(215 days)
The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
The sterile insulin syringe for single use with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The sterile insulin syringe for single use with the calibration unit of insulin for U-40 is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
The Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock consists of a Piston, Plunger, and Barrel. It is EO Sterilized and intended for Prescription use by Medical professionals and trained care givers. It is for single use and operates by pulling and pushing the plunger along inside the barrel to take in and expel fluids. It comes in various lengths, diameters, tip types, needle tip configurations, nozzle types, barrel marking specs, volumes, sizes, and needle lengths. Materials include Isoprene Rubber, PP, PE, and SUS304.
The Sterile Insulin Syringe for Single use, with needle consists of a Needle Cap, Needle, Piston, Plunger, Barrel, and End Cap. It is EO Sterilized and intended for Prescription use by patients. It is for single use and operates by pulling and pushing the plunger along inside the barrel to take in and expel fluids. It comes in 0.3ml, 0.5ml, and 1ml volumes with fixed needles of 8mm and 13mm lengths. Materials include Isoprene Rubber, PP, PE, and SUS304.
The Sterile Hypodermic needle for Single use consists of a Protective cap, Needle, Adhesives, and Needle hub. It is EO Sterilized and intended for Prescription use by Medical professionals and trained care givers. It is for single use and for Manual Use Only. It comes in various sizes and needle lengths. Materials include PP, Epoxy resin, and SUS304.
This document is a 510(k) summary for hypodermic syringes, insulin syringes, and hypodermic needles. It describes the devices, their indications for use, and a comparison to a predicate device (K190002). The document primarily focuses on demonstrating substantial equivalence to the predicate device through comparisons of technological characteristics and compliance with recognized performance standards. It certifies that the devices meet various ISO standards and biological evaluation requirements.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a "table of acceptance criteria and reported device performance" as you might expect for a diagnostic AI device with metrics like sensitivity, specificity, or AUC. Instead, for these medical devices (syringes and needles), acceptance criteria are met through compliance with established international standards for design, performance, and biocompatibility. The reported device performance is stated as "Complied with" these standards.
Here's how we can infer the acceptance criteria and reported performance from the text:
| Device Component/Characteristic | Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|---|
| Hypodermic Syringe | ISO 7886-1 (Sterile hypodermic syringes for single use - Part 1: Syringes for manual use) | Complied with ISO 7886-1 |
| ISO 7864 (Sterile hypodermic needles for single use) | Complied with ISO 7864 | |
| ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices) | Complied with ISO 9626 | |
| ISO 10993-4 (Biological Evaluation - Interactions with Blood) | Complied with ISO 10993-4 (Hemolytical effect) | |
| ISO 10993-5 (Biological Evaluation - In Vitro Cytotoxicity) | Complied with ISO 10993-5 (Cytotoxicity) | |
| ISO 10993-10 (Biological Evaluation - Irritation and Skin Sensitization) | Complied with ISO 10993-10 (Irritation, Sensitization) | |
| ISO 10993-11 (Biological Evaluation - Systemic Toxicity) | Complied with ISO 10993-11 (Acute Systemic Toxicity) | |
| USP 788 (Particulate Matter in Injections) | Complied with USP 788 | |
| ISO 10993-7 (Ethylene oxide sterilization residuals) | Complied with ISO 10993-7 | |
| ISO 11135 (Sterilization of health-care products – Ethylene oxide) | Complied with ISO 11135 | |
| ISO 11607-2 (Packaging for terminally sterilized medical devices) | Complied with ISO 11607-2 | |
| SAL (Sterility Assurance Level) | 10^-6 | |
| Endotoxin Limit | 20 EU per device | |
| Pyrogenicity | Complied with European Pharmacopoeia 9.0 (2.6.8) | |
| Insulin Syringe | ISO 8537 (Sterile single-use syringes, with or without needle, for insulin) | Complied with ISO 8537 |
| ISO 10993-4 (Biological Evaluation - Interactions with Blood) | Complied with ISO 10993-4 (Hemolytical effect) | |
| ISO 10993-5 (Biological Evaluation - In Vitro Cytotoxicity) | Complied with ISO 10993-5 (Cytotoxicity) | |
| ISO 10993-10 (Biological Evaluation - Irritation and Skin Sensitization) | Complied with ISO 10993-10 (Irritation, Sensitization) | |
