Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard mechanical insulin syringe and does not mention any AI or ML components or functionalities.

Therapeutic

No.
A therapeutic device is one that treats a disease or condition. This device is used to administer insulin, which is a therapeutic agent, but the syringe itself is a delivery mechanism, not a treatment.

Diagnostic

No

The device is a disposable syringe for insulin administration. Its intended use is to deliver medication, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (cylinder, piston, plunger, needle, etc.) made of medical grade plastic and stainless steel, and the performance studies focus on physical and biological properties, not software validation.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the administration of insulin to a patient with diabetes. This is a therapeutic action, delivering a substance into the body.
Device Description: The description details a syringe and needle, which are instruments used for injection.
Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are typically used to detect, measure, or identify substances or characteristics in samples like blood, urine, or tissue.

This device falls under the category of a medical device used for drug delivery, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Disposable syringe for insulin administration, for the patient with diabetes.

Product codes (comma separated list FDA assigned to the subject device)

FMF

Device Description

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
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

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K162180

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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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)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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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.

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.

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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.

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Presentations to be marketed. See Table 1.

Table 1

	Syringe volume	Needle gauge	Needle length
Insulin syringe with integrated
needle DLPJECT®.	1 mL, 0.5 mL y 0.3 mL	30G, 31G y 32G.	4 mm, 6 mm, 8 mm y
13 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 administered
iquids 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 cover
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
from slipping when the plunger is operated inside the end it allows the entry of a piston and at the opposite end the
needle is integrated. It has enough clarity to allow to see the destify possible ocuded bubbles in the liguid to be
transferred. The interior of the cylinder or barrel is lubricated with medical grade silicone, which should not be rops. The
pivoted cylinder or barrel must have a minimum length of 79 mm. The cylinder or barrel must have in insulin units, the scale
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
be approximately half the length of the zero must start at the perimeter of the cylinder, at the end that has the
reduction. Adjacent to the longest graduation line the corresponding number, (10,20,30,40,50 60, 70, 80 90 and 100 U.). At the
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
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
syringe in mL and the symbol of not reusing. The numbers must not be less than 3 mm. Graduation lines, numbers and units must
be clearly defined, be uniformly thick between 0.2 and 0.4 mm, you are placed in planes perpendicular to the scale and scale
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
user's finger from sipping when operating the cylinder or barrel. At the opposite end, the piston is assembled. The plunger
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
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

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		symbol of the manufacturer, nominal capacity in cm3 or ml and single graduated scale.
23	Label and counter-label
NOM-137-SSA1-2008	Complies with NOM-137-SSA1-2008, Medical Device Labeling.
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.

Biocompatibility.

The product meets the following biocompatibility tests. See Table 3.

Tests	Methodology	Specifications	Result
Cytotoxicity
(elution)	According to ISO 10993,
Biological Evaluation of medical
devices. Part 5: Test for in vitro
cytotoxicity.	Reactivity grade:
0 - 2	Reactivity grade:
0
None
Discrete intracytoplasmic
granules, without cell lysis.
Not cytotoxic
Cytotoxicity
(agar diffusion)	According to ISO 10993,
Biological Evaluation of medical
devices. Part 5: Test for in vitro
cytotoxicity.	Reactivity grade:
0 - 2	Reactivity grade:
0 None
Undetectable zone around or
below the sample.
Not cytotoxic
¥ Irritability	In accordance with the
International Standard ISO
10993-10:2010, Biological
evaluation of medical devices.
Part 10: Test for irritation and skin
sensitization, pp. 7 - 11.	0 to 0,4: Not measurable
0,5 to 1,9: Slight
2 to 4,9: Moderate
5 to 8: Severe	0,0: Not measurable
¥ Sensitization	In accordance with the
International Standard ISO	Grade 0:
No visible change	Grade 0:
No visible change

Table 3

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| | 10993-10:2010, Biological
evaluation of medical devices.
Part 10: Test for irritation and skin
sensitization, pp.20 - 23. | Grade 1:
Slight or irregular erythema
Grade 2:
Moderate and confluent erythema
Grade 3:
Intense erythema or swelling | |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Systemic Toxicity | According to ISO 10993-11 Third
edition 2017-09 Biological
evaluation of medical devices
Part 11: Tests for systemic
toxicity | If during the observation period
none of the animals treated with
the sample extract exhibits a
significantly greater biological
reaction than the animals treated
with the blank, the sample meets
the test requirements. | During the observation period
none of the animals treated with
the sample extract exhibited a
significantly greater biological
reaction than the animals treated
with the blank, the sample meets
the test requirements. |
| Pyrogens | According to ISO 10993-12,
Biological evaluation of medical
devices - Part 12: Sample
preparation and reference
materials. | For information only | The sum of the temperature
increments of the test animals is
0.26 °C so the sample is
considered apyrogenic |
| Acute toxicity | According to ISO 10993-12:2012.
Biological evaluation of medical
devices, Part 12: Sample
preparation and
reference materials. | The saline solution extract of the
medical device (insulin syringes)
for 72±2h a 37±1°C must not
show adverse clinical effects
during the acute toxicity study in
male Wistar rats. | The saline solution extract of the
medical device (insulin syringes)
for 72±2h a 37±1°C did not show
adverse clinical effects during the
acute toxicity study in male Wistar
rats. |

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| Subacute toxicity | According to ISO 10993-11 Third
edition 2017-09 Biological
evaluation of medical devices
Part 11: Tests for systemic
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. | 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. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subchronic toxicity | According to ISO 10993-11 Third
edition 2017-09 Biological
evaluation of medical devices
Part 11: Tests for systemic
toxicity. | The saline solution extract of the
medical device (insulin syringes)
for $72 \pm 2$ h at $37 \pm 1$ °C must not
show adverse clinical effects
during the subchronic toxicity
study in male and female rats of
the Wistar strain. | The saline solution extract of the
medical device (insulin syringes)
for $72 \pm 2$ h at $37 \pm 1$ °C did not
show adverse clinical effects
during the subchronic toxicity
study in male and female rats of
the Wistar strain. |

Sterility

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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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| Subchronic toxicity | The saline solution
extract of the medical
device (insulin syringes)
for $72 \pm 2$ h at $37 \pm 1$
°C did not show
adverse clinical effects
during the subchronic
toxicity study in male
and female rats of the
Wistar 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

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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.

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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.