Insulin syringe with integrated needle DL

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in two lines. DLP Medical Products, Corp. Luis Ernesto Paniagua Director of Operations 203 S. St. Mary's St., Suite 160 San Antonio, Texas 78205 February 9, 2023 Re: K203211 Trade/Device Name: Insulin syringe with integrated needle DL Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: February 2, 2023 Received: February 2, 2023 Dear Luis Ernesto Paniagua: 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 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 {1}------------------------------------------------ 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 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. Alan M. Stevens -S3 CAPT Alan M. 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) K203211 Device Name Insulin syringe with integrated needle DL® Indications for Use (Describe) Disposable syringe for insulin administration, for the patient with diabetes. 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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for DLP Medical Products, Corp. The logo features a blue circle on the left side with a white caduceus symbol inside. To the right of the circle is the text "DLP Medical Products, Corp." in blue font. The logo is clean and professional, suggesting a company in the healthcare industry. #### 510 (k) Summary This 510 (k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92 - (1) Date of preparation: January 20th, 2023 #### (2) Submitter: DLP Medical Products, Corp. 203 S. St. Mary's St., Suite 160 San Antonio Texas 78205 USA. Luis Ernesto De La Puente Paniagua, Operations Director +525543306265 ledelapuente@corporativodl.com.mx # (3) Identification of the proposed device Insulin syringe with integrated needle DL®. #### (4) Proposed Device | Trade name of the product: | Insulin syringe with integrated needle DL®. | |----------------------------|------------------------------------------------| | Classification: | Disposable sterile plastic syringe with needle | | | Class II | | Regulation No: | 21 CFR 880.5860 | | Product code: | FMF- Pistón siringe | | Review panel: | General Hospital | # (5) Predicate Device K162180 Disposable Insulin Syringe # (6) Description of the medical device. Insulin syringe with integrated extra thin stainless-steel needle and dead space less than 0.005 ml, made of medical grade plastic, sterile, disposable, pyrogen free and non-toxic. Sterilized by ethylene oxide. The product is composed of the following parts: Cylinder or barrel. Part of the syringe or flange that serves to support the user's fingers and prevent them from slipping when the plunger is operated inside the cylinder or barrel, at one end it allows the entry of a piston and at the opposite end it is reduced in a conical shape forming the pivot. It has enough clarity to allow to see the dosage without difficulty and to identify possible occluded bubbles in the liquid to transfuse. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for DLP Medical Products, Corp. The logo features a blue circle on the left side with a white caduceus symbol inside. To the right of the circle, the text "DLP Medical Products, Corp." is written in a blue, sans-serif font. Piston. Rubber portion that has two rings, one upper and one lower, which serves as an adjustment or hermetic seal against the walls of the cylinder or barrel. The piston does not disassemble during normal syringe use and slides easily into the cylinder or barrel. Plunger. The piston rod or guide, which is operated inside the cylinder or barrel, has a protrusion at the distal end with a finish that prevents the user's finger from slipping when operating the the cylinder or barrel. At the opposite end, a piston is assembled. Needle. Puncture device used attached to the syringe for the introduction of the liquid into the human body. May have a medical grade silicone coating. Needle cover or protector. Medical grade plastic piece with a design to perfectly cover the needle protecting the edge and avoiding accidental punctures. #### (7) Indications for use: Disposable syringe for insulin administration, for the patient with diabetes. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for DLP Medical Products, Corp. The logo features a blue circle on the left side with a white caduceus symbol inside. To the right of the circle, the text "DLP Medical Products, Corp." is written in blue font. Presentations to be marketed. See Table 1. Table 1 | | Syringe volume | Needle gauge | Needle length | Graduated scale | |-----------------------------------------------------|-----------------------|-----------------|-----------------------------|--------------------------------------------------| | Insulin syringe with integrated<br>needle DLPJECT®. | 1 mL, 0.5 mL y 0.3 mL | 30G, 31G y 32G. | 4 mm, 6 mm, 8 mm y<br>13 mm | 0 a 30 units.