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, Piston, Plunger, Needle, Needle cover or protector.

AI/ML Overview

This document describes the acceptance criteria and study results for the "Insulin syringe with integrated needle DL®" (proposed device), demonstrating its substantial equivalence to a predicate device (Disposable Insulin Syringe, K162180).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from international standards (ISO series) and national standards (MGA, NOM). The "Specifications" column represents the acceptance criteria, and the "Insulin syringe with integrated needle DLPJECT®" column represents the reported device performance.

#	Test	Acceptance Criteria (Specifications)	Reported Device Performance ("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.	Insulin syringe with integrated needle. Syringe type 7. Capacity: 0.3 mL and 1 mL. Sterile and disposable.
2	Product description	Medical use article, disposable, sterile, pyrogen-free, non-reactive tissue materials. Must be sterile, non-toxic, pyrogen-free and non-reactive tissue.	Compliant (detailed description provided)
	Cylinder or barrel (clarity, lubrication, length, scale)	Enough clarity to see dosage and identify bubbles. Interior lubricated with medical grade silicone (no drops). Minimum length 79 mm. Insulin unit scale (min 57 mm). Graduation lines on longitudinal axis.	Compliant (detailed description provided)
	Graduation lines (length, numbering, appearance)	Longer lines for zero and every five lines (approx half length of zero). Zero starts at perimeter. Clear numbering (10, 20...100 U.). "U.I." and "U-100" at end. "mL" or "ml" for total capacity. "Not reusing" symbol. Numbers >= 3mm. Lines 0.2-0.4mm thick. Clear contrast.	Compliant (detailed description provided)
	Plunger	Operated inside cylinder/barrel. Protrusion at distal end prevents slipping. Piston assembled at opposite end. Plunger + piston length 88 x 2 mm.	Compliant (detailed description provided)
	Needle	Puncture device attached to syringe for liquid introduction. May have medical grade silicone coating.	Compliant (detailed description provided)
	Needle cover or protector	Medical grade plastic, perfectly covers needle, protects edge, avoids accidental punctures.	Compliant (detailed description provided)
3	Finish	Free of defects (burrs, bubbles, perforations, fractures, roughness, deformations, sharp parts, non-uniform thickness). Needle assembly firm and not separated by normal use.	Compliant (detailed description provided)
4	Dimensions	Volume (mL/cc): 0.3, 0.5, 1.0Scale division (ml): 5 U.I.Scale subdivision (ml): 1 U.I. (0.3/0.5ml), 2 U.I. (1.0ml)Min length of scale (mm): 41.0 (0.3ml), 43.0 (0.5ml), 57.0 (1.0ml)Max silicone mass (mg): Lubricant will not form fluid droplets on inner surface.	Compliant (values match specification)Compliant (values match specification)Compliant (values match specification)Compliant (values match specification)Compliant (matches specification)
	Scale tolerance (when ref line > 50% nominal capacity)	± 5% (0.3ml), ± 4% (0.5ml), ± 4% (1.0ml)	Compliant (values match specification)
5	Scale numbering	0.5 units (0.3ml), 1.0 units (0.5ml), 2.0 units (1.0ml)	Compliant (values match specification)
6	Scale position	Ends of similarly long graduation lines align vertically with barrel axis and each other (tolerance +0.5mm) when held vertically.	Compliant (matches specification)
7	Characteristics of the cylinder or barrel	Eyebrow/flange for finger support. Enough clarity. Lubricated with medical grade silicone (no drops). Useful capacity no less than 10% more than nominal capacity or 3mm plunger travel beyond scale mark (whichever is less).	Compliant (detailed description provided)
8	Flange	Syringe does not rotate more than 180° when placed on a flat surface with scale upwards at 10° from horizontal.	Compliant (matches specification)
9	Plunger and piston features	Plunger can be pushed by thumb when barrel is held with one hand. Plunger head has grooves to prevent slipping.	Compliant (matches specification)
10	Reference line	Defined, visible edge at piston end for capacity reference. In contact with inner surface of barrel.	Compliant (matches specification)
11	Dead space	Volume in barrel/cylinder and pivot when piston fully inserted: max 0.005 mL.	Compliant (matches specification)
