Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical design and passive safety mechanism of a retractable syringe, with no mention of AI or ML.

Therapeutic

Yes
The device is a syringe intended for the administration of medications (intramuscular, intradermal, and subcutaneous injections), which are therapeutic uses.

Diagnostic

No

Explanation: The device is described as an automatically retractable safety syringe intended for the aspiration and injection of fluids, specifically for administering medications. Its purpose is to deliver substances, not to diagnose conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (syringe body, needle group, threaded connection, plunger) and a mechanical safety mechanism, indicating it is a hardware device. There is no mention of software as a component or function.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the device is for "aspiration of fluids and for the injection of fluids immediately after filling" and for the "administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC))". This describes a device used for administering substances into the body or withdrawing substances from the body, which is a direct interaction with the patient's body.
IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
Device Description: The description reinforces the intended use by detailing how the syringe and needle are assembled and used for injection/aspiration. It also highlights the safety mechanism for preventing needlestick injuries, which is relevant to direct patient interaction.
Lack of IVD Language: There is no mention of analyzing samples, diagnostic purposes, or any procedures performed on specimens outside the body.

Therefore, the SafeR® automatically Retractable Safety Syringe is a medical device used for administering or withdrawing fluids from the body, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting, Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in prevention of possible infection due to needlestick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand. SafeR Sting blunt fill needle is designed only for drug preparation and it is not in contact with human body. SafeR Syringe with SafeR Sting maintain standard injection techniques.

Product codes

MEG, FMI, FMF

Device Description

SafeR® (SafeR Syringe and SafeR Sting) is an automatically retractable safety syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids or for the injection of fluids immediately after filling.

SafeR® system is composed by a body syringe (SafeR Syringe) and a needle group (SafeR Sting). SafeR Syringe and SafeR Sting are 2 (two) products, packaged and sold separately, but designed to be coupled for use. Before use, the end user needs to assemble the body syringe and needle group through a clockwise rotation. Body syringe and needle group are connected by means of a threaded connection and conical mating surfaces between Screw Connector and Barrel. Geometry of the threaded connection was designed to ensure appropriate coupling only between SafeR Sting screw connector and SafeR Syringe barrel. Once assembled with its needle (SafeR Sting), incorporates a passive safety mechanism which retracts and contains the contaminated needle into a hollow stem of the plunger after use, aiding in the prevention of possible infections due to needle stick injuries and syringe reuse. Needle retraction is activated by the syringe user with one hand.

Its intended condition is sterile, single use, for hospital or home use.

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

hospital or home use.

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 tests (bench) were conducted to verify that SafeR Syringe and SafeR Sting meet all design specifications as is substantially equivalent (SE) to the predicate device. The test results and the comparison with predicate performances show that the subject product is substantially equivalent to the predicate device in performance.

Sterile barrier packaging testing were performed on the proposed device. The test results showed that the device package can maintain its integrity.

Sterilization testing per ISO 11135 and shelf-life testing were performed on the proposed device. EO residue and Endotoxin did not exceed the limits of relevant Standards. Shelflife test results showed that the device can maintain its performance during the claimed shelf life.

Biological evaluation for SafeR Syringe and SafeR Sting has been performed per ISO 10993-1 and all biological endpoints relevant for the biological safety assessment have been evaluated. The results of the biocompatibility testing confirm that SafeR Syringe and SafeR Sting are biocompatible in compliance for indirect blood path with limited contact duration were provided for both components.

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

Not Found

Predicate Device(s)

K132120

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 29, 2022

Roncadelle Operations srl Massimo Rossi Quality & Regulatory Manager Via Renolda 10 Castel Mella (Brescia), Lombardia 25030 Italy

Re: K221981

Trade/Device Name: SafeR Syringe and SafeR Sting Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG. FMI. FMF Dated: November 16, 2022 Received: December 1, 2022

Dear Massimo Rossi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the name Courtney Evans -S on the left side of the image. On the right side of the image, it says "Digitally signed by Courtney Evans -S Date: 2022.12.29 10:45:46 -05'00'". The image appears to be a digital signature.

For Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K221981

Device Name SafeR Syringe and SafeR Sting

Indications for Use (Describe)

SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting, Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in prevention of possible infection due to needlestick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand. SafeR Sting blunt fill needle is designed only for drug preparation and it is not in contact with human body. SafeR Syringe with SafeR Sting maintain standard injection techniques.

