(266 days)
Not Found
No
The device description and intended use clearly describe a manually operated syringe with a safety feature. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is a sterile disposable syringe used to withdraw and insert solutions into the body, which is a delivery mechanism, not a therapeutic agent itself.
No
Explanation: The device is a syringe, intended for withdrawing and inserting solutions into the body. Its purpose is for administration, not for obtaining information to make a diagnosis.
No
The device description clearly outlines physical components (barrel, plunger, piston, needle, safety cap) and mentions manual operation, 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 clearly states the device is for "withdraw[ing] solutions into patient's body" and "insert[ing] solutions into patient's body." This describes a device used for administering or withdrawing substances directly from or into a living patient.
- Device Description: The description details the physical components of a syringe and needle, which are tools for direct patient interaction.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is designed for direct interaction with the patient's body.
N/A
Intended Use / Indications for Use
Sterile Disposable Syringe is intended to be used to withdraw solutions into patient's body. Sterile Disposable Syringe with needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient's body. Sterile Disposable Syringe with safety needle is intended to be used with a luer slip or luer lock syringe to withdraw solutions into patient's body. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Product codes
FMF, FMI, MEG
Device Description
The Sterile Disposable Syringe consists of barrel, plunger and piston. The proposed device is available in luer slip or luer lock connector types which are intended to be connected with a hypodermic needle. The Sterile Disposable Syringe with Needle is available in 18-19, 21-26 gauge and 3/8 – 2 inch lengths. The proposed device is also available with fixed needle 25-26 gauge and 1/2 – 1 inch length. The Sterile Disposable Syringe with Safety Needle is available in 18-19, 21-26 gauge and 3/8 – 2 inch lengths. The safety cap will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. All subject device are operated manually.
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
Hospital
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
Nonclinical tests were conducted to verify that the proposed device met all design specifications to establish Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- . ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in Vitro Cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and skin sensitization
- ISO 10993-23:20212021 Biological evaluation of medical devices- Part 23: Test for irritation
- ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
- ISO 10993-4:2017 Biological evaluation of medical devices--Part 4: Selection of Tests for Interactions with Blood
- ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for ●Flexible Packaqinq by Visual Inspection
- . ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
- . ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- 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 ●
- ISO 6009:2016 Hypodermic needles for single use Colour coding for identification ●
- ISO 80369-7:2016 Small-bore connectors for liguids and gases in healthcare applications ● — Part 7: Connectors for intravascular or hypodermic applications
- ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual . use
- ISO 10993-7:2008 Biological Evaluation of Medical Device-Part 7: Ethylene Oxide ● Sterilization Residuals
- . ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- USP Bacterial Endotoxins Test
- USP Pyrogen Test
- USP Particulate Matter in Injections ●
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic ● Single Lumen Needles
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Svringes
- Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 12, 2024
Perfect Medical Industry (VN) Co., Ltd. % Thomas Huang Lead Consultant, Quality and Regulatory Affairs Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin. Texas 78746
Re: K232950
Trade/Device Name: Sterile Disposable Syringe, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe with Safety Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI, MEG Dated: May 9, 2024 Received: May 9, 2024
Dear Thomas Huang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Shruti N. Mistry -S
Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232950
Device Name
Sterile Disposable Syringe, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe with Safety Needle
Indications for Use (Describe)
Sterile Disposable Syringe is intended to be used to withdraw solutions into patient's body. Sterile Disposable Syringe with needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient's body. Sterile Disposable Syringe with safety needle is intended to be used with a luer slip or luer lock syringe to withdraw solutions into patient's body. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
510(k) Submitter
[K232950]
| Device Submitter: | Perfect Medical Industry (VN) Co., Ltd.
