RMS SUBCUTANEOUS NEEDLE SET
Device Facts
| Record ID | K102512 |
|---|---|
| Device Name | RMS SUBCUTANEOUS NEEDLE SET |
| Applicant | Repro-Med Systems, Inc. |
| Product Code | FPA · General Hospital |
| Decision Date | May 20, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
RMS Subcutaneous Needle Sets are intended for the delivery of medication to the subcutaneous tissue.
Device Story
RMS Subcutaneous Needle Set is a sterile, single-use intravascular administration set for subcutaneous medication delivery. Device consists of a 90-degree stainless steel needle mounted to a butterfly, medical-grade PVC tubing, and a luer lock. Available in single or multi-needle (2-6) configurations using Y or multi-connectors. Includes a slide clamp for flow control and a snap-together capture mechanism for disposal. Used in clinical or home settings to facilitate infusion from an external pump or syringe. Healthcare providers or patients use the device to deliver medication; the needle set provides the fluid path to the subcutaneous tissue. Benefits include controlled medication delivery and reduced residual volume compared to predicate devices.
Clinical Evidence
Bench testing only. Performance testing included fluid flow rate (SOP 5071), priming/residual volume measurements, needle tip dimension analysis, and wing flexibility force measurements. Biocompatibility testing conducted per ISO 10993, including cytotoxicity, irritation, sensitization, thrombogenicity, and hemocompatibility (PTT, hemolysis). All tests passed.
Technological Characteristics
Materials: Stainless steel needle, PVC tubing, polypropylene butterfly, 3M adhesive dressing. Energy: None (gravity/pump-driven). Connectivity: None. Sterilization: Gamma radiation. Form factor: 90-degree needle with butterfly and luer lock. Flow control: Slide clamp. Multi-needle configurations available via Y-connectors.
Indications for Use
Indicated for the delivery of medication to the subcutaneous tissue for use not to exceed 24 hours.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for RMS Medical Products. The logo consists of a geometric shape on the left, followed by the letters "RMS" in a stylized font. Below the letters, the words "MEDICAL PRODUCTS" are printed in a smaller, sans-serif font. The logo is black and white.
หมาร เพียนเติม หางนนตเร 7. Summary
חלקחחול 270K
K102512
# 510(k) Summary
MAY 2 0 2011
[As required by 21 CFR 807.92]
| 1. Submitter: | Repro-Med Systems, Inc. dba RMS Medical Products<br>24 Carpenter Road<br>Chester, NY 10918 USA<br>845-469-2042 |
|-----------------------|----------------------------------------------------------------------------------------------------------------|
| | Fax 845-469-5518 |
| Contact Person(s): | Andrew Sealfon, President & CEO |
| Prepared on: | April 25, 2011 |
| 2. 510k Number: | K102512 |
| Trade Name: | RMS Subcutaneous Needle Set |
| Classification Name: | Intravascular Administration Set |
| Classification Code: | FPA (per 21 CFR 880.5440)<br>Class II |
| 3. Predicate Devices: | Evans Medical, Inc.<br>Evans Sub-q MC4206<br>K020530 |
| | Marcal Medical, Inc.<br>Subcutaneous Needle Infusion Set<br>K082818 |
#### 4. Device Description:
The RMS Subcutaneous Needle Set is a Class II Intravascular Administration Set per 21 CFR 880.5440 and intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile packaged kit including the infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set has a 90-degree stainless steel needle mounted to a butterfly on one end, and a luer lock on the other end, connected by medical grade tubing. Each set is equipped with a slide clamp used to stop flow immediately, as well as a snap together capture arrangement used to close the set upon completion. RMS Subcutaneous Needle Sets are available as single sets, as well as 2-needle, 3-needle, 4-needle, 5-needle and 6-needle assemblies, with the use of a low residual volume Y or multi-connector. The device is for single use only.
Registration Number 1318360 K102512 510k Submission Page 1 of 5 24 Carpenter Road • Chester, NY 10918 • USA • toll free 800-624-9600 • local 845-469-5518 • www.msmedpo.com
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Image /page/1/Picture/0 description: The image shows the logo for RMS Medical Products. The logo consists of a geometric shape on the left, followed by the letters "RMS" in bold, sans-serif font. Below the letters, the words "MEDICAL PRODUCTS" are printed in a smaller font size. A registered trademark symbol is located to the right of the letter "S".
#### । ਸ Indications for Use
RMS Subcutaneous Needle Sets are intended for the delivery of medication to the subcutaneous tissue for use not to exceed 24 hours.
