(254 days)
Not Found
No
The device description and performance studies focus on mechanical design, material properties, and standard safety features of a syringe and needle protection device. There is no mention of AI or ML in the provided text.
No.
A therapeutic device is used to treat or cure a disease or condition. This device is an injection/aspiration system used for fluid management, which is a supportive function, not a direct treatment.
No
This device is described as an injection and aspiration device, used for administering or withdrawing fluids, rather than analyzing or interpreting data for diagnostic purposes.
No
The device description clearly details physical components like a needle, syringe, hub, sheath, and plunger, and the performance studies focus on biocompatibility, sterilization, shelf-life, and bench testing of these physical attributes. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to inject fluids into 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 syringe and needle system designed for injecting or aspirating fluids. It focuses on features related to fluid delivery/withdrawal and needle safety.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living organism) to provide information for diagnostic, monitoring, or compatibility purposes. The provided description does not mention any such use or interaction with patient specimens outside the body.
Therefore, this device falls under the category of a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.
Product codes (comma separated list FDA assigned to the subject device)
QNQ, FMI, MEG
Device Description
The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is intended for injection or aspiration of fluids using a Luer lock (LL) or Luer slip syringe. The device is provided sterile and is for single use only. The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is an extension of Smiths Medical's Hypodermic Needle-Pro® EDGE™ product portfolio. The Low Dead-Space (LD) Syringe new component - is added to form new device combo with the previously cleared Hypodermic Needle-Pro® EDGE™ Safety Device. The device combo is intended to offer an optimization of the volume of fluids injected to patients, and thus reduce the amount of medical product remaining in the needle and the syringe's hub after injection.
The Needle-Protection (Needle-Pro) EDGE™ safety device covers the needle after use to help prevent needle sticks. The device features a one-viece design of polypropylene needle hub and protective sheath with a living hinge. The stainless-steel needle cannula is permanently affixed into the hub. After a procedure is completed, the needle is pressed into the sheath using a one-handed technique and the needle is contained within the sheath.
The Low Dead-Space (LD) Syringe is a new component to be used along with the Hypodermic Needle-Pro® EDGE™ Safety Device. The LD Syringe is designed with luer lock (LL) connection to provide a secure and leak-free connection between the syringe and the needle and maintain a continuous lumen for fluid flow. The LD Syringe plunger is designed for less product waste without changing the use of the device. The Syringe plunger tip extends into the syringe neck reducing fluid waste. The fluid waste is about 0.010 mL (10 µL), max = 0.015 mL (15 µL) for the LD syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing was performed per ISO 10993-1:2018.
Sterilization testing was performed per ISO 11135:2014 and AAMI TIR28:2016.
Shelf-Life testing was performed per ISO 11607:2019.
Non-Clinical Bench Verification Testing was performed per ISO 80369-1:2018 and ISO 7886-1:2017.
The subject device was adopted into the following non-clinication testing of the predicate device: ISO 7864:2016, ISO 23908:2011, ISO 9626:2016.
All performance testing was conducted according to the applicable ISO standards and met all predefined acceptance criteria. As such, the subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Hypodermic Needle-Pro® EDGE™ Safety Device (Smiths Medical ASD, Inc.) K211634
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 31, 2024
Smiths Medical ASD, Inc. Benjamin Rappaport Regulatory Affairs Specialist 6000 Nathan Lane North Minneapolis, Minnesota 55442
Re: K232943
Trade/Device Name: Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QNQ, FMI, MEG, Dated: April 30, 2024 Received: May 1, 2024
Dear Benjamin Rappaport:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Silicelely,
Shruti N. Mistry =S 2024.05.31 15:07:21
Shruti N. Mistry =S =04'00'
Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232943
Device Name
Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe
Indications for Use (Describe)
This device is intended for use to inject fluids into 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)
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3
K232943-510(k) Summary
Date Prepared
April 30, 2024
a. Device Information
- Device Names Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe
b. Manufacturer Information
| Applicant, 510(k) owner | Smiths Medical ASD, Inc.
6000 Nathan Lane North
Minneapolis, MN 55442
Establishment Registration: 3012307300 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Benjamin Rappaport
Regulatory Affairs Associate II
6000 Nathan Lane North
Minneapolis, MN 55442
Telephone: (763) 383-3000 |
c. Device Classification and Number
| Name of the Devices: | Hypodermic Needle-Pro® EDGET™ Safety Device with Low Dead Space Syringe |
|---|---|
| Common or Usual Names: | Sterile Low Dead Space Piston Syringe, Needle, Hypodermic |
| Classification: | II |
| Regulation Numbers and Names: | 21CFR880.5860 – Piston syringe |
| 21CFR880.5570 – Hypodermic Single Lumen Needles | |
| 510(k) Review Panels: | General Hospital |
| Product Codes: | QNQ, FMI, MEG |
d. Predicate Devices Information
Hypodermic Needle-Pro® EDGE™ Safety Device (Smiths Medical ASD, Inc.) K211634
e. Indications for Use
4
This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.
f. Device Description
The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is intended for injection or aspiration of fluids using a Luer lock (LL) or Luer slip syringe. The device is provided sterile and is for single use only. The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is an extension of Smiths Medical's Hypodermic Needle-Pro® EDGE™ product portfolio. The Low Dead-Space (LD) Syringe new component - is added to form new device combo with the previously cleared Hypodermic Needle-Pro® EDGE™ Safety Device. The device combo is intended to offer an optimization of the volume of fluids injected to patients, and thus reduce the amount of medical product remaining in the needle and the syringe's hub after injection.
