VacHeal Negative Pressure Wound Therapy System

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 18, 2026 VacHeal, LLC Tiffany Morrison President 40 E. Montgomery Ave. 4th Floor Ardmore, Pennsylvania 19003 Re: K254160 Trade/Device Name: VacHeal Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4683 Regulation Name: Non-Powered suction apparatus device intended for negative pressure wound therapy Regulatory Class: Class II Product Code: OKO Dated: December 19, 2025 Received: December 22, 2025 Dear Tiffany Morrison: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254160 - Tiffany Morrison Page 2 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" (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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. {2} K254160 - Tiffany Morrison Page 3 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). Sincerely, YU-CHIEH CHIU -S Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K254160 | ? | | Please provide the device trade name(s). | | ? | | VacHeal™ Negative Pressure Wound Therapy (NPWT) System | | | | Please provide your Indications for Use below. | | ? | | The VacHeal™ NPWT System is indicated for patients who would benefit from wound management via application of negative pressure to remove small amounts of exudate from closed surgical incisions. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} K254160 ## 510(K) Summary K254160 ### Contact Details | Applicant Name | VacHeal, LLC | | --- | --- | | Applicant Address | 40 East Montgomery Ave. 4^{th} Floor Ardmore PA 19003 United States | | Applicant Contact Telephone | 717-856-1202 | | Applicant Contact | Ms. Tiffany Morrison | | Applicant Contact Email | tiffany@parvizisurgical.com | ### Device Name | Device Trade Name | VacHeal™ Negative Pressure Wound Therapy (NPWT) System | | --- | --- | | Common Name | Non-Powered suction apparatus device intended for negative pressure wound therapy | | Classification Name | Negative Pressure Wound Therapy Non-Powered Suction Apparatus | | Regulation Number | 878.4683 | | Product Code(s) | OKO | ### Legally Marketed Predicate Devices | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | --- | --- | --- | | K151710 | SNaP® Wound Care System | OKO | ### Device Description The VacHeal™ Negative Pressure Wound Therapy (NPWT) System is a non-powered, portable, single patient use, sterile, disposable NPWT System that is intended for wound management via application of negative pressure to closed surgical incisions for removal of small amounts of exudate. The VacHeal™ System maintains Negative Pressure Wound Therapy in the -75 mmHg to -125 mmHg nominal range and has a wear time up to 7 days. ### Intended Use/ Indications for Use The VacHeal™ NPWT System is indicated for patients who would benefit from wound management via application of negative pressure to remove small amounts of exudate from closed surgical incisions. Page 1 of 4 {5} K254160 ## Indications for Use Comparison The VacHeal™ Negative Pressure Wound Therapy (NPWT) System and SNaP® Wound Care System share the same intended purpose of applying negative pressure to wounds to allow wound management through the removal of small amounts of exudate. While the SNaP® Wound Care System is intended for the management of wound types including chronic, acute, traumatic, subacute, and dehisced wounds; partial-thickness burns; ulcers (e.g., diabetic or pressure); surgically closed incisions; flaps; and grafts, VacHeal™ NPWT System is intended only for the use on closed surgical incisions. The VacHeal™ NPWT System does not introduce new indications or expand upon the intended use of the predicate device. Therefore, the VacHeal™ NPWT System is substantially equivalent to the SNaP® Wound Care System with respect to intended use and indications for use. ## Technical Comparison The VacHeal™ NPWT System, the predicate SNaP® Wound Care System, are non-powered, portable, single-use, disposable Negative Pressure Wound Therapy (NPWT) systems intended for wound management via the application of negative pressure to remove exudate. These devices utilize suction and mechanically generated negative pressure without the use of electrically powered components. In the VacHeal™ NPWT System and SNaP® System, negative pressure is generated and regulated through spring-based mechanical mechanisms within a closed system, providing continuous therapy. Maximum pressure limitation and over-pressure prevention are achieved through mechanical means. Each system incorporates visual indicators to confirm proper operation and locking mechanisms to prevent pressure loss and maintain pressure stability over time. The VacHeal™ NPWT System and the SNaP® Wound Care System differ in certain technological characteristics. The VacHeal™ NPWT System delivers variable negative pressure within a nominal pressure range of -75 mmHg to -125 mmHg, whereas the SNaP® Wound Care System delivers fixed negative pressure levels (75, 100, or 125 mmHg) depending on cartridge size. Pressure stability in the VacHeal™ NPWT System is maintained via a Lock/Unlock knob, while the SNaP® Wound Care System utilizes an activation/reset key that is removed after activation. Additional differences include dressing configuration and exudate management. The VacHeal™ NPWT System utilizes a one-piece dressing with AQUAZONE® polyester foam and a 30 mL pump-mounted reservoir/canister for fluid collection. The SNaP® Wound Care System utilizes a proprietary hydrocolloid dressing with reticulated open-cell foam and a gel-containing 60 mL cartridge for exudate containment. Dressing change frequency differs, with the VacHeal™ NPWT System, the dressing is intended for single use for up to 7 days, with frequency adjusted by the clinician as appropriate. Page 2 of 4 {6} K254160 All patient-contacting materials for both devices comply with ISO 10993-1. The identified differences in technological characteristics do not alter the fundamental principle of operation and do not raise new questions of safety or effectiveness. Performance and bench testing demonstrate that the VacHeal™ NPWT System performs as intended and is as safe and effective as the predicate device. ### **Non-Clinical and/or Clinical Tests Summary** The following performance data were provided in support of the substantial equivalence determination. #### ***Non-Clinical Testing*** Non-clinical testing was conducted on the VacHeal™ NPWT System according to the special controls guidance document "Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT) - Class II Special Controls Guidance for Industry and FDA Staff" (issued June 16, 2026) and in accordance with the international standard ISO 10993-1 "Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Non-clinical testing included: - Pumping Time to Operating Pressure - Pressure Decay Vs. Time - Cycle Test Pressure System and Locking Mechanism - Umbrella Relief Valve Pressure - Bulb Press Force - Cycle Test Bulb - Drop Test - Pull Test on Tubing Joints - Flag Indicator Verification Testing - Pressure and Exudate Handling Over Time Test (7-Day Wear) - Shelf Life Test Biocompatibility: -Cytotoxicity -Sensitization -Irritation -Material Medicated Pyrogenicity -Acute and Subacute systemic toxicity Page 3 of 4 {7} K254160 -Closed Surgical Incision Wound Healing animal study in porcine model ### Clinical Testing Not Applicable ### Conclusions The test data submitted for the VacHeal™ NPWT System support the safety of the device and that the device shall perform as intended in the specified use conditions. The data demonstrate that the VacHeal™ NPWT System is substantially equivalent to the predicate device with respect to the intended use and technical comparison. The performance data demonstrates that any technological differences between the subject and predicate device do not raise new issues of safety and effectiveness and is therefore the VacHeal™ NPWT System is substantially equivalent to SNaP® Wound Care System. Page 4 of 4