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 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.

AI/ML Overview

The provided text describes the PeriFLEX Needle, an aspiration needle for collecting tissue from intrapulmonary regions through a bronchoscope. The submission focuses on demonstrating substantial equivalence to a predicate device through performance testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests conducted. While specific quantitative acceptance criteria are not explicitly stated for each test in a table format, the narrative indicates that the device "met the pre-determined acceptance criteria as outlined in the test protocols."

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance
Sheath and Needle Insertion and Withdrawal Force	Met pre-determined acceptance criteria
Stylet Insertion and Withdrawal Force	Met pre-determined acceptance criteria
Bronchoscope Angulation	Met pre-determined acceptance criteria
Handle Activation Force	Met pre-determined acceptance criteria
Plastic Deformation Angle	Met pre-determined acceptance criteria
Transmission Force	Met pre-determined acceptance criteria
Handle Assembly Strength	Met pre-determined acceptance criteria
Handle Durability	Met pre-determined acceptance criteria
Durability	Met pre-determined acceptance criteria
Vacuum Leak Test	Met pre-determined acceptance criteria
Sheath to Handle Joint Strength	Met pre-determined acceptance criteria
Biopsy Sample Size (Ex Vivo)	Met pre-determined acceptance criteria; direct comparison to reference device (Olympus NA-1C Needle) also conducted
Sterilization & Biocompatibility
Sterilization Validation	Met pre-determined acceptance criteria
Product Adoption	Met pre-determined acceptance criteria
Comparative Resistance	Met pre-determined acceptance criteria
Packaging and Shelf Life	Met pre-determined acceptance criteria
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Hemocompatibility, Toxicity, Pyrogenicity)	Met pre-determined acceptance criteria; the results demonstrate that the performance and technological characteristics meet defined design requirements.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): Not explicitly stated with a specific number for each test. The document refers to "in vitro (bench) and ex vivo testing" and "simulated use - ex vivo (bovine lung) bench testing" for biopsy sample size.
Data Provenance: The testing was conducted as "in vitro (bench)" and "ex vivo (bovine lung) bench testing." This suggests laboratory-based testing rather than human subject data. The country of origin is not specified but is presumably where Spiration, Inc. conducts its R&D, likely the USA given the Redmond, Washington address. The testing is considered prospective as it was performed specifically to support this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for the test set. The tests described are primarily engineering and material performance assessments (e.g., force, strength, leak tests, biocompatibility) rather than diagnostic accuracy assessments requiring expert interpretation of results.
For the "Biopsy Sample Size" test, it involved ex vivo bovine lung, which implies objective measurement of tissue obtained rather than expert consensus on its characteristics.

4. Adjudication Method for the Test Set

No adjudication method is mentioned or relevant as the testing described is not clinical or diagnostic in nature requiring expert review or consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or reported. The device is an aspiration needle, not an imaging or diagnostic AI device that would typically undergo such a study. The focus is on the physical and mechanical performance of the tool itself.

6. Standalone (Algorithm Only) Performance

This is not applicable as the PeriFLEX Needle is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for the performance tests was based on engineering specifications, material science standards, and objective measurements derived from the in vitro and ex vivo tests. For example, force measurements, leak detection, and observed physical integrity against pre-determined thresholds. For biopsy sample size, it would be the objective measurement of the collected tissue from the ex vivo bovine lung.

8. Sample Size for the Training Set

Not applicable. There is no algorithm or AI model being developed or trained for this device.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned or implied.

In summary, the information provided focuses on the physical, mechanical, and biological performance of the PeriFLEX Needle against engineering and safety specifications, rather than clinical efficacy or diagnostic accuracy that would typically involve a "test set" and "ground truth" derived from human clinical data or expert consensus. The study described is a series of pre-clinical bench and ex vivo tests demonstrating the device's conformance to its design requirements and equivalence to predicate devices.

Summary

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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 (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,

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.6675 185th Avenue NERedmond, WA 98052
Contact Person:	Aadarsh S. ViswanathanRegulatory Affairs SpecialistPhone: (425) 636.5535Fax: (425) 497.8802

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

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-222Needle	Olympus NA-1C Needle(K904667)
	(K162611)	(K914181)	(Reference Device)
	(Subject Device)	(Predicate Device)
Intended UseStatement	This device is intended to beused through a compatiblebronchoscope for thecollection of tissue from theintrapulmonary regions. Donot use for any purposeother than its intended use	Used to puncture thetrachobronchial wall andaspirate sufficient tissueand/or cell specimens tostage bronchogeniccarcinoma.	These needles are intendedfor endoscopic submucosaland extra-bronchialaspiration of tissue andfluids. Do not use them forany purpose other than theirintended function.
Anatomical Site	Lung	Lung	Lung
Use Conditions	Surgical suite, endoscopy orbronchoscopy suite, usedwith a bronchoscope	Surgical suite, endoscopy orbronchoscopy suite, usedwith a bronchoscope	Surgical suite, endoscopy orbronchoscopy suite, usedwith a bronchoscope
Intended User	By or under the supervisionof a physician	By or under the supervisionof a physician	By or under the supervisionof a physician
Mechanics of Action	Manual	Manual	Manual
Mode of Action	Single/multiple puncture andaspirate	Single/multiple puncture andaspirate	Single/multiple puncture andaspirate
General Design	Handle, Sheath, Needle,Stylet	Handle, Sheath, Needle,Stylet	Handle, Sheath, Needle,Stylet
Biocompatible	Yes	Yes	Yes
Patient Contacting& Fluid PathMaterials	Stainless Steel, PEBAX,PTFE, Nitinol	Stainless Steel, Teflon(PTFE)	Information Not Available
Sterility	Sterile	Sterile	Sterile (the sheath must besterilized before use by theuser)
Sterilization Method	Ethylene Oxide	Information Not Available	Ethylene Oxide (30%)/CO2(70%)
Single Use Only	Single Use Only	Single-Use Only	Single Use Needle Section,Reusable Sheath
Working OD (mm)	1.5	1.9	1.8
Catheter Length(cm)	115	140	105
Catheter CrossSection	Single Lumen	Single and Double LumenAvailable	Single Lumen
	PeriFLEX Needle(K162611)(Subject Device)	Conmed Wang MW-222Needle(K914181)(Predicate Device)	Olympus NA-1C Needle(K904667)(Reference Device)
Needle Gauge(Size)	21G	22G	21G
Needle Tip Material	Stainless Steel	Stainless Steel	Stainless Steel
Needle Length(mm)	20	13	13
Needle Flexibility	Distal 20 cm flexible due tolaser-cut.	Information Not Available	Not designed for greaterflexibility
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.

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
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.(b)
Classification. Class II.