Who is the manufacturer of 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe?

Becton, Dickinson and Company filed the 510(k) submission for 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe (K231161).

What is the FDA product code for 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe?

NGT. It is classified under 21 CFR 880.5200 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe?

510(k) clearance (submission type: Traditional).

What are the predicate devices for 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe?

0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Syringe (K153481).

Who can help prepare an FDA 510(k) submission like 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe

K231161 · Becton, Dickinson and Company · NGT · Jul 21, 2023 · General Hospital

Device Facts

Record ID	K231161
Device Name	0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe
Applicant	Becton, Dickinson and Company
Product Code	NGT · General Hospital
Decision Date	Jul 21, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5200
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices.

Device Story

Device is a sterile, single-use, 10mL prefilled syringe containing 0.9% sodium chloride USP solution. Used by clinicians to flush indwelling vascular access devices; maintains line patency by displacing fluids. Operation involves manual removal of tip cap and depression of plunger rod to deliver saline. Device is packaged in film-on-film blister pack and sterilized via gamma irradiation. Enables use within sterile fields. Benefits include maintenance of vascular access device patency and prevention of occlusion.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench performance testing, packaging integrity, and biocompatibility testing (ISO 10993 series).

Technological Characteristics

Materials: Polypropylene-polyethylene random copolymer barrel/tip cap, styrene-butadiene rubber stopper, silicone lubricant. Energy: Manual. Connectivity: None. Sterilization: Gamma irradiation. Form factor: 10mL prefilled syringe. Packaging: Film-on-film blister pack.

Indications for Use

Indicated for flushing indwelling vascular access devices in patients requiring maintenance of line patency.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Syringe (K153481)

