(210 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and biocompatibility of a simple needle, with no mention of AI or ML capabilities.
No.
The device is intended to inject fluids, but it does not have a therapeutic effect itself; it is an accessory used for drug delivery.
No
Explanation: The device, an intradermic needle, is intended to inject fluids, which is a therapeutic or delivery function, not a diagnostic one.
No
The device description explicitly details physical components (metal tube, cannula, hub, pilot needle) and performance studies related to physical properties and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids intradermally." This describes a procedure performed on the body (in vivo), not a test performed on a sample taken from the body (in vitro).
- Device Description: The description details a needle designed for injection, a physical act of delivering a substance into the skin.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on the results of a test performed on a sample.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for the delivery of substances into the body.
N/A
Intended Use / Indications for Use
The MV intradermic needles are intended to inject fluids intradermally.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
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.
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)
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.
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.
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
§ 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).
0
510(K) NOTIFICATION
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, 7 |
| Gonzaga (MN), Italy 46023 | ||
| Manufacturing facility: | Via Don G. Dossetti, 5/7 | |
| Gonzaga (MN), Italy 46023 | ||
| US Agent: | Laura Andreatta | |
| N. Devon Rd., Columbus, OH 43212, | ||
| Phone +1-614-246-1141 | ||
| Fax: +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 Bisson |
| Studio 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 -
1
DEVICE DESCRIPTION
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.
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
2
.
| MV INTRADERMIC NEEDLES | K051783 | |
|---|---|---|
| Intended / | ||
| Indications | ||
| For Use | The MN intradermic needles are | |
| intended to inject fluids | ||
| intradermally. | To inject fluids into, or withdraw | |
| fluids from, parts of the body | ||
| below the surface of the skin. | ||
| Cannula | ||
| material | AISI 304 Stainless Steel | AISI 304 Stainless Steel |
| Hub material | Polypropylene | Polypropylene |
| Needle | ||
| diameter | 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 | |
| Tip | ||
| configuration | closed blunt tip, lateral opening | |
| (intradermic needle), | ||
| triple sharpened, non-coring (pilot | ||
| needle) | triple sharpened, non-coring | |
| Hub | color coded ISO 6009 | color coded ISO 6009 |
| Connection | ||
| to 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.
·
・
3
Image /page/3/Picture/1 description: The image shows a logo with a stylized bird in flight. The bird is composed of three curved lines that suggest movement and feathers. The logo is encircled by text, which is difficult to read due to the image quality. The overall design is simple and abstract, conveying a sense of freedom and flight.
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.
4
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
5
INDICATIONS FOR USE
510(k) Number (if known):
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