12	Hypodermic Needle (Dimensions)	Gauge (G): 30, 31, 32Nominal external diameter (mm): 0.298-0.320 (30G), 0.254-0.266 (31G), 0.229-0.241 (32G)Minimum nominal inner diameter (mm): 0.133 (30G), 0.114 (31G), 0.089 (32G)Useful length: Needle length tolerance within ± 1.25 mm.Primary angle: 9° to 11°Color code: Orange for U-100	Compliant (values match specification)Compliant (values match specification)Compliant (values match specification)Compliant (matches specification)Compliant (matches specification)Compliant (matches specification)
13	Cannula adhesion (N)	Minimum joint resistance of needle tube with nominal external diameter < 0.33 should be 11 N.	Complies (matches specification)
14	Hermeticity	None of the syringes should leak.	Complies (matches specification)
15	Systemic injection	MGA-DM 3083. Passes the Test.	Passes the Test.
16	Intracutaneous reactivity	MGA-DM 3071. Passes the Test.	Passes the Test.
17	Pyrogens	MGA 0711 or MGA 0316 (Bacterial Endotoxins). Satisfies the test method.	Satisfies the test method.
18	Sterility	MGA 0381. Passes the Test.	Passes the Test.
19	Ethylene oxide residues	Complies with ISO 10993-7:2008, 4 mg maximum/24h.	Complies with ISO 10993-7:2008, 4 mg maximum/24h.
20	Acidity or alkalinity	MGA-DM 0001, Method II, Test compliance.	Test compliance.
21	Removable metal limit	Sample extract in total < 5 mg/L of lead, tin, zinc, iron. Cadmium content < 0.1 mg/L.	Complies (matches specification)
22	Product marking	Clear, legible, permanent characters: name, company name/symbol, nominal capacity (cm3 or ml), single graduated scale.	Complies (matches specification)
23	Label and counter-label NOM-137-SSA1-2008	Complies with NOM-137-SSA1-2008, Medical Device Labeling.	Complies with NOM-137-SSA1-2008.
24	Labeling of the primary Packaging / RIS health supplies regulation	Complies with the provisions of the Regulation of Inputs for Health. Second section. Labeling and packaging.	Complies with the provisions.
Biocompatibility Tests
Cytotoxicity (elution)	Reactivity grade: 0 - 2	Reactivity grade: 0 (None, Not cytotoxic)
Cytotoxicity (agar diffusion)	Reactivity grade: 0 - 2	Reactivity grade: 0 (None, Not cytotoxic)
Irritability	0 to 0.4: Not measurable	0.0: Not measurable
Sensitization	Grade 0: No visible change; Grade 1: Slight or irregular erythema; Grade 2: Moderate and confluent erythema; Grade 3: Intense erythema or swelling	Grade 0: No visible change
Systemic Toxicity	No significantly greater biological reaction than blank in treated animals.	No significantly greater biological reaction than blank in treated animals.
Pyrogens	For information only (sum of temperature increments).	Sum of temperature increments 0.26 °C; considered apyrogenic.
Acute toxicity	Saline solution extract of medical device must not show adverse clinical effects.	Saline solution extract did not show adverse clinical effects.
Subacute toxicity	Saline solution extract of medical device must not show adverse clinical effects.	Saline solution extract did not show adverse clinical effects.
Subchronic toxicity	Saline solution extract of medical device must not show adverse clinical effects.	Saline solution extract did not show adverse clinical effects.
Sterility
Sterilization method	Ethylene oxide (validated per ISO 11135-1.2015).	Ethylene oxide. Validated per ISO 11135-1.2015.
Pyrogens (ISO 10993-12)	Compliant with ISO 10993-12.	Compliant with ISO 10993-12.
Sterility Assurance Level (SAL)	10-6	Minimum SAL of 10-6.
Microbial Ingress (Sterile barrier)	Passes analytical test procedures.	Passes analytical test procedures.
Syringe air bubble leak (Sterile barrier)	Passes analytical test procedures.	Passes analytical test procedures.
Packaging Integrity	ASTM D4109-22: acceptable for protection and sterility.	Acceptable per ASTM D4109-22.
Shelf-life	Supported by real-time stability testing.	Real time stability testing supports shelf-life of years.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document extensively references international ISO standards (e.g., ISO 9626:2016, ISO 7864-1:2016, ISO 8537:2016, ISO 10993 series) and national standards (MGA, NOM-137-SSA1-2008, ASTM D4109-22). These standards typically specify the number of samples required for each test. For instance:

