MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM®

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. October 5, 2023 PromaMedical Inc. % Michael Nilo President & Principal Consultant Nilo Medical Consulting Group, LLC 3491 Denny Street Pittsburgh, Pennsylvania 15201 # Re: K230070 Trade/Device Name: MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318): MESORAM® Hypodermic Needle (712303): MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306): MESORAM® Hypodermic Needle (812400): MESORAM® Hypodermic Needle (812402) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: November 22, 2022 Dear Michael Nilo: Received: January 10, 2023 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. {1}------------------------------------------------ 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" (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 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-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 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. 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-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. {2}------------------------------------------------ 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, Juliane C. Lessard -S Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use | Submission Number (if known) | | |------------------------------|--| |------------------------------|--| | Submission Number (if known) | K230070 | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | MESORAM® Hypodermic Needle (710301);<br>MESORAM® Hypodermic Needle (710302);<br>MESORAM® Hypodermic Needle (712305);<br>MESORAM® Hypodermic Needle (712315);<br>MESORAM® Hypodermic Needle (710303);<br>MESORAM® Hypodermic Needle (710307);<br>MESORAM® Hypodermic Needle (710306);<br>MESORAM® Hypodermic Needle (712308);<br>MESORAM® Hypodermic Needle (712318);<br>MESORAM® Hypodermic Needle (712303);<br>MESORAM® Hypodermic Needle (712307);<br>MESORAM® Hypodermic Needle (712306);<br>MESORAM® Hypodermic Needle (812400);<br>MESORAM® Hypodermic Needle (812402) | | Indications for Use (Describe) | The MESORAM® Hypodermic Needles are intended to inject fluids intradermally. | | 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 "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}------------------------------------------------ This 510(k) Summary was prepared in accordance with 21 CFR 807.92 #### Submitter 1. | Applicant: | PromaMedical Inc.<br>4585 Ponce De Leon Blvd., Suite 719<br>Miami, FL 33146 | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Contact: | Christian Wehrenpfennig<br>President<br>Phone: (239) 850-0885<br>Email: wehrenpfennigc@promamedical.com | | Application<br>Correspondent: | Michael Nilo<br>President and Principal Consultant, Nilo Medical Consulting Group<br>Phone: (717) 421-4396<br>Email: michael.nilo@nilomedicalconsulting.com | | Date Prepared: | 05 October 2023 | ## Device Information 2. | Trade Name: | MESORAM® Hypodermic Needles | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Hypodermic Needle | | Device Classification: | Name: Needle, Hypodermic, Single Lumen<br>Regulation No.: 21 CFR 880.5570<br>Product Code: FMI – Needle, Hypodermic, Single Lumen<br>Class: II<br>Classification Panel: General Hospital | ### 3. Predicate Device Information | Trade Name: | Meso-Relle (AAL34, AAL36, AM30G) | | | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | 510(k) Number: | K161255 | | | | Common Name: | Hypodermic Needle | | | | Device Classification: | Name: Needle, Hypodermic, Single Lumen<br>Regulation No.: 21 CFR 880.5570<br>Product Code: FMI – Needle, Hypodermic, Single Lumen<br>Class: II<br>Classification Panel: General Hospital | | | {5}------------------------------------------------ #### Device Description 4. MESORAM hypodermic needles are single lumen hypodermic needles that will inject fluids into the intradermal space. The device consists of an AISI 304 stainless steel tube that is sharpened at one end, with the other end joined to a female connector (luer) designed to mate with a male connector. MESORAM hypodermic needles are available in gauges 27 G, 30 G, 32 G, and 33 G, with varying needle lengths and outer diameters. The needles feature a protective tip cover which is formed of rigid polypropylene. #### 5. Intended Use MESORAM hypodermic needles are intended to inject fluids intradermally. #### Comparison of Technical Characteristics with the Predicate Device 6. There are no differences in the technological characteristics between the proposed device and the predicate (K161255) device. The proposed and predicate devices have identical indications for use. The proposed device is made from the same supplier as the predicate device and shares the same materials, design, and sterilization method as the predicate device. Table 1 provides a technological comparison between the proposed and predicate devices. {6}------------------------------------------------ | Category | Subject Device<br>MESORAM® Hypodermic<br>Needle | Predicate Device<br>Meso-Relle<br>(AAL34, AAL36, AM30G) | Comments | |------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | PromaMedical Inc.