#### 6. Characteristics
RMS Subcutaneous Needle Sets are identical in performance, physical properties, using similar materials, and having the same indications for use as the predicate devices. Although the design differs in tubing length and needle gauge, performance testing shows that the performance and residual volume of the 26 gauge needle and 20″ tubing has equal to or better flow characteristics as compared to the 27 and 24 gauge 36 inch sets, therefore no new issues of safety or effectiveness are introduced by these changes.
| Predicate Device Comparison Chart | | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | RMS Sub-q Set<br>K102512 (New) | Evans Sub-q Set<br>K020530 | Marcal Sub-q Set<br>K082818 |
| Tubing Length<br>(inches) | 20 | 2, 4, 3.5, 5, 36, 42 | 36, 42 |
| Tubing Material | Medical Grade PVC<br>Plastic | Medical Grade<br>Polyethylene<br>Plastic | Medical Grade PVC<br>Plastic |
| Needle Material | Stainless Steel | Stainless Steel | Stainless Steel |
| Needle Gauge | 26 | 24, 27 | 24, 27 |
| Needle Length<br>(mm) | 6, 9, 12 | 4, 6, 9, 12, 14 | 6, 9, 12, 14 |
| Sterilization<br>Method | Gamma | ETO | ETO |
| Indications for Use | RMS Subcutaneous<br>Needle Sets are<br>intended for the<br>delivery of<br>medication to the<br>subcutaneous<br>tissue. | Evans Winged<br>Subcutaneous<br>Infusion Set is<br>intended to provide<br>subcutaneous<br>infusion of<br>medicine from an<br>external infusion<br>pump or syringe. | The Subcutaneous<br>Infusion Set is<br>designed<br>specifically for the<br>delivery of<br>medication to the<br>subcutaneous<br>tissue. |
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Registration Number 1318360
24 Carpenter Road • Chester, NY 10918 • USA • toll free 800 • local 845-469-2042 • fax 845-469-5518 • www.msmedpo.com
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Image /page/2/Picture/0 description: The image shows the logo for RMS Medical Products. The logo consists of a geometric shape on the left, followed by the letters "RMS" in bold, sans-serif font. Below the letters, the words "MEDICAL PRODUCTS" are written in a smaller font. The logo has a registered trademark symbol.
### Materials Comparison:
| Materials Comparison Chart | | | | |
|----------------------------|----------------|--------------|---------------|----------------------|
| | Female<br>Luer | Tubing | Butterfly | Adhesive<br>Dressing |
| RMS Needle Sets | PVC | PVC | Polypropylene | Dressing by 3M |
| Evans Sub-q Sets | PVC | Polyethylene | PVC | Dressing by 3M |
| Marcal Sub-q Sets | n/a | PVC | Polyethylene | n/a |
- 7. Performance Testing: Fluid flow rate testing was performed according to RMS "Needle Set Fluid Flow Rate Test Procedure" (SOP 5071) to determine the flow rates of the RMS needle set, compared to the Evans and Marcal needle sets. Results:
| Average Normalized Flow Rate Comparison | | | | | |
|-----------------------------------------|---------|---------|---------|---------|---------|
| | Needle | | | | |
| | 1 | 2 | 3 | 4 | Total |
| RMS Medical Products 26G | 491.36 | 479.25 | 502.06 | 513.70 | 1996.35 |
| Evans Medical 27G | 246.40 | 225.49 | 129.73 | 243.31 | 838.98 |
| Evans Medical 24G | 503.25 | 501.82 | 491.84 | 484.00 | 1988.98 |
| Marcal Medical 24G | 1018.61 | 1014.81 | 1037.62 | 1001.03 | 4041.17 |
Patency of Lumens (Summary) by Leg and Total Flow Rate
Priming/Residual volumes also were measured and compared with the predicate devices. The performance testing indicates that the RMS Subcutaneous Needle Sets have simillar performance to the predicate devices specifically indicating substantially equivalent fluid flows and residual volumes.
#### Priming/Residual Volume Measurements by Needles Connected:
| Priming/Residual<br>Volume (ml) | RMS Sub-q Set<br>26g<br>K102512 (New) | Evans Sub-q Set<br>27g<br>K020530 | Marcal Sub-q Set<br>27g<br>K082818 |
|---------------------------------|---------------------------------------|-----------------------------------|------------------------------------|
| 1-Needle | .074 | .23 | .15 |
| 2-Needle | .245 | .40 | .25 |
| 3-Needle | .417 | .60 | .45 |
| 4-Needle | .588 | .80 | .50 |
| 5-Needle | .760 | 1.00 | .65 |
| 6-Needle | .931 | 1.20 | .80 |
K102512 510k Submission
Registration Number 1318360
24 Carpenter Road · Chester, NY 10918 · USA · toll free 800 · local 845-469-5518 · vivw.msnedpro.com
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Image /page/3/Picture/0 description: The image shows the logo for RMS Medical Products. The logo consists of a geometric shape on the left, followed by the letters "RMS" in a bold, stylized font. Below the letters, the words "MEDICAL PRODUCTS" are printed in a smaller, sans-serif font. The logo is black and white.
