Revital Cady

• K Number: K231519
• Device Name: Revital Cady
• Manufacturer: Revital Healthcare (EPZ) Limited
• Date Cleared: 2023-11-06 ( 165 days)
• Product Code: FMF FMI
• Regulation Number: 880.5860

Intended Use

Auto-Disable Syringe is used to administer intramuscular / intravenous medicines or fixed dose immunization.

Device Description

The Revital Cady is an Auto Disable Fixed Dose Immunization Syringe. It is a three-piece Syringe having male 6% luer slip connection. The Syringe is supplied sterile with nonintegrated Needle having female 6% luer slip connection. The device is sterilized by ETO gas. lt is a disposable, single use and non-pyrogenic device. The Syringe is available in volume of 0.5ml and packed with a needle of 23G size. It is individually packed in blister pouch. The Syringe has an early activation auto disable feature. When the plunger is pulled back, it is connected to a stainless-steel clip inside the barrel and the auto-disable feature is activated at the start of dose administration. After completion of administration, the plunger is detached from the gasket by pulling back. The Syringe consist of four components i.e. 1. Barrel 2. Plunger 3. Gasket 4. S.S Clip The barrel is made of Polypropylene (PP) with graduated scale printed on its outer wall. The barrel has a nozzle with 6% male luer slip connector that facilitates the connection with the female luer slip connection of the needle. The graduated scale on barrel is indicated in millimetres. The plunger is a solid rod made of Polypropylene. It is used to draw fluid in and out of the barrel by pulling and pushing. The plunger has small rectangular holes on which a clip is fitted. The clip is made up of stainless steel and it is use to activate the auto disable feature. The gasket is made up of PTFE and fitted on top of the plunger. The Syringe is supplied with a Hypodermic Needle is made of three components i.e. 1. Needle tube 2. Needle hub 3. Needle cap The Needle is made up of stainless steel and bonded to the Needle hub by epoxy and UV glue. The hub and cap of the Needle is made of Polypropylene. The cap is used to protect the needle tip from damage as well as injury.

Predicate Devices

K210464, K211214

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a purely mechanical auto-disable syringe with no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The performance studies are focused on physical and biological properties, not algorithmic performance.

Therapeutic

No

The device is an Auto-Disable Syringe used to administer medicines or immunization, which is an administration device rather than a therapeutic one designed to treat a disease or condition.

Diagnostic

No

This device is an auto-disable syringe used to administer medicines or immunizations, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical syringe with multiple hardware components (barrel, plunger, gasket, clip, needle, hub, cap) and describes manufacturing processes (sterilization, packaging). There is no mention of software as a component or function of the device.

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 to "administer intramuscular / intravenous medicines or fixed dose immunization." This describes a device used for delivering substances into the body, which is a therapeutic or procedural use, not a diagnostic one.
• Device Description: The description details a syringe and needle designed for injection. There is no mention of the device being used to examine specimens derived from the human body for the purpose of providing information for diagnostic, monitoring, or compatibility purposes.
• Performance Studies: The performance studies focus on the physical and biological properties of the syringe and needle (e.g., ISO standards for syringes and needles, biocompatibility, sterilization). These are relevant to a device used for injection, not for in vitro diagnostic testing.

IVD devices are specifically designed to perform tests on samples taken from the body (like blood, urine, tissue) to diagnose diseases, monitor health, or determine compatibility. This syringe does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Auto-Disable Syringe is used to administer intramuscular / intravenous medicines or fixed dose immunization.

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

FMF, FMI

Device Description

The Revital Cady is an Auto Disable Fixed Dose Immunization Syringe. It is a three-piece Syringe having male 6% luer slip connection. The Syringe is supplied sterile with nonintegrated Needle having female 6% luer slip connection. The device is sterilized by ETO gas. It is a disposable, single use and non-pyrogenic device. The Syringe is available in volume of 0.5ml and packed with a needle of 23G size. It is individually packed in blister pouch.

