(14 days)
The Yield Mini Doppler Probe with Broncus® Monitor is intended for use through a bronchoscope to detect blood flow behind airway walls in the tracheobronchial tree.
This premarket notification covers Broncus' Yield Mini Doppler System, which comprises the Yield Mini Doppler Probe and Broncus Monitor. The Mini Doppler System will enable the bronchoscopist to identify vessel-free areas prior to performing transbronchial procedures such as needle aspiration or biopsy.
Acceptance Criteria and Study for Yield™ Mini Doppler System (K090743)
The provided documentation for the Yield™ Mini Doppler System (K090743) is a 510(k) Summary and an FDA clearance letter. These documents attest to the device's substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in the context of a clinical performance trial with specific metrics.
Therefore, much of the requested information regarding specific acceptance criteria, performance metrics, sample sizes, ground truth establishment, and multi-reader studies is not explicitly available in the provided text. The submission focuses on demonstrating safety and equivalence through engineering testing and comparison to existing cleared devices.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document does not specify quantitative clinical acceptance criteria or performance metrics such as sensitivity, specificity, or diagnostic accuracy that would be typically found in a clinical performance study for an AI/algorithm-based device. The "acceptance criteria" discussed are primarily related to manufacturing, safety, and functionality.
| Acceptance Criteria Category | Description / Testing Performed | Reported Device Performance |
|---|---|---|
| Mechanical Safety | Performance testing was conducted. | All items tested were within specification tolerances. No failures. |
| Thermal Safety | Performance testing was conducted. | All items tested were within specification tolerances. No failures. |
| Electrical Safety | Performance testing was conducted. | All items tested were within specification tolerances. No failures. |
| Biocompatibility | Performed in accordance with ISO 10993, Biological Evaluation of Medical Devices. | Pass/Meets ISO 10993 requirements. |
| Sterilization | Device is intended to be sterilized using e-beam sterilization. (While not an "acceptance criterion" in the same way, this is a critical aspect of device safety and manufacturing control). | Appropriate sterilization method identified. |
| Functional Equivalence | The Yield Mini Doppler System has the same intended use, methods of introduction, method of operation, and design features as the predicate devices (Exhale Doppler System K010649 and P.D. Access Percutaneous Doppler Vascular Device K973713). The intended use is to detect blood flow behind the airway wall in the tracheobronchial tree. | Determined to be substantially equivalent to predicate devices, implying functional performance is comparable for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "performance testing" but does not detail the nature or sample size of any clinical or in-vitro test set for evaluating the device's ability to detect blood flow. The clearance is based on equivalence to predicate devices and engineering testing.
- Data Provenance: Not applicable, as there's no clinical test set data from patients described. The testing described (mechanical, thermal, electrical safety, biocompatibility) are engineering and laboratory tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. There is no mention of a human-read test set or expert ground truth establishment for a clinical performance evaluation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document does not describe any MRMC study comparing human reader performance with or without AI assistance. This device is a diagnostic tool, not an AI-assisted interpretation product.
6. Standalone Performance Study
- Standalone Performance Study: The document describes "Performance testing of the Yield Mini Doppler System included mechanical, thermal and electrical safety testing." These are standalone engineering tests. However, a standalone clinical performance study (e.g., sensitivity, specificity for detecting blood flow compared to a definitive reference standard in a patient population) that would typically be associated with an AI algorithm's standalone performance is not described. The clearance relies on substantial equivalence to predicate devices.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "Performance Data" mentioned (mechanical, thermal, electrical safety, biocompatibility), the ground truth would be engineering specifications, regulatory standards (e.g., ISO 10993), and safety requirements. For the device's core function of detecting blood flow, while not explicitly detailed, the inherent design and operation are deemed equivalent to previously cleared devices which would have established their ability to detect blood flow. There's no mention of pathology, outcomes data, or expert consensus as ground truth for a clinical efficacy study within this submission.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a Doppler system, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for an AI/machine learning algorithm.
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K090743
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Appendix A: 510(k) SUMMARY
- Date of Summary
March 2, 2009
APR - 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: | Nancy Isaac |
|---|---|
| Phone: | (650) 428-1600 ext. 305 |
| Fax: | (650) 428-1542 |
| e-mail: | nisaac@broncus.com |
3. Device Overview
| Trade Name: | Yield™ Mini Doppler System |
|---|---|
| Common Name: | Doppler Probe and Processing Unit |
| Classification Name: | Radiology Device21 CFR 892.1550Product Code IYN |
4. Predicate Device
The predicate devices identified for the Yield Mini Doppler Probe are as follows:
| Trade Name | 510(k) Submitter | 510(k) Number |
|---|---|---|
| Exhale Doppler System | BroncusTechnologies, Inc | K010649, cleared to marketon March 20, 2001 |
| P.D. Access PercutaneousDoppler Vascular Deviceand P.D. Access DualFrequency Monitor | CardiovascularDynamics, Inc | K973713, cleared to marketon January 23, 1998 |
5. Device Description
This premarket notification covers Broncus' Yield Mini Doppler System, which comprises the Yield Mini Doppler Probe and Broncus Monitor. The Mini Doppler System will enable
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the bronchoscopist to identify vessel-free areas prior to performing transbronchial procedures such as needle aspiration or biopsy.
6. Intended Use
The Yield Tissue Mini Doppler Probe with Broncus Monitor is intended for use through a bronchoscope to detect blood flow behind the airway wall in the tracheobronchial tree.
7. Comparison to Predicate Device
The Yield Mini Doppler System is substantially equivalent to the predicates. The Mini Doppler System has the same intended use, methods of introduction, method of operation and design features. Furthermore, all materials were tested for biocompatibility per ISO10993, Biological Evaluation of Medical Devices.
8. Performance Data
Performance testing of the Yield Mini Doppler System included mechanical, thermal and electrical safety testing. These tests demonstrate that all items tested were within specification tolerances. There were no failures during the testing.
9. Safety and Effectiveness
The Yield Mini Doppler Probe and Broncus Monitor labeling contain 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 ISO10993, Biological Evaluation of Medical Devices. In addition, the device will be sterilized using e-beam sterilization.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Broncus Technologies, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K090743
Trade/Device Name: Yield™ Mini Doppler System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN and ITX Dated: March 19, 2009 Received: March 20, 2009
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device . referenced above and we 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). 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.
APR - 3 2009
This determination of substantial equivalence applies to the following transducers intended for use with the Yield™ Mini Doppler System, as described in your premarket notification:
Transducer Model Number
Yield Mini Doppler Probe 11781
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.
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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); 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.
This letter will allow you to begin marketing your device as described in your 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 market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If vou have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.
Sincerely yours,
Jules Reiner
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Indications for Use Statement
K 090743 510(k) Number:
Device Name: Yield™ Mini Doppler System
Indications for Use: The Yield Mini Doppler Probe with Broncus® Monitor is intended for use through a bronchoscope to detect blood flow behind airway walls in the tracheobronchial tree.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-CounterUse (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
[signature]
(Division Sign Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
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| Ultrasound Indications for Use Form | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | Yield Mini Doppler System | |||||||
| Transducer: | Yield Mini Doppler Probe 11781 | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| General(Track 1Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging&Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | Nº | |||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N4: Intraluminal ultrasound for the tracheobronchial tree.
N = new Indication; P = previously cleared by FDA; E = added under this appendix D
"Examples of other modes of operation may include, Andritude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Moton Doppler, and Color Velocity Imaging Dopplar, and Color Velocity Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use) (per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K090743
Page . of
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.