(183 days)
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 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).
This document is a 510(k) premarket notification for a medical device (syringes and needles). The key to fulfilling your request is to understand that a 510(k) submission primarily relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel performance against specific acceptance criteria like an AI/ML device would.
Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," and "training set" do not directly apply in the context of this 510(k) submission for a non-AI/ML device like a syringe.
Instead, the submission focuses on comparing the proposed device's characteristics and performance to those of a previously cleared predicate device and demonstrating compliance with relevant industry standards.
Here's how to interpret the document in the context of your request, reframing the information to reflect what is actually present in a 510(k) for this type of device:
For a medical device like the Lifelong Matrix/Lifelong Premium/Safeway syringe with or without needle, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily demonstrated through comparison to a legally marketed predicate device and compliance with established international and national standards. This is typical for a 510(k) premarket notification for a Class II device that is not an AI/ML product.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this isn't an AI/ML device with specific accuracy metrics, the "acceptance criteria" are implicitly met by demonstrating similar technological characteristics and compliance with recognized standards as the predicate device. The "reported device performance" is presented as a comparison to the predicate and confirmation of adherence to these standards.
Here's a table summarizing the key comparisons that serve as the basis for "acceptance" in a 510(k) context for this device:
| Characteristic/Test | Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance (Subject Device K210103) | Comparison to Predicate (K060211) |
|---|---|---|---|
| Indications for Use | Same as predicate device | "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." | Identical |
| Product Code | Same as predicate device (FMF, FMI) | FMF, FMI | Same |
| Regulation Number | Same as predicate device (21 CFR 880.5860, 21 CFR 880.5570) | 21 CFR 880.5860, 21 CFR 880.5570 | Same |
| Device Class | Same as predicate device (Class II) | Class II | Same |
| Needle Gauge | Similar range as predicate device | 16G, 18G, 19G, 20G, 21G, 22G, 23G, 25G, & 26G | Same |
| Syringe Size | Similar range to predicate device (smaller range acceptable if no new safety concerns) | 1mL, 2mL, 3mL, 5mL, 10mL & 20mL | Similar (Predicate has 30mL, 60mL, 100mL additional models; deemed to not raise new safety issues) |
| Needle Length | Similar range to predicate device | 1", 1¼", 1½" (for 16G-24G) and ½", ¾", ⅝", 1", 1¼", 1½" (for 25G-26G) | Same |
| Needle Bevel | Similar to predicate device | 09° to 13° | Same |
| Needle Wall Type | Similar to predicate device | 16G to 25G Thin wall, 26G Regular wall | Same |
| Needle Sharpness | Free from defects, sharpness force & gliding force within 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 | Within acceptable ISO 7886-1 limits (ranges provided in table) | Meets the specified ranges for various syringe sizes and tested volumes (e.g., 1mL: 0.392-0.412mL at 0.4mL volume) | Similar (Both conform to standards) |
| Inner Diameter (Needle) | Within acceptable ISO 9626 limits (ranges provided in table) | Meets the specified ranges for various needle gauges (e.g., 16G: 1.281-1.289mm) | Similar & meets ISO 9626 |
| Residual Volume (Dead Space) | Within acceptable ISO 7886-1 limits (ranges provided in table) | Meets the specified ranges for various syringe sizes (e.g., 1mL: 0.037-0.045mL) | Similar & meets ISO 7886-1 |
| Needle Cover Removal Force | Within acceptable range | 15N to 25N | Similar |
| Needle Hub/Needle Bond Strength | Within acceptable ISO 7864 limits (ranges provided in table) | Meets the specified ranges for various needle gauges (e.g., 16G: 110-195N) | Similar & meets ISO 7864 |
| Sterility | EO sterilized, meets ISO 11135-1, ISO 10993-7 (residuals), USP (endotoxin) | EO sterilized, validated as per ISO 11135-1:2014. EO residual meets ISO 10993-7:2008. Bacterial endotoxin testing by Gel-Clot Method meets USP. | Same (Sterilization method) |
