(229 days)
The Global Medi Products Retractable Safety Syringe is a sterile, single use, disposable and non-reusable manual retractable safety syringe intended for medical purposes for injection of fluids into the body, while reducing the risks of sharps injuries and the potential for syringe reuse.
The GMP Retractable Safety Syringe are always provided with preassembled needs whereas the DuoProSS can be ordered with and without needles. GMP Retractable Safety Syringe currently uses a male luer lock needle connector design where the DuoProSS uses a luer slip ne connector design. Both syringes are provided sterile, single use, and disposable. There are minor differences between the GMP Retractable Safety Syringe and DuoProSS which is syringe volume (and associated dimensions). Both syringes have two part plungers. The distal part holds the hypodermic needle and the proximal part has a projection spike that mates with the distal part, thereby locking the needle to the plunger. Both syringes require the user to manually retract the needle-plunger into the syringe barrel, break of the plunger rod, and discard the pieces.
The provided text describes a 510(k) summary for the Global Medi Products Retractable Safety Syringe, dated October 17, 2012. This device is a manual retractable safety syringe intended for injecting fluids into the body while reducing the risks of sharps injuries and preventing syringe reuse.
The submission claims substantial equivalence to the Meditech Co, DuoProSS Ret retractable safety syringe (K022806).
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific numerical acceptance criteria alongside reported device performance values. Instead, it states that the Global Medi Products Retractable Safety Syringe "is substantially equivalent and meets the same acceptance criteria as the predicate device in K022806" and lists the standards against which it was tested.
However, we can infer the acceptance criteria are adherence to the listed international and national standards for syringe and needle performance. The reported performance is that the device meets these standards.
| Acceptance Criteria (Standards Adhered To) | Reported Device Performance |
|---|---|
| Biocompatibility: ISO 10993-4 (Interactions with blood), ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation & Sensitization), ISO 10993-11 (Systemic Toxicity) | Device found to comply with biocompatibility standards. |
| Syringe Performance: ISO 7886-1 (Sterile hypodermic syringes for manual use), ISO 7886-4 (Syringes with re-use prevention feature) | Device found to comply with syringe performance standards, including manual use and re-use prevention features. |
| Conical Fittings: ISO 594 (Conical fittings with a 6% (Luer) taper for syringes) | Device found to comply with Luer taper fitting standards. (The document mentions minor differences in Luer lock vs. Luer slip connector design compared to the predicate, but asserts this does not affect performance). |
| Sterilization Validation: ISO 11135 (Ethylene Oxide Sterilization), GB/T 14233.1-1998 Part 1 (Methods for chemical analysis - EO Residuals), ISO 10993-7 (Biological evaluation of medical devices - Ethylene oxide sterilization residuals, including allowable limits for EO and ECH) | Device found to comply with sterilization validation standards using Ethylene Oxide, and residual limits for EO and ECH. |
| Hypodermic Needle Performance: ISO 7864:1993 (Sterile hypodermic needles for single use), ISO 594-1:1986 & ISO 594-2:1998 (Conical fittings with a 6% (Luer) taper) | Device's hypodermic needles found to comply with standards for single-use needles and Luer taper conical fittings. |
| Substantial Equivalence to Predicate Device K022806: Comparisons in intended use, design, technological, and operational characteristics and performance. | The submitting company believes the device is substantially equivalent to the predicate device K022806, with minor differences (syringe volume, luer lock vs. luer slip) that do not affect safety or effectiveness. All specifications and performance are comparable. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of units) used for each of the performance tests (e.g., biocompatibility lot size, number of syringes tested for ISO 7886-1).
The data provenance is not explicitly stated as retrospective or prospective, nor does it detail the country of origin for the data itself beyond the submitter's location in Australia. However, the tests are performed against international ISO standards and a Chinese national standard (GB/T), suggesting either international lab testing or internal testing conforming to these global benchmarks.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing described is performance-based against engineering and biological standards, not expert-opinion based "ground truth" for diagnostic or AI systems.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. "Adjudication method" typically refers to how disagreements among multiple experts are resolved to establish a ground truth in studies involving human interpretation (e.g., imaging studies). The tests performed here are objective measurements against defined technical standards (e.g., sterility, strength, fluid flow), not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This type of study is used for diagnostic algorithms or imaging systems where human readers interpret cases. The Global Medi Products Retractable Safety Syringe is a physical medical device, not an AI or diagnostic tool. Therefore, there's no concept of human readers or AI assistance in this context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance study of an algorithm is not applicable to this device, as it is a physical medical device and not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests of this physical device is established by compliance with pre-defined technical and biological standards (e.g., ISO 7886-1 for syringe performance, ISO 10993 for biocompatibility). For example, a successful biocompatibility test means the device material passed specific cytotoxicity, irritation, sensitization, and systemic toxicity limits as defined by the ISO 10993 series. There is no expert consensus, pathology, or outcomes data used as "ground truth" in the way it might be for a diagnostic tool.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. Training sets are used in machine learning and AI model development. This submission describes performance testing of a physical medical device against established standards, not the development or validation of an algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set for this device, this question is not applicable.
