(330 days)
The Safety Auto-Disable Syringe with Needle (Auto-Lock) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.
It has a detachable needle with a dedicated fitting. The Safety Auto-Disable Syringe with Needle (Auto-Lock) contains an inner mechanism used to allow the needle to be retracted inside the plunger rod of the syringe after the operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
The proposed device is a single use, sterile syringe composed of barrel, plunger, plunger, push-button, spring, spring holder, rubber stopper, needle cap, and autodisable part.
The document provided is a 510(k) premarket notification for a "Safety Auto-Disable Syringe with Needle (Auto-Lock)". It describes the device, its intended use, and a comparison to predicate devices, along with summaries of performance testing.
Here's an analysis of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" against "reported device performance" for each individual test in the format usually expected for a medical device. Instead, it lists various bench tests and indicates that the device conforms to relevant ISO standards. For the simulated clinical study, a specific performance metric related to the failure rate is given.
Here's a table based on the information provided, focusing on the simulated clinical study's outcome as the most direct "performance" metric stated:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Failure rate no higher than 0.7% (with 97.5% confidence) OR failure rate no higher than 1.1% (with 99.5% confidence) | No failures observed in 512 device trial. |
For other tests, the document generally states "Conforms to [ISO Standard]" or "Comply to [ISO Standard]" as the performance, implying that the standards themselves define the acceptance criteria. Examples include:
| Test Name | Acceptance Criteria (Implied from standard) | Reported Device Performance |
|---|---|---|
| Sterile test | Conforms to sterility requirements | Meets standard |
| Bacterial Endotoxin test | Conforms to endotoxin limits | Meets standard |
| Residual of EO test | Conforms to EO residue limits | Meets standard |
| Needle point piecing strength test | Conforms to ISO 7864 | Meets standard |
| Piston in barrel fitness test | Conforms to ISO 7886-1 | Meets standard |
| Tolerance on graduated capacity (delivery accuracy) test | Comply to ISO 7886-1 | Meets standard |
| Hub/needle bond strength | Conform to ISO 7864 | Conform to ISO 7864 |
| Reuse durability | Can't be re-used according to ISO 7886-4 | Can't re-used according to ISO 7886-4 |
2. Sample size used for the test set and the data provenance
- Sample Size for Simulated Clinical Study: 512 devices.
- Data Provenance: The simulated clinical study and a "clinical investigation" were "performed in China per the requirements of China FDA." This indicates the data is prospective, acquired from China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of "experts" to establish ground truth in the context of the simulated clinical study or other performance tests. The tests performed are primarily bench tests and a simulated clinical study, which would rely on objective measurements and established protocols rather than expert consensus on a "ground truth" (e.g., as in image interpretation).
4. Adjudication method for the test set
Not applicable. The tests described are objective performance and safety evaluations, not subjective assessments requiring adjudication by multiple readers or experts.
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
Not applicable. This is a medical device (syringe), not an AI-powered diagnostic or assistive tool where MRMC studies would be relevant to evaluate AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical syringe, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, clinical outcomes) is not directly applicable to the performance testing of this physical medical device. The "ground truth" for the tests mentioned (e.g., sterility, fluid delivery accuracy, needle integrity) would be defined by the specifications and measurable parameters within the referenced ISO standards. For example, for "Sterile test," the ground truth is "sterile" as determined by microbiology methods conforming to standards. For "hub/needle bond strength," the ground truth is a specific force threshold defined in ISO 7864.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2015
Guangdong Intmed Medical Appliance Co., Ltd. Mr. Sanfei Wang Management Representative 1# South Shunhe Road Europe Industry Park Shunde District, Foshan Guangdong 528300 CHINA
Re: K143497
Trade/Device Name: Safety Auto-Disable Syringe with Needle (Auto-Lock) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG, FMF, FMI Dated: September 23, 2015 Received: October 5, 2015
Dear Mr. Wang:
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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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 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/Resourcesfor You/Industry/default.htm. 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 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 vours.
Tina
Kiang-S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143497
Device Name
Safety Auto-Disable Syringe with Needle (Auto-Lock)
Indications for Use (Describe)
The Safety Auto-Disable Syringe with Needle (Auto-Lock) is used for aspiration of fluids from vials and a variety of fluid injections below the surface of the skin except phlebotomy.
