(8 days)
Not Found
No
The summary describes a mechanical tissue sampling device and does not mention any AI or ML components or functionalities.
No
The device is described as a tissue sampler and aspiration needle, used for retrieving tissue samples for diagnostic purposes rather than for treating a condition.
Yes
The device is used to retrieve tissue samples from lesions, which are then typically analyzed to diagnose medical conditions.
No
The device description explicitly states it is a "transbronchial aspiration needle," which is a physical hardware component used for tissue retrieval. The performance studies also focus on physical characteristics like dimensional, strength, aspiration, and biocompatibility testing, further indicating it is a hardware device.
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 in carinal, paratracheal and hilar lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample. This describes a procedure to obtain a sample from the body, not a test performed on a sample outside the body.
- Device Description: The device is described as a transbronchial aspiration needle used for transbronchial retrieval of tissue samples. This further reinforces its role in sample collection from within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze or test a sample in vitro (outside the living organism). IVDs are typically used to diagnose diseases or conditions by examining samples like blood, urine, or tissue in a laboratory setting.
The Yield Tissue Sampler is a device used for sample collection from the body, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Yield Tissue Sampler is indicated for use in aspiration in carinal, paratracheal and hilar lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
This premarket notification covers Broncus' Yield Tissue Sampler. The Yield Tissue Sampler is a transbronchial aspiration needle used for transbronchial retrieval of tissue samples. It is compatible with flexible 2-mm working channel bronchoscopes and is available in two sizes, 18 and 21 gauge.
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)
Performance testing of the Yield Tissue Sampler included dimensional, strength, aspiration and biocompatibility testing. These tests demonstrate that all items tested were within specification tolerances. All tests passed pre-established acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Appendix A: 510(k) Summary
APR - 7 2009
1. Date of Summary
March 3, 2009
2. 510(k) Applicant
Broncus Technologies, Inc. 1400 N. Shoreline Blvd., Bldg. A, Suite 8 Mountain View, California 94043 Phone: (650) 428-1600 FAX: (650) 428-1542
| Contact Person: | Mahtab Fatemi |
|---|---|
| Phone: | (650) 428-1600 |
| Fax: | (650) 428-1542 |
| e-mail: | mfatemi@broncus.com |
3. Device Overview
| Trade Name: | Yield TM Tissue Sampler |
|---|---|
| Common Name: | Transbronchial Aspiration Needle |
| Classification Name: | Bronchoscope (flexible or rigid) and accessories |
| 21 CFR 874.4680 | |
| Product Code EOQ |
4. Predicate Device
The predicate devices identified for the Yield Tissue Sampler are as follows:
| Trade Name | 510(k) Submitter | 510(k) Number |
|---|---|---|
| TBAN | Boston Scientific | K963252, cleared on |
| September 20, 1996 | ||
| eXcelon® Transbronchial | ||
| Aspiration Needle | Boston Scientific | K040018, cleared on |
| January 20, 2004 |
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5. Device Description
This premarket notification covers Broncus' Yield Tissue Sampler. The Yield Tissue Sampler is a transbronchial aspiration needle used for transbronchial retrieval of tissue samples. It is compatible with flexible 2-mm working channel bronchoscopes and is available in two sizes, 18 and 21 gauge.
6. Intended Use
The Yield Tissue Sampler is indicated for use in aspiration in carinal, paratracheal and hilar lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.
7. Comparison to Predicate Device
The Yield Tissue Sampler is substantially equivalent to the predicate. The Tissue Sampler has the same intended use, methods of introduction, method of operation and design features. Furthermore, all materials were tested for biocompatibility per ISO 10993, Biological Evaluation of Medical Devices.
8. Performance Data
Performance testing of the Yield Tissue Sampler included dimensional, strength, aspiration and biocompatibility testing. These tests demonstrate that all items tested were within specification tolerances. All tests passed pre-established acceptance criteria.
9. Safety and Effectiveness
The Tissue Sampler labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. The biocompatibility assessment was performed in accordance with ISO 10993, Biological Evaluation of Medical Devices. In addition, the device will be sterilized using e-beam sterilization.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Broncus Technologies, Inc. c/o Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
APR - 7 2009
Re: K090853
Trade/Device Name: Yield™ Tissue Sampler Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (rigid or flexible) and accessories Regulatory Class: Class II Product Code: EOQ Dated: March 27, 2009 Received: March 30, 2009
Dear Mr. Job:
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.
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 agencies. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. B. Egolins, my
Malvina B. Eydelman, 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
510(k) Number: K
Yield™ Tissue Sampler Device Name:
Indications for Use: The Yield Tissue Sampler is indicated for use in aspiration in carinal, paratracheal and hilar lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K090653