Block D7/I, No. 1B Road, Vinh Loc Industrial Zone, Binh Hung Hoa B
Ward, Binh Tan District,
Ho Chi Minh City, 700000 Vietnam
Telephone: +0084.915.521.775
Fax: +0084.283.765.3135
2017@pwuhui.com.tw |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas Huang
Lead Consultant, Quality and Regulatory Affairs
Emergo Global Consulting, LLC
2500 Bee Cave Road, Building 1, Suite 300
Austin, Texas 78746 USA
Telephone: (512) 327-9997
Fax: (512) 327-9998
LST.AUS.ProjectManagement@ul.com |
| Date Prepared | May 03, 2024 |
l Device
| Trade Name of Device: | Sterile Disposable
Syringe, Sterile
Disposable Syringe
with Needle, Sterile
Disposable Syringe
with Safety Needle |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number: | 21 CFR 880.5860,
21 CFR 880.5570 |
| Classification Name: | Piston syringe |
| Product Code: | FMF, FMI, MEG |
| Regulation Name: | Piston Syringe |
| Common name | Syringes with Needle |
| Regulatory Class | II |
| Review Panel | Injection |
4
II Predicate Devices
| 510k Number | K211329 |
|---|---|
| Trade Name of Device: | Sterile Disposable |
| Syringe with Safety | |
| Needle, Sterile | |
| Disposable Syringe | |
| with Needle, Sterile | |
| Disposable Syringe, | |
| Sterile Disposable | |
| Safety Needle, Sterile | |
| Disposable Needle | |
| Regulation Number: | 21 CFR 880.5860, |
| 880.5570 | |
| Regulation Name: | Piston Syringe |
| Regulatory Class | II |
| Product Code: | MEG, FMF, FMI |
III Device Descriptions
The Sterile Disposable Syringe consists of barrel, plunger and piston. The proposed device is available in luer slip or luer lock connector types which are intended to be connected with a hypodermic needle. The Sterile Disposable Syringe with Needle is available in 18-19, 21-26 gauge and 3/8 – 2 inch lengths. The proposed device is also available with fixed needle 25-26 gauge and 1/2 – 1 inch length. The Sterile Disposable Syringe with Safety Needle is available in 18-19, 21-26 gauge and 3/8 – 2 inch lengths. The safety cap will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. All subject device are operated manually.
5
IV Indications for use
V Technological Characteristics Comparison
Sterile Disposable Syringe are intended to be used to withdraw solutions and insert solutions into patient's body. Sterile Disposable Syringe with needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient's body. Sterile Disposable Syringe with safety needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient's body. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
| Attribute | Subject Device | Predicate Device, K211329 | Comparison |
|---|---|---|---|
| Syringe Type: | FMF, FMI, MEG | FMF, FMI, MEG | Same |
| Indications for Use: | 1. Sterile Disposable Syringe are intended to be used to withdraw solutions and insert solutions into patient's body. |
- Sterile Disposable Syringe with needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient's body.
- Sterile Disposable Syringe with safety needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert | 1. The Sterile Disposable Syringe is a sterile luer slip or luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
- The Sterile Disposable Syringe with Needle is intended for use in the aspiration and injection of fluids for medical purpose.
- The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration | Same |
VI-1: Comparison of Piston Syringe
6
| solutions into
patient's body. After
withdrawal of the
needle from the
body, the attached
needle safety shield
can be manually
activated to cover
the needle
immediately after
use to minimize risk
of accidental
needlestick. | and injection of
fluids for medical
purpose. After
withdrawal of the
needle from the
body, the attached
needle safety shield
can be manually
activated to cover
the needle
immediately after
use to minimize risk
of accidental needle
sticks.
4. The Sterile
Disposable Needle
is intended to be
used with a luer slip
or luer lock syringe
for aspiration and
injection of fluids for
medical purpose.
5. The Sterile
Disposable Safety
Needle is intended
to be used with a
luer slip or luer lock
syringe for
aspiration and
injection of fluids for
medical purpose.
