(367 days)
Not Found
No
The device description and performance studies focus on the physical components and flow rate of a subcutaneous needle set, with no mention of AI or ML capabilities.
Yes
The device is indicated for the subcutaneous infusion of medications, specifically plasma-derived immunoglobulins, which are used to treat medical conditions.
No
The device is described as a "Subcutaneous Needle Set" used for the "subcutaneous infusion of medications," indicating it is for drug delivery, not for diagnosing a condition.
No
The device description clearly outlines physical components such as needles, tubing, luer locks, and adhesive dressings, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "subcutaneous infusion of medications." This involves delivering substances into the body, not analyzing samples from the body.
- Device Description: The description details a needle set, tubing, and connectors designed for delivering fluids. This aligns with an infusion 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 diagnostic, monitoring, or compatibility purposes. This device's function is purely for administering medication.
N/A
Intended Use / Indications for Use
RMS High-FLO Super26TM Subcutaneous Needle Sets are indicated for subcutaneous infusion of medications in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling for the capacity for infusion of high flow rates including human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling for: Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring); and Cuvitru™ Immune Globulin Infusion (Human) 20% (manufactured by Shire).
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The RMS HIgH-Flo Super26™ Subcutaneous Needle Sets are sterile, non-pyrogenic, single use, Class II Subcutaneous Administration Set, per 21 CFR 880.5440, comprised of a Super 26-gauge needle assembly, combined with 24-gauge needle tubing and are intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set is a 90-degree, 26gauge stainless steel needle, mounted to a butterfly winged safety closure on one end which is used to close the set upon completion. The other end consists of a luer lock which connects to PVC medic al grade tubing (Figure I). Additionally, each tubing set is equipped with a slide clamp used to stop flow, immediately; as needed. RMS HigH-Flo Super 26TM Subcutaneous Needle Sets are available as a single-needle set, as well as 2-needle, 4- needle, 5-needle, 6-needle sets; through use of a Y-connector, 7-needle and 8-needle sets may also be assembled. The device is for single use only.
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
home, hospital, or ambulatory settings
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)
Bench Performance Studies:
Flow Rate Testing: Tables indicating estimated maximum achievable flow rates with RMS HIgH-Flo Super26™ Subcutaneous Needle Sets when used in combination with RMS Precision Flow Rate TubingTM and RMS Freedom Syringe Drivers for Hizentra - FI With Super 20, Hizentra® CIDP with Super26™, and Cuvitru™ Pl with Super26™. The tables show ml/hr/site for various needle counts and flow rates (F45, F60, F120, F180, F275, F420, F500, F600, F900, F1200, F2400).
Key results: Bench testing has been conducted to verify that the product performance of the subject device and predicate device are substantially equivalent. The verification testing was limited to flow rate testing and biocompatibility. The device performs as intended and 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
§ 880.5440 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
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 & 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.
April 4, 2019
Repro-Med Systems, Inc. dba RMS Medical Products Cynthia Lacatena Senior Regulatory Associate 24 Carpenter Road Chester, New York 10918
Re: K180843
Trade/Device Name: HIgH-Flo Super26 Subcutaneous Needle Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: February 28, 2019 Received: March 4, 2019
Dear Cynthia Lacatena:
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, 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
1
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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, fi 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 comprehensive regulatory information about medical devices and radiation-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.
for 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) K180843
Device Name
HIgH-Flo Super26TM Subcutaneous Needle Sets
Indications for Use (Describe)
RMS High-FLO Super26™ Subcutaneous Needle Sets are indicated for subcutaneous infusion of medications in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling for the capacity for infusion of high flow rates including human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling for: Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring); and Cuvitru™ Immune Globulin Infusion (Human) 20% (manufactured by Shire).
