(28 days)
Not Found
No
The summary describes a mechanical aspiration needle and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is used for diagnostic sampling and delivery of materials, not primarily for treating a condition, disease, or injury.
No
Explanation: The device is a needle used to acquire samples from lesions (for further analysis) or deliver injectable materials. It is an accessory to an echoendoscope and facilitates the collection of diagnostic samples or therapeutic delivery, but it does not itself perform a diagnostic function.
No
The device description clearly describes a physical needle and its use with an echoendoscope, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to sample targeted lesions and deliver materials or devices. While the sample obtained might be used for subsequent in vitro diagnostic testing, the needle itself is a tool for obtaining the sample and performing procedures, not for performing the diagnostic test itself.
- Device Description: The description focuses on the physical characteristics and function of the needle for aspiration and delivery, not on analyzing biological samples or providing diagnostic information directly.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro to provide information about a physiological state, health, or disease.
In summary, the Expect™ Slimline (SL) Needle is a medical device used for obtaining samples and performing procedures within the body, which are then potentially used for IVD testing, but the needle itself is 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. It can also be used for delivery of injectable materials (fluids) or fiducials into tissue or for passage of accessory devices.
Product codes (comma separated list FDA assigned to the subject device)
ODG, FCG
Device Description
The Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle is and 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 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. Per manufacturer's instructions, the Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle can also be used for delivery of injectable materials (fluids) or fiducials into tissue or for passage of accessory devices.
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 (SL) device. Bench Testing includes simulated use testing.
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
§ 876.1500 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
October 27, 2017
Boston Scientific Jennifer Edouard Regulatory Specialist, Regulatory Affairs 100 Boston Scientific Way Marlborough, MA 01752
Re: K173184
Trade/Device Name: Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: ODG, FCG Dated: September 28, 2017 Received: September 29, 2017
Dear Jennifer Edouard:
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.
1
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-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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,
Benjamin R. 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
2
Indications for Use
510(k) Number (if known) Unknown K173184
Device Name
Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle
Indications for Use (Describe)
The Expect™ Slimline (SL) Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope. It can also be used for delivery of injectable materials (fluids) or fiducials into tissue or for passage of accessory devices.
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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REVISED - SECTION 6 - 510(k) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Jennifer Edouard Regulatory Affairs Specialist Telephone: 508-683-6134 Fax: 508-683-5939
Date Prepared: September 28, 2017
2. Proposed Device:
Trade Name: Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle Classification Name: Endoscope and Accessories Regulation Number: 876.1500 Product Code: ODG & FCG Classification: Class II
3. Predicate Device:
Trade Name: Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle 510(k) Number: K163058 Classification Name: Endoscopic Ultrasound System, Gastroenetrology-Urology and Biopsy Needle Regulation Number: 876.1500 & 876.1075 Product Code: ODG & FCG Classification: Class II
4. Proposed Device Description:
The Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle is and 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 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. Per manufacturer's instructions, the Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle can also be used for delivery of injectable materials (fluids) or fiducials into tissue or for passage of accessory devices.
4
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. It can also be used for delivery of injectable materials (fluids) or fiducials into tissue or for passage of accessory devices.
6. Technological Characteristics:
There are no differences in the technological characteristics between the proposed device and the predicate Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K163058). The physical device will remain unchanged from the predicate K163058. The only change is to the allowable fiducial marker size that is compatible with the Expect Slimline 22ga Needle. The allowed fiducial size has increased from a 0.35mm OD to a 0.46mm OD. The original design specifications remain unchanged; however, additional performance testing was conducted to evaluate the ability of the device design to support the proposed change.
7. Performance Data:
Bench testing has been performed on the proposed Expect™ Slimline (SL) device. Bench Testing includes simulated use testing.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Expect™ Slimline (SL) is substantially equivalent to the Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K163058).