After withdrawal of
the needle from the
body, the attached
needle safety shield
can be manually
activated to cover
the needle
immediately after
use to minimize risk |
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
7
| of accidental needle | |||
|---|---|---|---|
| sticks. | |||
| Principle of | |||
| Operation | For manual use only | For manual use only | Same |
| Specific Drug Use | N/A | N/A | Same |
| Length | Complied with ISO | ||
| 7886-1:2017 | Complied with ISO | ||
| 7886-1:2017 | Same | ||
| Diameter | Complied with ISO | ||
| 7886-1:2017 | Complied with ISO | ||
| 7886-1:2017 | Same | ||
| Tip Type | Luer lock, luer slip, | ||
| fixed | Luer lock, luer slip | Different, see | |
| analysis below | |||
| Volume | 1mL, 3mL, 5mL, | ||
| 10mL, 20mL, 30mL, | |||
| 50mL | 1ml, 2ml, 3ml, 5ml, | ||
| 10ml, 20ml, 30mL, | |||
| 50ml, 60ml | Different, see | ||
| discuss below | |||
| Needle Length | 3/8", 1/2", 5/8", 3/4", | ||
| 1", 1-1/4", 1-1/2", 2" | 1/2", 5/8", 3/4", 1", | ||
| 1-1/4", 1-1/2" | Different, see | ||
| discuss below | |||
| Needle Gauge | 18G, 19G, 21G, 22G, | ||
| 23G, 24G, 25G, 26G | 23G | Different, see | |
| discuss below | |||
| Needle Tip | |||
| Configuration | Bevel tip | ||
| Complied with ISO | |||
| 7864:2016 | Complied with ISO | ||
| 7864:2016 | Same, see analysis | ||
| below | |||
| Nozzle Type | Luer lock, luer slip | Luer lock, luer slip | Same |
| Barrel Marking Spec | Graduated scale: | ||
| 1cc: 0.01 mL; 3cc:0.1 | |||
| mL; 5cc, 10cc:0.2 | |||
| mL; | |||
| 20cc, 30cc, | |||
| 50cc:1mL. | |||
| Length of scale | |||
| (Min): | |||
| 1cc: 57mm, 3cc: | |||
| 27mm, 5cc: 36mm, | |||
| 10cc: 44mm, 20cc: | |||
| 52mm, 30cc:67mm, | |||
| 50cc: 75mm | |||
| Complied with ISO | |||
| 7886-1:2017 | Complied with ISO | ||
| 7886-1:2017 | Same, see analysis | ||
| below | |||
| Gradations Legibility | Complied with ISO | ||
| 7886-1:2017 | Complied with ISO | ||
| 7886-1:2017 | Same | ||
| Needle Cover | |||
| Dimensions | ID : min 5.9mm; OD: | ||
| min 7.2mm; | |||
| Length: | |||
| 42mm~70mm | |||
| Complied with ISO | |||
| 7864:2016 | Complied with ISO | ||
| 7864:2016 | Same, see analysis below | ||
| Needle Cover Color | unpigmented | ||
| Complied with ISO | |||
| 7864:2016 | Complied with ISO | ||
| 7864:2016 | Same, see analysis below | ||
| Lubricant | |||
| Composition | Silicone oil | Silicone oil | Same |
| Lubricant | |||
| Amount/cm2 | Complied with ISO | ||
| 7886-1:2017 | Complied with ISO | ||
| 7886-1:2017 | Same | ||
| Barrel Transparency | Transparent | ||
| Complied with ISO | |||
| 7886-1:2017 | Complied with ISO | ||
| 7886-1:2017 | Same, see analysis below | ||
| Delivery Accuracy | 1cc and 3cc: ±5% of | ||
| expelled volume | |||
| when it filled equal | |||
| to or greater than | |||
| half nominal | |||
| capacity; | |||
| ±(1.5% of volume + | |||
| 2% of expelled | |||
| volume when it | |||
| filled less than half | |||
| nominal capacity | |||
| 5cc, 10cc, 20cc, 30cc, | |||
| 50cc: ±4% of | |||
| expelled volume | |||
| when it filled equal | |||
| to or greater than | |||
| half nominal | |||
| capacity; | |||
| ±(1.5% of volume + | |||
| 1% of expelled | |||
| volume when it | |||
| filled less than half | |||
| nominal capacity | Complied with ISO | ||
| 7886-1:2017 | Same, see analysis below | ||
| Complied with ISO | |||
| 7886-1:2017 | |||
| Reuse Durability | Single use | Single use | Same |
| Needle Cover | |||
| Strength | 0.4-1.8kgf | ||
| Complied with ISO | |||
| 7864:2016 | Complied with ISO | ||
| 7864:2016 | Same, see analysis | ||
| below | |||
| Hub/Needle Bond | |||
| Strength | Min. 22-69N | ||
| Complied with ISO | |||
| 7864:2016 | Complied with ISO | ||
| 7864:2016 | Same, see analysis | ||
| below | |||
| Biocompatibility | Cytotoxicity, | ||
| Irritation, | |||
| Sensitization, | |||
| Systemic Toxicity, | |||
| Hemolysis, Pyrogen | Cytotoxicity, | ||
| Irritation, | |||
| Sensitization, | |||
| Systemic Toxicity, | |||
| Hemolysis, Pyrogen | Same | ||
| Materials | Gasket: | ||
| Polyisoprene | |||
| Rubber; Barrel: | |||
| Polypropylene (PP); | |||
| Plunger: | |||
| Polypropylene (PP); | |||
| Needle: Stainless | |||
| Steel 304; | |||
| Needle cap: | |||
| Polypropylene (PP) | Gasket: | ||
| Polyisoprene | |||
| Rubber; Barrel: | |||
| Polypropylene (PP); | |||
| Plunger: | |||
| Polypropylene (PP); | |||
| Needle: Stainless | |||
| Steel SUS 304; | |||
| Needle cap: | |||
| Polypropylene (PP) | Same | ||
| Labeling | Complied with 21 | ||
| CFR part 801 | Complied with 21 | ||
| CFR part 801 | Same | ||
| Sterilization method | EO Sterilized | EO Sterilized | Same |
| Environment of use | Hospital | Hospital | Same |
| Shelf life | 3 years. | ||
| Complied with | |||
| ASTM F1980-07 | 5 years. | ||
| Complied with | |||
| ASTM F1980-07 | Different, see | ||
| analysis below | |||
| Transport | |||
| conditions | Complied with ISTA | ||
| 2A:2011 | Not public | Different, see | |
| analysis |
8
9
Difference Analysis:
Tip Type: The tip configuration of the proposed device is similar to the predicate device. However, this difference is in a fixed connector. The difference in technological characteristics does not raise new questions of safety and effectiveness. Connectivity to the needle is
10
assessed with performance data.
