Flexible 19G EBUS Needle

K142909 · Spiration, Inc. · EOQ · Apr 24, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K142909
• Device Name: Flexible 19G EBUS Needle
• Applicant: Spiration, Inc.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Apr 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended Use

The Flexible 19G EBUS Needle has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.

Device Story

Flexible 19G EBUS Needle is a single-use, sterile aspiration device used with ultrasound endoscopes for tissue biopsy. Device components include a handle, sheath, needle, and removable stylet. Operation involves inserting the catheter through a bronchoscope working channel (2.2mm), advancing the needle to penetrate a target lesion, and applying manual suction at the handle to collect the sample. Used in clinical settings (endoscopy/bronchoscopy suites) by trained medical professionals. The device facilitates tissue acquisition for diagnostic purposes, aiding clinical decision-making regarding lesion pathology. Benefits include improved access to tracheobronchial lesions via a larger, more flexible distal tip compared to smaller-gauge needles.

Clinical Evidence

Bench testing only. In vitro and ex vivo (bovine lung) testing performed to verify mechanical integrity, including insertion/withdrawal forces, handle durability, echogenicity, and biopsy sample size. Comparison testing conducted against the predicate (21G) and a reference 19G needle. Biocompatibility testing (cytotoxicity, sensitization, irritation, hemocompatibility, systemic toxicity) passed. All testing met predetermined acceptance criteria.

Technological Characteristics

Materials: PTFE, Stainless Steel, Nitinol, PEBAX, HDPE. Manual actuation. 19G needle gauge. 1.9mm working diameter. 70cm catheter length. Sterile, single-use. EO sterilization. No software or electronic components.

Indications for Use

Indicated for patients requiring ultrasound-guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Single Use Aspiration Needle (K050503)

Reference Devices

• Boston Scientific 19G Scientific eXcelon Transbronchial Aspiration Needle

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

April 24,2015

Cyndy Adams Senior Regulatory Affairs Manager Spiration, Inc. 6675 185th Avenue Ne Redmond, WA 98052

Re: K142909

Trade/Device Name: Flexible 19G EBUS Needle Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: II Product Code: EOQ Dated: March 26, 2015 Received: March 27, 2015

Dear Ms. Adams:

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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Page 2 - Ms. Adams

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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K142909

Device Name Flexible 19G EBUS Needle

Indications for Use (Describe)

The Flexible 19G EBUS Needle has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.

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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FORM FDA 3881 (8/14)

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PSC Publishing Services [phone] EF

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### 510(k) Summary

## Submitter Information

| Date of 510(k) Summary Preparation: | April 24, 2015 |
|-------------------------------------|--------------------------------------------------------------------------------------------------|
| Name and Address of Manufacturer: | Spiration, Inc.<br>6675 185th Avenue Ne<br>Redmond, WA 98052 |
| Contact Person: | Cyndy Adams<br>Senior Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone] |

#### Subject Device

| Device Trade Name: | Flexible 19G EBUS Needle |
|--------------------|--------------------------------------------------|
| Common Name: | Aspiration Needle |
| Classification: | Bronchoscope (flexible or rigid) and accessories |
| Regulation : | 21 CFR 874.4680 |
| Product Code: | EOQ |
| Review Panel: | ENT |

# Predicate Device

| Trade Name: |
|----------------|
| 510(k) Number: |
| Manufacturer: |

Single Use Aspiration Needle K050503, cleared 05/12/05 Olympus Medical Systems Corporation

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### Device Description

The Flexible 19G EBUS Needle is intended for use with compatible ultrasound endoscopes for Transbronchial Needle Aspiration (TBNA) of submucosal and extramural lesions of the tracheobronchial tree. The device is supplied sterile and intended for single patient use.

The device consists of a handle, sheath, needle, and stylet. The sheath and needle are attached to the handle, and the removable stylet is located within the needle.

To perform biopsies, the flexible catheter portion is first inserted into a bronchoscope's working channel (2.2mm) then pushed forward until fully inserted. The handle is then affixed to the channel port of the endoscope using an adapter biopsy valve. The handle facilitates advancement of the needle during puncture of the targeted biopsy site. The sample is obtained by penetrating the lesion with the needle while applying suction at the proximal of the handle. The device is available with a needle size of 19 qauqe (19G).

#### Indications for Use

The Flexible 19G EBUS Needle has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.

#### Comparison to Predicate

The Flexible 19G EBUS Needle) is substantially equivalent to the currently marketed predicate, the Olympus Single Use Aspiration Needle cleared under K050503. The 19G Needle has the same technological characteristics as the predicate, that is, they operate in the same manner to obtain a tissue biopsy using an ultrasound endoscope. The intended use of the 19G Needle is a subset of the predicate intended use.