| Biocompatibility | Conforms to ISO 10993 series for specified contact | Conforms to ISO 10993 series (10993-5, 10993-10, 10993-11, 10993-4, 10993-3). No Cytotoxicity, Irritation, Sensitization, Hemolysis. Material-mediated Pyrogenicity tested. | Same |
| Packaging Integrity | Meets ISO 11607-2, ASTM F 1929-15 | Validated as per ISO 11607-2:2019. Testing performed as per ASTM F 1929-15. | Same (Adherence to standards) |
| Shipping Validation | Meets ASTM D4169-16 | Conducted in accordance with ASTM D4169-16. | Same (Adherence to standards) |
| Shelf-life | Established and validated via accelerated aging | 5 years. Validated using ASTM F1980-16. | Similar (Both seek to establish shelf-life) |
| Conical Fitting | Meets relevant ISO standards for luer connectors | Complies with ISO 80369-7:2016 | Different standard (ISO 594-1/-2 for predicate vs. ISO 80369 for subject device), but ISO 80369 is an updated version and does not raise new safety concerns. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a distinct "test set" sample size in the way an AI/ML study would. Instead, compliance with various ISO and ASTM standards implies specific sample sizes and test methodologies as defined within those standards (e.g., how many syringes are tested for dose accuracy, or how many needles for bond strength). These details are not explicitly itemized in the summary provided, but rather are referenced by the standard itself.
- Data Provenance: The device manufacturer is Lifelong Meditech Private Limited, located in Gurugram, Haryana, India. All testing would have been conducted to demonstrate compliance with international standards (ISO, ASTM, USP) for the purpose of U.S. FDA clearance. The studies referenced are performance testing and biocompatibility testing, which are inherently prospective in nature, conducted on the actual manufactured device Lot(s) to demonstrate their properties.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. For a medical device like a syringe and needle, "ground truth" is not established by human experts in the way it is for image interpretation in AI/ML. Instead, performance is measured against objective physical, chemical, and biological standards (e.g., volume accuracy, material composition, sterility, biocompatibility). These measurements are typically performed by technicians and validated by quality control personnel in certified laboratories.
4. Adjudication Method for the Test Set:
- Not Applicable. As "ground truth" is based on objective measurements against standards rather than subjective human interpretation, there is no need for an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC study is relevant for AI/ML devices that assist or replace human readers (e.g., radiologists interpreting images). This device is a syringe, a hardware medical device; its safety and effectiveness are not assessed via human reader performance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not Applicable. This is not an AI/ML algorithm. Its "performance" is assessed directly through physical and chemical testing.
7. The Type of Ground Truth Used:
-
The "ground truth" for this device is based on objective measurements against established performance standards and material specifications. This includes:
- Dimensional accuracy (e.g., needle inner diameter, volume calibration)
- Physical properties (e.g., bond strength, plunger force, needle sharpness)
- Chemical properties (e.g., EO residuals, material composition)
- Biological properties (e.g., sterility, absence of pyrogens, biocompatibility)
- Functionality (e.g., luer lock compatibility)
These are defined by standards such as ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, ISO 10993 series, ISO 11135-1, ASTM D4169-16, ASTM F1929-15, ASTM F1980-16, and USP guidelines.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm. The "training" for such a device is in its design, manufacturing process, and quality control, not via data-driven model training.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for an AI/ML algorithm, this question does not apply. The device's design and manufacturing are based on well-established engineering principles and adherence to regulatory and quality standards, the "ground truth" for which are the physical and chemical properties of materials and established mechanical and biological principles.
