(178 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functional performance of a pen needle, with no mention of AI or ML.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a pen needle used for subcutaneous injection of drug products, which is a delivery mechanism, not a therapeutic action in itself. The drug products it delivers might be therapeutic, but the device itself is a drug delivery device.
No
The device is a pen needle intended for drug injection, not for diagnosing medical conditions.
No
The device description explicitly states it is a "pen needle device" which is a physical, hardware component. The performance studies also focus on physical characteristics and functional performance of the needle.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous injection of fluid drug products." This describes a device used to administer substances into the body, not to test samples from the body.
- Device Description: The description details a "pen needle device" used for injection, focusing on its physical components for delivering fluid. This aligns with an injection device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for drug delivery.
N/A
Intended Use / Indications for Use
Omnican fine is intended for use with compatible needle-based injection for subcutaneous injection of fluid drug products.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Omnican fine is a pen needle device that is a sterile, individually packaged, single use, hypodermic single lumen needle; intended for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products. Omnican fine is a double-ended needle consisting of a tri-beveled tip, hollow steel cannula, and needle hub packaged in a hard plastic sealed container. Specific versions contain an inner needle shield. The Omnican fine provides a fluid path from a drug container to subcutaneous tissue. There are no restrictions in the patient/user population.
To utilize the needle, the primary package is opened by removal of the seal and the exposed part of the needle is securely fastened onto the injection device. Once fastened, the needle penetrates the septum of the cartridge inside the injector. The primary container is then removed from the lower (distal) part, the patient end, of the needle. For versions that contain an inner needle shield, the shield is to be removed shortly before injection. The device is now ready for use for subcutaneous injection of fluid drug products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
any patient population
Intended User / Care Setting
physician prescribed device
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)
The Omnican fine was subjected to functional performance testing to demonstrate that the device performs as intended. The following tests were performed:
- Dimensions
- Usable length of needle tube
- Length cartridge end of needle
- Flow Rate
- According to product specification
- Blockage/Patency of inner lumen
- Connection of needle hub to the needle tube
- Connection of needle hub
- Tensile load
- Tube Tips
- Needle tube tip patient end
- Needle tube tip cartridge end
- Freedom from damages and defects
- Lubricants
- Siliconizing needle tube patient end
- Siliconizing needle tube cartridge end
- Dislocation of measuring point at patient end of pen needle
- Compatibility with needle based injection system (NIS)
- Torque on/off
- Dose accuracy
- Ease of assembly/disassembly
- Accelerated ageing was conducted to prove a shelf life of 5 years
Omnican fine met all established acceptance criteria required for performance and design verification testing. Results of the functional performance and biocompatibility testing conducted along with the same indications for use, intended use and similar technological characteristics demonstrate that the Omnican fine 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.
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
§ 880.5570 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 contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two distinct elements: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 11, 2018
B. Braun Medical Inc. Kimberly Smith Sr. Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109
Re: K173803
Trade/Device Name: Omnican fine Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: May 11, 2018 Received: May 11, 2018
Dear Kimberly Smith:
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.
1
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); 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tina Kiang -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Omnican fine
Indications for Use (Describe)
Omnican fine is intended for use with compatible needle-based injection for subcutaneous injection of fluid drug products.
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
| 510(k) Summary | K173803 |
|---|---|
| SUBMITTER: | B. Braun Medical Inc. |
| 901 Marcon Boulevard | |
| Allentown, PA 18109-9341 | |
| 610-266-0500 | |
| Contact: Kimberly Smith, Sr. Regulatory Affairs Specialist | |
| Phone: (610) 596-2326 | |
| Fax: (610) 266-4962 | |
| E-mail: Kim.smith@bbraun.com | |
| DATE: | December 13, 2017 |
| DEVICE NAME: | Omnican fine |
| COMMON NAME: | Pen needle; Hypodermic single lumen needle |
| CLASSIFICATION: | Class II per 21 CFR 880.5570, Needle, hypodermic, single lumen |
| Product Code: FMI | |
| Panel: General Hospital | |
| PREDICATE DEVICE: | Pencylcap |
| B. Braun Melsungen AG | |
| K152050, Class II, FMI, 880.5570 |
Description
The Omnican fine is a pen needle device that is a sterile, individually packaged, single use, hypodermic single lumen needle; intended for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products. Omnican fine is a double-ended needle consisting of a tri-beveled tip, hollow steel cannula, and needle hub packaged in a hard plastic sealed container. Specific versions contain an inner needle shield. The Omnican fine provides a fluid path from a drug container to subcutaneous tissue. There are no restrictions in the patient/user population.
To utilize the needle, the primary package is opened by removal of the seal and the exposed part of the needle is securely fastened onto the injection device. Once fastened, the needle penetrates the septum of the cartridge inside the injector. The primary container is then removed from the lower (distal) part, the patient end, of the needle. For versions that contain an inner needle shield, the shield is to be removed shortly before injection. The device is now ready for use for subcutaneous injection of fluid drug products.
Intended Use
Omnican fine is intended for use with needle-based injection devices for subcutaneous injection of fluid drug products. Omnican fine is intended for single usage with the needle-based injection
4
system (NIS) according to the instructions of the NIS. The Omnican fine pen needle may be used for any patient population. The Omnican fine is a physician prescribed device.
Indications for Use
Omnican fine is intended for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products.
