(183 days)
Not Found
No
The device description and performance studies focus on the physical components and standard performance testing of a syringe and needle, with no mention of AI or ML capabilities.
Yes
The device is used to inject or withdraw fluids from the body for medical purposes, which are therapeutic actions.
No
Explanation: The device is a syringe used for injecting or withdrawing fluids, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly outlines a physical syringe and needle, made of materials like polypropylene and stainless steel, and sterilized by ETO gas. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to inject fluids into or withdraw fluids from the body." This describes a device used for direct interaction with the body for therapeutic or diagnostic purposes in vivo (within the living organism).
- Device Description: The description details a standard syringe and needle, which are tools for administering or collecting substances from the body, not for performing tests on those substances outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to be used outside the body to analyze samples and provide diagnostic information. This syringe and needle are used on the body.
N/A
Intended Use / Indications for Use
Lifelong Matrix/Lifelong Premium/Safeway syringe with or without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMI
Device Description
The Lifelong Matrix/Lifelong Premium/SAFEWAY syringe with or without needle is a standard piston syringe that consists of a calibrated hollow barrel and a movable plunger. The needle consists of needle tube, needle hub, needle cap. At one end of the barrel there is a male Luer Slip/Lock connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle or for attaching other devices with a female Luer. The syringe and needles are sterilized by ETO gas. It is a non-pyrogenic and single use device. The main raw materials for syringes are polypropylene and thermoplastic elastomer and for needles raw materials are polypropylene and stainless steel (SS-304).
The proposed device is available in a variety of combination of needle size and syringe volume. The syringe size, needle gauges is provided in following table.
| Syringe Size | Needle Gauge | Needle length | Wall type |
|---|---|---|---|
| 1mL, 2mL, 3mL, 5mL, 10mL, 20mL | 16G, | 1", 1¼", 1½" | Thin Wall |
| 18G, | 1", 1¼", 1½" | Thin Wall | |
| 19G, | 1", 1¼", 1½" | Thin Wall | |
| 20G, | 1", 1¼", 1½" | Thin Wall | |
| 21G, | 1", 1¼", 1½" | Thin Wall | |
| 22G, | 1", 1¼", 1½" | Thin Wall | |
| 23G, | 1", 1¼", 1½" | Thin Wall | |
| 24G, | 1", 1¼", 1½" | Thin Wall | |
| 25G, | ½", ¾", ⅝", 1", 1¼", 1½" | Thin Wall | |
| 26G. | ½", ¾", ⅝", 1", 1¼", 1½" | Regular Wall |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device complies with the following standards:
A. Hypodermic Needles:
- ISO 7864:2016 "Sterile hypodermic needles for single use - Requirements and test methods"
- ISO 9626:2016 "Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods"
- ISO 6009 Fourth edition: Hypodermic needles for single use – Color coding for Identification
B. Syringes:
- ISO 7886-1:2017 "Sterile hypodermic syringes for single use – Part 1: Syringes for manual use
- ISO 80369-7:2016 "Small-bore connectors for liquids and gases in healthcare applications . — Part 7: Connectors for intravascular or hypodermic applications
Biocompatibility:
In accordance with ISO 10993-1 the syringe with needle is classified as external communicating device coming in contact with blood path indirect for contact period for less than 24hrs.
The Stainless-Steel part of Needle is considered as external communicating device coming in contact with circulating blood for contact period for less than 24 hours.
The biocompatibility tests were performed in accordance with the following standards:
- Cytotoxicity ISO 10993-5:2009 (E) "Biological evaluation of medical devices Part 5
- Intracutaneous Reactivity ISO 10993-10:2010 (E) "Biological Evaluation of Medical Devices - Part 10
- Skin Sensitization ISO 10993-10:2010 (E): "Biological Evaluation of Medical Devices Part 10
- Acute Systemic Toxicity ISO 10993-11:2006 (E): "Biological Evaluation of Medical Devices -Part 11
- Hemolysis ISO 10993-4:2017 (E): "Biological Evaluation of Medical Devices Part 4
- Bacterial Reverse Mutation (AMES) ISO 10993-3:2014 "Biological evaluation of medical devices — Part 3
- Material-mediated Pyrogenicity ISO 10993-11:2017(E): "Biological Evaluation of Medical Devices-Part-11
- Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria
Sterility, Shipping, and Shelf-life:
The device is sterilized by Ethylene oxide sterilization method, the sterilization process was validated as per ISO 11135-1: 2014 "Sterilization of health-care products — Ethylene oxide —Requirements for the development, validation and routine control of a sterilization process for medical devices.
