(268 days)
Safe Block Pen Needle is intended for use with pen injector devices for the injection of fluids, including insulin. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental sticks from the patient end of the needle. The shield also serves to conceal the needle before and after injection.
SAFETY PEN NEEDLE. Safe Block Pen Needle is designated for use with pen injector for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. Safe Block Pen Needle are offered in one gauge size (31G) and in a various lengths (5mm and 8mm). The Safe Block Pen Needle is sterile (ETO sterilization), non toxic and non-pyrogenic. It's a disposable single use device. Additionally the Safe Block Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. Prior to injection the user will attach the Safe Block Pen Needle to the pen. The shield of Safe Block Pen Needle will hide the needle from the user prior to use. As the user proceeds with inserting the needle into the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. The Safe Block Pen Needle should be removed from the pen and discarded.
The provided document is a 510(k) premarket notification for the "Safe Block Pen Needle." It details the device's description, indications for use, comparison to predicate devices, and non-clinical testing performed. However, it does not contain a dedicated section outlining specific acceptance criteria or a detailed study report that proves the device meets those criteria.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics, materials, and a declaration that bench testing was performed.
Here's an analysis based on the information provided, specifically addressing your points:
-
A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria linked to specific performance results for the Safe Block Pen Needle in the format requested. Performance is generally stated as meeting relevant ISO standards or internal protocols.However, there is a "Table of specifications (including relevant tests)" on page 7 which lists characteristics for the applicant device and predicate devices. This table indicates the tests performed to ensure compliance with standards.
Feature / Characteristics Acceptance Criteria (Implied by standard and predicate comparison) Reported Device Performance (Applicant Device) Intended Use Consistent with predicate devices and safety features Intended for use with pen injector devices for injection of drugs, including insulin. Safety shield automatically locks in place, reduces accidental sticks, and conceals the needle. Length / Tolerance As per ISO 11608-2 5 mm, 8 mm (tolerance as per ISO 11608-2) Gauge As per ISO 9626 G31 (as per ISO 9626) Tip configuration As per ISO 11608-2, section 4.5 Per ISO 11608-2, section 4.5, visually sharp at 2.5X magnification, designed to minimize coring and fragmentation. Hub/needle bond strength As per ISO 11608-2 Per ISO 11608-2 Biocompatibility As per ISO 10993-1 As per ISO 10993-1 (successfully passed tests for Cytotoxicity, Hemocompatibility, Sensitization/Skin Reactivity, Acute Systemic Toxicity) Compatibility test (type A needles) As per ISO 11608-2 (torque test) ISO 11608-2 (torque test) Lubrication As per ISO 11608-2 As per ISO 11608-2 Safety mechanism Activation As per ISO 23908 and internal protocol As per ISO 23908, internal protocol and test results. Safety overriding/unlocking force after activation As per ISO 23908 and internal protocol As per ISO 23908, internal protocol and test results. Sterilization As per ISO 11135-1:2007 (for ETO) and ISO 11138-1:2006 (HSKP method) Sterilization process validated using current standard ISO 11135-1:2007 using HSKP method (ISO 11138-1:2006). Shelf life 5 years 5 years from production date. -
Sample sizes used for the test set and the data provenance
The document states "Testing demonstrated the safety feature performance through laboratory testing and simulated user studies." However, it does not specify sample sizes for these tests or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "internal protocol and test results" for the safety mechanism. -
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. The tests mentioned are non-clinical, laboratory, and "simulated user studies," which typically wouldn't involve expert ground truth in the manner of diagnostic image interpretation. -
Adjudication method
This information is not provided as it's not relevant for the type of bench and simulated user testing described. -
If a multi reader multi case (MRMC) comparative effectiveness study was done
No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests were conducted in support of this 510(k) submission." -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical medical device (pen needle with safety feature), not an algorithm or AI system. -
The type of ground truth used
For the non-clinical tests, the "ground truth" would be established by physical measurements against engineering specifications and relevant ISO standards. For the "simulated user studies," the ground truth would be based on predefined criteria for successful activation and locking of the safety mechanism. Pathology or outcomes data are not applicable here as there were no clinical studies. -
The sample size for the training set
This is not applicable as the document describes a physical medical device, not an AI or algorithm that requires a training set. -
How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
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Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2016
Artsana S.p.A c/o Mr. H. Carl Jenkins Official Correspondent The Wood Burditt Group, LLC 10 E. Scranton Ave., Ste. 201 Lake Bluff, Illinois 60044
Re: K151311
Trade/Device Name: Safe Block Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: January 7, 2016 Received: January 11, 2016
Dear Mr. Jenkins:
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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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 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,
Tina Kiang -S
for Erin I. Keith, M.S. 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) K151311
Device Name Safe Block Pen Needle
Indications for Use (Describe)
Safe Block Pen Needle is intended for use with pen injector devices for the injection of fluids, including insulin. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental sticks from the patient end of the needle.
The shield also serves to conceal the needle before and after injection.
Type of Use (Select one or both, as applicable)
| Research Use (Part 21 CFR 601 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201 Subpart G) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for "The Wood Burditt Group". The logo consists of the words "the WOOD BURDITT group" arranged in three lines. A teal-colored curved line wraps around the words "WOOD" and "BURDITT", visually connecting the two words.
