(25 days)
Not Found
No
The description focuses on the mechanical aspects of a biopsy needle and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is designed to sample targeted gastrointestinal lesions, which is a diagnostic purpose, not a therapeutic one. It acquires a sample, it does not treat the lesion.
No
This device is a biopsy device designed to acquire tissue samples, which are then used for diagnostic purposes. The device itself does not perform the diagnosis.
No
The device description clearly details a physical biopsy needle with adjustable components, a handle, and accessories like a syringe and stopcock, indicating it is a hardware device.
Based on the provided information, the Acquire S Fine Needle Biopsy Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to sample lesions. It is a tool for obtaining a biological specimen.
- Device Description: The description focuses on the mechanical aspects of the device for acquiring a sample (needle penetration, suction, manipulation). It does not describe any components or processes for analyzing the sample itself.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic purposes. This device's function is to collect the specimen, not to perform the diagnostic analysis on it.
- Performance Studies: The performance studies described focus on the mechanical and physical properties of the device (durability, forces, lengths), not on the diagnostic accuracy of analyzing samples obtained with the device.
The Acquire S Fine Needle Biopsy Device is a medical device used for obtaining a sample, which is then likely sent to a laboratory for in vitro diagnostic testing. The device itself is a tool for sample collection, not the diagnostic test itself.
N/A
Intended Use / Indications for Use
The Acquire S Fine Needle Biopsy Device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
Product codes (comma separated list FDA assigned to the subject device)
ODG, FCG
Device Description
The Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is an endoscopic ultrasound biopsy 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 device sheath length can be adjusted to accommodate different model echoendoscopes. The need to acquire samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. Both the sheath and needle length can be adjusted based on distance to the target lesion. The sheath and needle length adjustments are set and locked by the physician by using the locking knob mechanisms on the handle of the device. A sample is obtained by penetrating the lesion with the needle while applying suction and manipulating the needle in a back and forth motion to acquire a sample. The sample can be prepared per normal institutional protocol. The Acquire™ Needle has echogenic (visible under ultrasound) features at the distal end to facilitate real time visualization of the device under ultrasound.
Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Gastrointestinal lesions, within and adjacent to the digestive system's major lumens.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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)
Non-clinical performance bench testing, simulated use testing, biocompatibility per the requirements of ISO 10993, and sterilization validation per the requirements of ISO 11135 were completed to evaluate the design of the Acquire™ S device for the change in stylet tip geometry.
Bench Testing included:
- Device Durability
- Stylet Removal Force
- Needle Extension Length
- Adjustable Catheter Length
- Stylet Cap Tensile
All testing was passing and demonstrates the device's ability to fulfill non-clinical performance bench testing, biocompatibility, and sterilization requirements.
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
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December 30, 2022
Boston Scientific Corporation Kyra Mcnamara Regulatory Affairs Specialist II 100 Boston Scientific Wav Marlborough, MA 01752
Re: K223616
Trade/Device Name: Acquire™ S 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: December 2, 2022 Received: December 5, 2022
Dear Kyra Mcnamara:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sivakami Venkatachalam -S
for
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223616
Device Name
Acquire S endoscopic ultrasound fine needle biopsy (fib) device
Indications for Use (Describe)
The Acquire S 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
Primary Contact: Kyra McNamara Regulatory Affairs Specialist II Telephone: (508)-382-0375 Date Prepared: December 2, 2022
2. Proposed Device:
| Trade Name: | Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy
(FNB) Device |
|----------------------|---------------------------------------------------------------------|
| Classification Name: | Endoscopic ultrasound system, gastroenterology-urology |
| Regulation Number: | 21 CFR 876.1500 & 876.1075 |
| Product Code: | ODG and FCG |
| Regulatory Class: | Class II |
3. Predicate Device:
| Trade Name: | Acquire TM Endoscopic Ultrasound Fine Needle Biopsy
(FNB) Device |
|----------------------|---------------------------------------------------------------------|
| Manufacturer: | Boston Scientific |
| 510(k) Number: | K160845 |
| Classification Name: | Endoscopic ultrasound system, gastroenterology-urology |
| Regulation Number: | 21 CFR 876.1500 & 876.1075 |
| Product Code: | ODG and FCG |
| Regulatory Class: | Class II |
4. Device Description:
Device Name: Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
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K223616 Page 2 of 3
The Acquire™ S device is comprised of the following:
- One (1) Acquire STM needle ●
- One (1) Vacuum Syringe .
- One (1) One-Way Stopcock ●
The Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is an endoscopic ultrasound biopsy 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 device sheath length can be adjusted to accommodate different model echoendoscopes. The need to acquire samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. Both the sheath and needle length can be adjusted based on distance to the target lesion. The sheath and needle length adjustments are set and locked by the physician by using the locking knob mechanisms on the handle of the device. A sample is obtained by penetrating the lesion with the needle while applying suction and manipulating the needle in a back and forth motion to acquire a sample. The sample can be prepared per normal institutional protocol. The Acquire™ Needle has echogenic (visible under ultrasound) features at the distal end to facilitate real time visualization of the device under ultrasound.
Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample.
5. Intended use/ Indications for Use:
The Acquire™ S 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™ S device is a 139cm long needle used to acquire samples in the digestive tract by coupling it with an ultrasound curvilinear endoscope. The proposed Acquire™ S device is identical to the predicate Acquire™ device, with the exception of the stylet tip geometry. The proposed Acquire™ S device will have a taper point stylet, compared to the currently cleared Acquire™, which has a ball point stylet tip. The proposed Acquire™ S device shares the same technical characteristics as its predicate, the currently cleared Acquire ™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K160845).
7. Performance Data:
Non-clinical performance bench testing, simulated use testing, biocompatibility per the requirements of ISO 10993, and sterilization validation per the requirements of ISO 11135 were completed to evaluate the design of the Acquire™ S device for the change in stylet tip geometry.
Bench Testing included:
- Device Durability ●
- . Stylet Removal Force
- Needle Extension Length ●
- Adjustable Catheter Length ●
- Stylet Cap Tensile
All testing was passing and demonstrates the device's ability to fulfill non-clinical performance bench testing, biocompatibility, and sterilization requirements.
5
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is substantially equivalent to the currently cleared Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K160845).