(67 days)
Not Found
No
The description focuses on the mechanical function of a needle for aspiration and does not mention any computational or analytical capabilities that would suggest AI/ML. The performance studies are bench tests of mechanical properties.
No
The device is described as an aspiration needle designed to sample lesions, not to treat them.
No.
This device is designed for obtaining aspiration samples from lesions, which is a method of acquiring biological material for analysis, rather than performing a diagnostic function itself. The diagnostic function would be carried out by a separate analysis of the acquired sample.
No
The device description clearly states it is an "endoscopic ultrasound aspiration needle" and describes physical components and bench testing related to hardware performance (durability, locking force, actuation force, etc.). It is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The tests are performed outside the body (in vitro).
- Device Function: The Expect™ Slimline (SL) Needle is a device used to collect a sample (aspiration sample) from a lesion within the body. It is a tool for obtaining the sample, not for performing a diagnostic test on the sample itself.
- Intended Use: The intended use is to "sample targeted submucosal and extramural gastrointestinal lesions." This describes the process of obtaining a sample, not analyzing it for diagnostic purposes.
- Device Description: The description focuses on the mechanical aspects of the needle and its use in acquiring a sample. It doesn't mention any components or processes related to analyzing the sample or providing diagnostic information.
The sample collected by this needle would likely be sent to a laboratory for in vitro diagnostic testing, but the needle itself is a sample collection device, not an IVD.
N/A
Intended Use / Indications for Use
The Expect™ Slimline (SL) Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
Product codes
ODG, FCG
Device Description
The Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle is an endoscopic ultrasound aspiration needle that can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope with a standard luer connection and delivered into the digestive tract. The needle is used to acquire aspiration samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. An aspiration sample is obtained by penetrating the lesion with the needle while applying suction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
submucosal and extramural gastrointestinal lesions
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)
Bench Testing has been performed on the proposed Expect" Slimline device, which demonstrates that the modified handle design met the required specifications for completed design verification tests. Bench Testing includes:
- Device Durability
- Needle and Sheath Adjustment Locking Force
- Handle (Needle) Actuation Force
- Device Handle Tensile Test
- Locking Knob Retention
- Smooth Actuation of Handle
- Needle Extension Length
- Device (Handle) Resistance to Torque
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
JAN - 3 2014
SECTION 6. 510(K) SUMMARY
510(k) SUMMARY
- Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Yingying Gao: 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 25th, 2013
- Proposed Device:
Trade Name: Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle Classification Name: Endoscope and Accessories & Endoscopic Ultrasound System Regulation Number: 876.1500 & 876.1075 Product Code: ODG and FCG Classification: Class II
3. Predicate Device:
Trade Name: Expect™ Endoscopic Aspiration Needle Manufacturer and Clearance Number: Boston Scientific Corp, K110030 Classification Name: Endoscope and Accessories & Endoscopic Ultrasound System Regulation Number: 876.1500 & 876.1075 Product Code: ODG and FCG Classification: Class II
And
Trade Name: Expect" Endoscopic Aspiration Needle Manufacturer and Clearance Number: Boston Scientific Corp, K112198 Classification Name: Endoscope and Accessories & Endoscopic Ultrasound System Regulation Number: 876.1500 & 876.1075 Product Code: ODG and FCG Classification: Class II
Special 510(k) Premarket Notification, Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle SECTION 6
. IQ
1
4. Device Description:
The Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle is an endoscopic ultrasound aspiration needle that can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope with a standard luer connection and delivered into the digestive tract. The needle is used to acquire aspiration samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. An aspiration sample is obtained by penetrating the lesion with the needle while applying suction.
5. Indications for Use:
The Expect™ Slimline (SL) Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
6. Technological Characteristics:
The proposed Expect™ Slimline device is a new configuration, including slim handle design, low profile locking knobs with retention feature and modified handle internal components. The currently cleared Expect™ EUS-FNA needle is composed of an ergonomic handle with bigger outer diameter (K110030 & K112198).
7. Performance Data:
Bench Testing has been performed on the proposed Expect" Slimline device, which demonstrates that the modified handle design met the required specifications for completed design verification tests. Bench Testing includes:
- . Device Durability
- Needle and Sheath Adjustment Locking Force .
- . Handle (Needle) Actuation Force
- . Device Handle Tensile Test
- . Locking Knob Retention
- Smooth Actuation of Handle .
- . Needle Extension Length
- Device (Handle) Resistance to Torque
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Expect™ Slimline Endoscopic Aspiration Needle is substantially equivalent to the currently cleared Expect EUS-FNA devices (K110030 & K112198).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 3, 2014
Boston Scientific Corporation Yingying Gao Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
- Re: K133312
Trade/Device Name: Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODG, FCG Dated: December 5, 2013 Received: December 6, 2013
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
3
Page 2 - Yingying Gao
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin Fisher -S
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
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SECTION 4. INDICATIONS FOR USE STATEMENT
K133312 510(k) Number (if known): Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Device Name: Needle The Expect™ Slimline (SL) Needle is designed to sample Indications for Use: . targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
Prescription Use AND/OR X (Part 21 CFR 801 Subpert D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IP NEBORD)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin Risher -S 2014.01.03 12 12 12 2017 -05 00
Special 510(k) Premistici Notification, Experile Slimline (SL) Enicscopic Ultrassund Aspiration Newlo 88CHON 5
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