The 19G Needle has a larger, more flexible distal tip relative to the predicate device. A comparison of the 19G Needle and the Olympus Aspiration Needle is provided in the following table.

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## Comparison of Key Characteristics

| | Predicate Device (K050503) | Subject Device |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Characteristics | Olympus 22G & 21G Needles | Flexible 19G EBUS Needle |
| Indications for Use | This instrument has been designed to<br>be used with ultrasonic endoscopes<br>for ultrasonically guided fine needle<br>aspiration (FNA) of submucosal and<br>extramural lesions of the<br>tracheobronchial tree and the<br>gastrointestinal tract. Do not use this<br>instrument for any purpose other than<br>its intended use. | The Flexible 19G EBUS Needle<br>has been designed to be used with<br>ultrasound endoscopes for<br>ultrasound guided fine needle<br>aspiration (FNA) of submucosal<br>and extramural lesions of the<br>tracheobronchial tree. Do not use<br>this device for any purpose other<br>than its intended use. |
| Use Conditions | Surgical suite, endoscopy or<br>bronchoscopy suite, used with a<br>bronchoscope | Identical |
| Mechanics of Action | Manual | Identical |
| Mode of Action | Single/multiple puncture and aspirate | Identical |
| General Design | Handle, Sheath, Needle, Stylet | Identical |
| Biocompatible per 10993-1 | | |
| Materials | PTFE | PTFE |
| | Stainless Steel | Stainless Steel |
| | Nitinol | Nitinol |
| | | PEBAX |
| | | HDPE |
| Product Specifications and<br>Properties | Engineering bench testing confirms that the Olympus 19G Needle meets its<br>product specifications, which are equivalent to those of the predicate<br>Olympus Aspiration Needles, including the 21G. | |
| Sterilization | EO | Identical |
| Single Use Only | Yes | Identical |
| Working Outside Diameter<br>(mm) | 1.9 | Identical |
| Catheter Length (cm) | 70 | Identical |
| | Predicate Device (K050503) | Subject Device |
| Device Characteristics | Olympus 22G & 21G Needles | Flexible 19G EBUS Needle |
| Needle gauge size | 22G & 21G | 19G |
| Typical Needle Length<br>(mm) | 20 | Identical |
| Max Needle Length (mm) | 40 | Identical |

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### Performance Data

Device performance of the Flexible 19G EBUS Needle was verified through in vitro (bench) and ex vivo testing. Testing was designed to mimic stresses encountered in a clinical setting; acceptance criteria (specifications) were either identical to those of the predicate or established to verify design differences in the 19G Needle relative to the predicate. All testing met the predetermined acceptance criteria as outlined in the test protocols.

Testing to Specifications Identical to the those of the Predicate

| Insertion and Withdrawal Force | Pass |
|---------------------------------------|------|
| Stylet Insertion and Withdrawal Force | Pass |
| Activation Force | Pass |
| Plastic Deformation Angle | Pass |
| Durability | Pass |
| Handle Durability | Pass |

#### Testing to Specifications Developed for the 19G Needle

(These were deemed important parameters to test on the 19G Needle. Where relevant, the predicate was also tested.) Bronchoscope Angulation Pass Penetration Force 1 Pass Transmission Force Pass Vacuum Leak Test Pass Sheath to Handle Joint Strength Pass Echogenicity 2 Pass Biopsy Sample Size1, 2 Pass Simulated use - ex vivo (bovine lung) bench testing Pass

1 For direct comparison to a commercially available device of the same size, testing was also conducted on the Boston Scientific 19G Scientific eXcelon Transbronchial Aspiration Needle. 2 Testing also conducted on the predicate 21G Olympus Aspiration Needle.

| Additional Testing of the 19G Needle to Support Substantial Equivalence | |
|-------------------------------------------------------------------------|------|
| Sterilization Validation | Pass |
| Packaging and Shelf Life | Pass |
| Biocompatibility | Pass |
| Cytotoxicity (MEM Elution) | Pass |
| Sensitization (Maximization) | Pass |

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| Irritation (Intracutaneous Reactivity) | Pass |
|----------------------------------------------------------------------|------|
| Hemocompatibility (Extract and Direct Contact Hemolysis) | Pass |
| Systemic Toxicity (Systemic Injection and Material Mediated Pyrogen) | Pass |

The results from this testing demonstrate that the performance and technological characteristics of the Flexible 19G EBUS Needle meet defined design requirements and that the device performs equivalently to the predicate aspiration needle devices for its intended use.

### Conclusion (Statement of Equivalence)

The data and information presented within this 510(k) Premarket Notification (including in vitro bench and ex vivo testing) support a determination of substantial equivalence, and therefore market clearance of the Flexible 19G EBUS Needle.