(121 days)
No
The description focuses on the mechanical aspects of a steerable biopsy needle and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is intended for the collection of tissue (biopsy), which is a diagnostic procedure, not a therapeutic one.
No
Explanation: This device is a biopsy needle used for collecting tissue samples. While these samples may subsequently be used for diagnostic purposes, the device itself is a tool for tissue acquisition, not for performing the diagnosis.
No
The device description clearly details a physical, sterile, single-use needle with a handle, shaft, and needle, designed for tissue collection. It involves mechanical components for steering and sampling, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the Compass Steerable Needle is for the collection of tissue from the intrapulmonary regions.
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease. While the collected tissue may be used for subsequent in vitro diagnostic testing, the device itself is a tool for obtaining the sample, not for performing the diagnostic test on the sample.
- Device Description: The device description focuses on the mechanical aspects of the needle for tissue acquisition (steerability, sampling mechanism, etc.). It does not describe any components or functions related to analyzing or testing the collected tissue.
The Compass Steerable Needle is a biopsy device, which is a type of surgical instrument used to obtain tissue samples. These samples are then typically sent to a laboratory for analysis, which may include IVD tests, but the biopsy device itself is not an IVD.
N/A
Intended Use / Indications for Use
The Compass Steerable Needle is a steerable biopsy needle intended be used through a compatible working channel bronchoscope or Medtronic Extended Working Channel (EWC) for the collection of tissue from the intrapulmonary regions.
Product codes
KTI
Device Description
The Compass Steerable Needles (CSN) are sterile, single use, 22-gauge needles with a unidirectional, steerable distal tip for the acquisition of tissue from the intrapulmonary regions.
The Steerable Needle consists of a handle, shaft, and needle. The handle provides the user with control of device rotation, extension, retraction, distal tip articulation of 70°±10° unidirectionally within a plane and a sampling mechanism to extend and retract the needle out of the shaft to obtain tissue samples. A Luer connector on the proximal end of the device provides the connection for the stylet or a syringe for aspiration during sampling. There are two models of the Compass Steerable Needle.
Model CSN1001 can be coupled to Olympus® 190 or Pentax® bronchoscopes with a 2.0 working channel and 600 mm working length. It is packaged with a stylet, and adapters.
Model CSN1002 can be coupled to the Medtronic Illumisite™ Extended Working Channel (EWC) with a 2.0 mm working channel. It is packaged with a stylet.
The Compass Steerable Needles with stylet are inserted and coupled to either a bronchoscope or a Medtronic Illumisite EWC. The translation arm advances the device into the lung. Depressing the plunger articulates the distal end of the shaft. The sampling mechanism is depressed extending the needle to obtain a sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intrapulmonary regions, Lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians trained in bronchoscopy devices, accessories, and procedures, in a simulated bronchoscopy suite.
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
Bench Testing - pre and post aging:
- Visual: Inspect with the naked eye or under a X scope. Results: Devices met acceptance criteria.
- Dimensional: Measure: OD, ID, Length, Needle Throw, Articulation Length, Stylet Protrusion Length, Stylet OD, Travel, Retraction. Results: Devices met acceptance criteria.
- Force - Insertion, plunger and sampling mechanism: Measure insertion force into the scope; force to depress plunger/sampling mechanism with Instron. Results: Devices met acceptance criteria.
- Articulation: Measure angle, length, curve profile, stability and planarity. Results: Devices met acceptance criteria.
- Tensile: Tensile test all joints and coupling. Results: Devices met acceptance criteria.
- Adapter Vacuum/pneumostasis: Ability to hold a vacuum of 20 Hg mercury. Results: Devices met acceptance criteria.
- Needle Leak: Flush 5ml saline, inspect for leak. Results: Devices met acceptance criteria.
- Durability: Condition device simulating use during a procedure, visual, articulation and functional. Results: Devices met acceptance criteria.
- Bending/Buckling: Measure bending and buckling force. Results: Devices met acceptance criteria.
- Torque Transmission / Integrity: Measure peak torque at 90° rotation / no joint separation after 720° rotation. Results: Devices met acceptance criteria.
- Lumen patency needle: Ensure stylet can be inserted. Results: Devices met acceptance criteria.