Related Devices

K161552 — 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe · Becton, Dickinson and Company · Feb 2, 2017
K042061 — 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE · Becton Dickinson · Aug 26, 2004
K201286 — 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch · Nurse Assist, LLC · Aug 11, 2020
K133685 — 0.9% SODIUM CHLORIDE FLUSH SYRINGE · Am USA · Aug 13, 2014
K060339 — KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY · Tyco Healthcare/Kendall · Apr 28, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 21, 2023 Becton, Dickinson and Company Samhitha Mohan Sr. Staff Regulatory Affairs Specialist 1 Becton Dr Franklin Lakes, New Jersey 07417 Re: K231161 Trade/Device Name: 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: April 24, 2023 Received: April 24, 2023 Dear Samhitha Mohan: 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 (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 located 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. 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 {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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. 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, Bifeng Qian -S Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231161 Device Name 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe Indications for Use (Describe) The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices. Type of Use (Select one or both, as applicable) X 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." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the BD logo, which includes an orange sunburst symbol and the letters "BD" in blue. Below the logo is the text "0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringe". The text describes the product as a saline flush syringe containing 0.9% sodium chloride. | | Submitter Name: | Becton, Dickinson and Company | |--------------------------|-----------------------|----------------------------------------------------------------------------------| | Submitter Information | Submitter Address: | 1 Becton Dr Franklin Lakes NJ 07417 | | | Contact Person: | Samhitha Mohan Sr. Staff Regulatory Affairs Specialist | | | | Email Address: | | | Phone Number: | (214)-971-0979 | | | Fax Number: | (201)-847-5307 | | | Date of Preparation: | 21 July, 2023 | | | Trade Name: | 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringe | | Subject Device | Common Name: | 0.9% Sodium Chloride Injection Flush Syringe | | | Regulation Number: | 21 CFR 880.5200 | | | Device Class: | Class II | | | Classification Name: | Saline, Vascular Access Flush | | | Product Code: | NGT | | | Classification Panel: | General Hospital | | | Trade Name: | 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Syringe | | Predicate Device | 510(k) Number: | K153481 | | | Classification Name: | Saline, Vascular Access Flush | | | Regulation Number: | 21 CFR 880.5200 | | | Regulatory Class: | Class II | | | Product Code: | NGT | | | Classification Panel: | General Hospital | ## 510(k) Summary (21 CFR §807.92) {4}------------------------------------------------ | Device Description | 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringe is a polypropylene syringe intended to flush indwelling vascular access devices. It is a sterile, single use syringe prefilled with 0.9% sodium chloride injection, USP, and sealed with a tip cap. The device is packaged in a film-on-film blister pack and sterilized by gamma irradiation. External sterility of the device enables it to be used in the sterile field. The subject device is available only in 10mL syringe configuration. | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices. | | Technological Characteristic-s | The following table provides a comparison between the subject and predicate devices – | {5}------------------------------------------------ | Attribute | Subject Device (0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe) | Predicate Device (0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Syringe) - K153481 | Compar -ison | |---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/Indications for Use | The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices. | The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are intended to be used only for the flushing of indwelling vascular access devices. | Similar; "Saline Flush" is added to the name of the subject device | | Operating Principle | The tip cap is twisted off from the barrel and plunger rod is depressed to drive the flow of 0.9% sodium chloride USP solution through the indwelling vascular access devices. The saline solution 'cleans out' or displaces any other fluid and maintains patency of the line. | The tip cap is twisted off from the barrel and plunger rod is depressed to drive the flow of 0.9% sodium chloride USP solution through the indwelling vascular access devices. The saline solution 'cleans out' or displaces any other fluid and maintains patency of the line. | Identical | | Syringe Configuration | 10mL | 10mL | Identical | | Single Use? | Yes | Yes | Identical | | Sterile? | Yes | Yes | Identical | | Use in Sterile Field? | Yes | Yes | Identical | | Content of syringe package | One pre-filled syringe per pack | One pre-filled syringe per pack | Identical | | Device Components | Barrel 0.9% NaCl USP solution Plunger Rod Tip Cap Stopper | Barrel 0.9% NaCl USP solution Plunger Rod Tip Cap Stopper | Identical | | Barrel Material | Polypropylene- Polyethylene Random Copolymer | Polypropylene Homopolymer | Similar; Subject device material is assessed as per ISO 10993-1 | | Barrel Lubricant | Silicon e | Silicone | Identical | | Plunger Rod Material | Polypropylene | Polypropylene | Identical | | Stopper Material | Styrene-Butadiene Rubber | Styrene-Butadiene Rubber | Identical | | Stopper Lubricant | Silicon e | Silicone | Identical | | Tip Cap Material | Polypropylene- Polyethylene Random Copolymer | Polypropylene Homopolymer | Similar; Subject device material is assessed as per ISO 10993-1 | | Tip Cap Colorant | White | White | Identical | | Packaging Configuration | Blister pack Shelf Carton Case Carton | Blister pack Shelf Carton Case Carton | Identical | | Primary Packaging Material | Film on film | Paper on film | Different; Appropriate packaging tests are performed to ensure sterile barrier integrity is maintained | | Mode of Sterilization | Gam ma | Autoclave | Different | | SAL | 10-6 | 10-6 | Identical | | Shelf Life | 1 year | 3 years | Different; Subject device shelf life has been assessed by appropriate bench performance testing | | Tip Cap Removal Torque | Measure the torque required to remove the tip cap from the syringe | Measure the torque required to remove the tip cap from the syringe | Same as Predicate | | Tip Cap Leakage | Measure the resistance to leakage in between the Luer and the tip cap for pre-filled syringes | Measure the resistance to leakage in between the Luer and the tip cap for pre-filled syringes | Same as Predicate | | Breakloose Force | Measure the initial maximum force required to move the plunger rod/stopper in the syringe barrel | Measure the initial maximum force required to move the plunger rod/stopper in the syringe barrel | Same as Predicate | | Breakout Force | Measure the maximum force required to move the plunger rod/stopper in the syringe barrel a short time after initially moving the plunger rod/stopper | Measure the maximum force required to move the plunger rod/stopper in the syringe barrel a short time after initially moving the plunger rod/stopper | Same as Predicate | | Sustaining Force | Measure the average force required to move the plunger rod/stopper in the syringe barrel | Measure the average force required to move the plunger rod/stopper in the syringe barrel | Same as Predicate | | Reflux | Measure the potential blood reflux into the catheter from PosiFlush™ SF syringe | Measure the potential blood reflux into the catheter from PosiFlush™ SF syringe | Same as Predicate | | Retaining Ring Force | Measure the force necessary to remove the plunger rod / stopper assembly from the syringe barrel after assembly | Measure the force necessary to remove the plunger rod / stopper assembly from the syringe barrel after assembly | Same as Predicate | | Leakage past Stopper | Measure the resistance to leakage in between the barrel and stopper for pre-filled syringes | Measure the resistance to leakage in between the barrel and stopper for pre- filled syringes | Same as Predicate | | Expelled Volume | Measure the volume of saline solution | Measure the volume of saline solution expelled from the syringe | Same as Predicate | | Sterility | To verify 10-6 Sterility Assurance Level (SAL) on all surface (fluid path and external surface) of syringe, fluid path and inside surface of primary packaging | To verify 10-6 Sterility Assurance Level (SAL) on all surface (fluid path and external surface) of syringe, fluid path and inside surface of primary packaging | Same as Predicate | | NaCl Solution Stability | Following tests to comply with 0.9% NaCI Injection USP Monograph – NaCl Assay, pH, Endotoxin, Particulate Matter, Iron, Heavy metals, UV/Vis | Following tests to comply with 0.9% NaCl Injection USP Monograph – NaCl Assay, pH, Endotoxin, Particulate Matter, Iron, Heavy metals, UV/Vis | Same as Predicate | | Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Same as Predicate | | Sensitization | Non-Sensitizer | Non-Sensitizer | Same as Predicate | | Irritation or Intracutaneous Activity | Non-irritant | Non-irritant | Same as Predicate | | Acute Systemic Toxicity | No acute systemic toxicity | No acute systemic toxicity | Same as Predicate | | Material Mediated Pyrogenicity | Not a material mediated-pyrogen | Not a material mediated-pyrogen | Same as Predicate | | Hemocompatibility | Non-hemolytic | Non-hemolytic | Same as Predicate | | Genotoxicity | Non-genotoxic | Non-genotoxic | Same as Predicate | | LAL Endotoxin | Below the Endotoxin Limit 0.5 EU/device | Below the Endotoxin Limit 0.5 EU/device | Same as Predicate | | Extractable and Leachable Analysis | Extractable and leachable substances showed toxicologically acceptable levels. | Extractable and leachable substances showed toxicologically acceptable levels. | Under the condition of the chemical characterization testing, there were no extractables and leachables identified that indicated significant risk concerns | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ ### Discussion: The subject device and predicate device are different with respect to the following items: - 1. "Saline Flush" is added to the name of the subject device - 2. The mode of sterilization was changed from autoclave (predicate) to gamma irradiation (subject). The gamma sterilized test samples were evaluated for performance, packaging integrity and biocompatibility. - 3. The barrel and tip cap resin of both subject and predicate device is polypropylene. However, the subject device polypropylene has small amount of polyethylene which ensures compatibility with gamma sterilization process. Appropriate performance tests and biocompatibility tests were performed to ensure safety and effectiveness. - 4. The blister pack was changed from paper on film to film on film material. This change ensures compatibility with gamma sterilization process. Package integrity tests were performed to evaluate the material change. - 5. The shelf life of the subject device is lowered to 1 year. Stability tests were performed to support 1 year shelf life of the subject device. The different technological characteristics between the subject and predicate device are evaluated in bench performance testing, packaging integrity and biocompatibility tests demonstrating that there are no new or different questions of safety and effectiveness. BD has performed the following performance tests in accordance with 21 CFR §820.30 to demonstrate that the Non-Clinical PosiFlush™ SF Syringe performs equivalent to the predicate Testing devices. The following tests were performed on the subject device to an internal specification or a