AdheResp Smart Breath-actuated Mesh Nebulizer

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION June 20, 2025 HCmed Innovations Co., Ltd. % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Drive NE Saint Petersburg, Florida 33704 Re: K250583 Trade/Device Name: AdheResp Smart Breath-actuated Mesh Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: May 19, 2025 Received: May 19, 2025 Dear Paul Dryden: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250583 - Paul Dryden Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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). {2} K250583 - Paul Dryden Page 3 Sincerely, John S. Bender -S 2025.06.20 10:11:59 -04'00' for Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K250583 Device Name AdheResp Smart Breath-actuated Mesh Nebulizer Indications for Use (Describe) The AdheResp Smart Breath-actuated Mesh Nebulizer is a system to aerosolize liquid medications for inhalation for patients ranging from pediatrics equal to or greater than 5 years old to adults who can coordinate breathing. The environment of use are Hospital/institutional settings, home care use, schools, and long-term care facilities 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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 &gt; "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." {4} K250583 # 510(k) Summary Page 1 of 7 Date Prepared: 13-Jun-25 Sponsor: HCmed Innovations Co., Ltd. Rm.B, 10F., No.319, Sec.2, Dunhua S. Rd. TEL: +886-02-2732-6596 Sponsor Contact: Michelle Pieh michelle@hcmed-inno.com Submission Correspondent: Paul Dryden ProMedic, LLC Proprietary or Trade Name: AdheResp Smart Breath-actuated Mesh Nebulizer Classification Name: Nebulizer Product Code: CAF Predicate Device: Pulmogine® Vibrating Mesh Nebulizer – K202171 Classification Name: Nebulizer Product Code: CAF Reference Device: Respironics AAD – K042991 Classification Name: Nebulizer Product Code: CAF Device Description: The AdheResp Smart Breath-actuated Mesh Nebulizer consists of a main unit, medication reservoir, mouthpiece, key tag and charging cable, or power adapter. The medication reservoir could be further separated into a medication container and an aerosol chamber. Principle of Operation: There are two key features in the AdheResp Smart Breath-actuated Mesh Nebulizer, which are vibrating mesh nebulization and breath-actuation functions. The AdheResp Smart Breath-actuated Mesh Nebulizer is an active mesh nebulizer. Active mesh nebulizers operate by electrically activating a piezoelectric (PZT) ceramic element that rapidly contracts and expands when applied a voltage to it. The vibrations of the PZT are transmitted to the mesh membrane, which is in contact with the liquid medication loaded in the medication container. This vibration pushes the liquid or suspension through the fine conical holes of the mesh, forming aerosol droplets for the user to inhale. Indications for Use: The AdheResp Smart Breath-actuated Mesh Nebulizer is a system to aerosolize liquid medications for inhalation for {5} K250583 # 510(k) Summary Page 2 of 7 patients ranging from pediatrics equal to or greater than 5 years old to adults who can coordinate breathing. The environment of use are Hospital/institutional settings, home care use, schools, and long-term care facilities. **Patient Population:** Pediatrics equal to or greater than 5 years old to Adults who can coordinate breathing. **Environments of use:** Hospital/institutional settings, home care use, schools, and long-term care facilities. {6} K250583 510(k) Summary Page 3 of 7 Comparison and Differences vs. Predicate and Reference | | Subject Device AdheResp K250583 | Predicate Device HcMed Pulmogine® K202171 | Reference Device Respironics AAD K042991 | Comment | | --- | --- | --- | --- | --- | | Classification | 21 CFR 868.5630 CAF - Nebulizer - Direct patient interface | 21 CFR 868.5630 CAF - Nebulizer - Direct patient interface | 21 CFR 868.5630 CAF - Nebulizer - Direct patient interface | Similar | | Indications for use | The AdheResp Smart Breath-actuated Mesh Nebulizer is a system to aerosolize liquid medications for inhalation for patients ranging from pediatrics equal to or greater than 5 years old to adults who can coordinate breathing. The environment of use are Hospital/institutional settings, home care use, schools, and long-term care facilities. | The Pulmogine(r) Vibrating Mesh Nebulizer is a system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital / institutional settings, home care use, schools, and long-term care facilities. | The intended purpose of the I-neb AAD System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the 1-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment. | Similar | | Intended Use Environment | Hospital/institutional settings, home care use, schools, and long-term care facilities. | Hospital/institutional settings, home care use, schools, and long-term care facilities. | Home care, nursing home, sub-acute institution, or hospital environment | Similar | | Principle of Operation | Vibrating Mesh | Vibrating Mesh | Vibrating Mesh | Similar | | Aerosolization Mode | Breath actuated | Continuous only | Breath actuated | Similar to reference | | Breath Actuation | Delivers aerosol during a portion of the inhalation cycle | Continuous only during whole inhalation cycle | Delivers aerosol during a portion of the inhalation cycle | Similar to reference | {7} K250583 510(k) Summary Page 4 of 7 | | Subject Device AdheResp K250583 | Predicate Device HcMed Pulmogine® K202171 | Reference Device Respironics AAD K042991 | Comment | | --- | --- | --- | --- | --- | | Maximum Fill Volume | 8+ml | 10 ml | 6ml | Similar | | Components | Main unit with rechargeable battery Reservoir chamber – multi-use Mouthpiece | Main unit with rechargeable battery Reservoir chamber – multi-use Mouthpiece | Main unit with rechargeable battery Reservoir chamber – multi-use Mouthpiece | Similar | | Breath actuation | Pressure drop with sensor | Not applicable | Pressure drop with sensor | Similar to reference | | Algorithm for Inhalation Aerosol delivery | Measures breath and averages the cycle, then delivers aerosol during the designated period | Not applicable | Measures breath and averages the cycle, then delivers aerosol during the designated period | Similar to reference | | Aerosol delivery Range during Inhalation | 40%~80% Default setting - 60%. | Not applicable | 50%~80% Up to last 1 second of inhalation | Similar to reference | | Nebulization rate | ≥0.25 ml/min | ≥0.25 ml/min | | Similar | | Wireless connectivity | Yes | No | Yes | Similar to reference | | Biocompatibility | Surface Contact, mucosal and Externally Communicating, Tissue contact, Permanent Duration ISO 10993-1 testing ISO 18562 testing | Surface Contact, mucosal and Externally Communicating, Tissue contact, Permanent Duration ISO 10993-1 testing ISO 18562 testing | Surface Contact, mucosal and Externally Communicating, Tissue contact, Permanent Duration ISO 10993-1 testing ISO 18562 testing | Similar | {8} K250583 510(k) Summary Page 5 of 7 Breathe Actuated Particle Characterization Performance Comparison to Predicate | Comparative Performance Testing – Breath Actuated 15 LPM and 30 LPM | | | | | | | --- | --- | --- | --- | --- | --- | | | | Subject Device 15 LPM | Predicate 15 LPM | Subject Device 30 LPM | Predicate 30 LPM | | MMAD [μm] | Albuterol | 3.98 ±0.18 | 4.52 ±0.21 | 3.48 ±0.15 | 3.93 ±0.41 | | | Ipratropium | 3.984 ±0.11 | 4.29 ±0.17 | 3.39 ±0.21 | 3.66 ±0.18 | | | USP Cromolyn | 4.07 ±0.14 | 4.46 ±0.29 | 3.58 ±0.15 | 3.77 ±0.35 | | GSD | Albuterol | 1.82 ±0.03 | 2.01 ±0.12 | 1.89 ±0.09 | 1.93 ±0.18 | | | Ipratropium | 1.94 ±0.10 | 2.15 ±0.14 | 1.98 ±0.16 | 2.09 ±0.11 | | | USP Cromolyn | 1.88 ±0.02 | 2.15 ±0.08 | 1.90 ±0.07 | 2.04 ±0.08 | | Total Delivered Dose (mg) | Albuterol | 4.25 ±0.36 | 4.06 ±0.42 | 3.83 ±0.29 | 3.78 ±0.29 | | | Ipratropium | 0.45 ±0.07 | 0.45 ±0.08 | 0.40 ±0.04 | 0.40 ±0.06 | | | USP Cromolyn | 16.23 ±1.35 | 14.73 ±2.24 | 14.65 ±1.09 | 13.69 ±1.75 | | Respirable Dose <5μm [mg] | Albuterol | 2.71 ±0.32 | 2.16 ±0.21 | 2.67 ±0.21 | 2.33 ±0.39 | | | Ipratropium | 0.28 ±0.03 | 0.24 ±0.04 | 0.27 ±0.03 | 0.24 ±0.03 | | | USP Cromolyn | 10 ±0.85 | 7.7 ±1.08 | 9.95 ±0.71 | 8.42 ±0.52 | | Coarse Particle Dose <4.7μm [mg] | Albuterol | 1.47 ±0.10 | 1.56 ±0.19 | 1.05 ±0.28 | 1.20 ±0.39 | | | Ipratropium | 0.15 ±0.02 | 0.16 ±0.02 | 0.11 ±0.01 | 0.12 ±0.02 | | | USP Cromolyn | 5.85 ±0.65 | 5.51 ±0.09 | 4.55 ±0.72 | 4,57 ±1.12 | | Fine Particle Dose <4.7μm [mg] | Albuterol | 2.56 ±0.30 | 2.01 ±0.19 | 2.54 ±0.21 | 2.16 ±0.21 | | | Ipratropium | 0.27 ±0.03 | 0.23 ±0.04 | 0.26 ±0.03 | 0.23 ±0.03 | | | USP Cromolyn | 9.41 ±0.65 | 7.35 ±0609 | 9.46 ±0.48 | 8.00 ±0.47 | | Ultra-Fine Particle Dose <1μm [mg] | Albuterol | LOD | LOD | 0.21 ±0.06 | 0.20 ±0.04 | | | Ipratropium | 0.01 ±0.00 | 0.01 ±0.00 | 0.02 ±0.01 | 0.03 ±0.01 | | | USP Cromolyn | LOD | LOD | 0.58 ±0.05 | 0.58 ±0.11 | Testing was performed with 3 samples of each device in triplicate with the 3 drugs. Testing was performed at flow rates of 15 L/min and 30 L/min. The above comparative results and performance are similar for both the proposed device and the predicate. {9} K250583 510(k) Summary Page 6 of 7 # Substantial Equivalence Discussion ## Substantial Equivalence Discussion The tables above compare the key features of the subject device with the identified predicate and reference. The comparison demonstrates that the subject device can be found to be substantially equivalent to the predicate and any differences are addressed with the reference device. ## Indications for Use – The indications for use are similar for the subject device when compared to the predicate. ## Technology and construction – The technology and principle of operation is similar for the subject device when compared to the predicate and reference devices. ## Environment of Use – The environments of use are similar to the predicate device. ## Patient Population – The patient population is similar to the predicate device. # Non-Clinical Testing Summary – ## Bench testing Performance testing demonstrated that the subject device met its acceptance criteria. Testing included: - Nebulization rate - Inter- and Intra-sample Variability - Aerosol Performance - Comparative (Subject vs. Predicate) Aerosol Performance - Minimum Breath Actuation Tests ## Biocompatibility Applicable ISO 10993 and ISO 18652 testing was performed. ## Reprocessing, Sterility, and Shelf-Life - Cleaning Validation - Aging - Simulated Life (cleaning, aging, drop) ## Discussion of Differences The subject device differs in the following ways from the predicate: - The predicate device is not breath actuated {10} K250583 510(k) Summary Page 7 of 7 - It does not include wireless connectivity - These have been addressed by use of a reference device ## Discussion of Differences The differences between the subject and predicate and reference devices do not raise new concerns regarding the safety and effectiveness as demonstrated by performance testing. ## Substantial Equivalence Conclusion The sponsor has demonstrated through performance testing, design and non-clinical testing that the subject device and predicate have been found to be substantially equivalent.