(109 days)
Not Found
No
The device description and intended use are for a standard hypodermic syringe, and there is no mention of AI or ML in the provided text.
No.
A therapeutic device is one that treats or manages a disease or condition. This device is used to inject or withdraw fluids, which is a delivery mechanism, not a treatment in itself.
No
This device is a syringe, which is used for injecting or withdrawing fluids from the body, not for diagnosing conditions.
No
The device description clearly outlines physical components made of materials like polypropylene, polyethylene, and stainless steel, indicating it is a hardware device (a syringe). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to inject fluid into or withdraw fluid from body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo (within the living organism).
- Device Description: The description details a syringe and needle, which are tools for administering or collecting substances directly from the body.
- Lack of IVD Characteristics: An IVD device is intended for use in vitro (outside the living organism) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description. It is not used to analyze blood, urine, tissue, etc., in a lab setting.
Therefore, this device is a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMI
Device Description
1 ml Sterile Hypodermic Syringe is 3-piece design. These 3 pieces are piston, plunger and barrel. The piston is made from isoprene rubber. Barrel is made from polypropylene. Plunger is made from polypropylene and polyethylene combination. Needle is made from stainless steel 304 grade and hub of needle is made from polypropylene. There are with or without needle configurations within this Special 510k submission. There are luer and luer-lock configurations within this special 510k submission. This special 510k submission only covers the 1ml syringe but several needle dimensions including 21Gx5/8", 23Gx1", and 25Gx1". The barrel marking scale interval is 0.1 ml and legible for all configurations covered by this Special 510k submission. Luer and Luer-lock have a 6% conical design. The barrel is transparent. The length (without needle), outside diameter are 99.30/100.2mm, 6.9/6.75 and 4.70/4.70, respectively for luer and luer-lock configurations. Intended users are medical professionals and trained caregivers. It is prescription use only.
It is EtO sterile and a single use device. Packaging combination is maintained from a transparent sterilization film and Tyvek paper appropriate to EtO sterilization.
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 to the patient.
The products covered in this special 510k are in compliance with ISO 10993-1 and ISO 7886-1.
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
Medical professionals and trained care givers / Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The sterile, hypodermic syringe 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
The sterile, hypodermic 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
Set Medikal Sanayi Ve Ticaret Anonim Sirketi % Mehmet Ormeci Consultant Medcer Uluslararasi Medikal Belgelendirme Anonim Sirketi Taspinar Mahallesi 2800. Caddesi A-2 Apt. No:6 B/49 Ankara. 06830 Turkey
Re: K210200
Trade/Device Name: 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: April 7, 2021 Received: April 16, 2021
Dear Mehmet 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.
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
1
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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Rumi Young Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210200
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) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image contains the logo for Ser Medikal. The logo consists of a blue square with a white "S" shape inside of it. To the right of the square is the text "ser medikal" in a sans-serif font.
Special 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 Esenyurt |
| İstanbul/TURKEY | |
| 510(k) Submitter Telephone No | +90-212-622-0400 |
| Primary Correspondent Contact Information | Mehmet Fatih Ormeci (Consultant) |
| +90-532-397-3043 | |
| mformeci@gmail.com | |
| Fax Number: +90 (212) 689 4 828 | |
| Summary Preparation Date | 05/12/2021 |
| Trade or
| Proprietary Name | Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock |
|---|---|
| Common Name | Hypodermic Syringe |
| Classification Name | Piston Syringe |
| Regulation Number | 21 CFR 880.5860 |
| Product Code | FMF, FMI |
| | Subject Device Special
510k No | Predicate Device 510k
No | Predicate Device
Manufacturer |
|-----------------------------------------------------------------------------------------|-----------------------------------|-----------------------------|----------------------------------------------------|
| Sterile Hypodermic
Syringe for Single use,
with/without needle;
luer/luer-lock | K210200/S002 | K201284 | SET MEDIKAL SANAYI
VE TICARET ANONIM
SIRKETI |
Indications for Use:
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.