510(k) Summary
Date prepared: May 12, 2015
| Submitter / Contact Person | H. Carl JenkinsThe Wood Burditt Group10 E. Scranton Ave, Suite 201Lake Bluff, IL 60044 |
|---|---|
| (ph) 847-234-7500 x 205(fax) 847-578-0728(email) hcjenkins@woodburditt.com |
| Applicant | Artsana S.p.A Via Saldarini Catelli 1, 22070 GrandateCOMO – ITALYRegistration Number: 9612764 |
|---|---|
| Manufacturer | Artsana S.p.A Unit Production N°30, Via Saldarini catelli6/10, 22070 GrandateCOMO - ITALY |
Device Name
| Trade Name | Safe Block Pen Needle |
|---|---|
| Proprietary Name | Safe Block Pen Needle G31x5mmSafe Block Pen Needle G31x8mm |
| Common Name | Sterile Disposable Safety Pen Needle |
| Classification Name | Hypodermic Single Lumen Needle |
| Classification Panel | 80 – General Hospital |
| Regulation | 21 CFR 880.5570 |
| Product Code | FMI |
| Classification | II |
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Reason for 510(k) Submission
The applicant device is a new device.
Device Description
SAFETY PEN NEEDLE. Safe Block Pen Needle is designated for use with pen injector for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. Safe Block Pen Needle are offered in one gauge size (31G) and in a various lengths (5mm and 8mm). The Safe Block Pen Needle is sterile (ETO sterilization), non toxic and non-pyrogenic. It's a disposable single use device.
Additionally the Safe Block Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. Prior to injection the user will attach the Safe Block Pen Needle to the pen. The shield of Safe Block Pen Needle will hide the needle from the user prior to use. As the user proceeds with inserting the needle into the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. The Safe Block Pen Needle should be removed from the pen and discarded.
Indications for Use:
Safe Block Pen Needle is intended for use with pen injector devices for the injection of fluids, including insulin. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental sticks from the patient end of the needle. The shield also serves to conceal the needle before and after injection.
Predicate Device Summary Table
Based on the comparison of the device features, materials, intended use and performance the Safe Block Pen Needle was shown to be substantially equivalent to the commercially available predicate devices indicated in the table below.
| Product | Applicant | 510(k) # | Clearance Date |
|---|---|---|---|
| Artsana Hypodermic needles, Artsana Insupen insulin pen needle | Artsana S.p.A. | K051783 | 2005.10.04 |
| Novo Fine Auto Cover | Novo Nordisk Inc | K050106 | 2005.03.30 |
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Technological characteristics and comparison
Artsana Safe Block 31Gx5 mm and 31Gx8 mm is substantially equivalent to the Novo Nordisk -Novo Fine Autocover (K050106) and the Artsana pen needles (K051783). They are all class II devices and, as explained below, the intended use is the same for all the three products. They are all designed for single use in conjunction with pen injection for subcutaneous administration of drugs approved for delivery using a pen needle, both in hospital and domestic environment. Furthermore, both NovoFine Autocover and Safe Block have safety features to prevent people from needlestick injuries. For what is concerned to the injection, the working principle is the same for all the three devices: before the injection, the protective seal is removed from the plastic primary container. Then, keeping the needle in the container, the threaded hub is screwed on the injection device (as explained in the Safe Block directions for use) and the injection is prepared according to the pen injector directions for use. After the primary container is removed, both Safe Block and Autocover have a further needle shield, that is not removable, hiding the cannula before and after the injection (this is an important feature for people that are afraid of needles).
The needle cover is pushed on the skin, retracting into the product: in this way, the cannula penetrates into the patient's skin and the drug can be delivered. Then, when the cannula is removed from the skin, the shield automatically covers the cannula again: now the shield is permanently locked, protecting the needle tip and both preventing from the pen needle reuse and reducing the risk of accidental injuries. Finally, the needle is removed from the injection device and disposed as per local safety practices and regulations on sharp devices.
| ProductDimensions | Colour ofthe hub | Colour of theprimary container(cover) | Configuration of the tip |
|---|---|---|---|
| G31x5mm | Purple | White | Per ISO 11608-2, section4.5, visually sharp at 2.5Xmagnification, designed tominimizecoring and fragmentation |
| G31x8mm | Light blue | White | Per ISO 11608-2, section4.5, visually sharp at 2.5Xmagnification, designed tominimizecoring and fragmentation |
Predicate device Autocover and applicant device Safe Block have the same working principle of the safety mechanism and they're very similar also in terms of product dimensions and shape.
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Image /page/6/Picture/0 description: The image shows the logo for "The Wood Burditt Group". The words "the" and "group" are stacked on the top and bottom right of the logo. The words "Wood" and "Burditt" are stacked on the top and bottom left of the logo. A teal-colored crescent shape is in the middle of the logo.
Component materials are presented in the table below:
| Component | Applicant Device Material | Predicate Device Material (K051783) |
|---|---|---|
| External cover | PP (non toxic, medical grade) | Identical |
| Needle hub | PP (non toxic, medical grade) | Identical |
| Ring | HDPE (non toxic, medical grade) | Identical |
| Shield | HDPE (non toxic, medical grade) | Identical |
| Primary Container | HDPE (non toxic, medical grade) | Identical |
| Seal | Medical Paper | Identical |
| Cannula | Stainless Steel | Identical |
| Glue | UV acrylate | Identical |
| Lubricant | Silicone oil mixture (non toxic, medical grade) composed by 3 different elements (Dispersion fluid, Medical Silicone, Solvent) | Identical |
| Spring | Stainless Steel | N/A |
| Colorants | Pigments for polymer | Identical |
Clinical test:
No clinical tests were conducted in support of this 510(k) submission.
Non Clinical Tests performed:
Testing demonstrated the safety feature performance through laboratory testing and simulated user studies.
Bench testing related to performance, safety, effectiveness and specifications of the proposed device was also conducted in order to verify the equivalence of performances with the predicate devices.
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Image /page/7/Picture/0 description: The image shows the logo for "The Wood Burditt Group". The words "the" and "group" are stacked on the top and bottom right of the logo. The words "Wood" and "Burditt" are stacked on the left side of the logo. A teal-colored arc is in the middle of the logo.
The Wood Burditt Group LLC
Total E. Scranton Ave., Suite 2011
10 E. Scranton Ave., Suite 2014 144
10 L. Scranton Ave., 2017 14:44
847. 2234. 17. 2234. 17. 12. 12. 12. 12. 12. www.woodburditt.com
| Table of specifications (including relevant tests) for applicant and predicate devices, below: | |||
|---|---|---|---|
| Feature /Characteristics | Applicant Device | Predicate K051783(ARTSANA PENNEEDLES,ARTSANAINJECTIONNEEDLES) | Predicate K050106(NOVOFINEAUTOCOVER 30Gx 8mm) |
|---|---|---|---|
| Intended Use | It is intended for usewith pen injectordevices for theinjection of drugs,including insulin.Additionally theattached safety shieldautomatically locks inplace and reduces theoccurrence ofaccidental sticks fromthe patient end of theneedle. The shieldalso serves to hidethe needle before andafter injection | Insulin delivery | For use inconjunction withinsulin injectiondelivery devices forsubcutaneousadministration ofsterile parenteralinsulin products. |
| Length / Tolerance | 5 mm, 8 mm(toleranceas per ISO 11608-2) | 6 mm, 8 mm, 12 mm(tolerance as per ISO11608-2) | 8 mm (tolerance asper ISO 11608-2) |
| Gauge | G31 (as per ISO9626) | G31, G29 (as per ISO9626) | G30 (as per ISO9626) |
| Tip configuration | Per ISO 11608-2,section4.5, visually sharp at2.5X magnification,designed to minimizecoring andfragmentation | Per ISO 11608-2,section 4.5, visuallysharp at 2.5Xmagnification,designed to minimizecoring andfragmentation | Per ISO 11608-2,section 4.5, visuallysharp at 2.5Xmagnification,designed tominimize coring andfragmentation |
| Cover colour | White | White | Transparent / White |
| Hub/needle bondstrength | Per ISO 11608-2 | Per ISO 11608-2 | - |
| Biocompatibility | As per ISO 10993-1 | As per ISO 10993-1 | - |
| Compatibility test | ISO 11608-2 (torque | ISO 11608-2 (torque | - |
| (type Aneedles) | test) | test) | |
| Lubrication | As per ISO 11608-2 | ISO 11608-2 | - |
| Safety mechanismActivation | As per ISO 23908,internal protocol andtest results | - | As per ISO 23908,internal protocol andtest results |
| Safetyoverriding/unlockingforceafter activation | As per ISO 23908,internal protocol andtest results | - | As per ISO 23908,internal protocol andtest results |
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Image /page/8/Picture/0 description: The image shows the logo for "The Wood Burditt Group". The words "the", "WOOD", and "BURDITT" are stacked on top of each other on the left side of the logo. The word "group" is on the right side of the logo. A teal-colored curved line connects the left and right sides of the logo.
Sterilization:
Product is EO sterilized in house by manufacturer. Sterilization process is validated using current standard ISO 11135-1:2007.
The method used to validate the sterilization cycle is HSKP method (ISO 11138-1:2006)
The shelf life of the product, considering the integrity of the packaging and the sterility and physical properties, is 5 years from the production date. The expiring date and sterilization methods are clearly indicated on the pack. The product shelf life is ensured if the product is stored and transported in compliance with the environmental condition stated on the pack and on the external carton.
Biocompatibility:
The product has successfully undergone the biocompatibility evaluation required by ISO 10993-1 for:
- Cytotoxicity (ISO 10993-5) ,
- Emocompatibility (ISO 10993-4, ASTM F756),
- -Sensitization and skin reactivity (ISO 10993-10),
- -Acute systemic toxicity (ISO 10993-11).
Conclusion
The applicant device is substantially equivalent in its intended use, technology / principal of operation, materials, and performance to the predicate devices identified in this 510(k) submission.
§ 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).