3DOSE 1ml Syringe

{0} FDA U.S. FOOD & DRUG ADMINISTRATION July 3, 2025 Bimed Teknik Aletler Sanayi & Ticaret A.S. Aysel Kilic Medical Quality Manager Beylikduzu OSB Mah. Leylak Cd. No:16 Beylikduzu/Istanbul Istanbul, 34520, Turkey Re: K250733 Trade/Device Name: 3DOSE 1ml Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: June 4, 2025 Received: June 4, 2025 Dear Aysel Kilic: 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" (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). U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250733 - Aysel Kilic Page 2 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} K250733 - Aysel Kilic Page 3 Sincerely, # Shruti N. Mistry -S Shruti Mistry Assistant 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} 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) K250733 Device Name 3DOSE 1ml Syringe Indications for Use (Describe) The 3 DOSE 1 ml Syringe is intended for use by health care professionals for general purpose fluid aspiration/ injection. 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} bimed K250733 Date Prepared: June 27, 2025 # K250733 510(k) SUMMARY ## Contact Details Applicant Name: Bimed Teknik Aletler Sanayi & Ticaret A.S. Applicant Address: Beylikdüzü OSB Mah. Leylak Cd. No:16 Beylikdüzü/Istanbul Istanbul - 34520 Turkey Applicant Contact Telephone: +90 0212 875 73 Applicant Contact: Mrs. Aysel Kilic Applicant Contact Email: aysel.kilic@bimedteknik.com ## Device Name Device Trade Name: 3DOSE 1ml Syringe Common Name: Piston syringe Classification Name: Syringe, Piston Regulation Number: 880.5860 Product Code: FMF ## Predicate Device Trade Name: TK Sterile Piston Syringe without Needle 510(k) Number: K191642 Classification Name: Syringe, Piston Regulation Number: 880.5860 Product Code: FMF ## Device Description Summary The 3DOSE 1ml Syringe is a sterile, single-use, disposable and non-reusable manual syringe which is intended for injection of fluids into the body. The syringe can be used for pulling up any mixture, and after operating the locking handle for accurate dosing according to the ml/unit scale on the plunger. The 3DOSE 1ml Syringe is used like a classic syringe, but includes a feature that provides tactile and audible feedback to the user during dosing. Models: 3DOSE 1ml Syringe (125 GREEN) 3DOSE 1ml Syringe (100 ORANGE) BİMED TEKNİK ALETLER SAN. VE TİC. A.Ş. Bakır ve Pirinç Sanayi Sitesi Leylak Caddesi No: 16, 34520 Beylikdüzü, İstanbul/Türkiye | T: +90 0212 875 73 76 (Pbx) | F: +90 0212 875 70 52 Tic.Sic: 198367 - 145900 | Marmara Kurumlar VD 8430026332 bimedteknik.com - bimedmedical.com - info@bimedteknik.com {5} bimed K250733 Date Prepared: June 27, 2025 Material used: - 1ml luer lock syringe : polypropylene - Syringe plunger-100-a: polyacetal - Syringe plunger-125-b: polyacetal - Syringe locking arm-orange: polyacetal - Syringe locking arm-green: polyacetal - Plastic part-a: polyacetal - Plastic part-b: polyacetal - Spring: stainless steel - Colours (white ym-by-107, blue mv-74542 (p.649 u), orange 3682, green yl-83030) # Intended Use/Indications for Use The 3DOSE 1ml Syringe is intended for use by health care professionals for general purpose fluid aspiration/ injection. ## Technological Comparison | Characteristic | 3DOSE 1ml Syringe K250733 | TK Sterile Piston Syringes without Needle K191642 | Discussion | | --- | --- | --- | --- | | Common Name | Piston syringe | Piston syringe | Same – both devices are identified as piston syringes. | | Classification Name | Syringe, Piston | Syringe, Piston | Same – both devices fall under the classification “Syringe, Piston.” | | Product Code | FMF | FMF | Same – both devices share the product code FMF. | | Classification | Class II | Class II | Same – both devices are classified as Class II. | | Regulation Number | 880.5860 | 880.5860 | Same – both devices fall under regulation number 880.5860. | | Indications for use | The 3DOSE 1ml Syringe is intended for use by health care professionals for general purpose fluid aspiration/ injection | TK Sterile Piston Syringe without Needle is intended for use by health care professionals for general purpose fluid aspiration/ injection. | Same-both devices are