(112 days)
Not Found
No
The device description and performance studies focus on the physical components and functional performance of an infusion set, with no mention of AI or ML capabilities.
No.
The device facilitates the delivery of therapeutic fluids but is not inherently therapeutic itself.
No
The device is described as an infusion catheter indicated for the subcutaneous infusion of fluids, specifically immunoglobulin, for treatment. It does not perform any diagnostic function.
No
The device description clearly details physical components such as luer lock connectors, tubing, splitter blocks, subcutaneous catheters, stainless steel needles, adhesive pads, and tubing clamps. It also mentions packaging and sterilization, indicating a physical medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "infusion of fluids into the body below the surface of the skin". This describes a therapeutic or delivery function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details a system for delivering fluids subcutaneously, including needles, tubing, and connectors. This aligns with an infusion device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: The text does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
Therefore, this device falls under the category of a medical device for therapeutic delivery, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The sets are intended for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The neria™ multi product is a multisite infusion catheter. The product has a luer lock connector that is designed to be attached to a furcation or splitter block, which splits the fluid flow into two, three or four subcutaneous Infusion catheters. Each tube that exits the splitter terminates in a subcutaneous catheter with a stainless steel infusion needle set at 90 degrees from an adhesive pad.
The neria™ multi line will include three different needle lengths of 8, 10 and 12 mm. The product is provided with a separate tubing clamp or clamps to enable the user to selectively stop infusion to one or more sites as necessary. The sets are packaged in custom formed blisters sealed with a Sterikraft paper lid and sterilized in a validated EO gas cycle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
below the surface of the skin
Indicated Patient Age Range
patients of all ages
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)
The devices were tested for the following attributes and conform to all predefined criteria.
Dimensional Tests
Needle length
Tubing Length
Functional Tests
Leak test
Flow test
Pull (Tension) tests
Furcator - tubing
Set base tubing
Luer tubing
Set base adhesive
Biological Tests
Biocompatibility Test meet the requirements of ISO 8.11.8.1 10993-1, Biological evaluation of Medical Devices.
Chemical Testing
Drug/Device compatibility test - the sets were tested for Drug compatibility with Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, manufactured by CSL Behring
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
8.0 510(K) SUMMARY
Date Prepared: January 31, 2012
8.1 SUMMARY OF SAFETY AND EFFECTIVENESS John M. Lindskog Submitted By:
. President Unomedical A/S Infusion Devices Aaholmvej 1-3, Osted DK-4320 Leire. Denmark Telephone: + 45 48 16 70 00
- 8.2 Trade/Proprietary Name: neria™ multi Subcutaneous Infusion Set
- Common/Usual Name 8.3
- Subcutaneous Infusion Set
- Classification Name 8.4
8.5 Classification
. '
Intravascular administration set . Class: II
Panel: 80 Product Code: FPA Cite: 21 CFR 880.5440
8.6 Predicate Devices
The neria™ multi Subcutaneous Infusion Sets are substantially equivalent to the Unomedical Contact™ Subcutaneous Infusion Sets (K945617) and the MarCal Medical Sub Q Needle infusion set (K082818).
8.7 Indication for Use
The sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.
8.8 Intended Use
These neria™ multi sets are intended to be used by patients of all ages who have been prescribed subcutaneous infusion of immunoglobulin (IgG) for the treatment of Primary Immunodeficiency Disease (PID).
8.9 Product Description
The neria™ multi product is a multisite infusion catheter. The product has a luer lock connector that is designed to be attached to an infusion pump reservoir. The tubing from the luer connector is attached to a furcation or splitter block, which splits the fluid flow into two, three or four subcutaneous Infusion catheters. Each tube that exits the splitter terminates in a subcutaneous catheter with a stainless steel infusion needle set at 90 degrees from an adhesive pad.
The neria™ multi line will include three different needle lengths of 8, 10 and 12 mm. The product is provided with a separate tubing clamp or clamps to enable the user to selectively stop infusion to one or more sites as necessary. The sets are packaged in custom formed blisters sealed with a Sterikraft paper lid and sterilized in a validated EO gas cycle.
MAY 3 0 2012
Image /page/0/Picture/22 description: The image contains a handwritten string of characters. The string starts with the letter 'K', followed by the numbers '120395'. The characters are written in a simple, slightly irregular style, typical of handwriting.
1
8.10 Technological Characteristics
The neria™ multi Subcutaneous Infusion Sets have the same technological characteristics as the current marketed products.
| CHARACTERISTICS | neriaTM multi | contactTM | Sub Q Needle
infusion set |
|-----------------------------------|------------------------------------------------|------------------------------|------------------------------|
| DRUG
COMPATIBILITY/THERAPY | IMMUNE GLOBULIN
SUBCUTANEOUS
(HUMAN)/PID | NONE SPECIFIED | NONE SPECIFIED |
| NUMBER OF
CATHETERS/FURCATIONS | 2, 3 AND 4 | 1 WITH NO
FURCATIONS | 1, 2, 3 AND 4 |
| CLAMPS PROVIDED | 1 OR 2 | 0 | 1, 2, 3, OR 4 |
| NEEDLE MATERIAL | STAINLESS STEEL,
AISI 304 | STAINLESS STEEL,
AISI 304 | STAINLESS STEEL |
| NEEDLE LENGTHS | 8, 10, 12 mm | 6, 8, 10 mm | 6, 9, 12, 14 mm |
| NEEDLE GAUGES | 27 | 27 AND 29 | 24 AND 27 |
| ANGLE OF INSERTION | 90 DEGREES
PERPENDICULAR | 90 DEGREES
PERPENDICULAR | 90 DEGREES
PERPENDICULAR |
| FIXATION TO SKIN | ADHESIVE PAD | ADHESIVE PAD | ADHESIVE
"BUTTERFLY" |
| MATERIALS COMPONENTS | SAME AS CONTACTTM | SAME AS NERIATM
MULTI | UNKNOWN |
| STERILIZATION METHOD | ETO | ETO | GAMMA RADIATION |
8.11 Performance Data
The devices were tested for the following attributes and conform to all predefined criteria.
8.11.1 Dimensional Tests
8.11.2 Needle length
8.11.3 Tubing Length
8.11.4 Functional Tests
8.11.5 Leak test
8.11.6 Flow test
8.11.7 Pull (Tension) tests
8.11.7.1 Furcator - tubing
- 8.11.7.2 Set base tubing
- 8.11.7.3 Luer tubing
- 8.11.7.4 Set base adhesive
- 8.11.8 Biological Tests
- Biocompatibility Test meet the requirements of ISO 8.11.8.1 10993-1, Biological evaluation of Medical Devices.
- 8.11.9 Chemical Testing
- 8.11.9.1 Drug/Device compatibility test - the sets were tested for Drug compatibility with Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, manufactured by CSL Behring
8.12 Conclusion
Unomedical concludes based on the information presented that the new product is substantially equivalent to products currently legally marketed in the USA.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Unomedical A/S C/O Lee H. Leichter MBA, RAC President P/L Biomedical 10882 Stonington Avenue Fort Myers, Florida 33913-8414
MAY 3 0 2012
Re: K120395
Trade/Device Name: neria" multi Subcutaneous Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 10, 2012 Received: May 15, 2012
Dear Mr. Leichter:
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.
3
Page 2 - Mr. Leichter
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
for
Q. Q. Q
@ Founta
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (If Known):
Device Name:
Indications for Use:
neria™ multi infusion set
The sets are intended for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.
Prescription Use _ ﮯ (Per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use_ (Per 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
All C Ay 5/24/12
Division Sign-Off) ivision of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: K120395