(27 days)
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
The superDimension i·Logic inReach System is a device that guides a bronchoscope and endoscopic tools to a target in or adjacent to the bronchial tree on a path identified by CT scan. The superDimension i·Logic inReach System also allows visualization of the target and the interior of the bronchial tree; placement of catheters in the bronchial tree; and placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery. superDimension is introducing the Edge Catheter System for use with the superDimension i·Logic inReach System. The i·Logic inReach System accomodates both the Edge Catheter and the currently available inReach Catheter System.
This 510(k) submission (K102604) for the superDimension® i·Logic™ inReach® System with Edge™ Catheter is a Special 510(k), which indicates a modification to an already cleared device. For such submissions, the FDA typically relies on design control processes, risk management, and verification/validation activities rather than new clinical trials to demonstrate substantial equivalence, especially when the fundamental scientific technology and intended use remain the same.
Therefore, the provided document explicitly states: "Clinical tests were not required to validate the changes to the superDimension inReach System."
This means that the submission does not include a detailed study proving the device meets specific acceptance criteria through a clinical trial or performance study comparing it against predefined metrics. Instead, the justification for meeting acceptance criteria is based on:
- Design Control Process: The Edge Catheter System, i·Logic inReach Software, and Instructions for Use were subjected to the superDimension design control process.
- Risk Management: Risk management was performed to analyze potential hazards associated with the changes.
- Design Verification and Validation: Appropriate design verification and validations were performed to assure the superDimension i Logic inReach System continues to be safe and effective for its intended use.
Since no clinical study data is provided in the document, I cannot fill in the table or answer questions related to sample size, data provenance, expert panels, adjudication, MRMC studies, standalone performance, or training set details. The acceptance criteria themselves are implicitly met through the "safe and effective for its intended use" statement, supported by the design control process rather than quantitative performance metrics from a new clinical study in this specific 510(k).
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510(k) Summary superDimension, Ltd. Special 510(k) superDimension® i·Logic™ inReach® System Addition of Edge™ Catheter System
OCT - 7 2010
Date Prepared:
09/07/2010
510(k) Applicant:
superDimension, Ltd. 8 Hamenofim St., P.O. Box 2045 Herzliya 46120 Israel Ph: +972-(0)9-971-3700 Fax: +972-(0)9-971-3701
510(k) Application Correspondent:
Jonathan Kovach Vice President, Quality and Regulatory Affairs superDimension, Inc. 161 Cheshire Lane, Suite 100 Minneapolis, MN 55441 Phone: 763-210-4015 Cell : 763-360-4984 763-210-4098 Fax : Email : jkovach(@superdimension.com
Name of Device :
- superDimension i·Logic inReach System Trade Name : superDimension inReach System superDimension/Bronchus
Bronchoscope Common Name: Classification Name: Computed tomography x-ray system 21 CFR Part 892.1750 Product code JAK
Equivalent Legally-Marketed Device:
superDimension i·Logic inReach System, K071473/K092365
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Description:
The superDimension i·Logic inReach System is a device that guides a bronchoscope and endoscopic tools to a target in or adjacent to the bronchial tree on a path identified by CT scan. The superDimension i·Logic inReach System also allows visualization of the target and the interior of the bronchial tree; placement of catheters in the bronchial tree; and placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery.
superDimension is introducing the Edge Catheter System for use with the superDimension i·Logic inReach System. The i·Logic inReach System accomodates both the Edge Catheter and the currently available inReach Catheter System.
Intended Use:
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
Summary of Characteristics Compared to Predicate Device:
The Edge Catheter System is an alternate catheter system for use with the superDimension i Logic inReach System. The Edge Catheter System includes modifications to the existing inReach Catheter System, procedure software, and instructions for use. The Edge Catheter and inReach Catheter systems may both be used with the superDimension i Logic inReach System. No changes are being made to the electromagnetic components or fundamental scientific technology of the i·Logic inReach System.
Performance Data:
The Edge Catheter System, i·Logic inReach Software, and Instructions for Use were subjected to the superDimension design control process. Risk Management was performed to analyze the potential hazards associated with the changes. Appropriate design verification and validations were performed to assure the superDimension i Logic inReach System continues to be safe and effective for its intended use.
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Clinical Data:
Clinical tests were not required to validate the changes to the superDimension inReach System.
Conclusion:
The superDimension i·Logic inReach System with the Edge Catheter is safe and effective for its intended use.
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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 eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
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
SuperDimension, Ltd. % Mr. Jonathan Kovach Vice President, Quality and Regulatory Affairs 161 Cheshire Lane, Suite 100 MINNEAPOLIS MN 55441
OCT - 7 2010
Re: K102604
Trade/Device Name: superDimension® i-Logic™ inReach® System with Edge™ Catheter Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 7, 2010 Received: September 10, 2010
Dear Mr. Kovack:
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/SafetyReportaProblem/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 number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
David G. Brown, Ph.D. 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):
Device Name: superDimension® i·Logic™ inReach® System with Edge™ Catheter
Indications for Use:
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Page 1 of __
OCT - 7 2010
Division of Radiological Devi Division of Radiological Co., Office of In Vitro Diagnostic
K102604
510K
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.