(30 days)
The DropSafe™ Sicura™ are sterile, single-use passive safety injection needles to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection.
DropSafe™ Sicura™ are Sterile, single-use passive safety injection needles to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection. DropSafe™ Sicura™ are single patient and used by HCP (Healthcare professionals: nurses, pharmacist and physician). DropSafe™ Sicura™ passive safety injection needles, are hypodermic needles intended for subcutaneous and intramuscular injection of fluids using syringes with male luer slip or luer lock fitting. Passive safety injection needles are equipped with passive sharps prevention feature. They are sterilized with ETO. Non-toxic single use, single patient devices. The device is designed to minimize the risk from accidental needle sticks with an already used needle by application of a sharps injury prevention feature. Following use, the slider of the needle is automatically locked out preventing reuse. The needle is protected by an external cover, the cover must be in place during the connection between the needle and the syringe. After removing the external cover the needle is still protected by a transparent slider, the slider will protect the needle and the user during the injection activity (sharp prevention feature). The slider is transparent for allowing the user to have a clear view of the cannula during the injection. During the injection the slider progressively uncovers the cannula; this action is possible thanks to the presence of two components (spring and sleeve) which let the slider moves up and down. Once the injection is done and the needle removed from the slider automatically covers the cannula and remain blocked, guaranteeing the sharp prevention feature. The confirmation about the blocking is done thanks to the appearing of red marks visible through the housing. DropSafe™ Sicura™ is not intended to be used for the drawing up of drugs from vials and/or ampule, for which it's indicated to use blunt needles. Each DropSafe™ Sicura™ is individually packaged in a sealed container. The DropSafe™ Sicura™ is used by opening the blister and applying the needle on a syringe filled with drug. While inserting the needle into the skin at a 90° or 45° angle (with or without skin fold), the slider glides into the housing. While the slider glides into the housing, the safety feature is activated. Following injection, the slider glides back into its initial position, completely covering the needle where it remains locked. The red safety lock indicator tells the user that the safety lock has been activated. Once the DropSafe™ Sicura™ is in the locked mode, it cannot be reused. The DropSafe™ Sicura™ is detached from the syringe and disposed of into a sharps container according to local requirements. The DropSafe™ Sicura™ assembly consists of a cannula that is assembled into an injection molded hub using an UV glue. The hub has been designed in order to guarantee a proper connection with luer lock and luer slip nozzle of syringes. The cannula is lubricated using a silicone-based lubricant for ease of injection and thus reduce friction during the injection. The other components that are assembled onto hub/cannula components are stainless steel spring, injection molded housing, sleeve with red coloured stripes and slider. The coupling of spring, sleeve and slider let have the safety prevention feature of the device, avoiding accidental needle-sticks. This needle assembly is inserted into a protective injection molded cover and blistered with a peel away medical grade paper which provides a sterility barrier.
Here is the requested information regarding the acceptance criteria and study proving the device meets those criteria, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Test parameter | Acceptance Criteria (Requirement) | Reported Device Performance (Result) |
|---|---|---|
| Cannula Materials | The needle shall be made of tubing materials specified in ISO 9626:2016 and ISO 15510:2014. | Meets standard |
| Dimensions | The needles diameters are in compliance with clause 4.10.1 of ISO 7864:2016 and requirements of ISO 9626:2016. Tolerances on lengths shall be in accordance to ISO 7864:2016 (clause 4.10.2). | Meets standard |
| Bond between hub and needle tube | The union of the hub and needle tube shall not break when tested in accordance to ISO 7864 (Clause 4.12). | Meets standard |
| Freedom from defects | The needle tube shall fulfill the requirements of ISO 7864 (clause 4.10.3). | Meets standard |
| Lubrication | The needle tube should be lubricated. The lubricant shall not, under normal or corrected-to-normal vision, be visible as droplets of fluid on the outer or inner surfaces of the needle tube. The quantity of lubricant used should not exceed 0.25 mg/cm² of the lubricated surface area of the needle tube. | Meets standard |
| Cleanliness | When inspected by normal or corrected-to-normal vision without magnification under an illuminance of 300 lx to 700 lx, the surface of the hypodermic needle tube shall appear free from particles and extraneous matter. When examined under 2.5× magnification, the hub socket (fluid path surface) shall appear free from particles and extraneous matter. | Meets standard |
| Limits for Acidity or Alkalinity | When determined with a laboratory pH meter and using a general purpose electrode, the pH value of an extract prepared in accordance with Annex A shall be within one unit of pH of that of the control fluid. | Meets standard |
| Limits for extractable metals | When tested by a recognized microanalytical method, for example by an atomic absorption method, an extract prepared in accordance with Annex A shall, when corrected for the metals content of the control fluid, contain not greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0.1 mg/l. | Meets standard |