<br>0 a 50 units.<br>0 a 100 units. | The product needle: Insulin syringe with integrated needle DL®, conforms to the attributes set out in ISO 7864-1:2016. With regard to the product "Integrated needle DL®", conform to the attributes set out in ISO 8537:2016: "Sterile single-use syinges, with or without needle, for insulin". {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for DLP Medical Products, Corp. The logo features a blue circle on the left side with a white caduceus symbol inside. To the right of the circle, the text "DLP Medical Products, Corp." is written in blue font. # Table 2 | # | Tests | Specifications "Insulin syringe with integrated needle DLPJECT®". | | | |----|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------| | 1 | Product designation | Insulin syringe with integrated needle. Syringe type 7. Capacity: 0.3 mL and 1 mL. Sterile and disposable. | | | | | | Medical use article, disposable, sterile, pyrogen free, made non-reactive tssue materials. The article must be sterile, non-<br>toxic pyrogen free and non-reactive tissue. Must andor waste materials. Surfaces that come into contact with the administered<br>iquids or with the patient's tissues must not be able to release that could dissolve or cause reactions with them.<br>The product is composed of the following parts: Cylinder or barrel, with the body, piston, plunger, needle and needle cover<br>or protector. | | | | | | Cylinder or barrel with needle into the body. Part of the syringe of flange that serves to support the user's fingers and prevent them<br>from slipping when the plunger is operated inside the end it allows the entry of a piston and at the opposite end the<br>needle is integrated. It has enough clarity to allow to see the destify possible ocuded bubbles in the liguid to be<br>transferred. The interior of the cylinder or barrel is lubricated with medical grade silicone, which should not be rops. The<br>pivoted cylinder or barrel must have a minimum length of 79 mm. The cylinder or barrel must have in insulin units, the scale<br>must have a minimum length of 57 mm. Graduation ines must be the longitudinal axis of the barel or cylinder. | | | | 2 | Product description | Graduation lines. The graduation lines should be longer when the zero of the scale and every five lines should<br>be approximately half the length of the zero must start at the perimeter of the cylinder, at the end that has the<br>reduction. Adjacent to the longest graduation line the corresponding number, (10,20,30,40,50 60, 70, 80 90 and 100 U.). At the<br>end of the scale it must have adjacent to the indicates the value of the last graduation line, an " U.I.", which indicates that it insuin<br>units. Similarly, the text U-100 must be mentioned. At the scale should be pinted the abbreviation mL or ml, the total capacity of the<br>syringe in mL and the symbol of not reusing. The numbers must not be less than 3 mm. Graduation lines, numbers and units must<br>be clearly defined, be uniformly thick between 0.2 and 0.4 mm, you are placed in planes perpendicular to the scale and scale<br>numbers must be readable and of a color that clearly contrasts with the syringe. | | | | | | Plunger. The piston rod or guide, which is operated inside or barrel, has a protrusion at the distal end with a finish that prevents the<br>user's finger from sipping when operating the cylinder or barrel. At the opposite end, the piston is assembled. The plunger<br>including the piston should be 88 x 2 mm in length. | | | | | | Needle. Puncture device that is used to the syringe for the introduction of liquid to the human body. May have a medical grade<br>silicone coating. | | | | | | Needle cover or protector. Medical grade plastic piece with a design to perfectly cover the needle protecting the edge and avoiding accidental punctures. | | | | | | The parts that make up the product must be free of defects such as internal burrs, external burrs, bubbles, perforations, fractures, roughness, deformations, sharp parts and non-uniform thickness. In all cases the assembly with the hypodermic needle must be firm and not separated by the action of normal use of the article. | | | | 3 | Finish | | | | | 4 | Dimensions | | | | | | Volume or nominal capacity in mL/cc | 0.3 | 0.5 | 1.0 | | | Scale division in ml | 5 U.I. | 5 U.I. | 5 U.I. | | | Scale subdivision in ml | 1 U.I. | 1 U.I. | 2 U.I. | | | Minimum length of the scale in mm, up to the nominal capacity line | 41.0 | 43.0 | 57.0 | | | Maximum silicone mass in mg | If the inner surfaces of the syringe, including the plunger piston, are lubricated, the lubricant will not form fluid droplets on the