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Image /page/4/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 on the left side of the image. To the right of the square is the text "SER MEDIKAL" in a gray, sans-serif font. The text is slightly stylized, with the letters having a modern, geometric appearance.
Special 510k Summary Piston Syringe: K210200/S002
| Syringe Size | Gauge | Length | Wall Type | Approval Number |
|---|---|---|---|---|
| 1mL | 21 | 5/8" | TW | K210200 Current |
| Submission | ||||
| 1mL | 23 | 1" | TW | |
| 1mL | 25 | 1" | RW | |
| 2mL | 20 | 1 1/2" | TW | |
| 2mL | 21 | 5/8" | TW | |
| 2mL | 22 | 1 1/4" | TW | |
| 2mL | 23 | 1 1/4" | TW | K201284 |
| 2mL | 25 | 1" | TW | |
| 2mL | 27 | 2" | RW | |
| 2mL | 27 | 1 1/2" | RW | |
| 2,5mL | 21 | 1 1/2" | TW | |
| 2,5mL | 21 | 5/8" | TW | |
| 2,5mL | 22 | 1 1/2" | TW | |
| 2,5mL | 22 | 1 1/4" | TW | |
| 2,5mL | 23 | 1 1/4" | TW | K201284 |
| 2,5mL | 25 | 1" | TW | |
| 2,5mL | 25 | 1" | RW | |
| 2,5mL | 27 | 1 1/2" | RW | |
| 2,5mL | 27 | 2" | RW | |
| 3mL | 21 | 1 1/2" | TW | |
| 3mL | 21 | 5/8 | TW | |
| 3mL | 22 | 1 1/4" | TW | |
| 3mL | 22 | 1 1/2" | TW | K201284 |
| 3mL | 23 | 1 1/4" | TW | |
| 3mL | 23 | 1" | TW | |
| 3mL | 25 | 1" | RW | |
| 5mL | 18 | 1 1/2" | TW | |
| 5mL | 20 | 1 1/2" | TW | |
| 5mL | 21 | 1 1/2" | TW | |
| 5mL | 21 | 5/8" | TW | |
| 5mL | 22 | 1 1/4" | TW | |
| 5mL | 22 | 1 1/2" | TW | |
| 5mL | 23 | 1 1/4" | TW | K201284 |
| 5mL | 23 | 1" | TW | |
| 5mL | 25 | 1" | RW | |
| Syringe Size | Gauge | Length | Wall Type | Approval Number |
| 10 ml | 18 | 1 1/2" | TW | K201284 |
| 20 | 1 1/2" | TW | ||
| 21 | 5/8" | TW | ||
| 21 | 1 1/2" | TW | ||
| 22 | 1 1/4" | TW | ||
| 22 | 1 1/2" | TW | ||
| 23 | 1" | TW | ||
| 23 | 1 1/4" | TW | ||
| 20 ml | 18 | 1 1/2" | TW | K201284 |
| 20 | 1 1/2" | TW | ||
| 21 | 5/8" | TW | ||
| 21 | 1 1/2" | TW | ||
| 22 | 1 1/4" | TW | ||
| 22 | 1 1/2" | TW | ||
| 23 | 1" | TW | ||
| 23 | 1 1/4" | TW | ||
| 50 ml | 15 | 1" | TW | K201284 |
| 16 | 1" | TW | ||
| 18 | 1 1/2" | TW | ||
| 19 | 1 1/2" | TW | ||
| 20 | 1 1/2" | TW | ||
| 21 | 5/8" | TW | ||
| 21 | 1 1/2" | TW | ||
| 23 | 1 1/4" | TW |
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Image /page/5/Picture/0 description: The image shows the logo for SER Medikal. The logo consists of a blue diamond shape with a white "S" inside of it. To the right of the diamond is the text "SER medikal" in a gray, sans-serif font.
