(176 days)
No
The device description and performance studies focus on the mechanical aspects and physical performance of the needle and associated components. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
Explanation: The device is described as an aspiration needle for collecting samples (FNA) from lesions. This is a diagnostic function, not a therapeutic one. It is used to identify a condition, not to treat it.
No
Explanation: This device is used to collect samples (biopsy) from lesions, which are then typically sent for laboratory analysis for diagnosis. The device itself is not performing the diagnosis.
No
The device description explicitly lists physical components (needle, adaptor, syringe, stopcock) and describes their mechanical functions. There is no mention of software as a component or its function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to collect a sample (fine needle aspiration) from lesions within the tracheobronchial tree using ultrasound guidance. It is a tool for obtaining a biological specimen from the body.
- Device Description: The description details a needle, adaptor, syringe, and stopcock used for the physical act of aspiration. It describes the mechanics of the device for sample collection.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device's purpose is to obtain the specimen, not to analyze it. There is no mention of reagents, assays, or any process for analyzing the collected sample.
In summary, the Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is a surgical/procedural device used for sample collection, not an IVD device used for analyzing samples.
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 no use this instrument for any purpose other than its intended use.
Product codes
EOO, EOQ
Device Description
The Expect™ Pulmonary device is comprised of the following:
- Expect™ Pulmonary needle
- Expect™ Pulmonary adaptor
- Syringe.
- Stopcock.
The Expect™ Pulmonary device 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 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
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
Not Found
Summary of Performance Studies
Non-clinical performance testing was conducted on the Expect™ Pulmonary device which demonstrates the device met the required specifications. The proposed Boston Scientific Expect™ Pulmonary device and packaging were successfully verified after nominal and accelerated age tests, showing the Expect™ Pulmonary device met its shelf life requirements.
The following bench tests were performed:
- 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
- Packaging
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2015
Boston Scientific Corporation Yingying Gao Senior RA Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K151315
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: EOO Dated: October 1, 2015 Received: October 2, 2015
Dear Ms. 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
1
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 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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) K151315
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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3
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: October 29, 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: | Bronchoscope (flexible or rigid) and accessories | |
| Regulation Number: | 874.4680 | |
| Product Code: | EOQ | |
| Classification: | Class II | |
3. Predicate Device:
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 |
4
| Regulation Number: | 876.1075 |
|---|---|
| Product Code: | FCG |
| Classification: | Class II |
| And | |
| Reference device: | |
| Trade Name: | Expect™ Slimline (SL) Endoscopic Ultrasound |
| Aspiration needle | |
| 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 |
4. Device Description:
Device Name: Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
The ExpectTM Pulmonary device is comprised of the following:
- Expect™ Pulmonary needle ●
- Expect™ Pulmonary adaptor ●
- Syringe .
- Stopcock .
The Expect™ Pulmonary device 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 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.
5
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/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 is designed to acquire sample in the Airway 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
Comparison to Predicate:
The proposed Expect Pulmonary device is substantially equivalent to the current marketed predicate, the Olympus Single Use Aspiration Needle NA-201SX-4022 (K050503). The Expect Pulmonary device has similar technological characteristics as the predicate, that is, they operate in the same manner to obtain a tissue biopsy using an ultrasound endoscope. The indication for use of the proposed Expect Pulmonary device is nearly identical to the predicate device.
The comparison of the proposed Expect Pulmonary device and the Olympus Vizishot device is provided in the following Table 6-1.
6
| Device Characteristics | Predicate Olympus Vizishot device
K050503 | Proposed Device BSC Expect™
Pulmonary Device |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | This instrument has been designed to
be used with ultrasonic endoscopes
for ultrasonically guided fine needle
aspiration (FNA) of submucosal and
extramural lesions of the
tracheobronchial tree and the
gastrointestinal tract.
Do not use this instrument for any
purpose other than its intended 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. |
| 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 | 21ga & 22ga | 22ga & 25ga |
| 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 21ga) | Identical. 2.0mm (for both 22ga and
25ga) |
| Device to scope
attachment | Adaptor biopsy valves Attachment for
Olympus ultrasound bronchoscopes. | Adaptor Attachment compatible with
Olympus and Fujinon ultrasound
bronchoscopes. |
Table 6-1 . Comparison of Key Characteristics
7
The primary difference between the proposed Expect™ Pulmonary device and its predicate devices is the gauge size, patient contact materials and adjustable needle length. With the fully completed biocompatibility and performance bench testing, BSC considers these differences do not raise questions about the safety or effectiveness of the device. Based on the comparison above BSC considers the proposed Expect™ Pulmonary device substantially equivalent to the predicate devices.
The currently cleared Boston Scientific device Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration needle (K133312) is used as a reference device based on its design similarity to the Expect™ Pulmonary device.
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.
Sterilization Testing summary:
The proposed Boston Scientific Expect™ Pulmonary devices 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 10 °. 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".
Performance Testing Summary:
Non-clinical performance testing was conducted on the Expect™ Pulmonary device which demonstrates the device met the required specifications. The proposed Boston Scientific Expect™ Pulmonary device and packaging were successfully verified after nominal and accelerated age tests, showing the Expect™ Pulmonary device met its shelf life requirements.
The following bench tests were performed:
-
- 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
8
-
- 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
-
- Packaging
8. Conclusion:
Boston Scientific has demonstrated that the proposed Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is substantially equivalent to the currently marketed Olympus Single Use Aspiration Needle NA-201SX-4022 (K050503).