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.

AI/ML Overview

The provided text describes a 510(k) summary for the RMS Subcutaneous Needle Set, which aims to demonstrate substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria in the sense of a novel AI or diagnostic device. Therefore, several of the requested sections about AI-specific criteria (e.g., sample size for AI test and training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable to this type of submission.

However, I can extract information related to performance testing that served to support the claim of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are implicitly defined by demonstrating that the device performs similarly to or better than the legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The reported performance is compared directly to the predicate devices.

Performance Characteristic	Acceptance Criteria (Implicit: Comparable or Better than Predicate)	RMS Device Performance (K102512)	Predicate Device 1 Performance (Evans Medical, K020530)	Predicate Device 2 Performance (Marcal Medical, K082818)
Fluid Flow Rate	Comparable or better than predicate devices	1996.35 (Total for 26G)	838.98 (Total for 27G), 1988.98 (Total for 24G)	4041.17 (Total for 24G)
Priming/Residual Volume	Comparable or better than predicate devices	Lower values across all needle counts (e.g., 0.074ml for 1-needle)	Higher values across all needle counts (e.g., 0.23ml for 1-needle)	Higher values across all needle counts (e.g., 0.15ml for 1-needle)
Needle Tip Dimensions	No substantial difference from predicate devices	Top Angle: 52.3°, Side Angle: 16.5°, Length: 0.018 in	Top Angle: 52.3°, Side Angle: 16.5°, Length: 0.022 in	Top Angle: 51.9°, Side Angle: 16.3°, Length: 0.016 in
Wing Flexibility	Equal or better (less force to flex) than predicate devices	Mean: 22 grams (less force)	Mean: 39 grams	Mean: 48 grams
Sterility 10-6	PASS	PASS	(Not explicitly stated for predicates, assumed to meet standard)	(Not explicitly stated for predicates, assumed to meet standard)
Biocompatibility	PASS for various tests (Cytotoxicity, Irritation, Sensitization, Hemocompatibility)	PASS for all listed tests	(Implicitly comparable as per textual claim for thrombogenicity and hemocompatibility)	(Implicitly comparable as per textual claim for thrombogenicity and hemocompatibility)
Materials	Similar enough not to raise new issues of safety/effectiveness	PVC, Polypropylene, 3M Dressing	PVC, Polyethylene, 3M Dressing	PVC, Polyethylene

2. Sample Size Used for the Test Set and Data Provenance

Fluid Flow Rate Testing: The table shows results for 4 individual measurements for each needle set configuration (Needle 1, 2, 3, 4). The "Total" represents the sum of these four measurements for each device type. Therefore, a sample size of 4 measurements per device type/configuration was used.
Priming/Residual Volume Measurements: Not explicitly stated, but measurements are provided for 1-needle to 6-needle configurations for each device.
Needle Tip Measurements: One measurement is provided for each characteristic (Top Angle, Side Angle, Length) for each company.
Wing Flexibility: For each of the three manufacturers (RMS, Marcal, Evans Medical), 4 individual "Butterfly" measurements are provided for flexibility, along with a calculated mean.
Biocompatibility/Sterility: These are standard compliance tests, typically performed on a statistically significant sample based on the specific ISO standards, but the exact sample sizes for each test are not detailed in this summary.
Data Provenance: Not explicitly stated. The tests were performed according to RMS's "Needle Set Fluid Flow Rate Test Procedure" (SOP 5071) and ISO standards. The data is likely from laboratory testing conducted as part of the submission process, not from patient studies or specific geographical regions. It is retrospective in the sense that it was generated for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The device is a medical accessory (subcutaneous needle set), and the testing performed involves objective physical and material performance measurements (e.g., flow rate, volumes, dimensions, flexibility, biocompatibility), not diagnostic image analysis or clinical assessment requiring expert consensus ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the tests are objective laboratory measurements, not subjective evaluations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This is not applicable. This is a 510(k) submission for a physical medical device, not an AI/diagnostic software.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This is a 510(k) submission for a physical medical device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the performance comparisons in this 510(k) submission consists of objective physical measurements, material properties, and compliance with specified standards (e.g., ISO for sterility and biocompatibility). The predicate devices' performance serves as the benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable as there is no "training set" for physical device performance testing in this context.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no "training set" for physical device performance testing in this context.

Summary

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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 Products24 Carpenter RoadChester, NY 10918 USA845-469-2042
	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 MC4206K020530
	Marcal Medical, Inc.Subcutaneous Needle Infusion SetK082818

4. Device Description:

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 SetK102512 (New)	Evans Sub-q SetK020530	Marcal Sub-q SetK082818
Tubing Length(inches)	20	2, 4, 3.5, 5, 36, 42	36, 42
Tubing Material	Medical Grade PVCPlastic	Medical GradePolyethylenePlastic	Medical Grade PVCPlastic
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
SterilizationMethod	Gamma	ETO	ETO
Indications for Use	RMS SubcutaneousNeedle Sets areintended for thedelivery ofmedication to thesubcutaneoustissue.	Evans WingedSubcutaneousInfusion Set isintended to providesubcutaneousinfusion ofmedicine from anexternal infusionpump or syringe.	The SubcutaneousInfusion Set isdesignedspecifically for thedelivery ofmedication to thesubcutaneoustissue.

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

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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
	FemaleLuer	Tubing	Butterfly	AdhesiveDressing
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/ResidualVolume (ml)	RMS Sub-q Set26gK102512 (New)	Evans Sub-q Set27gK020530	Marcal Sub-q Set27gK082818
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

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

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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.

TestPerformed	Standard	Test Name	TestResult	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 injectiontest
Biocompatibility	ISO 10993-10	Sensitization	PASS	Magnusson-KligmanMethod
Biocompatibility	ISO 10993-4	Hemocompatability	PASS	Complement ActivationGLP Report
Biocompatibility	ISO 10993-4	Hemocompatability/clotting	PASS	Partial ThromboplastinTime (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

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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

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.