(28 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes no modifications to the existing software, which was approved in 2008, a time when AI/ML in medical devices was less common. The focus is on using the existing software for planning and CT-viewing.
No
The device is used for displaying images and guiding tools, not for treating a condition or disease.
No
The "Intended Use / Indications for Use" section explicitly states, "It does not make a diagnosis." The device is intended to aid in guiding endoscopic tools and enabling marker placement, not for diagnostic purposes.
No
The device is described as a "Planning Laptop" which is a hardware component, and the submission discusses its use either stand-alone or with "other system components," implying a larger hardware system. While the software is a key part, the device itself is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to display images to aid a physician in guiding endoscopic tools and placing markers. It explicitly states it "does not make a diagnosis." IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a laptop with software for planning bronchoscopy and CT-viewing. This is a tool for image visualization and procedural planning, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing tests on samples, or providing diagnostic information based on laboratory results.
The device is clearly intended for image-guided procedures and planning, which falls outside the scope of In Vitro Diagnostics.
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 (comma separated list FDA assigned to the subject device)
LLZ
Device Description
superDimension is proposing that the inReach™ Planning Laptop, with its current software be approved to be used either as a stand-alone for performing bronchoscopy planning, as currently approved (K081379, June 11, 2008) or for CT-Viewing, or with the other system components in places outside of the endoscopy room. There are no modifications proposed to the software, firmware, firmware, product design or specifications, or manufacturing processes as currently approved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT-Viewing
Anatomical Site
tracheobronchial tree, pulmonary tract, lung tissue
Indicated Patient Age Range
Not for pediatric use.
Intended User / Care Setting
Physician / outside of the endoscopy room
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. There are no modifications proposed to the software, firmware, product design or specifications, or manufacturing processes as currently approved (K081379, June 11, 2008). The inReach System and software design input/output requirements are not changing and will continue to meet the user needs and intended uses, performing to design specifications. Therefore software and design validations/verifications are not required to be performed. There are no new, increased, altered, or eliminated risks associated with this minor modification. A risk analysis is not required to be performed. The risk analysis documents presented in K081379 have not changed, and still apply to the Planing Laptop. Appropriate labeling changes are identified in the User Manual and summarized in the User Manual Change Revision Table. Clinical tests were not required to validate the changes to the inReach System to incude the Planning Laptop.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
SEP 1 6 2008
510(k) Summary
superDimension, Ltd. Special 510(k) Proposed Minor Modifications to inReach™ Planning Laptop
Date Prepared:
08/18/2008
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:
Margarct DePuydt, P.E., RAC Regulatory Affairs Manager superDimension, Inc. 161 Cheshire Lane, Suite 100 Minneapolis, MN 55441 Phone: 763-210-4052 Cell : 612-845-7771 Fax : 763-210-4098 Email : mdepuydt@superdimension.com
Name of Device :
| Trade Name : | - superDimension®/ inReach™ Planning Laptop
- inReach™ Planning Laptop |
|----------------------|---------------------------------------------------------------------------|
| Common Name: | inReach™ Planning Laptop - Bronchoscopy Planning/CT-Viewing |
| Classification Name: | Picture Archiving and Communications System |
| | 21 CFR 892.2050 |
| | Product code LLZ |
Equivalent Legally-Marketed Device: inReach System, K081379
FDA CDRH DMC
AUG 19 2008
Received
1
Description;
superDimension is proposing that the inReach™ Planning Laptop, with its current software be approved to be used either as a stand-alone for performing bronchoscopy planning, as currently approved (K081379, June 11, 2008) or for CT-Viewing, or with the other system components in places outside of the endoscopy room.
There are no modifications proposed to the software, firmware, firmware, product design or specifications, or manufacturing processes as currently approved.
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:
Minor modifications are being proposed to the Instruction for Use (inReach User Manual) to reflect the proposal that the Planning Laptop be used as a stand-alone for bronchoscopy planning or CT-Viewing, or with the other system components,
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. There are no modifications proposed to the software, firmware, product design or specifications, or manufacturing processes as currently approved (K081379, June 11, 2008). The inReach System and software design input/output requirements are not changing and will continue to meet the user needs and intended uses, performing to design specifications. Therefore software and design validations/verifications are not required to be performed.
There are no new, increased, altered, or eliminated risks associated with this minor modification. A risk analysis is not required to be performed. The risk analysis documents presented in K081379 have not changed, and still apply to the Planing Laptop.
Appropriate labeling changes are identified in the User Manual and summarized in the User Manual Change Revision Table.
2
Clinical Data:
Clinical tests were not required to validate the changes to the inReach System to incude the Planning Laptop.
Conclusion:
The inReach System is safe and effective for its intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2008
superDimension, Ltd. % Ms. Margaret DePuydt Regulatory Affairs Manager superDimension, Inc. 161 Cheshire Lane, Suite 100 MINNEAPLOIS MN 55441
Re: K082386
Trade/Device Name: inReach Planning Laptop Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 15, 2008 Received: August 19, 2008
Dear Ms. DePuydt:
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 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.
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Page 2
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 complive oth 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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.
hope M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _ K 082386
Device Name: inReach Planning Laptop
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)
Hulda Reimer
(Division Sign-Off) Division of Reproductive, Abdominal ar Radiological Devices 510(k) Number _
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