Who is the manufacturer of SafeR Syringe and SafeR Sting?

Roncadelle Operations Srl filed the 510(k) submission for SafeR Syringe and SafeR Sting (K221981).

What is the FDA product code for SafeR Syringe and SafeR Sting?

MEG. It is classified under 21 CFR 880.5860 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for SafeR Syringe and SafeR Sting?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SafeR Syringe and SafeR Sting?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SafeR Syringe and SafeR Sting

Q: What are the predicate devices for SafeR Syringe and SafeR Sting?

WTF SECURA SYRINGE AND NEEDLE (K132120).

K221981 · Roncadelle Operations Srl · MEG · Dec 29, 2022 · General Hospital

Device Facts

Record ID	K221981
Device Name	SafeR Syringe and SafeR Sting
Applicant	Roncadelle Operations Srl
Product Code	MEG · General Hospital
Decision Date	Dec 29, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5860
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

SafeR® (SafeR Syringe and SafeR Sting) is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). The syringe, once assembled with its needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in the prevention of possible infections due to needle stick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand.

Device Story

SafeR system comprises a piston syringe and a separate needle group (SafeR Sting) assembled via threaded connection; intended for fluid aspiration and IM/ID/SC medication injection. Features passive safety mechanism; user-activated one-handed needle retraction into plunger hollow stem post-injection; prevents needlestick injuries and syringe reuse. Used in hospital or home settings by clinicians or patients. Output is the delivered medication dose; device design ensures standard injection techniques. Benefits include reduced risk of accidental needlestick injuries and prevention of reuse.

Clinical Evidence

Bench testing only. Testing included visual inspection, dimensional verification, pH, corrosion resistance, extractables, lubricant amount, needle point/bonding/penetration, volume/dead space, leakage (air/liquid), piston force, and safety feature activation per ISO 7886-1, ISO 7864, ISO 23908, and ISO 80369. Biocompatibility (ISO 10993), sterilization (ISO 11135), and shelf-life testing confirmed performance and safety. Usability evaluation conducted per EN 62366-1.

Technological Characteristics

Piston syringe with retractable needle. Materials: Polypropylene barrel/plunger/hub, lubricated isoprene stopper, stainless steel needle/spring, medical silicone lubricant. Luer lock connection. Sterile, single-use. Complies with ISO 7886-1 (syringe), ISO 7864 (needle), ISO 23908 (sharps protection), ISO 11135 (EO sterilization), and ISO 10993 (biocompatibility).

Indications for Use

Indicated for aspiration and injection of fluids (IM, ID, SC) in patients requiring medication administration. Contraindicated for use with the SafeR Sting blunt fill needle on the human body.

Regulatory Classification

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.

