The Artiglass NRFit tip Glass Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard textbooks. These syringes are not intended for injection or aspiration.

Device Description

The Artiglass NRFit TM tip Glass Syringes provided not sterile with ISO 80369-6 (NRFit™) compliant fittings. They are available in 5mL and 10mL, lock and slip configurations and 5mL and 10mL lock configurations. The NRFit™ tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a borosilicate neutral with a graduated scale in milliliters (mL), a borosilicate neutral glass plunger and a nickel-plated brass tip. The plunger rod is amber colored to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the Artiglass NRFit™ Tip L.O.R. Glass Syringes. It is typically submitted to the FDA to demonstrate that a device is substantially equivalent to a predicate device already on the market. Such submissions generally focus on demonstrating equivalence through comparison of technological characteristics and performance testing based on established standards, rather than clinical trials with human subjects or complex AI model evaluation.

Therefore, the sections of your request related to AI model evaluation, multi-reader multi-case studies, expert consensus on ground truth, and separate training/test sets for AI are not applicable to this document. The document describes a physical medical device, not an AI/ML diagnostic or prognostic tool.

Here's an analysis of the provided text based on the elements that are applicable:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are generally defined by the relevant ISO standards. The document states that the testing "demonstrates the proposed devices conform to the applicable requirements" of these standards. While a detailed table with specific numerical results vs. criteria isn't provided, it indicates compliance.

Acceptance Criteria (Defined by ISO Standard) Type of Test	Requirement Defined in ISO 80369-6	Test Method Defined in ISO 80369-20	Reported Device Performance
Fluid leakage requirement	Clause 6.1.1	Annex B	Conforms to applicable requirements
Leakage by pressure decay	Clause 6.1.2	Annex B	Conforms to applicable requirements
Sub-atmospheric-pressure air leakage	Clause 6.2	Annex D	Conforms to applicable requirements
Stress Cracking	Clause 6.3	Annex E	Conforms to applicable requirements
Resistance to separation from axial load	Clause 6.4	Annex F	Conforms to applicable requirements
Resistance to separation from unscrewing	Clause 6.5	Annex G	Conforms to applicable requirements
Resistance to overriding	Clause 6.6	Annex H	Conforms to applicable requirements
Additional Tests (Referenced Standards)
Leakage between piston and barrel	per ISO 595-2		Conforms (implied by overall conclusion)
Ink adhesion (permanence of marking)	per ISO 595-2		Conforms (implied by overall conclusion)
Identification of burrs, hooks, cracks, foreign contamination, missing components	per visual inspection		Conforms (implied by overall conclusion)
Biocompatibility Compliance	ISO 10993 series, ASTM F756-17		Considered adequate based on predicate device testing; tests repeated for updated standards

2. Sample sizes used for the test set and the data provenance

The document does not specify exact sample sizes for each non-clinical test (e.g., how many syringes were tested for leakage). It mentions that "Connector testing performed on the proposed device," implying that a sample was used, but the specific number is not provided.

Data Provenance: The tests are non-clinical, meaning they are performed in a lab setting on the manufactured device, not using patient data. The country of origin of the data is implicitly the location where Artiglass Srl conducts its manufacturing and testing, which is Italy. The data is prospective in the sense that the testing is performed on the newly manufactured device to demonstrate its performance.

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

Not applicable. This is a physical device, and the "ground truth" for performance is established by objective measurements against engineering standards (ISO norms), not by expert interpretation of data like in an AI/ML context.

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

Not applicable, as no human experts are adjudicating "ground truth" in the context of device performance testing against objective standards.

