EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
Device Facts
| Record ID | K230909 |
|---|---|
| Device Name | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) |
| Applicant | Cook Ireland, Ltd. |
| Product Code | FCG · Gastroenterology, Urology |
| Decision Date | May 30, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1075 |
| Device Class | Class 2 |
Intended Use
This device is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal and extramural lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.
Device Story
EchoTip® AcuCore™ is a single-use endoscopic ultrasound (EUS) biopsy needle (22Ga) used by physicians to obtain tissue samples from GI tract lesions. Device consists of handle, sheath, stylet, and cobalt-chromium needle cannula with Franseen tip. Operated manually through accessory channel of ultrasound endoscope. Physician uses ultrasound imaging to guide needle into target lesion; needle punctures tissue to collect core sample. Syringe provides suction to assist sample acquisition. Device design features coiled stylet for easier management and PTFE-coated stainless steel sheath. Intended to provide high-quality histological core tissue samples for diagnostic evaluation. Benefits include sharpness retention, kink resistance, and column strength provided by cobalt-chromium material. Used in clinical settings; output is tissue sample for pathology.
Clinical Evidence
Bench testing only. Performed tests include: needle crumpling compression, suction test, needle puncture test, needle extension length test, stylet pull test, and simulated use testing in a tortuous path. All test articles met acceptance criteria. No clinical data provided.
Technological Characteristics
Needle: Cobalt chromium, 22Ga, Franseen tip. Sheath: PTFE-coated 304 stainless steel coiled sheath. Handle: ABS luer lock, overmolded attachment. Stylet: Nitinol wire, coiled style. Sterilization: Ethylene Oxide (EO). Single-use. Manual operation. Compatible with 2.8mm endoscope channels.
Indications for Use
Indicated for fine needle biopsy (FNB) of submucosal and extramural lesions, mediastinal masses, lymph nodes, and intraperitoneal masses within or adjacent to the GI tract using an ultrasound endoscope.
Regulatory Classification
Identification
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Predicate Devices
- EchoTip ProCore® HD Ultrasound Biopsy Needle (K210476)
Reference Devices
- Acquire Endoscopic Ultrasound Needle Biopsy (FNB) Device (K160845)
Related Devices
- K142688 — Echotip Procore HD Ultrasound Biopsy Needle · Cook Ireland, Ltd. · Dec 19, 2014
- K180363 — Clear-Tip EUS-FNA · Finemedix Co., Ltd. · Nov 1, 2018
- K163058 — Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle · Boston Scientific · Jan 30, 2017
- K171596 — ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle · Wilson-Cook Medical, Inc. · Aug 4, 2017
- K180668 — Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N · Olympus Medical Systems Corp. · Nov 15, 2018
Submission Summary (Full Text)
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May 30, 2023
Cook Ireland Ltd. % Paul Meyer Regulatory Scientist Cook Medical 750 Daniels Way Bloomington, IN 47404
Re: K230909
> Trade/Device Name: EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: FCG, ODG Dated: March 31, 2023 Received: March 31, 2023
Dear Paul Meyer:
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
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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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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,
# Shanil P. Haugen -S
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 Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K230909
Device Name
EchoTip(@ AcuCore T M Ultrasound Biopsy Needle (ECHO-BX-3-22)
Indications for Use (Describe)
This device is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal and extramural lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.