Predicate Devices

WTF SECURA SYRINGE AND NEEDLE (K132120)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 29, 2022 Roncadelle Operations srl Massimo Rossi Quality & Regulatory Manager Via Renolda 10 Castel Mella (Brescia), Lombardia 25030 Italy Re: K221981 Trade/Device Name: SafeR Syringe and SafeR Sting Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG. FMI. FMF Dated: November 16, 2022 Received: December 1, 2022 Dear Massimo Rossi: 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 {1}------------------------------------------------ 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, Image /page/1/Picture/5 description: The image shows the name Courtney Evans -S on the left side of the image. On the right side of the image, it says "Digitally signed by Courtney Evans -S Date: 2022.12.29 10:45:46 -05'00'". The image appears to be a digital signature. For Alan Stevens 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) K221981 Device Name SafeR Syringe and SafeR Sting #### Indications for Use (Describe) SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting, Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in prevention of possible infection due to needlestick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand. SafeR Sting blunt fill needle is designed only for drug preparation and it is not in contact with human body. SafeR Syringe with SafeR Sting maintain standard injection techniques. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><div>☑</div><div>Prescription Use (Part 21 CFR 801 Subpart D)</div></div> | <div style="display:flex; align-items:center;"><div>☐</div><div>Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> | #### 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." {3}------------------------------------------------ # 510(k) Summary K221981 The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary: ## 1. Submitter Information | Company: | Roncadelle Operations srl Via Renolda 10 Castel Mella (Brescia), Lombardia 25030 Italy Telephone: + 39 030 672 4322 | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Massimo Rossi Quality & Regulatory Manager Roncadelle Operations srl Via Renolda 10 Castel Mella (Brescia), Lombardia 25030 Italy Telephone: + 39 030 672 4322 massimo.rossi@roncadelle-operations.com | | Date Summary Prepared: | December 27, 2022 | # 2. Device Name and Classification | Trade Name: | SafeR Syringe and SafeR Sting | |----------------------|---------------------------------------| | Common Name: | Safety syringe and retractable needle | | Classification Name: | Syringe, Antistick | | Review Panel: | General Hospital | | Regulation: | 880.5860 | | Class: | Class II | | Product Code: | MEG, FMI, FMF | # 3. Predicate Device The SafeR Syringe and SafeR Sting is equivalent to the WTF SECURA SYRINGE AND NEEDLE (K132120), manufactured by BEIJING WANTEFU MEDICAL APPARATUS Co., Ldt.. {4}------------------------------------------------ ### 4. Indication for use SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM). intradermal and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting. Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in prevention of possible infection due to needlestick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand. SafeR Sting blunt fill needle is designed only for drug preparation, and it is not intended to come in contact with human body. SafeR Syringe with SafeR Sting maintain standard injection techniques. # 5. Device Description SafeR® (SafeR Syringe and SafeR Sting) is an automatically retractable safety syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids or for the injection of fluids immediately after filling. SafeR® system is composed by a body syringe (SafeR Syringe) and a needle group (SafeR Sting). SafeR Syringe and SafeR Sting are 2 (two) products, packaged and sold separately, but designed to be coupled for use. Before use, the end user needs to assemble the body syringe and needle group through a clockwise rotation. Body syringe and needle group are connected by means of a threaded connection and conical mating surfaces between Screw Connector and Barrel. Geometry of the threaded connection was designed to ensure appropriate coupling only between SafeR Sting screw connector and SafeR Syringe barrel. Once assembled with its needle (SafeR Sting), incorporates a passive safety mechanism which retracts and contains the contaminated needle into a hollow stem of the plunger after use, aiding in the prevention of possible infections due to needle stick injuries and syringe reuse. Needle retraction is activated by the syringe user with one hand. Its intended condition is sterile, single use, for hospital or home use. {5}------------------------------------------------ # 6. Substantial Equivalence Comparison | Substantial Equivalence Table | | | | |---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | Proposed Device: SafeR Syringe and SafeR Sting | Primary Predicate Device: WTF SECURA SYRINGE AND NEEDLE (K132120) | Same /Similar /Different | | Intended Use | SafeR® (SafeR Syringe and SafeR Sting) is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). The syringe, once assembled with its needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in the prevention of possible infections due to needle stick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand. | The WTF Secura Syringe (with needle) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin. The WTF Secura Syringe (with needle) has a manually attached WTF Secura Retracting Needle. The WTF Secura Syringe (with needle) contains an inner passive safety mechanism used to allow the WTF Secura Retracting Needle to be retracted inside the plunger rod of the syringe when operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needlesticks during normal handling and disposal of the used needle/ syringe combination. | Similar (Intended use of subject device falls within the intended use of predicate device) | | Indication for Use | SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting. Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in prevention of possible infection due to needlestick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand. SafeR Sting blunt fill needle is designed only for drug preparation and it is not intended to come in contact with human body. SafeR Syringe with SafeR Sting maintain standard injection techniques. | The WTF Secura Syringe (with Similar needle) is used for aspiration of (Indication for use fluids from vials and ampoules of subject device anda variety of fluid injections below the surface of the skin. The WTF Secura Syringe (with needle) has a manually attached WTF Secura Retracting Needle. The WTF Secura Syringe (with needle) contains an inner passive safety mechanism used to allow the WTF Secura Retracting Needle tobe retracted inside the plunger rod of the syringe when operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needlesticks during normal handling and disposal of the used needle/ syringe combination. | falls within the indication for use of predicate device) | | Device Configuration and Materials | Barrel: Polypropylene Plunger: Polypropylene Plunger stopper: Lubricated Isoprene rubber Safety mechanism spring: Stainless Steel Needle hub and screw connector: Polypropylene Needle: stainless steel Syringe and Needle Lubricant: Silicone Medical | Barrel: Polypropylene Plunger: Polypropylene Plunger seal: Lubricated Isoprene rubber Safety mechanism spring: Stainless Steel Needle hub: Polypropylene Needle: stainless steel Syringe and Needle Lubricant: Silicone Medical | Same | | Syringe Volume | SafeR Syringe and SafeR Sting 1/2/2.25/3/5 ml | Syringe volume: 1/2.5/3/5/10 ml | Similar (the proposed device has syringe volumes 1/2/2.25/3/5 ml that fall within the volume range of the predicate device (1/2.5/3/5/10 ml) | | Syringe Design | Piston Syringe (Syringe Antistick) with hypodermic single lumen needle | Syringe Design: Piston Syringe (Syringe Antistick) with hypodermic single lumen needle | Same | | Needle Design | Tip Type: Tri-Beveled Tip Needle tip configuration: Regular point | Needle Design: Tri-Beveled Tip | Same | | Connection | Needle hub luer lock connector. Needle & syringe separable | Needle hub luer lock connector. Needle & syringe separable | Same | | Safety features | Passive safety feature, manually activated by user | Passive safety feature, manually activated by user | Same | | Needle length tolerances | Conform to ISO 7864 | Conform to ISO 7864 | Same | | Needle system colour coding | Conform to ISO 6009 | Conform to ISO 6009 | Same | | Syringe Dimension characteristics | Barrel flanges sizes are adequate to enable the syringe to be held securely according to ISO 7886-1 | Conform to ISO 7886-1 | Same | | Barrel Transparency | Clear as required by ISO 7886-1 | Clear as required by ISO 7886- 1 | Same | | Gradation legibility | Legible as per ISO 7886-1 requirements | Conform to ISO 7886-1 | Same | | Tolerance on graduated capacity | Conform to ISO 7886-1 | Conform to ISO 7886-1 | Same | | Graduated scale characteristics | Conform to ISO 7886-1 requirements | Conform to ISO 7886-1 | Same | | Deliver accuracy/ capacity | Conform to ISO 7886-1 | Conform to ISO 7886-1 | Same | | Barrel performances | Dead space lower than upper specification given in ISO 7886-1; Safer Syringes are free from air and liquid leakage and there is no plunger stopper detachment as per ISO 7886-1 requirements | Conformity to ISO 7886-1 claimed | Same | | Syringe limits for acidity or alkalinity and for extractables metals | When tested according to the method described in ISO 7886-1 The pH value of distilled water exposed to the finish syringe product does not change more than 1 unit and the overall content of metals (lead, tin, zinc and iron) does not exceed 5mg/kg | Conformity to ISO 7886-1 is claimed | Same | | Syringe lubricant amount | < 0.25mg/cm2 as per ISO 7886-1 requirements | Conformity to ISO 7886-1 is claimed | Same | | Retractable Needles gauge and length | 20 G – 1" 1 ¼" and 1 ½" 21 G – 1" 1 ¼" and 1 ½" 22 G – 1" 1 ¼" and 1 ½" 23 G – 1" 1 ¼" and 1 ½" 25 G – 5/8" and 1" 26 G – 5/8" and 1" 27 G – ½" | 21 G – 1 1/8" and 1 ¼" 22 G – 1 ¼" and 1" 23 G – 1" 25 G – 1" 30 G 1" | Similar (The proposed device has a higher choice of needle lengths and gauges respect to the predicate device.) | | Dosing needle gauge and length | 18G - 1 ¼" | 18G - 1" | Similar | | Needle performances | In accordance with ISO 7864 requirements, needle point is sharp and free from defects, needle surface is smooth and free from defects and needle-hub bonding strengths are higher than the specification given in the standard | Conformity to ISO 7864 is claimed | Same | | Sharp Injury protection feature and reuse prevention feature performances | Conform to ISO 7886-4 and ISO 23908 | Conform to ISO 7886-4 (alleged compliance to ISO 23908 given the claimed compliance to 7886-1 in which it is stated "Syringes with integrated or add-on sharps protection shall comply with ISO 23908") | Same | | Primary Packaging barrier | Sterile barrier of primary packaging according to ISO 11607 1/2 | Sterile barrier of primary packaging according to ISO 11607 1/2 | Same | | Biocompatibilit y | Conform to ISO 10993 | Conform to ISO 10993 | Same | | Sterilization | SAL 10-6 EO sterilization according to ISO 11135 | SAL 10-6 EO sterilization according to ISO 11135 | Same | | Ethylene Oxide residuals | Conform to ISO 10993-7 | Conform to ISO 10993-7 | Same | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ # 7. Non-Clinical Performance Testing Table below summarizes the purpose of each test performed and the reference standard requirements. | Test | Ref. Standard requirements | |--------------------------------------------|---------------------------------------------------| | Syringe Visual Inspection | ISO 7886-1:2017 ISO 7864:2016 ISO 9626:2016 | | Dimensional Verification | ISO 7886-1:2017 ISO 7864:2016 | | Syringe pH verification | ISO 7886-1:2017 | | Needle pH verification | ISO 7864:2016 | | Corrosion resistance | ISO 9626:2016 | | Extractables Metals | ISO 7886-1:2017 | | Lubricant amount | ISO 7886-1:2017 ISO 7864:2016 ISO 9626:2016 | | Needle point | ISO 7864:2016 | | Needle outer surface | | | Needle bonding strength | ISO 7864:2016 | | Needle Penetration and Drag Force | | | Volume Verification and Dead Space | | | Air Leakage | ISO 7886-1:2017 | | Piston operating force | | | Liquid Leakage | | | Sharp Injury protection feature activation | ISO 23908:2011 ISO 7886-4:2018 | | Access the device in the safe mode | ISO 23908:2011 | | Positive pressure Liquid leakage | | | Sub-atmospheric pressure air leakage | ISO 80369-7:2021 | | Resistance to separation from axial load | ISO 80369-20:2015 | | Resistance to separation from unscrewing | | | Usability Test | EN 62366-1:2020 | {10}------------------------------------------------ | Health Care Workers SafeR Usability Evaluation | | |------------------------------------------------|-----------------------------------------------------| | Visual Inspection for Packaging | ASTM F1886/F1886M-16 | | Bubble leak test | UNI EN ISO 11607-1:2021, ASTM F2096-11 (2019) | | Peeling strength seal bond…

SafeR Syringe and SafeR Sting

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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SafeR Syringe and SafeR Sting

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Indications for Use

Device Story

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Technological Characteristics

Indications for Use

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Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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