(143 days)
No
The device description and performance studies focus on the mechanical aspects of a biopsy needle and do not mention any AI/ML components or capabilities.
No.
The device is used for the collection of tissue (diagnostic) and not for treating a disease or condition (therapeutic).
No
The device is described as being used for the collection of tissue, which is a biopsy procedure. While a biopsy can be part of a diagnostic process, the device itself is a tool for collecting a sample, not analyzing it or providing a diagnosis. Its function is to acquire the sample, which is then typically sent for laboratory analysis for diagnosis.
No
The device description clearly outlines physical components (handle, sheath, needle, stylet) and the performance studies focus on mechanical and material properties, indicating a hardware-based device. There is no mention of software as a component or function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection of tissue from the intrapulmonary regions. It is a tool for obtaining a sample.
- Device Description: The description details a mechanical device with a needle, sheath, handle, and stylet. Its function is to physically acquire a tissue sample.
- Lack of Diagnostic Function: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is solely to collect the specimen, not to perform any analysis or diagnostic test on it.
- Anatomical Site: The device is used in vivo (inside the body) to collect the sample. IVDs are used in vitro.
This device is a surgical instrument used for biopsy, specifically a transbronchial needle aspiration (TBNA) device. It is used to obtain a sample that would then likely be sent to a laboratory for in vitro diagnostic testing (e.g., pathology, cytology). The PeriFLEX Needle itself is not performing the diagnostic test.
N/A
Intended Use / Indications for 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.
Product codes
EOQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
By or under the supervision of a physician / Surgical suite, endoscopy or bronchoscopy suite, used with a bronchoscope.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Tests conducted:
- 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 Size (Simulated use - ex vivo (bovine lung) bench testing)
Additional Testing:
- 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
Key results: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three faces in profile, stacked on top of each other, resembling a bird-like shape.
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.
1
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
2
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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3
510(k) Summary
Submitter Information
| Date of 510(k) Summary Preparation: | February 3, 2017 |
|---|---|
| Name and Address of Manufacturer: | Spiration, Inc. |
| 6675 185th Avenue NE | |
| Redmond, WA 98052 | |
| Contact Person: | Aadarsh S. Viswanathan |
| Regulatory Affairs Specialist | |
| Phone: (425) 636.5535 | |
| Fax: (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
4
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.
5
Comparison of Predicates and the PeriFLEX Needle
| | PeriFLEX Needle | Conmed Wang MW-222
Needle | Olympus NA-1C Needle
(K904667) |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (K162611) | (K914181) | (Reference Device) |
| | (Subject Device) | (Predicate Device) | |
| Intended Use
Statement | 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 | Used to puncture the
trachobronchial wall and
aspirate sufficient tissue
and/or cell specimens to
stage bronchogenic
carcinoma. | These needles are intended
for endoscopic submucosal
and extra-bronchial
aspiration of tissue and
fluids. Do not use them for
any purpose other than their
intended function. |
| Anatomical Site | Lung | Lung | Lung |
| Use Conditions | Surgical suite, endoscopy or
bronchoscopy suite, used
with a bronchoscope | Surgical suite, endoscopy or
bronchoscopy suite, used
with a bronchoscope | Surgical suite, endoscopy or
bronchoscopy suite, used
with a bronchoscope |
| Intended User | By or under the supervision
of a physician | By or under the supervision
of a physician | By or under the supervision
of a physician |
| Mechanics of Action | Manual | Manual | Manual |
| Mode of Action | Single/multiple puncture and
aspirate | Single/multiple puncture and
aspirate | Single/multiple puncture and
aspirate |
| General Design | Handle, Sheath, Needle,
Stylet | Handle, Sheath, Needle,
Stylet | Handle, Sheath, Needle,
Stylet |
| Biocompatible | Yes | Yes | Yes |
| Patient Contacting
& Fluid Path
Materials | Stainless Steel, PEBAX,
PTFE, Nitinol | Stainless Steel, Teflon
(PTFE) | Information Not Available |
| Sterility | Sterile | Sterile | Sterile (the sheath must be
sterilized before use by the
user) |
| 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 Cross
Section | Single Lumen | Single and Double Lumen
Available | Single Lumen |
| | PeriFLEX Needle
(K162611)
(Subject Device) | Conmed Wang MW-222
Needle
(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 to
laser-cut. | Information Not Available | Not designed for greater
flexibility |
| Stylet OD (in) | 0.0185 | Information Not Available | 0.0115 |
6
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
7
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.