| 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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# 510(k) Summary
# EchoTip® AcuCore™ Ultrasound Biopsy Needle 21 CFR §876.1075 Date Prepared: 19 May 2023
| Submitted By: | |
|-----------------------|-------------------------------------------|
| Submission: | Traditional 510(k) Premarket Notification |
| Applicant: | Cook Ireland Ltd |
| Applicant Address: | O'Halloran Road |
| | National Technology Park |
| | Plassey Limerick V94 N8X2, Ireland |
| Contact: | Laura O'Reilly |
| Email: | laura.oreilly@cookmedical.com |
| Contact Phone Number: | +35361334440 |
#### Device Information:
Trade Name: Device Common Name: Classification Regulation: Device Class: Classification Panel:
EchoTip® AcuCore™ Ultrasound Biopsy Needle Gastrointestinal tube and accessories 21 CFR §876.1075, Product Code FCG Class II Gastroenterology/Urology
# Predicate Device:
Primary Predicate: EchoTip ProCore® HD Ultrasound Biopsy Needle (K210476, Cook Ireland Ltd)
Reference Device: Acquire Endoscopic Ultrasound Needle Biopsy (FNB) Device (Boston Scientific, K160845)
## Device Description:
The EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) is an endoscopic ultrasound needle consisting of a needle assembly and syringe. The needle assembly is comprised of a handle, sheath, stylet and needle cannula. This device is available in one 22Ga needle size. Please see attachment for full device description.
## Indications for Use:
This device is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal and extramural lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.
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## Technological Comparison:
A comparison of the features of the subject device, EchoTip® AcuCore™ Ultrasound Biopsy Needle, and the predicate device, EchoTip® ProCore HD Ultrasound Biopsy Needle are presented in Table 1.1 below.
| Parameter | Comparison | | |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Predicate Device: | Subject Device: | Reference Device: |
| | EchoTip® ProCore HD<br>Ultrasound Biopsy Needle | EchoTip® AcuCore™<br>Ultrasound Biopsy Needle | Boston Scientific<br>Acquire Endoscopic<br>Ultrasound Fine<br>Needle Biopsy (FNB)<br>Device |
| Manufacturer | Cook Ireland Ltd. | Identical to predicate | Boston Scientific |
| Regulation Number | 21 CFR 876.1075 | Identical to predicate | Identical to predicate |
| Product Code | FCG | Identical to predicate | ODG, FCG |
| Classification Name | Gastroenterology - Urology<br>biopsy instrument | Identical to predicate | Identical to predicate |
| Device Class | II | Identical to predicate | Identical to predicate |
| Submission | K210476 | K230909 | K160845 |
| Indications for Use | This device is used with an<br>ultrasound endoscope for fine<br>needle biopsy (FNB) of<br>submucosal lesions,<br>mediastinal masses, lymph<br>nodes and intraperitoneal<br>masses within or adjacent to<br>the gastrointestinal tract. | This device is used with an<br>ultrasound endoscope for<br>fine needle biopsy (FNB),<br>of submucosal and<br>extramural lesions,<br>mediastinal masses, lymph<br>nodes and intraperitoneal<br>masses within or adjacent<br>to the GI tract. | The Acquire™ Fine<br>Needle Biopsy Device<br>is designed to sample<br>targeted submucosal<br>and extramural<br>gastrointestinal<br>lesions through the<br>accessory channel of a<br>curvilinear<br>echoendoscope. |
| Needle Cannula: | | | |
| Parameter | Comparison | | |
| Device Name | Predicate Device:<br>EchoTip® ProCore HD<br>Ultrasound Biopsy Needle | Subject Device:<br>EchoTip® AcuCore™<br>Ultrasound Biopsy Needle | Reference Device:<br>Boston Scientific<br>Acquire Endoscopic<br>Ultrasound Fine<br>Needle Biopsy (FNB)<br>Device |
