(14 days)
Not Found
No
The summary describes a physical aspiration needle and does not mention any software, image processing, or AI/ML terms.
No.
The device is used for aspiration of tissue for diagnostic purposes, not for treating a disease or condition.
Yes
The device is used for "aspiration of tissue" from "carinal, paratracheal and hilar lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample," which is a process to obtain samples for diagnosis.
No
The device description clearly states it is a "needle catheter used for aspiration of tissue," indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for aspiration of tissue from specific anatomical sites (carinal, paratracheal, and hilar lesions of the bronchial tree) for the purpose of obtaining a sample. This is a procedure to collect a sample from the body.
- Device Description: The device is described as a needle catheter used for aspiration of tissue. This is a tool for collecting a sample, not for analyzing a sample in vitro.
- Lack of In Vitro Analysis: There is no mention of the device being used to analyze samples outside of the body. IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) in a laboratory or other setting outside of the living organism.
This device is a tool for sample collection, which is a step that might precede an in vitro diagnostic test, but the device itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
The eXcelon™ Transbronchial Aspiration Needle is intended for use in aspiration in carinal, paratracheal and hilar lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.
Product codes
EOQ
Device Description
The eXcelon™ Transbronchial Aspiration Needle is a needle catheter used for aspiration of tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carinal, paratracheal and hilar lesions of the bronchial tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Corporation |
| One Boston Scientific Place | |
| Natick, MA 01760 | |
| CONTACT PERSON: | James D. McMahon |
| Senior Regulatory Affairs Specialist | |
| DEVICE: | |
| Trade Name: | |
| Common Name: | |
| Classification: | eXcelon™ Transbronchial Aspiration Needle |
| Transbronchial Aspiration Needle | |
| Class II, per 21 CFR Part 874.4680 | |
| PREDICATE DEVICE: | Boston Scientific Stifcor™ Transbronchial Aspiration Needle |
| (K963252) | |
| DESCRIPTION: | The eXcelon™ Transbronchial Aspiration Needle is a needle |
| catheter used for aspiration of tissue. | |
| INTENDED USE: | The eXcelon™ Transbronchial Aspiration Needle is intended for |
| use in aspiration in carinal, paratracheal and hilar lesions of the | |
| bronchial tree where biopsy forceps cannot obtain a submucosal | |
| sample. | |
| 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. |
1
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.
2
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
3
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 of |
| the bronchial tree where biopsy forceps cannot obtain a submucosal | |
| sample. |
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