(76 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
Yes
The device is intended to provide subcutaneous infusion of medicine, which is a therapeutic activity.
No
The document states the device is intended to provide subcutaneous infusion of medicine, which is a therapeutic action, not a diagnostic one.
No
The device description clearly outlines physical components such as needles, tubing, connectors, and adhesive dressing, indicating it is a hardware 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 provide subcutaneous infusion of medicine. This is a therapeutic delivery of a substance into the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a set of components for delivering fluid into the subcutaneous tissue (needles, tubing, connectors, luer lock). This aligns with a drug delivery device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to deliver medication, which is a treatment, not a diagnostic process.
N/A
Intended Use / Indications for Use
SUB-Q Subcutaneous Tissue Infusion Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe.
Product codes
FPA
Device Description
The EMED SUB-Q Subcutaneous Tissue Infusion Set (SUB-Q Set) device consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. Each infusion set has a luer lock at one end and a 90 degree 24g or 27g needle mounted to a standard or closing wing-stabilizer at the distal end of one or more lumens. Each lumen is connected by lengths of tubing and a number connectors, depending on configuration. The luer lock is used to connect to the infusion source. The needles are treated with medical grade silicone for ease of insertion into the skin. The device is for single use.
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)
Non-clinical testing of the EMED SUB-Q Set included leakage, occlusion, and jointstrength which demonstrated the device meets the requirements for its intended use. The testing also demonstrates that the EMED SUB-Q Set meets performance criteria and is substantially equivalent to the predicate device as related to device performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Section 5. 510(k) Summary
K Number K140131
APR 0 3 2014
Submission Date:
January 14, 2014
General Information
Classification
Class II
FPA, Class II
Trade Name
SUB-Q Subcutaneous Tissue Infusion Set
Common Name:
I.V. Administration Set
Classification Name and Reference:
Intravascular Administration Set 21 CFR §880.5440
Product Code and Class
Predicate Device
Evans SUB-Q Subcutaneous Tissue Infusion Set (K020530)
Submitter
Peter Kollings EMED Technologies Corporation 1264 Hawks Flight Ct., Ste. 200 El Dorado Hills, Ca 95762 Tel: 916.932.0071 x114 916.932.0074 Fax:
Purpose of Submission
This submission is intended to provide notification of modifications to our current legally marketed SUB-Q Subcutaneous Tissue Infusion Set device cleared under K020530. These modifications are the result of variations to the original device, resulting in a selection of infusion sets intended to satisfy individual user needs. Label changes are to reflect current corporate identity of the SUB-Q Subcutaneous Tissue Infusion Set.
Device Description
The EMED SUB-Q Subcutaneous Tissue Infusion Set (SUB-Q Set) device consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. Each infusion set has a luer lock at one end and a 90 degree 24g or 27g needle
1
mounted to a standard or closing wing-stabilizer at the distal end of one or more lumens. Each lumen is connected by lengths of tubing and a number connectors, depending on configuration. The luer lock is used to connect to the infusion source. The needles are treated with medical grade silicone for ease of insertion into the skin. The device is for single use.
Intended-Use
The SUB-Q Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe.
This is the same intended use as previously cleared for the Evans SUB-Q Subcutaneous Tissue Infusion Set (K020530).
Technological Characteristics
The EMED SUB-Q Set has the same intended use as previously cleared for the predicate device (K020530).
The EMED SUB-Q Set incorporates the core design, same operating principle, and same materials as the predicate product (see K020530).
The EMED SUB-Q Set is assembled at the same facility as the predicate, under the same manufacturing processes as the predicate, and are tested against the same performance and batch release criteria as the predicate.
The EMED SUB-Q Set is packaged in the same manner using the same packaging materials and process as the predicate product (see K020530).
The EMED SUB-Q Sets are be sterilized to a sterility assurance level (SAL) of 10th using the same validated process as the predicate, and have the same specified storage conditions and 5 year shelf-life as the predicate (see K020530).
The EMED SUB-Q Set contains the following modifications to the predicate device (K020530):
- Various numbers of lumens were made available as configuration options. -
- PVC bi-furcator and tri-furcator tubing connectors were added to the design to create from 2 to 6 lumens.
- 24g needle was made an available configuration option, with a corresponding ・ change to tubing diameter.