- Corrosion resistance: Test per ISO 10555-1:2013. Results: Devices met acceptance criteria.
- Packaging: Distribution per ASTM D4169:2016, Aging per ASTM F1980:2016, Packaging per ISO 11607-1:2019, Visual per ASTM F1886/F1886M-16, Bubble Leak per ASTM F2096-11:2019. Results: Packages met accept criteria.
Validation testing: Performed demonstrating the Compass Steerable Needles user needs and intended use were met. Testing under simulated use conditions was performed in accordance with the Instructions for Use. Human cadavers were used to demonstrate clinical performance within the human lung anatomy. Cadaver testing demonstrated the Compass Steerable Needles Instructions for Use are understandable, and the device meets the intended use no new risks identified.
Human Factors Usability: Formative studies were conducted to identify and minimize use errors. A limited Summative Validation with study was conducted. The Instructions for Use and Reference Guide were assessed in the usability study. The device was found to be safe and effective for its intended use, by the intended users, in its intended use environment.
Biocompatibility: Testing performed in accordance with ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO-10993". All endpoints were met.
Sterilization: Validated using ANSI/AAMI/ISO 11607-1:2019, ANSI/AAMI/ISO 11135:2014, and FDA Guidance: Submission and Review of Sterility Information in Pre-Market Notification 510(k) Submissions for Device Labeled as Sterile (January 21, 2016). All endpoints were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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August 25, 2022
Serpex Medical, Inc. % Laurie Lewandowski Vice President Honkanen Consulting, Inc. 738 Saddle Wood Drive Eagan, Minnesota 55123
Re: K221206
Trade/Device Name: Compass Steerable Needle Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: KTI Dated: July 22, 2022 Received: July 25, 2022
Dear Laurie Lewandowski:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Brandon Blakely, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221206
Device Name Compass Steerable Needle
Indications for Use (Describe)
The Compass Steerable Needle is a steerable biopsy needle intended be used through a compatible working channel bronchoscope or Medtronic Extended Working Channel (EWC) for the collection of tissue from the intrapulmonary regions.
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) |
|| | 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
1. SUBMITTER INFORMATION
Submitter: Serpex Medical, Inc. Sasha Schrode 3350 Scott Blvd, Suite 37B Santa Clara, CA 95054 sschrode(@serpexmedical.com Email:
Primary Contact: Laurie Lewandowski Consultant, Honkanen Consulting, Inc. 738 Saddle Wood Drive Eagan, MN 55123 Telephone: 612-770-4038 (cell) Email: llewandowski(@serpexmedical.com
DATE PREPARED:
August 25, 2022
2. DEVICE INFORMATION
| Proprietary Name: |
|---|
| Common/Usual Name: |
| Classification Name: |
| Regulatory Class: |
| Product Code: |
| Regulation Number: |
Compass Steerable Needle Aspiration Needle Bronchoscope Accessory Class II KTI 21 CFR 874.4680
3. PREDICATE AND REFERENCE DEVICE INFORMATION
PRIMARY PREDICATE DEVICE:
| Proprietary Name: | PeriView Flex |
|---|---|
| Common/Usual Name: | Aspiration Needle |
| Classification Name: | Bronchoscope Accessory |
| 510K Number: | K171232 |
SECONDARY PREDICATE DEVICE:
Proprietary Name: Common/Usual Name: Classification Name: 510K Number:
Ion™ Endoluminal System; Flexision™ Biopsy Needle Aspiration Needle Bronchoscope (Flexible or Rigid) and Accessories K182188
4
REFERENCE DEVICE:
Proprietary Name: Common/Usual Name: Classification Name: 510K Number:
Morrison Steerable Needle Biopsy Needle Instrument, Biopsy K151396
4. DEVICE DESCRIPTION
The Compass Steerable Needles (CSN) are sterile, single use, 22-gauge needles with a unidirectional, steerable distal tip for the acquisition of tissue from the intrapulmonary regions.
The Steerable Needle consists of a handle, shaft, and needle. The handle provides the user with control of device rotation, extension, retraction, distal tip articulation of 70°±10° unidirectionally within a plane and a sampling mechanism to extend and retract the needle out of the shaft to obtain tissue samples. A Luer connector on the proximal end of the device provides the connection for the stylet or a syringe for aspiration during sampling. There are two models of the Compass Steerable Needle.
