(14 days)
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
The Soma Access Systems ExactTrack™ I Procedure Kit consists of five disposable, sterile components: (1) needle/hub/magnet and needle protective sheath assembly, (2) cable sleeve, (3) elastic bands, (4) top shield assembly, and (5) bottom shield assembly. The needle/hub/magnet assembly consists of the needle, hub, magnet, and needle protective sheath. The needle is 18 gauge stainless steel and accepts a standard guidewire; the hub is an industry standard configuration modified to retain the magnet which is detected by OEM equipment electromagnetic sensors; the needle sheath protects the needle/hub/magnet during packaging and transportation. The cable sleeve is attached at one end to the assembled top and bottom shield by an elastic band and extends over the ultrasound transducer cable to prevent the transducer cable from coming in direct contact with the sterile field. The top and bottom shields' configuration has been designed to snap together while fitting tightly over OEM transducers. The top and bottom shields utilize a needle guide and needle lock during ultrasound procedures.
The provided 510(k) summary for the Soma Access Systems ExactTrack™ I Procedure Kit does not contain the detailed information typically found in acceptance criteria and study reports for software-based devices, especially those involving AI or image analysis. This device is a procedure kit, which is a physical medical device, not a software or AI-driven diagnostic tool.
Therefore, the requested information (acceptance criteria, reported device performance, sample size, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not applicable and not present in the provided document.
The "Performance data" section states:
"Bench testing was performed to support a determination of substantial equivalence and consisted of comparative, biocompatibility, sterilization, and design verification. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. A risk analysis for the proposed device was performed, and testing was conducted to validate the systems overall operations."
This describes general engineering and safety testing for a hardware device, not the rigorous clinical or algorithmic performance evaluation typically associated with acceptance criteria for software or AI medical devices. It focuses on physical properties, safety, and functionality rather than diagnostic accuracy or clinical effectiveness metrics.
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510(k) Summary
510(k) Summary for the Soma Access Systems ExactTrack™ 7 I Procedure Kit
The 510(k) Summary is provided on the following pages.
Section 7
Soma Access Systems LLC Soma Accocss Bystonio 220
ExactTrack™ I Procedure Kit Confidential
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DEC 2 9 2011
510(k) Summary
Soma Access Systems ExactTrack™ I Procedure Kit
| 510(k) Summary | This summary of 510(k) safety and effectiveness information isbeing submitted in accordance with the requirements of 21C.F.R & 807.92. |
|---|---|
| Applicant | Soma Access Systems LLC |
| Submitter | Soma Access Systems LLC.109 Laurens Road, Suite 4CGreenville, SC 29607Tel: 612-990-0631Fax: 651-209-0556 |
| Contact Person | Genoa Atwood, Director of Quality |
| Date Prepared | August 30, 2011 |
| Device Trade NameDevice Common Name | Soma Access Systems ExactTrackTM I Procedure KitUltrasonic pulsed echo imaging system |
| Classification Name | EMT Device, Product Code IYO |
| Classification Panel | Radiology |
| Predicate Devices | eTRAX Needle System, eTRAX Variable Angle NeedleGuidance System, Virtutrax Universal Tracker (K092619). |
| Intended use | The device is intended to provide physicians with tools forelectromagnetic tracking of instruments with respect to imagedata. |
| Device Description | The Soma Access Systems ExactTrack™ I Procedure Kitconsists of five disposable, sterile components: (1)needle/hub/magnet and needle protective sheath assembly, (2)cable sleeve, (3) elastic bands, (4) top shield assembly, and (5)bottom shield assembly. The needle/hub/magnet assemblyconsists of the needle, hub, magnet, and needle protectivesheath. The needle is 18 gauge stainless steel and accepts astandard guidewire; the hub is an industry standard configurationmodified to retain the magnet which is detected by OEMequipment electromagnetic sensors; the needle sheath protectsthe needle/hub/magnet during packaging and transportation.The cable sleeve is attached at one end to the assembled top andbottom shield by an elastic band and extends over the ultrasoundtransducer cable to prevent the transducer cable from coming indirect contact with the sterile field. The top and bottom shields'configuration has been designed to snap together while fitting |
| tightly over OEM transducers. The top and bottom shieldsutilize a needle guide and needle lock during ultrasoundprocedures. | |
| Performance data | Bench testing was performed to support a determination ofsubstantial equivalence and consisted of comparative,biocompatibility, sterilization, and design verification. Resultsfrom this testing provide assurance that the proposed device hasbeen designed and tested to assure conformance to therequirements for its intended use. A risk analysis for theproposed device was performed, and testing was conducted tovalidate the systems overall operations. |
| Summary of SubstantialEquivalence | The Soma Access Systems ExactTrack™ I Procedure Kit utilizessubstantially equivalent performance attributes and safetycomponents as the predicate device. It shares the followingsimilarities to the predicate devices:Needle Guide Sterile Sheath Covering of transducer/transducer cable Needle Handle Assembly Needle technology Packaging Principle of Operation |
| Conclusion | Based on the identical indications for use, technologicalcharacteristics and performance testing, Soma Access SystemsLLC believes the Soma Access Systems ExactTrack™ IProcedure Kit is substantially equivalent to the eTRAX NeedleSystem, eTRAX Variable Angle Needle Guidance System,Virtutrax Universal Tracker (K092619). |
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and the comments of the comments of the comments of the comments of the comments of
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
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
DEC 2 9 2011
SOMA Access Systems LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K113680
Trade/Device Name: Soma Access Systems ExactTrackTM I Procedure Kit Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO & ITX Dated: December 14, 2011 Received: December 15, 2011
Dear Mr. Job:
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 medical device related adverse o viality systems (QS) regulation (21 CFR Part 820). This letter requirences as be form inrketing your device as described in your Section 510(k) premarket with anow you to begally maing of your device of your device to a legally marketed nonlicate 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 11 you don't optice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5 150. The 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 Tou inay of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel, Sc.D. 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 Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: __ Soma Access Systems ExactTrack™ I Procedure Kit
Indications for Use:
The Soma Access Systems ExactTrack™ I Procedure Kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C) ಸ್ತ್ರ
:今のみないとなる
彩
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
May S. Potter
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 5113680
Page 1 of 1
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. 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 biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging 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.