(330 days)
No
The summary describes a mechanical safety syringe with an auto-disable feature based on a spring mechanism. There is no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is a syringe used for fluid aspiration and injection, primarily for drug delivery or fluid removal, not for treating a disease or condition itself. Its safety features are about preventing needle sticks, not therapy.
No
Explanation: The device description clearly states it is a "Safety Auto-Disable Syringe with Needle" used for "aspiration of fluids... and a variety of fluid injections," which are therapeutic or procedural actions, not diagnostic ones. There is no mention of it being used to identify or determine the nature of a disease or condition.
No
The device description clearly outlines physical components like a barrel, plunger, needle cap, and an autodisable part, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy." This describes a device used for administering substances into the body or withdrawing substances from containers, not for testing samples in vitro (outside the body) to diagnose conditions.
- Device Description: The description details the components of a syringe and needle, which are used for injection and aspiration in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing samples.
Therefore, this device falls under the category of a medical device used for therapeutic or procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
MEG, FMI, FMF
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
below the surface of the skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Bench Testing:
Sterile test
Bacterial Endotoxin test
Residual of EO test
Springe holder deactivating test
Auto-disable part activating strength test
Auto-disable part resisting force test
Binding strength between auto-disable part and needle tube test
Force to unplug push button test
Needle point piecing strength test
Piston in barrel fitness test
Tolerance on graduated capacity(delivery accuracy) test
Dead space test
Binding strength between Needle hub & Sheath
Freedom from leakage at needle hub & syringe nozzle
Liquid and air leakage past piston
Nozzle conical fitting tests
Biocompatibility/In vivo testing:
In vitro cytotoxicity (ISO Elution)
Irritation (Intracutaneous Reaction)
Sensitization (ISO Guinea Pig Maximization)
Hemolysis in vitro
Acute systemic toxicity
Packaging testing:
packaging sealing strength test
package integrity test
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.
Key Metrics
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%.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
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 (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
2
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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3
K143497
510(k) Summary
| Submitter: | Guangdong Intmed Medical
Application Co., Ltd
1# South Shunhe Road Europe Industry Park, Shunde
District, Foshan, Guangdong, P.R. China, 528300 | | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact: | Mr. Wang, Sanfei Management
Representative
Phone: (86)18616806984
Fax: (86) 757-28093036
Email: 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 Safety | |||
| Syringe (with Needle) | Beijing WanTeFu | ||
| Medical Apparatus Co., | |||
| Ltd | MEG, FMF, | ||
| and FMI | K132120 |
2. Reference Predicate Devices:
| Device | Company | Product Code | 510(k) Number |
|---|---|---|---|
| BD Spring Based | |||
| Syringe | BD Medical | MEG and | |
| FMF | K011103 | ||
| BD Integra 1ml | |||
| Syringe | BD Medical Surgical | MEG and | |
| FMF | K023752 |
4
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 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Size | ||||||||
| Volume | 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 of | ||||||||
| needle 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.
5
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 holder | ||
| deactivating test | Dead space test | Hemolysis in vitro |
| Auto-disable part | ||
| activating strength test | Binding strength between | |
| Needle hub & Sheath | Acute systemic toxicity | |
| Auto-disable part | ||
| resisting force test | Freedom from leakage at | |
| needle hub & syringe nozzle | ||
| Binding strength | ||
| between auto-disable | ||
| part and needle tube test | Liquid and air leakage past | |
| piston | ||
| Force to unplug push | ||
| button 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'':
6
| ELEMENT OF
COMPARISON | SUBJECT DEVICE | (Primary) Predicate Device
K132120 | Reference Predicate Devices | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | WTF Secura Syringe (with
needle) | Device 1 (K011103) | Device 2 (K023752) |
| 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. | The WTF Secura
Syringe (with needle) is
used for aspiration of
fluids from vials and
ampoules and a variety
of fluid injections below
the surface of the skin.
The WTF Secura
Syringe( with needle)
has a manually attached
WTF Secura Retracting
Needle. The WTF
Secura Syringe (with
needle) contains an
inner mechanism used
to allow the WTF
Secura Retracting
Neelde to be retracted
inside the plunger rod of
the syringe when
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 | BD Spring Based
Syringe is used for
general purpose
injection and
aspiration of fluid from
vials, ampoules and
part of the body below
the surface of the skin
except phlebotomy.
The BD Spring Based
Syringe has a
detachable needle
with a dedicated
fitting. The dedicated
interface prevents
clinician from
attaching BD Spring
Based Syringe
components to a
standard syringe or
needle.
The BD Spring Based
Syringe contains a
tool used to cut
through the stopper
and inner hub allowing
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 BD Integra™
Syringe is used for
aspiration of fluids
from vials and
ampoules and a
variety of fluid
injections below the
surface of the skin. It
is not intended to be
used for phlebotomy.
The insulin syringe
has scale lines in
insulin units and is
used for insulin
injections. The
tuberculin syringe can
be used for any of the
3 types of common
injections (intra-
dermal, intra-muscular
or subcutaneous).
The BD Integra™ Iml
Syringe has a
permanently attached
needle. The BD
Integra™ 1 nil Syringe
contains a tool used to
cut through the hub
and stopper allowing
the needle to become
retracted inside the
plunger rod of the
syringe after use.
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. |
| Brief Summary: The subject device has smaller intended application scope compare to | | | | |
| WTF Secura Safety Syringe since subject device is not used for phlebotomy, and
smaller 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 |28G | 21/ 22/ 23/25/30 G | 18G ~ 25 G | 25G ~ 30 G |
| 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
| 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 (with
needle) | BD Spring Based Syringe | The BD IntegraTM Syringe |
| Primary package
barrier | Sterile barrier of
primary package
according ISO
11607-1/-2 | Sterile barrier of primary
package according ISO
11607-1/-2 | Sterile barrier of
primary package
according ISO 11607-
1/-2 | Sterile barrier of
primary package
according ISO 11607-
1/-2 |
| Re-used
prevention
features | Conform to ISO
7886-4, and FDA
guidance,
Submission for
Medical Device with
Sharps Injury
Prevention Features | Conform to ISO 7886-4
(Not clear the result of
this FDA guidance) | Conform to ISO 7886-4
(Not clear the result of
this FDA guidance) | Conform to ISO 7886-4
(Not clear the result of
this FDA guidance) |
| Materials:
Barrel
Plunger
Piston
Needle Hub
Needle
Needle Sheath
Lubricant
0 Ring | Polypropylene
Polypropylene
lsoprene rubber
Polypropylene
Stainless Steel
Stainless Steel
PDMS
Silicone rubber | Polypropylene
Polypropylene
lsoprene rubber
Polypropylene
Stainless Steel
Stainless Steel
Un-identified
Silicone rubber | Polypropylene
Polypropylene
lsoprene rubber
Polypropylene
Stainless Steel
Stainless Steel
Un-identified
Silicone rubber | Polypropylene
Polypropylene
lsoprene rubber
Polypropylene
Stainless Steel
Stainless Steel
Un-identified
Silicone rubber |
| Biocompatibility | Conforms to
ISO10993 | Conforms to ISO10993 | Conforms to
ISO10993 | Conforms to
ISO10993 |
| Performance | Conforms to ISO
7864, ISO 7886-1,
ISO 7886-4 | Conforms to ISO 7864,
ISO 7886-1, ISO 7886-4 | Conforms to ISO
7864, ISO 7886-1,
ISO 7886-4 | Conforms to ISO
7864, ISO 7886-1,
ISO 7886-4 |
| labeling | Conform to ISO
7886, ISO 7886-1,
ISO 7886-4, and 21
CFR Part 801 | Conform to ISO 7886,
ISO 7886-1, ISO 7886-
4, and 21 CFR Part 801 | Conform to ISO 7886,
ISO 7886-1, ISO
7886-4, and 21 CFR
Part 801 | Conform to ISO 7886,
ISO 7886-1, ISO
7886-4, and 21 CFR
Part 801 |
| Sterilization level
and method | SAL 10-6
EO sterilization
according to ISO
11135 | SAL 10-6
EO sterilization
according to ISO 11135 | SAL 10-6
EO sterilization
according to ISO
11135; Gamma
sterilization | SAL 10-6
EO sterilization
according to ISO
11135; Gamma
sterilization |
7
Guangdong Intmed Medical Application Co., Ltd
8
Guangdong Intmed Medical Application Co., Ltd
9
| Comparison
| Summary | 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. |
10
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.