ISO 10993 (Biocompatibility): Tests like cytotoxicity, irritation, sensitization, acute, subacute, and subchronic toxicity, and pyrogenicity often involve in-vitro (cell cultures) or in-vivo (animal models like Wistar rats) testing with specific animal group sizes outlined in the respective ISO parts. For example, Pyrogens in Table 3 mentions "The sum of the temperature increments of the test animals is 0.26 °C so the sample is considered apyrogenic," implying in-vivo testing.
Physical/Performance Tests (e.g., Dimensions, Cannula adhesion, Hermeticity): These are typically performed on a statistically significant number of production samples according to the specific test methods outlined in the cited ISO standards. While exact numbers are not explicitly stated in this summary, the compliance with these standards implies that the required sample sizes were met.

The data provenance is not explicitly stated as "country of origin." However, the tests are conducted in accordance with international (ISO) and potentially national (MGA, NOM from Mexico, given the submitter's address) standards, suggesting these tests were performed in certified laboratories adhering to these guidelines. The studies appear to be prospective as they are testing the newly developed "Insulin syringe with integrated needle DL®" against established criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of medical device (insulin syringe) does not typically involve human expert "ground truth" establishment in the same way an AI diagnostic algorithm might. The "ground truth" for the performance and biocompatibility tests is based on objective measurements and established scientific protocols as defined by the international standards (ISO) and regulatory guidelines (MGA, NOM, ASTM). The "experts" involved would be the certified laboratory technicians and scientists performing these tests and interpreting the results against the defined specifications. Their qualifications would be in analytical chemistry, microbiology, toxicology, materials science, and medical device testing, following Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) principles. The number of such professionals is generally defined by the laboratory's quality system and standard operating procedures for each test.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in subjective assessments for diagnostic devices (e.g., radiologists reviewing images). For this type of device, which relies heavily on objective physical, chemical, and biological testing, traditional adjudication methods are not applicable. The "adjudication" is inherent in the test methodology itself:

Compliance with numerical specifications: If a measurement falls within the specified range, it passes.
Qualitative observations: For tests like "Finish" (absence of defects) or "Cytotoxicity" (reactivity grade), trained personnel make observations and record results based on predefined criteria in the standard. If a result is deemed "Non-cytotoxic" or "Passes the Test" according to the standard's interpretation guidelines, it meets the criterion.
The reporting of results as "Complies," "Passes the Test," or specific measurement within tolerance indicates that the results were directly compared to the acceptance criteria without a separate adjudication panel.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The "Insulin syringe with integrated needle DL®" is a physical medical device, not a diagnostic imaging or AI software product, so such a study would not apply.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone (algorithm-only) performance study was not done. This concept is also specific to AI/software as a medical device (SaMD) where an algorithm makes a determination independently. The device here is a physical syringe. Its "standalone" performance refers to its intrinsic physical and biological properties as tested against the standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device's evaluation is primarily established through:

International Standards and Regulatory Specifications: The core ground truth is defined by the detailed requirements and test methods of standards like ISO 9626, ISO 7864, ISO 8537, ISO 10993 series, MGA, NOM, and ASTM. These standards define acceptable material properties, dimensions, performance characteristics, and biological compatibility limits.
Objective Measurement and Analytical Testing: Laboratory tests provide objective data (e.g., dimensional measurements, force required for cannula adhesion, chemical residue levels, cell reactivity grades, animal physiological responses) which are quantitatively or qualitatively compared to the predefined acceptance criteria from the standards.
Biological Endpoints: For biocompatibility, endpoints like cell viability (cytotoxicity), skin reactions (irritation/sensitization), and animal physiological responses (pyrogenicity, acute/subchronic toxicity) serve as the ground truth indicators as interpreted against the ISO 10993 series.

