(104 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a needle and associated accessories for tissue aspiration, with no mention of AI or ML capabilities.
No
The device is used for fine needle aspiration (FNA) to collect samples for diagnostic purposes, not for treating a condition.
Yes
The device is used for fine needle aspiration (FNA) of lesions, which is a procedure to collect tissue samples for diagnostic purposes. While the device itself doesn't perform the diagnosis, it is an essential tool in the diagnostic process by enabling the collection of samples needed for diagnosis.
No
The device description explicitly lists physical components such as a needle, adaptor, syringe, and stopcock, indicating it is a hardware device, not software-only.
Based on the provided information, the Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health.
- Device Function: The Expect™ Pulmonary device is used to collect a sample (fine needle aspiration) from lesions inside the body (gastrointestinal tract) using ultrasound guidance. It is a tool for obtaining a specimen, not for analyzing it.
- Intended Use: The intended use clearly states it's for "ultrasound guided fine needle aspiration (FNA) of the submucosal and extramural lesions of the gastrointestinal tract." This describes a procedure to collect a sample, not a test performed on a sample.
- Device Description: The description details the components and how they are used to collect a sample, not how a sample is analyzed.
While the collected sample may be used for subsequent in vitro diagnostic testing, the Expect™ Pulmonary device itself is a surgical/procedural tool for sample collection, not an IVD.
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 gastrointestinal tract. Do not use this instrument for any purpose other than its intended use.
Product codes (comma separated list FDA assigned to the subject device)
FCG
Device Description
The Expect™ Pulmonary device is comprised of the following:
- Expect™ Pulmonary needle
- Expect™ Pulmonary adaptor.
- Syringe
- Stopcock
The Expect™ Pulmonary needle is an Endobronchial Ultrasound guided Transbronchial Aspiration Needle used for fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract. 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 to be attached and locked onto the biopsy port of the bronchoscope. It allows Expect™ Pulmonary needle to pass through it and to be secured in place with a luer connection.
Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample. They also can 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
submucosal and extramural lesions of the gastrointestinal tract
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)
Non-clinical comparative performance bench testing was successfully completed to establish substantial equivalence between the proposed Expect™ Pulmonary devices and its primary predicate device Expect™ Slimline device. The following tests were conducted on the Expect™ Pulmonary devices:
-
- Device Flexibility
-
- Device Passability
-
- Device Durability (Robustness)
-
- Needle and Sheath Adjustment Locking Force
-
- Handle actuation force (Needle extension)
-
- Needle Sharpness
-
- Stylet Removal Force
-
- Handle Home Position
-
- Needle Extension Length
-
- Adjustable Working Length (Sheath Extension length)
-
- Needle to Luer Tensile Strength
-
- Sheath to Sheath Hub (Actuation Guide)
-
- Tensile strength; Adaptor to scope tensile
-
- Device Luer to Adaptor Luer to Scope Tensile
-
- Adaptor Lock & Unlock Force
-
- Adaptor Suction
-
- Needle Extension Length Marking
-
- Sheath Length Adjustment Markings
-
- Handle Rotation
-
- Smooth Actuation
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
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
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 stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2015
Boston Scientific Corporation Yingying Gao Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K151895
Trade/Device Name: Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: II Product Code: FCG Dated: September 24, 2015 Received: September 25, 2015
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 of medical device
1
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.
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 yours,
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) To Be Determined - K151895
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 gastrointestinal tract. 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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SECTION 6. 510(K) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Yingying Gao Sr. 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: July 9, 2015
2. Device:
| Trade Name: | Expect TM Pulmonary Endobronchial Ultrasound
Transbronchial Aspiration Needle |
|----------------------|----------------------------------------------------------------------------------------------|
| Device Common Name: | Endobronchial Ultrasound Transbronchial Aspiration
Needle/ EBUS-TBNA needle |
| Classification Name: | Gastroenterology-urology biopsy instrument |
| Regulation Number: | 876.1075 |
| Product Code: | FCG |
| Classification: | Class II |
3. Predicate Device:
Primary Predicate device:
| Trade Name: | Expect™ Slimline (SL) Endoscopic Ultrasound
Aspiration needle |
| ------------- | ------------------------------------------------------------------ |
|---|
Premarket Notification, Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle SECTION 6
4
| Device Common Name: | Endoscopic Ultrasound Aspiration needle /
EUS-FNA needle |
|----------------------|-------------------------------------------------------------|
| Manufacturer: | Boston Scientific Corporation |
| Clearance Number: | K133312 |
| Classification Name: | Endoscope and accessories |
| Regulation Number: | 876.1500 |
| Product Code: | ODG and FCG |
| Classification: | Class II |
And
Secondary Predicate device:
| Trade Name: | Single Use Aspiration Needle NA-201SX-4022 |
|---|---|
| Device Common Name: | Endobronchial Ultrasound Transbronchial Aspiration |
| Needle/ EBUS-TBNA needle | |
| Manufacturer: | Olympus Medical Systems Corporation |
| Clearance Number: | K050503 |
| Classification Name: | Gastroenterology-urology biopsy instrument |
| Regulation Number: | 876.1075 |
| Product Code: | FCG |
| Classification: | Class II |
4. Device Description:
Device Name: Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
The Expect™ Pulmonary device is comprised of the following:
- Expect™ Pulmonary needle ●
- Expect™ Pulmonary adaptor .
