The device is comprised of a metal tube. On one end the tip is closed and blunt, while the cannula has an opening laterally at a lower point under the tip. On the other end the device is joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe.

The MV intradermic needle is marketed alone or combined with a pilot needle. The pilot needle is an hypodermic single lumen needle intended to prepare the site for injection. The tip of the pilot needle is sharpened at one end, while the other end is joined to a hub. The pilot needle can be any traditional legally marketed hypodermic needle.

The MV intradermic needles are single-use devices sold as sterile.

AI/ML Overview

This document describes a 510(k) submission for the "MV Intradermic Needles," a medical device. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific acceptance criteria and detailed performance metrics as one might see for novel AI/ML devices.

Here's an analysis based on your requested information, acknowledging the nature of this particular 510(k):

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

For this type of device (a hypodermic needle), acceptance criteria are primarily based on established consensus standards and material properties, demonstrating that the device functions as intended and is safe. There isn't a "performance" metric in the sense of accuracy, sensitivity, or specificity as seen with diagnostic AI/ML devices. Instead, performance relates to compliance with physical and biological standards.

Acceptance Criteria (from Recognized Consensus Standard ISO 7864)	Reported Device Performance
Cleanness	Compliant; No issues
Acidity or alkalinity limits	Compliant; No issues
Limits for extractable metals	Compliant; No issues
Needle tube - Length requirements	Compliant; No issues
Needle tube - Absence of defects	Compliant; No issues
Execution - Hub/tube bond strength	Compliant; No issues
Execution - Evidence of lumen	Compliant; No issues

Biocompatibility Acceptance Criteria (after STERILE finished device tests):

Acceptance Criteria	Reported Device Performance
Cytotoxicity	Compliant; No issues
Sensitization	Compliant; No issues
Intracutaneous reactivity	Compliant; No issues
Systemic toxicity	Compliant; No issues
Haemocompatibility	Compliant; No issues

The study that "proves" the device meets these criteria is a series of non-clinical (laboratory-based) tests and risk analysis, as outlined in the "DISCUSSION OF NON CLINICAL TESTS" section. The document states: "None of the data raised any issues of safety and effectiveness" for the performance tests and "None of the result of the tests arised any issues of biocompatibility" for the biological tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a quantitative sample size for the non-clinical or biological tests. It states "Following performance tests were performed on the MV Intradermic Needles" and "Following biological tests were performed on the sterile finished device," implying that samples were tested to demonstrate compliance.

Sample Size: Not explicitly stated (likely adequate for standard testing per ISO norms, but not specified in the document).
Data Provenance: Not explicitly stated, but the tests were performed by the manufacturer (M.V. s.r.l.) or a testing lab in Italy, where the company is located. Given the nature of a 510(k) for a medical device like a needle, these are prospective tests conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device submission. Ground truth, in the context of expert consensus, is typically relevant for diagnostic devices that interpret images or data. For a hypodermic needle, "ground truth" is established by physical measurements and standard biological assays according to recognized standards, not by expert interpretation of clinical outcomes.

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

Not applicable. Adjudication methods are used to resolve disagreements among human readers or experts in complex diagnostic tasks. The tests described here are objective, pass/fail measurements against defined 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. MRMC studies are used for evaluating the performance of diagnostic AI/ML algorithms, particularly in improving human reader performance. This submission is for a physical medical device (a needle) and does not involve AI or human interpretation tasks.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" here is adherence to recognized consensus standards (ISO 7864 for performance, and standard biocompatibility test protocols for biological safety). These standards define objective criteria (e.g., specific limits for cleanness, extractable metals, bond strength, and biological responses like cytotoxicity).

8. The sample size for the training set

Not applicable. "Training set" refers to data used to train AI/ML models. This device is a physical product and does not involve machine learning.

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

Not applicable, as there is no training set for this device.