8. The sample size for the training set

This device does not involve machine learning algorithms, thus there is no "training set" in the context of AI. The "training" in the manufacturing process refers to process validation and quality control, ensuring that the manufacturing process consistently produces devices meeting specifications. The exact numbers of units produced and tested during process validation are not provided, but they would be governed by internal quality systems and relevant manufacturing standards.

9. How the ground truth for the training set was established

As there is no AI training set for this physical device, this question is not applicable. The "ground truth" for the device's design and manufacturing process would refer to the adherence to verified design specifications, material inputs, and validated manufacturing procedures, all established through engineering principles, regulatory requirements, and quality management systems.

Summary

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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

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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

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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)

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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.

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.

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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.

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Presentations to be marketed. See Table 1.

Table 1

	Syringe volume	Needle gauge	Needle length	Graduated scale
Insulin syringe with integratedneedle DLPJECT®.	1 mL, 0.5 mL y 0.3 mL	30G, 31G y 32G.	4 mm, 6 mm, 8 mm y13 mm	0 a 30 units.0 a 50 units.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".

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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-toxic pyrogen free and non-reactive tissue. Must andor waste materials. Surfaces that come into contact with the administerediquids or with the patient's tissues must not be able to release that could dissolve or cause reactions with them.The product is composed of the following parts: Cylinder or barrel, with the body, piston, plunger, needle and needle coveror 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 themfrom slipping when the plunger is operated inside the end it allows the entry of a piston and at the opposite end theneedle is integrated. It has enough clarity to allow to see the destify possible ocuded bubbles in the liguid to betransferred. The interior of the cylinder or barrel is lubricated with medical grade silicone, which should not be rops. Thepivoted cylinder or barrel must have a minimum length of 79 mm. The cylinder or barrel must have in insulin units, the scalemust 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 shouldbe approximately half the length of the zero must start at the perimeter of the cylinder, at the end that has thereduction. Adjacent to the longest graduation line the corresponding number, (10,20,30,40,50 60, 70, 80 90 and 100 U.). At theend of the scale it must have adjacent to the indicates the value of the last graduation line, an " U.I.", which indicates that it insuinunits. Similarly, the text U-100 must be mentioned. At the scale should be pinted the abbreviation mL or ml, the total capacity of thesyringe in mL and the symbol of not reusing. The numbers must not be less than 3 mm. Graduation lines, numbers and units mustbe clearly defined, be uniformly thick between 0.2 and 0.4 mm, you are placed in planes perpendicular to the scale and scalenumbers 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 theuser's finger from sipping when operating the cylinder or barrel. At the opposite end, the piston is assembled. The plungerincluding 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 gradesilicone 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

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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-labelNOM-137-SSA1-2008	Complies with NOM-137-SSA1-2008, Medical Device Labeling.
24	Labeling of the primaryPackaging / RIS healthsupplies 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(elution)	According to ISO 10993,Biological Evaluation of medicaldevices. Part 5: Test for in vitrocytotoxicity.	Reactivity grade:0 - 2	Reactivity grade:0NoneDiscrete intracytoplasmicgranules, without cell lysis.Not cytotoxic
Cytotoxicity(agar diffusion)	According to ISO 10993,Biological Evaluation of medicaldevices. Part 5: Test for in vitrocytotoxicity.	Reactivity grade:0 - 2	Reactivity grade:0 NoneUndetectable zone around orbelow the sample.Not cytotoxic
¥ Irritability	In accordance with theInternational Standard ISO10993-10:2010, Biologicalevaluation of medical devices.Part 10: Test for irritation and skinsensitization, pp. 7 - 11.	0 to 0,4: Not measurable0,5 to 1,9: Slight2 to 4,9: Moderate5 to 8: Severe	0,0: Not measurable
¥ Sensitization	In accordance with theInternational Standard ISO	Grade 0:No visible change	Grade 0:No visible change