intended to be used by health care professionals for general fluid aspiration and injection | | Operation Mode | For manual use only | For manual use only | Same – both devices are manually operated by the user. | | Intended user | These syringes are intended for use by health care professionals. | These syringes are intended for use by health care professionals. | Same – both devices are intended to be used by trained health care professionals. | | Syringe Volume | 1 ml | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml | Different - the subject device is only offered in 1 ml capacity. The limitation of capacity does not introduce new concerns and is evaluated for performance | BÍMED TEKNIK ALETLER SAN. VE TÍC. A.Ş. Bakir ve Pirinç Sanayi Sitesi Leylak Caddesi No: 16, 34520 Beylikdüzü, İstanbul/Türkiye | T: +90 0212 875 73 76 (Pbx) | F: +90 0212 875 70 52 Tic.Sic: 198367 - 145900 | Marmara Kurumlar VD 8430026332 bimedteknik.com - bimedmedical.com - info@bimedteknik.com {6} bimed K250733 Date Prepared: June 27, 2025 | Nozzle type | Luer Lock | Luer Slip and Luer Lock | Different – the nozzle type for the subject device only includes Luer Lock. The predicate device's nozzle type covers that of subject device. Therefore, the differences do not raise new questions about safety and effectiveness. | | --- | --- | --- | --- | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same – both devices are sterilized using ethylene oxide (EO) sterilization method. | | Shelf – life | 5 years | 5 years | Same – both devices have a validated shelf-life of 5 years. | | Single Use | Yes | Yes | Same – both devices are intended for single use only. | | Performance specifications | Complies with ISO 7886-1:2017 Sterile Hypodermic syringes for single use- Part 1: Syringes for manual use Complies with ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications-- Part 7: Connectors for intravascular or hypodermic applications Complies with ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications-- Part 20: Common test methods | - Complies with ISO 7886-1:2017 Sterile Hypodermic syringes for single use- Part 1: Syringes for manual use - Complies with ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications-- Part 7: Connectors for intravascular or hypodermic applications - Complies with ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications-- Part 20: Common test methods | Same – both devices comply with the applicable ISO standards for sterile hypodermic syringes and small-bore connector performance. | | Configuration and material | Barrel - Polypropylene (PP) Plunger - Polyacetal Piston - Polyisoprene Rubber | Barrel - Polypropylene (PP) Plunger - Polypropylene (PP) Piston - Polyisoprene Rubber | Different – the materials of the plungers are different between the proposed device and predicate device. The biocompatibility test of the proposed device was conducted to demonstrate that the subject device is biocompatible. This difference does not raise any new safety and effectiveness questions. | | Biocompatibility | The biocompatibility evaluation for the 3DOSE 1ml Syringe was conducted 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 and the “Use of International Standard ISO 10993-1 “Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process”. The syringe of testing included the following tests: Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Pyrogenicity Hemocompatibility | The biocompatibility evaluation for the TK Sterile Piston Syringe without needle was conducted 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 and the “Use of International Standard ISO 10993-1 “Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process”. The syringe of testing included the following tests: Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Pyrogenicity Hemocompatibility | Same – both devices were evaluated per ISO 10993 standards and passed the full panel of required biocompatibility tests. | BIMED TEKNIK ALETLER SAN. VE TIC. A.