| Color of hub | The hub shall be made either of pigmented or of unpigmented material. If pigmented, the color shall be in accordance with ISO 6009. | Meets standard |
| Needle point | When examined under 2.5× magnification the needle point shall appear sharp and free from feather edges, burrs and hooks. The needle point should be designed so as to minimize coring and fragmentation when penetrating vial closures. Penetration testing can provide an indication of the needle point sharpness and lubrication. | Meets standard |
| Patency of lumen | The flow rate of water through the needle shall not be less than 80% of an unprocessed needle tube of equivalent outer diameter and length having a minimum inner diameter in accordance with ISO 9626 when tested under the same pressure. | Meets standard |
| Sharp injury protection | The needle shall meet the requirements of ISO 23908, the conformity to this standard has been verified also through usability and Sharps injury prevention studies. | Meets standard |
| Hub conical fitting | The conical socket of the hypodermic needle hub shall meet the requirements of ISO 80369-7. | Meets standard |
| Sterility and Biocompatibility | The needle in its unit packaging shall have been subjected to a validated sterilization process resulting in a Sterility Assurance Level of at least 10^-6 in accordance with recognized ISO standards. The needle shall be free from biological hazard in accordance with the requirements of ISO 10993-1. | Meets standard |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample size for the test set used in the non-clinical performance data.
- Data Provenance: The tests were conducted according to international standards (ISO 7864:2016, ISO 9626:2016, ISO 23908:2011, and ISO 80369-7:2021). The information does not specify the country of origin of the data, but it is implied to be from a conformity assessment by the manufacturer (Pikdare S.p.A, Italy). The studies appear to be prospective as they are verification/validation tests performed to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document for the non-clinical performance tests. The tests are based on established ISO standards, which define the ground truth through their methodologies and established limits.
- For the "Simulated Use Study" for sharps injury prevention, it states "the participation of clinical users," but the number and qualifications of these users are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided for any of the tests mentioned. The non-clinical tests are standard measurements against ISO requirements, which typically don't involve complex adjudication among experts. For the simulated use study, the adjudication method is not described.
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:
- No MRMC comparative effectiveness study was done as the device is a hypodermic needle and not an AI/imaging device that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A standalone performance assessment was done for the device through the "Non-Clinical Performance Data" by testing various physical and material properties against ISO standards. This demonstrates the device's inherent design and manufacturing qualities.
- A "Simulated Use Study" also evaluated the function of the safety feature, which in a sense tests the "standalone" operation of the safety mechanism in a simulated but human-involved environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Non-Clinical Performance Data," the ground truth is established by well-defined international standards (ISO). These standards define specific measurement methodologies, performance limits, and material requirements.
- For the "Sharps injury protection" and "Simulated Use Study", the ground truth is based on the requirements of ISO 23908 and the functionality validation against the Instructions For Use (IFU) with the participation of clinical users. This implies a functional ground truth rather than a consensual interpretation of data.
8. The sample size for the training set:
- This information is not applicable as the device is a physical medical device (hypodermic needle) and not an AI or machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable as the device is a physical medical device and does not involve a training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 2, 2022
Pikdare SpA % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K223353
Trade/Device Name: DropSafe™ Sicura™ Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: FMI Dated: October 30, 2022 Received: November 2, 2022
Dear Dave Yungvirt:
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.
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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 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, Subpart 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/cdrh-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.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is by Courtney Evans -S. The date of the signature is 2022.12.02. The time of the signature is 11:41:35 -05'00'.
For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K223353
Device Name DropSafeTM Sicura™
Indications for Use (Describe)
The DropSafe™ Sicura™ are sterile, single-use passive safety injection needles to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection
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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510(k) Summary - K223353
As required by the Safe Medical Devices Act of 1990 and in accordance with 21 CFR §807.92(a).
