Disposable sterile needle retractable safety syringe

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January 31, 2020 Guangdong Haiou Medical Apparatus Stock Co., Ltd Mr. Salon Chen System Engineer GHTF Medical & Drug Technology Services Institutions Tianbao Office Room 225, Sha Tai Road No. 209 Baiyun District of Guangzhou, Guangdong Province CHINA Re: K141349 Trade/Device Name: Disposable sterile needle retractable safety syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG Dated: February 10, 2015 Received: March 12, 2015 Dear Salon Chen: This letter corrects our substantially equivalent letter of April 10, 2015. 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. {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 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 (QS) 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 medical devices and radiation-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. Alan M. Stevens -S Alan Stevens 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}------------------------------------------------ Sponsor: Guangdong Haiou Medical Apparatus Stock Co., Ltd Subject Device: Disposable sterile needle retractable safety syringe Title: Traditional Section 510(k) Submission Report -004_chapter Indications for Use # Indications for Use 510(k) Number (if known): Device Name: Disposable sterile needle retractable safety syringe Indications for Use: Disposable sterile needle retractable safety syringe is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into patient. Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ ## The date the summary was prepared: on April10, 2015 This 510(k) Summary of 510(k) is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. #### Basic Information 1. - A Company Name: Guangdong Haiou Medical Apparatus Stock Co., Ltd - A Establishment Registration Number: Not registered yet - > Address: Mazha Industrial Area, Liusha town, Puning city, Guangdong province, China,518034 - Phone:+86-663-2900999 A - Fax: +86-663-2905999 > - > Contact Person(Title):Jacky (General Manager) - > E-mail: qc@haiou.net.cn #### Application Correspondent 2. - > Company Name: GHTF Medical & Drug technology service institutions - > Address: : Tianbao office room 225,Sha Tai Road No.209, Baiyun District of Guangzhou City, Guangdong Province, China - Phone: +86-020-66228028 > - A Fax: +86-020-62809168 - > Contact Person(Title):Salon Chen - E-mail: 33999439@qq.com > #### Subject Device Information: 3. - > Product Code: MEG - > Regulation Number:880.5860 - A Class:2 - > Classification Name: Piston Syringe - > Trade Name: Disposable sterile needle retractable safety syringe ### Predicate Devices: | 510K<br>Number | Submitted Device | Manufacturer | Syringe type | Product Code | |----------------|---------------------------------------------------------|-----------------------------------------------------|--------------------|--------------| | K113587 | Automatically<br>Retractable<br>Syringe(With<br>Needle) | Shantou<br>Wealy<br>medical instrument<br>Co., Ltd. | Anti-stick syringe | MEG | ### 4. Device Description Disposable sterile needle retractable safety syringe is a piston syringe. The device is intended for medical purposes and consists of a protective cover, Needle base, circle ring, Pull & back {4}------------------------------------------------ part, Piston, Plunger and barrel. The needle is fixed on the syringe. The device is used to inject fluids into the body. The subject device of Disposable sterile needle retractable safety syringe is available in 0.5ml, 1ml, 3ml, 5ml and 10 ml volumes. The subject device is provided sterilized. Disposable sterile needle retractable safety syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. After the injection is completed, the groove of the upper end of the plunger locks the needle. The plunger is retracted completely after the injection. The needle is retracted completing into the barrel of the syringe. #### 5. Intended use Disposable sterile needle retractable safety syringe is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into patient. #### 6. Performance Summary Bench tests were conducted to verify that the subject device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards: ISO 7886-1:1993, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use ISO 7886-4:2006, Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature ISO 10993-1:2009 Biological evaluation of medical devices-Parts 1: Evaluation and testing ISO 10993-4:2002 Biological evaluation of medical devices-Parts 4: Selection of test for interactions with blood ISO 10993-5:2009 Biological evaluation of medical devices-Parts 5: Tests for In Vitro cytotoxicity ISO 10993-7:2008 Biological evaluation of medical devices - part 7: ethylene oxide sterilization residuals. ISO 10993-10:2010 Biological evaluation of medical devices-Parts 10: Tests for irritation and skin sensitization ISO 10993-11:2006 Biological evaluation of medical devices-Parts 11: Tests for systemic toxicity ISO11607 -1:2006 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems. ISO11607 -2:2006 Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes ISO11135:2007 Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices {5}------------------------------------------------ ISO11737- 1:2006 Sterilization of medical devices -- Microbiological methods -Part 1: Determination of a population of microorganisms on products ISO9626-1991Stainless steel needle tubing for the manufacture of medical devices-Apparatus, confirmatory test arrangement and guidance ASTM-F1980-2002 Standard Guide for Accelerated Aging of Sterile Medical Device Packages ASTM F1929-1998 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration # 7. Comparison to Predicate Device Comparison with predicate devcie --- the below the comparison table | Elements of Comparison | Predicate Device | Subject Device | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------| | Company Name | Shantou Wealy medical<br>instrument Co., Ltd. | Guangdong Haiou Medical Apparatus Stock<br>Co., Ltd | | 510K Number | K113587 | N/A | | Device Name | Automatically Retractable<br>Safety Syringe (With Fixed | Disposable sterile needle retractable safety<br>syringe | | Product Code | MEG | Same | | Regulation<br>No. | 880.5860 | Same | | Syringe type | Anti-stick syringe | Same | | Class | 2 | Same | | Intended use | Automatically Retractable<br>Safety Syringe (With Fixed<br>Needle) is a sterile,<br>single-use, disposable and<br>non-reusable, retractable<br>safety syringe which is<br>intended to provide a safe and<br>reliable method for<br>intramuscular and<br>subcutaneous injection of<br>medication into a patient | Same | | Nozzle Type | Fixed Needle | Same | | Specific drug use | Conventional drugs | Same | | Needle type | Tri-Beveled Tip | Same | | Reuse | Non-reusable | Same | | Lubricant Composition | Polydimethylsiloxane (PDMS) | Same | {6}------------------------------------------------ Sponsor: Guangdong Haiou Medical Apparatus Stock Co., Ltd Subject Device: Disposable sterile needle retractable safety syringe Title: Traditional Section 510(k) Submission Report -005_chapter 510(k) Summary File No.: GHTF-2014-04-29 | Barrel marking specs | Scale: conforms to ISO<br>7886-1:1993/Corrigendum1:199<br>5 | Same | |----------------------|----------------------------------------------------------------|---------------------------------------------------------------------| | Needle cover-color | colorless | Same | | Barrel transparency | Clear | Same | | Volume | 5ml | 0.5ml, 1ml, 3ml, 5ml, 10ml(Analysis1) | | Performance Testing | Conform to ISO<br>7886-1:1993/Corrigendum | Conform to ISO 7886-1:1993/Corrigendum<br>1:1995 and ISO7886-4:2006 | | Material | Barrel--PP | Same | | | Plunger--PP | Same | | | Protective cover--PP | Same | | | Needle base--PP | Same | | | N/A(Analysis2) | Circle ring-- Silica gel | | | | Pull & back part-- ABS | | | Piston-- Polypropylene rubber | Same | | | Needle--SUS | Same | | Biocompatibility | Conform to the<br>requirement of ISO 10993<br>series Standards | Same | | Cytotoxicity | No Cytotoxicity | Same | | Irritation | No intracutaneous<br>reactivity | Same | | Sensitization | No delayed dermal contact<br>sensitization | Same | | Sterilization | SAL--106<br>Method--EO | Same | | | Validation-- Conforms to ISO<br>11135 | Same | | | Package Integrity-- Conforms to<br>ISO 11607 | Same | | | EO Residual-- Conforms to ISO<br>10993-7 | Same | | | pyrogen free | Same | {7}------------------------------------------------ #### Analysis 1: The subject device has only five kinds of volumes which are 0.5ml, 1ml, 5ml and 10ml while the predicate device has only one kind of volume which is 5ml. The difference in the volume will not affect the function. So the difference of the volume will not affect the safety and effectiveness of the subject device. #### Analysis 2: The subject device and the predicate device are same in structure. Only subject device detailed described two parts with Circle ring and pull & back part, circle ring is the sealing function and prevents leakage, pull & back part is the role of retractable gravitation. Compared with predicate devices, the subject devices are very similar in design principle, intended use, indication for use functions, material and the applicable standards. The differences between subject devices and predicate devices do not raise any new questions of safety or effectiveness. ### 8. Conclusion The subject device has the same functional features as the predicate. The differences in the safety feature mechanism of action and the syringe sizes do not raise new questions of safety or effectiveness in the subject device, thus the subject devices are substantially equivalent to the predicate.