<br>4585 Ponce De Leon Blvd.,<br>Suite 719<br>Miami, FL 33146 USA | Biotekne SRL<br>Via Della Bastia 9<br>Casalecchio De Rino, Italy<br>40033 | N/A | | 510(k) Number | N/A | K161255 | N/A | | Regulation Number | 880.5570 | 880.5570 | Identical | | Product Code | FMI | FMI | Identical | | Classification Name | Needle, Hypodermic, Single<br>Lumen | Needle, Hypodermic, Single<br>Lumen | Identical | | Indication | Intended to inject fluids<br>intradermally | Intended to inject fluids<br>intradermally | Identical | | Needle Material | AISI 304 Stainless Steel | AISI 304 Stainless Steel | Identical | | Needle Lengths | 4-25 mm | 4-12 mm | Substantially Equivalent:<br>While the MESORAM<br>needles offer longer lengths,<br>they were evaluated to the<br>same testing standards as the<br>predicate device and raise no<br>new questions of safety or<br>effectiveness. | | Category | Subject Device<br>MESORAM® Hypodermic | Predicate Device<br>Meso-Relle | Comments | | | Needle | (AAL34, AAL36, AM30G) | | | Needle Gauges | 27-33 G | 30 G | Substantially Equivalent:<br>While the MESORAM<br>needles offer larger gauges (32<br>& 33 G), they were evaluated<br>to the same testing standards<br>as the predicate device and<br>raise no new questions of<br>safety or effectiveness. | | Needle Tip<br>Configurations | Triple sharpened, non-coring | Triple sharpened, non-coring | Identical | | Hub Material | Polypropylene<br>(MG03MA) | Polypropylene<br>(MG03MA) | Identical | | Needle Cover<br>Material | Rigid cover, polypropylene<br>J801 | Rigid cover, polypropylene or<br>polypropylene / ethylene<br>copolymer rigid cover,<br>polyethylene | Substantially Equivalent:<br>Subject device is identical to<br>one of the configurations of<br>the predicate device | | Adhesive<br>(Needle to Hub bond) | Epoxy | Epoxy | Identical | | Lubricant | Medical grade silicone oil | Medical grade silicone oil | Identical | | Sterilization Method | EtO | EtO | Identical | | Biocompatibility<br>Conformance | ISO 10993-1 | ISO 10993-1 | Identical | | Performance Testing<br>Conformance | ISO 7864:2016<br>ISO 9626:2016<br>ISO 594-1:1986 | ISO 7864:2016<br>ISO 9626:2016<br>ISO 594-1:1986 | Identical | Table 1: Comparison of Subject Device to Predicate Device {7}------------------------------------------------ {8}------------------------------------------------ #### 7. Performance Standards FDA has established performance standards which apply to this device, and the proposed device was evaluated per those standards: - . ISO 594-1:1986 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain other Medical Equipment - ISO 7864-2:2016: Sterile Hypodermic Needles for Single Use Requirements and Test . Methods - ISO 9626:2016: Stainless Steel Needle Tubing for the Manufacture of Medical Devices ● Requirements and Test Methods ### Summary of Non-Clinical Testing 8. The MESORAM Hypodermic Needles met all in-vitro acceptance criteria as set forth in the consensus standards mentioned as well as the April 1993 FDA Document Guidance on the Content of Premarket Notification [501(k)] Submissions for Hypodermic Single Lumen Needles. Biocompatibility testing performed on the needles included: - Cytotoxicity (ISO 10993-5, ISO 10993-12) ● - Sensitization (ISO 10993-10) . - Irritation / Intracutaneous Reactivity (ISO 10993-10) - Acute Systemic Toxicity (ISO 10993-11) - Indirect Hemolvsis (ISO 10993-4) . All samples met the biocompatibility acceptance criteria. The sterility of the MESORAM Hypodermic Needles is assured by means of a validated sterilization method complying with the recognized consensus standard AAMI/ANSI/ISO 11135:2014 Sterilization of Health Care Products – Ethylene Oxide – Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices. ### 9. Summary of Clinical Testing No clinical data were required for this submission. #### 10. Conclusion The MESORAM Hypodermic Needles have the same indications for use and share the identical technological characteristics as the predicate device. The results of performance testing show the proposed device is substantially equivalent to the predicate in performance as all test results show conformity to recognized consensus standards for this device type. Based on their intended use, technological characteristics, and performance testing results, the proposed MESORAM Hypodermic Needles can be considered substantially equivalent to the predicate.