Summary

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510(K) NOTIFICATION

K110606

M.V. Intradermic Needle

SEP 2 9 2011

510 (k) Summary of safety and effectiveness

SUBMITTER INFORMATION

A.	Company Name:	M.V. s.r.l.
B.	Company Address:	Via F.lli Cervi, 7Gonzaga (MN), Italy 46023
	Manufacturing facility:	Via Don G. Dossetti, 5/7Gonzaga (MN), Italy 46023
	US Agent:	Laura AndreattaN. Devon Rd., Columbus, OH 43212,Phone +1-614-246-1141Fax: +1-614-725-0890
C.	Company Phone:	+39 0376 536995
	Company Fax:	+39 0376 530441
	Company e-mail	info@mvsrl.it
D.	Contact Person:	Enrico BissonStudio ingegneria Enrico Bisson
E.	Contact Phone:	+39 0498630080
	Contact Fax	+39 0498630080
	Contact E-mail	enrico.bisson@isoplan.org
F.	Date Summary Prepared:	February 28, 2011

DEVICE IDENTIFICATION

A. Device name: M.V. Intradermic Needles
B. Trade/Proprietary Name: M.V. Intradermic Needles
். Hypodermic Single Lumen Needle (21 CFR §880.5570) Classification name:
FMI D. Product Code:

LEGALLY MARKETED DEVICES (PREDICATE DEVICES)

ARTSANA HYPODERMIC NEEDLES, K051783 -

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DEVICE DESCRIPTION

The MV intradermic needles are single-use devices sold as sterile.

INTENDED USE

The MV intradermic needles are intended to inject fluids intradermally.

DISCUSSION OF NON CLINICAL TESTS

Following performance tests were performed on the MV Intradermic Needles to test their compliance with Recognized Consensus Standard ISO 7864 Sterile hypodermic needles for single use:

Cleanness

Acidity or alkalinity limits Limits for extractable metals Needle tube - Length requirements Needle tube - Absence of defects Execution - Hub/tube bond strength Execution - Evidence of lumen

None of the data raised any issues of safety and effectiveness. Additionally, a risk analysis was conducted according to Recognized Consensus Standard ISO 14971:2007.

Following biological tests were performed on the sterile finished device to evalute biocompatibility:

Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity

Haemocompatibility.

None of the result of the tests arised any issues of biocompatibility.

SUBSTANTIAL EQUIVALENCE

The MV Intradermic Needles are same or similar in design, materials and intended use to the predicate devices. In further support of a substantial equivalence determination, Section 10 provides a comparison chart of the submitted device and the predicate devices. Main comparison element are as follows:

Confidential

Page 15 -3

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	MV INTRADERMIC NEEDLES	K051783
Intended /IndicationsFor Use	The MN intradermic needles areintended to inject fluidsintradermally.	To inject fluids into, or withdrawfluids from, parts of the bodybelow the surface of the skin.
Cannulamaterial	AISI 304 Stainless Steel	AISI 304 Stainless Steel
Hub material	Polypropylene	Polypropylene
Needlediameter	22G, 25G, 27G, 30G;21G, 23G, 26G, 27G	21G, 22G, 23G, 25G, 26G, 27G,30G and more
Needle length(mm)	25, 27, 35, 37, 40, 50, 57, 70;13, 25	13, 25, 40 and more
Tipconfiguration	closed blunt tip, lateral opening(intradermic needle),triple sharpened, non-coring (pilotneedle)	triple sharpened, non-coring
Hub	color coded ISO 6009	color coded ISO 6009
Connectionto syringe	Luer taper	Luer taper

Based on the available information, we conclude that the M.V. Intradermic Needles are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act. Therefore, the applicant device is determined as safe and effective.

SAMPLE

Sample of the MV Intradermic Needles is included in this submission.

・

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rood ... d Drig Adminstration 16903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

M.V. S.R.L. C/O Mr. Enrico Bisson President Studio di Ingegneria Enrico Bisson .Via Marzia 9 Abano Terme, Padova Italy 35031

SEP 2 9 2011

Re: K110606 Trade/Device Name: MV Intradermic Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 9, 2011 Received: September 16, 2011

Dear Mr. Bisson:

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. Bisson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 331-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/MedicalDevices/Safetv/Reportal/roblem/default.htmlfor 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/Industry/default.htm.

Sincerely vours.

Wh for

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

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

K110606

Device Name:

MV intradermic needles

Indications for Use:

The MV intradermic needles are intended to inject fluids intradermally.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rhd C. Chyn 9/28/1,
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K110606

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).