Table 3

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	10993-10:2010, Biologicalevaluation of medical devices.Part 10: Test for irritation and skinsensitization, pp.20 - 23.	Grade 1:Slight or irregular erythemaGrade 2:Moderate and confluent erythemaGrade 3:Intense erythema or swelling
Systemic Toxicity	According to ISO 10993-11 Thirdedition 2017-09 Biologicalevaluation of medical devicesPart 11: Tests for systemictoxicity	If during the observation periodnone of the animals treated withthe sample extract exhibits asignificantly greater biologicalreaction than the animals treatedwith the blank, the sample meetsthe test requirements.	During the observation periodnone of the animals treated withthe sample extract exhibited asignificantly greater biologicalreaction than the animals treatedwith the blank, the sample meetsthe test requirements.
Pyrogens	According to ISO 10993-12,Biological evaluation of medicaldevices - Part 12: Samplepreparation and referencematerials.	For information only	The sum of the temperatureincrements of the test animals is0.26 °C so the sample isconsidered apyrogenic
Acute toxicity	According to ISO 10993-12:2012.Biological evaluation of medicaldevices, Part 12: Samplepreparation andreference materials.	The saline solution extract of themedical device (insulin syringes)for 72±2h a 37±1°C must notshow adverse clinical effectsduring the acute toxicity study inmale Wistar rats.	The saline solution extract of themedical device (insulin syringes)for 72±2h a 37±1°C did not showadverse clinical effects during theacute toxicity study in male Wistarrats.

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Subacute toxicity	According to ISO 10993-11 Thirdedition 2017-09 Biologicalevaluation of medical devicesPart 11: Tests for systemictoxicity	The saline solution extract of themedical device (syringes forinsulin) for $72 \pm 2$ h at $37 \pm 1$ °Cdid not show adverse clinicaleffects during the subaqueoustoxicity study in male and femalerats of the Wistar strain.	The saline solution extract of themedical device (syringes forinsulin) for $72 \pm 2$ h at $37 \pm 1$ °Cdid not show adverse clinicaleffects during the subaqueoustoxicity study in male and femalerats of the Wistar strain.
Subchronic toxicity	According to ISO 10993-11 Thirdedition 2017-09 Biologicalevaluation of medical devicesPart 11: Tests for systemictoxicity.	The saline solution extract of themedical device (insulin syringes)for $72 \pm 2$ h at $37 \pm 1$ °C must notshow adverse clinical effectsduring the subchronic toxicitystudy in male and female rats ofthe Wistar strain.	The saline solution extract of themedical device (insulin syringes)for $72 \pm 2$ h at $37 \pm 1$ °C did notshow adverse clinical effectsduring the subchronic toxicitystudy in male and female rats ofthe Wistar strain.

Sterility

Sterilization method. Sterilization by ethylene oxide. Meets. ISO 10993-7:2008. Ethylene oxide residues: < 4 mg / 24 h < 4 mg / 24 h in compliance with ISO 10993-7: 2008. Ethylenenhydrin residues: < 9 mg / 24 h < 4 mg / 24 h in compliance with ISO 10993-7: 2008.

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(8) Identification of the predicated device

Predicated device:

Number 510 (k): K162180 Product name: Disposable Insulin Syringe Berpu Medical Technology Co., Ltd. (China)

Indication for use

Characteristics	Proposed Device"Insulin syringes with integrated needle DLPJECT®"	Predicate DeviceDisposable Insulin SyringeK162180
Indication for use	Disposable syringe for insulin administration, for thepatient with diabetes.	The disposable insulin syringe is designed for medical purposes formanual aspiration of Insulin 100 U and for the injection of insulin intoparts of the body below the surface of the skin.
Prescription Only orOver the counter	Prescription Use	Prescription Use

The indications for use statement for the subject device is similar to the predicate device.

There are only editorial differences to the indications for use statement between the subject device which do not change the indications.

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Substantial equivalence

Technological Characteristics

The technological characteristics of the Integrated needle DLPUECT® are similar to those of the predicate device. A summary of the differences between Insuin syringes with integrated needle DLPJECT® subject device and Disposable Insulin Syringe cleared under K162180 are outlined in table below.