Model CSN1001 can be coupled to Olympus® 190 or Pentax® bronchoscopes with a 2.0 working channel and 600 mm working length. It is packaged with a stylet, and adapters.
Model CSN1002 can be coupled to the Medtronic Illumisite™ Extended Working Channel (EWC) with a 2.0 mm working channel. It is packaged with a stylet.
The Compass Steerable Needles with stylet are inserted and coupled to either a bronchoscope or a Medtronic Illumisite EWC. The translation arm advances the device into the lung. Depressing the plunger articulates the distal end of the shaft. The sampling mechanism is depressed extending the needle to obtain a sample.
5. INTENDED USE/INDICATION FOR USE
The Compass Steerable Needle is a steerable biopsy needle intended be used through a compatible working channel bronchoscope or Medtronic Extended Working Channel (EWC) for the collection of tissue from the intrapulmonary regions.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The Compass Steerable Needles have the same basic technological characteristics as the primary predicate, PeriView Flex, cleared under K171232 with a Franseen shaped needle and the ability to articulate and couple to bronchoscopes. The secondary predicate Ion™ Endoluminal System; Flexision™ Biopsy Needle (K182188) and the reference device, the Morrison Biopsy Needle (K151396) were used to support articulation and needle size. The subject and predicate devices all operate in the same manner to obtain tissue during sampling in the lungs.
5
A comparison of the Compass Steerable Needles and the PeriView Flex are shown in the following table with a discussion following.
| Attribute | Proposed Device
Compass Steerable Needle | PeriView Flex
K171232
Primary Predicate | Difference and
Impact on
Substantial
Equivalence |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Intended Use | To collect tissue from the
intrapulmonary regions. | Identical | SE |
| Indications
for use | The Compass Steerable Needle is a
steerable biopsy needle intended be
used through a compatible working
channel bronchoscope or Medtronic
Extended Working Channel (EWC)
for the collection of tissue from the
intrapulmonary regions. | 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. | SE
Similar to primary
predicate with minor
wording differences |
| | Users | Clinicians trained in bronchoscopy
devices, accessories, and procedures | Identical |
| Anatomic Site | Lung | Identical | SE |
| Method of
Introduction | Endobronchial delivered to the target
through a flexible endoscope or
EWC. | Endobronchial delivered to
the target through a
flexible endoscope or
EWC. | SE |
| Required
Working
Channel | 2mm | 2mm | SE |
| General
Design | Handle,
Shaft,
Needle,
Stylet,
Adapters | Handle,
Sheath,
Needle,
Stylet | SE
Adapters to couple the
device. |
| Needle Size | 22G | 21G | SE |
| Needle Tip | Franseen | Chiba (angled beveled) | See discussion |
| Needle
Protrusion
Length | 15 mm | 20 mm | See discussion |
| Coupling | Coupled to bronchoscope | N/A | See discussion |
| Mode of
Sampling
Action | Single / multiple puncture and
aspirate manually controlled | Single / multiple puncture
and aspirate
manually controlled | SE |
| Angle of
Articulation | Shaft articulates 70° in a single
direction | N/A | See discussion |
| Dimensions | Shaft OD ≤ 1.93mm
Working Length
CSN1001 CSN1002
715- 1035-
800mm 1085mm | Shaft OD = 1.5mm
Total Length = 115cm | SE
All work within a 2.0
bronchoscope or
working channel |
| Stylet OD | 0.43mm | 0.47 mm | SE |
| Attribute | Proposed Device
Compass Steerable Needle | PeriView Flex
K171232
Primary Predicate | Difference and
Impact on
Substantial
Equivalence |
| | | | Both stylets fit inside |
| | | | needle |
| Radiopaque | Yes | Yes | SE |
| Life/Sterility | Single Use, EO sterilized | Identical | SE |
| Patient
Contacting
Materials | Pebax
Vestamid
Stainless steel
PET Heat Shrink
Nitinol | Stainless Steel,
PTFE,
Pebax,
Nitinol | SE
All devices comprised
of standard medical
device materials |
| Biocompatible | Yes, conforms to 10993-1 | Yes, conforms to 10993-1 | SE |
6
Discussion: The Compass Steerable Needles are the same as the primary predicate in terms with the exception of the needle gauge, needle tip, protrusion, articulation and coupling to a bronchoscope.