| ISO 10993-11 (Biological Evaluation - Systemic Toxicity) (Acute, Sub-acute, Sub-chronic) | Complied with ISO 10993-11 (Acute Systemic Toxicity, Sub-acute Systemic Toxicity, Sub-chronic Systemic Toxicity) | |
| USP 788 (Particulate Matter in Injections) | Complied with USP 788 | |
| ISO 10993-7 (Ethylene oxide sterilization residuals) | Complied with ISO 10993-7 | |
| ISO 11135 (Sterilization of health-care products – Ethylene oxide) | Complied with ISO 11135 | |
| ISO 11607-2 (Packaging for terminally sterilized medical devices) | Complied with ISO 11607-2 | |
| SAL (Sterility Assurance Level) | 10^-6 | |
| Endotoxin Limit | 20 EU per device | |
| Pyrogenicity | Complied with European Pharmacopoeia 9.0 (2.6.8) | |
| Hypodermic Needle | ISO 7864 (Sterile hypodermic needles for single use) | Complied with ISO 7864 |
| ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices) | Complied with ISO 9626 | |
| ISO 10993-4 (Biological Evaluation - Interactions with Blood) | Complied with ISO 10993-4 (Hemolytical effect) | |
| ISO 10993-5 (Biological Evaluation - In Vitro Cytotoxicity) | Complied with ISO 10993-5 (Cytotoxicity) | |
| ISO 10993-10 (Biological Evaluation - Irritation and Skin Sensitization) | Complied with ISO 10993-10 (Irritation, Sensitization) | |
| ISO 10993-11 (Biological Evaluation - Systemic Toxicity) | Complied with ISO 10993-11 (Acute Systemic Toxicity) | |
| USP 788 (Particulate Matter in Injections) | Complied with USP 788 | |
| ISO 10993-7 (Ethylene oxide sterilization residuals) | Complied with ISO 10993-7 | |
| ISO 11135 (Sterilization of health-care products – Ethylene oxide) | Complied with ISO 11135 | |
| ISO 11607-2 (Packaging for terminally sterilized medical devices) | Complied with ISO 11607-2 | |
| SAL (Sterility Assurance Level) | 10^-6 | |
| Endotoxin Limit | 20 EU per device | |
| Pyrogenicity | Complied with European Pharmacopoeia 9.0 (2.6.8) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for test sets in the traditional sense of a clinical trial or algorithm evaluation. The testing referenced refers to compliance with ISO standards, which typically involve specific sampling plans and test methods for manufacturing quality control and performance validation.
- Test Set Sample Size: Not explicitly stated as individual numbers for device testing. Compliance with ISO standards implies that appropriate sample sizes were used according to those standards for each specific test (e.g., performance, biocompatibility).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are "performance testing" and "biocompatibility studies" conducted to demonstrate compliance with international standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists) is relevant for diagnostic medical devices or AI algorithms. For syringes and needles, the "ground truth" is defined by the technical specifications and performance requirements outlined in the ISO standards themselves, verified through physical and chemical testing.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods (e.g., 2+1) are used to resolve disagreements among multiple human readers in the context of diagnostic evaluations, typically for AI or imaging studies. For the direct performance testing of syringes and needles against standards, there isn't a "ground truth" established by human readers that requires adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable. MRMC studies are designed to compare the diagnostic performance of human readers, often with and without AI assistance, especially in radiology or pathology. This submission is for physical medical devices (syringes and needles), not a diagnostic AI system, so such a study would not be relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This information is not applicable. This refers to the performance of a software algorithm or AI model without human intervention. The devices being reviewed are physical medical instruments (syringes and needles), not software or AI.
7. Type of Ground Truth Used:
The "ground truth" in this context is adherence to the technical specifications and safety/performance parameters defined by internationally recognized standards (e.g., ISO 7886-1 for syringes, ISO 7864/9626 for needles, ISO 8537 for insulin syringes, and ISO 10993 series for biocompatibility). This is established through objective technical measurements and laboratory test results that demonstrate the device meets these pre-defined (standardized) criteria. It is not expert consensus, pathology, or outcomes data in the sense of diagnostic device validation.
