0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE

{0}------------------------------------------------ # 510(k) Summary - K141311 # JUL 2 5 2014 | Submitted By: | Juma Hoshino<br>Regulatory Affairs Specialist<br>BD Medical - Medical Surgical Systems<br>1 Becton Drive<br>Franklin Lakes, NJ 07417<br>Phone: (201)847-4260; Fax: (201)847-5307 | | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Date Prepared: | July 24, 2014 | | | Trade Name: | 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe<br>0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe | | | Common Name: | 0.9% Sodium Chloride Injection Flush Syringe | | | Classification Name: | Saline, Vascular Access Flush (Class II, 21 CFR §880.5200) | | | Product Code: | NGT | | | Predicate Device: | K121050<br>0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe<br>0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe | | ## Device Description The 0.9% Sodium Chloride Injection, USP, BD PosiFlush" SP and SF Syringe (also referred to as BD PosiFlush " SP and SF Syringe) is a three-piece, sterile, single use syringe with a 6% (luer) connector prefilled with 0.9% sodium chloride injection, USP, and sealed with a tip cap. The BD PosiFlush™ SP Syringe is provided with a sterile fluid path, and the BD PosiFlush™ SF Syringe is provided externally sterile for use on a sterile field. Both configurations are sterilized via moist heat. The modified BD PosiFlush™ SP Syringe and BD PosiFlush™ SF Syringe, the subject of this 510(k), includes a new resin material in the barrel of the prefilled syringe. #### Intended Use The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringes and 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are intended to be used only for the flushing of indwelling vascular access devices. Catalog Number 306547 10 mL 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringes are generally compatible for use with syringe pumps. #### Technological Characteristics The subject BD PosiFlush™ SP and SF Syringe is equivalent to that of the predicate BD PosiFlush™ SP and SF Syringe in intended use, materials and performance characteristics. The new syringe barrel resin material does not raise any new questions regarding safety or effectiveness. {1}------------------------------------------------ | | Element of Comparison | Equivalence | |----------------------|-----------------------|--------------------------| | Syringe<br>Materials | Barrel | Equivalent to predicate. | | | Plunger Rod | Identical to predicate. | | | Stopper | Identical to predicate. | | | Stopper Lubricant | Identical to predicate. | | | Tip Cap | Identical to predicate. | | Solution | | Identical to predicate. | | Sterilization Method | | Identical to predicate. | | Sterile | | Identical to predicate. | | SAL | | Identical to predicate. | | Shelf Life | | Identical to predicate. | ## Non-Clinical Testing BD has performed the following non-clinical testing based on the risk analysis conducted and the results of these tests demonstrate that the BD PosiFlush™ SP and SF Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended. | Performance Characteristic | | Acceptance Criteria | |--------------------------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Functional Testing | Container Closure Integrity | No Dye in Solution<br>No Leakage in the luer well or tip threads<br>No Leakage Past the Stopper Ribs<br>No Dye Between Stopper Ribs | | | Break Loose Force | Equivalence to Predicate | | | Break Out Force | Equivalence to Predicate | | | Sustaining Force | Equivalence to Predicate | | | Retaining Ring Force | Equivalence to Predicate | | | Tip Cap Removal Force | Equivalence to Predicate | | Sodium Chloride<br>Injection, USP, Testing | Bacterial Endotoxin | Per USP Monograph, Sodium Chloride | | | Particulate Matter | Injection | | | Assay of NaCl | | | | Heavy Metals | | | | Iron | | | | pH | | | Biocompatibility Testing | | Per ISO10993 Series<br>LC/DAD/MS, GC-MS, ICP; acceptable<br>extractable test. | #### Clinical Testing Clinical testing was not required for this submission. ## Substantial Equivalence Statement The 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringes and 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are substantially equivalent in intended use, principles of operation and technology, design and materials, and performance. The modified device does not raise new concerns of safety and effectiveness. {2}------------------------------------------------ ## Conclusion The 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringes and 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes have been validated to meet the established performance criteria. The results of the analysis and verification studies demonstrate that the BD PosiFlush™ SP and SF Syringes perform as intended and based on the non-clinical tests performed the subject device is as safe, as effective and performs as safely and effectively as the legally marketed predicate devices. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000 Public Health Service July 25, 2014 Becton, Dickinson and Company Ms. Juma Hoshino Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417 Re: K141311 Trade/Device Name: 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Saline, Vascular Access Flush Regulatory Class: II Product Code: NGT Dated: June 24, 2014 Received: June 25, 2014 Dear Ms. Hoshino We have reviewed your Section 510(k) promarket 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. 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 docs 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 cither 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. {4}------------------------------------------------ # Page 2 - Ms. Hoshino 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Tejasbri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clipical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known): K141311 # Device Name: 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe 0.9% Sodium Chloride Injection, USP, BD PosiFlushTM SF Syringe Indications for Use: The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringes and 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are intended to be used only for the flushing of indwelling vascular access devices. Catalog Number 306547 10 mL 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringes are generally compatible for use with syringe pumps. Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Sreekanth Signed by Sreekanth G Gutala -S Digitally signed by Sreekanth Gutala ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=200054 0490, cn=Sreekanth Gutala -S Date: 2014.07.25 10:22:08 -04'00'