(14 days)
Indicated for use in aspiration in carinal, paratracheal and hilar lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.
The eXcelon™ Transbronchial Aspiration Needle is a needle catheter used for aspiration of tissue.
The provided document is a 510(k) Premarket Notification for a medical device, the eXcelon™ Transbronchial Aspiration Needle. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies with defined acceptance criteria and detailed performance reporting.
Therefore, the document does not contain the information requested in several of your points. Specifically, it does not include:
- A table of acceptance criteria and reported device performance for clinical use.
- Details on sample size, data provenance, or ground truth establishment from clinical studies.
- Information on expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
Here's a breakdown of what can be extracted from the document based on your request, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance in the context of clinical outcomes or diagnostic accuracy. The submission is based on demonstrating substantial equivalence through:
- Comparison of Characteristics: "The modified device is substantially equivalent to the predicate device, as they have the same operating principal and intended use. In addition, the results of design control activities do not raise any new issues of safety or effectiveness."
- Performance Data: "FDA's "Guidance for the Content of Premarket Notifications", and the results of physical comparison and functional testing support a determination of substantial equivalence for the modified device when compared to the predicate device. The modified device is substantially equivalent to the currently marketed Boston Scientific Stifcor™ Transbronchial Aspiration Needle in terms of performance characteristics, biocompatibility, and intended use."
The "performance characteristics" mentioned here refer to bench testing and physical comparisons to ensure the new device functions similarly to the predicate, not clinical performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This information would be relevant for a clinical study assessing a diagnostic or therapeutic outcome. The 510(k) focuses on a device (a needle) and its equivalence to a previously cleared device, not on diagnostic performance or clinical efficacy requiring a test set of patient data. The "functional testing" and "physical comparison" mentioned are likely bench or lab-based tests, not human studies.
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)
Not applicable. No clinical test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication is described.
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. This device is a medical instrument (a needle), not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument (a needle), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for clinical ground truth. The "ground truth" for this 510(k) is essentially the established performance and safety profile of the predicate device (Boston Scientific Stifcor™ Transbronchial Aspiration Needle, K963252). The new device (eXcelon™) is compared against the predicate through physical comparison and functional testing to ensure it meets similar standards.
8. The sample size for the training set
Not applicable. No training set for a clinical algorithm or predictive model is described.
9. How the ground truth for the training set was established
Not applicable. No training set for a clinical algorithm or predictive model is described.
In summary:
This 510(k) clearance is for a medical device (a transbronchial aspiration needle) and relies on demonstrating substantial equivalence to an already legally marketed predicate device through engineering design control activities, physical comparison, and functional testing. It is not based on clinical studies involving patient cohorts, diagnostic accuracy assessments, or AI performance metrics, and therefore, the requested information related to such studies is not present in this document.
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Special 510(k) Premarket Notification Transbronchial Aspiration Needle (TBAN) Boston Scientific Corporation January 5, 2004
| JAN 2 0 2004 | 510 (k) SUMMARY |
|---|---|
| SPONSOR: | Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760 |
| CONTACT PERSON: | James D. McMahonSenior Regulatory Affairs Specialist |
| DEVICE: | |
| Trade Name:Common Name:Classification: | eXcelon™ Transbronchial Aspiration NeedleTransbronchial Aspiration NeedleClass II, per 21 CFR Part 874.4680 |
| PREDICATE DEVICE: | Boston Scientific Stifcor™ Transbronchial Aspiration Needle(K963252) |
| DESCRIPTION: | The eXcelon™ Transbronchial Aspiration Needle is a needlecatheter used for aspiration of tissue. |
| INTENDED USE: | The eXcelon™ Transbronchial Aspiration Needle is intended foruse in aspiration in carinal, paratracheal and hilar lesions of thebronchial tree where biopsy forceps cannot obtain a submucosalsample. |
| COMPARISON OFCHARACTERISTICS: | The modified device is substantially equivalent to the predicatedevice, as they have the same operating principal and intendeduse. In addition, the results of design control activities do notraise any new issues of safety or effectiveness. |
| PERFORMANCE DATA: | FDA's "Guidance for the Content of Premarket Notifications",and the results of physical comparison and functional testingsupport a determination of substantial equivalence for themodified device when compared to the predicate device. Themodified device is substantially equivalent to the currentlymarketed Boston Scientific Stifcor™ Transbronchial AspirationNeedle in terms of performance characteristics, biocompatibility,and intended use. |
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The text is in all caps and is in a sans-serif font. The logo is black and white.
JAN 2 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corp. c/o James D. McMahon Senior Regulatory Affairs Specialist One Boston Scientific Place Mail Stop A1, Endo Regulatory Natick, MA 01760-1537
Re: K040018
Trade/Device Name: eXcelon™ Transbronchial Aspiration Needle Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ Dated: January 5, 2004 Reccived: January 6, 2004
Dear Mr. McMahon:
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 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 agencics. 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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Page 2 - James D. McMahon
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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Aeryl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
| 510(k)Number | To be determined |
|---|---|
| Device Name | eXcelon™ Transbronchial Aspiration Needle |
| Indications For Use | Indicated for use in aspiration in carinal, paratracheal and hilar lesions ofthe bronchial tree where biopsy forceps cannot obtain a submucosalsample. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
Keuy A. Bohn
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devise
510(k) Number.
Proprietary and Confidential Information of Boston Scientific Corporation
§ 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.