(129 days)
No
The device description and performance studies focus on the mechanical aspects of a needle and adaptor for aspiration, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is designed for fine needle aspiration (FNA) of lesions for diagnostic purposes, not for treating diseases or conditions.
Yes
Explanation: The device is used for fine needle aspiration (FNA) of lesions, which is a procedure to collect tissue samples for analysis. The collection of these samples is a key step in diagnosing diseases or conditions.
No
The device description clearly outlines physical components such as a needle, adaptor, syringe, and stopcock, indicating it is a hardware-based medical 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 ultrasound guided fine needle aspiration (FNA) of lesions in the tracheobronchial tree. This is a procedure to collect a sample of tissue or fluid from the body.
- Device Description: The device is a needle and associated components designed to physically collect a sample from within the body.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples outside of the body (in vitro). The performance studies described are bench tests related to the physical function of the device (lock force, suction, leakage), not tests on biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. This device is used to obtain the specimen, not to test it.
N/A
Intended Use / Indications for Use
The Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is designed to be used with endobronchial ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of the submucosal and extramural lesions of the tracheobronchial tree. Do not use this instrument for any purpose other than its intended use.
Product codes
EOQ
Device Description
The Expect™ Pulmonary device is comprised of the following:
- . One (1) Expect™ Pulmonary needle
- One (1) Expect™ Pulmonary adaptor .
- One (1) Syringe .
- One (1) Stopcock .
The Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is an Endobronchial Ultrasound guided Transbronchial Aspiration Needle used for fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. The device consists of a sheath covered needle which extends into the accessory channel of an endobronchial ultrasound (EBUS) endoscope and is locked into place. A handle on the proximal end of the device is used to actuate the needle in order gather samples. Both the sheath and needle length are adjustable while in the scope. A stylet is in place in order to provide protection to the inside of the sheath during device passage through the scope. The stylet may also be used to expel the sample after the procedure.
Expect™ Pulmonary adaptor is an accessory component of the Expect™ Pulmonary device. This needle adaptor is attached and locked onto the biopsy port of the bronchoscope. It allows the Expect™ Pulmonary needle to pass through it and to be secured in place with a luer connection. The adaptor is also designed to seal off the biopsy port while using the suction feature on an EBUS bronchoscope. The proposed Expect™ Pulmonary adaptor will facilitate scope flushing by allowing the adaptor to be attached to the bronchoscope.
Syringe and stopcock accessory components provide and control the vacuum suction to aspirate the sample. They can also be used to expel the samples after the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
tracheobronchial 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
Four (4) non-clinical bench performance tests have been performed on the proposed Expect™ Pulmonary device with the modified needle adaptor. The passing results of these tests demonstrate that the modified needle adaptor design met the pre-defined performance specifications acceptance criteria. Bench testing includes:
- Adaptor Lock and Unlock Force. This is the same performance requirement for both ● the proposed and the predicate Expect™ Pulmonary device. The test is to verify that the compressive force required to attach the proposed adaptor to the biopsy port of the bronchoscope and the force required to detach the proposed adaptor from the biopsy port meet the performance specification requirements.
- . Adaptor Suction. This is the same performance requirement for both the proposed and the predicate Expect™ Pulmonary device. The test is to verify that the proposed Expect Pulmonary adaptor is able to seal off the bronchoscope biopsy port under suction, after the passes of the Expect Pulmonary needle.
- Adaptor Flushing Compatibility. This is a new performance requirement for the ● proposed Expect™ Pulmonary adaptor. This test is to verify that the proposed adaptor seal can allow fluid to pass through without causing leakage at the adaptor.
- ISO 594-1 Liquid Leakage Testing. This is a new performance requirement for the proposed Expect™ Pulmonary adaptor. This test is to verify that the conical female luer connection on the Adaptor meet ISO 594-1 liquid leakage test.
