(44 days)
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
The superDimension/Bronchus Premium 2 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 provided text is a 510(k) summary for the superDimension/Bronchus Premium 2 device, dated July 12, 2007. It describes changes made to an already cleared device (K062315).
Based on the document, the following observations can be made regarding acceptance criteria and the study:
1. A table of acceptance criteria and the reported device performance:
The document states: "Appropriate verification and validation tests were performed to assure that the design output met the design input requirements and that the modified device continues to meet its user needs and intended uses." However, specific quantitative acceptance criteria and reported device performance are not detailed in this 510(k) summary. This summary focuses on the administrative aspects of a special 510(k) and asserts that the device continues to meet its previous requirements rather than establishing new ones or reporting specific performance metrics for the modified device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document explicitly states: "Clinical tests were not required to validate the changes made to the superDimension/Bronchus Premium 2." This indicates that no new clinical test data was generated, and therefore, there is no sample size for a test set or data provenance to report from this specific submission. The submission relies on the substantial equivalence to the predicate device and the verification and validation (V&V) activities against design inputs for the modified components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
As no clinical tests were required, no experts were used to establish ground truth for a test set related to this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Since no clinical tests were required, there was no adjudication method employed for a test set in this submission.
5. 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:
The device described is a navigation system for bronchoscopy, not an AI or imaging interpretation device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted for this device, and there is no mention of AI assistance or its effect size.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is not an algorithm that performs standalone analysis. It is a system that aids a physician in guiding endoscopic tools. Therefore, no standalone algorithm-only performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
As no clinical testing was performed for this specific 510(k) submission, no new ground truth data was generated or used. The assessment relies on the existing clearance of the predicate device and the V&V activities.
8. The sample size for the training set:
The document does not describe any machine learning or AI components that would require a training set. Therefore, no sample size for a training set is provided.
9. How the ground truth for the training set was established:
As there is no mention of a training set, the question of how its ground truth was established is not applicable to this document.
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510(k) Summary
JUL 12 2007
superDimension Ltd. Special 510(k) Changes to superDimension/Bronchus Premium 2
Date Prepared:
05/25/2007
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:
Clay Anselmo President and COO Reglera 555 Zang St., Suite 100 Lakewood, CO 80228 303-223-4303 Ph: 303-907-2955 Cell: 303-832-6700 Fax: Email: anselmoc@reglera.com
Name of Device:
superDimension/Bronchus Premium 2 Trade name: Common name: Bronchoscope Computed tomography x-ray system Classification name: 21 CFR 892.1750 Product code JAK
Equivalent Legally-Marketed Device:
superDimension/Bronchus Premium 2, K062315
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Description:
The superDimension/Bronchus Premium 2 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.
Intended Use:
The superDimension/Bronchus Premium 2 is indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool. It is not for pediatric use.
Summary of Characteristics Compared to Predicate Device:
Changes are being made to the superDimension/Bronchus Premium 2 to include modifications to some of its disposable components and changes to portions of its labeling.
The intended use and indications for use of the modified device, as described in its labeling, are the same as the intended use and indications for use of the 510(k) Applicant's unmodified predicate device.
The modified device has the same technological characteristics as the unmodified predicate device.
Performance Data:
The changes being made to the superDimension/Bronchus Premium 2 were subjected to superDimension's design control process. A risk analysis was performed to analyze the hazards associated with the changes. Appropriate verification and validation tests were performed to assure that the design output met the design input requirements and that the modified device continues to meet its user needs and intended uses.
Clinical Data:
Clinical tests were not required to validate the changes made to the superDimension/Bronchus Premium 2.
Conclusion:
The superDimension/Bronchus Premium 2 is safe and effective for its intended use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes and a stylized body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SuperDimension Ltd. % Mr. Clay Anselmo President and CEO Reglera 555 Zang Street, Suite 100 LAKEWOOD CO 80228
JUL 1 2007
Re: K071473
Trade/Device Name: superDimension/Bronchus Premium 2 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulation Numer: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: II Product Code: JAK and EOQ Dated: May 25, 2007 Received: May 29, 2007
Dear Mr. Anselmo:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below that is the acronym "FDA" in a stylized font. The word "Centennial" is written below the acronym. There are three stars below the word "Centennial".
closing and Premoting Public Hoatth
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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 comply with all the Act's requirements, including, but not limited to: registration and fisting (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" (21CFR Part 807.97). 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/cdrlv/industry/support/index.html.
Sincerely vours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ___ Ko714 73
Device Name: ___superDimension/Bronchus Premium 2
Indications for Use:
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulut Reiner
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __
Page _ of _
000006
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.