The Expect™ EUS-FNA device is intended for sampling targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
The Expect™ Endoscopic Ultrasound Aspiration Needle (EUS-FNA) 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.
The provided document describes a 510(k) premarket notification for a medical device, the Expect™ Endoscopic Aspiration Needle, and not a study assessing the device's diagnostic performance for an AI/ML product. The document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than clinical performance data typical of AI/ML software.
Therefore, many of the requested categories in your prompt related to clinical study design, AI/ML performance metrics, ground truth, and expert evaluation cannot be extracted from this document.
Here's an analysis of what can be extracted based on the provided text, and where information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Required specifications for design verification and biocompatibility tests for the nitinol needle component. | The nitinol needle component met the required specifications for the completed design verification and biocompatibility tests. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This was a bench test of a physical device component, not an AI/ML diagnostic test with a "test set" of clinical data.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth as typically defined for AI/ML diagnostic studies is not relevant here as it's a bench test of mechanical and material properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication process was described for the bench testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study was not conducted as this is a physical medical device, not an AI/ML diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. No algorithm is involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device's performance relies on engineering specifications and validated test methods for mechanical and material properties (design verification) and biocompatibility, not clinical data or expert consensus on diagnosis.
8. The sample size for the training set
- Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
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K12198
SEP 1 4 2011
SECTION 6 510(k) SUMMARY
510(k) SUMMARY
- Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4359 Fax: 508-683-5939
Contact: Ashley Pyle Regulatory Affairs Manager Date Prepared: July 29, 2011
2. Proposed Device:
Trade Name: Expect 101 Endoscopic Aspiration Needle Classification Name: Endoscope and Accessories & Endoscopic Ultrasound System Regulation Number: 876.1500 & 876.1075 Product Code: FCG and ODG Classification: Class II
3. Predicate Device:
Trade Name: Expect™ Endoscopic Aspiration Needle Manufacturer and Clearance Number: Boston Scientific Corp. K110030 & K100712 Classification Name: Endoscope and Accessories & Endoscopic Ultrasound System Regulation Number: 876.1500 & 876.1075 Product Code: FCG and ODG Classification: Class II
4. Device Description:
The Expect™ Endoscopic Ultrasound Aspiration Needle (EUS-FNA) 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™ EUS-FNA device is intended for sampling targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
Special 510(k) Premarket Notification, Expect Endoscopic Ultrasound Aspiration Needle
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K112198
6. Technological Characteristics:
The proposed Expect™ EUS-FNA device is a new configuration, which has a needle composed of nitinol. The currently cleared Expect™ EUS-FNA needle is composed of chromium cobalt material (K110030).
7. Performance Data:
Bench Testing has been performed on the proposed Expect™ EUS-FNA device with nitinol needle component, which demonstrates that the nitinol needle component met the required specifications for the completed design verification and biocompatibility tests.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Expect™ Endoscopic Aspiration Needle with the nitionl needle component is substantially equivalent to the currently cleared Expect™ EUS-FNA devices with chromium cobalt needle components (K110030).
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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 depiction of an eagle or bird-like figure 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 emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Ashley Pyle Regulatory Affairs Manager Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752
SEP 1 4 2011
Re: K112198
Trade/Device Name: Expect™ Endoscopic Aspiration Needle Regulation Number: 21 CFR$ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODG, FCG Dated: August 25, 2011 Received: August 26, 2011
Dear Ms. Pyle:
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-related
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Page 2
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Hichard Lemming
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
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KII2198
SECTION 5 INDICATIONS FOR USE STATEMENT
-510(k) Number (if known): ---------------------------------------------------------------------------------------------------------------------------------------------------
Device Name:
Expect™ Endoscopic Aspiration Needle
Indications for Use:
The Expect™ Needle is designed to sample targeted submucosal and extramural lesions through the accessory channel of a curvilinear echoendoscope.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | 8 |
|---|---|
| Division of Reproductive, Gastro Renal, and Urological Devices | |
| 510(k) Number | K112198 |
Special 510(K) Premarket Notification, Expect Endoscopic Ultrasound Aspiration Needle
000015
§ 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.