(61 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 is a device that guides a bronchoscope and bronchial tool to a target in the bronchial tree on a path indicated by CT scan, and to visualize the interior of the tree and target
Here's an analysis of the provided text regarding the superDimension/Bronchus device, focusing on acceptance criteria and study details.
Based solely on the provided text, there is very limited information about specific acceptance criteria or a detailed clinical study demonstrating the device meets those criteria. The submission is a 510(k) summary, which often provides high-level information.
Here's a breakdown of what is available and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance (as stated in the document) |
|---|---|
| Functional Safety Standards: Meets requirements of EN60601-1-2 | The superDimension/Bronchus "satisfies the requirements of EN60601-1-2." |
| Bench Testing: Extensive bench testing was performed. | The entire system "has had extensive bench testing." |
| Animal Tests: Animal tests were performed. | The superDimension/Bronchus "has had animal tests." |
| Clinical Evaluation: Clinical evaluation was performed. | The superDimension/Bronchus "has had... a clinical evaluation." |
| Intended Use: Device aids in guiding endoscopic tools. | The device "aids the physician in guiding endoscopic tools in the pulmonary tract." |
| Clinical Conclusion: Safe and effective for intended use. | The device is "safe and effective for its intended use." |
Critique: The document states that the device meets these criteria rather than defining specific thresholds or metrics for the criteria (e.g., "guiding accuracy must be within X mm"). This is common in 510(k) summaries which declare substantial equivalence rather than presenting detailed performance specifications.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for the clinical evaluation (test set), nor does it break down the number of animal subjects. It only states "animal tests" and "a clinical evaluation."
- Data Provenance: The document doesn't specify the country of origin for the clinical data. It does state that superDimension Ltd. is located in Herzliya, Israel, which might imply the study was conducted there, but this is not explicitly stated for the clinical evaluation. It also doesn't explicitly state if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: This information is not provided in the document.
- Qualifications of Experts: This information is not provided in the document.
4. Adjudication Method for the Test Set
- The adjudication method is not specified in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- There is no mention of an MRMC comparative effectiveness study in the provided text.
- Therefore, no effect size for human readers improving with AI vs. without AI assistance can be determined from this document.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
- The device's intended use is to "aid the physician in guiding endoscopic tools," implying a human-in-the-loop system. The document does not describe any "standalone" performance evaluation of the algorithm without human intervention. Its stated purpose is as a guidance tool, not an autonomous diagnostic or procedural tool.
7. The Type of Ground Truth Used
- The document does not explicitly state the type of ground truth used for its "clinical evaluation" or "animal tests." Given the device's function as a guidance system for the tracheobronchial tree, potential ground truths could include:
- Direct visualization/localization: Confirmation of tool tip position relative to the target using a reference standard (e.g., fluoroscopy, repeat CT scan with markers, direct visual confirmation if accessible).
- Pathology/Biopsy results: If the guidance was for biopsy, the success of reaching a lesion later confirmed by pathology might be an indirect measure.
- Expert Consensus: Clinical assessment by experienced bronchoscopists regarding the accuracy and ease of guidance.
8. The Sample Size for the Training Set
- The document does not provide any information regarding a "training set" or its sample size. This is a pre-market submission for a device, not a detailed paper about algorithm development. It's likely that the product integrates software and algorithms, but the specifics of their development and training are not disclosed here.
9. How the Ground Truth for the Training Set Was Established
- Since there's no mention of a training set or its sample size, there's also no information on how its ground truth was established.
Summary of Missing Information:
This 510(k) summary provides a high-level overview focused on establishing substantial equivalence. It lacks the granular detail about clinical study design, specific performance metrics, ground truth establishment, or expert involvement that would typically be found in a detailed clinical report or peer-reviewed publication. The "Performance Data" section indicates that tests were done and standards met, but not the specifics of how these were measured or the quantitative results beyond a general conclusion of safety and effectiveness.
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SuperDimension/Bronchus
NOV - 8 2004
Page A 2
510(k) Summary
superDimension Ltd. 510(k) Submission Bronchus August 13, 2004
1. Submitter Information
Name: superDimension Ltd.
Address:
14 Shenkar 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: August 30, 2004
2. Name of Device
Trade Name: superDimension/Bronchus Common Name: Bronchoscope Classification name: Bronchoscope (flexible or rigid) Regulation: 21 CRF 874.4680
3. Equivalent legally- marketed devices:
| Ultraguide CTG 2000sa K022354 | JAK |
|---|---|
| Olympus UM-2R/3R K982323 | ITX |
| Olympus BF 1T160 K023984 | EOG - ENT |
4. Description
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SuperDimension/Bronchus
The superDimension/Bronchus is a device that guides a bronchoscope and bronchial tool to a target in the bronchial tree on a path indicated by CT scan, and to visualize the interior of the tree and target
5. Intended Use
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
6. Performance Data
Non – clinical tests
The superDimension/Bronchus satisfies the requirements of EN60601-1-2. The entire system has had extensive bench testing.
Clinical tests
The superDimension/Bronchus has had both animal tests and a clinical evaluation.
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 the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2004
superDimension Ltd. % Mr. George Myers President *Medsys, Inc. 377 Route 17 S HASBROUCK HEIGHTS NJ 07604 Re: K042438
Trade/Device Name: superDimension/Bronchus Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system
Regulatory Class: II Product Code: 90 JAK
Dated: September 5, 2004 Received: September 8, 2004
Dear Mr. Myers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have levewed your Scellon 910(ts) premantially equivalent (for the indications for use stated in above and have decemined the devices marketed in interstate commerce prior to the enclosure) to regary marketed precisations and Device Amendments, or to devices that have been May 26, 1970, the clacultion date 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 do not require approval of a premance approvince of the Act. The general controls provisions of the Act device, subject to the general controly prove, 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 If your device is classified (Sec ao ro) into call additional controls. Existing major regulations affecting your Apploval), it thay be subject to such aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA wevice can of round in the occerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please or advised mar 1 DA s tosalites of evice complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the rederal statues and regulations administrited 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) (21 CFN Fall 801), good managians pratis. 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 510(k) I his letter will anow you to begin manteting of substantial equivalence of your device to a legally premarket nothleation: "The I Driving or our 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 specific advice for your correst on 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 Also, please note the regulation on your responsibilities under the Act from the 807.97). You may outlined there general missistance at its toll-free number (800) DVNSIon of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.html
Sincerely yours,
Nancy C. brogdon
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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superDimension/Bronchus
Page 8
Indications for Use
KC42438 510(k) Number (if known):
Device Name: superDimension/Bronchus
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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broudon
Division Sign Division of Reproduc and Radiological Devi 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.