EasyPoint Blood Collection Plus

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Retractable Technologies, Inc. Becky Piroga Regulatory Affairs Manager 511 Lobo Lane Little Elm. Texas 75068 #### Re: K202325 Trade/Device Name: EasyPoint Blood Collection Plus Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA. FMI Dated: March 1, 2021 Received: March 9, 2021 #### Dear Becky Piroga: 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 Mav 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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. # James M. Simpson Jr ## -57 for Paval Patel Acting 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K202325 Device Name EasyPoint® Blood Collection Plus Indications for Use (Describe) The EasyPoint® Blood Collection Plus is intended for use with evacuated blood collection tubes for venous blood collection, while aiding in the prevention of needlestick injuries and contaminated needle exposure. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | 区 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}------------------------------------------------ #### K202325 510(k) SUMMARY EASYPOINT® BLOOD COLLECTION PLUS (21 CFR 807.92) | I. SUBMITTER | Retractable Technologies, Inc.<br>511 Lobo Lane<br>Little Elm, TX 75068 | |----------------------|---------------------------------------------------------------------------------| | FDA Registration: | 1647137 | | Phone: | 972-294-1010 | | Fax: | 972-294-4400 | | Contact Person: | Becky Piroga, Regulatory Affairs Manager | | Date Prepared: | November 15, 2019 | | II. DEVICE | | | Name of Device: | EasyPoint® Blood Collection Plus | | Common Name: | Blood collection tube holder with attached needle | | Classification Name: | -Tubes, vials, systems, serum separators, blood collection (21<br>CFR 862.1675) | | Regulatory Class: | II | | Product Codes: | JKA, FMI | | 510k Number: | K202325 | ### IV. DEVICE DESCRIPTION III. PREDICATE DEVICE The EasyPoint® Blood Collection Plus is a blood collection tube holder with an attached needle, and is intended to facilitate blood collection from patients. The device contains a sharps injury prevention feature (needlestick prevention feature - chamber, utilizing automated retraction technology) which covers the entire needle when activated. The EasyPoint® Blood Collection Plus aids in the prevention of needlestick injuries during normal handling and disposal, and prevents re-use of a contaminated needle. K982541 - Vacutainer® Eclipse™ Blood Collection Needle The EasyPoint® Blood Collection Plus allows for multiple sample draws from a single venipuncture. After blood collection is complete, the retraction mechanism is activated and the device disassembles itself by retracting the contaminated needle into the safety chamber. The safety mechanism allows the user to activate the needle retraction while the needle is still in the patient, preventing exposure to the contaminated needle. The safety mechanism can be activated using one step and allows the user's hands to remain behind the sharp during activation. #### V. INDICATIONS FOR USE The EasyPoint® Blood Collection Plus is intended for use with evacuated blood collection tubes for venous blood collection, while aiding in the prevention of needlestick injuries and contaminated needle exposure, The device contains a sharps injury prevention feature which covers the entire needle when activated. The safety mechanism allows the user to activate the needle retraction while the needle is still in the patient, preventing exposure to the contaminated needle. VI. COMPARISON TO THE PREDICATE DEVICE {4}------------------------------------------------ | Feature | Subject Device:<br>EasyPoint® Blood<br>Collection Plus | Predicate Device:<br>Vacutainer® Eclipse™<br>Blood Collection Needle | Comparison | |------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Classification<br>Name | Hypodermic single lumen<br>needle | Hypodermic single lumen<br>needle | Same | | Regulatory Class | II | II | Same | | FDA Product Code | JKA, FMI | FMI | Same, with additional<br>category (blood collection) | | Intended Use | Intended for use with<br>evacuated blood collection<br>tubes for venous blood<br>collection, while aiding in<br>the prevention of<br>needlestick injuries and<br>contaminated needle<br>exposure. | Designed for use with<br>Vacutainer® Blood<br>Collection Needle<br>Holders in performing<br>venipuncture to obtain<br>blood samples. | Same, except the<br>EasyPoint® Blood<br>Collection Plus is already<br>attached to a blood<br>collection tube holder (no<br>need for a separate<br>accessory device).<br>*Comparison tests were<br>performed using<br>Vacutainer® Eclipse™<br>Blood Collection Needle<br>with Pre-attached Holder. | | Indications for Use | May be used for blood<br>collection for diagnostic<br>purposes of any patient<br>population with<br>consideration given to<br>patient size, per<br>institutional protocol.<br>Single Use Only. Supplied<br>Sterile. | May be used for blood<br>collection for diagnostic<br>purposes. Recommends<br>referring to institutional<br>protocol for venipuncture<br>procedures; does not<br>restrict usage to a<br>particular patient<br>population.<br>Single Use Only.<br>Supplied Sterile. | Same. Neither provides<br>criteria for population-<br>specific use of the product.<br>Both products recommend<br>referring to institutional<br>protocol for appropriate<br>venipuncture procedures.