[807.92 (a)(1,2)]
| Date SummaryPrepared: | July 20, 2022 |
|---|---|
| Submitted By: | Pikdare S.p.AVia Saldarini Catelli 1022070 Casnate con Bernate – COMO - ItalyPhone: +39 031 7297757 |
| Primary Contact: | Roberta Zanoni - RAroberta.zanoni@pikdare.com |
| Secondary Contact: | Sylvie verdon - RA USSylvie.Verdon@htl-strefa.com |
| Trade Name: | DropSafe™ Sicura™ |
Models:
| Reference number | Description |
|---|---|
| 02094000180250 | DropSafe™ Sicura™ G18X25 |
| 02094000210250 | DropSafe™ Sicura™ G21X25 |
| 02094000220250 | DropSafe™ Sicura™ G22X25 |
| 02094000230250 | DropSafe™ Sicura™ G23X25 |
| 02094000250160 | DropSafe™ Sicura™ G25X16 |
| 02094000250250 | DropSafe™ Sicura™ G25X25 |
| 02094000270130 | DropSafe™ Sicura™ G27X13 |
| 02094000300130 | DropSafe™ Sicura™ G30X13 |
| Common Name: | Passive Safety Injection Needle |
|---|---|
| Regulation Number: | 21 CFR § 880.5570 |
| Product Code: | FMI |
| Device Classification: | II |
| Review Panel: | 80 General Hospital |
Section 8 Page 1 of 10
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Predicate Device
[807.92(a)(3)]
The legally marketed devices to which substantial equivalence is claimed are:
| Manufacturer | Trade Name | 510(k) Number |
|---|---|---|
| Terumo Europe NV | K-pack SurshieldTM | K111797 |
Description of Device:
[807.92(a)(4)]
Device description
DropSafe™ Sicura™ are Sterile, single-use passive safety injection needles to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection.
DropSafe™ Sicura™ are single patient and used by HCP (Healthcare professionals: nurses, pharmacist and physician).
DropSafe™ Sicura™ passive safety injection needles, are hypodermic needles intended for subcutaneous and intramuscular injection of fluids using syringes with male luer slip or luer lock fitting. Passive safety injection needles are equipped with passive sharps prevention feature. They are sterilized with ETO. Non-toxic single use, single patient devices.
The device is designed to minimize the risk from accidental needle sticks with an already used needle by application of a sharps injury prevention feature. Following use, the slider of the needle is automatically locked out preventing reuse. The needle is protected by an external cover, the cover must be in place during the connection between the needle and the syringe.
After removing the external cover the needle is still protected by a transparent slider, the slider will protect the needle and the user during the injection activity (sharp prevention feature). The slider is transparent for allowing the user to have a clear view of the cannula during the injection.
During the injection the slider progressively uncovers the cannula; this action is possible thanks to the presence of two components (spring and sleeve) which let the slider moves up and down.
Once the injection is done and the needle removed from the slider automatically covers the cannula and remain blocked, guaranteeing the sharp prevention feature.
The confirmation about the blocking is done thanks to the appearing of red marks visible through the housing.
DropSafe™ Sicura™ is not intended to be used for the drawing up of drugs from vials and/or ampule, for which it's indicated to use blunt needles.
Each DropSafe™ Sicura™ is individually packaged in a sealed container. The DropSafe™ Sicura™ is used by opening the blister and applying the needle on a syringe filled with drug. While inserting the needle into the skin at a 90° or 45° angle (with or without skin fold), the
Section 8 Page 2 of 10
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slider glides into the housing. While the slider glides into the housing, the safety feature is activated. Following injection, the slider glides back into its initial position, completely covering the needle where it remains locked. The red safety lock indicator tells the user that the safety lock has been activated. Once the DropSafe™ Sicura™ is in the locked mode, it cannot be reused. The DropSafe™ Sicura™ is detached from the syringe and disposed of into a sharps container according to local requirements.
