(34 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 Premium 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 nearnet aod the interior of the tree. It has been modified to permit external video monitoring and recording devices. Other minor improvements have been made also.
The provided text describes the superDimension/Bronchus Premium device but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The document is a 510(k) summary for a Special 510(k), which implies that the device is substantially equivalent to a previously cleared device (superDimension/Bronchus 4.1, K052260) and incorporates minor modifications.
Here's a breakdown of why the requested information is absent based on the provided text:
- Acceptance Criteria and Reported Device Performance: This information is not present. The document states, "Since no new technology is used, clinical tests are not required." This indicates that the device's performance was not evaluated through a new clinical study with pre-defined acceptance criteria, but rather by demonstrating substantial equivalence to a predicate device.
- Sample size for the test set and data provenance: No test set is mentioned because no new clinical testing was deemed necessary.
- Number of experts and their qualifications: Not applicable as no new ground truth establishment process is described.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or mentioned.
- Standalone (algorithm only) performance: Not applicable, as this is a device for guiding a bronchoscope, not a diagnostic algorithm.
- Type of ground truth used: Not applicable as no new clinical study to establish ground truth was performed.
- Sample size for the training set: Not applicable as "no new technology is used."
- How the ground truth for the training set was established: Not applicable.
Summary from the provided text:
| Information Requested | суперDimension/Bronchus Premium |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Not provided a new study. The device satisfied EN60601-1 and EN 60601-1-2 and underwent extensive bench testing. Its substantial equivalence to superDimension/Bronchus 4.1 (K052260) was used for clearance. |
| 2. Sample size for test set & data provenance | Not applicable; no new clinical tests were required. |
| 3. Number and qualifications of experts for ground truth | Not applicable; no new clinical tests were required. |
| 4. Adjudication method | Not applicable; no new clinical tests were required. |
| 5. MRMC comparative effectiveness study | No. |
| 6. Standalone performance study | No. |
| 7. Type of ground truth used | Not applicable; no new clinical tests were required. |
| 8. Sample size for training set | Not applicable; no new technology was used, and no new clinical tests were required. |
| 9. How ground truth for training set was established | Not applicable; no new technology was used, and no new clinical tests were required. |
Reasoning for "Not applicable":
The document explicitly states: "Since no new technology is used, clinical tests are not required." This means that the device's clearance was based on its substantial equivalence to a predicate device, rather than new clinical data demonstrating its performance against specific acceptance criteria. The modifications were minor, primarily allowing external video monitoring/recording and other minor improvements. Therefore, the detailed information about clinical studies, test sets, ground truth establishment, and expert involvement is not present in this 510(k) summary.
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superDimension Ltd. Special 510(k)
super/Dimension Bronchus Premium 510(k) Summary September 20, 2005
1. Submitter Information
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 Premium Common Name: Bronchoscope Classification name: System, x-ray, tomography, computed
3. Equivalent legally- marketed devices:
superDimension/Bronchus 4.1, K052260
4. Description
The superDimension/Bronchus Premium 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 nearnet aod
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the interior of the tree. It has been modified to permit external video monitoring and recording devices. Other minor improvements have been made also.
5. Intended Use
The superDimension/Bronchus Premium is intended to image the upper airways and tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not a bronchial tool
6. Performance Data
Non - clinical tests
The superDimension/Bronchus Premium 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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ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ
NOV 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
superDimension Ltd. c/o George H. Myers, Sc.D. Official Correspondent Medsys, Incorporated 377 Route 17 South HASBROUCK HEIGHTS NJ 07604
Re: K052852
Trade/Device Name: superDimension/Bronchus Premium Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 7, 2005 Received: October 11, 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 clectronic 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 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.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 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 (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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Page 9
Indications fo
510(k) Number (if known):
Device Name: superDimension/Bronchus Premium
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 X (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)
Yancy C. Buradon
Division of Reproductive, At and Radiological De 510(k) Number
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.