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) |
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3
Submitted By: Harry Shaffer Director, Regulatory and Quality Affairs Repro Med System, Inc., D/B/A RMS Medical Products 24 Carpenter Road Chester, NY 10918 Tel: 845-469-2042 Fax: 845-469-5518
Summary Prepared: April 2, 2019
- RMS HIgH-Flo Super26TM Subcutaneous Needle Set Device Name: Trade Name: Common Name: Intravascular Administration Set Classification: Class II device, 21 CFR §880.5440 Product Code: FPA
Legally marketed predicate device to which substantial equivalence is claimed: (K162613) Integrated Catch-up Freedom Syringe Driver Infusion System
Device Description:
The RMS HIgH-Flo Super26™ Subcutaneous Needle Sets are sterile, non-pyrogenic, single use, Class II Subcutaneous Administration Set, per 21 CFR 880.5440, comprised of a Super 26-gauge needle assembly, combined with 24-gauge needle tubing and are intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set is a 90-degree, 26gauge stainless steel needle, mounted to a butterfly winged safety closure on one end which is used to close the set upon completion. The other end consists of a luer lock which connects to PVC medic al grade tubing (Figure I). Additionally, each tubing set is equipped with a slide clamp used to stop flow, immediately; as needed. RMS HigH-Flo Super 26TM Subcutaneous Needle Sets are available as a single-needle set, as well as 2-needle, 4- needle, 5-needle, 6-needle sets; through use of a Y-connector, 7-needle and 8-needle sets may also be assembled. The device is for single use only.
Image /page/3/Picture/7 description: The image shows a medical device with a white connector on the left side and a clear adhesive patch in the center. The device has thin wires that connect the connector to the patch. There is also a white clip on the right side of the device, which is attached to the wires.
Figure I
4
Indications for Use:
RMS High-FLO Super26™ Subcutaneous Needle Sets are indicated for subcutaneous infusion of medications in the home, hospital, or ambulatory settings, when administered according to the approved biologic or drug product labeling for the capacity for infusion of high flow rates including human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling ; for: Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring); and Cuvitru™ Immune Globulin Infusion (Human) 20% (manufactured by Shire).
Comparison to Predicate Device:
The subject device utilizes the same fundamental scientific technology as the predicate device. The purpose for this submission is to introduce a design modification/combination of the needle gauge and tubing diameter. Bench testing has been conducted to verify that the product performance of the subject device and predicate device are substantially equivalent. The table below gives a comparison of both devices.
| Feature | Subject Device:
HlgH-FloSuper26™ Sub-Q Needle Sets | Predicate Device:
Integrated Freedom Syringe Driver Infusion System |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K180843 | K162613 |
| Manufacturer | Same as Predicate | Repro Med Systems, Inc.,
dba RMS Medical Products |
| Product Code | Same as Predicate | FPA |
| Regulation Number | Same as Predicate | 880.5440 |
| Regulation Name | Same as Predicate | Intravascular Administration Set |
| Intended Use | RMS High-FLO Super26™
Subcutaneous Needle Sets are
indicated for subcutaneous infusion
of medications in the home,
hospital, or ambulatory settings
when administered according to the
approved biologic or drug product
labeling for the capacity for
infusion of high flow rates
including human plasma-derived
immunoglobulins when used
according to the FDA approved
biologic labeling for: Hizentra®,
Immune Globulin Subcutaneous
(Human) 20% Liquid
(manufactured by CSL Behring);
and Cuvitru™ Immune Globulin
Infusion (Human) 20%
(manufactured by Shire). | The Integrated Catch-Up Freedom
Syringe Driver Infusion System