Type of Use (Select one or both, as applicable)
☑Prescription Use (Part 21 CFR 801 Subpart D)	☐Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(k) Summary K221981

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:

1. Submitter Information

| Company: | Roncadelle Operations srl
Via Renolda 10
Castel Mella (Brescia), Lombardia 25030
Italy
Telephone: + 39 030 672 4322 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Massimo Rossi
Quality & Regulatory Manager
Roncadelle Operations srl
Via Renolda 10
Castel Mella (Brescia), Lombardia 25030
Italy
Telephone: + 39 030 672 4322
massimo.rossi@roncadelle-operations.com |
| Date Summary Prepared: | December 27, 2022 |

2. Device Name and Classification

Trade Name:	SafeR Syringe and SafeR Sting
Common Name:	Safety syringe and retractable needle
Classification Name:	Syringe, Antistick
Review Panel:	General Hospital
Regulation:	880.5860
Class:	Class II
Product Code:	MEG, FMI, FMF

3. Predicate Device

The SafeR Syringe and SafeR Sting is equivalent to the WTF SECURA SYRINGE AND NEEDLE (K132120), manufactured by BEIJING WANTEFU MEDICAL APPARATUS Co., Ldt..

4

4. Indication for use

SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM). intradermal and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting. Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in prevention of possible infection due to needlestick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand. SafeR Sting blunt fill needle is designed only for drug preparation, and it is not intended to come in contact with human body. SafeR Syringe with SafeR Sting maintain standard injection techniques.

5. Device Description

SafeR® (SafeR Syringe and SafeR Sting) is an automatically retractable safety syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids or for the injection of fluids immediately after filling.

SafeR® system is composed by a body syringe (SafeR Syringe) and a needle group (SafeR Sting). SafeR Syringe and SafeR Sting are 2 (two) products, packaged and sold separately, but designed to be coupled for use. Before use, the end user needs to assemble the body syringe and needle group through a clockwise rotation. Body syringe and needle group are connected by means of a threaded connection and conical mating surfaces between Screw Connector and Barrel. Geometry of the threaded connection was designed to ensure appropriate coupling only between SafeR Sting screw connector and SafeR Syringe barrel. Once assembled with its needle (SafeR Sting), incorporates a passive safety mechanism which retracts and contains the contaminated needle into a hollow stem of the plunger after use, aiding in the prevention of possible infections due to needle stick injuries and syringe reuse. Needle retraction is activated by the syringe user with one hand.

Its intended condition is sterile, single use, for hospital or home use.