| Needle Gauge | 19 Ga, 20 Ga, 22 Ga, 25 Ga | 22 Ga, Identical to<br>predicate | 22 Ga, 25 Ga |
| Needle Material<br>Composition | Stainless steel | Cobalt chromium | Cobalt chromium |
| Needle Length<br>Extension Range | 0-8cm | Identical to predicate | Unknown |
| Needle Tip Bevel | Lancet | Franseen | Franseen |
| Side bevel feature | Present | Not present | Not present |
| Luer material | Nickel-plate brass | ABS | Unknown |
| Strain Relief | Yes | Identical to predicate | Unknown |
| Stylet: | | | |
| Wire Material | Nitinol | Identical to predicate | Unknown |
| Needle stylet tip type | Ball | Identical to predicate | Unknown |
| Stylet Shape Upon<br>Removal | 19 Ga, 22 Ga, 25 Ga: Straight<br>20 Ga: Coiled | Coiled | Unknown |
| Total number of<br>dimples | 19 Ga: 735 ± 22<br>20 Ga: 735 ± 22<br>22 Ga: 1444 ± 43<br>25 Ga: 912 ± 27 | 22 Ga: 1444 ± 43 | None |
| Sheath: | | | |
| Parameter | Comparison | | |
| Device Name | Predicate Device:<br>EchoTip® ProCore HD<br>Ultrasound Biopsy Needle | Subject Device:<br>EchoTip® AcuCore™<br>Ultrasound Biopsy Needle | Reference Device:<br>Boston Scientific<br>Acquire Endoscopic<br>Ultrasound Fine<br>Needle Biopsy (FNB)<br>Device |
| Sheath Outer<br>Diameter (Fr) at<br>Largest Point | 19 Ga: 4.8 Fr<br>20 Ga: 7.95 Fr<br>22 Ga: 5.2 Fr<br>25 Ga: 5.2 Fr | 5.3 Fr | Unknown |
| Sheath Length<br>Extension Range | 0 - 5 cm, adjustable | Identical to predicate | Unknown |
| Sheath Material | 19 Ga, 22 Ga, 25 Ga: Grey<br>Polyetheretherketone (PEEK)<br>20 Ga: Polytetrafluoroethylene<br>(PTFE) covered stainless steel<br>coil spring sheath with nylon<br>covering. | Polytetrafluoroethylene<br>(PTFE) coated 304<br>Stainless Steel (SS) coiled<br>sheath | Unknown |
| Adaptor | MLLA | Identical to predicate | Unknown |
| Handle: | | | |
| Method for Sheath /<br>Needle Adjustment | Handle with a safety ring and<br>sheath adjuster including<br>thumbscrews that enable<br>needle and sheath adjustment.<br>Graduation markers indicate<br>extension. | Identical to predicate | Unknown |
| Sheath Adjuster | Yes | Identical to predicate | Unknown |
| Other: | | | |
| Minimum<br>Endoscope Channel | 19, 22, 25 Ga: 2.8 mm | 2.8 mm | Unknown |
| Parameter | Comparison | | |
| Device Name | Predicate Device:<br>EchoTip® ProCore HD<br>Ultrasound Biopsy Needle | Subject Device:<br>EchoTip® AcuCore™<br>Ultrasound Biopsy Needle | Reference Device:<br>Boston Scientific<br>Acquire Endoscopic<br>Ultrasound Fine<br>Needle Biopsy (FNB)<br>Device |
| Size Compatibility | 20 Ga: 3.7 mm | Identical to same gauge<br>size of predicate device. | |
| Supplied with<br>Syringe (with<br>Stopcock) | Yes | Identical to predicate | Unknown |
| Principle/Mechanism<br>of Operation | Manual | Identical to predicate | Identical to predicate |
| Device Usage | For Professional Use | Identical to predicate | Identical to predicate |
| Single Use or<br>Reusable | Single Use | Identical to predicate | Identical to predicate |
| Method of<br>Sterilization | EO | Identical to predicate | Unknown |
| Patient contact type | Directly patient contacting | Identical to predicate | Identical to predicate |
| Packaging | Product placed in tray with<br>Tyvek Lidstock | Identical to predicate | Unknown |
| Shelf Life | 3 years | 1 year | Unknown |
Table 1.1: Substantial Equivalence Comparison.
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The subject EchoTip® AcuCore™ Ultrasound Biopsy Needle shares many design features with the predicate EchoTip ProCore® HD Ultrasound Biopsy Needle, however, there are some differences. The differences between the subject and predicate device are described below.