Standard: {11}------------------------------------------------ | Test | Purpose | Acceptance Criteria | Result | | |------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------|--| | | Performance/Design Verification Tests | | | | | Tip Cap Removal Torque | Measure the torque required to remove the tip cap from the syringe | Tip Cap can be twisted off as per BD validated force | Pass | | | Reflux | Measure the potential blood reflux into the catheter from PosiFlush™ SF syringe | Reflux greater than BD validated internal value | Pass | | | Tip Cap Leakage | Evaluate the resistance to leakage between the barrel Luer and the tip cap for pre-filled syringes | No evidence of Tip Cap leakge | Pass | | | Leakage past Stopper | Evaluate the resistance to leakage between the barrel and stopper ribs | No leakage of solution past the stopper ribs | Pass | | | Breakloose force | Measure the initial maximum force required to move the plunger rod/stopper in the syringe barrel | | Pass | | | Breakout Force | Measure the maximum force required to move the plunger rod/stopper in the syringe barrel a short time after initially moving the plunger rod/stopper | Force to move plunger rod/stopper is less than the BD validated force | Pass | | | Sustaining Force | Measure the average force required to move the plunger rod/stopper in the syringe barrel | | Pass | | | Retaining Ring Force | Measure the force necessary to remove the plunger rod/stopper assembly from the syringe barrel after assembly | Force to move plunger rod/stopper is greater than the BD validated force | Pass | | | Expelled Volume | Measure the volume of saline solution expelled from the syringe | USP43-NF38 <697>Container Content for Injections | Pass | | | NaCl Assay | Measure the NaCl concentration saline solution in syringe samples | 0.9% NaCl Injection USP Monograph | Pass | | | pH | Measure the pH of saline solution in syringe samples | 0.9% NaCl Injection USP Monograph and USP43-NF38 <791> pH | Pass | | | Iron | Measure the amount of iron in saline solution | 0.9% NaCl Injection USP Monograph and | Pass | | | | | USP43-NF38 <241> Iron | | | | Heavy Metals | Measure the heavy metals such as Cadmium, Arsenic, Cobalt, Vanadium, Copper, Lead, Nickel, Lithium, Antimony and Mercury in saline solution | USP43-NF38 <232> Elemental Impurities - Limits | Pass | | | NaCl solution weight loss | Measure the weight loss of saline solution in pre-filled saline syringes | USP43-NF38 <671> Containers Performance Testing | Pass | | | UV Analysis | Measure the UV absorbance between 220-360 nm for pre-filled saline syringes | < 0.4 AU | Pass | | | Bacterial Endotoxin | Determine the amount of endotoxin in saline pre-filled syringes | 0.9% NaCl Injection USP Monograph and USP43-NF38 <85> Bacterial Endotoxins Test | Pass | | | Sterility | To verify 10-6 SAL in the fluid path. | Sterile; No growth | Pass | | | Surface Sterility | To verify 10-6 SAL on all surface of syringe and inside surface of primary packaging | in media | Pass | | | Particulate Matter | Measure the number of particulates in saline pre-filled syringes | USP43-NF38 <788> Particular Matter in Injections | Pass | | | Appearance and Solution Clarity/ Barrel Transparency | Examine the appearance, solution clarity and barrel transparency in pre-filled saline syringes | Solution and components are clear | Pass | | | Primary Package Integrity | Evaluates the sterile barrier system of the pre-filled syringe throughout shelf life | No leaks when tested by Vacuum Bubble Leak (ASTM F2096-11) | Pass | | | | | Non-porous Seal strength and width value as per BD validated force and width measurements respectively | Pass | | | | | No defects in packaging seals when visually inspected | Pass | | | | | Clean peel of blister pack with no foreign matter | Pass | | | | | Biocompatibility | | | | Cytotoxicity | ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Grade ≤ 2 | Pass | | | Sensitization | ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization | Non-Sensitizer | Pass | | | Irritation | ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 23: Tests for Irritation | Final Test Sample Score ≤ 1 | Pass | | | Acute Systemic Toxicity | ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | No significantly greater biological reaction than the control | Pass | | | Material Mediated Pyrogenicity | ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity USP43-NF38 <151>Pyrogen Test (USP Rabbit Test) | No temperature rise ≥ 0.5° C | Pass | | | Hemocompat -ibility | ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials | ≤ 5% hemolysis | Pass | | | Genotoxicity | ISO 10993-3: 2014 Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | Non-mutagenic | Pass | | | LAL Endotoxin | USP 43-NF38 <161> Medical Devices – Bacterial Endotoxin | Below the Endotoxin Limit 0.5 EU/device | Pass | | | | USP43-NF38 <85> Bacterial Endotoxins Test ANSI AAMI ST72:2019 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing | | | | | Extractable and Leachable Analysis | ISO 10993-18: 2020 Biological evaluation of medical devices - Part 18: Chemical characterization of materials ISO 10993-17: 2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances | N/A | See Note 1 below | | {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ Note 1: Under the condition of the chemical characterization testing, there were no extractables and leachables identified that indicated significant risk concerns The subject device met all the predetermined acceptance criteria for the above listed performance, packaging, and biocompatibility tests. | Clinical Testing | Not applicable. | |------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion | The conclusions drawn from the nonclinical tests demonstrate that the BD PosiFlush™ SF is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153481. |

0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe

Device Facts

Intended Use

Device Story

Clinical Evidence

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Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe