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.

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 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.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Disposable sterile needle retractable safety syringe" are primarily based on conformity to a set of international ISO and ASTM standards. The study demonstrates compliance with these standards.

Acceptance Criteria (Standard)	Reported Device Performance
ISO 7886-1:1993 (Sterile hypodermic syringes for manual use)	Conforms to ISO 7886-1:1993/Corrigendum1:1995 (Performance Testing and Barrel marking specs)
ISO 7886-4:2006 (Syringes with re-use prevention feature)	Conforms to ISO 7886-4:2006 (Performance Testing)
ISO 10993-1:2009 (Biological evaluation of medical devices - General)	Conforms to the requirement of ISO 10993 series Standards (Biocompatibility)
ISO 10993-4:2002 (Selection of tests for interactions with blood)	Conforms to the requirement of ISO 10993 series Standards (Biocompatibility - implicitly covered)
ISO 10993-5:2009 (Tests for In Vitro cytotoxicity)	No Cytotoxicity (Cytotoxicity)
ISO 10993-7:2008 (Ethylene oxide sterilization residuals)	Conforms to ISO 10993-7 (EO Residual)
ISO 10993-10:2010 (Tests for irritation and skin sensitization)	No intracutaneous reactivity (Irritation); No delayed dermal contact sensitization (Sensitization)
ISO 10993-11:2006 (Tests for systemic toxicity)	Conforms to the requirement of ISO 10993 series Standards (Biocompatibility - implicitly covered)
ISO 11607-1:2006 (Packaging for terminally sterilized medical devices)	Conforms to ISO 11607 (Packaging Integrity)
ISO 11607-2:2006 (Validation requirements for forming, sealing, etc.)	Conforms to ISO 11607 (Packaging Integrity - implicitly covered)
ISO 11135:2007 (Sterilization of health care products - EO)	SAL-10^6, Method-EO, Validation-Conforms to ISO 11135 (Sterilization)
ISO 11737-1:2006 (Sterilization of devices - Microbiological methods)	Conforms to the requirement of ISO 11135 and general sterilization best practices (Implicitly covered as part of sterilization validation)
ISO 9626-1991 (Stainless steel needle tubing)	Conforms to industry standards for materials (Needle material SUS)
ASTM F1980-2002 (Accelerated Aging of Sterile Medical Device Packages)	Performance Testing (Implicitly covered under packaging integrity and shelf-life considerations)
ASTM F1929-1998 (Detecting Seal Leaks in Porous Medical Packaging)	Performance Testing (Implicitly covered under packaging integrity)
Pyrogen free	Pyrogen free (Sterilization)
Design Specifications	Met all design specifications (General statement)

2. Sample Size Used for the Test Set and Data Provenance

The document states that "Bench tests were conducted to verify that the subject device met all design specifications." However, it does not specify the sample size used for these bench tests.

The data provenance is from tests conducted by the manufacturer, Guangdong Haiou Medical Apparatus Stock Co., Ltd., based in China. The study appears to be retrospective in the sense that the results are being presented as part of a 510(k) submission, confirming the device meets the standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document does not provide information on the number of experts used or their qualifications to establish ground truth for the bench tests. The tests are based on established international standards, implying compliance with methods defined by accredited testing bodies rather than expert consensus on individual test outcomes.

4. Adjudication Method for the Test Set

This document does not describe any adjudication method. The performance is assessed against the requirements of the standards, which typically have defined pass/fail criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is more common for imaging or diagnostic devices where human interpretation plays a significant role. This document concerns a physical medical device (syringe) that is evaluated through bench testing and material compatibility.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the study is essentially a standalone (algorithm only) performance evaluation, where "algorithm" refers to the device itself and its functional characteristics tested against pre-defined performance standards. There is no human-in-the-loop component in the evaluation of the syringe's mechanical, material, or biological properties.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on the objective, empirically defined pass/fail criteria and specifications within the referenced international ISO and ASTM standards. For example, cytotoxicity is measured against a standard threshold for cellular viability, and sterility is confirmed against a Sterility Assurance Level (SAL).

8. The Sample Size for the Training Set

This product is a physical medical device (syringe), not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, information about a training set is not applicable and not provided.

9. How the Ground Truth for the Training Set Was Established

As explained above, a "training set" is not relevant for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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.

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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

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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:

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)

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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:

510KNumber	Submitted Device	Manufacturer	Syringe type	Product Code
K113587	AutomaticallyRetractableSyringe(WithNeedle)	ShantouWealymedical instrumentCo., 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

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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

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

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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 medicalinstrument Co., Ltd.	Guangdong Haiou Medical Apparatus StockCo., Ltd
510K Number	K113587	N/A
Device Name	Automatically RetractableSafety Syringe (With Fixed	Disposable sterile needle retractable safetysyringe
Product Code	MEG	Same
RegulationNo.	880.5860	Same
Syringe type	Anti-stick syringe	Same
Class	2	Same
Intended use	Automatically RetractableSafety Syringe (With FixedNeedle) is a sterile,single-use, disposable andnon-reusable, retractablesafety syringe which isintended to provide a safe andreliable method forintramuscular andsubcutaneous injection ofmedication 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

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File No.: GHTF-2014-04-29

Barrel marking specs	Scale: conforms to ISO7886-1:1993/Corrigendum1:1995	Same
Needle cover-color	colorless	Same
Barrel transparency	Clear	Same
Volume	5ml	0.5ml, 1ml, 3ml, 5ml, 10ml(Analysis1)
Performance Testing	Conform to ISO7886-1:1993/Corrigendum	Conform to ISO 7886-1:1993/Corrigendum1:1995 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 therequirement of ISO 10993series Standards	Same
Cytotoxicity	No Cytotoxicity	Same
Irritation	No intracutaneousreactivity	Same
Sensitization	No delayed dermal contactsensitization	Same
Sterilization	SAL--106Method--EO	Same
	Validation-- Conforms to ISO11135	Same
	Package Integrity-- Conforms toISO 11607	Same
	EO Residual-- Conforms to ISO10993-7	Same
	pyrogen free	Same

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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.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).