(14 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.
LungPoint Procedure Planning, a software only device. As with the predicate, it provides the physician with 3D reconstruction of the patient's lungs, derived from the CT images and thus provides a more realistic view of the lungs. The physician can use the 3D virtual animation and associated images to view and explore pre-selected targets in the lung tissue before conducting a procedure. Like the predicate, the software allows for printing the procedure plan as a map, which consists of a bifurcation-by-bifurcation description of the route to the selected target. The LungPoint Procedure Planning software is installed on an off-the-shelf PC computer, and is intended to be used in conjunction with commercially-available CT scan images that are saved in DICOM format.
The provided text does not contain the detailed performance data, acceptance criteria, or study specifics typically found in a scientific study or detailed regulatory submission for proving a device meets acceptance criteria.
The document is a 510(k) summary for a software-only medical device (LungPoint™ Procedure Planning Software) and primarily focuses on establishing substantial equivalence to a predicate device. It highlights that the modified device has the same intended use, technological characteristics, and hardware as the planning phase of the predicate, using the exact same software and core algorithms.
Here's a breakdown of what can be extracted and what is missing based on your request:
Acceptance Criteria and Device Performance (Not explicit in the document)
The document does not explicitly state specific acceptance criteria in terms of quantitative metrics (e.g., accuracy, precision, sensitivity, specificity) for the LungPoint Procedure Planning Software. Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided text.
The closest statement regarding "performance" is in Section 8: "The planned modifications were subjected to the Broncus design control process. Appropriate labeling changes, risk analysis, and design verification were performed to assure that the Procedure Planning software continues to meet its intended use." This indicates that verification activities were performed, but the specific metrics used and the results are not detailed.
Study Details (Largely Not Reported)
Since specific performance metrics and a formal study are not detailed, many of your requested items cannot be definitively answered from this 510(k) summary.
1. Sample size used for the test set and the data provenance:
- Not reported. The document states "design verification were performed" but does not specify the size or characteristics of any test set used.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not reported. No information about expert involvement in establishing ground truth for testing is provided.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not reported. Adjudication methods are not mentioned.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. A multi-reader multi-case comparative effectiveness study is not mentioned or implied. The device is described as "aiding the physician" but no comparative effectiveness study results are provided.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- It's implied that standalone verification was done ("design verification were performed"), but no specific performance metrics or study details for standalone performance are provided. The device is "software only" and "aids the physician," suggesting its primary function is standalone image processing for planning.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not reported. With no detailed study information, the type of ground truth used for any verification is not specified.
7. The sample size for the training set:
- Not reported. This document pertains to a modification of an already cleared device, and it states the "exact same software (including core algorithms)" are used as the predicate. Information about the training set for the original predicate device or any retraining for this version is not provided.
8. How the ground truth for the training set was established:
- Not reported. As above, no details on the training set or its ground truth establishment are given.
Summary of what the document does indicate regarding "performance" and "studies":
- Reliance on Predicate Device: The core argument for safety and effectiveness is that the LungPoint Procedure Planning Software version 2.0 is substantially equivalent to the planning phase of its predicate device (K091160). It explicitly states: "Both products provide guidance to the physician and use the exact same software (including core algorithms) for planning. The key features: 3D animation and printable plan/map; are identical to those of the planning phase of the predicate device and the same software algorithms are used." This implies that the performance characteristics of the planning component were established with the predicate.
- Design Control Process: "The planned modifications were subjected to the Broncus design control process. Appropriate labeling changes, risk analysis, and design verification were performed to assure that the Procedure Planning software continues to meet its intended use." This is a general statement indicating internal verification processes were followed, but without specific data.
- Risk Management: "Risk management is ensured via a hazard analysis and FMECA, which are used to identify potential hazards. These potential hazards are controlled via software development, verification testing and/or validation testing." This confirms that testing was done to mitigate risks, but again, without specific performance outcomes.
To reiterate, this 510(k) summary provides a high-level overview for regulatory clearance based on substantial equivalence, rather than a detailed scientific publication outlining specific performance studies with quantitative results and acceptance criteria.
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K093423
pg 1 of 2
510(k) Summary
1. Date of Summary
October 16, 2009
2. 510(k) Applicant
NOV 1 7 2009
Broncus Technologies, Inc. 1400 N. Shoreline Blvd., Bldg. A, Suite 8 Mountain View, California 94043 Phone: (650) 428-1600 FAX: (650) 428-1542
| Contact Person: | Plamena Entcheva-Dimitrov, Ph. D. | |
|---|---|---|
| Phone: | (650) 428-1600 x 320 | |
| Fax: | (650) 428-1542 | |
| e-mail: | pdimitrov@broncus.com |
3. Device Overview
| Trade Name: | LungPoint™ Procedure Planning Software |
|---|---|
| Common Name: | Picture Archiving and Communications Systems |
| Classification Name: | System, Image Processing, Radiological21 CFR 892.2050Product Code LLZ |
4. Predicate Device
The predicate device identified for the LungPoint VBN is as follows:
| Trade Name | 510(k) Submitter | 510(k) Number |
|---|---|---|
| LungPoint™ VirtualBronchoscopic NavigationSoftware | Broncus Technologies,Inc. | K091160, cleared tomarket 5 May, 2009 |
5. Device Description
..
LungPoint Procedure Planning, a software only device. As with the predicate, it provides the physician with 3D reconstruction of the patient's lungs, derived from the CT images and thus provides a more realistic view of the lungs. The physician can use the 3D virtual animation and associated images to view and explore pre-selected targets in the lung tissue before conducting a procedure.
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Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of alphanumeric characters and page numbering. The top line reads 'K093423', which could be an identification code or reference number. The second line says 'pg 2 of 2', indicating it is the second page of a two-page document. The handwriting style is cursive and slightly stylized.
Like the predicate, the software allows for printing the procedure plan as a map, which consists of a bifurcation-by-bifurcation description of the route to the selected target.
The LungPoint Procedure Planning software is installed on an off-the-shelf PC computer, and is intended to be used in conjunction with commercially-available CT scan images that are saved in DICOM format.
6. 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.
7. Comparison to Predicate Device
The LungPoint Procedure Planning software version 2.0 has the same intended use. technological characteristics and hardware as the predicate's planning phase. Both products provide guidance to the physician and use the exact same software (including core algorithms) for planning. The key features: 3D animation and printable plan/map; are identical to those of the planning phase of the predicate device and the same software algorithms are used. The only difference is that the real-time navigation tools are removed from the Procedure Planning product.
The User Manual was updated to reflect the modifications.
8. Performance Data
The planned modifications were subjected to the Broncus design control process. Appropriate labeling changes, risk analysis, and design verification were performed to assure that the Procedure Planning software continues to meet its intended use.
9. Safety and Effectiveness
The LungPoint Procedure Planning labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the software. Risk management is ensured via a hazard analysis and FMECA, which are used to identify potential hazards. These potential hazards are controlled via software development, verification testing and/or validation testing.
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Image /page/2/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 stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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
Broncus Technology, Inc. % Mr. Mark Job Reviewer Regulatory Technology Services LLC 1394 25th Street NW BUFFALO, MN 55313
NOV 1 7 2009
Re: K093423
Trade/Device Name: LungPoint Procedure Planning Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communication Systems Regulatory Class: II Product Code: LLZ Dated: November 2, 2009 Received: November 3, 2009
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 either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical
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Page 2 -
Enclosure
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use .
510(k) Number (if known): K693423
Device Name: LungPoint™ Procedure Planning Software
*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.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-CounterUse (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K093423
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of _
§ 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).