(ICFSDIS), which includes the
FREEDOM60® and FreedomEdge®
syringe pumps, is indicated for the
intravenous or subcutaneous infusion
of medications and fluids in the home,
hospital, or ambulatory settings when
administered according to the approved
biologic or drug product labeling. The
ICFSDIS is specifically indicated for
the subcutaneous infusion of the
following human plasma-derived
immunoglobulins when used according
to the FDA approved biologic labeling:
Hizentra, Immune Globulin
Subcutaneous (Human) 20% Liquid
(manufactured by CSL Behring);
Gammagard Liquid, Immune Globulin
Infusion (Human) 10% (manufactured
by Shire); and Cuvitru Immune
Globulin Infusion (Human) 20%
(manufactured by Shire). The ICFSDIS
is specifically indicated for the
intravenous infusion of the following |
5
| | antibiotics when used according to the
FDA approved drug product labeling:
meropenem, ertapenem, oxacillin, and
tobramycin. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System components | Syringe Infusion System plus Needle Set |
| Needle Insertion Method | Manual |
| Angle of Insertion | 90 degrees |
| Needle Material | Stainless Steel |
| Needle Gauge | 26 |
| Needle Length (mm) | 4, 6, 9, 12, 14 |
| Needle Usage | Single Use |
| Needle Set Configurations | Available as a single-needle set, as well as 2-needle, 3-needle, 4- needle sets; through use of a Y-connector, 7-needle and 8-needle sets may also be assembled. |
| Needle Safety Feature | Yes |
| Tubing Length (inches) | 20 |
| Tubing Diameter (inches) | 0.019 |
| Tubing Material | Medical Grade PVC Plastic |
| Tubing Connection Type | Luer Tip |
| Provided Sterile | Yes |
| Sterilization Method | Gamma SAL 10-6 |
| Shelf Life | 3 years |
| Packaging | Sterile Tubing and Needle Set |
| Indications for Use | Delivery of medication to the subcutaneous tissue |
Discussion of differences:
Tubing Diameter: the diameter of the tubing used in the subject device (HlgH-FloSuper26™ Sub-Q Needle Sets) with 26G needles is 0.033 inches, which is different from the predicate's 0.019 inches.
Needle Set Configurations: The subject device contains 5 and 6 needle sets used without the Y connector. These configurations are not available in the predicate.
6
These differences do not raise different questions of safety and effectiveness as compared to the predicate. Also, performance testing has been conducted to ensure these differences do not impact device safety and effectiveness and demonstrate the device performs as intended.
Biocompatibility Studies:
Biocompatibility testing had been conducted on the predicate device in accordance with ISO 10993 series standards. This testing included Modified ASTM Hemolysis (Direct Contact Method) testing was conducted, concluding that the difference between the hemolytic indexes of the test article, RMS Subcutaneous Needle Sets: 8-Needle Set Configuration [(2) 4-Needle Set Configuration connected via (1) RMS Y-Connector] and the negative control was 0.68 percent. This places the test article in a non-hemolytic range. The subject device and predicate device are manufactured utilizing identical materials and composition. Based on the identical materials and manufacturing processes between the predicate and subject device. RMS concludes that the performance test data on the predicate device demonstrates that HlgH-Flo Super26™ Subcutaneous Needle Set meets the biocompatibility requirements of ISO 10993.
Bench Performance Studies Included The Following Test Methods:
The subject device has the same technological characteristics as the predicate device which was cleared under K162613. The verification testing was limited to the following tests.
Flow Rate Testing:
Achievable Flow Rates with Super26™ and Specific Medications/Indications
NOTE: The tables below indicate the estimated maximum achievable flow rates with RMS HIgH-Flo Super26™ Subcutaneous Needle Sets when used in combination with RMS Precision Flow Rate TubingTM and RMS Freedom Syringe Drivers.
