PeriFLEX

K162611 · Spiration, Inc. · EOQ · Feb 9, 2017 · Ear, Nose, Throat

Device Facts

• Record ID: K162611
• Device Name: PeriFLEX
• Applicant: Spiration, Inc.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Feb 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended Use

This device is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. Do not use for any purpose other than its intended use.

Device Story

PeriFLEX Needle is a manual biopsy device used during bronchoscopy to collect tissue from intrapulmonary regions. The device consists of a handle, sheath, needle, and removable stylet. The user inserts the sheath and needle through the bronchoscope working channel to the target site; a manual needle slider on the handle extends and retracts the needle to puncture tissue and aspirate samples. A vacuum syringe and biopsy valve may be attached to assist collection. The stylet aids in sample removal. Used in surgical or endoscopy suites by physicians. The device features a laser-cut flexible distal tip to facilitate access to distal lesions and a smaller diameter for compatibility with modern bronchoscopes. It provides clinicians with tissue samples for diagnostic evaluation, potentially benefiting patients by enabling minimally invasive biopsy of lung tissue.

Clinical Evidence

Bench testing only. Performance verified through in vitro and ex vivo (bovine lung) testing. Tests included insertion/withdrawal forces, handle activation force, plastic deformation, transmission force, handle strength/durability, vacuum leak testing, and joint strength. Biocompatibility testing included cytotoxicity, sensitization, irritation, hemocompatibility, and pyrogenicity. Results met all pre-determined acceptance criteria.

Technological Characteristics

Materials: Stainless steel, PEBAX, PTFE, Nitinol. Manual operation. Single-lumen catheter. 21G needle size. Laser-cut distal tip for flexibility. Sterile, single-use. Sterilization: Ethylene Oxide. Compatible with standard bronchoscopes.

Indications for Use

Indicated for the collection of tissue from intrapulmonary regions in patients undergoing bronchoscopy. Used by or under the supervision of a physician.

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

• Wang MW-222 Transbronchial Aspiration Needle (K914181)

Reference Devices

• Olympus NA-1C Needle (K904667)

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

February 9, 2017

Spiration, Inc. Aadarsh Viswanathan Regulatory Specialist 6675 185th Ave NE Redmond, Washington 98052

Re: K162611

Trade/Device Name: Periflex Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: January 10, 2017 Received: January 11, 2017

Dear Aadarsh Viswanathan:

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 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.

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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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K162611

Device Name PeriFLEX

Indications for Use (Describe)

This device is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. Do not use for any purpose other than its intended use.

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

## Submitter Information

| Date of 510(k) Summary Preparation: | February 3, 2017 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------|
| Name and Address of Manufacturer: | Spiration, Inc.<br>6675 185th Avenue NE<br>Redmond, WA 98052 |
| Contact Person: | Aadarsh S. Viswanathan<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |

## Subject Device

Device Trade Name: Common Name:

Classification: Regulation:

Product Code: Review Panel:

## Predicate Device

Trade Name: 510(k) Number: Manufacturer:

## Reference Device

Trade Name: 510(k) Number: Manufacturer:

Transbronchial Aspiration Needle III Bronchoscope (flexible or rigid) and accessories 21 CFR 874.4680

EOQ ENTB

PeriFLEX

Wang MW-222 Transbronchial Aspiration Needle K914181 Conmed, Inc.

Olympus NA-1C Needle K904667 Olympus Corporation

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## Device Description

The PeriFLEX Needle is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. The device is supplied sterile and intended for single patient use.

The main components of the device are a handle, a sheath, a needle, and a stylet. The sheath and needle (together termed the insertion portion) are attached to the handle. The removable stylet runs the full length of the device and fits inside the lumen of the handle and the needle.

The needle is housed within the sheath. These components, i.e., the insertion portion, are inserted into the working channel of the endoscope and advanced to the target site. The handle is connected to the insertion and has a needle slider component. The needle slider is controlled manually by the user to extend and retract the needle from the sheath at the target site. Once a sample is collected, the stylet may be used to assist with removing the sample from the needle.

The PeriFLEX Needle is available in one model only (PERIFLEX-21G), with a needle size of 21 gauge (21G). The PeriFLEX Needle can be used with the following accessories: vacuum syringe (to assist with sample collection), biopsy valve (to assist with creating a vacuum), and guide sheath (to extend the working length). However, these accessories are not included with the PeriFLEX Needle's packaging and must be obtained separately by the user.

## Indications for Use

The PeriFLEX Needle is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. Do not use for any purpose other than its intended use.

#### Comparison to Predicate Device

The PeriFLEX Needle is substantially equivalent to the chosen predicate, the Conmed Wang MW-222 Needle cleared under K914181. The PeriFLEX Needle has similar technological characteristics as the predicate device; there are no differences that raise different questions of safety and effectiveness relative to the predicate devices. Both devices operate in the same manner to obtain a tissue biopsy using a bronchoscope.

The primary difference between the subject and predicate device lies in the flexibility of the needle; the PeriFLEX Needle has a more flexible tip than the predicate device. Other differences between the subject device and the predicate device include a smaller diameter to facilitate compatibility with newer bronchoscopes with smaller working channels and a longer needle for better accessibility to distal lesions.

A detailed comparison of the PeriFLEX Needle, the chosen predicate device, and the reference device is provided in the following table.

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## Comparison of Predicates and the PeriFLEX Needle

| | PeriFLEX Needle | Conmed Wang MW-222<br>Needle | Olympus NA-1C Needle<br>(K904667) |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (K162611) | (K914181) | (Reference Device) |
| | (Subject Device) | (Predicate Device) | |
| Intended Use<br>Statement | This device is intended to be<br>used through a compatible<br>bronchoscope for the<br>collection of tissue from the<br>intrapulmonary regions. Do<br>not use for any purpose<br>other than its intended use | Used to puncture the<br>trachobronchial wall and<br>aspirate sufficient tissue<br>and/or cell specimens to<br>stage bronchogenic<br>carcinoma. | These needles are intended<br>for endoscopic submucosal<br>and extra-bronchial<br>aspiration of tissue and<br>fluids. Do not use them for<br>any purpose other than their<br>intended function. |
| Anatomical Site | Lung | Lung | Lung |
| Use Conditions | Surgical suite, endoscopy or<br>bronchoscopy suite, used<br>with a bronchoscope | Surgical suite, endoscopy or<br>bronchoscopy suite, used<br>with a bronchoscope | Surgical suite, endoscopy or<br>bronchoscopy suite, used<br>with a bronchoscope |
| Intended User | By or under the supervision<br>of a physician | By or under the supervision<br>of a physician | By or under the supervision<br>of a physician |
| Mechanics of Action | Manual | Manual | Manual |
| Mode of Action | Single/multiple puncture and<br>aspirate | Single/multiple puncture and<br>aspirate | Single/multiple puncture and<br>aspirate |
| General Design | Handle, Sheath, Needle,<br>Stylet | Handle, Sheath, Needle,<br>Stylet | Handle, Sheath, Needle,<br>Stylet |
| Biocompatible | Yes | Yes | Yes |
| Patient Contacting<br>& Fluid Path<br>Materials | Stainless Steel, PEBAX,<br>PTFE, Nitinol | Stainless Steel, Teflon<br>(PTFE) | Information Not Available |
| Sterility | Sterile | Sterile | Sterile (the sheath must be<br>sterilized before use by the<br>user) |
| Sterilization Method | Ethylene Oxide | Information Not Available | Ethylene Oxide (30%)/CO2<br>(70%) |
| Single Use Only | Single Use Only | Single-Use Only | Single Use Needle Section,<br>Reusable Sheath |
| Working OD (mm) | 1.5 | 1.9 | 1.8 |
| Catheter Length<br>(cm) | 115 | 140 | 105 |
| Catheter Cross<br>Section | Single Lumen | Single and Double Lumen<br>Available | Single Lumen |
| | PeriFLEX Needle<br>(K162611)<br>(Subject Device) | Conmed Wang MW-222<br>Needle<br>(K914181)<br>(Predicate Device) | Olympus NA-1C Needle<br>(K904667)<br>(Reference Device) |
| Needle Gauge<br>(Size) | 21G | 22G | 21G |
| Needle Tip Material | Stainless Steel | Stainless Steel | Stainless Steel |
| Needle Length<br>(mm) | 20 | 13 | 13 |
| Needle Flexibility | Distal 20 cm flexible due to<br>laser-cut. | Information Not Available | Not designed for greater<br>flexibility |
| Stylet OD (in) | 0.0185 | Information Not Available | 0.0115 |

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## Performance Data

Device performance of the PeriFLEX Needle was verified through in vitro (bench) and ex vivo testing. Testing was designed to mimic stresses encountered in a clinical setting met the pre-determined acceptance criteria as outlined in the test protocols.

Sheath and Needle Insertion and Withdrawal Force Stylet Insertion and Withdrawal Force Bronchoscope Angulation Handle Activation Force Plastic Deformation Angle Transmission Force Handle Assembly Strength Handle Durability Durability Vacuum Leak Test Sheath to Handle Joint Strength Biopsy Sample Size1 Simulated use - ex vivo (bovine lung) bench testing

1 For direct comparison to a reference device, testing was also conducted on the Olympus NA-1C Needle

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Additional Testing of the PeriFLEX Needle to Support Safety and Effectiveness

- Sterilization Validation Product Adoption Comparative Resistance Packaging and Shelf Life Biocompatibility Cytotoxicity (MEM Elution) Sensitization (Magnusson-Kligman Method) Irritation (Intracutaneous Toxicity) Hemocompatibility (Indirect and Direct Contact) Toxicity Pyrogenicity
The results from this testing demonstrate that the performance and technological characteristics of the PeriFLEX Needle meet defined design requirements and that the device performs equivalently to the predicate aspiration needles.

## 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 of the PeriFLEX Needle to the cleared Conmed Wang MW-222 Needle.