The Needle-Protection (Needle-Pro) EDGE™ safety device covers the needle after use to help prevent needle sticks. The device features a one-viece design of polypropylene needle hub and protective sheath with a living hinge. The stainless-steel needle cannula is permanently affixed into the hub. After a procedure is completed, the needle is pressed into the sheath using a one-handed technique and the needle is contained within the sheath.
The Low Dead-Space (LD) Syringe is a new component to be used along with the Hypodermic Needle-Pro® EDGE™ Safety Device. The LD Syringe is designed with luer lock (LL) connection to provide a secure and leak-free connection between the syringe and the needle and maintain a continuous lumen for fluid flow. The LD Syringe plunger is designed for less product waste without changing the use of the device. The Syringe plunger tip extends into the syringe neck reducing fluid waste. The fluid waste is about 0.010 mL (10 µL), max = 0.015 mL (15 µL) for the LD syringe.
g. Technological Characteristics Compared to Predicate Device
The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is substantially equivalent in performance, indication, design, and materials to the current Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe, cleared under Premarket notification K211634.
The introduction of the proposed configuration has modified the existing syringe by lengthening 0.043". The physical characteristics differ in the materials used, which are addressed through biocompatibility testing per ISO 10993-1:2018. The differences are in comparison with the predicate: Hypodermic Needle-Pro® EDGETM Safety Device with Syringe.
Device Comparison Table
| Characteristic | Predicate Device – K211634 | Subject Device | Comparison |
|---|---|---|---|
| Hypodermic Needle-Pro® | |||
| EDGE™ Safety Device with | |||
| Syringe | Hypodermic Needle-Pro® | ||
| EDGE™ Safety Device with | |||
| Syringe | |||
| General |
5
| Characteristic | Predicate Device – K211634 | Subject Device | Comparison | |||
|---|---|---|---|---|---|---|
| Hypodermic Needle-Pro® | ||||||
| EDGE™ Safety Device with | ||||||
| Syringe | Hypodermic Needle-Pro® | |||||
| EDGE™ Safety Device with | ||||||
| Syringe | ||||||
| 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. | 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 | |||||
| Single Use | Yes | Yes | Same | |||
| Prescription | Yes | Yes | Same | |||
| Packaging | Form Fill Seal, Coated Paper | |||||
| "top web"/polyethylene- nylon | ||||||
| coextrusion "bottom web" | Form Fill Seal, Coated Paper | |||||
| "top web"/polyethylene- nylon | ||||||
| coextrusion "bottom web" | Same | |||||
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same | |||
| Hypodermic Needle-Pro® EDGE™ Safety Device | ||||||
| Safety Feature (Active | ||||||
| or Passive) | Active | Active | Same | |||
| On-handed Safety | ||||||
| Activation | Yes | Yes | Same | |||
| Hinge Style Safety | ||||||
| Feature | Yes | Yes | Same | |||
| Needle Permanently | ||||||
| attached to the Needle- | ||||||
| Protection | Yes | Yes | Same | |||
| Color Code to Reflect | ||||||
| Needle Gauge Size | Yes, for needle hub and | |||||
| protective sheath | Yes, for needle hub and | |||||
| protective sheath | Same | |||||
| Safety Feature as | ||||||
| Integral part of the | ||||||
| Hypodermic Needle | Yes | Yes | Same | |||
| Needle Gauge X | ||||||
| Length | ||||||
| (Available on the finished | ||||||
| goods. See also Combo | ||||||
| below) | 18G X 1" | |||||
| 19G X 1" | ||||||
| 20G X 1" | ||||||
| 21G X 1" | ||||||
| 22G X 1" | ||||||
| 23G X 1" | ||||||
| 25G X 1" | ||||||
| 27G X ½" | 18G X 1 ½" | |||||
| 19G X 1 ½" | ||||||
| 20G X 1 ½" | ||||||
| 21G X 1 ½" | ||||||
| 22G X 1 ½" | ||||||
| 23G X 1 ½" | ||||||
| 25G X 5/8" | 23G X 1 ½" | |||||
| 25G X 1" | 23G X 1 ½" | |||||