inside surface of the syringe. | | | | | Scale tolerance. When the reference line coincides with any line on the scale that is greater than 50% of the nominal capacity, the percentage tolerance is set to: | $\pm$ 5% | $\pm$ 4% | $\pm$ 4% | | 5 | Scale numbering | 0.5 units | 1.0 units | 2.0 units | | 6 | Scale position | When the syringe is held vertically, the ends of all similarly long graduation lines will align vertically with the barrel axis and with each other, within a tolerance of + 0.5 mm. | | | | 7 | Characteristics of the cylinder or barrel | Part of the syringe with an eyebrow or flange that serves to support the user's fingers and prevent them from slipping when the plunger is operated inside the cylinder or barrel, at one end it allows the entry of a piston and at the opposite end the needle is integrated. It has enough clarity to allow the user to see the dosage without difficulty and to identify possible occluded bubbles in the liquid to be transferred. The interior of the cylinder or barrel is lubricated with medical grade silicone, which should not be observed in the form of drops. The length of the barrel is such that the syringe has a useful capacity of no less than 10% more than the nominal capacity or 3 mm of plunger travel beyond the scale mark. | | | | | | whichever is less. | | | | 8 | Flange | The end of the barrel or cylinder is fitted with a finger flange, which ensures that the syringe does not rotate more than 180° when placed on a flat | | | | | | surface and with the scale facing upwards, at an angle of 10º degrees from the horizontal. | | | | 9 | Plunger and piston | The design of the plunger and plunger head is such that when the barrel or cylinder is held with one hand, the plunger can be pushed by the | | | | | features | thumb of that hand The plunger head has grooves or other configuration such that it prevents the user's finger from slipping during injection. | | | | 10 | Reference line | There is a defined and clearly visible edge at the end of the piston that serves as a reference line to determine the capacity corresponding to any | | | | | | reading on the syringe scale. This line is in contact with the inner surface of the barrel or cylinder. This is verified immediately. | | | | 11 | Dead space | The volume of liquid contained in the barrel or cylinder and in the pivot when the piston is fully inserted complies with maximum 0.005 mL. | | | | 12 | Hypodermic Needle (Dimensions) | | | | | | Gauge (G) | 30 | 31 | 32 | | | Nominal external diameter | | | | | | (mm) | 0.298-0.320 | 0.254-0.266 | 0.229-0.241 | | | Minimum nominal inner | 0.133 | 0.114 | 0.089 | | | diameter (mm) | | | | | | Useful length | Needle length tolerance should be within ± 1.25 mm. | | | | | Primary angle | 9° a 11° | | | | | Color code | The colors used to identify the concentration of insulin will be as follows Orange for U-100 | | | | 13 | Cannula adhesion (N) | The minimum joint resistance of the needle tube with nominal external diameter less than 0.33 should be 11 N. | | | | 14 | Hermeticity | None of the syringes should leak. | | | | 15 | Systemic injection | MGA-DM 3083. Passes the Test. | | | | 16 | Intracutaneous reactivity | MGA-DM 3071. Passes the Test. | | | | 17 | Pyrogens | MGA 0711. This determination can also be carried out with the MGA 0316 method, Bacterial Endotoxins. In both cases it satisfies the test | | | | | | method. | | | | 18 | Sterility | MGA 0381. Passes the Test. | | | | 19 | Ethylene oxide residues | Complies with ISO 10993-7:2008, 4 mg maximum/24h | | | | 20 | Acidity or alkalinity | MGA-DM 0001, Method II, Test compliance | | | | 21 | Removable metal limit | MGA 0331. The sample extract shall not contain in total more than 5 mg/L of lead, tin, zinc and iron. The cadmium content in the extract will be | | | | | | less than 0.1 mg/L. | | | | 22 | Product marking | The marking on the syringe must be in clear, legible and permanent characters during use, and includes the following: name, company name or | | | 4 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for DLP Medical Products, Corp. The logo features a blue circle on the left side with a caduceus symbol inside. To the right of the circle is the text "DLP Medical Products, Corp." in a sans-serif font. 5 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for DLP Medical Products, Corp. The logo features a blue circle on the left side with a white caduceus symbol and the letters "DLP" in white. To the right of the circle, the text "Medical Products, Corp." is written in blue. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for DLP Medical Products, Corp. The logo features a blue circle on the left side with a white caduceus symbol inside. To the right of the circle, the text "DLP Medical Products, Corp." is written in blue font. | | | symbol of the manufacturer, nominal capacity in cm3 or ml and single graduated scale. | |----|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | 23 | Label and counter-label<br>NOM-137-SSA1-2008 | Complies with NOM-137-SSA1-2008, Medical Device Labeling. | | 24 | Labeling of the primary<br>Packaging / RIS health<br>supplies regulation | Complies with the provisions of the Regulation of Inputs for Health. Second section. Labeling and packaging. | #### Biocompatibility. The product meets the following biocompatibility tests. See Table 3. | Tests | Methodology | Specifications | Result | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Cytotoxicity<br>(elution) | According to ISO 10993,<br>Biological Evaluation of medical<br>devices. Part 5: Test for in vitro<br>cytotoxicity. | Reactivity grade:<br>0 - 2 | Reactivity grade:<br>0<br>None<br>Discrete intracytoplasmic<br>granules, without cell lysis.<br>Not cytotoxic | | Cytotoxicity<br>(agar diffusion) | According to ISO 10993,<br>Biological Evaluation of medical<br>devices. Part 5: Test for in vitro<br>cytotoxicity. | Reactivity grade:<br>0 - 2 | Reactivity grade:<br>0 None<br>Undetectable zone around or<br>below the sample.<br>Not cytotoxic | | ¥ Irritability | In accordance with the<br>International Standard ISO<br>10993-10:2010, Biological<br>evaluation of medical devices.<br>Part 10: Test for irritation and skin<br>sensitization, pp. 7 - 11. | 0 to 0,4: Not measurable<br>0,5 to 1,9: Slight<br>2 to 4,9: Moderate<br>5 to 8: Severe | 0,0: Not measurable | | ¥ Sensitization | In accordance with the<br>International Standard ISO | Grade 0:<br>No visible change | Grade 0:<br>No visible change | Table 3 {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for DLP Medical Products, Corp. The logo features a blue circle on the left side with a white caduceus symbol inside. To the right of the circle, the text "DLP Medical Products, Corp." is written in blue font. | | 10993-10:2010, Biological<br>evaluation of medical devices.<br>Part 10: Test for irritation and skin<br>sensitization, pp.20 - 23. | Grade 1:<br>Slight or irregular erythema<br>Grade 2:<br>Moderate and confluent erythema<br>Grade 3:<br>Intense erythema or swelling | | |-------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Systemic Toxicity | According to ISO 10993-11 Third<br>edition 2017-09 Biological<br>evaluation of medical devices<br>Part 11: Tests for systemic<br>toxicity | If during the observation period<br>none of the animals treated with<br>the sample extract exhibits a<br>significantly greater biological<br>reaction than the animals treated<br>with the blank, the sample meets<br>the test requirements. | During the observation period<br>none of the animals treated with<br>the sample extract exhibited a<br>significantly greater biological<br>reaction than the animals treated<br>with the blank, the sample meets<br>the test requirements. | | Pyrogens | According to ISO 10993-12,<br>Biological evaluation of medical<br>devices - Part 12: Sample<br>preparation and reference<br>materials. | For information only | The sum of the temperature<br>increments of the test animals is<br>0.26 °C so the sample is<br>considered apyrogenic | | Acute toxicity | According to ISO 10993-12:2012.<br>Biological evaluation of medical<br>devices, Part 12: Sample<br>preparation and<br>reference materials. | The saline solution extract of the<br>medical device (insulin syringes)<br>for 72±2h a 37±1°C must not<br>show adverse clinical effects<br>during the acute toxicity study in<br>male Wistar rats. | The saline solution extract of the<br>medical device (insulin syringes)<br>for 72±2h a 37±1°C did not show<br>adverse clinical effects during the<br>acute toxicity study in male Wistar<br>rats. | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for DLP Medical Products, Corp. The logo features a blue circle on the left side with a white caduceus symbol and the letters "DLP" in white. To the right of the circle, the text "Medical Products, Corp." is written in blue. | Subacute toxicity | According to ISO 10993-11 Third<br>edition 2017-09 Biological<br>evaluation of medical devices<br>Part 11: Tests for systemic<br>toxicity | The saline solution extract of the<br>medical device (syringes for<br>insulin) for $72 \pm 2$ h at $37 \pm 1$ °C<br>did not show adverse clinical<br>effects during the subaqueous<br>toxicity study in male and female<br>rats of the Wistar strain. | The saline solution extract of the<br>medical device (syringes for<br>insulin) for $72 \pm 2$ h at $37 \pm 1$ °C<br>did not show adverse clinical<br>effects during the subaqueous<br>toxicity study in male and female<br>rats of the Wistar strain. | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…