(20 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.
The superDimension/Bronchus 4.1 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 target and the interior of the tree.
The information provided indicates that no clinical studies were performed for the superDimension/Bronchus 4.1 device due to its classification as not using new technology. Therefore, many of the requested details regarding acceptance criteria, study design, and performance metrics are not available in the given text.
Here's a breakdown of the available information and the details that are not provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-clinical tests: | Satisfies the requirements of EN60601-1 and EN 60601-1-2. Extensive bench testing has been performed on the entire system. |
| Clinical tests: | None required as "no new technology is used." |
2. Sample size used for the test set and the data provenance
- Not Applicable: No clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: No clinical test set was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No clinical test set was used.
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
- Not Applicable: No MRMC study was performed as no clinical studies were conducted. The device (superDimension/Bronchus 4.1) is a tool to guide a bronchoscope, not an AI for interpretation or improvement of human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: The device is a guidance system for endoscopic tools, not a standalone diagnostic algorithm. No standalone performance study was mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: Since no clinical studies were performed, no ground truth types were established from patient data. The "ground truth" for non-clinical testing refers to meeting technical standards (EN60601-1 and EN 60601-1-2) which are objective engineering specifications.
8. The sample size for the training set
- Not Applicable: No training set for an algorithm was mentioned, as "no new technology is used" and no clinical studies were conducted. The device is a guidance system, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable: No training set was used.
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superDimension/Bronchus 4.1
510(k) Summary
Page A 2 SEP - 8 2005
superDimension Ltd. Special 510(k) Submission super/Dimension Bronchus 4.1 510(k) Summary July 26, 2005
Submitter Information 1.
Name: superDimension Ltd.
Address:
8 Hamenofim St., POB 2045 Herzliya 46120 Israel
Tel. +972-(0)9-971-3700 Fax +972-(0)9-971-3701
Contact person:
Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Tel.: 201-727-1703 Fax: 201-727-1708
Date prepared: July 26, 2005
2. Name of Device
Trade Name: superDimension/Bronchus 4.1 Common Name: Bronchoscope Classification name: System, x-ray, tomography, computed
3. Equivalent legally- marketed devices:
superDimension/Bronchus, K042438
4. Description
The superDimension/Bronchus 4.1 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 target and the interior of the tree.
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5. Intended Use
The superDimension/Bronchus 4.1 is intended to image the upper airways and tracheobronchial tree to aid
. In a bronchial tool
6. Performance Data
Non – clinical tests
The superDimension/Bronchus 4.1 satisfies the requirements of EN60601-1 and EN 60601-1-2. The entire system has had extensive bench testing.
Clinical tests
Since no new technology is used, clinical tests are not required.
7. Conclusion
The superDimension/Bronchus is safe and effective for its intended use.
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Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
SEP = 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
superDimension Ltd. % George H. Myers, Sc.D. Official Correspondent Medsys, Inc. 377 Route 17 South HASBROUCK HEIGHTS NJ 07604 Re: K052260
Trade/Device Name: superDimension/Bronchus 4.1 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system
Regulatory Class: II
Product Code: JAK Dated: August 17, 2005 Received: August 19, 2005
Dear Dr. Myers:
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.
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.
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This letter will allow you to begin marketing your device as described in your Section 5 I 0(k) This letter will anow you to begin mancing your avoice of your device of your device to a legally premarket notification. The PDA Inding of Sacsantal Pryour 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 If you desire spectic advice for your device on our be of the regulation 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" (21 CFR Also, please note the regulation childer, "hisorizion on your responsibilities under the Art from the 180 807.97). You may outlin outcr general mionitance on the programer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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):
Device Name: superDimension/Bronchus 4.1
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.
X 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 Device Evaluation (ODE)
Nanarc Broodon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number V052260
Page 1 of __
§ 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.