Ş. Bakir ve Pirinç Sanayi Sitesi Leylak Caddesi No: 16, 34520 Beylikdüzü, İstanbul/Türkiye | T: +90 0212 875 73 76 (Pbx) | F: +90 0212 875 70 52 Tic.Sic: 198367 - 145900 | Marmara Kurumlar VD 8430026332 bimedteknik.com - bimedmedical.com - info@bimedteknik.com {7} bimed K250733 Date Prepared: June 27, 2025 | Chemical properties | Chemical performances inspection are based on ISO 7886-1, inspection items are as follows: Limits for acidity or alkalinity, Limits for extractable metals. Results conform to ISO7886-1. | Chemical performances inspection are based on ISO 7886-1, inspection items are as follows: Limits for acidity or alkalinity, Limits for extractable metals. Results conform to ISO7886-1. | Same – both devices were evaluated for chemical properties per ISO 7886-1 and met the acceptance criteria. | | --- | --- | --- | --- | | Graduation lines and audible/tactile feature | The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. Additionally, there are extra parts to use the audible/tactile feature (locking arm, plastic part). There are graduation lines and teeth on the plunger. | The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. | Different – There are graduation lines on the barrel and piston. The extra parts integrated into the device enable the operation of the ratcheting dose mechanism, which provides both audible and tactile feedback to the user during injection. In addition, the additional audio notification feature of our device provides feedback to the user during the injection process and does not change the basic technological functionality and purpose of use of the device. In order to ensure the safety and effectiveness of the audio notification feature, in-process quality control tests were performed. These tests confirmed that the audio notification mechanism works correctly and does not have a negative effect on the overall performance of the device. For these reasons, it was concluded that our device is 'Substantially Equivalent' (SE) with the equivalent product in terms of safety and effectiveness. | | Ratcheting Lock Mechanism | Included – the device contains a ratcheting lock mechanism to initiate injection and provide tactile/audible feedback. | Not included | Different – The subject device includes a locking arm and a plastic part not present in the predicate device. The locking arm is set to a "free" mode before drawing up the medicine, and once the syringe is filled, it is switched to "operation" mode, making the syringe ready for injection. The plastic part functions as a housing element, connecting the locking mechanism to the syringe body. This | BIMED TEKNIK ALETTER SAN. VE TIC. A.Ş. Bakir ve Pirinç Sanayi Sitesi Leylak Caddesi No: 16, 34520 Beylikdüzü, İstanbul/Türkiye | T: +90 0212 875 73 76 (Pbx) | F: +90 0212 875 70 52 Tic.Sic: 198367 - 145900 | Marmara Kurumlar VD 8430026332 bimedteknik.com - bimedmedical.com - info@bimedteknik.com {8} bimed K250733 Date Prepared: June 27, 2025 | | | | feature enhances ease of use but does not alter the fundamental operating principle of the device. It was evaluated through performance testing and determined not to raise new questions of safety or effectiveness. | | --- | --- | --- | --- | # Non-Clinical and/or Clinical Tests Summary & Conclusions **Functional Performance Testing** ISO 7886-1 ISO 80369-7 **Sterility** ISO 11135 ISO 11607-1 ISO 11607-2 ISO 10993-7 **Biocompatibility Testing** ISO 10993-1 ISO 10993-4 ISO 10993-5 ISO 10993-10 ISO 10993-11 USP<788> The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the 3DOSE 1ml Syringe meet the established specifications necessary for safety and performance during its intended use. In addition, the collective bench testing demonstrates that the subject device does not raise different questions of safety or effectiveness when compared to the predicate device. # Conclusions: The 3DOSE 1 ml Syringe is substantially equivalent to the TK Sterile Piston Syringe without Needle. The materials, performance, and operational features of both the subject device and the predicate device are substantially equivalent. BIMED TEKNIK ALETLER SAN. VE TIC. A.Ş. Bakir ve Pirinç Sanayi Sitesi Leylak Caddesi No: 16, 34520 Beylikdüzü, İstanbul/Türkiye | T: +90 0212 875 73 76 (Pbx) | F: +90 0212 875 70 52 Tic.Sic: 198367 - 145900 | Marmara Kurumlar VD 8430026332 bimedteknik.com - bimedmedical.com - info@bimedteknik.com