Shelf-life testing was not required because the design modification made to adaptor did not impact the adaptor materials. The proposed Expect™ Pulmonary devices will be labeled with the identical shelf life to the predicate Expect™ Pulmonary device (K151315).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility evaluation and testing have been completed on the patient contacting portions of the proposed Expect™ Pulmonary adaptor in accordance with ISO 10993-1:2009/Cor 1: 2010 Evaluation and Testing. The unchanged patient contacting components of the Expect™ Pulmonary needle were evaluated previously in accordance with ISO 10993-1:2009 in K151315.The passing results of these biocompatibility tests demonstrate that the proposed Expect™ Pulmonary device with the modified adaptor is biocompatible. Testing included:
- . Cytotoxicity
- . Sensitization
- Intracutaneous Reactivity (Irritation) ●
- Acute Systemic Toxicity ●
- Material-Mediated Pyrogenicity ●
Sterilization testing is not required for the Expect™ Pulmonary device with the proposed adaptor. The design modification made to adaptor seal shape will not impact the existing Expect™ Pulmonary device sterilization qualification (K151315). The Expect™ Pulmonary devices with the proposed adaptor still meet the requirements of ISO 11135-1:2007 "Sterilization of health care products - Ethylene oxide -- Part 1: Medical devices requirements for development, validation and routine control of a sterilization process for medical devices". This product's Ethylene oxide (EO) sterilization cycle is validated to achieve a minimum sterility assurance level (SAL) of 106. And the product Ethylene oxide residual levels conform to ISO 10993-7:2008 (R: 2012) "Biological Evaluation of Medical Devices- Part 7: Ethylene Oxide Sterilization Residuals".
All device non-clinical bench test results are acceptable. Data demonstrate that Expect Pulmonary device with the proposed adaptor meets the design specifications and the predefined acceptance criteria. The Expect Pulmonary device with the proposed adaptor continues to perform according to its intended use and labeled shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2017
Boston Scientific Corporation Yingying Gao Sr. RA Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K163248
Trade/Device Name: Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOQ Dated: February 21, 2017 Received: February 22, 2017
Dear Yingying Gao:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) To Be Determined
Device Name
Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
Indications for Use (Describe)
The Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is designed to be used with endobronchial ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of the submucosal and extramural lesions of the tracheobronchial tree. Do no use this instrument for any purpose other than its intended use.
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the logo for Boston Scientific. The words "Boston Scientific" are written in a serif font. The color of the text is blue.
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Yingying Gao Senior Regulatory Affairs Specialist Telephone: 508-683-4356 Fax: 508-683-5939
Secondary Contact: Ashley Santos Regulatory Affairs Manager Telephone: 508-683-4359 Fax: 508-683-5939
Date Prepared: March 20, 2017
2. Proposed Device:
Trade Name: Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle Classification Name: Bronchoscope (Flexible or Rigid) and Accessories Regulation Number: 21 CFR 874.4680 Product Code: EOQ Classification: Class II
3. Predicate Device:
Trade Name: Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle Manufacturer and Clearance Number: Boston Scientific Corp, K151315 Classification Name: Bronchoscope (Flexible or Rigid) and Accessories Regulation Number: 21 CFR 874.4680 Product Code: EOQ Classification: Class II
4. Device Description:
Device Name: Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
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Image /page/4/Picture/0 description: The image shows the logo for Boston Scientific. The text is in a serif font and is a dark blue color. The word "Boston" is on top of the word "Scientific".
The Expect™ Pulmonary device is comprised of the following:
- . One (1) Expect™ Pulmonary needle
- One (1) Expect™ Pulmonary adaptor .
- One (1) Syringe .
- One (1) Stopcock .
The Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is an Endobronchial Ultrasound guided Transbronchial Aspiration Needle used for fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. The device consists of a sheath covered needle which extends into the accessory channel of an endobronchial ultrasound (EBUS) endoscope and is locked into place. A handle on the proximal end of the device is used to actuate the needle in order gather samples. Both the sheath and needle length are adjustable while in the scope. A stylet is in place in order to provide protection to the inside of the sheath during device passage through the scope. The stylet may also be used to expel the sample after the procedure.
