(36 days)
The Acquire™ Fine Needle Biopsy Device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
The Acquire™ device is comprised of the following:
- One (1) Acquire™ needle
- One (1) Syringe
- One (1) Stopcock
The Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is a sterile singleuse device. It 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.
Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample.
This document is a 510(k) premarket notification for a medical device called the Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device. It describes the device and claims substantial equivalence to a predicate device.
Based on the provided text, the following information can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| "Franseen" Needle Grind Specification | The modified needle tip design met the pre-defined product specification. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "No performance testing is required to evaluate the new needle tip design. Verification activity has been performed on the proposed Acquire™ device, which demonstrates that the modified needle tip design met the pre-defined product specification: 'Franseen' Needle Grind Specification."
This indicates that a formal clinical "test set" with patient data was not used for the determination of substantial equivalence based on clinical performance. The testing focused on meeting specific engineering/design specifications of the new needle tip. Thus, there is no information about the sample size of a test set nor its provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
As direct clinical performance testing on a "test set" to establish ground truth about diagnostic accuracy or effectiveness was not conducted according to the document, this information is not applicable and therefore not provided. The verification focused on physical specifications.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set for diagnostic performance was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document states that "No performance testing is required to evaluate the new needle tip design." The focus was on engineering specifications and substantial equivalence to a predicate device based on similar intended use and technological characteristics, with the exception of the needle tip geometry.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable to this medical device. The Acquire™ device is a physical, sterile, single-use endoscopic ultrasound aspiration needle used by a human operator (a clinician) to acquire tissue samples. It is not an algorithm or an AI-powered device.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the "Franseen" Needle Grind Specification. The performance verification ensured the manufactured device adhered to this engineering specification, rather than to a medical "ground truth" like pathology results.
8. The Sample Size for the Training Set
Not applicable. The device is a physical medical instrument, not an AI or algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2016
Boston Scientific Corporation Yingying Gao Sr. RA Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K160845
Trade/Device Name: Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODG, FCG Dated: April 27, 2016 Received: April 28, 2016
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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.
for
Sincerely yours,
Herbert P. Lerner -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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Indications for Use
510(k) Number (if known)
Device Name
Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
Indications for Use (Describe)
The Acquire™ Fine Needle Biopsy Device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Yingying Gao Senior 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: March 24, 2016
2. Proposed Device:
Trade Name: Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device Classification Name: Endoscopic Ultrasound System, gastroenterology-urology Regulation Number: 876.1500 & 876.1075 Product Code: ODG and FCG Classification: Class II
3. Predicate Device:
Trade Name: Expect™ Slimline Endoscopic Ultrasound Aspiration Needle Manufacturer and Clearance Number: Boston Scientific Corp, K133312 Classification Name: Endoscopic ultrasound system, gastroenterology-urology Regulation Number: 876.1500 & 876.1075 Product Code: ODG and FCG Classification: Class II
4. Device Description:
Device Name: Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
The Acquire™ device is comprised of the following:
- One (1) Acquire™ needle ●
- One (1) Syringe ●
- One (1) Stopcock ●
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The Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is a sterile singleuse device. It 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.
Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample.
5. Intended use/ Indications for Use:
The Acquire™ Fine Needle Biopsy Device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
6. Technological Characteristics:
The proposed Acquire™ device is used to acquire samples in the digestive tract by coupling it with an ultrasound curvilinear endoscope. The proposed Acquire™ device is identical to the predicate Expect™ Slimline device, with the exception of the needle tip geometry. The proposed Acquire™ device will be offered with a Franseen needle tip (three-pronged tip). The proposed Acquire™ device shares the same technical characteristics as its predicate, the currently cleared Expect™ Slimline EUS-FNA needle (K133312).
7. Performance Data:
No performance testing is required to evaluate the new needle tip design. Verification activity has been performed on the proposed Acquire™ device, which demonstrates that the modified needle tip design met the pre-defined product specification: "Franseen" Needle Grind Specification.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is substantially equivalent to the currently cleared Expect™ Slimline EUS-FNA needle (K133312).
§ 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.