<br>Both products are supplied<br>sterile and are indicated for<br>single use only. Both<br>products are indicated for<br>blood collection for<br>diagnostic purposes. | | Needle Gauge Size<br>used in comparison<br>studies | 21G x 1 ¼" | 21G x 1 ¼" | Same | | Additional Needle<br>Gauge Sizes Available | 22G x 1 ¼" | 22G x 1 ¼" | Same | | | | | | | Materials for<br>Components in<br>Common | Needle Cap:<br>Polypropylene | Needle Cap:<br>Polypropylene | Same except for needle<br>holder and needle adhesive. | | | Needle Cannula:<br>304 Stainless Steel | Needle Cannula:<br>304 Stainless Steel | | | | Needle Lubricant:<br>Silicone Lubricant | Needle Lubricant:<br>Silicone Lubricant | | | | Needle Adhesive:<br>UV Cure Adhesive | Needle Adhesive:<br>Epoxy Resin | | | | Needle Holder:<br>Polycarbonate | Needle Holder:<br>Polystyrene | | | | Needle Rubber Sleeve:<br>Synthetic Polyisoprene<br>Rubber (not made with<br>natural rubber latex) | Needle Rubber Sleeve:<br>Synthetic Rubber (not<br>made with natural rubber<br>latex) | | | | Tube Holder:<br>Polypropylene | Tube Holder*:<br>Polypropylene | | | Materials for<br>Components that<br>Differ | Retraction Spring:<br>304 Stainless Steel | Collar:<br>Polystyrene<br>Safety Shield:<br>Polypropylene | N/A | | | Device Body:<br>Polypropylene | | | | | Tube Holder Connector:<br>Polypropylene | | | | Safety Mechanism | Automated Retraction<br>Technology | Hinged Safety Shield | The EasyPoint® Blood<br>Collection Plus utilizes a<br>retraction safety<br>mechanism, which retracts<br>the contaminated needle<br>into a safety chamber using<br>automated retraction<br>technology. The<br>Vacutainer® Eclipse™<br>Blood Collection Needle<br>utilizes a safety shield safety<br>mechanism, which covers<br>the contaminated needle<br>after use using a hinged<br>safety shield activated with<br>thumb pressure. | | Sterilization Method | Ethylene Oxide | Radiation | The sterilization methods<br>are different, but both<br>provide the same level of<br>sterility assurance. Both<br>products, through validated<br>sterilization methods to their<br>respective ISO standards<br>(ISO 11135 and ISO | | | | | 11137), guarantee a SAL of<br>10-6. | | Biocompatibility | ISO 10993-1<br>Cytotoxicity, etc [list tests] | ISO 10993-1 | Same. Both products<br>conform to ISO 10993-1,<br>Biological evaluation of<br>medical devices –<br>Evaluation and testing<br>within a risk management<br>process. | | Precautions and<br>Symbols Indicated on<br>Packaging | -Sterile (EO)<br>-Do not re-use<br>-Do not use if package is<br>damaged<br>-Not Made With Natural<br>Rubber Latex<br>-LOT number<br>-Expiration Date<br>-Non-toxic<br>-Non-pyrogenic<br>-Consult instructions for<br>use | -Sterile (R)<br>-Do not re-use<br>-Do not use if package is<br>damaged<br>-Not Made With Natural<br>Rubber Latex<br>-LOT number<br>-Expiration Date<br>-Keep away from sunlight<br>-Caution | Similar. Biocompatibility<br>and cytotoxicity testing has<br>been performed by<br>Retractable Technologies,<br>Inc. to validate the claims of<br>Non-toxic and Non-<br>pyrogenic. | {5}------------------------------------------------ {6}------------------------------------------------ Additional information on performance and material comparison studies can be found in the body of this submission. {7}------------------------------------------------ #### VII. PERFORMANCE DATA #### Biocompatibility Testing A Biological Safety Evaluation (BSE) of the EasyPoint® Blood Collection Plus was conducted in accordance with ISO 10993-1, ISO 14971, and the FDA Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1." It was found to be non-cytotoxic, a non-sensitizer, a non-irritant, nonpyrogenic, non-hemolytic, and to not produce acute systemic toxicity. Additional details and reports can be found in the body of this submission. #### Mechanical Testing Engineering and performance testing on the EasyPoint® Blood Collection Plus was performed according to applicable design requirements of ISO 7864 and ISO 9626. Performance tests were developed by Retractable Technologies, Inc. to measure the functionality (retraction) force, needle pullout force, rubber sleeve pullout force, needle cap separation force, puncture/penetration force, and to verify that the device does not leak under pressure. Additional details and reports can be found in the body of this submission. #### Simulated Use Study A simulated use pre-market study was conducted to demonstrate through human factors validation testing that the EasyPoint® Blood Collection Plus device performs safely and effectively when used by a variety of healthcare workers in a simulated use scenario. The study showed that the EasyPoint® Blood Collection Plus is comparable to currently legally marketed blood collection tube holders with regards to safety, ease of use. effective use, needlestick prevention, and device functionality. Additional details, including the final report from the pre-market study, can be found in the body of this submission. #### Sterilization Validation Sterilization validation was performed according to ISO 11135 = "Sterilization of healthcare products – Ethylene Oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices." The sterilization chamber and process used to sterilize the EasyPoint® Blood Collection Plus has been successfully used for many other products manufactured by Retractable Technologies, Inc. This revalidation to specifically address the addition of the EasyPoint® Blood Collection Plus demonstrated that the sterilization process continues to be effective and to meet the sterility assurance level (SAL) of 10t6. Additional details and reports can be found in the body of this submission. #### VIII. CONCLUSION Results of testing have demonstrated that the EasyPoint® Blood Collection Plus meets requirements for its intended use. The EasyPoint® Blood Collection Plus is substantially equivalent to its predicate device, the Vacutainer® Eclipse™ Blood Collection Needle, The intended uses are the same, the materials are effectively the same, and no new concerns regarding safety and effectiveness were raised during comparison testing.