It has a detachable needle with a dedicated fitting. The Safety Auto-Disable Syringe with Needle (Auto-Lock) contains an inner mechanism used to allow the needle to be retracted inside the plunger rod of the syringe after the operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
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)
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K143497
510(k) Summary
| Submitter: | Guangdong Intmed MedicalApplication Co., Ltd1# South Shunhe Road Europe Industry Park, ShundeDistrict, Foshan, Guangdong, P.R. China, 528300 | ||
|---|---|---|---|
| Contact: | Mr. Wang, Sanfei ManagementRepresentativePhone: (86)18616806984Fax: (86) 757-28093036Email: fthxm@163.com | ||
| Date Prepared: | Sep. 23, 2015 | ||
| Device Trade Name: | Safety Auto-Disable Syringe with Needle (Auto-Lock) | ||
| Device Common Name: | Safety Syringe (with Needle) | ||
| Class: | II | ||
| Classification Name: | 880.5860 Piston Syringe | ||
| Product Code: | MEG, FMI, FMF |
1. Predicate Device (Primary Predicate Device):
| Device | Company | Product Code | 510(k) Number |
|---|---|---|---|
| WTF Secura SafetySyringe (with Needle) | Beijing WanTeFuMedical Apparatus Co.,Ltd | MEG, FMF,and FMI | K132120 |
2. Reference Predicate Devices:
| Device | Company | Product Code | 510(k) Number |
|---|---|---|---|
| BD Spring BasedSyringe | BD Medical | MEG andFMF | K011103 |
| BD Integra 1mlSyringe | BD Medical Surgical | MEG andFMF | K023752 |
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3. Indications for Use:
The Safety Auto-Disable Syringe with Needle (Auto-Lock) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.
It has a detachable needle with a dedicated fitting. The Safety Auto-Disable Syringe with Needle (Auto-Lock) contains an inner mechanism used to allow the needle to be retracted inside the plunger rod of the syringe after the operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
3. Product Description:
It has a detachable needle with a dedicated fitting. The Safety Auto-Disable Syringe with Needle (Auto-Lock) contains an inner mechanism used to allow the needle to be retracted inside the plunger rod of the syringe after the operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
The proposed device is a single use, sterile syringe composed of barrel, plunger, plunger, push-button, spring, spring holder, rubber stopper, needle cap, and autodisable part.
| Specification | ||||||||
|---|---|---|---|---|---|---|---|---|
| SizeVolume | 28G(0.36x12mm) | 27G(0.4x12mm) | 26G(0.45x16mm) | 25G(0.5x16mm) | 24G(0.55x25mm) | 23G(0.6x32mm) | 22G(0.7x38mm) | 21G(0.8x38mm) |
| 1ml | ● | ● | ● | ● | ||||
| 3ml | ● | ● | ● | ● | ||||
| 5ml | ● | ● | ● | ● | ||||
| 10ml | ● | ● | ● | |||||
| Color ofneedle hub | Blue-Green | Gray | Brown | Orange | Purple | Blue | Black | Green |
Product Specification
Note: the part of size include both external diameter and needle length and in unit of mm
4. Summary of Technology Characteristics and Performance Testing:
The intended use and technology characteristics of the proposed Safety Auto-Disable Syringe with Needle (Auto-Lock), and the substantial equivalence to the predicate device have been demonstrated via data collected in design verifications, clinical simulation investigation and clinical investigation performed in China per the requirements of China FDA. The results of these tests and clinical report provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new performance issues were raised during the testing. All materials used in the proposed device meet the requirements of ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process, same as predicate devices.
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Guangdong Intmed Medical Application Co., Ltd
| Bench Testing | Bench Testing(continued) | Biocompatibility/In vivo testing |
|---|---|---|
| Sterile test | Needle point piecing strength test | In vitro cytotoxicity (ISO Elution) |
| Bacterial Endotoxin test | Piston in barrel fitness test | Irritation (Intracutaneous Reaction) |
| Residual of EO test | Tolerance on graduated capacity(delivery accuracy) test | Sensitization (ISO Guinea Pig Maximization) |
| Springe holderdeactivating test | Dead space test | Hemolysis in vitro |
| Auto-disable partactivating strength test | Binding strength betweenNeedle hub & Sheath | Acute systemic toxicity |
| Auto-disable partresisting force test | Freedom from leakage atneedle hub & syringe nozzle | |
| Binding strengthbetween auto-disablepart and needle tube test | Liquid and air leakage pastpiston | |
| Force to unplug pushbutton test | Nozzle conical fitting tests |
Also we have packaging testing non-clinical performance data including packaging sealing strength test, and package integrity test.