8. Sample Size for the Training Set:
This information is not applicable. A "training set" is used for machine learning or AI model development. These devices are physical medical products, not AI systems, so there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated in point 8.
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Image /page/0/Picture/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 14, 2020
Set Medikal Sanayi Ve Ticaret Anonim Sirketi % Mehmet Fatih Ormeci Consultant Medcer Uluslararasi Medikal Belgelendirme Anonim Sirketi Taspinar Mahallesi 2800. Caddesi A-2 Apt. No:6 B/49 Ankara, 06830 Turkey
Re: K201284
Trade/Device Name: Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: November 11, 2020
Received: November 16, 2020
Dear Mehmet Fatih Ormeci:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 medical devices and radiation-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,
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)
Device Name
Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock
Indications for Use (Describe)
The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Indications for Use
510(k) Number (if known)
Device Name
Sterile Insulin Syringe for Single use, with needle
Indications for Use (Describe)
The sterile insulin syringe for single use with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The sterile insulin syringe for single use with the calibration unit of insulin for U-40 is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Indications for Use
510(k) Number (if known)
Device Name
Sterile Hypodermic needle for Single use
Indications for Use (Describe)
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/5/Picture/0 description: The image contains the logo for "SET MEDIKAL". The logo consists of a blue square with a stylized "S" inside it on the left, followed by the text "SET MEDIKAL" in a gray, sans-serif font. The "S" in the square is also stylized, with a gap in the middle.
K201284 510(k) Summary
| 510(k) Submitter Name | SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI |
|---|---|
| 510(k) Submitter Address | Osmangazi Mahallesi Maresal Fevzi Cakmak Caddesi No:18 Esenyurtİstanbul/TURKEY |
| 510(k) Submitter Telephone No | +90-212-622-0400 |
| Primary Correspondent Contact Information | Mehmet Fatih Ormeci (Consultant)+90-532-397-3043mformeci@gmail.comFax Number: +90 (212) 689 4 828 |
| Summary Preparation Date | 11/24/2020 |
| Trade Or Proprietary Name | Sterile Hypodermic Syringe for Single use, with/without needle;luer/luer-lock |
|---|---|
| Sterile Insulin Syringe for Single use, with needle | |
| Sterile Hypodermic needle for Single use | |
| Common Name | Hypodermic Syringe |
| Insulin Syringe | |
| Hypodermic needle | |
| Classification Name | Piston Syringe |
| Piston Syringe | |
| Hypodermic Single Lumen Needle | |
| Regulation Number | 21 CFR 880.5860 |
| 21 CFR 880.5860 | |
| 21 CFR 880.5570 | |
| Product Code | FMF |
| FMF | |
| FMI |
| Subject Device 510k No | Predicate Device 510kNo | Predicate DeviceManufacturer | |
|---|---|---|---|
| Sterile HypodermicSyringe for Single use,with/without needle;luer/luer-lock | K201284 | K190002 | Shanghai KohopeMedical Devices Co.,Ltd |
| Sterile Insulin Syringefor Single use, withneedle | K201284 | K190002 | Shanghai KohopeMedical Devices Co.,Ltd |
| Sterile Hypodermicneedle for Single use | K201284 | K190002 | Shanghai KohopeMedical Devices Co.,Ltd |
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Image /page/6/Picture/0 description: The image contains the logo for SER Medikal. The logo features a blue diamond shape with a stylized "S" inside. To the right of the diamond is the text "SER medikal" in a gray, sans-serif font. The text is all lowercase and has a modern, slightly futuristic appearance.