Special 510k Summary Piston Syringe: K210200/S002
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Image /page/6/Picture/0 description: The image contains a logo for "Ser Medikal". The logo consists of a blue square with a stylized "S" inside it, followed by the text "Ser Medikal" in a gray, sans-serif font. The "S" in the square is also stylized and appears to be made up of multiple lines.
| Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock | |||
|---|---|---|---|
| ITEM | Legally Marketed Device / | ||
| Predicate Device | |||
| K201284 | Modified Device | ||
| (Adding New Size, 1ml) | Comparison | ||
| Product name | Sterile Hypodermic Syringe | ||
| for Single use, with/without | |||
| needle; luer/luer-lock | Sterile Hypodermic Syringe | ||
| for Single use, with/without | |||
| needle; luer/luer-lock | Same | ||
| Product code | FMF | FMF | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Indications for use | 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 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. | Same | ||
| Configuration | Piston | ||
| Plunger | |||
| Barrel | Piston | ||
| Plunger | |||
| Barrel | Same | ||
| Sterility condition | EO Sterilized | EO Sterilized | Same |
| Environment of use | Prescription use | Prescription use | Same |
| Intended users | Medical professionals and | ||
| trained care givers | Medical professionals and | ||
| trained care givers | Same | ||
| Single use | Yes | Yes | Same |
| 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 to the | |||
| patient. | 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 to the patient. | Same | ||
| Label/labeling | Complied with 21 CFR part | ||
| 801 | Complied with 21 CFR part | ||
| 801 | Same | ||
| Product | |||
| performance | Complied with | ||
| ISO 7886-1 | |||
| ISO 7864 | |||
| ISO 9626 | Complied with | ||
| ISO 7886-1 | |||
| ISO 7864 | |||
| ISO 9626 | Same | ||
| Volume | 2ml, 2,5ml, 3ml, 5ml, 6ml, 10ml, | ||
| 12ml, 20ml, 24ml, 50ml | 1ml | Difference 1 | |
| Sizes | 14G,15G,16G,18G,19G,20G, | ||
| 21G,22G,23G,24G,25G,26G,27G, | |||
| 28G,29G,30G | 21G, 23G, 25G | Same | |
| Needle Lengths | 4-50 mm | 4-50 mm | Same |
| Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock | |||
| ITEM | Legally Marketed Device / | ||
| Predicate Device | |||
| K201284 | Modified Device | ||
| (Adding New Size, 1ml) | Comparison | ||
| Patient contact component and material | |||
| Piston | Isoprene Rubber | Isoprene Rubber | Same |
| Barrel | PP | PP | Same |
| Plunger | PP/PE | PP/PE | Same |
| Needle | PP, SS304 | PP, SUS304 | Same |
| Sterilization | |||
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
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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 tilted at a 45-degree angle with a white stylized letter "S" inside. To the right of the square is the text "SER MEDIKAL" in a modern, sans-serif font, with the letters in a light gray color.
Device Description
1 ml Sterile Hypodermic Syringe is 3-piece design. These 3 pieces are piston, plunger and barrel. The piston is made from isoprene rubber. Barrel is made from polypropylene. Plunger is made from polypropylene and polyethylene combination. Needle is made from stainless steel 304 grade and hub of needle is made from polypropylene. There are with or without needle configurations within this Special 510k submission. There are luer and luer-lock configurations within this special 510k submission. This special 510k submission only covers the 1ml syringe but several needle dimensions including 21Gx5/8", 23Gx1", and 25Gx1". The barrel marking scale interval is 0.1 ml and legible for all configurations covered by this Special 510k submission. Luer and Luer-lock have a 6% conical design. The barrel is transparent. The length (without needle), outside diameter are 99.30/100.2mm, 6.9/6.75 and 4.70/4.70, respectively for luer and luer-lock configurations. Intended users are medical professionals and trained caregivers. It is prescription use only.
It is EtO sterile and a single use device. Packaging combination is maintained from a transparent sterilization film and Tyvek paper appropriate to EtO sterilization.
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 to the patient.
The products covered in this special 510k are in compliance with ISO 10993-1 and ISO 7886-1.
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Image /page/8/Picture/0 description: The image contains a logo for "ser medikal". The logo consists of a blue square with a stylized "S" inside it on the left side. To the right of the square is the text "ser medikal" in a gray, sans-serif font.
