH 84042 T 801.796.7363 F 801.796.0529

K092713

JUL 1 3 2010

510(k) Summary

I. General Information

Submitter:

TransAmerican Medical Imaging 965 West 325 North Lindon, UT 84042 USA

Contact Person:

Robert H. Woodward President

Summary Preparation Date: January 12, 2009

II. Names

Predicate Device Name: Standard Footswitch or Hand Switch (common name and classification name)

Substantially Equivalent Device Name: Spectre Wireless Encrypted Footswitch and Hand switch System

Primary Classification Name: Accessory for:

System, X-Ray, Stationary .
System X-ray, Mobile .
. Angiographic X-ray system
Image-intensified Fluoroscopic X-ray System .
Non-image-intensified Fluoroscopic X-ray System .

III. Predicate Devices:

Philips Medical Systems Standard Footswitch --- Accessory for:

V Series Angiographic system (K973482)
. H Series Cardiographic System (K971365)
. FD Series Cath/Angio System (K041949)
Mobile C-arm System (K010762) .
R&F System (K032046) .

GE/OEC Medical Systems Standard Footswitch-Accessory for:

OEC 9800 Mobile C-Arm System (K024012)
OEC 9900 Mobile C-Arm System (K073543)

Sect 5 TMl 510K Sub V01132009

A CANYON RIDGE COMPANY WWW.transamericanmedical.com

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IV. Product Description:

The predicate device in this submission is an accessory to the main predicate devices listed, and is covered under those device registrations. Individual device listings for the accessory footswitch and hand switches were not found for the predicate devices listed. One wireless footswitch classification was found in an unrelated but parallel classification. That was the Iridex Wireless Footswitch (K062074) for ophthalmic lasers, Classification Product Code HQF, Regulation number 886.4390.

The common footswitch or hand switch of the predicate device is comprised of a set of switches connected to a base that send signals through a cable to the main x-ray generator. Signals sent typically are fluoroscopy or x-ray exposure commands, or other simplified configuration commands such as lights on or off, last image hold, etc. These signals are simple "on/off" analog signals, usually less than 24 VDC, and are interpreted by the predicate device to perform its function. The disadvantage to the common footswitch or hand switch is the cable that attaches them to the predicate device. These cables become a trip hazard to personnel because they lay on the floor or on other spaces. They are also a contamination hazard and are difficult to clean. Because these cables are flexed continually, cable breakage is common, creating maintenance and equipment performance problems.

V. Indications for Use:

The Spectre System is intended for use with compatible diagnostic x-ray systems in hospital or outpatient facilities. The Spectre System is indicated for use as an accessory to provide input control to compatible xray systems. This accessory includes a wireless footswitch, a hand switch, and a receiver. It is cleared for use only for the particular indications of the X-ray system to which it is attached. Attachment to any other device other than the predicate device it is designed for may result in damage to the Spectre system or to the connected device.

VI. Rationale for Substantial Equivalence

Non clinical testing in our facility included the installation of the Spectre system onto the predicate devices listed, and conducting functional testing of the Spectre system to insure exact functional performance as compared to the predicate footswitch and hand switches. Test results showed in each individual condition that the Spectre system performed identically to the predicate devices. 100 iterations of each possible signal configuration were tested. There were no malfunctions noted during the tests. Long term testing using the Spectre system over a period of weeks also produced reliable functionality results from the system. During these tests, no malfunction was recorded.

The Spectre System shares the same indications for use, device operation, and overall technical and functional capabilities of all cabled footswitches and hand switches used by the predicate devices. It is therefore substantially equivalent to the predicate devices:

Sect 5 TMI 510K sub V01132009

A CANYON RIDGE COMPANY WWW.transamericanmedical.com

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VII. Safety and Effectiveness Information

The purpose for using the Spectre wireless encrypted Footswitch and Hand Switch System is to increase the safety of patients by elimination the contamination hazards of cables as well as improving the overall performance record of the predicate device, thus making it a safer device by eliminating the cables. This system also increases the safety and efficiency of the medical personnel by allowing the cable free "trip free" workspace provided by the wireless system.

Non clinical functional testing showed complete functionality of the system without error. Significant studies done by independent sources (shown in section 18) have demonstrated the safety, efficiency and reliability of wireless systems in the medical environment. All components are UL listed for Medical use, and are therefore tested and demonstrated to be as safe in the medical environment as the predicate devise. The review of the indications for use and technical characteristics provided demonstrates that the Spectre system is substantially equivalent to the predicate devices.

VIII. Conformance to Standards

All design, testing, manufacturing and documentation was performed in conformance with IEC 60601-1, Medical Electrical Equipment-Part 1: General Requirements for Safety, 1988; amendment 1, 1991-11; amendment 2, 1995 (General). Independent testing was conducted by Underwriter's Laboratories, Inc. for compliance to the above mentioned standard. The complete report is included in section 18 of this submission. These tests concluded that this system complies and conforms to all applicable sections of this standard.

Additional testing by an independent Laboratory demonstrates compliance to the following standards: IEC 60601-1-2 Medical Device (ed 2.1) (2004) which includes IEC 61000-4-2(ed 1.2) 2001. IEC 61000-4-3 (ed 3) 2006, IEC 61000-4-4(ed 2) 2004, IEC 61000-4-5(ed 1.1) 2001, IEC 61000-4-6(ed 2) 2003, and IEC 61000-4-11(ed 2) 2004. Also included in that testing was compliance to EN Emissions Class B for Radiated Emissions(1998) and Conducted Emissions (1998). The complete testing is found in section 18. These tests concluded that the Spectre System is in conformance to FCC Standards, and all applicable sections of IEC 60606-1-1-2 Medical Device (ed 2.1) 2004.

IX. Conclusion

The Spectre System was designed and manufactured to be a replacement for the cabled devices used with the predicate devices. Internal testing shows it performs the exact same tasks, but simply uses proven new technologies to eliminate the need for hazardous cabling. It is substantially equivalent to the predicate devices in similar indications of use, similar design and functional features with, and thus is substantially equivalent to, the predicate devices. Independent testing conformance to all applicable standards.

Sect 5 TMI 510K sub V01132009

A CANYON RIDGE COMPANY WWW.transamericanmedical.com

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the logo.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

TransAmerica Medical Imaging % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories 333 Pfingsten Road NORTHBROOK IL 60062

JUL 1 3 2010

Re: K092713

Trade/Device Name: Spectre Wireless Encrypted Footswitch and Hand switch System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: March 12, 2010 Received: March 16, 2010

Dear Mr. Devine:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free ne (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Donald J. St.Pierre Acting Director . Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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・・・

Indications for Use

510(k) Number (if known): K OG 27 | 3

Device Name: Spectre Wireless Encrypted Footswitch and Hand switch System

Indications for Use:

Prescription Use; Yes (Part 21 CFR 801 Subpart D)

Over-The-Counter Use: No AND/OR (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device: Evaluation (ODE)

(Division Sign-Off)
Division of Radiological Devices

sion of Radiologic

510K. K092713

Sect 4 TMI 510K submission V12262008

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.