Expect™ Pulmonary adaptor is an accessory component of the Expect™ Pulmonary device. This needle adaptor is attached and locked onto the biopsy port of the bronchoscope. It allows the Expect™ Pulmonary needle to pass through it and to be secured in place with a luer connection. The adaptor is also designed to seal off the biopsy port while using the suction feature on an EBUS bronchoscope. The proposed Expect™ Pulmonary adaptor will facilitate scope flushing by allowing the adaptor to be attached to the bronchoscope.
Syringe and stopcock accessory components provide and control the vacuum suction to aspirate the sample. They can also be used to expel the samples after the procedure.
5. Indications for Use:
The Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is designed to be used with endobronchial ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of the submucosal and extramural lesions of the tracheobronchial tree. Do not use this instrument for any purpose other than its intended use.
6. Technological Characteristics:
The proposed Expect™ Pulmonary device shares the same technological characteristics with its predicate, the currently cleared Expect™ Pulmonary EBUS-TBNA device (K151315). The only technological difference is the adaptor modification, which allows for flushing. The new technological characteristic introduced by the proposed Expect™ Pulmonary device is "Adaptor flushing capability".
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Image /page/5/Picture/0 description: The image shows the logo for Boston Scientific. The words "Boston Scientific" are written in a serif font. The color of the text is blue.
Both the proposed and predicate Expect™ Pulmonary devices are intended to acquire samples in the airway by coupling it with an ultrasound curvilinear bronchoscope. The proposed Expect™ Pulmonary device shares the identical needle, syringe and stopcock designs and materials as the predicate Expect™ Pulmonary device (K151315). Thus, the technological characteristics of the proposed Expect™ Pulmonary needle are the same as the technological characteristics cleared in K151315 previously.
The only difference between the proposed and the predicate Expect™ Pulmonary device is the needle adaptor component. The proposed Expect™ Pulmonary device will be offered with a re-designed needle adaptor, which can facilitate scope flushing while the adaptor is in place.
The comparison of the predicate and the proposed Expect™ Pulmonary devices is provided in the following Table 1.
| Device Characteristics | The predicate Expect™
Pulmonary device (K151315) | The proposed Expect™
Pulmonary device |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Indications for Use | The Expect™ Pulmonary
Endobronchial Ultrasound
Transbronchial Aspiration Needle is
designed to be used with
endobronchial ultrasound
endoscopes for ultrasound guided
fine needle aspiration (FNA) of the
submucosal and extramural lesions
of the tracheobronchial tree.
Do not use this instrument for any
purpose other than its intended use. | Identical |
| Single-Use | Single Use | Identical |
| Sterile | EO | Identical |
| Mechanism of Action for
Needle Advancement | Manual | Identical |
| Mechanism for Tissue
Sampling | Aspiration | Identical |
| Number of Device Passes
during a procedure | Multiple Passes | Identical |
| Needle Gauge Size | 22ga & 25ga | Identical |
| Ability to Visualize with
Endoscopic Ultrasound | Echogenic signature on distal end of
device | Identical |
| Sheath Length | Adjustable | Identical |
| Minimum Working Channel
Compatibility | 2.0mm (for both 22ga and 25ga) | Identical |
| Table 1 Device Comparison of Key Design Characteristics | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | --------------------------------------------------------- |
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Image /page/6/Picture/0 description: The image shows the logo for Boston Scientific. The text is in a serif font and is a dark blue color. The word "Boston" is on the top line, and the word "Scientific" is on the bottom line. The logo is simple and clean, and it is easy to read.