The Syringe has an early activation auto disable feature. When the plunger is pulled back, it is connected to a stainless-steel clip inside the barrel and the auto-disable feature is activated at the start of dose administration. After completion of administration, the plunger is detached from the gasket by pulling back.

The Syringe consist of four components i.e.

1. Barrel
2. Plunger
3. Gasket
4. S.S Clip

The barrel is made of Polypropylene (PP) with graduated scale printed on its outer wall. The barrel has a nozzle with 6% male luer slip connector that facilitates the connection with the female luer slip connection of the needle. The graduated scale on barrel is indicated in millimetres.

The plunger is a solid rod made of Polypropylene. It is used to draw fluid in and out of the barrel by pulling and pushing. The plunger has small rectangular holes on which a clip is fitted. The clip is made up of stainless steel and it is use to activate the auto disable feature. The gasket is made up of PTFE and fitted on top of the plunger.

The Syringe is supplied with a Hypodermic Needle is made of three components i.e.

1. Needle tube
2. Needle hub
3. Needle cap

The Needle is made up of stainless steel and bonded to the Needle hub by epoxy and UV glue. The hub and cap of the Needle is made of Polypropylene. The cap is used to protect the needle tip from damage as well as injury.

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)

Non-clinical tests were conducted to verify that the proposed device met all design specifications, and is Substantially Equivalent (SE) to the predicate device and reference device. The device was tested in accordance with ISO 7886-3:2020, ISO 7886-1:2017, ISO 80369-7:2016, ISO 7864:2016, ISO 9626:2016 standards and results were found satisfactory. The device has also cleared all biocompatibility testing, sterility tests, bacterial endotoxin test, particulate contamination test, packaging & transit study, and EO residual test.
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.

K210464, K211214

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 shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.

November 6, 2023

Revital Healthcare (EPZ) Limited % Atonu Dutta CEO Alceon Medtech Consulting 1008, 10th Floor, "OCEAN", Sarabhai Compound Near Centre Square mall, Dr. V.S. Marg Vadodara, Gujarat 390007 India

Re: K231519

Trade/Device Name: Revital Cady Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: October 4, 2023 Received: October 10, 2023

Dear Atonu Dutta:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

1

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Juliane C. Lessard -S

Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors

2

OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K231519

Device Name REVITAL CADY

Indications for Use (Describe)

Auto-Disable Syringe is used to administer intramuscular / intravenous medicines or fixed dose immunization.

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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K231519 510(K) Summary

1. Submission Sponsor

Ankur Vora

(Director Operations/MR) Revital Healthcare (EPZ) Limited LR No. 5025/1239 Takaungu P.O. Box 80713-80100 Mombasa, Kenya Phone: [phone] Email: [e-mail]; [e-mail]

2. Primary Correspondent

Mr. Atonu Dutta (CEO, Alceon Medtech Consulting) 1008, 10th Floor, "OCEAN", Sarabhai Compound, Near Centre Square mall, Dr. V.S. Marg, Vadodara, Gujarat-390023, India. Phone: [phone] Email: [e-mail]

3. Date of preparing the summary

11/4/2023

4. Device Details

Table 1: Device details

Device name (Generic):	Hypodermic Auto Disable Syringe with Needle
Device name (Trade Name):	Revital Cady
Classification Regulation:	21 CFR 880.5860, 21 CFR880.5570
Device Class:	Class II
Product Code:	FMF, FMI
Panel:	General hospital

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5. Predicate Device

Table 2: Predicate Device

| Subject Device
Manufacturer | Subject Device | Primary Predicate
Device 510K | Secondary
Predicate
Device510K |
|----------------------------------------|--------------------------------------------------------------------|----------------------------------|--------------------------------------|
| Revital
Healthcare (EPZ)
Limited | Auto Disable Syringe with
Needle for Fixed Dose
Immunization | K210464 | K211214
(For Needle) |

6. Device Description

The Revital Cady is an Auto Disable Fixed Dose Immunization Syringe. It is a three-piece Syringe having male 6% luer slip connection. The Syringe is supplied sterile with nonintegrated Needle having female 6% luer slip connection. The device is sterilized by ETO gas. lt is a disposable, single use and non-pyrogenic device. The Syringe is available in volume of 0.5ml and packed with a needle of 23G size. It is individually packed in blister pouch.

