Safety Blood Collection Set

{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 stylized image of three human profiles facing right, stacked on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 14, 2017 Jiangsu Shenli Medical Production Co., Ltd % Charles Mack Principal Engineer IRC 7808 Rush Creek Drive Pasco. Washington 99301 Re: K163093 Trade/Device Name: Safety Blood Collection Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: February 8, 2017 Received: February 22, 2017 Dear Charles Mack: 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, 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. {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 devicerelated 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" (21 CFR 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, Tina Kiang -S 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K163093 Device Name Safety Blood Collection Set #### Indications for Use (Describe) The Safety Blood Collection Set and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) # PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ## FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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." 62 {3}------------------------------------------------ Jiangsu Shenli Medical Production Co., Ltd. # K163093 ## 510(k) Summary (21 CFR §807.92) | Submitter<br>Information | | | | |--------------------------|-----------------------|------------------------------------------------------------------------------------|--| | | Submitter Name: | Jiangsu Shenli Medical Production Co., Ltd. | | | | Address: | No 20, Changzheng Road, Zhenglu,<br>Changzhou City, Jiangsu Province, China 213111 | | | | Contact Person: | Ms. Tina Cai<br>General Manager<br>charliemack@irc-us.com<br>931-625-4938 | | | | Date of Preparation: | March 13, 2017 | | | Subject Device | | | | | | Trade Name: | Safety Blood Collection Set | | | | Common Name: | Hypodermic single lumen needle | | | | Regulation Number: | 21 CFR §880.5570 | | | | Regulation Name: | Hypodermic single lumen needle | | | | Regulatory Class: | II | | | | Product Code: | FMI | | | | Classification Panel: | General Hospital | | | Predicate<br>Device | | | | | | Trade Name: | Improve Blood Collection Set and Improsafe Blood Collection Set | | | | 510(k) Reference: | K123987 | | | | Common Name: | Hypodermic single lumen needle | | | | Regulation Number: | 21 CFR §880.5570 | | | | Regulation Name: | Hypodermic single lumen needle | | | | Regulatory Class: | II | | | | Product Code: | FMI | | ## Purpose of Submission This is a new submission of a Safety Blood Collection set. There have been no previous submissions of this product. ## Indications for Use Safety Blood Collection Set and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needle stick injury. {4}------------------------------------------------ ## Device Description The Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The product is to be used by appropriately trained healthcare professionals. The Blood Collection Needle is manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber sleeve and a hard plastic needle cap. The opposite end of the needle is ¾" for withdrawing blood and is fitted with a color coded hard plastic needle cap. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that permits identification and acts as a seal integrity. The Safety Blood Collection Set is delivered sterile and is intended for single use only. | Technological Characteristics | | |-------------------------------|--| | | | | Feature | Proposed Device | Predicate Device | |--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | Jiangsu Shenli Medical Production Co., Ltd | Innovative Medical Technologies, Incorporated | | FDA510(K) Number | K163093 | K123987 | | Device Name | Safety Blood Collection Set | Improsafe Blood Collection Set | | FDA Classification | Same | 21CFR880.5570, Product code- FMI | | Indication for Use | Safety Blood Collection Set and blood collection<br>tube/syringe are used together for the collection of<br>venous blood. The winged needle is designed with<br>a safety shield which can be activated to cover<br>the needle immediately following blood collection to<br>aid in the protection against accidental needle<br>stick injury. | Improve Blood Collection Set and Improsafe Blood Collection Set are<br>winged blood collection needles with flexible tubing and a female luer<br>adapter intended for venipuncture to obtain blood samples from<br>patients. Some reorder numbers are provided with a male luer adapter.<br>The male luer adapter contains a non- patient needle end for puncturing<br>the stopper of an evacuated blood collection tube. Those without a male<br>luer adapter are provided with a protective cap on the end of the female<br>luer adapter. The Improsafe Blood Collection Set is provided with an<br>attached safety shield for covering the used needle prior to disposal.<br>After withdrawal of the needle from the patient's vein, the attached<br>safety shield can be manually activated to cover the needle immediately<br>after use to minimize risk of accidental needle stick. The Improve Blood<br>Collection Set and Improsafe Blood Collection Set is also indicated for<br>short-term (up to 2 hours) intravenous administration of fluids and may<br>be used for any patient population with consideration given to patient<br>size, appropriateness for the solution being infused and duration of<br>therapy. For devices that include the male liter adapter: after removing<br>the attached male luer adapter from the blood collection set, connect the<br>female luer adapter to a syringe or other compatible/appropriate device. | | Feature | The needle is locked in safety sheath by slide the<br>translucent yellow safety shield forward with pulling<br>the tubing backward until an audible click is heard. | The needle is completely retracted and locked by slide the translucent<br>yellow safety shield forward with pulling<br>the tubing backward until an audible click is heard. | | Material: | | | | Needle sheath | PE | HDPE | {5}------------------------------------------------ | Needle tube | SUS304 | SUS304 | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | Needle holder | Ethylene/propylene copolymer | Polypropylene | | Safety shield | Polypropylene | Polypropylene | | Flexing tube | PVC | PVC | | Rub sleeve | Polyisoprene | Rubber (Synthetic) | | Luer adapter | ABS | ABS | | Lubricate | Medical Highly Activated Silicone | Unknown | | Colors: | | | | 21G | Green | Green | | Length | 3/4" x 12"(needle length x tube length) | 3/4" x 12"(needle length x tube length) | | Gauge | 21G | 21G, 23G, 25G | | Hub/Needle bond strength<br>Biocompatibility | Complying with ISO7864:<br>21G>44N | Complying with ISO7864:<br>21G>44N<br>23G>34N | | | Complying with ISO10993-1<br>In Vitro Cytotoxicity Test (ISO10993-5) Skin<br>Sensitization Test (ISO10993-10) Intracutaneous<br>Reactivity Test (ISO10993-10)<br>Acute Systemic Toxicity Test (ISO10993-11)<br>Haemocompatibility:<br>-In Vitro Hemolytic Properties Test (ASTM F756-13)<br>-Coagulation Test (ISO10993-4)<br>-Complement Activity (ISO10993-4) | Complying with ISO10993-1 | | Sterilization | EO | EO | | Sterile | Yes | Yes | | SAL | 10-6 | 10-6 | | Disposable | Yes | Yes | | Single Patient Use | Yes | Yes | The predicate device (K123987) has two devices types cleared for marking; Improsafe and Improve. The subject device is claiming substantial equivalence to the Improsafe device. The indications for use between the predicate device and subject device are similar as both used in routine venipunture. However, the subject device is not intended for intravenous medication adminstration. The minor differences in indications for use between subject and predicate device do not raise different questions of safety or effectiveness. All the labeling and characteristics of the submitted Safety Blood Collection Set is the same as the predicate devices and most typical Safety Blood Collection Sets currently on the market. The basic design of the submitted device specifications is substantially the same as the predicate, with differences in the plastic material. Though the plastic material is different, biocompatibility characteristics of the subject and predicate devices are equivalent. {6}------------------------------------------------ ## Summary of Performance Tests The following performance testing was performed to demonstrate substantial equivalence of the subject device Safety Blood Collection Set, and applicable standards: - Sterility ● - Toxin in bacteria ● - . Reducing Substance - Metal Ion ● - pH Value ● - Residue after evaporation - Ultraviolet absorbency degree - EO gas residue ● - ECH gas residue ● - Particle pollution - Connection firmness - Needle Tube . - Lubricant ● - Needle Handle - Rubber Sleeve - Leakage ● - Flow Rate ● - Length of needle tube ● - Needle tip ● - Needle base to connection base ● - Flexing tube ● - Protective safety sheath ● All of the pre-determined acceptance criteria were met. # Summary of Substantial Equivalence Based on the indications for use, technological characteristics, and performance testing, the subject Safety Blood Collection Set has demonstrated to be substantially equivalent to the predicate IMPROSAFE Blood Collection Set.