Device Description
Table 5.1. Device Description Summary for Hypodermic Syringe
| ITEM | Subject Device |
|---|---|
| Product name | Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock |
| Indications for use | The Sterile Hypodermic Syringe for Single Use with/without needle isintended to be used for medical purposes to inject fluid into or withdraw fluidfrom body. |
| Configuration | Piston, Plunger, Barrel |
| Sterility condition | EO Sterilized |
| Environment of use | Prescription use |
| Intended users | Medical professionals and trained care givers |
| Single use | Yes |
| Operation mode | The plunger of syringe can be pulled and pushed along inside the barrel, allowingthe syringe to take in and expel the fluids through the connector to the patient. |
| length | 64-182mm |
| diameter | 6,6mm-31,6mm |
| tip type | luer/ luer lock/catheter/perfusion |
| needle tip configuration | Back bevel needle |
| nozzle type | Luer / Lock, %6 conical, 1,2 mm |
| barrel marking specs | 0,05ml-1ml |
| graduation legibility | Legible |
| needle cover dimensions | L: 35-55mm, D: 6-9mm |
| needle cover color | Transparent |
| lubricant composition | Silicone |
| barrel transparency | Transparent/ UV resistant/ opaque |
| needlecover strength | min. 2N max. 20N |
| hub/ needle bond strength | min. 22-69N |
| Productperformance | Complied with ISO 7886-1, ISO 7864, ISO 9626 |
| Volume | 2ml, 2,5ml, 3ml, 5ml, 6ml, 10ml, 12ml, 20ml, 24ml, 50ml and 60 ml |
| Sizes | 14G,15G,16G,18G,19G,20G,21G,22G,23G,24G,25G,26G,27G,28G,29G,30G |
| Needle Lengths | 4–50 mm |
| Piston material | Isoprene Rubber |
| Barrel material | PP |
| Plunger material | PP/PE |
| Needle material | PP, SUS304 |
| SAL | $10^{-6}$ |
| Endotoxin Limit | 20 EU per device |
| Biocompatibility | Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, SensitizationAcute Systemic Toxicity. Hemolytical effect) |
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Image /page/7/Picture/0 description: The image shows the logo for SER Medikal. The logo consists of a blue square with a white "S" inside of it. To the right of the square is the text "SER MEDIKAL" in a gray, sans-serif font. The logo is simple and modern, and the colors are clean and professional.
Table 5.2. Device Description Summary for Insulin Syringe
| ITEM | Subject Device |
|---|---|
| Product name | Sterile Insulin Syringe for Single use, with needle |
| Indications for use | The sterile insulin syringe for single use with needle, with the calibration unit ofinsulin for U-100, is a device intended for medical purposes for the manualaspiration of insulin, and for the injection of insulin into parts of the bodybelow the surface skin.The sterile insulin syringe for single use with needle, with the calibration unit ofinsulin for U-40 is a device intended for medical purposes for the manualaspiration of insulin, and for the injection of insulin into parts of the bodybelow the surface skin. |
| Configuration | Needle Cap, Needle, Piston, Plunger, Barrel, End Cap |
| Sterility condition | EO Sterilized |
| Environment of use | Prescription use |
| Intended users | Patient use |
| Single use | Yes |
| Operation mode | The plunger of syringe can be pulled and pushed along inside the barrel,allowing the syringe to take in and expel the fluids through the connector tothe patient. |
| Productperformance | Complied with ISO 8537 |
| Volume | 0.3ml, 0.5ml, 1ml volumes with fixed needle |
| Needle Lengths | 8mm, 13mm |
| Piston material | Isoprene Rubber |
| Barrel material | PP |
| Plunger material | PP |
| Needle material | SUS304 |
| Needle Cap material | PP |
| End Cap material | PP |
| SAL | 10-6 |
| Endotoxin Limit | 20 EU per device |
| Biocompatibility | Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, SensitizationAcute Systemic Toxicity, Subchronic Toxicity, Hemolytic effect) |
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Image /page/8/Picture/0 description: The image contains the logo for SER Medikal. The logo consists of a blue square with a white "S" inside, followed by the text "SER medikal" in a gray, sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.
