Freedom Syringe

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 27, 2017 Procedure Products, Inc. Mr. Doug Rowley QA Manager 1801 W. 4th Plain Blvd. Vancouver, Washington 98660 Re: K161812 Trade/Device Name: Freedom™ Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: February 17, 2017 Received: February 21, 2017 Dear Mr. Doug Rowley: 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. The general controls provisions of the Act include requirements for annual registration. Isting 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. {1}------------------------------------------------ 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". There is also a "-s" below the name. The signature is a complex series of loops and lines, and it is placed to the left of the name. Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Change Control Table, Change History # Change Control Table | Version | Document Author | Document Approver | Date Approved | |---------|---------------------|---------------------|---------------| | 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY | Complete Change Control Table (all versions) retained in SWIFT Docs. {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K161812 Device Name Freedom™ Syringe Indications for Use (Describe) The Freedom™ Syringe is intended to inject fluids into, or withdraw fluids from, the body. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <b> <span style="font-family: Wingdings;">☑</span> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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}------------------------------------------------ PROCEDURE PRODUCTS INC. 1801 WEST FOURTH PLAIN BLVD. VANCOUVER, WASHINGTON 98660 360.693.1832 TELEPHONE 360.690.4473 FAX WWW.PROCEDUREPRODUCTS.COM Image /page/4/Picture/1 description: The image contains the logo for Procedure Products Inc. The logo is in blue text, with the words "Procedure Products Inc." stacked on top of each other. To the left of the text is a square made up of four smaller squares in yellow, blue, green, and red. Below the main text is the phrase "Safety Color TM" in a smaller font. Page 1/4 # 510(k) Summary K161812 510(k) Number: ## General Provisions Address: Fax Number: Procedure Products, Inc. Submitter's Name: > 1801 W 4th Plain Blvd. Vancouver, WA 98660 > > Doug Rowley (360) 693-1832 or (888) 532-3396 Telephone Number: (360) 690-4473 Contact Person: (360) 693-1832 Date of Preparation: 03/09/2017 # Subject Device Freedom™ Svringe Trade Name: 21 CFR 880.5860 Regulation Number: Regulation Name: Piston Syringe Requlatory Class: = FMF Product Code: Classification Panel: General Hospital # Predicate Device Trade Name: Requlation Number: Requlation Name: Regulatory Class: Product Code: Classification Panel: Premarket Notification #: DMC Medical Single-Use Polycarbonate Syringe 21 CFR 880.5860 Piston Syringe = FMF General Hospital K103736 {5}------------------------------------------------ PROCEDURE PRODUCTS INC. 1801 WEST FOURTH PLAIN BLVD. VANCOUVER, WASHINGTON 98660 360.693.1832 TELEPHONE 360.690.4473 FAX WWW.PROCEDUREPRODUCTS.COM Image /page/5/Picture/1 description: The image shows the logo for Procedure Products Inc. The logo consists of the words "Procedure" and "Products Inc." in blue font. To the left of the words is a square made up of four smaller squares in the colors yellow, blue, green, and red. Below the words "Products Inc." is the phrase "Safety Color TM" in a smaller blue font. Page 2/4 # Indications for Use The Freedom™ Syringe is intended to inject fluids into, or withdraw fluids from, the body. ## Device Description The Freedom™ Syringe is a single-use medical device consisting of a calibrated hollow barrel and movable plunger (piston). The plunger contains a rubber stopper on the end that is positioned within the syringe barrel. A small amount of medical-grade silicone is used as a lubricant. The lubricant, stopper on the end of the plunger, and the syringe barrel are the components which make contact with the fluid path of the device. The syringe barrel contains a standard male luer lock connector that is compatible with standard female luer hubs. Freedom™ Syringes have a nominal capacity of 10ml, and are available sterile or non-sterile for further processing. The syringe is available in 5 different plunger colors: white, blue, red, yellow, or green. ## Principles of Operation Freedom™ Syringes are manually operated by the user through the advancement and/or withdrawal of the syringe plunger within the barrel. Syringe content volume is measured by the user through the printed scale on the outside of the syringe barrel. These operating principles are identical to that of the predicate device and the vast majority of piston syringes currently on the market. #### Comparison to Predicate Device The indications for use, technological characteristics, and principles of operation