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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
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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
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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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3.1 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
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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/withoutneedleK210103 | Wuzhou Syringe with/withoutneedleK060211 | |
| Indication for Use | Lifelong Matrix/ LifelongPremium/ Safeway syringewith/without needle intended tobe used for medical purposes toinject fluids into or withdrawfluids from the body. | The Wuzhou Syringe,with/without needle is intendedto be used for medicalpurposes to inject fluids into orwithdraw fluids from the body. |
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| Prescription Only or Overthe 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:
| TechnologicalCharacteristics | Subject DeviceK210103 | Predicate Device(K060211) | Comparison | |
|---|---|---|---|---|
| Indications for Use | Lifelong Matrix/LifelongPremium/Safewaysyringe with or withoutneedle is intended to beused for medicalpurposes to inject fluidsinto or withdraw fluidsfrom the body. | The Wuzhou Syringe,with/without needle isintended to be used formedical purposes to injectfluids into or withdrawfluids 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, thepredicate deviceincludes additionalmodels of 30mL,60mL & 100mL,which do not raiseany issue in safetyand effectivenessof our device. | |
| Needlelength | 16G to 24G | 1", 1¼", 1½" (25mm to40mm) | 1", 1¼", 1½" (25mm to40mm) | Same |
| TechnologicalCharacteristics | Subject DeviceK210103 | 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 | |
| Needlewall 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) | Volumetested(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 |
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| TechnologicalCharacteristics | Subject DeviceK210103 | 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 | NeedleGauge | Inner diameter | NeedleGauge | Inner diameter | Similar & meetsthe requirementsof ISO 9626. | ||
| 16G | 1.281 | to1.289mm | 16G | 1.279 | to1.288mm | ||
| 18G | 0.980 | to0.990mm | 18G | 0.981 | to0.989mm | ||
| 19G | 0.780 | to0.790mm | 19G | 0.779 | to0.787mm | ||
| 20G | 0.495 | to0.505mm | 20G | 0.492 | to0.500mm | ||
| 21G | 0.570 | to0.580mm | 21G | 0.569 | to0.575mm | ||
| 22G | 0.460 | to0.470mm | 22G | 0.461 | to0.469mm | ||
| 23G | 0.400 | to0.405mm | 23G | 0.401 | to0.405mm | ||
| 24G | 0.360 | to0.370mm | 24G | 0.359 | to0.371mm | ||
| 25G | 0.295 | to0.305mm | 25G | 0.292 | to0.303mm | ||
| 26G | 0.350 | to0.450mm | 26G | 0.351 | to0.452mm | ||
| Residual volume(Dead Space) | SizeofSyringe | Residualvolume | SizeofSyringe | Residualvolume | Similar & meetsthe requirementsof ISO7886-1. | ||
| 1mL | 0.037 | to0.045mL | 1mL | 0.046 | to0.054mL | ||
| 2mL | 0.054 | to0.062mL | 2mL | 0.058 | to0.065mL | ||
| 3mL | 0.055 | to0.065mL | 3mL | 0.055 | to0.064mL | ||
| 5mL | 0.060 | to0.065mL | 5mL | 0.057 | to0.063mL | ||
| 10mL | 0.077 | to0.090mL | 10mL | 0.085 | to0.092mL | ||
| 20mL | 0.087 | to0.120mL | 20mL | 0.097 | to0.115mL |
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| TechnologicalCharacteristics | Subject DeviceK210103 | Predicate Device(K060211) | Comparison | ||
|---|---|---|---|---|---|
| Needle coverremoval force | 15N to 25N | 13N to 24N | Similar | ||
| Needle hub/needlebond strength | Needle Gauge | Bond strength | Needle Gauge | Bond strength | Similar & meetsthe requirementsof 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 | PlungerBarrelGasketNeedle HubNeedle CoverNeedle Tube | PlungerBarrelGasketNeedle HubNeedle CoverNeedle 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 therequirement of ISO10993 series Standards | Conforms to therequirement of ISO 10993series 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 withISO 7886-1ISO 7864ISO 9626ISO 80369 | Complies withISO 7886-1ISO 7864ISO 9626ISO 594-1/-2 | The predicatedevice complied toISO 594-1/2. TheISO 594-1/2 isreplaced with ISO80369 |
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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:
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- 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 <788> 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.
§ 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).