The subject product, Safety Auto-Disable Syringe with Needle, was compared with the primary predicate device, WTF Secura Syringe (with needle) K132120, and reference predicate devices, BD Spring Based Syringe K011103, and BD Integra 1ml Syringe K023752, using following criteria following the suggestion from "Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes'':
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| ELEMENT OFCOMPARISON | SUBJECT DEVICE | (Primary) Predicate DeviceK132120 | Reference Predicate Devices | |
|---|---|---|---|---|
| WTF Secura Syringe (withneedle) | Device 1 (K011103) | Device 2 (K023752) | ||
| Indications for Use | The Safety Auto-Disable Syringe withNeedle (Auto-Lock)is used for aspirationof fluids from vialsand ampoules and avariety of fluidinjections below thesurface of the skinexcept phlebotomy.It has a detachableneedle with adedicated fitting.The Safety Auto-Disable Syringe withNeedle (Auto-Lock)contains an innermechanism used toallow the needle tobe retracted insidethe plunger rod ofthe syringe after theoperator's thumbforce released. Afteractivation the needleis fully containedinside the syringeguarding againstaccidental needlesticks during normalhandling anddisposal of the usedneedle/syringecombination. | The WTF SecuraSyringe (with needle) isused for aspiration offluids from vials andampoules and a varietyof fluid injections belowthe surface of the skin.The WTF SecuraSyringe( with needle)has a manually attachedWTF Secura RetractingNeedle. The WTFSecura Syringe (withneedle) contains aninner mechanism usedto allow the WTFSecura RetractingNeelde to be retractedinside the plunger rod ofthe syringe whenoperator's thumb forcereleased. Afteractivation the needle isfully contained insidethe syringe guardingagainst accidentalneedle sticks duringnormal handling anddisposal of the usedneedle/ syringecombination | BD Spring BasedSyringe is used forgeneral purposeinjection andaspiration of fluid fromvials, ampoules andpart of the body belowthe surface of the skinexcept phlebotomy.The BD Spring BasedSyringe has adetachable needlewith a dedicatedfitting. The dedicatedinterface preventsclinician fromattaching BD SpringBased Syringecomponents to astandard syringe orneedle.The BD Spring BasedSyringe contains atool used to cutthrough the stopperand inner hub allowingthe needle is fullycontained inside thesyringe guardingagainst accidentalneedle sticks duringnormal handling anddisposal of the usedneedle / syringecombination. | The BD Integra™Syringe is used foraspiration of fluidsfrom vials andampoules and avariety of fluidinjections below thesurface of the skin. Itis not intended to beused for phlebotomy.The insulin syringehas scale lines ininsulin units and isused for insulininjections. Thetuberculin syringe canbe used for any of the3 types of commoninjections (intra-dermal, intra-muscularor subcutaneous).The BD Integra™ ImlSyringe has apermanently attachedneedle. The BDIntegra™ 1 nil Syringecontains a tool used tocut through the huband stopper allowingthe needle to becomeretracted inside theplunger rod of thesyringe after use.After activation theneedle is fullycontained inside thesyringe guardingagainst accidentalneedle sticks duringnormal handling anddisposal of the usedneedle/syringecombination. |
| Brief Summary: The subject device has smaller intended application scope compare to | ||||
| WTF Secura Safety Syringe since subject device is not used for phlebotomy, andsmaller intended application scope compare to BD Integra 1m syringe since subject | ||||
| device is not used for insulin injection. | ||||
| ELEMENT OF | SUBJECT DEVICE | (Primary) Predicate Device Reference Predicate Devices | ||
| COMPARISON | K132120 | Device 1 (K011103) | Device 2 (K023752) | |
| WTF Secura Syringe (with needle) | BD Spring Based Syringe | The BD IntegraTM Syringe | ||
| syringe type | Plunger, anti-stick with hypodermic needle | Plunger, anti-stick with hypodermic needle | Plunger, anti-stick with hypodermic needle | Plunger, anti-stick with hypodermic needle |
