(26 days)
Not Found
No
The summary describes a system for image-guided navigation based on CT scans, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms. The focus is on guiding tools and visualizing the anatomical structures.
No
The device aids in guiding endoscopic tools and placing markers, but it explicitly states "It does not make a diagnosis and is not an endoscopic tool." and its primary function is displaying images and guidance. While it supports therapeutic procedures, it is not a therapeutic device itself.
No
The "Intended Use / Indications for Use" states, "It does not make a diagnosis."
No
The device description explicitly states "The inReach System is a device that guides a bronchoscope and bronchial tool," implying the system includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is a system that uses CT scans to guide endoscopic tools within the pulmonary tract and place markers in lung tissue. It is an image-guided navigation system used during a medical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use is to aid the physician in guiding tools and placing markers, not to diagnose a condition based on analysis of a biological sample.
Therefore, this device falls under the category of a medical device used for image-guided procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
JAK
Device Description
The inReach System is a device that guides a bronchoscope and bronchial tool to a target in or adjacent to the bronchial tree on a path indicated by CT scan, and visualizes the target and the interior of the tree. The inReach System also enables the placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
tracheobronchial tree, pulmonary tract, soft lung tissue
Indicated Patient Age Range
Not for pediatric use.
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The planned modifications were subjected to the superDimension design control process. Appropriate labeling changes, risk analysis, software and design validations were performed to assure the inReach System continues to meet the its intended use. Clinical tests were not required to validate the changes to the inReach System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K6r13779
510(k) Summary
superDimension, Ltd. Special 510(k) Changes to inReach System Software Version 5.0
JUN 1 1 2008
Date Prepared:
05/15/2008
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 :
| Trade Name : | - superDimension®/Bronchus
- inReach™ System |
|----------------------|------------------------------------------------------------------------------|
| Common Name: | Bronchoscope |
| Classification Name: | Computed tomography x-ray system
21 CFR Part 892.1750
Product code JAK |
Equivalent Legally-Marketed Device:
inReach System, K080271
1
Description:
The inReach System is a device that guides a bronchoscope and bronchial tool to a target in or adjacent to the bronchial tree on a path indicated by CT scan, and visualizes the target and the interior of the tree. The inReach System also enables the placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery.
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 planning software has been modified to add the generation and visualization of a three-dimensional (3D) bronchial tree map, an enhanced graphical user interface (GUI), improved 3D-pathway planning and verification, the addition of the product brand name (inReach™), and a splash screen.
The procedure software has been modified to include the 3D-Map view of the bronchial tree, GUI enhancements, increased navigation ability with navigation guidance enhancements, a backup/cleanup utility, the addition of the product brand name (inReach™), and a splash screen.
Modifications are being made to the Instructions for Use (inReach User Manual) to reflect the aforementioned software modifications.
No changes are being made to the hardware or intended use, or technological characteristics of the current marketed device.
Performance Data:
The planned modifications were subjected to the superDimension design control process. Appropriate labeling changes, risk analysis, software and design validations were performed to assure the inReach System continues to meet the its intended use.
Clinical Data:
Clinical tests were not required to validate the changes to the inReach System.
Conclusion:
The inReach System is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 2008
SuperDimension, Ltd. % Mr. Jonathan Kovach Vice President, Quality and Regulatory Affairs SuperDimension, Inc. 161 Cheshire Lane, Suite 100 MINNEAPOLIS MN 55441
Re: K081379
Trade/Device Name: inReach System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 15, 2008 Received: May 16, 2008
Dear Mr. Kovach:
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 such 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.
3
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.
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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
Indications for Use
510(k) Number (if known): _ K 08 / 3 7 9
Device Name: inReach System
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 X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arni Khang
Page _________________________________________________________________________________________________________________________________________________________________________ of
(División Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081379