of the Freedom™ Syringe are substantially equivalent to those of the DMC Medical Single-Use Polycarbonate Syringe product line (predicate device). Both devices have been designed and tested to ensure compliance with the same set of consensus standards. The table on the following page provides additional comparison between the subject device (Freedom™ Syringe) and the predicate device (the DMC Medical Single-Use Polycarbonate Syringe). {6}------------------------------------------------ PROCEDURE PRODUCTS INC. 1801 WEST FOURTH PLAIN BLVD. VANCOUVER, WASHINGTON 98660 360.693.1832 TELEPHONE 360.690.4473 FAX WWW.PROCEDUREPRODUCTS.COM Image /page/6/Picture/1 description: The image is a logo for Procedure Products Inc. The logo features the company name in blue, with the words "Procedure" stacked on top of "Products Inc." To the left of the company name is a plus sign made up of four squares, each in a different color: yellow, blue, green, and red. Below the company name is the phrase "Safety Color TM" in a smaller, blue font. | Component / Characteristic | DMC Medical Single-Use<br>Polycarbonate Syringe<br>(Predicate Device) | Freedom™ Syringe<br>(Subject Device) | |-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Barrel | Polycarbonate | Triton® MX731 Copolyester | | Plunger | ABS | ABS | | Stopper | Elastomer | Polyisoprene Elastomer | | Lubricant | Medical Grade Silicone | Medical Grade Silicone | | Sterilization Method<br>(when applicable) | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | | Syringe Size(s) (nominal capacity) | Various, including 10ml | 10ml | | ISO 10993-1 Compliance | Yes | Yes | | ISO 7886-1 Compliance | Yes | Yes | | ISO 594-1 & 594-2 Compliance | Yes | Yes | | FDA 510(k) Numbers | K103736 | K161812 | | Intended Use / Indications for Use | DMC Medical piston type<br>syringes are single use<br>syringes, intended for injecting<br>fluids into or withdrawing fluids<br>from the body. | The Freedom™™ Syringe is<br>intended to inject fluids into, or<br>withdraw fluids from, the body. | | Commentary regarding Indications for Use | As seen within the row above, the Indications for Use for the predicate<br>device are not identical to the Indications for Use of the Freedom™™<br>Syringe. However, the Freedom™™ Syringe is a piston type, single use<br>syringe, and as such the differences between the two Indications for<br>Use are not considered to impact substantial equivalence. | | # Technological Differences between Predicate and Subject Device The only known technological difference between the Freedom™ Syringe and the predicate device is the differing materials that make up the syringe barrel (as noted in the table above). The Copolyester material utilized in the Freedom™ Syringe has been tested according to all applicable standards and found to be equivalent to the polycarbonate syringe barrel used by the predicate device with respect to function and compliance with these standards. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Procedure Products Inc. The logo features the company name in blue, with the word "Procedure" stacked on top of "Products Inc." To the left of the company name is a colorful square made up of smaller squares in yellow, blue, green, white, and red. Below the company name is the phrase "Safety Color TM" in blue. Freedom™ Syringes have been tested to ensure conformance to all applicable performance requirements within the following standards: | Standard Number | Standard Title | |-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 7886-1 | Sterile hypodermic syringes for single use – Part 1: Syringes for manual use | | ISO 594-1 | Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment –<br>Part 1: General Requirements | | ISO 594-2 | ISO 594-2; Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical<br>equipment – Part 2: Lock fittings | | ISO 11135-1 | Sterilization of health-care products - ethylene oxide - Requirements for the development,<br>validation and routine control of a sterilization process for medical devices | | ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management<br>process | | ISO 10993-4 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | | ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | | ISO 10993-7 | Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals | | ISO 10993-10 | Biological evaluation of medical devices - Part 10, Tests for Irritation and Skin Sensitization | | ISO 10993-11 | Biological evaluation of medical devices - Part 11, Tests for systemic toxicity | | ANSI/AAMI ST72 | Bacterial endotoxin - Test methods, routine monitoring and alternatives to batch testing | # Conclusions Drawn Based on the indications for use, technological characteristics, testing performed and principles of operation, the Freedom™ Syringe meets all identified requirements and is considered to be substantially equivalent to the predicate device.