| Active safety | Active safety feature, | Active safety feature, | Active safety feature, | |
| Safety Features | feature, manually activated by user | manually activated by user | manually activated by user | manually activated by user |
| tip type | Tri-Beveled Tip | Tri-Beveled Tip | Tri-Beveled Tip | Tri-Beveled Tip |
| volume | 1 / 3/ 5 / 10 ml | 1/ 2.5/ 3 /5 /10 ml | 3 ~10 ml | 1 ml |
| needle length | Tolerances on length comply to ISO 7864 | Tolerances on length comply to ISO 7864 | Tolerances on length comply to ISO 7864 | Tolerances on length comply to ISO 7864 |
| needle gauge | 21G~28G | 21/ 22/ 23/25/30 G | 18G ~ 25 G | 25G ~ 30 G |
| needle tip configuration | 15 oC regular point | 15 oC regular point | 15 oC regular point | 15 oC regular point |
| nozzle type | Needle hub Luer connector; Needle & syringe separable | Needle hub Luer connector; Needle & syringe separable | Needle hub Locking-fit; Needle & syringe separable | Needle hub Locking-fit; Needle & syringe not separable |
| barrel marking specs | Scales as required by ISO 7886-1 | Scales as required by ISO 7886-1 | Scales as required by ISO 7886-1 | Scales as required by ISO 7886-1 |
| gradations legibility | Scales as required by ISO 7886-1 | Legible according to ISO 7886-1 | Scales as required by ISO 7886-1 | Scales as required by ISO 7886-1 |
| needle cover dimensions | Traditional Cover comply to ISO 7864 | Traditional Cover comply to ISO 7864 | Traditional Cover comply to ISO 7864 | Traditional Cover comply to ISO 7864 |
| needle cover color | Colorless according to ISO 7864 | Colorless according to ISO 7864 | Colorless according to ISO 7864 | Colorless according to ISO 7864 |
| lubricant amount | Comply ISO 7864 & ISO 7886-1 | Comply ISO 7864 & ISO 7886-1 | Comply ISO 7864 & ISO 7886-1 | Comply ISO 7864 & ISO 7886-1 |
| barrel transparency | Clear as required by ISO 7886-1 | Clear as required by ISO 7886-1 | Clear as required by ISO 7886-1 | Clear as required by ISO 7886-1 |
| delivery accuracy/ Capacity Tolerance | Comply to ISO 7886-1 | Comply to ISO 7886-1 | Comply to ISO 7886-1 | Comply to ISO 7886-1 |
| reuse durability | Can't re-used according to ISO 7886-4 | Can't re-used according to ISO 7886-4 | Can't re-used according to ISO 7886-4 | Can't re-used according to ISO 7886-4 |
| hub/needle bond strength | Conform to ISO 7864 | Conform to ISO 7864 | Conform to ISO 7864 | Conform to ISO 7864 |
| ELEMENT OF | SUBJECT DEVICE | (Primary) Predicate Device | Reference Predicate Devices | |
| COMPARISON | K132120 | Device 1 (K011103) | Device 2 (K023752) | |
| WTF Secura Syringe (withneedle) | BD Spring Based Syringe | The BD IntegraTM Syringe | ||
| Primary packagebarrier | Sterile barrier ofprimary packageaccording ISO11607-1/-2 | Sterile barrier of primarypackage according ISO11607-1/-2 | Sterile barrier ofprimary packageaccording ISO 11607-1/-2 | Sterile barrier ofprimary packageaccording ISO 11607-1/-2 |
| Re-usedpreventionfeatures | Conform to ISO7886-4, and FDAguidance,Submission forMedical Device withSharps InjuryPrevention Features | Conform to ISO 7886-4(Not clear the result ofthis FDA guidance) | Conform to ISO 7886-4(Not clear the result ofthis FDA guidance) | Conform to ISO 7886-4(Not clear the result ofthis FDA guidance) |
| Materials:BarrelPlungerPistonNeedle HubNeedleNeedle SheathLubricant0 Ring | PolypropylenePolypropylenelsoprene rubberPolypropyleneStainless SteelStainless SteelPDMSSilicone rubber | PolypropylenePolypropylenelsoprene rubberPolypropyleneStainless SteelStainless SteelUn-identifiedSilicone rubber | PolypropylenePolypropylenelsoprene rubberPolypropyleneStainless SteelStainless SteelUn-identifiedSilicone rubber | PolypropylenePolypropylenelsoprene rubberPolypropyleneStainless SteelStainless SteelUn-identifiedSilicone rubber |
| Biocompatibility | Conforms toISO10993 | Conforms to ISO10993 | Conforms toISO10993 | Conforms toISO10993 |
