(32 days)
Not Found
No
The summary describes a mechanical aspiration needle and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is used for aspiration/sampling of lesions within the bronchial tree, which is a diagnostic procedure, not a therapeutic one.
No
This device is used for aspiration of samples (obtaining a submucosal sample) from the bronchial tree for potential subsequent analysis, not for diagnosis itself. It's a sample collection tool, not a diagnostic one.
No
The device description clearly describes a physical medical device with specific dimensions and components (catheter, needle). There is no mention of software as the primary or sole 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 samples from the bronchial tree. This is a procedure performed in vivo (within the living body) to obtain a sample.
- Device Description: The device is a needle designed for aspiration, which is a physical process of collecting material from the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body in vitro (outside the living body) to provide information for diagnostic purposes. This device is used to collect the specimen, not to analyze it.
The device is a tool used in a medical procedure to obtain a sample for potential subsequent in vitro diagnostic testing, but the device itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
The Transbronchial Aspiration Needle is indicated for use in aspiration in carinal, paratracheal, hilar, and peripheral lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.
Product codes
78 FBK
Device Description
The Modified Transbronchial Aspiration Needle is a double lumen device with a retractable needle. It has a catheter length of 150 cm and an outer catheter OD of 1.8. The needle sizes available are 18, 19, and 21 Ga, with needle lengths of 14 mm and 20 mm. It is intended for use with a bronchoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carinal, paratracheal, hilar, and peripheral 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
Laboratory testing regarding characteristics was performed Modified Transbronchial Aspiration Needle to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Modified Transbronchial Aspiration Needle with satisfactory results.
Key Metrics
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
SECTION 9 510(K) SUMMARY
FOI RELEASABLE
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.
| > COMMON/USUAL NAMES: | Needle, Endoscopic | ||
|---|---|---|---|
| > TRADE/PROPRIETARY NAME: | TBAN | ||
| > CLASSIFICATION NAME & | |||
| DEVICE CLASSIFICATION: | Class II | ||
| Name | Number | 21 CFR Ref. | |
| Needle, Endoscopic | 78 FBK | 876.1500 | |
| > DEVICE PANEL/BRANCH: | Gastroenterology-Urology (GU) | ||
| Gastro-Renal (GRDB) | |||
| > OWNER/OPERATOR: | Boston Scientific Corporation | ||
| One Boston Scientific Place | |||
| Natick, MA 01760 | |||
| > CONTACT PERSON: | Lisa M. Quaglia, Regulatory Affairs Specialist |
INDICATIONS FOR USE
The Transbronchial Aspiration Needle is indicated for use in aspiration in carinal, paratracheal, hilar, and peripheral lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.
CONTRAINDICATIONS
There are no known contraindications with this device.
POTENTIAL COMPLICATIONS
Possible complications include, but may not be limited to, inadvertent perforation of the bronchial tree.
Premarket Notification, Modified Transbronchial Aspiration Needle, August 16, 1996
1
DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
1
Boston Scientific Corporation believes that the Modified Transbronchial Aspiration Needle is substantially equivalent to the currently-marketed Boston Scientific's TBAN and Mill Rose's Transbronchial Aspiration Needles. Figure 9-1 compares the descriptive characteristics of these products.
PERFORMANCE CHARACTERISTICS
Laboratory testing regarding characteristics was performed Modified Transbronchial Aspiration Needle to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Modified Transbronchial Aspiration Needle with satisfactory results.
PACKAGING, STERILIZATION, AND PYROGENICITY
The Modified Transbronchial Aspiration Needle will be packaged in a pouch. The Modified Transbronchial Aspiration Needle will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization. Pvrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels.
CONCLUSION
Boston Scientific Corporation believes that its Modified Transbronchial Aspiration Needle is substantially equivalent to the currently-marketed Boston Scientific Transbronchial Aspiration Needle and the Mill-Rose Transbronchial Aspiration Needle. Figure 9-1 compares the descriptive characteristics of these products. As demonstrated in Figure 9-1, the Modified Transbronchial Aspiration Needle is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the Modified Transbronchial Aspiration Needle will meet the minimum requirements that are considered acceptable for its intended use.
2
Figure 9-1: Similarities and Differences between modified Transbronchial Aspiration Needle, Boston Scientific's TBAN, and Mill-Rose's Transbronchial Aspiration Needle
| | Modified
Transbronchial
Aspiration Needle
(This 510(k)) | Boston
Scientific's TBAN
(K840033) | Mill-Rose's
Transbronchial
Aspiration Needle
(K914181) |
|-------------------------|-----------------------------------------------------------------------------|------------------------------------------|-----------------------------------------------------------------|
| USE | | | |
| Indication | Aspiration in carinal,
hilar, paratracheal,
and peripheral
lesions | Aspiration | Aspiration for
cytology/histology |
| Route of Administration | Bronchoscope | Bronchoscope | Bronchoscope |
| DESIGN FEATURES | | | |
| Cross Section | Double Lumen | Double Lumen | Single or double
Lumen |
| Retractable Needle | Yes | Yes | Yes |
| DIMENSIONS | | | |
| Catheter Length (cm) | 150 | 150 | 140 |
| Outer Catheter OD | 1.8 | 1.8 | 1.8 |
| Needle Size (Ga) | 18, 19, & 21 | 18 & 21 | 19 – 22 |
| Needle Length (mm) | 14 & 20 | 13 & 20 | 13 & 15 |
Premarket Notification, Modified Transbronchial Aspiration Needle, August 16, 1996