(261 days)
The meso-relle needles are intended to inject fluids intradermally.
The meso-relle® needles are single lumen needle intended to inject fluids intradermally. 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. Needles have different length, which make them suitable to inject fluids intradermally. The meso-relle are not intended for injection in the bloodstream. The devices do not contact the central nervous system. The meso-relle® needles are suitable for administration of fluids intradermally. Each needle is provided with a protective cap (cover is rigid and not colored. The dimensions are suitable to accommodate the corresponding needle and vary according to the dimensions of the needle. The meso-relle® needles are disposable single use devices, sold sterilized by ethylene oxide.
The provided document describes the acceptance criteria and the study conducted for the meso-relle needles (AAL34, AAL36, AM30G), a hypodermic single lumen needle intended to inject fluids intradermally.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a dedicated table format with corresponding numerical performance values. Instead, it states that the meso-relle needles were tested according to specific ISO standards and "met the acceptance criteria." The device's performance is reported indirectly by stating its compliance with these standards and demonstrating substantial equivalence to predicate devices.
However, based on the non-clinical performance data section and the comparison table, we can infer the acceptance criteria are met by conforming to the specified ISO standards and achieving substantial equivalence to the predicate devices in terms of materials, design, and functional characteristics.
| Acceptance Criteria (Inferred from Standards & Predicate Comparison) | Reported Device Performance (Compliance Statement) |
|---|---|
| Biocompatibility: Meets requirements of ISO 10993-1. | Passed tests for Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity, and Haemolysis. |
| Sterility: Achieves SAL 10-6 via Ethylene Oxide (EO) sterilization. | Sterilization method complies with AAMI / ANSI / ISO 11135-1:2007. EO and ECH residuals met acceptance criteria per UNI EN ISO 10993-7:2008. |
| Functional Performance (Hypodermic Needles): Meets requirements of ISO 7864. | Tested according to ISO 7864:2016 and deemed to show substantial equivalence. |
| Functional Performance (Stainless Steel Needle Tubing): Meets requirements of ISO 9626. | Tested according to ISO 9626:2016 and deemed to show substantial equivalence. |
| Functional Performance (Conical Fittings - Luer taper): Meets requirements of ISO 594-1. | Tested according to ISO 594-1:1986 and deemed to show substantial equivalence. |
| Material Composition: AISI 304 Stainless Steel cannula, Polypropylene hub. | Same or similar to predicate devices. |
| Tip Configuration: Triple sharpened, non-coring. | Same as the MV pilot needle and reference predicate device. |
| Connection to Syringe: Luer taper. | Same as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each non-clinical performance test. It mentions that "tests were performed on the final finished device," suggesting a representative sample was used for each test (biocompatibility, sterility, functional testing).
The data provenance is retrospective, as the tests were conducted on the finished devices to demonstrate compliance with existing standards and equivalence to already marketed predicate devices. The country of origin of the data is not explicitly stated, but the manufacturer (Biotekne S.r.l.) and contact person (Enrico Bisson) are located in ITALY.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and study. The ground truth for hypodermic needles is established by compliance with international engineering and medical device standards (e.g., ISO standards for materials, sterility, and functional performance) and comparison to established predicate devices, not by expert consensus on clinical images or outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of medical data (e.g., radiology images) where there may be disagreement among experts. This study focuses on objective engineering and performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the focus of this device (a hypodermic needle).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an AI algorithm.
7. Type of Ground Truth Used
The ground truth used for this device is based on:
- International Standards: Compliance with ISO 10993-1 (Biocompatibility), AAMI / ANSI / ISO 11135-1:2007 and UNI EN ISO 10993-7:2008 (Sterility), ISO 7864:2016 (Hypodermic Needles), ISO 9626:2016 (Stainless Steel Needle Tubing), and ISO 594-1:1986 (Luer Taper Fittings).
- Performance of Predicate Devices: The established safe and effective performance of the legally marketed predicate devices (K110606, MV Intradermic Needles and K051783, Artsana Hypodermic Needles). The subject device demonstrates "substantial equivalence" to these predicates.
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of validating a physical medical device like a hypodermic needle. Training sets are used for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as in point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2017
Biotekne S.r.1. % Enrico Bisson President Studio di Ingegneria Enrico Bisson Via Marzia 9 Abano Terme, Padova 35031 ITALY
Re: K161255
Trade/Device Name: meso-relle (AAL34, AAL36, AM30G) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 21, 2016 Received: December 22, 2016
Dear Enrico 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.