The Syringe has an early activation auto disable feature. When the plunger is pulled back, it is connected to a stainless-steel clip inside the barrel and the auto-disable feature is activated at the start of dose administration. After completion of administration, the plunger is detached from the gasket by pulling back.

The Syringe consist of four components i.e.

• 1. Barrel
• 2. Plunger
• 3. Gasket
• 4. S.S Clip

The barrel is made of Polypropylene (PP) with graduated scale printed on its outer wall. The barrel has a nozzle with 6% male luer slip connector that facilitates the connection with the female luer slip connection of the needle. The graduated scale on barrel is indicated in millimetres.

6

The plunger is a solid rod made of Polypropylene. It is used to draw fluid in and out of the barrel by pulling and pushing. The plunger has small rectangular holes on which a clip is fitted. The clip is made up of stainless steel and it is use to activate the auto disable feature. The gasket is made up of PTFE and fitted on top of the plunger.

The Syringe is supplied with a Hypodermic Needle is made of three components i.e.

• 1. Needle tube
• 2. Needle hub
• 3. Needle cap

The Needle is made up of stainless steel and bonded to the Needle hub by epoxy and UV glue. The hub and cap of the Needle is made of Polypropylene. The cap is used to protect the needle tip from damage as well as injury.

Raw Materials:

Table 3: Raw Materials

Components	Material	Grade	CAS No.	Type of Body Contact
Syringe
Barrel	Polypropylene	RG568MO	9003-07-0	Indirect contact with blood path
Plunger	Polypropylene	RG568MO	9002-88-4	Indirect contact with blood path
Gasket	Thermoplastic elastomer	3250-01	66070-58-4	Indirect contact with blood path
Clip	Stainless Steel	SS304	-	No Contact
Needle
Needle tube	Stainless steel	SS304	Not applicable	Direct contact with blood path
Needle cap	Polypropylene	RG568MO	-	No contact
Needle hub	Polypropylene	RG568MO	-	No contact

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• Indication for use:

Auto – Disable Syringe is used to administer intramuscular / intravenous medicines or for fixed dose immunization.

7. Comparison to a predicate device

1. Comparison of Auto Disable Syringe to Predicate device

| Description | Subject Device
(K231519) | Primary Predicate Device
(K210464) | Comparison |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Product | Auto Disable Syringe with
Needle | Auto Disable Syringe | Same |
| Product code | FMF | FMF | Same |
| Regulation
Number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Indication for
Use | Auto - Disable Syringe is
used to administer
intramuscular /
intravenous medicines or
for fixed dose
immunization. | The AUTO DISABLE
SYRINGE is intended
for use in the suction and
injection of vaccine for
medical purposes.
Additionally, after injection
to the body, the plunger
can be automatically
locked by the triggered
mechanism to prevent the
re-use of this syringe. | Same |
| Technological Characteristics | | | |
| Configuration | Barrel
Plunger
Gasket
Clip | Barrel
Plunger
Gasket
Clip | Same |
| Materials | Barrel - Polypropylene
Plunger - Polypropylene
Gasket- Thermoplastic
Elastomer
Clip- Stainless Steel | Barrel - Polypropylene
Plunger - Polypropylene
Gasket- Polyisoprene
Rubber
Clip- Stainless Steel | Different 1 |
| Reuse
Prevention
(Safety) Feature | Auto - Disable, prevents
syringe re-use | Auto - Disable, prevents
syringe re-use | Same |
| Auto disable
feature
activation | Automatically Activate | Automatically Activate | |
| Type of Needle | Non-integrated | Integrated | Different 2 |
| Description | Subject Device
(K231519) | Primary Predicate Device
(K210464) | Comparison |
| Dose Setting /
Volumes | Fixed dose: 0.5 ml | 0.05ml, 0.10ml, 0.20ml,
0.25ml, 0.30ml, 0.40ml,
0.50ml, 1.0ml | Same
(Predicate
device have
some
additional
volume sizes
syringes) |
| Barrel
transparency | Transparent & Clear | Transparent & Clear | Same |
| Lubricant | Silicon Oil | Silicon Oil | Same |
| Biocompatibility | 1. Cytotoxicity
2. Sensitization
3. Irritation or
Intracutaneous
reactivity
4. Acute systemic
toxicity
5. Material mediated
pyrogenicity
6. Hemocompatibility | 1. Cytotoxicity
2. Sensitization
3. Irritation or
Intracutaneous
reactivity
4. Acute systemic
toxicity
5. Material mediated
pyrogenicity
6. Hemocompatibility | Same |
| Syringe
Performance | Complied with ISO 7886-3,
ISO 7886-1, ISO 9626, ISO
80369-7, ISO 7864 | Complied with ISO 7886-3,
ISO 7886-1, ISO 9626, ISO
7864 | Same |
| Sterilization
Method | EO Sterilized | EO Sterilized | Same |
| Single Use | Yes | Yes | Same |
| Shelf Life | 5 years | 5 years | Same |
| Labeling | Complies with 21 CFR Part
801 | Complies with 21 CFR Part
801 | Same |