| Hizentra - FI With Super 20 - Max Flow Rate Per Site (ml/hr/site) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| F45 | F60 | F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
| 1 needle | 4.5 | 5.8 | 10.6 | 13.4 | 19.5 | ||||||
| 2 needles | 2.3 | 3.0 | 5.6 | 7.2 | 10.9 | 17.0 | 17.3 | 20.9 | |||
| 3 needles | 1.5 | 2.0 | 3.8 | 4.9 | 7.6 | 12.1 | 12.3 | 15.1 | 20.8 | ||
| 4 needles | 1.2 | 1.5 | 2.9 | 3.7 | 5.8 | 9.4 | 9.5 | 11.8 | 16.5 | 22.5 | |
| 5 needles | 0.9 | 1.2 | 2.3 | 3.0 | 4.7 | 7.6 | 7.8 | 9.6 | 13.7 | 18.9 | |
| 6 needles | 0.8 | 1.0 | 1.9 | 2.5 | 3.9 | 6.5 | 6.6 | 8.2 | 11.7 | 16.3 | |
| 7 needles | 0.7 | 0.9 | 1.7 | 2.2 | 3.4 | 5.6 | 5.7 | 7.1 | 10.2 | 14.3 | |
| 8 needles | 0.6 | 0.8 | 1.5 | 1.9 | 3.0 | 4.9 | 5.0 | 6.3 | 9.1 | 12.8 | 23.5 |
Exceeds drug manufacturer's maximum indicated flow rate.
Subsequent infusions after 1st infusion only.
7
| Hizentra® CIDP with Super26™ - Max Flow Rate Per Site (ml/hr/site) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| F45 | F60 | F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
| 1 needle | 4.5 | 5.8 | 10.6 | 13.4 | 19.5 | 28.9 | 29.3 | 34.3 | 43.4 | ||
| 2 needles | 2.3 | 3.0 | 5.6 | 7.2 | 10.9 | 17.0 | 17.3 | 20.9 | 28.2 | 36.4 | |
| 3 needles | 1.5 | 2.0 | 3.8 | 4.9 | 7.6 | 12.1 | 12.3 | 15.1 | 20.8 | 27.8 | 44.3 |
| 4 needles | 1.2 | 1.5 | 2.9 | 3.7 | 5.8 | 9.4 | 9.5 | 11.8 | 16.5 | 22.5 | 37.6 |
| 5 needles | 0.9 | 1.2 | 2.3 | 3.0 | 4.7 | 7.6 | 7.8 | 9.6 | 13.7 | 18.9 | 32.7 |
| 6 needles | 0.8 | 1.0 | 1.9 | 2.5 | 3.9 | 6.5 | 6.6 | 8.2 | 11.7 | 16.3 | 28.9 |
| 7 needles | 0.7 | 0.9 | 1.7 | 2.2 | 3.4 | 5.6 | 5.7 | 7.1 | 10.2 | 14.3 | 25.9 |
| 8 needles | 0.6 | 0.8 | 1.5 | 1.9 | 3.0 | 4.9 | 5.0 | 6.3 | 9.1 | 12.8 | 23.5 |
.............................................................................................................................................................................. Site (ml/br/cito) OGTM NA
Exceeds drug manufacturer's maximum indicated flow rate.
Subsequent infusions after 1st infusion only.
Cuvitru™ Pl with Super26™ - Max Flow Rate Per Site (ml/hr/site)
| F45 | F60 | F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 needle | 4.4* | 5.7* | 10.3 | 13.1 | 19.1 | 28.3 | 28.7 | 33.6 | 42.5 | 51.5 | |
| 2 needles | 2.2* | 2.9* | 5.5* | 7.1* | 10.7 | 16.7 | 17.0 | 20.5 | 27.6 | 35.6 | 52.8 |
| 3 needles | 1.5* | 2.0* | 3.7* | 4.8* | 7.4* | 11.8 | 12.0 | 14.8 | 20.4 | 27.2 | 43.4 |
| 4 needles | 1.1* | 1.5* | 2.8* | 3.7* | 5.7* | 9.2* | 9.3* | 11.5 | 16.2 | 22.0 | 36.9 |
Exceeds drug manufacturer's maximum indicated flow rate. Subsequent infusions after 1st two infusions only.
*Flow rate per site is lower then what is recommended on the biologic labe NOTE: Drug manufacturer indicates maximum of up to four infusion sites
Conclusion:
The device performs as intended and is substantially equivalent to the predicate device.