# 1. Change to Intended Use statement:
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The Intended Use of the EchoTip® AcuCore™ Ultrasound Biopsy Needle device will differ in indications from the existing EchoTip ProCore® HD Ultrasound Biopsy Needle devices. Changes to Intended use statement will be from:
"This device is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract."
#### to:
"This device is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal and extramural lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract."
This change involves the addition of extramural lesions as an anatomical site, referring to lesions that have originated from outside of the gastrointestinal wall. The objective of this change is to align with the market standard of fine biopsy needle devices used with ultrasound endoscopes, for example Boston Scientifics "Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device" which includes extramural gastrointestinal lesions within the intended 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."
This change increases clarity around appropriate relevant anatomical sites by acknowledging that the extramural anatomical site is within the scope of sites that a FNB needle is used to biopsy and aligns the EchoTip® AcuCore™ Ultrasound Biopsy Needle device with the state-of-the-art intended use for this device type and intended use. This update to the indications of use falls within the intended use of the predicate EchoTip ProCore® HD Ultrasound Biopsy Needle. Impact assessment of the change as per the Cook Ireland quality system did not identify new risks to The performed Needle Puncture Test supports this indication update by procedural steps. demonstrating the ability to puncture beyond the walls of the GI tract by using a worst case material representative of liver and pancreatic tissue. The addition of the extramural anatomical site does not raise any new concerns regarding the safety and effectiveness of the use or performance of the modified device when compared to that of the predicate. Therefore, this difference does not constitute a new intended use and does not raise any new questions of safety or effectiveness.
# 2. Needle Material Difference from Stainless Steel to Cobalt chromium
The Boston Scientific Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device also contains a three-point tipped cobalt chromium needle. This device has the same directly patient contacting needle material as the subject device, with a similar nature and duration of patient contact, and similar intended use, and was cleared by the FDA under K160845 on 03 May 2016.
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The key benefits delivered by the cobalt chromium biopsy needle are the ability of the component to incorporate a very thin wall while maintaining column strength, kink resistance, and pushability as well as sharpness retention.
Based on the testing carried out within Cook that indicates that there is no new risk associated with cobalt for the use condition when compared to the predicate material, and the supporting literature which proves that the benefits outweigh that of the risk associated with the use of cobalt in medical devices, there is no reason to source an alternative material and the use of cobalt chromium containing cobalt within the device is acceptable. Therefore, the difference in material does not raise any new questions of safety or effectiveness.
#### 3. Needle tip and side bevel
The needle tip of the predicate device will have a Franseen instead of a Lancet tip design. The Boston Scientific Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device also contains a three-point tipped Franseen design cobalt chromium needle. This device has the same directly patient contacting needle material as the subject device, with a similar nature and duration of patient contact, and similar intended use, and was cleared by the FDA under K160845 on 03 May 2016.
Fine needle biopsy (FNB) has been introduced in to obtain samples with preserved tissue architecture. Common FNB needle designs include reverse bevel needle, fork-tip needle and Franseen-type needle. One of the most recent introduced FNB needles mentioned above, threepronged cutting edges Franseen geometry needle, has been reported to acquire a high rate of histological core tissue sampling. Additionally, the bleeding complication rate associated with Franseen needle tip on Pancreas and liver biopsy is comparable with the overall bleeding complication rate using a fine needle aspiration (FNA)/FNB needle on pancreas and liver biopsy. Furthermore, the subject device's capability to perform as intended has been demonstrated through performance testing. Therefore, no new risks or concerns relating to safety and effectiveness of the subject device were raised by making the proposed needle tip design change, when compared to the currently marketed predicate device.