| Table 5.3. Device Description Summary for Needle | ||
|---|---|---|
| ITEM | Subject Device |
|---|---|
| Product name | Sterile Hypodermic needle for Single use |
| Indications for use | The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. |
| Configuration | Protective cap, Needle, Adhesives, Needle hub |
| Sterility condition | EO Sterilized |
| Environment of use | Prescription use |
| Intended users | Medical professionals and trained care givers |
| Single use | Yes |
| Operation mode | For Manual Use Only, For Single Use only |
| Product performance | Complied with ISO 7864, ISO 9626 |
| Sizes | 14G,15G,16G,18G,19G,20G,21G,22G,23G,24G,25G,26G,27G,28G,29G,30G |
| Needle Lengths | 4–50 mm |
| Protective cap material | PP |
| Adhesive material | Epoxy resin |
| Needle Hub material | PP |
| Needle material | SUS304 |
| SAL material | 10-6 |
| Endotoxin Limit material | 20 EU per device |
| Biocompatibility | Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect) |
Technological Characteristics
Table 5.4 Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock Predicate Comparison
| Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock | |||
|---|---|---|---|
| ITEM | Subject Device | Predicate DeviceK190002 | Comparison |
| Product name | Sterile Hypodermic Syringefor Single use, with/withoutneedle; luer/luer-lock | Sterile Hypodermic Syringefor Single use, with/withoutneedle | Similar |
| Product code | FMF | FMF | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock | |||
| ITEM | Subject Device | Predicate DeviceK190002 | Comparison |
| Indications for use | The Sterile HypodermicSyringe for Single Usewith/without needle isintended to be used formedical purposes to injectfluid into or withdraw fluidfrom body. | The Sterile HypodermicSyringe for Single Usewith/without needle isintended to be used formedical purposes to injectfluid into or withdraw fluidfrom body. | Same |
| Configuration | PistonPlungerBarrel | PistonPlungerBarrel | Same |
| Sterility condition | EO Sterilized | EO Sterilized | Same |
| Environment of use | Prescription use | Prescription use | Same |
| Intended users | Medical professionals andtrained care givers | Medical professionals andtrained care givers | Same |
| Single use | Yes | Yes | Same |
| Operation mode | The plunger of syringe can bepulled and pushed along insidethe barrel, allowing the syringeto take in and expel the fluidsthrough the connector to thepatient. | The plunger of syringe can bepulled and pushed alonginside the barrel, allowingthe syringe to take in andexpel the fluids through theconnector to the patient. | Same |
| Label/labeling | Complied with 21 CFR part801 | Complied with 21 CFR part801 | Same |
| Productperformance | Complied withISO 7886-1ISO 7864ISO 9626 | Complied withISO 7886-1ISO 7864ISO 9626 | Same |
| Volume | 2ml, 2,5ml, 3ml, 5ml, 6ml, 10ml,12ml, 20ml, 24ml, 50ml | 1ml, 3ml, 5ml, 6ml, 10ml,20ml, 30ml, 35ml, 50ml and60 ml | Difference 1 |
| Sizes | 14G,15G,16G,18G,19G,20G,21G,22G,23G,24G,25G,26G,27G,28G,29G,30G | 18G,19G,20G,21G,22G,23G,24G,25G,26G,27G,28G,29G,30G | Difference 2 |
| Needle Lengths | 4-50 mm | 4-38 mm | Difference 3 |
| Patient contact component and material | |||
| Piston | Isoprene Rubber | Isoprene Rubber | Same |
| Barrel | PP | PP | Same |
| Plunger | PP/PE | PP | Difference 4 |
| Needle | PP, SUS304 | PP, SUS304 | Same |
| Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock | |||
| ITEM | Subject Device | Predicate DeviceK190002 | Comparison |
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
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Image /page/9/Picture/0 description: The image shows the logo for SER Medikal. The logo consists of a blue square with rounded corners and a white "S" inside. To the right of the square is the text "SER MEDIKAL" in a gray, futuristic-looking font. The logo is simple and modern, and the colors are clean and professional.
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Image /page/10/Picture/0 description: The image shows the logo for "SER MEDIKAL". The logo consists of a blue square with a white "S" inside on the left. To the right of the square is the company name, "SER MEDIKAL", in a gray, futuristic-looking font. The logo is simple and modern.