GeneralInformation	Subject Device"Insulin syringes with integrated needleDLPJECT®"	Predicate Device:Disposable Insulin SyringeK162180	Comparison
Specific use drug	U-100 Insulins	U-100 Insulins	Same
Single Use Only	Yes	Yes	Same
Non-pyrogenic	Yes	Yes	Same
Sterilization	Ethylene oxide sterilization	Ethylene oxide sterilization	Same
SAL10-6	Yes	Yes	Same
Capacity	0.3mL, 0.5mL, 1.0mL	0.3mL, 0.5mL, 1.0mL	Same
Cannula GaugeSize(s)	30G, 31G, 32G	27G, 28G,29G, 30G, 31G	Different seeComment # 1
Mode of operation	Manual use	Manual use	Same

Bezel	Primary angle: 9° - 11°	Unknow	Different seeComment # 2
Operational Test	ISO 9626:2016ISO 7864-1:2016.ISO 8537:2016	Complies with:ISO 9626ISO 7864ISO 8536ISO 8537	Similar seeComment # 3

General	Subject Device	Predicate Device:	Comparison
Information	"Insulin syringes with integrated needle	Disposable Insulin Syringe
	DLPJECT®"	K162180Materials
Cannula(Needle)	SUS 304 stainless steel tube	Stainless Steel (SUS304)	Same
Protective end cap	Polypropylene RP250	Polypropylene (PP)	Same
Plunger	Polypropylene RP250	Polypropylene (PP)	Same
Barrel	Polypropylene RP250	Polypropylene (PP)	Same
Piston	Poly isoprene rubber	Polyisoprene Rubber	Same

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Protector dye	Orange concentrate 20342F		Unknow		Diferent
Silicone	Xiameter™ / PMX-200 Silicone Fluid 12500 cst		Unknow		In the predicate device, not
Scale Marking Ink	Solvent base ink used for polypropylene printing and SIB polymer resin		Unknow		all components are declared.See
Cannula Bonding Adhesive	Resin polymer 8E-13L		Unknow		Comment # 4
Needle Pavilion	Polypropylene RP250		Unknow
Plunger dye	Master batch white polyethylene base		Unknow
Biocompatibility	Test	Result	Test	Result
	Cytotoxicity (elution)	Reactivity grade:0NoneDiscreteintracytoplasmicgranules, without celllysis.Not cytotoxic	Cytotoxicity	Not cytotoxic	Similar.SeeComment # 5
	Cytotoxicity (agar diffusion)	Reactivity grade:0NoneUndetectable zonearound or below thesample.Not cytotoxic
	¥ Irritability	0,0: Not measurable	Irritation	No irritation reactivity
	¥ Sensitization	Grade 0:		No significant
	No visible change	Sensitization	evidence of skinsensitization
Systemic injection	During the observationperiod none of theanimals treated with thesample extract exhibiteda significantly greaterbiological reaction thanthe animals treated withthe blank, the samplemeets the testrequirements.	Systemic toxicity	No significantevidence of systemictoxicity
Pyrogens	The sum of thetemperature incrementsof the test animals is0.26 °C so the sampleis consideredapyrogenic	Pyrogens	No evidence ofpyrogens
Sterility	No microbial growth is

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	observed during the 14 days of incubation in the MFT or CST media.
Acute toxicity	The saline solution extract of the medical device (insulin syringes) for $72\pm2h$ a $37\pm1$ °C did not show adverse clinical effects during the acute toxicity study in male Wistar rats.
Subacute toxicity	The saline solution extract of the medical device (syringes for insulin) for $72 \pm 2$ h at $37 \pm 1$ °C did not show adverse clinical effects during the subaqueous toxicity study in male and female rats of the Wistar strain

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Image /page/18/Picture/0 description: The image shows the logo for DLP Medical Products, Corp. The logo features a caduceus symbol, which is a medical symbol with a staff and two snakes, on the left side. The text "DLP Medical Products, Corp." is written in a sans-serif font to the right of the symbol. The logo has a blue color scheme.

Subchronic toxicity	The saline solutionextract of the medicaldevice (insulin syringes)for $72 \pm 2$ h at $37 \pm 1$°C did not showadverse clinical effectsduring the subchronictoxicity study in maleand female rats of theWistar strain.
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There are no technological differences between and the predicate device except for the following: Cannula gauge size, bezel primary and some materials which are not declared in predicate device, there are similarities in operational and biocompatibility tests.

The intended use, principle of operations, and sterlizations, and sterlization information for the subject device.

Comment #1: Cannula Gauge Size differences.

The 32 G gauge is not offered in the predicate device and 27 G, 28 G and 29 G gauges are not offered in the proposed device.

The outer diamelers of the cannula offered in the been evaluated and the test results conforms to requirements the International Standard ISO 9626 (2016): Stainless steel needle tubine of medical devices. Requirements and test methods, for this reason, these new questions of safety or effectiveness.

Comment #2: Bezel primary angle differences

In the predicale device the bezel primary and device bezel primary ande was evaluated and the test results comply the SO 764:2016 Sterile hypodernic needles for since and test methods, therefore, the differences on configuration and materials does not affect substantially equivalence.

Comment #3: Operational test similarities

Both products are evaluated with the ISO 9626:2016, and ISO 8537:2016 standards, which demonstrate the functionally of the proposed device.

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This difference does not to affect the Substantialy (SE) belwen the proposed and predicate devices since all performance parameters were evaluated and demonstrated results in compliance with the standards.

Comment #4: Differences in some materials

The materials protective dye, cannula, lubrication, samula union, adhesive, needle, parilion, and dye plunger are not declared in the device predicae, so it is a difference between predicate device and subject device.

Based on the risk analysis caried out for the indication for use, user exposure time and the raw materials used for its manufacture were evaluated he biocompatibility tests carried out allow to demonstrate the biological safety of the product.

Some raw naterials of Insulin syrinces with integrated now predicate device. however, the biocompatibility for the subject device has been evaluated and the results comply with the requirements of ISO 10993. The differences does not raise new safety and efficacy issues.

Comment #5: Biocompatibility test similarities

The predicated device presented the following Iritation, Sensitization, Systemic toxicity, and Pyrogens. Both products were evaluated with the same biocompatibility tests and both products have similar performance, same exposure, and duration of contact time with the organism.

The biocompatibility tests of the product Integrated needle DL®, has been evaluated and the test results conforms to requirements the SO 10993-1, Biological evaluation of medical devices. These differences does not raise new safety and efficacy issues.

1. Substantial equivalence

Performance Testing:

The Insulin syringes with integrated neede DL® described in this summary were tested and demonstrated to be in contined standards:

ISO 9626:2016: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods

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ISO 7864-1:2016. Sterile hypodermic needles for single use — Requirements and test methods. ISO 8537:2016. Sterile single-use syringes, with or without needle, for insulin.

Biocompatibility testing

In accordance with ISO 1093-1, the device is classified as externally communicating with prolonged patient contact due to repeated use. The following Testing was conducted:

Cytotoxicity
Sensitization
Irritability
· Acute toxicity
Pyrogenicity
Systemic injection
Subacute and Subchronic Toxicity
· Particulate Testing, USP<788>

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Sterility, Shipping and Shelf-life

·The Insulin syringes with integrated needle DL®™s sterilization method is Ethylene oxide.

The sterlization method has been validated per ISO 11135-1.2015, which has thereby determined the routine control and monitoring parameters.

•The determinations of pyrogens carried out in accordance with the ISO 10993-12, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.

•Minimum Sterility Assurance Level of 10-6.

· Sterile barrier testing performed on the subject device:

-Microbial Ingress per analytical test procedures.
Syringe air bubble leak per analytical test procedures.

• Packaging Integrity Testing unditions were conducted to satisfy the requirements in ASTM D4109-22 Standard Practice for Performance Testing of Shipping Containers and Systems.

All packaging deemed acceptable for protection of product and sterility maintenance.

Real time stability testing has been conducted the sterility and performance of the Insuin syringes with integrated needle DL®" and is support shellified f years.

Clinical Test Summary

No clinical study is included in this submission.

203 S. ST. MARY'S ST., SUITE 160 SAN ANTONIO TEXAS 78205 USA.

ਹਰ

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Conclusion:

The difference in some materials of compration and sizes have been evaluated through non-clinical testing; the tests are in accordance with those established in the standards, ISO 9626: 2016, ISO 7864-1: 2016, ISO 8537:2016, and ISO 10993.

The differences between the predicate Insulin Syringe (K162180) and the subject device do not raise any new or different questions of safely or effectiveness. Performance testing data demonstrates is substantially equivalent with respect to the indications for use, target populations, and technological characteristics.

Regulation Number and Section

§ 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).