The Artiglass LOR 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 medical textbooks. These syringes are not intended for injection or aspiration.

Device Description

Artiglass L.O.R. Glass Syringe is glass syringe similar to that of a standard piston syringe. It 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. The Artiglass L.O.R. Glass Syringe is provided not sterile, in bulk form to other manufacturers as part of an epidural insertion trays as a component to the epidural kit. The syringe may be sterilized before use and it can be re-sterilized via Autoclave. Artiglass L.O.R. Glass Syringe is intended to be used only by qualified personnel. This syringe is not intended for injection or aspiration. The Artiglass L.O.R. Glass Syringe is available in volume of 5ml and 10 ml.

AI/ML Overview

The Artiglass L.O.R. Glass Syringe is a medical device designed to verify needle tip placement in the epidural space using the Loss of Resistance technique.

1. Acceptance Criteria and Reported Device Performance:

Item#	Performance Specification	Reported Device Performance (Status of Artiglass L.O.R. Glass Syringes)
1	ISO 594/1 Conical fitting with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements	Complying
2	ISO 595/1 Reusable all-glass or metal-and-glass syringes for medical use - Part 1: Dimensions	Complying
3	ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings	Complying
4	ISO 595-2 First Edition 1987-12-15 Reusable all-glass or metal-and-glass syringes for medical use - Part 2: Design, performance requirements tests	Complying
N/A	Operating principle similar to predicate device	Operates under the same operating principle as the predicate device.
N/A	Dimensions and component characteristics similar to predicate device	Is similar in dimension and component characteristics to the predicate device.
N/A	Glass luer tip and metal luer tip similar to predicate device	Has similar glass luer tip and metal luer tip of the predicate device.
N/A	Luer lock connector similar to predicate device	Has a similar luer lock connector as the predicate device.
N/A	Supplied non-sterile as predicate device	Is supplied not sterile as the predicate device.
N/A	Meets the requirements of ISO 14971:2009 (Risk management for medical devices)	Meets the requirements of ISO 14971:2009, as applicable to the intended use of the device.
N/A	Meets the requirements of ISO 10993 (Biological evaluation of medical devices)	Meets the requirements of ISO 10993 as applicable to the intended use, description and technological characteristics of the device.
N/A	Equivalent performance to the predicate device during design verification testing	Demonstrates equivalent performance to the predicate device during design verification testing.

Study Details Proving Device Meets Acceptance Criteria:

The device's performance was evaluated through Design Verification tests, which included bench and animal testing. The study was designed to assess the safety and effectiveness of the Artiglass L.O.R. Glass Syringes for their stated indications for use.

2. Sample Size and Data Provenance:

Test Set Sample Size: Not explicitly stated in the provided text. The document mentions "Design Verification tests" and "bench and animal testing" but does not quantify the sample sizes for these tests.
Data Provenance: Not explicitly stated. The manufacturer is Artiglass S.r.l. in Italy, suggesting the study likely originated there, but this is not confirmed. The study appears to be prospective in nature, as it involved performing new tests ("Design Verification tests were performed").

3. Number of Experts and Qualifications:

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The study discusses compliance with international standards (ISO), which implies review by qualified personnel, but individual expert qualifications are not detailed.

4. Adjudication Method:

Adjudication Method: Not applicable or not specified. This type of device (syringe) undergoes compliance testing against technical standards and direct performance assessment rather than a human-driven subjective assessment requiring adjudication (like image interpretation).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No. This is not an AI-assisted diagnostic device, but rather a physical medical instrument. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.

6. Standalone Performance (Algorithm Only):

Standalone Performance: Not applicable. This is a physical medical device, not an algorithm, so a standalone algorithm performance evaluation would not be relevant.

7. Type of Ground Truth Used:

Type of Ground Truth: The ground truth for this device is based on compliance with established international standards (ISO standards) for syringes and medical equipment, as well as direct performance assessment through bench and animal testing to ensure the device functions as intended and safely. This is not a diagnostic device relying on expert consensus or pathology for ground truth.

8. Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This is a physical medical device, not a machine learning algorithm, so there is no "training set."

9. How Ground Truth for the Training Set Was Established:

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

Summary

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K 122416

Artiglass S.r.l.