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2. Comparison of Needle to Predicate Device

| Description | Subject Device
(K231519) | Secondary Predicate
Device
(211214) | Comparison |
|-----------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Class | Class II | Class II | Same |
| Indication for Use | Auto - Disable
Syringe is used to
administer
intramuscular /
intravenous | The sterile hypodermic
needles for single use
are intended to used
with a luer lock or luer
slip syringe and | Different |
| Description | Subject Device
(K231519) | Secondary Predicate
Device
(211214) | Comparison |
| | medicines or for
fixed dose
immunization. | injection devices for
general purpose fluid
injection/aspiration | |
| Regulatory number | 21 CFR Part 880.5570 | 21 CFR Part 880.5570 | Same |
| Product code | FMI | FMI | Same |
| Configuration | Needle Hub
Needle Cap
(Protective cover)
Needle | Needle Hub
Protective cover
Needle | Same |
| Materials | | | |
| Needle Hub | Polypropylene | Polypropylene | Different 4 |
| Needle | Stainless steel | Stainless steel | |
| Needle Cover | Polypropylene | Polypropylene | |
| Technical specification | | | |
| Needle gauge | 23 G | 30G, 27G, 26G, 25G,
24G, 23G,
22G, 21G, 20G, 19G,
18G | Same- (Predicate
device have some
additional gauge
sizes) |
| Nozzle type | Luer-Slip | Luer-lock/ Luer-Slip | Same- (Predicate
device has
additional nozzle
type) |
| Needle hub color | Deep Blue (Color
coded as per ISO
6009) | Color coded as per ISO
6009 | Same |
| Hub/needle bond
strength | Complies as per ISO
7864:2016 | Complies as per ISO
7864:2016 | Same |
| Needle performance | ISO 9626, ISO 80369-
7, ISO 7864 | ISO 9626, ISO 80369-7,
ISO 7864 | Same |

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Substantial Equivalence Discussion:

Different 1:

Thermoplastic Elastomer has a property of elasticity, low Young's modulus and high yield strain. They are permeable and at ambient temperature relatively soft and deformable. Their primary uses are for seals, adhesives, and molded flexible parts¹. However, the device is tested in accordance with ISO 7886-3:2020, ISO 7886-1:2017, ISO 80369-7:2016, ISO

10

7864:2016, ISO 9626:2016 standards and results were found satisfactory. The device has also cleared all biocompatibility testing. Considering these factors, the difference of material does not create any safety issue and would perform as intended. Hence, the difference can be considered acceptable.