| Device Characteristics | The predicate Expect™ Pulmonary device (K151315) | The proposed Expect™ Pulmonary device |
|---|---|---|
| Device to scope attachment | Adaptor Attachment compatible with Olympus and Fujinon ultrasound bronchoscopes | Identical |
| Adaptor | --Provides a secure connection between the Expect™ Pulmonary needle and the Bronchoscope biopsy ports. | |
| --Seals the biopsy port when bronchoscope suction feature is in use | Similar: The proposed modified adaptor has the same secure connection and sealing feature as the predicate adaptor. |
The only difference is that the proposed adaptor can be attached to the bronchoscope for flushing. |
7. Performance Data:
Non-clinical Testing Summary:
Four (4) non-clinical bench performance tests have been performed on the proposed Expect™ Pulmonary device with the modified needle adaptor. The passing results of these tests demonstrate that the modified needle adaptor design met the pre-defined performance specifications acceptance criteria. Bench testing includes:
- Adaptor Lock and Unlock Force. This is the same performance requirement for both ● the proposed and the predicate Expect™ Pulmonary device. The test is to verify that the compressive force required to attach the proposed adaptor to the biopsy port of the bronchoscope and the force required to detach the proposed adaptor from the biopsy port meet the performance specification requirements.
- . Adaptor Suction. This is the same performance requirement for both the proposed and the predicate Expect™ Pulmonary device. The test is to verify that the proposed Expect Pulmonary adaptor is able to seal off the bronchoscope biopsy port under suction, after the passes of the Expect Pulmonary needle.
- Adaptor Flushing Compatibility. This is a new performance requirement for the ● proposed Expect™ Pulmonary adaptor. This test is to verify that the proposed adaptor seal can allow fluid to pass through without causing leakage at the adaptor.
- ISO 594-1 Liquid Leakage Testing. This is a new performance requirement for the proposed Expect™ Pulmonary adaptor. This test is to verify that the conical female luer connection on the Adaptor meet ISO 594-1 liquid leakage test.
Shelf-life testing was not required because the design modification made to adaptor did not impact the adaptor materials. The proposed Expect™ Pulmonary devices will be labeled with the identical shelf life to the predicate Expect™ Pulmonary device (K151315).
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Image /page/7/Picture/0 description: The image shows the logo for Boston Scientific. The words "Boston Scientific" are written in a serif font and are colored in blue. The word "Boston" is on the top line, and the word "Scientific" is on the bottom line.
Biocompatibility Testing Summary:
The biocompatibility evaluation and testing have been completed on the patient contacting portions of the proposed Expect™ Pulmonary adaptor in accordance with ISO 10993-1:2009/Cor 1: 2010 Evaluation and Testing. The unchanged patient contacting components of the Expect™ Pulmonary needle were evaluated previously in accordance with ISO 10993-1:2009 in K151315.The passing results of these biocompatibility tests demonstrate that the proposed Expect™ Pulmonary device with the modified adaptor is biocompatible. Testing included:
- . Cytotoxicity
- . Sensitization
- Intracutaneous Reactivity (Irritation) ●
- Acute Systemic Toxicity ●
- Material-Mediated Pyrogenicity ●
Sterilization summary:
Sterilization testing is not required for the Expect™ Pulmonary device with the proposed adaptor. The design modification made to adaptor seal shape will not impact the existing Expect™ Pulmonary device sterilization qualification (K151315). The Expect™ Pulmonary devices with the proposed adaptor still meet the requirements of ISO 11135-1:2007 "Sterilization of health care products - Ethylene oxide -- Part 1: Medical devices requirements for development, validation and routine control of a sterilization process for medical devices". This product's Ethylene oxide (EO) sterilization cycle is validated to achieve a minimum sterility assurance level (SAL) of 106. And the product Ethylene oxide residual levels conform to ISO 10993-7:2008 (R: 2012) "Biological Evaluation of Medical Devices- Part 7: Ethylene Oxide Sterilization Residuals".
8. Conclusion:
The biocompatibility test results are deemed acceptable for the intended use and the proposed Expect™ Pulmonary adaptor are considered biocompatible.
All device non-clinical bench test results are acceptable. Data demonstrate that Expect Pulmonary device with the proposed adaptor meets the design specifications and the predefined acceptance criteria. The Expect Pulmonary device with the proposed adaptor continues to perform according to its intended use and labeled shelf life.
Boston Scientific Corporation has demonstrated that the proposed Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle with modified needle adaptor component is substantially equivalent to the currently cleared Expect™ Pulmonary EBUS-TBNA device (K151315).