The DropSafe™ Sicura™ assembly consists of a cannula that is assembled into an injection molded hub using an UV glue. The hub has been designed in order to guarantee a proper connection with luer lock and luer slip nozzle of syringes. The c a n n u l a i s lubricated using a silicone-based lubricant for ease of injection and thus reduce friction during the injection. The other components that are assembled onto hub/cannula components are stain less steel spring, injection molded housing, sleeve with red coloured stripes and slider. The coupling of spring, sleeve and slider let have the safety prevention feature of the device, avoiding accidental needle-sticks. This needle assembly is inserted into a protective injection molded cover and blistered with a peel away medical grade paper which provides a sterility barrier.
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Indications for Use:
[807.92(a)(5)]
The DropSafe™ Sicura™ are sterile, single-use passive safety injection needles to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection.
Technological Characteristics:
[807.92(a)(6)]
A comparison of characteristics of DropSafe™ Sicura™ and the predicate d e v i c e s is shown in the table below:
| Device Name | New Device | Predicate Device |
|---|---|---|
| Manufacturer | Pikdare SPA | Terumo Europe NV |
| 510(k) Number | K223353 | K111797 |
| Intended use | Sterile, single-use passive safetyinjection needle to be used incombination with a (pre-)filledsyringe for subcutaneous andintramuscular injection | A single use injection needle with anintegrated passive sharps protectionfeature designed to reduce needle stickinjury and to be used in combinationwith a (pre-)filled syringe forsubcutaneous and intramuscularinjection |
| Indication foruse | Sterile, single-use passive safetyinjection needle to be used incombination with a (pre-)filledsyringe for subcutaneous andintramuscular injection | The K-Pack Surshield™ Needle is asterile hypodermic needle for single usewith a passive sharps protection featurethat covers the cannula immediately andpermanently after use; and is intended foruse in combination with hypodermicsyringes for subcutaneous andintramuscular injection. |
| Operationprinciple | Manual | Manual |
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| Design | Injection moulded HubCannulaGlueSpringInjection moulded SleeveInjection moulded SliderInjection moulded HousingInjection moulded CoverBlister | Injection moulded hubCannulaGlueInjection moulded tubeSpringInjection moulded gripInjection moulded sleeveInjection moulded sliderInjection moulded housingInjection moulded caseInjection moulded capPaper seal |
|---|---|---|
| Product Code | FMI | FMI |
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| Device Name | Subject Device | PredicateDevice | |
|---|---|---|---|
| Length | 25 mm - 16 mm - 13mm | 1/2" (12mm) | |
| Gauges | G18 - G21 - G22 - G23 - G25 -G27 - G30 | 27G | |
| Materials | Cannula | Stainless Steel | Stainless Steel |
| Hub | PolypropyleneMedical Grade | Polypropylene | |
| Housing | PolypropyleneMedical Grade | Plastic moulded part | |
| Cover | PolypropyleneMedical Grade | Plastic moulded part | |
| Slider | PolycarbonateMedical Grade (PC) | Plastic moulded part | |
| Sleeve | ABS (Food grade) | Plastic moulded part | |
| Spring | Stainless steel wire | Stainless steel wire | |
| Glue | UV Glue | UV Glue | |
| Lubricant | Silicone Medial Grade | Silicone Medical Grade | |
| Blister | Medical Paper and Plastic Film | ||
| Biocompatibility | Conforms toISO10993-1 | Conforms toISO 10993-1 | |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
The new device and the predicate device are classified under 21 CFR 880.5570, which states: "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 intended use of the devices is identical (intended for use with pre-filled syringes). Based upon the above comparisons to the predicate device, DropSafe™ passive safety injection needles do not raise any new issues of safety of effectiveness
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Reference Device
| Manufacturer Name | Trade Name | 510(k) Number |
|---|---|---|
| Terumo Corp | SurGuard 2 Safety | K051865 |
| Needle |
The reference device has been included in this submission to cover the gage and lengths of the New Device. The difference between the New Device and the Reference Device is the sharps prevention feature: the new device includes a sharp prevention feature based on an active sharp prevention system and Reference Device includes a Sharp prevention feature based on a passive sharp prevention system. The Reference device has been considered taking into account the offered lengths and gauges of the hypodermic needle included in a safety needle.