Volume: The Syringe volume for the subject device is different from the predicate device. However, this difference is in dimension. Different volume devices will be selected by the physician per the patient's condition. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.
Needle Length: The needle length for the subject device is different from the predicate device. This difference is in dimension. Different length devices will be selected by the physician per the patient's condition. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.
Needle Gauge: The needle size for the subject device is different from the predicate device. This difference is in dimension. Different size devices will be selected by the physician per the patient's condition. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.
Needle Tip Configuration: The needle tip for the subject device is different in needle point geometry from the predicate device. This difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.
Barrel Marking Spec: The Syringe Barrel Marking Spec for the subject device is different from the predicate device. However, different Marking Specs will be dependent on the Syringe volume. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.
Needle Cover Dimensions: The Needle Cover Dimensions for the subject device is different from the predicate device. However, this difference is in dimension. Different Needle Cover Dimensions will be dependent on the Needle Length. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.
Needle Cover Color: The Needle Cover Color for the subject device is different from the predicate device. However, this difference is in Color. Different colors will be dependent on either pigmented or unpigmented material. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.
Barrel transparency: The Barrel transparency for the subject device is different from the predicate device. However, this difference is in color. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.
11
Delivery accuracy: The Delivery accuracy for the subject device is different from the predicate device. However, this accuracy is dependent on the Syringe volume. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.
Needle cover strength: The needle cover strength for the subject device is different from the predicate device. However, differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device.
Hub/needle bond strength: The hub/needle bond strength for the subject device is different from the predicate device. However, differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device.
Shelf life: The Shelf life for subject device is different from the predicate device. However, differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device.
Transport conditions: The Transport conditions for the subject device is different from the predicate device. However, differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device.
VI Summary of Non-clinical Testing (Bench)
Nonclinical tests were conducted to verify that the proposed device met all design specifications to establish Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- . ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in Vitro Cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and skin sensitization
- ISO 10993-23:20212021 Biological evaluation of medical devices- Part 23: Test for irritation
- ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
- ISO 10993-4:2017 Biological evaluation of medical devices--Part 4: Selection of Tests for Interactions with Blood
- ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for ●
12
Flexible Packaqinq by Visual Inspection
- . ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
- . ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- 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 ●
- ISO 6009:2016 Hypodermic needles for single use Colour coding for identification ●
- ISO 80369-7:2016 Small-bore connectors for liguids and gases in healthcare applications ● — Part 7: Connectors for intravascular or hypodermic applications
- ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual . use
- ISO 10993-7:2008 Biological Evaluation of Medical Device-Part 7: Ethylene Oxide ● Sterilization Residuals
- . ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- USP Bacterial Endotoxins Test
- USP Pyrogen Test
- USP Particulate Matter in Injections ●
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic ● Single Lumen Needles
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Svringes
- Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff
VII Conclusion
The subject device has the same indications for use as the predicate device. Any minor differences in the technological characteristics of the subject device when compared to the predicate device have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject device, when compared to the predicate device does not raise any new questions of safety and effectiveness. Therefore, the subject device has been determined to be substantially equivalent to the predicate device.