Echotip Procore HD Ultrasound Biopsy Needle

K142688 · Cook Ireland, Ltd. · FCG · Dec 19, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K142688
• Device Name: Echotip Procore HD Ultrasound Biopsy Needle
• Applicant: Cook Ireland, Ltd.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Dec 19, 2014
• 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 lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

Device Story

EchoTip Procore HD Ultrasound Biopsy Needle is a manual surgical instrument used with ultrasound endoscopes for tissue sampling. Device consists of a stainless steel needle cannula with a bevelled tip and notch, a nitinol stylet, a sheath, and a handle. Operated by clinicians in clinical settings to perform fine needle biopsies of GI-adjacent masses. The needle tip features a dimpling pattern for enhanced visualization under ultrasound guidance. The clinician inserts the needle into the target site; the stylet is withdrawn to facilitate tissue collection, optionally aided by an attached syringe for aspiration. The handle allows for adjustment of needle and sheath length. The device is supplied sterile for single use. By enabling precise tissue acquisition under ultrasound visualization, the device assists in the diagnosis of lesions and masses, supporting clinical decision-making regarding patient pathology.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity), visual and dimensional inspection, simulated use, stylet removal force, and joint strength testing.

Technological Characteristics

Stainless steel needle cannula with dimpled tip and notch; nitinol stylet; handle for length adjustment. Single-use, sterile (EO). Manual operation. No electronic components or software.

Indications for Use

Indicated for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes, and intraperitoneal masses within or adjacent to the gastrointestinal 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

• Cook Endoscopic Ultrasound Needle (K083330)
• Biopsy Sciences, LLC Maxi-Cell Biopsy Needle (K021847)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19, 2014

Cook Ireland Ltd Nora O'Connor Regulatory Affairs Specialist O'halloran Road National Technology Park Limerick Ireland

Re: K142688

> Trade/Device Name: Echotip Procore® Hd Ultrasound Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: FCG Dated: September 18, 2014 Received: September 22, 2014

Dear Nora O'Connor,

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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -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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Cook Ireland EchoTip Procore® HD Ultrasound Biopsy Needle

510(k) Number (if known):

Device Name: EchoTip Procore® HD Ultrasound Biopsy Needle

Indications for Use:

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 gastrointestinal tract.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <div style="text-align:center;">✓</div> | AND/OR |
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Over-The-Counter Use ____________ (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 510(k) Summary

#### I. SUBMITTER

Cook Ireland Ltd. O'Halloran Road National Technology Park Limerick, Ireland

Phone: [phone] Fax: [phone]

Contact Persons: Nora O'Connor, Regulatory Affairs Specialist Jacinta Kilmartin, Senior Regulatory Affairs Specialist

Phone: [phone] Fax: [phone]

Date Prepared: October 31, 2014

#### II. DEVICE

Trade Name of Device: EchoTip Procore® HD Ultrasound Biopsy Needle. The model number is ECHO-HD-(3)-XX-C where XX denotes the needle gauge size.

Common or Usual Name: Endoscopic Ultrasound Needle (Biopsy Needle Kit)

Classification Name: Gastroenterology-urology biopsy instrument (21 CFR 876.1075)

Regulatory Class: II

Product Code: FCG

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#### III. PREDICATE DEVICE

Cook Endoscopic Ultrasound Needle, K083330. Biopsy Sciences, LLC Maxi-Cell Biopsy Needle, K021847

#### IV. DEVICE DESCRIPTION

The EchoTip Procore® HD Ultrasound Biopsy Needle is used in conjunction with an ultrasound endoscope and is available with needle gauge sizes of 19, 20, 22 and 25 ga. The device comprises of a needle assembly and a syringe. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The needle cannula has a bevelled tip design and a notch. The purpose of the needle cannula is for puncturing/biopsy of the target site. The preloaded nitinol stylet is withdrawn from the needle for biopsy. Some variants have a stylet that coils when not in the needle. The sheath covers the needle when it's not in use. The device handle allows for needle and sheath length adjustment. The syringe can aid in tissue aspiration. The device is supplied sterile and is intended for single use. The device is for Rx used only.

#### INDICATIONS FOR USE V.

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 gastrointestinal tract.

### COMPARISON OF TECHNOLOGICAL CHARACETERISTICS WITH A VI. PREDICTE DEVICE

The modified device is substantially equivalent to the currently marketed device, the Cook Endoscopic Ultrasound Needle, as cleared by K083330. Both devices operate in the same manner to obtain a tissue biopsy using an ultrasound endoscope.

The modified device is substantially equivalent to the currently marketed device, Biopsy Sciences, LLC Maxi-Cell Biopsy Needle, as cleared by K021847. Both the modified and predicate device operate in a similar manner to obtain a sample.

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At a high level, the modified device is identical to/ within the range of the Cook Endoscopic Ultrasound Needle predicate device with respect to the following:

- . Needle gauge range and material,
- . Needle length adjustment range and sheath extension adjustment range,
- Stylet diameter range and material,
- Stylet tip options, ●
- Compatibility with an ultrasound endoscope, ●
- . Use with a syringe,
- Mechanism/principle of operation (manual, sampling using cutting and aspiration),
- Method of needle and sheath adjustment (handle), .
- For single use, and
- Sterility (using EO).

The following technological differences exist between the modified device and the Cook Endoscopic Ultrasound Needle predicate device:

- . Needle cannula - addition of notch,
- Stylet shape upon removal (coiled), stylet distal tip location and stylet cap, ●
- . Sheath - material (addition of a covering, change in colour), outer diameter change,
- . Handle - colour change (non-patient contacting).

The modified device is identical to/ within the range of the Biopsy Sciences, LLC Maxi-Cell Biopsy Needle with respect to the following:

- Needle material , .
- Presence of a notch on the needle, .
- Used with a syringe, .
- Mechanism/principle of operation (manual, sampling using cutting and aspiration),
- For single use, and
- Sterility (using EO).

The EchoTip Procore® HD Ultrasound Biopsy Needle has the following differences to the features of the Biopsy Sciences, LLC Maxi-Cell biopsy needle:

- . Needle gauge range.
- Stylet material, shape upon removal, .
- The addition of a sheath, and ●
- The handle type.

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#### VII. PERFORMANCE DATA

The biocompatibility evaluation for EchoTip Procore® HD Ultrasound Biopsy Needle was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, G95-1 Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (May 1, 1995). The following tests were completed: Cytotoxicity, Sensitization and Intracutaneous reactivity.

The device specific guidance document was consulted in preparing this premarket submission, Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology. Performance testing such as visual inspection, dimensional inspection, simulated use, stylet removal force testing and joint strength testing were performed as per Cook Ireland's design control system.

#### CONCLUSIONS VIII.

Non-clinical testing carried out on the device supports the substantial equivalence of the EchoTip Procore® HD Ultrasound Biopsy Needle to the predicate devices and provides a reasonable assurance of safety and effectiveness.