(91 days)
Not Found
No
The device description and performance studies focus on mechanical safety features and standard medical device testing, with no mention of AI or ML.
No
The device is described as being for "injection or aspiration of fluids" and a "needle protection device." There is no indication that it is intended to cure, mitigate, treat, or prevent disease.
No
The device is intended for the injection or withdrawal of fluids, and it is not described as providing any diagnostic information or measurements.
No
The device description clearly details a physical hypodermic needle and syringe with a safety mechanism, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to inject fluids or withdraw fluids from the body." This describes a device used for direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo (within the living organism).
- Device Description: The description details a hypodermic needle and syringe with a safety mechanism. This is a device used for administering substances or collecting samples from the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples in vitro (in a test tube or lab setting). There is no mention of reagents, test strips, analyzers, or any other elements typically associated with IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This device's function is to facilitate the collection or administration of substances, not the analysis of those substances or other biological samples.
N/A
Intended Use / Indications for Use
The device is intended for use to inject fluids or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.
Product codes
FMI, FMF, MEG
Device Description
The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is intended for injection or aspiration of fluids using a Luer slip syringe. The Needle-Protection device covers the needle after use to help prevent needle sticks. The device features a "one-piece" design of polypropylene needle hub and protective sheath with a living hinge. The stainless-steel needle cannula is permanently affixed into the hub. The sheath has an "arrow" indicating the bevel orientation, i.e. when the sheath is oriented to the right, the bevel is in the "up position." After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the lugs on the needle hub snap into the clips of the protective sheath resulting in a "bottom snap" and the needle is contained within the sheath. In addition to the "bottom snap," the Needle-Protection sheath has 2 retaining hooks. The EDGE™ safety device may be removed from the syringe when required by a specific medical procedure.i.e., the EDGE™ safety device may be removed from a blood sampling syringe to process the blood sample. The EDGE™ safety device is then discarded into a sharps container. The Subject device is comprised of a 1mL Luer lock syringe with a 23G x 1.5in needle/cannula. This configuration is not currently offered within the Smiths Medical portfolio of Hypodermic Needle-Pro® EDGE™ with syringe devices.
The Subject Needle-Pro®EDGE™ Safetv Device with Svringe is offered in the following configurations.
Syringe Size (mL) Luer Lock: 1mL
Needle Gauge (G) and Length (in): 23G x 1 ½"
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
The following performance data were provided in support of the substantial equivalence determination:
- Biocompatibility Testing: Leveraged from the predicate submission.
- Sterilization: The device is sterilized by ethylene oxide according to the same method as the predicate device. A Microbiology Product Adoption confirmed the device is similar in componentry, packaging and complexity to other hypodermic needles and will not have an adverse effect on the currently validated Ethylene Oxide sterilization performed. No new sterilization validation is required.
- Shelf Life: Shelf-Life Verification studies were conducted at T=0 and T=2 under accelerated aging conditions to verify that the claimed shelf life of 2 years is supported. No failures were identified.
- Non-Clinical Bench Verification Testing: Device specific non-clinical bench testing was performed in accordance with the pertinent FDA consensus standards. The performance and design testing included:
- ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
- ISO 6009:2016 Hypodermic needles for single use Colour coding for identification
Compliance to ISO 594-2 for Luers on the Needle Hub/Safety Sheath and Hypodermic Syringe serves as risk mitigation for potential incompatibility issues. The remaining standards applied are derived from recommended consensus standards by product code and predicate submission.
- Clinical Studies: Not deemed necessary to support the substantial equivalence decision as device technologies are equivalent to the predicate device and it is not introduced for new clinical indications or environments.
Key results: Results of the testing conducted, demonstrate the Subject device will perform as intended for the identified indications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 26, 2021
Smiths Medical ASD, Inc. Adam Johnson Director, Global Regulatory & Quality Systems 6000 Nathan Lane North Minneapolis, Minnesota 55442
Re: K211634
Trade/Device Name: Hypodermic Needle-Pro EDGE Safety Device Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI, FMF Dated: July 28, 2021 Received: July 30, 2021
Dear Adam Johnson:
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.