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

Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is defined by the requirements and specifications within established international standards (e.g., ISO 80369-6, ISO 80369-20, ISO 595-2, ISO 10993 series). The device's performance is measured against these objective, predefined engineering and biocompatibility criteria.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

Summary

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May 19, 2022

Artiglass Srl Sabrina Baccarin Quality Director Via Piemonte 13 Due Carrare, Padova 35020 Italy

Re: K213800

Trade/Device Name: Artiglass NRFitTM Tip L.O.R. Glass Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QEH Dated: April 15, 2022 Received: April 21, 2022

Dear Sabrina Baccarin:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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, Sub part 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/cdrl-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,

Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental 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) K213800

Device Name Artiglass NRFit Tip L.O.R. Glass Syringes

Indications for Use (Describe)

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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X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Applicant:

Artiglass Srl via Piemonte 13, Due Carrare Padova. Italy

Contact Person:	Sabrina Baccarin
Contact Title:	Quality Director
Contact Phone Number:	+39 049 5290442
Contact Fax Number:	+39 049 5290446
E-mail:	regulatory@artiglass.it

Official Correspondent: same as Contact Person

Date Summary Prepared: April 15, 2022

Classification: 21 CFR § 880.5860, Class II Classification name: Piston Syringe Product Code: QEH Trade Names : Artiglass NRFit™ Tip L.O.R. Glass Syringes Generic/Common Name: NRFitTM Tip L.O.R. Glass Syringes

Predicate device

Predicate Device: Artiglass L.O.R. Glass Syringes 510(k) Number: K122416 510(k) Clearance Date: May 3, 2013 Regulation Number: 21 CFR § 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF

Indications for use

The Artiglass NRFit TM tip Glass Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard textbooks. These syringes are not intended for injection or aspiration.

Intended population

The syringe is intended for adult patient.

Product Description

Comparison of Technological Characteristics

The comparison table of technological characteristics is documented in the following table Predicate Device Comparison.

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Model	Special 510(k) ArtiglassNRFitTM Tip L.O.R. GlassSyringesSubject Device	510(k) ArtiglassL.O.R. GlassSyringes
	Subject Device	K122416
Product Code	QEH	FMF (1)
Common Name	Syringe, Piston	Same
Regulation Number	880.5860	Same
Regulation Description	Piston Syringe	Same
Submission Type	510(k) Special	510(k) Traditional
510(k) Number	NA	K122416
Intended Use	The Artiglass NRFit ™ tip GlassSyringe is intended for use, inconjunction with an epiduralneedle, to verify the needle tipplacement in the epidural spaceby the Loss of Resistancetechnique as explained instandard textbooks. Thesesyringes are not intended forinjection or aspiration. Thesyringe is intended for adultpatient.	Same
Reusable/Sigle use	Single use (7)	Reusable
Sterility	Provided not sterileThe non-sterile NRFit ™ syringeis intended to be sterilized priorto use to repackagers/medicaldevice manufacturers.	Same
Tip	NRFit ™ Connector, Luer Metaland Luer Lock	Luer Glass, LuerMetal and Luer Lock(2)
Tip material	Nickel plated brass	Same
Syringe Barrel	Borosilicate neutral glass	Same
Plunger	Borosilicate neutral glass	Same
Available Volumes	5 mL, 10 mL	Same
Model	Special 510(k) ArtiglassNRFitTM Tip L.O.R. GlassSyringesSubject Device	510(k) ArtiglassL.O.R. GlassSyringesK122416
Calibrated BarrelVolume	yes	Same
Recommendedsterilization method	Steam	Same
NRFit Connector	Yes; compliant with ISO80369-6	No; (2)
Package	Individually, in bulk	Same
BiocompatibilityCompliance	ISO 10993-1 Fifth edition 2018-08	ISO 10993-1 Fourthedition 2009-10-15(3)
	10993-4 Third edition 2017-04	ISO 10993-4:2002/amd 1:2006Hemocompatibility(Interaction withblood) (4)
	same	ISO 10993-5:2009
	same	ISO 10993-10:2010Irritation and skinsensitization
	10993-11 Third edition 2017-09	ISO 10993-11:2006Systemic toxicity(5)
Standard Compliance	ISO 595-1:1988, ISO 595-2:1987,ISO 80369-6:2016, ISO 80369-20:2015	ISO 594-1:1986, ISO594-2:1998,ISO 595-1:1988, ISO595-2:1987(6)