The needle size is substantially equivalent to the secondary predicate, the Flexision with needle sizes of 23G, 21G and 19G and reference device, the Morrison needle at 19G.
Franseen needle tips have been used for lung biopsy devices for > 20 years as supported by devices K770523 Needle Biopsy, Boyd Lung, and the Merit Medical Temno Elite Biopsy System (K201166).
The protrusion length is of the Compass Steerable Needle is within the same range as the secondary predicate, Flexision, of 1-3 cm.
The Compass Steerable Needle articulates the distal shaft 70° ± 10° in a single direction. The secondary predicate articulates the catheter 180° in all directions using electromechanical controls while the reference device articulates in two directions using manual controls.
Coupling of devices to a bronchoscope has previously been cleared in ultrasound bronchoscopes as supported by Olympus ViziShot 2 EBUS-TBNA (K193527).
The different technological characteristics of the new device do not raise different questions of safety and effectiveness.
7
7. PERFORMANCE DATA
Bench Testing - pre and post aging
| Test | Method | Results |
|---|---|---|
| Visual | Inspect with the naked eye or under a X scope | Devices met acceptance criteria |
| Dimensional | Measure: OD, ID, Length, Needle Throw, | |
| Articulation Length, Stylet Protrusion Length, | ||
| Stylet OD, Travel, Retraction | Devices met acceptance criteria | |
| Force - Insertion, plunger | ||
| and sampling mechanism | Measure insertion force into the scope; force to | |
| depress plunger/sampling mechanism with | ||
| Instron | Devices met acceptance criteria | |
| Articulation | Measure angle, length, curve profile, stability | |
| and planarity | Devices met acceptance criteria | |
| Tensile | Tensile test all joints and coupling | Devices met acceptance criteria |
| Adapter | ||
| Vacuum/pneumostasis | Ability to hold a vacuum of 20 Hg mercury | Devices met acceptance criteria |
| Needle Leak | Flush 5ml saline, inspect for leak | Devices met acceptance criteria |
| Durability | Condition device simulating use during a | |
| procedure, visual, articulation and functional | Devices met acceptance criteria | |
| Bending/Buckling | Measure bending and buckling force | Devices met acceptance criteria |
| Torque Transmission / | ||
| Integrity | Measure peak torque at 90° rotation / no joint | |
| separation after 720° rotation | Devices met acceptance criteria | |
| Lumen patency needle | Ensure stylet can be inserted | Devices met acceptance criteria |
| Corrosion resistance | Test per ISO 10555-1:2013 | Devices met acceptance criteria |
| Packaging | Distribution per ASTM D4169:2016 | |
| Aging per ASTM F1980:2016, | ||
| Packaging per ISO 11607-1:2019 | ||
| Visual per ASTM F1886/F1886M-16 | ||
| Bubble Leak per ASTM F2096-11:2019 | Packages met accept criteria |
The test results demonstrated that differences in device characteristics between the subject device and predicate device do not raise any new questions of safety or effectiveness.
Validation testing
Validation testing was performed demonstrating the Compass Steerable Needles user needs and intended use were met. Testing under simulated use conditions was performed in accordance with the Instructions for Use. Human cadavers were used to demonstrate
Serpex Medical, Inc. Compass Steerable Needle
8
clinical performance within the human lung anatomy. Cadaver testing demonstrated the Compass Steerable Needles Instructions for Use are understandable, and the device meets the intended use no new risks identified.
Human Factors Usability
Formative studies were conducted to identify and minimize use errors related to the use of the Compass Steerable Needles. Studies were conducted by intended user groups in a simulated bronchoscopy suite and involved preoperative preparation and simulated procedures. Since the user interface of the device is similar to the predicate device and the formative studies did not identify any new critical tasks unique to the device, a limited Summative Validation with study was conducted. The Instructions for Use and Reference Guide were assessed in the usability study. The Compass Steerable Needles has been assessed and found to be safe and effective for its intended use, by the intended users, in its intended use environment.
Biocompatibility
Biocompatibility testing was performed in accordance with:
- . ISO 10993-1:2018 for a limited (