CapnoSpot™ Pneumothorax Decompression Indicator

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 28, 2023 Pneumeric, Inc. Johnathon Aho Chief Executive Officer 823 4th Street SW, c/o Johnathon Aho Rochester, Minnesota 55902 Re: K223625 Trade/Device Name: CapnoSpot™ Pneumothorax Decompression Indicator Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument For General Use Regulatory Class: Class I Product Code: GAA Dated: March 1, 2023 Received: March 2, 2023 Dear Johnathon Aho: 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. 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 {1}------------------------------------------------ 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 mediation-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. | Mark<br>Trumbore -S | Digitally signed by<br>Mark Trumbore -S<br>Date: 2023.03.28<br>13:01:59-04'00' | |---------------------|--------------------------------------------------------------------------------| |---------------------|--------------------------------------------------------------------------------| Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223625 ## Device Name Pneumeric™ CapnoSpot™ Pneumothorax Decompression Indicator ## Indications for Use (Describe) Used for more accurate placement of pneumothorax decompression devices than the current standard of care auditory assessments. The Pneumothorax Decompression Indicator is a colorimetric capnography device indicated to detect the carbon dioxide in the gas passing through the device used to treat pneumothorax with suspected tension physiology. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the word "PNEUMERIC" in bold, black letters, with a trademark symbol next to it. To the left of the word is a gray image of lungs. The lungs are stylized and have a smooth, rounded shape. The image is set against a white background. # 6. 510(K) SUMMARY # 6.1 ADMINISTRATIVE INFORMATION Date of Summary Preparation: # 6.1.1 CONTACT INFORMATION | Submitter/Manufacturer | Johnathon M.E. Aho M.D., Ph.D.<br>Chief Executive Officer, Pneumeric, Inc.<br>823 4th St SW<br>Rochester, MN 55902<br>United States<br>507-206-1942<br>John.aho@pneumeric-medical.com<br>jaho@mtu.edu | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Submission Contact | Johnathon M.E. Aho M.D., Ph.D.<br>Chief Executive Officer, Pneumeric, Inc.<br>823 4th St SW<br>Rochester, MN 55902<br>United States<br>507-206-1942<br>John.aho@pneumeric-medical.com<br>jaho@mtu.edu | | Secondary Submission Contact | Jonathan Sackner-Bernstein M.D.<br>Chief Regulatory Officer, Pneumeric, Inc<br>jsb@jsbmd.com<br>+1.212.888.2589<br><br>Ming Cheng Chew<br>Regulatory Consultant,<br>Libra Medical Inc.<br>8401 73rd Ave North, Suite 63 | Minneapolis, MN 55428 Phone: 763-232-3701 Email: mcchew@libramed.com Veronica McDougall {4}------------------------------------------------ Regulatory Consultant, Nagl Medtech 3451 Commerce Pkwy Miramar F1 33025 Phone: 954-507-3830 Email: vmcdougall(@nmddo.com #### 6.1.2 DEVICE INFORMATION | Trade Name | CapnoSpot Pneumothorax Decompression<br>Indicator | |---------------------------|---------------------------------------------------| | Common Name | Decompression Indicator | | Classification Name | Needle, Aspiration and Injection, Disposable | | Classification Regulation | 878.4800 | | Class | I | | Panel | General & Plastic Surgery | | Product Code | GAA | | FDA Documents Related to | None | | Modified Device | C210112 | #### PREDICATE DEVICE 6.2 The Pneumeric CapnoSpot Pneumothorax Decompression Indicator ("CapnoSpot" or "device") is substantially equivalent to the Turkel Pneumothorax Kit (K923028). ### DEVICE DESCRIPTION 6.3 The Pneumeric Capnospot Pneumothorax Decompression Indicator is a capnography device that provides objective, real-time feedback during decompressive thoracostomy. Specifically, the device detects the presence of carbon dioxide in the gas from the decompressed pneumothorax, permitting more accurate placement of the needle or thoracostomy device compared to the current standard of care based upon auditory assessments. The Pneumeric Capnospot is a therapeutic device intended to guide the placement of pneumothorax decompression needles and thoracostomy devices. The product consists of a cylindrical polycarbonate tube containing a carbon dioxide detecting paper. The device has a male luer connector on the distal end of the device to connect to decompression needles and thoracostomy devices, a diaphragm to prevent backflow of gases, a color changing indicator and a female luer on the proximal end of the device that can be used to connect accessories. The product is shipped non-sterile and labeled for single use only. ### 6.4 INDICATIONS FOR USE/INTENDED USE Used for more accurate placement of pneumothorax decompression devices than the current standard of care auditory assessments. The Pneumothorax Decompression Indicator is a {5}------------------------------------------------ colorimetric capnography device indicated to detect the carbon dioxide in the gas passing through the device used to treat pneumothorax with suspected tension physiology. ### PERFORMANCE DATA 6.5 Testing was performed before and after accelerated aging. The relevant design verification and shelf life tests included: - Visual inspection ● - Dimensionals ● - Backflow - Cracking Pressure ● - Torque ● - Luer leakage - Animal Data ● The design verification and shelf life testing showed that the device meets specifications before and after aging. This indicates that the device is as safe and effective as the predicate device. ### SUBSTANTIAL EQUIVALENCE 6.6 # Table 6-1 Substantial Equivalence | Table 6-1 Substantial Equivalence | | | |------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | Predicate Device (K923028) | CapnoSpot (Subject Device) | | Intended Use | Evacuate fluid or gas from<br>either a body cavity or the<br>pleural space while providing<br>visualization of needle<br>placement for safety | Provide a visual indication for<br>the accurate placement of a<br>pneumothorax needle | | Indications for<br>Use | The Turkel Safety Fluid System<br>has application in:<br>-Thoracentesis Procedures –<br>Diagnostic and Therapeutic<br>-Paracentesis Procedures –<br>Diagnostic and Therapeutic | The Pneumothorax<br>Decompression Indicator is a<br>colorimetric capnography<br>device indicated to detect the<br>CO2 in the gas passing through<br>the device used to treat<br>Pneumothorax with suspected<br>tension physiology. | | Regulation Class<br>&<br>Product Code | Class I, GCB<br>878.4200 | Class I, GAA<br>878.4800 | | Included<br>Components | -Blunt cannula housed within a<br>sharp hollow needle<br>-In-line stopcock<br>-Color Change indicator<br>-Ball Valve<br>-One-way Valve | - Color Change indicator<br>- One-way valve | | Presence of One-<br>Way Valve to<br>prevent backflow | Yes | Yes | | Indicator Tube<br>and Luer Material | Unknown | Polycarbonate | | One Way Valve<br>Material | Unknown | Silicone | {6}------------------------------------------------ | Characteristic | Predicate Device (K923028) | CapnoSpot (Subject Device) | |------------------|----------------------------|----------------------------| | Indicator Method | Mechanical Spring | Colorimetric Paper | | Sterilization | SAL of 10-6 via EtO | Non-sterile | | Biocompatibility | ISO 10993-1 | N/A | | Single-use only? | Yes | Same | The differences between this device and its predicate do not raise new questions of safety or efficacy. ### 6.7 CONCLUSION The Pneumeric CapnoSpot Pneumothorax Decompression Indicator is substantially equivalent to the predicate device (K923028) in design, function, and intended use.