Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and fluid dynamics of a subcutaneous needle set, with no mention of AI or ML.

Therapeutic

No.

The device is intended for the "delivery of medication" to subcutaneous tissue. It is a tool for administering treatment, not a therapeutic device itself.

Diagnostic

No

Explanation: The device is described as an "Intravascular Administration Set" intended for the "delivery of medication to the subcutaneous tissue." It is a delivery mechanism, not a tool for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as needles, tubing, luer locks, and clamps, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

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 delivery of medication to the subcutaneous tissue." This is a therapeutic purpose, not a diagnostic one.
Device Description: The description details a device for administering fluids into the body, not for analyzing samples taken from the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
Classification: The device is classified as a "Class II Intravascular Administration Set per 21 CFR 880.5440," which is a classification for devices used to administer fluids into the circulatory system or subcutaneous tissue, not for in vitro diagnostics.

In vitro diagnostics are devices used to examine specimens, such as blood, tissue, or urine, that have been taken from the human body to detect diseases, conditions, or infections. This device does not perform such a function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

RMS Subcutaneous Needle Sets are intended for the delivery of medication to the subcutaneous tissue.

Product codes

FPA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

subcutaneous tissue

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

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. 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. A comparison of the needle tip dimensions indicates there is no substantial difference between the RMS needles and the predicate devices. 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. In accordance with ISO 10993, biocompatibility 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.

Key Metrics

Not Found

Predicate Device(s)

K020530, K082818

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

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
24 Carpenter Road
Chester, NY 10918 USA
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)
Class II |
| 3. Predicate Devices: | Evans Medical, Inc.
Evans Sub-q MC4206
K020530 |
| | Marcal Medical, Inc.
Subcutaneous Needle Infusion Set
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

1

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
K102512 (New)	Evans Sub-q Set
K020530	Marcal Sub-q Set
K082818
Tubing Length
(inches)	20	2, 4, 3.5, 5, 36, 42	36, 42
Tubing Material	Medical Grade PVC
Plastic	Medical Grade
Polyethylene
Plastic	Medical Grade PVC
Plastic
Needle Material	Stainless Steel	Stainless Steel	Stainless Steel
Needle Gauge	26	24, 27	24, 27
Needle Length
(mm)	6, 9, 12	4, 6, 9, 12, 14	6, 9, 12, 14
Sterilization
Method	Gamma	ETO	ETO
Indications for Use	RMS Subcutaneous
Needle Sets are
intended for the
delivery of
medication to the
subcutaneous
tissue.	Evans Winged
Subcutaneous
Infusion Set is
intended to provide
subcutaneous
infusion of
medicine from an
external infusion
pump or syringe.	The Subcutaneous
Infusion Set is
designed
specifically for the
delivery of
medication to the
subcutaneous
tissue.

Page 2 of 5

Registration Number 1318360

24 Carpenter Road • Chester, NY 10918 • USA • toll free 800 • local 845-469-2042 • fax 845-469-5518 • www.msmedpo.com

1 33 1 3 1 3

2

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
Luer	Tubing	Butterfly	Adhesive
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

1. 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
Volume (ml) | RMS Sub-q Set
26g
K102512 (New) | Evans Sub-q Set
27g
K020530 | Marcal Sub-q Set
27g
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

3

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

1. 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

4

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
Performed | Standard | Test Name | Test
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
test |
| Biocompatibility | ISO 10993-10 | Sensitization | PASS | Magnusson-Kligman
Method |
| Biocompatibility | ISO 10993-4 | Hemocompatability | PASS | Complement Activation
GLP Report |
| Biocompatibility | ISO 10993-4 | Hemocompatability/clotting | PASS | Partial Thromboplastin
Time (PTT) |
| Biocompatibility | ISO 10993-4 | Hemocompatability | PASS | Hemolysis Direct Contact |
| Biocompatibility | ISO 10993-4 | Hemocompatability | PASS | Hemolysis Extract Method |

Summary of Testing Performed:

1. 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

5

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.

6

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

7

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