- Needles received application of medical grade silicone lubricant to aid in insertion ﺖ
- and increase patient comfort and satisfaction.
- Various needle lengths were made available configuration options ﺴ
- Various tubing length variations were made available as configuration options. -
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- A proprietary wing closure mechanism was made an available configuration option to aid in handling and disposal.
- Open end slide clamps to stop flow. -
- Labeling updated to reflect the additional available configurations and current corporate identity (new ownership, logos, address, etc.).
The fundamental scientific technology, indications for use, materials, design, sterilization and packaging are not impacted by these changes, and remain identical between the proposed and predicate devices.
Table 5-1 below provides a comparison of technological and other characteristics of the EMED SUB-Q Set and the predicate (K020530).
| | EMED SUB-Q Subcutaneous
Tissue Infusion Set | Evans SUB-Q Subcutaneous
Tissue Infusion Set (K020530) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | Intended to provide subcutaneous
infusion of medicine from an
external infusion pump or syringe.
The device is supplied sterile, for
singly use only. It is a
prescription device. | Intended to provide subcutaneous
infusion of medicine from an
external infusion pump or syringe.
The device is supplied sterile, for
singly use only. It is a
prescription device. |
| Material/
Components | Biocompatible, non-toxic
materials widely used in medical
products, such as:
Luer: PVC
Luer Cap: Polypropylene
Tubing: PVC
Wings: PVC (std) and
Polyproylene (locking)
Connectors: PVC
Needlès: Stainless Steel
Slide Clamp: ABS
Bonding Agent: Loctite 3341 | Biocompatible, non-toxic
materials widely used in medical
products, such as:
Luer: PVC
Luer Cap: Polypropylene
Tubing: PVC
Wings: PVC
Connectors: None
Needles: Stainless Steel
Slide Clamp: None
Bonding Agent: Loctite 3341 |
| Device
Length | Ranging from 2" - 36"
(based on configuration) | 42" |
| Tubing ID | 0.200" (27g) | 0.200" (27g) |
Table 5-1
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| EMED SUB-Q Subcutaneous Tissue Infusion Set | Evans SUB-Q Subcutaneous Tissue Infusion Set (K020530) | |
|---|---|---|
| 0.260 (24g) | ||
| Needle gage | 24 gage and 27 gage | 27 gage |
| Needle Lengths | Ranging from 6 mm - 16 mm (based on configuration) | 6 mm |
| Number of Lumens | 1 - 6 | 1 |
| Wing type | Standard and Closing | Standard |
| Clamp Type | Slide | None |
| Needle Lubricant | Dow Corning 360 | |
| polydimethylsiloxane | None |
Device Performance
To date, no performance standards that affect this device have been finalized under Section 514 of the Act.
Non-clinical testing of the EMED SUB-Q Set included leakage, occlusion, and jointstrength which demonstrated the device meets the requirements for its intended use. The testing also demonstrates that the EMED SUB-Q Set meets performance criteria and is substantially equivalent to the predicate device as related to device performance.
Summary of Substantial Equivalence
The EMED Technologies Corporation SUB-Q Subcutaneous Tissue Infusion sets have the same basic design, fundamental scientific technology, indications for use, materials, sterilization, and packaging as the predicate, and therefore are substantially equivalent to the commercially available predicate device. Any differences between the EMED SUB-O Subcutaneous Tissue Infusion Set and the predicate do not raise any new issues of safety or effectiveness.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
April 3, 2014
EMED Technologies Corporation C/O Peter Kollings Director Regulatory Affairs and Quality Assurance 1264 Hawks Flight Court, Suite 200 El Dorado Hills, CA 95762
Re: K140131
Trade/Device Name: SUB-Q Subcutaneous Tissue Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 10, 2014 Received: March 12, 2014
Dear Mr. Kollings:
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.
5
Page 2 - Mr. Kollings
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner - S
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140131
Device Name
SUB-O Subcutaneous Tissue Infuset Set
Indications for Use (Describe)
SUB-Q Subcutaneous Tissue Infusion Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe.
Type of Use (Select one or both, as applicable)
Prescription Use {Part 21 CFR 801 Subpart D}
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | ||
|---|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | ||
| Image: FDA logo | Digitally signed by | |
| Richard C. Chapman | ||
| Date: 2014.04.03 | ||
| 10:58:53 -04'00' |
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