#### Needle Tip Measurements
A comparison of the needle tip dimensions indicates there is no substantial difference between the RMS needles and the predicate devices.
| Company | Top Angle (degrees) | Side Angle (degrees) | Length (inches) |
|---------|---------------------|----------------------|-----------------|
| RMS | 52.3 | 16.5 | 0.018 |
| Evans | 52.3 | 16.5 | 0.022 |
| Marcal | 51.9 | 16.3 | 0.016 |
#### Wing Flexibility
Measurements of wing flexibility indicate that the RMS needles require less force to flex than the predicate devices and thus may be considered equal or better in that regard.
| | RMS | Marcal | Evans Medical |
|-------------|-----|---------|---------------|
| | | (grams) | |
| Butterfly 1 | 20 | 50 | 45 |
| | 18 | 43 | 44 |
| Butterfly 2 | 15 | 44 | 38 |
| | 19 | 40 | 42 |
| Butterfly 3 | 25 | 58 | 32 |
| | 25 | 50 | 38 |
| Butterfly 4 | 28 | 45 | 30 |
| | 23 | 50 | 42 |
| Mean | 22 | 48 | 39 |
- 8. Biocompatibility: In accordance with ISO 10993, studies were performed including cytotoxicity, irritation, sensitization, thrombogenicity, and hemocompatability. The Complement Activation GLP Report and Partial Thromboplastin Time study compared the RMS needle sets with the predicate directly with similar acceptable results recorded.
Registration Number 1318360
24 Carpenter Road • Chester, NY 10918 • USA • toll free 800-624-9600 • local 845-469-5518 • www.rnsmediro.com
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Image /page/4/Picture/0 description: The image shows the logo for RMS Medical Products. The logo consists of a geometric shape on the left, followed by the letters "RMS" in a bold, stylized font. Below the letters, the words "MEDICAL PRODUCTS" are written in a smaller font. The logo is black and white.
| Test<br>Performed | Standard | Test Name | Test<br>Result | Other name |
|-------------------|--------------|----------------------------|----------------|--------------------------------------|
| Sterility 10-6 | ISO 11137-2 | Sterility | PASS | Vdmax |
| Biocompatibility | ISO 10993-5 | Cytotoxicity | PASS | MEM Elution Report |
| Biocompatibility | ISO 10993-10 | Irritation | PASS | Intracutaneous injection<br>test |
| Biocompatibility | ISO 10993-10 | Sensitization | PASS | Magnusson-Kligman<br>Method |
| Biocompatibility | ISO 10993-4 | Hemocompatability | PASS | Complement Activation<br>GLP Report |
| Biocompatibility | ISO 10993-4 | Hemocompatability/clotting | PASS | Partial Thromboplastin<br>Time (PTT) |
| Biocompatibility | ISO 10993-4 | Hemocompatability | PASS | Hemolysis Direct Contact |
| Biocompatibility | ISO 10993-4 | Hemocompatability | PASS | Hemolysis Extract Method |
### Summary of Testing Performed:
- 9. Substantial Equivalence: The data presented demonstrates that RMS Subcutaneous Needle Sets are substantially equivalent to the predicate devices in terms of function, safety, performance, intended use, technology/principles, mechanical properties, biocompatibility, and flow. Differences between the RMS Subcutaneous Needle Sets and the predicate devices do not raise any new issues of safety or effectiveness.
Registration Number 1318360
24 Carpenter Road • Chester, NY 10918 • USA • toll free 800-624-9600 • local 845-469-5518 • www.msmedpo.com
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the symbol. The caduceus is black, and the text is also black.
MAY .2 0-2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Andrew I. Sealfon President & CEO Repro-Med Systems, Incorporated 24 Carpenter Road Chester, New York 10918
Re: K102512
Trade/Device Name: RMS Subcutaneous Needle Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 6, 2011 Received: May 9, 2011
Dear Mr. Sealfon:
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.
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Page 2 - Ms. Sealfon
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.htm1.
Sincerely vours.
Antman O. m
Anthony 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
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## Section 4 Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
### Device Name:
RMS Subcutaneous Needle Set
#### Indications for Use:
RMS Subcutaneous Needle Sets are intended for the delivery of medication to the subcutaneous tissue.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rill Chyn 5/20/4
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number: ***_*****_**
K102512