| Performance | Conforms to ISO7864, ISO 7886-1,ISO 7886-4 | Conforms to ISO 7864,ISO 7886-1, ISO 7886-4 | Conforms to ISO7864, ISO 7886-1,ISO 7886-4 | Conforms to ISO7864, ISO 7886-1,ISO 7886-4 |
| labeling | Conform to ISO7886, ISO 7886-1,ISO 7886-4, and 21CFR Part 801 | Conform to ISO 7886,ISO 7886-1, ISO 7886-4, and 21 CFR Part 801 | Conform to ISO 7886,ISO 7886-1, ISO7886-4, and 21 CFRPart 801 | Conform to ISO 7886,ISO 7886-1, ISO7886-4, and 21 CFRPart 801 |
| Sterilization leveland method | SAL 10-6EO sterilizationaccording to ISO11135 | SAL 10-6EO sterilizationaccording to ISO 11135 | SAL 10-6EO sterilizationaccording to ISO11135; Gammasterilization | SAL 10-6EO sterilizationaccording to ISO11135; Gammasterilization |
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Guangdong Intmed Medical Application Co., Ltd
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Guangdong Intmed Medical Application Co., Ltd
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| ComparisonSummary | The subject device has the same or simpler intended use comparing to predicate devices. |
|---|---|
| The subject device has similar operation principle comparing to predicate devices. | |
| Except for BD Integra 1ml syringe (not separable), all devices have a detachable needle with a dedicated luer fitting. | |
| The key difference between the proposed and predicate devices are the applied syringe volumes and needle gauges have some differences. The proposed device has product volumes as 1 / 3 / 5 / 10 ml, comparing to WTF secura safety syringe's product volumes as 1/ 2.5/ 3 / 5 / 10 ml. And the proposed device has product needle gauges range as 21G – 28G, comparing BD spring based syringe & Integra 1ml syringe's product needle gauges 18G - 30G. | |
| Another different is the sterilization method. For both our proposed device and WTF secura safety syringe, only EO sterilization method is applied. However for BD spring based syringe, Gamma irradiation sterilization method can be applied too. | |
| However, this sterilization method non-identical will not impact to both proposed and predicate devices since relevant International ISO sterilization standards are followed to ensure the sterilization process to product. | |
| These differences do not have impact to product technology & performance to both subject and predicate devices, and do not raise new issues of product performance. | |
| With the same / smaller intended use scope & similar principle of operation, and complying to the same ISO standards, e.g. ISO 7886, ISO 7886-1, ISO 7886-4, and 21 CFR Part 801, and FDA guidance, Submission for Medical Device with Sharps Injury Prevention Features, the proposed device, Intmed safety auto-disable syringe with needle, performs in a similar manner to the predicate devices, WTF Secura Syringe (with needle), BD Spring Based Syringe, and BD Integra 1ml Syringe | |
| All these test / comparison have corresponding requirements/ control criteria following above mentioned standards. And the test results and comparison results show that the subject product is substantially equivalent to the predicate device in performance. |
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5. Simulated Clinical Study Summary:
Following the 'Guidance for Industry and FDA Staff- Medical Devices with Sharps Injury Prevention Features' (Aug., 9, 2005), the Intmed Safety Auto-Disable Syringe with Needle (Auto-Lock) had evaluated by simulated clinical study. During the simulated clinical study, there were no failures observed in a trial test run of 512 devices, we would be 97.5% confident that the true failure rate was no higher than 0.7% and 99.5% confident that it was no higher than 1.1%.
6. Conclusion:
Based on the intended use, technology characteristics, and performance testing, the proposed product, safety auto-disable syringe, has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate device.
§ 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).