The EO residual were tested which meets the requirements of ISO 10993-7: 2008 "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals".
The Bacterial endotoxin testing of subject devices was performed by "Gel-Clot Method" as per recommended guideline "United States Pharmacopeia" (USP).
Packaging integrity: Packaging validation tests were conducted in accordance with the following standard:
- ISO 11607-2:2019 "Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes".
- Transport validation tests were conducted in accordance with ASTM D4169-16 "Standard Practice for Performance Testing of Shipping Containers and Systems"
Sterile Barrier Packaging Testing performed on the proposed device: The packaging integrity of subject devices was performed as per the FDA recognized standard ASTM F 1929- 15 "Standard test method for detecting the sealing leak in porous medical packaging by dye penetration method".
Shelf life: Shelf life of Lifelong Premium/Safeway syringe with or with or without needle is 5years. Validated using the FDA recognized standard ASTM F1980-16 "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K060211 - Wuzhou Syringe with/without needle
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 16, 2021 Lifelong Meditech Private Limited Hamendra Srivastava Director & CEO Plot No.18. Sector-5. IMT Manesar Gurugram, Haryana 122050 India
Re: K210103
Trade/Device Name: Lifelong Matrix/Lifelong Premium/Safeway syringe with/without needle Regulation Number: 21 CFR 880.5860, 21 CFR 880.5570 Regulation Name: Piston Syringe, Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: June 10, 2021 Received: June 15, 2021
Dear Hamendra Srivastava:
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.
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
1
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 mediation-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,
For Rumi Young Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210103
Device Name
Lifelong Matrix/Lifelong Premium/Safeway syringe with or without needle
Indications for Use (Describe)
Lifelong Matrix/Lifelong Premium/Safeway syringe with or without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
3.1 Submission Sponsor:
Lifelong Meditech Private Limited Plot No.18, Sector-05, IMT, Manesar, Gurugram, Haryana (INDIA) Pin-122050.
3.2 Date:
July 14, 2021
3.3 Contact Person:
Hamendra Nath Srivastava, Director and CEO Tel: +91 9810661915; Fax Number: +91 124-4406699 Email: hsrivastava@lifelongindia.com
3.4 Device Identification:
Trade/Proprietary Name: Lifelong Premium/Safeway syringe with/without needle
Common/Usual Name: Piston Syringe, Hypodermic Single Lumen Needle
Classification Panel: General Hospital
Classification Regulation:
- . Piston Syringe- 21 CFR 880.5860.
- . Hypodermic Single Lumen Needle- 21 CFR 880.5570
Device Code:
- FMF- Piston Syringe ●
- FMI Hypodermic Single Lumen Needle .
Device Class: Class II
3.5 Predicate Device:
K060211 - Wuzhou Syringe with/without needle
4
3.6 Device Description:
The Lifelong Matrix/Lifelong Premium/SAFEWAY syringe with or without needle is a standard piston syringe that consists of a calibrated hollow barrel and a movable plunger. The needle consists of needle tube, needle hub, needle cap. At one end of the barrel there is a male Luer Slip/Lock connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle or for attaching other devices with a female Luer. The syringe and needles are sterilized by ETO gas. It is a non-pyrogenic and single use device. The main raw materials for syringes are polypropylene and thermoplastic elastomer and for needles raw materials are polypropylene and stainless steel (SS-304).
The proposed device is available in a variety of combination of needle size and syringe volume. The syringe size, needle gauges is provided in following table.
| Syringe Size | Needle Gauge | Needle length | Wall type |
|---|---|---|---|
| 1mL, 2mL, 3mL, | |||
| 5mL, 10mL, 20mL | 16G, | 1", 1¼", 1½" | Thin Wall |
| 18G, | 1", 1¼", 1½" | Thin Wall | |
| 19G, | 1", 1¼", 1½" | Thin Wall | |
| 20G, | 1", 1¼", 1½" | Thin Wall | |
| 21G, | 1", 1¼", 1½" | Thin Wall | |
| 22G, | 1", 1¼", 1½" | Thin Wall | |
| 23G, | 1", 1¼", 1½" | Thin Wall | |
| 24G, | 1", 1¼", 1½" | Thin Wall | |
| 25G, | ½", ¾", ⅝", 1", 1¼", 1½" | Thin Wall | |
| 26G. | ½", ¾", ⅝", 1", 1¼", 1½" | Regular Wall |
Table No.-01
3.7 Indication for Use:
Lifelong Matrix/Lifelong Premium/SAFEWAY syringe with or without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
| Characteristics | Subject Device | Predicate Device |
|---|---|---|
| Lifelong Matrix/ Lifelong Premium/ | ||
| Safeway syringe with/without | ||
| needle | ||
| K210103 | Wuzhou Syringe with/without | |
| needle | ||
| K060211 | ||
| Indication for Use | Lifelong Matrix/ Lifelong | |
| Premium/ Safeway syringe | ||
| with/without needle intended to | ||
| be used for medical purposes to | ||
| inject fluids into or withdraw | ||
| fluids from the body. | The Wuzhou Syringe, | |
| with/without needle is intended | ||
| to be used for medical | ||
| purposes to inject fluids into or | ||
| withdraw fluids from the body. |
5
| Prescription Only or Over
| the Counter | Prescription Only | Prescription Only |
|---|---|---|
| ------------------------------------------ | ------------------- | ------------------- |
Discussions of differences in Indication for use statement:
The indication for use statement for the subject device is identical to the predicate device.
3.8 Technological Differences:
The Lifelong Matrix/Lifelong Premium/SAFEWAY syringe with or without needle has the following similarities with the predicate device - Wuzhou Syringe, with/without needle (K060211) which is a 510 (K) cleared device:
| Technological
Characteristics | Subject Device
K210103 | Predicate Device
(K060211) | Comparison | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Indications for Use | Lifelong Matrix/Lifelong
Premium/Safeway
syringe with or without
needle is intended to be
used for medical
purposes to inject fluids
into or withdraw fluids
from the body. | The Wuzhou Syringe,
with/without needle is
intended to be used for
medical purposes to inject
fluids into or withdraw
fluids from the body. | Same | |
| Product Code | FMF, FMI | FMF, FMI | Same | |
| Regulation Number | 21 CFR 880.5860,
21 C.F.R. 880.5570 | 21 CFR 880.5860,
21 C.F.R. 880.5570 | Same | |
| Class | II | II | Same | |
| Needle Gauge | 16G, 18G, 19G, 20G,
21G, 22G, 23G, 25G, &
26G. | 16G, 18G, 19G, 20G,
21G, 22G, 23G, 25G, &
26G. | Same | |
| Size | 1ml, 2ml, 3ml, 5ml,10ml
& 20ml | 1mL. 2mL, 3mL, 5mL,
10mL, 20mL, 30mL,
50mL, 60mL and 100mL. | Similar, the
predicate device
includes additional
models of 30mL,
60mL & 100mL,
which do not raise
any issue in safety
and effectiveness
of our device. | |
| Needle
length | 16G to 24G | 1", 1¼", 1½" (25mm to
40mm) | 1", 1¼", 1½" (25mm to
40mm) | Same |
| Technological
Characteristics | Subject Device
K210103 | Predicate Device
(K060211) | Comparison | |
| 25G & 26G | 1/2", 3/4", 5/8", 1", 1¼", 1½"
(12mm to 40mm) | 1/2", 3/4", 5/8", 1", 1¼", 1½"
(12mm to 40mm) | Same | |
| Needle bevel | 09° to 13° | 09° to 13° | Same | |
| Needle
wall type | 16G to 25G Thin wall | Thin wall | Same | |
| | 26G Regular wall | Regular wall | | |
| Needle
(Sharpness test) | Needles point appear sharp, free from feather, edges, burrs and hooks.
Needle point sharpness force & gliding force is with in limit | Needles point appear sharp, free from feather, edges, burrs and hooks.
Needle point sharpness force & gliding force is with in limit | Same | |
| Dose accuracy | Capacity less than half of nominal capacity (mL) | Capacity less than half of nominal capacity (mL) | Similar | |
| | Size
(mL) | Volume
tested
(mL) | Accuracy
(mL) | |
| | 1mL | 0.4 | 0.392-
0.412 | |
| | 2mL | 0.5 | 0.498-
0.510 | |
| | 3mL | 1.0 | 1.011-
1.022 | |
| | 5mL | 2.0 | 2.011-
2.021 | |
| | 10mL | 2.0 | 2.011-
2.052 | |
| | 20mL | 5.0 | 5.038-
5.082 | |
| | Capacity greater than half of nominal capacity (mL) | Capacity greater than half of nominal capacity (mL) | | |
| | 1mL | 0.8 | 0.794-
0.814 | |
| | 2mL | 1.5 | 1.498-
1.510 | |
| | 3mL | 2.0 | 2.010-
2.032 | |
| | 5mL | 4.0 | 4.012-
4.032 | |
| | 1mL | 0.4 | 0.394-
0.410 | |
| | 2mL | 0.5 | 0.500-
0.508 | |
| | 3mL | 1.0 | 1.008-
1.020 | |
| | 5mL | 2.0 | 2.007-
2.016 | |
| | 10 mL | 2.0 | 2.012-
2.042 | |
| | 20 mL | 5.0 | 5.025-
5.060 | |
6
7
| Technological
Characteristics | Subject Device
K210103 | | | Predicate Device
(K060211) | | | Comparison |
|----------------------------------|---------------------------|--------------------|-------------------|-------------------------------|--------------------|-------------------|------------------------------------------------------|
| | 10mL | 8.0 | 8.012-
8.052 | 10 mL | 8.0 | 8.018-
8.062 | |
| | 20mL | 15.0 | 14.998-
15.096 | 20 mL | 15.0 | 15.098-
15.167 | |
| Inner diameter | Needle
Gauge | Inner diameter | | Needle
Gauge | Inner diameter | | Similar & meets
the requirements
of ISO 9626. |
| | 16G | 1.281 | to
1.289mm | 16G | 1.279 | to
1.288mm | |
| | 18G | 0.980 | to
0.990mm | 18G | 0.981 | to
0.989mm | |
| | 19G | 0.780 | to
0.790mm | 19G | 0.779 | to
0.787mm | |
| | 20G | 0.495 | to
0.505mm | 20G | 0.492 | to
0.500mm | |
| | 21G | 0.570 | to
0.580mm | 21G | 0.569 | to
0.575mm | |
| | 22G | 0.460 | to
0.470mm | 22G | 0.461 | to
0.469mm | |
| | 23G | 0.400 | to
0.405mm | 23G | 0.401 | to
0.405mm | |
| | 24G | 0.360 | to
0.370mm | 24G | 0.359 | to
0.371mm | |
| | 25G | 0.295 | to
0.305mm | 25G | 0.292 | to
0.303mm | |
| | 26G | 0.350 | to
0.450mm | 26G | 0.351 | to
0.452mm | |
| Residual volume
(Dead Space) | Size
of
Syringe | Residual
volume | | Size
of
Syringe | Residual
volume | | Similar & meets
the requirements
of ISO7886-1. |
| | 1mL | 0.037 | to
0.045mL | 1mL | 0.046 | to
0.054mL | |
| | 2mL | 0.054 | to
0.062mL | 2mL | 0.058 | to
0.065mL | |
| | 3mL | 0.055 | to
0.065mL | 3mL | 0.055 | to
0.064mL | |
| | 5mL | 0.060 | to
0.065mL | 5mL | 0.057 | to
0.063mL | |
| | 10mL | 0.077 | to
0.090mL | 10mL | 0.085 | to
0.092mL | |
| | 20mL | 0.087 | to
0.120mL | 20mL | 0.097 | to
0.115mL | |
8
| Technological
Characteristics | Subject Device
K210103 | Predicate Device
(K060211) | Comparison | | |
|---------------------------------------|--------------------------------------------------------------------------|-------------------------------|--------------------------------------------------------------------------|---------------|---------------------------------------------------------------------------------------------------------|
| Needle cover
removal force | 15N to 25N | 13N to 24N | Similar | | |
| Needle hub/needle
bond strength | Needle Gauge | Bond strength | Needle Gauge | Bond strength | Similar & meets
the requirements
of ISO7864. |
| | 16G | 110 to 195N | 16G | 96 to 165 N | |
| | 18G | 95 to 115 N | 18G | 85 to 110 N | |
| | 19G | 80 to 134 N | 19G | 82 to 130 N | |
| | 20G | 78 to 118 N | 20G | 85 to 128 N | |
| | 21G | 70 to 140 N | 21G | 70 to 125 N | |
| | 22G | 84 to 140 N | 22G | 80 to 130 N | |
| | 23G | 70 to 135 N | 23G | 72 to 125 N | |
| | 24G | 65 to 110 N | 24G | 60 to 110 N | |
| | 25G | 55 to 90 N | 25G | 55 to 85 N | |
| | 26G | 50 to 85 N | 26G | 52 to 87 N | |
| Storage conditions. | Store in a cool and dry place | | Store in cool and dry place | | Same |
| Configuration | Plunger
Barrel
Gasket
Needle Hub
Needle Cover
Needle Tube | | Plunger
Barrel
Gasket
Needle Hub
Needle Cover
Needle Tube | | Same |
| Operation Mode | For manual use only | | For manual use only | | Same |
| Connector Type | Luer Slip and Luer Lock | | Luer Slip and Luer Lock | | Same |
| Sterility condition | EO Sterilized | | EO Sterilized | | Same |
| Biocompatibility | Conforms to the
requirement of ISO
10993 series Standards | | Conforms to the
requirement of ISO 10993
series Standards | | Same |
| | No Cytotoxicity | | No Cytotoxicity | | Same |
| | No Irritation to Skin | | No Irritation to Skin | | Same |
| | No sensitization | | No sensitization | | Same |
| | No Hemolysis | | No Hemolysis | | Same |
| Performance safety
& effectiveness | Complies with
ISO 7886-1
ISO 7864
ISO 9626
ISO 80369 | | Complies with
ISO 7886-1
ISO 7864
ISO 9626
ISO 594-1/-2 | | The predicate
device complied to
ISO 594-1/2. The
ISO 594-1/2 is
replaced with ISO
80369 |
9
Discussions of Differences in Technological characteristics:
The differences between the predicate and the subject device are as follows:
- . The predicate device has additional models of syringes i.e. 30mL & 100mL, which do not raise any new or different questions on safety or effectiveness of the subject devices.
- . The conical fitting of predicate device complied with ISO 594-1/-2 and the conical fitting of subject device complies with the ISO 80369. The ISO 594-1/-2 has been updated and replaced with ISO 80369 in 2016, which does not raise any new or different questions of safety or effectiveness of the subject devices.
Hence, the device is considered as substantially equivalent to the predicate device.
3.9 Summary Performance Testing:
The device complies with the following standards:
A. Hypodermic Needles:
- . ISO 7864:2016 "Sterile hypodermic needles for single use - Requirements and test methods"
- . ISO 9626:2016 "Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods"
- . ISO 6009 Fourth edition: Hypodermic needles for single use – Color coding for Identification
B. Svringes:
- . ISO 7886-1:2017 "Sterile hypodermic syringes for single use – Part 1: Syringes for manual use
- ISO 80369-7:2016 "Small-bore connectors for liquids and gases in healthcare applications . — Part 7: Connectors for intravascular or hypodermic applications
Biocompatibility:
In accordance with ISO 10993-1 the syringe with needle is classified as external communicating device coming in contact with blood path indirect for contact period for less than 24hrs.
The Stainless-Steel part of Needle is considered as external communicating device coming in contact with circulating blood for contact period for less than 24 hours.
The biocompatibility tests were performed in accordance with the following standards:
10
- Cytotoxicity ISO 10993-5:2009 (E) "Biological evaluation of medical devices Part 5
- · Intracutaneous Reactivity ISO 10993-10:2010 (E) "Biological Evaluation of Medical Devices - Part 10
- Skin Sensitization ISO 10993-10:2010 (E): "Biological Evaluation of Medical Devices Part 10
- · Acute Systemic Toxicity ISO 10993-11:2006 (E): "Biological Evaluation of Medical Devices -Part 11
- · Hemolysis ISO 10993-4:2017 (E): "Biological Evaluation of Medical Devices Part 4
- Bacterial Reverse Mutation (AMES) ISO 10993-3:2014 "Biological evaluation of medical devices — Part 3
- Material-mediated Pyrogenicity ISO 10993-11:2017(E): "Biological Evaluation of Medical Devices-Part-11
- Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria
Sterility, Shipping, and Shelf-life:
The device is sterilized by Ethylene oxide sterilization method, the sterilization process was validated as per ISO 11135-1: 2014 "Sterilization of health-care products — Ethylene oxide —Requirements for the development, validation and routine control of a sterilization process for medical devices.
The EO residual were tested which meets the requirements of ISO 10993-7: 2008 "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals".
The Bacterial endotoxin testing of subject devices was performed by "Gel-Clot Method" as per recommended guideline "United States Pharmacopeia" (USP).
Packaqing integrity: Packaging validation tests were conducted in accordance with the following standard:
- . ISO 11607-2:2019 "Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes".
- Transport validation tests were conducted in accordance with ASTM D4169-16 "Standard Practice for Performance Testing of Shipping Containers and Systems"
Sterile Barrier Packaging Testing performed on the proposed device: The packaging integrity of subject devices was performed as per the FDA recognized standard ASTM F 1929- 15 "Standard test method for detecting the sealing leak in porous medical packaging by dye penetration method".
Shelf life: Shelf life of Lifelong Premium/Safeway syringe with or with or without needle is 5years. Validated using the FDA recognized standard ASTM F1980-16 "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices"
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Conclusion:
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Lifelong Matrix/Lifelong Premium/Safeway syringe with or without needle, is substantially equivalent to the Wuzhou Syringe with/without needle with respect to the indications for use, target populations, treatment method, and technological characteristics.