TBAN

K963252 · Boston Scientific Corp · EOQ · Sep 20, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K963252
• Device Name: TBAN
• Applicant: Boston Scientific Corp
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Sep 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended 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.

Device Story

Transbronchial aspiration needle used during bronchoscopy to obtain submucosal samples from bronchial tree lesions. Device features retractable needle design with double-lumen catheter. Operated by physician via bronchoscope. Provides tissue/cytology samples for diagnostic evaluation. Benefits patient by enabling biopsy of lesions inaccessible to standard forceps.

Clinical Evidence

Bench testing only. Biocompatibility assessment performed on patient- and fluid-contact materials with satisfactory results. No clinical data presented.

Technological Characteristics

Double-lumen catheter, retractable needle design. Dimensions: 150cm length, 1.8mm OD, 18/19/21 gauge needles. Sterilized via ethylene oxide gas per AAMI protocol. Packaged in pouch. Pyrogenicity testing performed periodically.

Indications for Use

Indicated for aspiration of carinal, paratracheal, hilar, and peripheral bronchial tree lesions where biopsy forceps cannot obtain submucosal samples. No specific age or gender restrictions; no known contraindications.

Regulatory Classification

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.

Predicate Devices

• Boston Scientific TBAN (K840033)
• Mill-Rose Transbronchial Aspiration Needle (K914181)

Submission Summary (Full Text)

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K963252

SEP 20 1996

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)<br/>Gastro-Renal (GRDB)
- OWNER/OPERATOR: Boston Scientific Corporation<br/>One Boston Scientific Place<br/>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

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Premarket Notification, Modified Transbronchial Aspiration Needle, August 16, 1996

# DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

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. Pyrogenicity 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.

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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 | Aspriation | 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