| 25G X 5/8" | Matching | |||||
| configurations | ||||||
| Needle Material | 304 SS cannula | 304 SS cannula | Same | |||
| Syringe | ||||||
| Syringe | ||||||
| Size | 1mL | x | x | |||
| 3mL | x | x | Matching | |||
| configurations | ||||||
| 5mL | x | |||||
| Characteristic | Predicate Device – K211634 | |||||
| Hypodermic Needle-Pro® | ||||||
| EDGE™ Safety Device with | ||||||
| Syringe | Subject Device | |||||
| Hypodermic Needle-Pro® | ||||||
| EDGE™ Safety Device with | ||||||
| Syringe | Comparison | |||||
| 10mL | x | - | ||||
| Syringe | ||||||
| Length | 1mL | 5.888" ± 0.005" | ||||
| with Needle Pro EDGE Long | ||||||
| ~3.767" | ||||||
| without Needle Pro EDGE Long | 3.724" ± 0.005" (94.6 mm) | |||||
| without Needle Pro EDGE Long | Slight difference | |||||
| between the | ||||||
| predicate device | ||||||
| syringe and | ||||||
| proposed subject | ||||||
| device about | ||||||
| 0.043" (1.1 mm). | ||||||
| 3mL | 5.510" ± 0.005" | |||||
| with Needle Pro EDGE Long | ||||||
| ~3.388" | ||||||
| without Needle Pro EDGE Long | 3.346" ± 0.005" (85 mm) | |||||
| without Needle Pro EDGE Long | ||||||
| Syringe | ||||||
| Assembly | ||||||
| Material | Gasket | Elastomer resin | IR rubber | Material | ||
| differences were | ||||||
| addressed | ||||||
| through | ||||||
| biocompatibility | ||||||
| testing per ISO | ||||||
| 10993-1:2018. | ||||||
| Plunger | Polypropylene | Polypropylene | ||||
| Barrel | Polypropylene | Polypropylene | ||||
| Lubricant | Silicone | Silicone | ||||
| Luer Lock | Yes | Yes | Same | |||
| Luer Compliance | ISO 594-1 and 594-2 | ISO 80369-7 | ||||
| Dead Space | ||||||
| Specification | Standard Dead Space | |||||
| ~ 0.070mL of fluid waste | Low Dead Space | |||||
| ~ 0.010mL of fluid waste | ||||||
| Max: ≤0.015mL | Lower fluid | |||||
| waste with the | ||||||
| subject device | ||||||
| Finished Good: Needle + Syringe Combo | ||||||
| Combo Configuration | ||||||
| (Syringe, Needle Gauge X | ||||||
| Length) | 1mL, 25G X 1" | |||||
| 1mL, 27G X ½" | ||||||
| 3mL, 18G X 1" | ||||||
| 3mL, 19G X 1" | ||||||
| 3mL, 20G X 1" | ||||||
| 3mL, 21G X 1" | ||||||
| 3mL, 22G X 1" | ||||||
| 3mL, 23G X 1" | ||||||
| 3mL, 25G X 1" | ||||||
| 5mL, 20G X 1" | ||||||
| 10mL, 20G X 1" | 1mL, 23G X 1 ½" | |||||
| 1mL, 25G X 5/8" | ||||||
| 3mL, 18G X 1 ½" | ||||||
| 3mL, 19G X 1 ½" | ||||||
| 3mL, 20G X 1 ½" | ||||||
| 3mL, 21G X 1 ½" | ||||||
| 3mL, 22G X 1 ½" | ||||||
| 3mL, 23G X 1 ½" | ||||||
| 3mL, 25G X 5/8" | ||||||
| 5mL, 21G X 1½" | ||||||
| 10mL, 20G X 1 ½" | ||||||
| 10mL, 21G X 1 ½" | 1mL, 23G X 1 | |||||
| 1/2" | ||||||
| 1mL, 25G X 1" | ||||||
| 3mL, 25G X 1" | 1mL, 25G X 5/8" | |||||
| 3mL, 23G X 1 ½" | Matching | |||||
| configurations | ||||||
| Note: Symbol “x”: available as part of the device combo | ||||||
| Symbol “-”: not available on the subject device combo |
6
h. Performance Data
Biocompatibility Testing was performed per ISO 10993-1:2018.
7
Sterilization testing was performed per ISO 11135:2014 and AAMI TIR28:2016.
Shelf-Life testing was performed per ISO 11607:2019.
Non-Clinical Bench Verification Testing was performed per ISO 80369-1:2018 and ISO 7886-1:2017.
The subject device was adopted into the following non-clinication testing of the predicate device: ISO 7864:2016, ISO 23908:2011, ISO 9626:2016.
All performance testing was conducted according to the applicable ISO standards and met all predefined acceptance criteria. As such, the subject device is substantially equivalent to the predicate device.
i. Conclusion
The subject device has the same intended use and indications for use as the predicate. The subject device has the same characteristics and principles of operation. The differences between devices are demonstrated through device non-clinical bench testing. The subject device is substantially equivalent to the predicate device.