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
1
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 medical devices and radiation-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,
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
2
Indications for Use
510(k) Number (if known) K211634
Device Name
Hypodermic Needle-Pro® EDGE™ Safety Device
Indications for Use (Describe)
The device is intended for use to inject fluids or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K211634
a. Device Name
Hypodermic Needle-Pro® EDGE™ Safety Device
Common Name
Hypodermic Syringe
b. Manufacturer Information
Applicant, 510(k) Owner
Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 Establishment Registration: 3012307300
Name of Contact Person
Dominique E. Neisz Senior Regulatory Affairs Specialist 6000 Nathan Lane North Minneapolis, MN 55442 Telephone: 763-383-3000
Date Prepared
August 26, 2021
c. Device Classification and Number
Name of Device: Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe Common or Usual Name: Needle, hypodermic, single lumen Classification: II
Classification Regulation Number & Name: 880.5570 (Hypodermic Single Lumen Needles) & 880.5860 (Piston Syringes) Panel: 80, General Hospital Product Code: FMI & FMF & MEG
d. Predicate Device Information
K071785 (Smiths Medical ASD, Inc.) Hypodermic Needle-Pro® EDGE™ Safety Device and EDGE™ Safety Device with Syringe. The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is substantially equivalent in performance, indications, design, and materials to the Hypodermic Needle-Pro® EDGE™ Safety Device, cleared under Premarket notification # K071785.
e. Device Description
Subject Device: The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is intended for injection or aspiration of fluids using a Luer slip syringe. The Needle-Protection device covers the needle after use to help prevent needle sticks. The device features a "one-piece" design of polypropylene needle hub and protective sheath with a living hinge. The stainless-steel needle cannula is permanently affixed into the hub. The sheath has an "arrow" indicating the bevel orientation, i.e. when the sheath is oriented to the right, the bevel Confidential Supplement to Special 510(k): K211634 1 of 69
4
is in the "up position." After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the lugs on the needle hub snap into the clips of the protective sheath resulting in a "bottom snap" and the needle is contained within the sheath. In addition to the "bottom snap," the Needle-Protection sheath has 2 retaining hooks. The EDGE™ safety device may be removed from the syringe when required by a specific medical procedure.i.e., the EDGE™ safety device may be removed from a blood sampling syringe to process the blood sample. The EDGE™ safety device is then discarded into a sharps container. The Subject device is comprised of a 1mL Luer lock syringe with a 23G x 1.5in needle/cannula. This configuration is not currently offered within the Smiths Medical portfolio of Hypodermic Needle-Pro® EDGE™ with syringe devices.
The Subject Needle-Pro®EDGE™ Safetv Device with Svringe is offered in the following configurations.
| Syringe Size
(mL)
| Luer Lock | 1mL |
|---|---|
| Needle Gauge | |
| (G) and Length | |
| (in) | 23G x 1 ½" |
Indications for Use of the Device: The device is intended for use to inject fluids or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.
Technological Characteristics Compared to Predicate Device: Hypodermic Needle iniection or aspiration therapies are commonly performed clinical practices, intended to either deliver a measured dosage of a medicinal product, or to obtain patient fluids from below the surface of the skin. This application is consistent in both the predicate and subject devices. The Hypodermic Needle-Pro® EDGE™ Safety Device is substantially equivalent in performance, indication, design, and materials to the current Hypodermic Needle-Pro® EDGE™ Safety Device, cleared under Premarket notification K071785 as summarized by the key technological characteristics listed below.
- Stainless Steel Cannula used to puncture the patient's skin and act as a sterile fluid path. ●
- Polypropylene Syringe primary operating mechanism for either the delivery or aspiration . of fluids.
- Needle Hub/Protection Sheath primary operating mechanism for sharps safety and . needle stick protection.
The introduction of the Subject device has not modified the existing technologies or physical characteristics of device components compared to the predicate Hypodermic Needle- Pro® EDGE™ Safety Device. The Subject device configuration presents the following differences from the predicate device.
1 mL Polypropylene Syringe combined with 1 1/2 in 23G Needle – The constituent . components (Hub and Needle) are offered in other configurations but not together as found in the Subject device.
A comprehensive comparison of the Subject device to the predicate device is provided in Table 3.