Special 510k Summary
Piston Syringe: K210200/S002
| Product Name | Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer lock | |||
|---|---|---|---|---|
| Instructions for use | 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. | ||||
| Volume | 1ml | |||
| Barrel Marking Specs (Scale interval) | 0.1ml | |||
| Tip type | Luer | ✓ | ||
| Luer lock | ✓ | |||
| Configuration | Barrel, plunger | ✓ | ||
| Piston, plunger, barrel | ✓ | |||
| Barrel | ||||
| Transparency | Transparent | ✓ | ||
| UV Resistant | - | |||
| Opaque | - | |||
| Needle (Needle configurations are mentioned in the | ||||
| hypodermic needle product description table) | With or without needle | |||
| Nozzle Type | Luer | Luer Lock | ||
| Length (without needle) | 99.30 | 100.2 | ||
| Diameter, Outside | 6.90 | 6.75 | ||
| Diameter, Inner | 4.70 | 4.70 | ||
| Plunger Material | PE | |||
| Barrel Material | PP | |||
| Piston Material | Isoprene rubber | |||
| Nozzle Type | Luer, Luer lock, 6% conical, 1,2mm | |||
| Lubricant Composition | Silicone | |||
| Sterility Condition | EO sterilized | |||
| Single Use | Yes | |||
| Environment of use | Prescription Use | |||
| Intended Users | Medical professionals and trained care givers | |||
| 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 to the patient. | |||
| Graduation Legibility | Legible | |||
| Endotoxin Limit | 20 EU per device | |||
| Biocompatibility | Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect) | |||
| SAL | 10-6 | |||
| Product Performance | Complied with ISO 7886-1 |
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Image /page/9/Picture/0 description: The image contains the logo for "ser medikal". The logo consists of a blue diamond shape with a stylized "S" inside it on the left. To the right of the diamond is the text "ser medikal" in a gray, sans-serif font.
| Product Name | Sterile Hypodermic needle for Single use | ||
|---|---|---|---|
| Sizes | 21G | 23G | 25G |
| Needle Lengths | $58$ " | 1" | 1" |
| (*): with 15 micron filter | |||
| Needle Bond Strength | Min. | ||
| 44N | Min. | ||
| 34N | Min. | ||
| 22N | |||
| Needle Cover Dimensions | $8×3$ | $8×3$ | $8×31$ |
| Needle Cover Strength | Min. 2N - max. 20N | ||
| Needle Cover Color | Transparent | ||
| Needle Tip Configuration | Back bevel needle | ||
| Configuration | Protective cap, Needle, Adhesives, Needle hub | ||
| Sterility Condition | EO sterilized | ||
| Single Use | Yes | ||
| Environment of use | Prescription Use | ||
| Intended Users | Medical professionals and trained care givers | ||
| 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 to the patient. | ||
| Graduation Legibility | Legible | ||
| Protective Cap Material | PP | ||
| Adhesive Material | Epoxy resin | ||
| Needle Hub Material | PP | ||
| Needle Material | PP (hub and cover), SUS304 Stainless Steel | ||
| Product Performance | Complied with ISO 7864, ISO 9626 | ||
| Endotoxin Limit | 20 EU per device | ||
| Biocompatibility | Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect) | ||
| SAL | 10-6 |
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Image /page/10/Picture/0 description: The image contains the logo for SER Medikal. The logo consists of a blue diamond shape with a white "S" inside of it. To the right of the diamond is the company name, "SER Medikal", in a gray, sans-serif font.
Modification Discussion
In this Special 510(k) submission, a new size: 1ml syringe luer/luer lock with or without needle is covered. The intended use, raw material, manufacturing site, sterilization method, sterilization site, packaging material is same with cleared device K201284.
Performance Testing
The sterile, hypodermic syringe 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
The sterile, hypodermic 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
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- 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
Conclusion
The differences between the cleared (predicate) and the modified device do not raise any new or different questions of safety or effectiveness since modified devices are tested in accordance with ISO 7886-1 standard. The subject devices are substantially equivalent to the predicate devices with respect to the indications for use, target populations, treatment method, and technological characteristics.