- Syringe ●
- . Stopcock
The Expect™ Pulmonary needle is an Endobronchial Ultrasound guided Transbronchial Aspiration Needle used for fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract. 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
5
through the scope. The stylet may also be used to expel the sample after the procedure.
Expect™ Pulmonary adaptor is an accessory to be attached and locked onto the biopsy port of the bronchoscope. It allows Expect™ Pulmonary needle to pass through it and to be secured in place with a luer connection.
Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample. They also can be used to expel the samples after the procedure.
5. Intended use and Indications for Use:
Intended use:
Expect™ Pulmonary device is intended to be used with ultrasound endoscope for fine needle aspiration of the submucosal and extramural lesions of the accessible organ svstems.
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 gastrointestinal tract. Do not use this instrument for any purpose other than its intended use.
6. Technological Characteristics:
The proposed Expect™ Pulmonary device is designed to acquire sample in the Esophagus by coupling with an ultrasound bronchoscope. It has the following technological characteristics:
- . Adjustable sheath length and sheath locking mechanism
- Adjustable needle length and needle locking mechanism ●
- . Needle sharpness
- Needle echogenicity in ultrasound image ●
- Stylet with kink resistance
- Smooth actuation ●
- Aspiration capability ●
- Passage of device through the scope to the target position
- Secure scope attachment .
The Expect™ Pulmonary device shares similar design characteristics with its primary predicate device Expect™ Slimline device. Both of them have the adjustable lengths of sheath and needle with similar sheath and needle locking mechanism. These two devices have the same sharp echogenic needle and kink resistant stylet with the exact same materials and designs. The only differences are Expect™ Pulmonary device has a shorter sheath length and a shorter adjustable needle length. In additional, the same
6
sheath material is shared between these two devices. The Expect™ Pulmonary sheath has a smaller outer and inner diameter and a shorter length. Based on the similarity of the needle, sheath, and the stylet, Expect™ Slimline and Expect™ Pulmonary devices have a similar actuation mechanism. The same syringe and stopcock are also shared between these two devices. As a result, their aspiration capabilities are identical.
The proposed Expect™ Pulmonary device has an adaptor that is attached and locked onto the biopsy port of the bronchoscope. The Expect™ Pulmonary device can pass through the adaptor and be secured in place with a luer connection. This Adaptor is similar to the adaptor biopsy valve of the Vizishot device.
The proposed device has the same intended use and similar technical characteristics as the currently marketed Boston Scientific Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration needle (K133312) and the Olympus Single Use Aspiration Needle NA-201SX-4022 (K050503).
7. Performance Data:
Biocompatibility Testing Summary:
The proposed Boston Scientific Expect™ Pulmonary devices were evaluated biocompatibility in accordance with ISO 10993-1:2009 Evaluation and Testing. The following tests were performed with acceptable results on the patient contacting portions of the Expect™ Pulmonary device: Cytotoxicity, Sensitization, Irritation, and Systemic Toxicity.
Performance Testing Summary:
Non-clinical comparative performance bench testing was successfully completed to establish substantial equivalence between the proposed Expect™ Pulmonary devices and its primary predicate device Expect™ Slimline device. The following tests were conducted on the Expect™ Pulmonary devices:
-
- Device Flexibility
-
- Device Passability
-
- Device Durability (Robustness)
-
- Needle and Sheath Adjustment Locking Force
-
- Handle actuation force (Needle extension)
-
- Needle Sharpness
-
- Stylet Removal Force
-
- Handle Home Position
-
- Needle Extension Length
-
- Adjustable Working Length (Sheath Extension length)
-
- Needle to Luer Tensile Strength
-
- Sheath to Sheath Hub (Actuation Guide)
-
- Tensile strength; Adaptor to scope tensile
-
- Device Luer to Adaptor Luer to Scope Tensile
-
- Adaptor Lock & Unlock Force
-
- Adaptor Suction
7
-
- Needle Extension Length Marking
-
- Sheath Length Adjustment Markings
-
- Handle Rotation
-
- Smooth Actuation
8. Conclusion:
Boston Scientific has demonstrated that the proposed Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is substantially equivalent to the currently marketed Boston Scientific Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration needle (K133312) and the Olympus Single Use Aspiration Needle NA-201SX-4022 (K050503).