5
Table 3: Predicate Device Comparison:
| Characteristic | Predicate Device - Hypodermic Needle-Pro®
EDGE™ Safety Device with Syringe: K071785 | Subject Device -
Hypodermic
Needle-Pro®
EDGE™ Safety
Device with
Syringe: K211634 |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Indications for Use | The device is intended for use to inject fluids or
withdraw fluids from the body. The needle protection
device covers the needle after use to help prevent
needle sticks. | Same |
| Sterilization Method | EtO | Same |
| Single Use | Yes | Same |
| Prescription | Yes | Same |
| Packaging | Form Fill Seal, Coated Paper "top web"/polyethylene-
nylon coextrusion "bottom web" | Same |
| Safety Feature (Active
or Passive) | Active | Same |
| On-handed safety
activation | Yes | Same |
| Hinge Style safety
feature | Yes | Same |
| Needle is permanently
attached to the
Needle-Protection | Yes | Same |
| Color Code reflects
needle gauge size | Yes, for needle hub and protective sheath | Same |
| Safety feature is
supplied as an integral
part of the hypodermic
needle | Yes | Same |
| Components | |||||
|---|---|---|---|---|---|
| Device | |||||
| Configuration | |||||
| Syringe and | |||||
| Needle Gauge X | |||||
| Length | 1mL | 3mL | 5mL | 10mL | Same, with the |
| addition of a | |||||
| configuration that | |||||
| includes a 1mL Luer | |||||
| lock syringe and 23G | |||||
| X 1 ½" needle |
6
| | 25G X 1"
25G X 5/8"
27G X 1/2" | 18G X 1"
18G X 1 ½"
19G x 1"
19G X 1 ½"
20G x 1"
20G X 1 ½"
21G X 1"
21G X 1 ½"
22G X 1"
22G X 1 ½"
23G X 1"
23G X 1 ½"
25G X 1"
25G X 5/8" | 20G X 1"
21G X 1 ½" | 20G X 1"
20G X 1 ½"
21G X 1 ½" | |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|--------------------------------------|------|
| Needle
Hub/Needle-
Protection Sheath | "One-piece" design with "bottom snap", no dead space is
added by protective sheath | | | Same | |
| Materials | | | | | |
| Needle | 304 SS cannula | | | | Same |
| Protection
Sheath/Hub | "one piece" polypropylene hub/protective sheath with
respective gauge size colorant, UV cured adhesive, silicone
lubricant | | | | |
f. Performance Data: The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility testing was leveraged from the predicate submission.
Sterilization
The Hypodermic Needle-Pro® EDGE™ Safety Device is sterilized by ethylene oxide according to the same method as the predicate device.
To confirm the changes to the Subject device automation parameters do not impact the sterility of the device a Microbiology Product Adoption was performed in accordance with AAMI TIR28:2016. The Microbiology Product Adoption confirmed the Subject device is similar in componentry, packaging and complexity as all other Hypodermic needles currently manufactured at the Smiths Medical Keene, NH site, and the Subject device will not have an adverse effect on the currently validated Ethylene Oxide sterilization performed. No new sterilization validation is required to use the Subject device with the existing validated Sterilization process.
Shelf Life
Shelf-Life Verification studies were conducted at T=0 and T=2 under accelerated aging conditions to verify that the claimed shelf life of 2 years is supported. There were no failures identified indicating the claimed expiration date is supported.
Non-Clinical Bench Verification Testing
Device specific non-clinical bench testing was performed in accordance with the pertinent FDA consensus standards. The performance and design testing conducted serve as the primary means for establishing substantial equivalence, the testing included the following:
7
- . ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- . ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- . ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- . ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
- ISO 6009:2016 Hypodermic needles for single use Colour coding for identification .
The compatibility of the Needle Hub/Safety Sheath and the Hypodermic Syringe was considered the technological characteristic which introduced the greatest risk of the Subject device. Potential incompatibility issues may result in misconnection, and consequently leakage, delay in therapy, or repeated procedures to ensure patients receive appropriate dosages. Compliance to ISO 594-2 for Luers found on the Needle Hub/Safety Sheath and Hypodermic Syringe serve as the risk mitigations to the aforementioned safety concerns.
The remaining standards applied for performance and design evaluation are derived from the recommended consensus standards by product code and the predicate submission.
Clinical Studies
Clinical studies were not deemed necessary to support the substantial equivalence decision. The device technologies in the subject device are equivalent to the predicate device. Additionally, the Subject device is not being introduced to cater to a new set of clinical indications or environments which may require additional clinical feedback to support the basis for substantial equivalence.
Conclusion
The non-clinical data received through the biocompatibility, sterilization, shelf-life, performance, and design testing provide the required information to support substantial equivalence. Results of the testing conducted, demonstrate the Subject device will perform as intended for the identified indications.
Based on the comparison and analysis above, the Subject device is determined to be Substantially Equivalent (SE) to the predicate devices.