Different 2:

The Hypodermic Auto Disable Syringe comes with integrated and non-integrated type of Needle. The performance of both type of Needle should comply to ISO 7886-3:2020 clause 12. The auto disable syringe manufactured by Revital Healthcare (EPZ) limited comes with non- integrated Needle. The non-integrated needle is tested according to ISO 7886-3:2020 clause 12, and results were found satisfactory. The device has also cleared other performance test required as per ISO 7886-3:2020, ISO 7886-1:2017, ISO 80369-7:2016, ISO 7864:2016, ISO 9626:2016 standards and results were found satisfactory. Considering these factors, the difference of type of Needle does not create any safety issue and would perform as intended. Hence, the difference can be considered acceptable.

Different 3:

The predicate device has an integrated needle, and the subject device has a non-integrated needle. To prove substantial equivalence of the subject device's non-integrated needle, the secondary predicate is selected. However, the subject device needle intends to be used with the subject device syringe only; therefore, the indications for use are considered the same for both the syringe and the needle. Additionally, the non-integrated needle was tested as per ISO 7886-3:2020, ISO 7864:2016, ISO 9626:2016, ISO 80369-7:2021 standard requirements, and the results met the acceptance criteria. Considering the difference of type of Needle does not create any safety issue and would perform as intended. Hence, the difference can be considered acceptable.

Different 4:

The material grade for the predicate device is unknown; therefore, it is considered different in comparison to Table 2. However, the subject device materials were tested for biocompatibility, and the results were acceptable. Considering these factors, the material difference creates no safety issue and the device would perform as intended. Hence, the difference can be considered acceptable.

8. Summary of non-clinical performance data

Non-clinical tests were conducted to verify that the proposed device met all design specifications, and is Substantially Equivalent (SE) to the predicate device and reference device.

STANDARDS	TEST PARAMETERS
-----------	-----------------

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| ISO 7886-1:2017 | ISO 7886-1 Second edition 2017-05 - Sterile hypodermic syringes for
single use - Part 1: Syringes for manual use |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 7886-3:2020 | ISO 7886-3 Second edition 2020-05 - Sterile hypodermic syringes for
single use - Part 3: Auto-disabled syringes for fixed-dose immunization |
| ISO 9626:2016 | ISO 9626 Second edition 2016-08-01 - Stainless steel needle tubing for
the manufacture of medical devices - Requirements and test methods |
| ISO 80369-7:2021 | ISO 80369-7 Second edition 2021-05 - Small-bore connectors for
liquids and gases in healthcare applications - Part 7: Connectors for
intravascular or hypodermic applications |
| ISO 7864:2016 | ISO 7864 Fourth edition 2016-08-01 - Sterile hypodermic needles for
single use - Requirements and test methods |
| USP | Sterility tests |
| USP | Bacterial endotoxin test |
| USP | Particulate contamination test |

Biocompatibility Test:

• Cytotoxicity, ISO 10993-5:2009
• Acute Systematic Toxicity, ISO 10993-11:2017
• Skin Sensitization, ISO 10993-10:2021 ●
• Intracutaneous Reactivity, ISO 10993-23:2021 ●
• Hemolysis (Direct & Indirect), ISO 10993-4:2017 & ASTM F756-17 0
• 0 Material Mediated Pyrogenicity

Packaging & Transits Study:

ISO 11607-1:2019 2nd edition - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems

ISO 11607-2:2019 2nd edition -Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing, and assembly processes

ASTM D4169-16 - Standard Practice for Performance Testing of Shipping Containers and Systems

Sterilization Test:

ISO 11135:2014/AMD 1:2018 2nd edition - Sterilization of health care products - Ethylene oxide - Requirements for development, validation, and routine control of a sterilization process for medical devices.

EO Residual Test:

ISO 10993-7:2008/Amd 1:2019 2nd edition- Biological evaluation of medical devices - Part 7:

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Ethylene oxide sterilization residuals, and it meets the requirements of the standard.

Bacterial Endotoxin Test:

The Bacterial endotoxin testing of subject devices was performed by the "Gel-Clot Method" and meets the requirement of USP .

9. Summary of clinical performance data

No clinical study is included in this submission.

10. Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.