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Table 5.5. Sterile Insulin Syringe for Single use, with needle Predicate Comparison
| Sterile Insulin Syringe for Single use, with needle | |||
|---|---|---|---|
| ITEM | Subject Device | Predicate DeviceK190002 | Comparison |
| Product name | Sterile Insulin Syringe forSingle use, with needle | Sterile Insulin Syringe forSingle use, with needle | Same |
| Product code | FMF | FMF | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Indications foruse | The sterile insulin syringe for singleuse with needle, with the calibrationunit of insulin for U-100, is a deviceintended for medical purposes forthe manual aspiration of insulin, andfor the injection of insulin into partsof the body below the surface skin.The sterile insulin syringe for singleuse with needle, with the calibrationunit of insulin for U-40 is a deviceintended for medical purposes forthe manual aspiration of insulin, andfor the injection of insulin into partsof the body below the surface skin. | The sterile insulin syringe for singleuse with needle, with the calibrationunit of insulin for U-100, is a deviceintended for medical purposes for themanual aspiration of insulin, and forthe injection of insulin into parts ofthe body below the surface skin.The sterile insulin syringe for singleuse with needle, with the calibrationunit of insulin for U-40 is a deviceintended for medical purposes for themanual aspiration of insulin, and forthe injection of insulin into parts ofthe body below the surface skin. | Same |
| Configuration | Needle CapNeedlePistonPlungerBarrelEnd Cap | Needle CapNeedlePistonPlungerBarrelEnd Cap | Same |
| Sterilitycondition | EO Sterilized | EO Sterilized | Same |
| Environmentof use | Prescription use | Prescription use | Same |
| Intended users | Patient use | Patient use | Same |
| Single use | Yes | Yes | Same |
| Operationmode | The plunger of syringe can be pulledand pushed along inside the barrel,allowing the syringe to take in and | The plunger of syringe can be pulledand pushed along inside the barrel,allowing the syringe to take in and | Same |
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Image /page/11/Picture/0 description: The image shows the logo for SER Medikal. The logo consists of a blue square with rounded corners and a white "S" inside. To the right of the square is the text "SER MEDIKAL" in a gray, sans-serif font. The logo is simple and modern, and the colors are clean and professional.
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T
| Sterile Insulin Syringe for Single use, with needle | |||
|---|---|---|---|
| ITEM | Subject Device | Predicate DeviceK190002 | Comparison |
| expel the fluids through theconnector to the patient. | expel the fluids through theconnector to the patient. | ||
| Label/labeling | Complied with 21 CFR part801 | Complied with 21 CFR part801 | Same |
| Productperformance | Complied with ISO 8537 | Complied with ISO 8537 | Same |
| Volume | 0.3ml, 0.5ml, 1ml volumeswith fixed needle | 0.3ml, 0.5ml, 1ml volumeswith fixed needle | Same |
| NeedleLengths | 8mm, 13mm | 8mm, 13mm | Same |
| Patient contact component and material | |||
| Piston | Isoprene Rubber | Isoprene Rubber | Same |
| Barrel | PP | PP | Same |
| Plunger | PP | PP | Same |
| Needle | SUS304 | SUS304 | Same |
| Needle Cap | PP | PP | Same |
| End Cap | PP | PP | Same |
| Sterilization | |||
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
| EndotoxinLimit | 20 EU per device | 20 EU per device | Same |
Table 5.6. Sterile Hypodermic needle for Single use Predicate Comparison
| Sterile Hypodermic needle for Single use | |||
|---|---|---|---|
| ITEM | Subject Device | Predicate DeviceK190002 | Comparison |
| Product name | Sterile Hypodermic needlefor Single use | Sterile Hypodermic needlefor Single use | Same |
| Product code | FMI | FMI | Same |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | II | II | Same |
| Indications for use | The Sterile Hypodermic Needle for singleuse is intended for use with syringes andinjection devices for general purposefluid injection/aspiration. | The Sterile Hypodermic Needlefor single use is intended foruse with syringes and injectiondevices for general purposefluid injection/aspiration. | Same |
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Image /page/12/Picture/0 description: The image contains the logo for SER Medikal. The logo consists of a blue square with a stylized white "S" inside, followed by the text "SER MEDIKAL" in a gray, sans-serif font. The logo appears to be for a medical company.