TABLE: Predicate Device Comparison

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K213800

SECTION 5 510 (K) Summary

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Discussions of differences in technological characteristics

(1) The Product code is different. The differences were addressed through ISO 80369-20 and performance testing.
(2) The tip of the subject device is specific. The differences were addressed through ISO 80369-20 performance testing.
(3) The differences were addressed through the "Artiglass NRFitTM Tip L.O.R. Glass Syringes Biological evaluation plan"
(4) The tests have been repeated according to 10993-4 Third edition 2017-04 and ASTM F756-17 (Hemolysis)
(5) The tests have been repeated according to 10993-11 Third edition 2017-09
(6) The differences were addressed through ISO 80369-6, ISO 80369-20 and ISO 7886-1 performance testing.
(7) The syringe is intended for a single use. This not affect the effectiveness and safety of the device itself.

Performance Testing in Support of Substantial Equivalence Determination

The performance of the subject Artiglass NRFitTM Tip L.O.R. Glass Syringes is demonstrated as tested per the applicable requirements of ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -Part 6: Connectors for neuraxial applications.

Non-Clinical Tests:

1. Leakage by pressure decay per ISO 80369-6
1. Sub-atmospheric-pressure air leakage per ISO 80369-6
1. Resistance to separation from axial load per ISO 80369-6
1. Resistance to separation from unscrewing per ISO 80369-6
1. Resistance to overriding per ISO 80369-6
1. Leakage between piston and barrel per ISO 595-2
1. Ink adhesion (permanence of marking) per ISO 595-2
1. Identification of burrs, hooks, cracks, foreign contamination, missing components per visual inspection
1. Fluid leakage requirement per ISO 80369-6
1. Stress Cracking per ISO 80369-6

Connector testing performed on the proposed device included the items listed below, in accordance with ISO 80369-6:2016, using the test methods provided in ISO 80369-20. The testing demonstrates the proposed devices conform to the applicable requirements of ISO 80369-6:2016

Individual test Defined in ISO 80369-6	Requirement Defined inISO 80369-6	Test Method Definedin ISO 80369-20
Fluid leakage requirement	Clause 6.1.1	Annex B
Leakage by pressure decay	Clause 6.1.2	Annex B
Sub-atmospheric-pressure air leakage	Clause 6.2	Annex D
Stress Cracking	Clause 6.3	Annex E
Resistance to separation from axial load	Clause 6.4	Annex F
Resistance to separation fromunscrewing	Clause 6.5	Annex G
Resistance to overriding	Clause 6.6	Annex H

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Even though the geometry of the tip is slightly different in the subject device manufactured by Artiglass, the results of the biocompatibility testing performed by Artiglass on the previously cleared syringe can be considered adequate also to assess the biocompatibility of the subject device.

The materials of the components of the test article are identical to the correspondent components of the subject medical device in its final finished form in formulation, processing, and no other chemicals have been added. No changes in material have occurred since the biocompatibility testing performed by the manufacturer on the predicate device Artiglass L.O.R. Glass Syringe. The tip shape does not pose new issues of biocompatibility as the test article represents a worst case in respect to the subject device.

Clinical and Animal Tests:

Clinical tests were not required to demonstrate performance of between the subject and predicate devices. Product functionality has been adequately assessed by nonclinical tests.

Conclusion:

The submitted and the predicate device have the same indications for use and technological characteristics. The test results and comparison results show that the proposed device is substantially equivalent to the predicate devices in performance, materials, intended use, technological and operational characteristics.

Based on the intended use, technological characteristics, and performance testing, the proposed Artiglass NRFitTM Tip L.O.R. Glass Syringes has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate device.

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).