5

6. Substantial Equivalence Comparison

Substantial Equivalence Table
Characteristic	Proposed Device: SafeR Syringe
and SafeR Sting	Primary Predicate Device:
WTF SECURA SYRINGE
AND NEEDLE (K132120)	Same /Similar
/Different
Intended Use	SafeR® (SafeR Syringe and
SafeR Sting) is an automatically
Retractable Safety Syringe, it is
intended to provide a safe,
accurate and reliable method for
the aspiration of fluids and for the
injection of fluids immediately
after filling. It is intended to be
used for the administration of
medications (intramuscular (IM),
intradermal (ID) and
subcutaneous
(SC)). The syringe, once
assembled with its needle,
incorporates a passive safety
mechanism which retracts and
contains the contaminated needle
after use, aiding in the prevention
of possible infections due to
needle stick
injuries and syringe re-use.
Needle retraction is activated by
the syringe user with one hand.	The WTF Secura Syringe (with
needle) is used for aspiration of
fluids from vials and ampoules
and a variety of fluid injections
below the surface of the skin.
The WTF Secura Syringe (with
needle) has a manually
attached WTF Secura
Retracting Needle. The WTF
Secura Syringe (with needle)
contains an inner passive safety
mechanism used to allow the
WTF Secura Retracting Needle
to be retracted inside the
plunger rod of the syringe
when operator's thumb force
released. After activation the
needle is fully contained inside
the syringe guarding against
accidental needlesticks during
normal handling and disposal
of the used needle/ syringe
combination.	Similar
(Intended use of
subject device
falls within the
intended use of
predicate device)
Indication
for
Use	SafeR® is an automatically
Retractable Safety Syringe, it is
intended to provide a safe,
accurate and reliable method for
the aspiration of fluids and for the
injection of fluids immediately
after filling. It is intended to be
used for the administration of
medications (intramuscular (IM),
intradermal (ID) and
subcutaneous (SC)).
SafeR® system is provided in 2
separate parts: SafeR Syringe and
the needle group SafeR Sting.
Before use, the end user needs to
assemble syringe and needle
group.
The syringe, once assembled with
his needle, incorporates a passive
safety mechanism which retracts
and contains the contaminated
needle after use, aiding in
prevention of possible infection
due to needlestick injuries and
syringe re-use. Needle retraction
is activated by the syringe user
with one hand.
SafeR Sting blunt fill needle is
designed only for drug
preparation and it is not intended
to come in contact with human
body.
SafeR Syringe with SafeR Sting
maintain standard injection
techniques.	The WTF Secura Syringe (with Similar
needle) is used for aspiration of (Indication for use
fluids from vials and ampoules of subject device
anda variety of fluid injections
below the surface of the skin.
The WTF Secura Syringe (with
needle) has a manually
attached WTF Secura
Retracting Needle. The WTF
Secura Syringe (with needle)
contains an inner passive safety
mechanism used to allow the
WTF Secura Retracting Needle
tobe retracted inside the
plunger rod of the syringe
when operator's thumb force
released. After activation the
needle is fully contained inside
the syringe guarding against
accidental needlesticks during
normal handling and disposal
of the used needle/ syringe
combination.	falls within the
indication for use
of predicate
device)
Device
Configuration
and Materials	Barrel: Polypropylene
Plunger: Polypropylene
Plunger stopper: Lubricated
Isoprene rubber
Safety mechanism spring:
Stainless Steel
Needle hub and screw connector:
Polypropylene
Needle: stainless steel
Syringe and Needle Lubricant:
Silicone Medical	Barrel: Polypropylene
Plunger: Polypropylene
Plunger seal: Lubricated
Isoprene rubber
Safety mechanism spring:
Stainless Steel
Needle hub: Polypropylene
Needle: stainless steel
Syringe and Needle Lubricant:
Silicone Medical	Same
Syringe
Volume	SafeR Syringe and SafeR Sting
1/2/2.25/3/5 ml	Syringe volume: 1/2.5/3/5/10
ml	Similar (the
proposed device
has syringe
volumes
1/2/2.25/3/5 ml
that fall within the
volume range of
the predicate
device
(1/2.5/3/5/10 ml)
Syringe Design	Piston Syringe (Syringe Antistick)
with hypodermic single lumen
needle	Syringe Design: Piston Syringe
(Syringe Antistick) with
hypodermic single lumen
needle	Same
Needle Design	Tip Type: Tri-Beveled Tip
Needle tip configuration: Regular
point	Needle Design: Tri-Beveled
Tip	Same
Connection	Needle hub luer lock connector.
Needle & syringe separable	Needle hub luer lock
connector.
Needle & syringe separable	Same
Safety features	Passive safety feature, manually
activated by user	Passive safety feature,
manually activated by user	Same
Needle length
tolerances	Conform to ISO 7864	Conform to ISO 7864	Same
Needle system
colour coding	Conform to ISO 6009	Conform to ISO 6009	Same
Syringe
Dimension
characteristics	Barrel flanges sizes are adequate
to enable the syringe to be held
securely according to ISO 7886-1	Conform to ISO 7886-1	Same
Barrel
Transparency	Clear as required by ISO 7886-1	Clear as required by ISO 7886-
1	Same
Gradation
legibility	Legible as per ISO 7886-1
requirements	Conform to ISO 7886-1	Same
Tolerance
on
graduated
capacity	Conform to ISO 7886-1	Conform to ISO 7886-1	Same
Graduated
scale
characteristics	Conform to ISO 7886-1
requirements	Conform to ISO 7886-1	Same
Deliver
accuracy/
capacity	Conform to ISO 7886-1	Conform to ISO 7886-1	Same
Barrel
performances	Dead space lower than upper
specification given in ISO 7886-1;
Safer Syringes are free from air
and liquid leakage and there is no
plunger stopper detachment as per
ISO 7886-1 requirements	Conformity to ISO 7886-1
claimed	Same
Syringe limits
for acidity or
alkalinity and
for extractables
metals	When tested according to the
method described in ISO 7886-1
The pH value of distilled water
exposed to the finish syringe
product does not change more
than 1 unit and the overall content
of metals (lead, tin, zinc and iron)
does not exceed 5mg/kg	Conformity to ISO 7886-1 is
claimed	Same
Syringe
lubricant
amount	were provided for both components.

8. Substantial Equivalence Conclusion

SafeR Syringe and SafeR Sting were compared to the predicate device WTF SECURA SYRINGE AND NEEDLE. Based on the evidence collected, the substantial equivalence between SafeR Syringe and SafeR Sting and predicate device has been verified. Through functional performance testing the subject device has demonstrated substantial equivalence to the predicate device.