(8 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Broncus Technologies, Inc. Yield™ Tissue Sampler. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving the device meets specific acceptance criteria related to AI or algorithm performance. Therefore, many of the requested categories are not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimensional specifications | Within specification tolerances |
| Strength requirements | Passed pre-established acceptance criteria |
| Aspiration performance | Passed pre-established acceptance criteria |
| Biocompatibility (ISO 10993) | Performed, materials confirmed to be biocompatible |
| Sterilization (e-beam) | Device will be sterilized using e-beam sterilization |
| General safety and effectiveness | Labeling contains instructions for use and necessary cautions/warnings |
Note: The document only states that the device "passed pre-established acceptance criteria" for strength and aspiration, and that "all items tested were within specification tolerances" for dimensional testing. Specific numerical values for acceptance criteria or performance are not provided.
2. Sample size used for the test set and the data provenance:
- Not applicable. This document describes performance testing for a medical device (transbronchial aspiration needle), not a study involving a test set of data for an AI algorithm. The performance tests mentioned (dimensional, strength, aspiration, biocompatibility) are laboratory-based and device-specific, not data-driven in the context of AI.
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. As above, this is not an AI algorithm study requiring expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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 physical medical instrument, not an AI system designed to assist human readers or perform diagnostic tasks.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For the physical device testing, "ground truth" would equate to established engineering standards, material properties, and manufacturing specifications.
8. The sample size for the training set:
- Not applicable. There is no AI training set mentioned or implied for this physical device.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI training set.
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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 accessories21 CFR 874.4680Product 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 onSeptember 20, 1996 |
| eXcelon® TransbronchialAspiration Needle | Boston Scientific | K040018, cleared onJanuary 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K090653
§ 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.