Substantial Equivalence
Predicate Device - B. Braun Melsungen AG, Pencylcap (K152050)
The Omnican fine is substantially equivalent to the predicate device. Both devices are sterile, individually packaged, for single use only. Both devices have the same intended use and indications for use. Both devices have the same principle of operation and the same fundamental scientific technology. Both devices are produced at the same manufacturing facility. The sterilization process is the same and has been validated according to the same procedures. Primary packaging that assures sterility and shelf life are the same for the critical sealing area. Besides the product name, the following differences apply to the Omnican fine compared to the predicate:
- · The shape of the needle container. This difference has no impact on the finished device.
- · The needle tube is glued to the needle hub for Omnican fine, whereas the Pencylcap needle tube is welded to the hub. This difference was assessed by B. Braun and found to have no impact on the safety and effectiveness of the Omnican fine. Both versions comply with the effective standards.
- · The material of the needle hub for Omnican fine is Polypropylene, for Pencylcap it is Copolyester. This difference was assessed by B. Braun and found to have no impact on the safety and effectiveness of the Omnican fine.
- · The optional needle shield component in the Omnican fine was not a component for the Pencylcap. As the needle shield has no direct body contact to the user and no special safety function, this change does not affect the safety and effectiveness of the Omnican fine.
- · Three additional sizes of the needle tube are included in the Omnican fine range.
Comparison of Technological Characteristics with the Predicate Device
The Omnican fine possesses similar technological characteristics as the predicate B. Braun Medical Pencylcap device cleared under 510(k) K152050. The following table provides a side by side summary of comparison.
| Feature | Predicate Device
Pencylcap K152050 | Proposed Device
Omnican fine |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Pencylcap is intended for use with needle- | Omnican fine is intended for use with |
| | based injection devices for subcutaneous | needle-based injection devices for |
| | injection of fluid drug products. Pencylcap | subcutaneous injection of fluid drug |
| | is intended for single usage with the needle- | products. Omnican fine is intended for |
| | based injection system (NIS) according to | single usage with the needle-based injection |
| | the instructions of the NIS. The Pencylcap | system (NIS) according to the instructions |
| | may be used for any patient population. The | of the NIS. The Omnican fine may be used |
| | Pencylcap pen needle is a physician | for any patient population. The Omnican |
| | prescribed device. | fine is a physician prescribed device. |
| | | |
| Feature | Predicate Device
Pencylcap K152050 | Proposed Device
Omnican fine |
| Indications for Use | The Pencylcap is intended for use with
needle-based injection devices for
subcutaneous injection of fluid drug
products. | Omnican fine is intended for use with
needle-based injection devices for
subcutaneous injection of fluid drug
products. |
| Operating Principle | Manually operated according to the
instructions for use provided with the
finished device. | Manually operated according to the
instructions for use provided with the
finished device. |
| Mechanism of Action | Allow subcutaneous injection of fluid drugs
when attached to a needle-based injection
system (NIS). | Allow subcutaneous injection of fluid drugs
when attached to a needle-based injection
system (NIS). |
| Declared compatible
needle-based injection
systems (NIS): | Gonal-f® RFF Redi-ject™ | BMS AstraZeneca:
Byetta® (BMS = Bristol-Myers Squibb)
Lilly:
HumaPen® Luxura, HumaPen® Luxura
HD, HumaPen® Memoir, HumaPen®
Savvio, KwikPenTM
Novo Nordisk:
FlexPen®, FlexTouch®, NovoPen Echo®,
Victoza®
Owen Mumford:
Autopen® 24, Autopen® Classic 1,
Autopen® Classic 2
Sanofi:
SoloStar® |
| Design / Technological
Characteristics | Needle is welded to hub. | Needle is glued to hub. |
| Lengths: | Needle tube length on patient end:
12mm | Needle tube length on patient end:
12 mm; 8 mm; 6 mm; 4 mm |
| OD/ID: | Needle tube diameter:
OD: 0.33 mm
ID: 0.19 ± 0.01 mm | Needle tube diameter:
OD: 0.33 mm; 0.25 mm
ID: 0.19 ± 0.01 mm; 0.125 + 0.035 mm |
| Gauge Sizes: | Gauge sizes: 29 Gauge
Features:
Tri-beveled needle tip configuration.
Single use only. | Gauge sizes: 29 Gauge; 31 Gauge
Features:
Tri-beveled needle tip configuration.
Single use only. |
| Feature | Predicate Device
Pencylcap K152050 | Proposed Device
Omnican fine |
| Summary of nonclinical
performance tests for
determination of
substantial equivalence | Measurement of needle tube length:
Injector end: 6.15 +0.5/-0.3 mm
Patient End: 12 +1.1/-0.8 mm | Measurement of needle tube length:
Injector end: 6.15 +0.5/-0.3 mm
Patient End: 12 +1.1/-0.8 mm
8 +1.1/-0.8 mm
6 +1.1/-0.8 mm
4 + 1.25/-0.0 mm |
| | Dislocation of measuring point at the end of
the needle:
≤ 1.1 mm based on a needle length of 12 mm | Dislocation of measuring point at the end of
the needle:
≤ 1.1 mm based on a needle length of 12 mm
≤ 0.9 mm based on a needle length of 8mm
≤ 0.7 mm based on a needle length of 6mm
≤ 0.6 mm based on a needle length of 4mm |
| | Bond between the needle hub and needle
tube:
The needle hub/needle tube bond must be
capable of withstanding a 22 N force
applied axially for 5 seconds. | Bond between the needle hub and needle
tube:
The needle hub/needle tube bond must be
capable of withstanding a 22 N force
applied axially for 5 seconds. |
| | Unscrewing torque of the needle: