(65 days)
This device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The target population is adult use only.
The ECHO-3-22: Echotip Ultra and the EUSN-1, EUSN-3: Echotip Ultrasound Needles are sterile, single use devices. The Ultrasound Needles consist of an adjustable luer slip handle, an outer and an inner catheter with a needle, extension locks (ECHO-3-22) or spacers (EUSN-1, EUSN-3), a stylet, and a syringe with a stopcock. All devices are compatible with ultrasound endoscopes with a minimum accessory channel of 2.8 mm. The catheter is made of polyether ether ketone, PEEK (ECHO-3-22), or polytetrafluoroethylene, PTFE (EUSN-1, EUSN-3), while the needle of all devices is stainless steel, and the stylet is nitinol. The tips of the needles are dimpled for echogenicity.
This document describes a 510(k) premarket notification for a medical device and is a regulatory submission, not a study report. Therefore, it does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance as typically expected for an AI/ML medical device.
The document states that "Performance testing consisting of non-clinical bench testing demonstrates that the Ultrasound Needles meet the performance requirements to fulfill the intended use of the device." and lists the types of non-clinical testing conducted. However, it does not provide:
- Specific acceptance criteria values or the reported device performance against those criteria.
- Any information about sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details because these are concepts typically associated with diagnostic or AI/ML device performance evaluations, not for a biopsy needle.
- Any training set information as this device is a physical medical instrument, not an AI/ML algorithm.
Therefore, I cannot populate the table or provide the requested details from the provided document. The document confirms that non-clinical bench testing was performed to demonstrate performance, but the specifics of that performance or the criteria used are not included in this summary.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
* Cannot be provided. The document states that "Performance testing ... demonstrates that the Ultrasound Needles meet the performance requirements" but does not define these requirements (acceptance criteria) or report specific performance metrics or values.
2. Sample size used for the test set and the data provenance:
* Cannot be provided. This document describes non-clinical bench testing of a physical device (a needle), not a diagnostic algorithm with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. Ground truth, in the context of expert consensus, is relevant for diagnostic device performance evaluation using patient data, not for the physical performance testing of a biopsy needle itself.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable. See point 3.
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. This is a physical medical device (biopsy needle), not an AI/ML diagnostic system. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not applicable. Ground truth is not relevant in the context of the physical performance testing of a biopsy needle against engineering specifications.
8. The sample size for the training set:
* Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
* Not applicable. See point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2017
Wilson-Cook Medical, Inc. Tiffanny A. Thomas Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K171596
Trade/Device Name: ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: II Product Code: FCG Dated: June 2, 2017 Received: June 5, 2017
Dear Tiffanny A. Thomas:
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.
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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 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 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.
Sincerely,
Charles Viviano -S
For
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
ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
Indications for Use (Describe)
This device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The target population is adult use only.
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
| Submission Information | |
|---|---|
| Type: | Traditional 510(k) Premarket Notification |
| Applicant Name: | Wilson-Cook Medical, Inc./ Cook Endoscopy |
| Applicant Address: | 4900 Bethania Station RoadWinston-Salem, North Carolina 27105 |
| Contact: | Tiffanny A. Thomas, Global Regulatory Affairs Specialist |
| Contact Phone: | 336.744.0157 |
| Contact Fax: | 336.201.5994 |
| Date: | May 31, 2017 |
| Subject Device | |
| Trade Name: | ECHO-3-22: Echotip Ultra; EUSN-1, EUSN-3: Echotip |
| Common/Usual Name: | Ultrasound NeedleBiopsy Needle |
| Classification: | Gastroenterology-Urology Biopsy Instrument21 CFR §876.1075, Class II |
| Procode: | FCG – Biopsy Needle |
| Predicate Device | |
| Name: | Endoscopic Ultrasound Needle |
| 510(k) Number: | K934356 |
| Date Cleared: | January 30, 1995 |
Device Description:
The ECHO-3-22: Echotip Ultra and the EUSN-1, EUSN-3: Echotip Ultrasound Needles are sterile, single use devices. The Ultrasound Needles consist of an adjustable luer slip handle, an outer and an inner catheter with a needle, extension locks (ECHO-3-22) or spacers (EUSN-1, EUSN-3), a stylet, and a syringe with a stopcock. All devices are compatible with ultrasound endoscopes with a minimum accessory channel of 2.8 mm. The catheter is made of polyether ether ketone, PEEK (ECHO-3-22), or polytetrafluoroethylene, PTFE (EUSN-1, EUSN-3), while the needle of all devices is stainless steel, and the stylet is nitinol. The tips of the needles are dimpled for echogenicity.
Intended Use
This device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The target population is adult use only.
Comparison to Predicate Device:
Design changes were made to the predicate Endoscopic Ultrasound Needle cleared to market via K934356. Changes to the device include: catheter length, material, needle dimple area extension length, gauge size, new handle designs and inclusion of a syringe with a stopcock. The subject Ultrasound Needles are equivalent to the predicate device with respect to intended use, key operating principles, and technological characteristics.
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Performance Data:
Performance testing consisting of non-clinical bench testing demonstrates that the Ultrasound Needles meet the performance requirements to fulfill the intended use of the device. Results from design validation and/or verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness.
Summary of non-clinical testing:
The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirmed that the subject devices perform as intended.
- Functional Testing
- Shelf Life Testing
- Packaging Validation
- Needle Verification and Validation Testing ●
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process."
Conclusions:
We believe that the subject device is substantially equivalent to the predicate device in terms of intended use, key operating principles, materials and technological characteristics. We consider the risks associated with the modifications to the subject device to have been adequately addressed through our Design Control Processes and do not affect safety or effectiveness of the device.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.