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education 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. 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
http://www.fda.gov/MedicalDevices/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 Industry and Consumer Education 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 yours.
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Tina Kiang, Ph.D. Acting 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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Indications for Use
510(k) Number (if known) K161255
Device Name meso-relle AAL34, AAL36, AM30G
Indications for Use (Describe) The meso-relle needles are intended to inject fluids intradermally.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Representation Use (Part 21 CFR 601 Subpart D) | ☐ Compassionate Use (21 CFR 601 Subpart E) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 05 510(k) Summary
510 (k) Summary
K161255
APPLICANT
| Company Name: | Biotekne S.r.l. |
|---|---|
| Company Address: | Via della Bastia, 9 |
| 40033 Casalecchio di Reno (BO) - ITALY | |
| Company Phone: | +39 051565211 |
| Company Fax: | +39 0516182524 |
| Company e-mail | info@biotekne.it |
| CONTACT PERSON: | Enrico Bisson - Studio ingegneria Enrico Bisson |
|---|---|
| Via Marzia n. 9 | |
| Abano Terme (PD) - ITALY | |
| Contact Phone: | +39 0498630080 |
| Contact Fax | +39 0498630080 |
| Contact E-mail | enrico.bisson@gmail.com |
Date Summary Prepared: January 17, 2017
DEVICE IDENTIFICATION
- A. Trade name: meso-relle AAL34, AAL36, AM30G
- B. Generic/ Common Name: Hypodermic Needle
- ். Classification name: Hypodermic single lumen needle, 21 CFR 880.5570, Class II
- D. Product Code: FMI
LEGALLY MARKETED DEVICES (PREDICATE DEVICES)
K110606, MV Intradermic Needles, MV S.R.L.
Reference Predicate Device: K051783, Artsana Hypodermic Needles, ARTSANA SPA.
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INDICATIONS FOR USE
The meso-relle needles are intended to inject fluids intradermally.
DEVICE DESCRIPTION
The meso-relle® needles are single lumen needle intended to inject fluids intradermally. 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. Needles have different length, which make them suitable to inject fluids intradermally. The
meso-relle are not intended for injection in the bloodstream. The devices do not contact the central nervous system. The meso-relle® needles are suitable for administration of fluids intradermally.
Each needle is provided with a protective cap (cover is rigid and not colored. The dimensions are suitable to accommodate the corresponding needle and vary according to the dimensions of the needle.
The meso-relle® needles are disposable single use devices, sold sterilized by ethylene oxide.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The meso-relle Needles are same or similar in materials, design and intended use to the predicate devices. Both the subject and the predicate devices are intended to inject fluids intradermally; they have the same indications for use. Each of the technical attributes of the meso-relle Needles are present in the predicate devices. The materials, tip configuration and other fundamental design characteristics are all the same. Comparison elements are as follows:
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| ATTRIBUTE / | meso-relle NEEDLES | MV Intradermic Needles | Artsana Hypodermic | Comparison |
|---|---|---|---|---|
| CHARACTERISTICS | (Submitted Product) | (Legally Marketed | Needles (Reference | |
| Predicate Device) | Predicate Device) | |||
| 'K" numbers | K161255 | K110606 | K051783 | |
| CFR Section | 880.5570 | 880.5570 | 880.5570 | same |
| Pro-code | FMI | FMI | FMI | same |
| Classification name | Hypodermic single lumen needle | Hypodermic single lumen needle | Hypodermic single lumen needle | same |
| Intended / IndicationsFor Use | The meso-relle needles areintended to inject fluidsintradermally. | The MV intradermic needlesare intended to inject fluidsintradermally. | Artsana disposable sterilehypodermic needles areintended for use to inject fluidsinto, or withdraw fluids from,parts of the body below thesurface of the skin. | same as the primarypredicate |
| Cannula material | AISI 304 Stainless Steel | AISI 304 Stainless Steel | AISI 304 Stainless Steel | same |
| Hub material | Polypropylene (PolypropyleneMG03MA) | Polypropylene (PolypropyleneMG03MA) | Polypropylene | same |
| Hub color | YellowCAS No.22094-93-5,Dispersant (CAS No.557-04-0)internal material code:SCP-19906color coded ISO 6009 | YellowCAS No.22094-93-5,Dispersant (CAS No.557-04-0)internal material code:SCP-19906color coded ISO 6009 | Not available | same as the primarypredicate |