| Sterile Hypodermic needle for Single use | |||
|---|---|---|---|
| ITEM | Subject Device | Predicate DeviceK190002 | Comparison |
| Configuration | Protective capNeedleAdhesivesNeedle hub | Protective capNeedleAdhesivesNeedle hub | Same |
| Sterility condition | EO Sterilized | EO Sterilized | Same |
| Environment ofuse | Prescription use | Prescription use | Same |
| Intended users | Medical professionals andtrained care givers | Medical professionals andtrained care givers | Same |
| Single use | Yes | Yes | Same |
| Operation mode | For Manual Use Only, ForSingle Use only | For Manual Use Only, ForSingle Use only | Same |
| Label/labeling | Complied with 21 CFR part801 | Complied with 21 CFR part801 | Same |
| Productperformance | Complied with:ISO 7864ISO 9626 | Complied with:ISO 7864ISO 9626 | Same |
| Sizes | 14G,15G,16G,18G,19G,20G,21G,22G,23G,24G,25G,26G,27G,28G,29G,30G | 18G,19G,20G,21G,22G,23G,24G,25G,26G,27G,28G,29G,30G | Difference1 |
| Needle Lengths | 4–50 mm | 4 – 38 mm | Difference2 |
| Patient contact component and material | |||
| Protective cap | PP | PP | Same |
| Adhesive | Epoxy resin | Epoxy resin | Same |
| Needle Hub | PP | PP | Same |
| Needle | SUS304 | SUS304 | Same |
| Sterilization | |||
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
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Substantial Equivalence Discussion
Hypodermic Syringe Discussion
The indications for use statement for the hypodermic syringe subject device is identical to the predicate device. There are no technological differences between the predicate and subject devices except for the following: syringe volumes, needle lengths, and plunger material.
- . Difference 1: The subject device includes different syringe volumes compared to the predicate. The subject device includes 2ml, 2.5ml, 12ml and 24 ml volume syringes while the predicate does not include these sizes. The predicate device includes 1 ml, 30 ml, 35 ml and 60 ml syringe volumes which the subject device does not include. These slight differences have no adverse effect on clinical safety and performance. All of the subject device hypodermic syringes are tested in accordance with ISO 7886-1 standard. The requirements of the standards are met.
- . Difference 2: The subject device includes additional needle gauges compared to the predicate. The subject device includes larger needle gauges, including 14G, 15G, and 16G. The needles are tested in accordance with ISO 7864 and ISO 9626 and released in accordance with the standards compliance. This was verified by performance testing according to ISO 7864 and ISO 9626.
- Difference 3: The subject device includes additional needle lengths compared to the predicate. The subject device includes the following additional needle lengths: 39 mm - 50 mm. The needles are tested in accordance to ISO 7864 and ISO 9626 and released in accordance with the standards compliance. This was verified by performance testing according to ISO 7864 and ISO 9626.
- Difference 4: The plunger material of the subject device is PP/PE, while the predicate device plunger material is PP. Biocompatibility studies are carried out in according to ISO 10993-1. Biological safety was demonstrated.
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The intended use, principle of operation, and sterilization for the subject device are the same as the predicate device. The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. Therefore, it can be determined that the proposed device is substantially equivalent to the predicate device.
Insulin Syringe Discussion
The indications for use statement for the subject device is identical to the predicate device. There are no technological differences between the subject and the predicate device. This was verified by performance testing according to ISO 8537. The intended use, principle of operation, materials, specifications and sterilization information for the subject device are the same as for the predicate device. Therefore, it can be determined that the proposed device is substantially equivalent to the predicate device.
Needle Discussion
The indications for use statement for the subject device is identical to the predicate device. There are no technological differences between the subject and the predicate device except for the following: needle gauge sizes and needle length.
- . Difference 1: The subject device includes additional needle gauges compared to the predicate. The subject device includes larger needle gauges, including 14G, 15G, and 16G. The needles are tested in accordance with ISO 7864 and ISO 9626 and released in accordance with the standards compliance. This was verified by performance testing according to ISO 7864 and ISO 9626.
- Difference 2: The subject device includes additional needle lengths compared to the predicate. The subject device includes the following additional needle lengths: 39 mm - 50 mm. The needles are tested in accordance to ISO 7864 and ISO 9626 and released in accordance with
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the standards compliance. This was verified by performance testing according to ISO 7864 and ISO 9626.
The intended use, principle of operation, materials, and sterilization information for the subject device are the same as the predicate device. The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. Therefore, it can be determined that the proposed device is substantially equivalent to the predicate device.
Performance Testing
The sterile, single lumen hypodermic needles described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 9626 Second edition: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- . ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- . ISO 7864:2016 Fourth Edition: Sterile hypodermic needles for single use — Requirements and test methods
- ISO 10993-4:2017 Biological Evaluation Of Medical Devices — Part 4: Selection Of Tests For Interactions With Blood
- . 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: Tests For Irritation And Skin Sensitization
- . ISO 10993-11:2017 Biological Evaluation Of Medical Devices — Part 11: Tests For Systemic Toxicity
- . USP 788 Particulate Matter in Injections
- . ISO 10993-7:2008 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
- . ISO 10993-12:2012 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
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- . ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
- . ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
The sterile, single lumen hypodermic needle is considered in the category of "External Communicating Devices" and are accepted to be in contact for a period less than 24 hours with "Tissue/Bone/Dentin". Thus, cytotoxicity (ISO 10993-5:2009, irritation and sensitization (ISO 10993-10:2010), acute systemic toxicity (ISO 10993-11:2017), hemocompatibility (EN ISO 10993-4:2017) and pyrogenicity (European Pharmacopoeia 9.0 (2.6.8)) were carried out for the device in question.
The sterile, insulin syringe described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- . ISO 8537 Third edition 2016-03-15 Sterile single-use syringes, with or without needle, for insulin
- . ISO 10993-4:2017 Biological Evaluation Of Medical Devices — Part 4: Selection Of Tests For Interactions With Blood
- 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: Tests For Irritation And Skin Sensitization
- . ISO 10993-11:2017 Biological Evaluation Of Medical Devices — Part 11: Tests For Systemic Toxicity
- USP 788 Particulate Matter in Injections
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide ● sterilization residuals
- ISO 10993-12:2012 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
- ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
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- . ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
The sterile, insulin syringe is considered in the category of "External Communicating Devices" and are accepted to be in contact for a period between 24 hours - 30 days because of repetitive use of patient with "Tissue/Bone/Dentin". Thus, cytotoxicity (ISO 10993-5:2009, irritation and sensitization (ISO 10993-10:2010), acute systemic toxicity (ISO 10993-11:2017), sub-acute systemic toxicity (ISO 10993-11:2017), sub-chronic systemic toxicity (ISO 10993-11:2017), hemocompatibility (EN ISO 10993-4:2017) and pyrogenicity (European Pharmacopoeia 9.0 (2.6.8)) were carried out for the device in question.
The sterile, needle described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 9626 Second edition: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 7864:2016 Fourth Edition: Sterile hypodermic needles for single use — Requirements and test methods
- . ISO 10993-4:2017 Biological Evaluation Of Medical Devices — Part 4: Selection Of Tests For Interactions With Blood
- 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: Tests For Irritation And Skin Sensitization
- ISO 10993-11:2017 Biological Evaluation Of Medical Devices — Part 11: Tests For Systemic Toxicity
- USP 788 Particulate Matter in Injections
- ISO 10993-7:2008 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
- ISO 10993-12:2012 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
- ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
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- . ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
The sterile, needle is considered in the category of "External Communicating Devices" and are accepted to be in contact for a period less than 24 hours with "Tissue/Bone/Dentin". Thus, cytotoxicity (ISO 10993-5:2009, irritation and sensitization (ISO 10993-10:2010), acute systemic toxicity (ISO 10993-11:2017), hemocompatibility (EN ISO 10993-4:2017) and pyrogenicity (European Pharmacopoeia 9.0 (2.6.8)) were carried out for the device in question.
Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The subject devices are substantially equivalent to the predicate devices 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).