MAY 0 3 2013

Artiglass L.O.R. Glass Syringe 510 (k) Summary

Submitted by:

Federico Baccarin (Managing Director) Artiglass S.r.I. Via Piemonte 13, Due Carrare, Padova, 35020 Italy. Tel: +39 0495290442 Fax: +39 0495290446

Date of submission:

April 29, 2013

Device name:

Trade name: Common name: Classification: Product Code:

Artiglass L.O.R. Glass Syringes Syringe, Piston Class II, 21 CFR 880.5860 FMF

Predicate device:

Trade name: Manufacturer: 510(K) Number: Spectra, LOR GLASS SYRINGE Spectra Medical device, Inc. K082674

Description of the device:

The Artiglass L.O.R. Glass Syringe is provided not sterile, in bulk form to other manufacturers as part of an epidural insertion trays as a component to the epidural kit. The syringe may be sterilized before use and it can be re-sterilized via Autoclave.

Artiglass L.O.R. Glass Syringe is intended to be used only by qualified personnel. This syringe is not intended for injection or aspiration.

The Artiglass L.O.R. Glass Syringe is available in volume of 5ml and 10 ml.

Intended Use:

The Artiglass LOR Glass Svringe 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 medical textbooks. These syringes are not intended for injection or aspiration.

Performance Testing

Design Verification tests were performed based on the risk analysis and product requirements. Results of the tests demonstrates that the Artiglass L.O.R. Glass Syringe performs in same modality of the predicate device and that it is safe and effective when used as intended.

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Design Verification tests for Artiglass L.O.R. Glass Syringes performance elements include:

Item#	Performance Specification	Status of ArtiglassL.O.R. Glass Syringes
1	ISO 594/1 Conical fitting with a 6% (Luer) taper for syringes, needles andcertain other medical equipment - Part 1: General requirements	Complying
2	ISO 595/1 Reusable all-glass or metal-and-glass syringes for medical use -Part 1: Dimensions	Complying
3	ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taperfor syringes, needles and certain other medical equipment - Part 2: Lockfittings	Complying
4	ISO 595-2 First Edition 1987-12-15 Reusable all-glass or metal-and-glasssyringes for medical use - Part 2: Design, performance requirements tests	Complying

Performance testing including bench and animal testing was conducted to assess the safety and effectiveness of the Artiglass L.O.R. Glass Syringes for the stated indications for use. Results of performance testing demonstrated that the Artiglass L.O.R. Glass Syringes is safe and effective in the proposed intended uses.

Technological characteristics:

As compared to the predicate device, the Artiglass L.O.R. Glass Syringe object of this 510(k) submission:

a) Operates under the same operating principle as the predicate device.
b) Is similar in dimension and component characteristics to the predicate device.
c) Has similar glass luer tip and metal luer tip of the predicate device.
d) Has a similar luer lock connector as the predicate device.
e) Is supplied not sterile as the predicate device.
Meets the requirements of ISO 594/1 and 594/2. f)
g) Meets the requirements of ISO 595/1 and 595/2.
h) Meets the requirements of ISO 14971:2009, as applicable to the intended use of the device.
i) Meets the requirements of ISO 10993 as applicable to the intended use, description and technological characteristics of the device.
Demonstrates equivalent performance to the predicate device during design verification j) testing. .

Conclusion:

The conclusions drawn from the actual conducted (as the referenced) analytical engineering evaluations, the non-clinical tests and the commercial use of similar predicate device demonstrate that Artiglass L.O.R. Glass Syringes are safe and that it performs at least as safely and effectively as the legally marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 3, 2013

Mr. Federico Baccarin Managing Director ArtiGlass S.r.l. Via Piemonte 13 Due Carrare Padova Italy 35020

Re: K122416

Trade/Device Name: Artiglass L.O.R. Glass Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 10, 2013 Received: April 15, 2013

Dear Mr. 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. 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.

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Page 2 - Mr. Baccarin

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/McdicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

for

Theta
urohits.s.
++

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Artiglass S.r.l.

510(k) Notification

Artiglass L.O.R. Glass Syringes

Indications for Use

Artiglass L.O.R. Glass Syringes

510(k) Number (if known): K122416

Device Name:

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C. Chapman 2013.05.02 10:48:15 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

510(k) Number: jk12e4716

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).