| Cover | rigid cover, polypropylene orpropylene\ethylenecopolymer | rigid cover, polyethylene | rigid cover, non toxicpropylene | same or similar |
| Adhesive | epoxy type adhesive | epoxy type adhesive | epoxy type adhesive | same |
| Lubricant | medical grade silicone oil | medical grade silicone oil | medical grade silicone oil | same |
| ATTRIBUTE /CHARACTERISTICS | meso-relle NEEDLES(Submitted Product) | MV Intradermic Needles(Legally MarketedPredicate Device) | Artsana HypodermicNeedles (ReferencePredicate Device) | Comparison |
| 'K" numbers | K161255 | K110606 | K051783 | |
| Needle diameter (gauge) | 30G | 22G, 25G, 26G, 27G, 30G /pilot needle: 21G, 23G, 26G,27G | 27G, 30G | The needle diameter of thesubject device is includedwithin the configuration ofthe predicate devices |
| Needle length (mm) | 4, 6, 12 | 25, 27,35, 37, 40, 50, 57, 70 /pilot needle: 13, 25 | 4, 6, 13 | The differences in the needlelength between the subjectand the primary predicatedevice do not raise newquestions of safety oreffectiveness for the subjectdevice. Shorter lengthneedles are more appropriatefor intradermal use. |
| Tip configuration | triple sharpened, non-coring | Injection needle: closed blunttip, lateral openingPilot needle: triple sharpened,non-coring | triple sharpened, non-coring | same as the MV pilot needleand as the referencepredicate device |
| Connection to syringe orinjection device | Luer taper | Luer taper | Luer taper | same |
| Sterilization | Ethylene Oxide (EO)Per ISO 11135-1:2007 | Ethylene Oxide (EO)Per ISO 11135-1:2007 | Not available | same as the primarypredicate |
| SAL Level | SAL 10-6 | SAL 10-6 | Not available | same as the primarypredicate |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Not available | same as the primarypredicate |
| ATTRIBUTE /CHARACTERISTICS | meso-relle NEEDLES(Submitted Product) | MV Intradermic Needles(Legally MarketedPredicate Device) | Artsana HypodermicNeedles (ReferencePredicate Device) | Comparison |
| "K" numbers | K161255 | K110606 | K051783 | |
| Functional testing | ISO 7864:2016ISO 9626:2016ISO 594-1:1986 | ISO 7864:1993ISO 9626:1991ISO 594-1:1986 | Not available | same as the primarypredicate |
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The shorter length of the subject device do not raise new issues of safety or effectiveness; shorter lengths are even more suitable for intradermal use as they are less invasive. This difference does not affect the substantial equivalence of the subject device.
The test results and comparison results show that the subject device is substantial equivalent to the predicate in performance.
NON-CLINICAL PERFORMANCE DATA
All materials used for the meso-relle needles have a long history of safe use for the same or equivalent intended use. Biocompatibility has been tested according to the requirements of ISO 10993-1. In consideration of the International Standard ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing, following biocompatibility tests were performed on the final finished device to evaluate: Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity and Haemolysis.
The sterility of the meso-relle Needles is assured by using a validated sterilization method which complies with the requirements of the Recognized Consensus Standard: AAMI / ANSI / ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. Ethylene oxide (EtO) and Ethylene Chlorohydrin (ECH) residuals were tested according to UNI EN ISO 10993-7: 2008 - Method K.4.3.+ HRGC/MS Detection for EtO and Method K.4.8+ HRGC/MS Detection for ECH and met the acceptance criteria.
Meso-relle Needles were tested according to ISO 7864:2016 "Requirements and test methods Sterile hypodermic needles for single use", ISO 9626:2016 "Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods" and ISO 594-1.1986 "Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements" in order to demonstrate that the proposed device is substantial equivalent to the predicate in safety and performance.
CONCLUSION:
The subject and the predicate devices have the same indications for use and they have same technological characteristics. The test results and comparison results show that the proposed device is substantial equivalent to the predicate in performance.
Based on the intended use, technological characteristics and performance testing, the proposed product meso-relle Needles is considered to be substantially equivalent to the predicate device.
§ 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).