#### 4. Luer material
The predicate EchoTip® ProCore HD Ultrasound Biopsy Needles' luer lock is composed of nickel-plated brass whereas the subject EchoTip® AcuCore™ Ultrasound Biopsy Needle's Luer lock is made of Acrylonitrile Butadiene Styrene (ABS). The process for creating the Luer attachment to the needle cannula is also proposed to change from soldering to overmolding. The Luer component is located on the proximal end of device and so, does not directly or indirectly
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contact the patient. Nevertheless, biocompatibility and performance testing on the device has demonstrated that the subject device meets the clinically relevant requirements. This difference does not significantly affect the use of the device and there were no new or significantly modified risks identified in the impact assessment of this change. Therefore, the difference in Luer material do not raise any new questions of safety or effectiveness.
#### 5. Sheath material and dimensional difference
The sheath holder assembly components of the predicate devices consist of a Polyetheretherketone (PEEK) tubing component in the 19 Ga, 22 Ga, 25 Ga sizes of the predicate device and a Polytetrafluoroethylene (PTFE) covered stainless steel coil spring sheath with nylon covering in the 20 Ga size of the predicate device. The subject device sheath holder assembly consists of a Polytetrafluoroethylene (PTFE) coated 304 stainless steel (SS) coiled sheath. The PTFE material is comparable and equivalent between the predicate and subject devices in terms of patient contacting material and patient contact type and duration. A biocompatibility assessment and biological testing supports the biological safety of the subject device when used as intended. Additionally, the subject device's capability to perform as intended has been demonstrated through performance testing. Therefore, this material change does not raise any risks or concerns relating to safety or effectiveness for the subject device. The sheath outer diameter (OD) of the modified device is 5.3Fr, the sheath OD for the same needle gauge size (22 Ga) of the predicate device is 5.2Fr. This change has been assessed as non-significant and does not raise new concerns related to safety or effectiveness when considering the subject device.
## 6. Stylet Style
The stylet of the subject 22 Ga EchoTip® AcuCore™ Ultrasound Biopsy Needle is a recoil stylet, whereas the predicate device's 22 Ga model has a straight stylet. The coiled shape of the stylet allows for easier management of the stylet on removal and reduces risk of contamination. The coiled shape of the subject device is already used in the 20 Ga size of the predicate device and the function of the stylet has been evaluated via performance testing and found to meet the relevant acceptance criteria. Therefore, this difference between the subject and predicate device does not raise any new questions of safety or effectiveness.
## 7. Shelf life
The shelf life of the modified device will be 1 year (the predicate device shelf life is 3 years). Simulated Use testing has been carried out on 13 months Accelerated Aged devices. This testing supports a 1-year shelf life for the subject device, which falls within the 3-year shelf life of the
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predicate device and, therefore, does not raise any concerns or questions regarding subject device safety or effectiveness.
# Non-Clinical and/or Clinical Tests Summary & Conclusions
The following non-clinical testing was performed on the subject device to support this submission.
- Needle Crumpling Compression test intended to challenge the ability of the ECHO family of -Endoscopic Ultrasound needles to withstand handle angulation. All test articles met the acceptance criteria.
- Suction Test intended to assess the ability of the performance of the device to meet the । requirement to perform suction at endoscopic ultrasound needle device based on the suction pressure created by the syringe. All test articles met the acceptance criteria.
- Needle Puncture Test intended to evaluate the comparative performance and function of -Endoscopic ultrasound needles in terms of puncture force. All test articles met the acceptance criteria.
- Needle Extension Length test intended to assess the performance of the device to meet the needle extension length test. All test articles met the acceptance criteria.
- Stylet pull test intended to evaluate the removal force for the device's stylet. All test articles met the acceptance criteria.
- Simulated use testing intended to qualitatively evaluate the performance of the device using a tortuous path that simulates the intended use conditions. All acceptance criteria as defined in the study protocol were met.
The results of these tests confirm that the EchoTip® AcuCore™ Ultrasound Biopsy Needle meets the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety and/or effectiveness and is substantially equivalent to the predicate device, the EchoTip ProCore® HD Ultrasound Biopsy Needle (K210476, Cook Ireland Ltd).
