(109 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.
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.
This is a 510(k) premarket notification for a medical device (Sterile Hypodermic Syringe for Single Use) and not a study on an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design for AI/ML, expert adjudication, MRMC studies, standalone performance, ground truth establishment, and training set details are not applicable as they relate to AI/ML device evaluations.
The document indicates that the device's performance was evaluated against recognized international standards. It states that the device complies with:
- ISO 7886-1: Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- ISO 7864: Sterile hypodermic needles for single use — Requirements and test methods
- ISO 9626: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 10993-4: Biological Evaluation of Medical Devices — Part 4: Selection of Tests for Interactions with Blood
- ISO 10993-5: Biological Evaluation of Medical Devices — Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10: Biological Evaluation of Medical Devices — Part 10: Tests for Irritation and Skin Sensitization
- ISO 10993-11: Biological Evaluation of Medical Devices — Part 11: Tests for Systemic Toxicity
The purpose of this submission is to demonstrate substantial equivalence to a predicate device (K201284) by adding a new size (1ml syringe). The conclusion states that the differences do not raise new questions of safety or effectiveness because the modified devices were tested in accordance with ISO 7886-1.
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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
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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
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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 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 | 05/12/2021 |
| Trade orProprietary 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 Special510k No | Predicate Device 510kNo | Predicate DeviceManufacturer | |
|---|---|---|---|
| Sterile HypodermicSyringe for Single use,with/without needle;luer/luer-lock | K210200/S002 | K201284 | SET MEDIKAL SANAYIVE TICARET ANONIMSIRKETI |
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 CurrentSubmission |
| 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 DeviceK201284 | Modified Device(Adding New Size, 1ml) | Comparison |
| Product name | Sterile Hypodermic Syringefor Single use, with/withoutneedle; luer/luer-lock | Sterile Hypodermic Syringefor Single use, with/withoutneedle; 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 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 canbe pulled 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 | 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 DeviceK201284 | 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 | ✓ | |||
| BarrelTransparency | Transparent | ✓ | ||
| UV Resistant | - | |||
| Opaque | - | |||
| Needle (Needle configurations are mentioned in thehypodermic 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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Image /page/11/Picture/0 description: The image contains the logo for "ser medikal". The logo consists of a blue, stylized letter "S" enclosed in a diamond shape, followed by the text "ser medikal" in a gray, sans-serif font. The logo is simple and modern, with a focus on the company's name.
- 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.
§ 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).