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K120641
page 1 of 2
Sec. 6: 510(k) Summary - Global Medi Products Retractable Safety Syrin
Image /page/0/Picture/2 description: This document is a 510(k) summary for the Global Medi Products Retractable Safety Syringe, dated October 17, 2012. The submitter and primary contact is Mr. Graeme Walton, President of Global Medi products, located in Queensland, Australia, and his email and phone number are listed. The device is classified as a piston syringe and a hypodermic single lumen needle, and it is designed to retract the contaminated needle after injection to prevent accidental needle sticks.
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| Intended Use | Indications for Use: The Global Medi Products Retractable Safety Syringe is a sterile, singleuse, disposable and non-reusable manual retractable safety syringe intended for medicalpurposes for injection of fluids into the body, while reducing the risks of sharps injuriesand the potential for syringe reuse. |
|---|---|
| TechnologicalCharacteristics | Global Medi Products makes the claim of substantial equivalence of the GMP Retractable Safety Syringe to theMeditech Co, DuoProSS Retractable Safety Syringe based on similarities in intended use, design,technological, and operational characteristics. Both are indicated for injecting fluids into the body, while helpingto reduce risks of sharps injuries. The GMP Retractable Safety Syringe are always provided with preassembledneeds whereas the DuoProSS can be ordered with and without needles. GMP Retractable Safety Syringecurrently uses a male luer lock needle connector design where the DuoProSS uses a luer slip ne connectordesign. Both syringes are provided sterile, single use, and disposable. There are minor differences betweenthe GMP Retractable Safety Syringe and DuoProSS which is syringe volume (and associated dimensions).This difference does not affect the performance of the syringe, since syringe size is typically determined bydrug volume to be administered and user preferences. Both syringes have two part plungers. The distal partholds the hypodermic needle and the proximal part has a projection spike that mates with the distal part,thereby locking the needle to the plunger. Both syringes require the user to manually retract the needle-plungerinto the syringe barrel, break of the plunger rod, and discard the pieces. Global Medi Products believes that thedifferences between the GMP Retractable Safety Syringe and the predicate device are minor and they raise nonew issues of safety or effectiveness. |
| Summary ofTesting | Global Medi Products Retractable Safety Syringe is substantially equivalent and meets the same acceptancecriteria as the predicate device in K022806. Non-clinical performance testing includes:Biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity, interactions with blood) incompliance with the methods of ISO 10993-4, -5, -10, -11, Syringe performance per ISO 7886-1 Sterilehypodermic syringes for single use -- Part 1: Syringes for manual use; ISO7886-4; Sterile hypodermicsyringes for single use -- Part 4: Syringes with re-use prevention feature, ISO 594, Conical fittings with a 6% (Luer) taper for syringes; ISO 11135; Sterilization Validation ETO, GB/T14233.1 (GB / T 14233.1- 1998Infusion, transfusion, injection equipment for test methods - Part 1 Methods for chemical analysis, (EOResiduals), ISO 10993-7, Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilizationresiduals. ISO 10993-7:2008 specifies allowable limits for residual ethylene chlorohydrin (ECH) inindividual EO-sterilized medical devices, procedures for the measurement of EO and ECH. Hypodermicneedles have been tested in accordance with ISO 7864: 1993; Sterile hypodermic needles for single useand ISO 594-1:1986 ISO594-2:1998 Conical fittings with a 6 % (Luer) taper. |
| SubstantialEquivalence | The Retractable Safety Syringe described in this 510(k) submission is substantially equivalent in allspecifications and performance compared to the predicate device identified in K022806 |
队|20641
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
OCT 17 2012
Global Medi Products C/O Robert O. Dean President Compliance Systems International, Limited Liability Company 1083 Delaware Avenue Buffalo, New York 14209
Re: K120641
Trade/Device Name: Global Medi Products Retractable Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: October 10, 2012 Received: October 16, 2012
Dear Mr. Dean:
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.
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Page 2- Mr. Dean
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
0,5Wa Introna
Anthony D. Watson. B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Indications for Use Form
Indications for Use:
510(k) Number (if known): K120641
Device Name: Global Medi Products Retractable Safety Syringe
Indications for Use: The Global Medi Products Retractable Safety Syringe is a sterile, single use, disposable and non-reusable manual retractable safety svringe intended for medical purposes for injection of fluids into the body, while reducing the risks of sharps injuries and the potential for syringe reuse.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C) . રજકુ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Rhal Chyn 10/18/12
(Division Sign-Off)
Division of Anesthestology, General Hospital Infection Control. Dental Devices
510(k) Number: K120641
§ 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).