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Non-Clinical Performance Data:
[(807.92(b)(1)]
Verification/Validation testing was conducted in compliance with the requirements of ISO 7864:2016, ISO 9626:2016, ISO 23908:2011 and ISO 80369-7:2021 as summarized below. All testing met the applicable requirements.
| Test parameter | Requirement | Result |
|---|---|---|
| Cannula Materials | The needle shall be made of tubing materialsspecified in ISO 9626:2016 andISO 15510:2014. | Meets standard |
| Dimensions | The needles diameters are in compliancewith clause 4.10.1 of ISO 7864:2016 andrequirements of ISO 9626:2016.Tolerances on lengths shall be inaccordance to ISO 7864:2016(clause4.10.2) | Meets standard |
| Bond between hub andneedle tube | The union of the hub and needle tube shall not breakwhen tested in accordance to ISO 7864 (Clause4.12). | Meets standard |
| Freedom from defects | The needle tube shall fulfill the requirements of ISO7864 (clause 4.10.3) | Meets standard |
| Lubrication | The needle tube should be lubricated. The lubricantshall not, under normal or corrected- to-normalvision, bevisible as droplets of fluid on the outer orinner surfaces of the needle tube. The quantity oflubricant used should not exceed 0.25 mg/cm² of thelubricated surface area of the needle tube | Meets standard |
| Cleanliness | When inspected by normal or corrected-to-normalvision without magnification under an illuminanceof 300 lx to 700 lx, the surface of the hypodermicneedle tube shall appear free from particles andextraneous matter. When examined under 2,5×magnification, the hub socket (fluid path surface)shall appear free from particles and extraneousmatter. | Meets standard |
| Limits for Acidity orAlkalinity | When determined with a laboratory pH meter andusing a general purpose electrode, the pH value ofan extract prepared in accordance with Annex Ashall be within one unit of pH of that of the controlfluid. | Meets standard |
| Limits for extractablemetals | When tested by a recognized microanalyticalmethod, for example by an atomic absorptionmethod, an extract prepared in accordance withAnnex A shall, when corrected for the metalscontent of the control fluid, contain not greater thana combined total of 5 mg/l of lead, tin, zinc andiron. The cadmium content of the extract shall,when corrected for the cadmium content of thecontrol fluid, be lower than 0,1 mg/l | Meets standard |
| Color of hub | The hub shall be made either of pigmented or ofunpigmented material. If pigmented, the color shallbe in accordance with ISO 6009. | Meets standard |
| Needle point | When examined under 2.5× magnification theneedle point shall appear sharp and free fromfeather edges, burrs and hooks. | Meets standard |
| The needle point should be designed so as tominimize coring and fragmentation whenpenetrating vial closures | ||
| Penetration testing can provide an indication of theneedle point sharpness and lubrication | ||
| Patency of lumen | the flow rate of water through the needle shall notbe less than 80 % of an unprocessed needle tube ofequivalent outer diameter and length having aminimum inner diameter in accordance with ISO9626 when tested under the same pressure. | Meets standard |
| Sharp injuryprotection | The needle shall meet the requirements of ISO23908, the conformity to this standard has beenverified also through usability and Sharps injuryprevention studies | Meets standard |
| Hub conical fitting | The conical socket of the hypodermic needle hubshall meet the requirements of ISO 80369-7 | Meets standard |
| Sterility andBiocompatibility | The needle in its unit packaging shall have beensubjected to a validated sterilization processresulting in a Sterility Assurance Level of at least10-6 in accordance with recognized ISO standards. | Meets standard |
| The needle shall be free from biological hazard inaccordance with the requirements of ISO 10993-1. |
Section 8 Page 8 of 10
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Clinical Performance Data:
[(807.92(b)(2)]
FDA GUIDANCE Medical Devices with Sharps Injury Prevention Features (issued on August 9, 2005).
Testing was performed to evaluate the function of the safety feature in a simulated clinical environment with the participation of clinical users. The Simulated Use Study was performed to validate the Instructions For Use (IFU) with the participation of clinical users. As evidenced in the study, the use of this device does not affect the injection technique or the functionality of the hypodermic needle coupled with a hypodermic syringe and is safe and effective when used as per the Instructions for Use.
Conclusion:
[(807.92(b)(3)]
DropSafe™ Sicura™ is substantially equivalent in the intended use, technology/principle of operation and performance to the predicate devices and do not raise any new questions of safety and effectiveness.
§ 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).