The RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are 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 grade needle mounted to a butterfly assembly on one end, and a luer lock on the other end, connected by medical grade tubing. The needles are available in 24 and 26 gauges and in lengths of 4mm, 6mm, 12mm and 14mm. The 4mm and 14mm lengths are added for children and obese adult patients, respectively. The optional convenience 24" Extension Set is used to add length to a needle set when desired.

There is a snap closure to safely capture the needle after use. This minimizes the potential for a needlestick injury. Each leg in a set is equipped with a slide clamp to stop flow immediately, if needed. The RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are available for up to 8 infusion sites using our basic sets of one, two, three or four legs ganged together using a low residual "Y-Connector" (for example to achieve a 7 site infusion, a RMS 4 set will be ganged with a RMS 3 set using a Y-Connector). All needle sets, regardless of combination, are for single use only.

AI/ML Overview

The provided text describes the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets and the studies performed to demonstrate its substantial equivalence to predicate devices, particularly focusing on performance, biocompatibility, and safety.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Aspect	Device Performance (RMS HIgH-Flo™ Subcutaneous Safety Needle Sets)	Study/Method to Prove Acceptance
Biocompatibility
Systemic Toxicity (Extract - NaCl)	Meets acceptable ISO criteria	ISO Systemic Toxicity Study
Systemic Toxicity (Extract - Sesame Oil)	Meets acceptable ISO criteria	ISO Systemic Toxicity Study
Subcutaneous Implantation (Rabbits - 6wks)	Meets acceptable ISO criteria	ISO Subcutaneous Implantation Study
Non-pyrogenic	Within acceptable USP limits (<151> and <85>)	Pyrogen Study (Material Mediated), Limulus Amebocyte Lysate
Cytotoxicity	Equal to, or better than, predicate devices	Studies submitted for predicate K102512
Irritation	Equal to, or better than, predicate devices	Studies submitted for predicate K102512
Sensitization	Equal to, or better than, predicate devices	Studies submitted for predicate K102512
Hemocompatibility	Equal to, or better than, predicate devices	Studies submitted for predicate K102512
Safety
Minimized needlestick injury potential	Snap closure safely captures needle after use	Device design, Clinical Simulated Use Study
Overall safety classification	Met criteria, classified as "safety sets"	RMS Clinical Simulated Use Study (per FDA guidance, FDA reviewed protocol)
No adverse effects/complications	No adverse effects or complications reported	RMS Clinical Simulated Use Study
Critical/Essential task evaluation	All critical and essential tasks evaluated, no difficulties	RMS Clinical Simulated Use Study
Performance (Flow Rate)
Flow rate with 7-needle sets (26G)	No degradation of flow compared to single 26G set	Comparison test (26 gauge sets up to 8-needles)
Leg-to-leg consistency (7th/8th needles)	No negative effect on leg-to-leg consistency	Additional test
Flow rate with 24 gauge needle set	Equal or better flow performance than Evans and MarCal predicate devices (up to 8-needle configurations)	Flow testing (24 gauge sets up to 8-needles)
Flow rate vs. predicate 27G	26 gauge RMS HIgH-Flo™ flows better	Flow testing (comparison to predicate 27G)
Flow rate vs. predicate Evans 24G	26 gauge RMS HIgH-Flo™ flows somewhat better	Flow testing (comparison to Evans 24G)
Flow rate vs. predicate MarCal 24G	26 gauge RMS HIgH-Flo™ flows slower	Flow testing (comparison to MarCal 24G)
Flow rate 24G vs. all predicates	Flows as well as, or better than, any listed predicate devices	Flow testing (comparison to all predicates)
Flow degradation with 7th/8th 24G needles	No degradation of flow rates	Second test (24 gauge, single vs. multiple configurations)
Flow variation (leg-to-leg 24G)	Less than 7%	Second test (24 gauge, leg-to-leg consistency)
Flow with 5cp viscosity fluid (24G)	Thicker drugs will flow as designed	Flow test (24 gauge with 5cp viscosity fluid)
Impact of 24" Extension Set (26G)	Minor impact on flow rate	Flow test
Residual Volume
Priming/residual volumes	Similar performance to predicate devices (substantially equivalent)	Priming/residual volume measurements
Sterilization & Shelf Life
Packaging/product integrity (3-year aging)	Acceptable integrity, no degradation of product	ISO 11137 aging studies (dye migration, bag seal, luer function, needle/hub bond, flexibility, butterfly wing performance, luer/tube integrity)
Material Characteristics	Identical or equivalent medical grade materials as predicates	Materials Comparison Chart
Device Characteristics	Equivalent physical properties, material grade, indications for use, compared to predicates for 4mm and 14mm needle lengths	Predicate Device Comparison Chart
Needle Tip Measurements	No substantial difference from predicate devices	Comparison of needle tip dimensions
Performance Testing (General)	Similar performance to predicate devices	Needle tip, stiffness, resistance to breakage and corrosion, conical fitting, and fatigue tests

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

The document does not explicitly state the numerical sample size for individual tests within the "Clinical Simulated Use Study" or the flow rate studies. It mentions "medical professionals participated" in the clinical study and "comparative tests" and "flow tested" for the performance studies without giving specific numbers of devices or test runs.

Provenance: This is a 510(k) summary submitted to the FDA (United States). The studies appear to be internal RMS Medical Products studies ("RMS internal procedure (SOP 8001)") or performed in accordance with international (ISO) and national (USP) standards, indicating the data is likely from studies conducted by or for the manufacturer. The document doesn't specify countries of origin for the test data beyond the manufacturer's location in New York, USA.
Retrospective/Prospective:
- Biocompatibility and Sterilization/Shelf Life: These are typically prospective laboratory/animal studies.
- Clinical Simulated Use Study: This was a prospective study ("medical professionals participated in an RMS Clinical Simulated Use Study, per FDA guidance documents with FDA review of the proposed protocol").
- Performance Testing (flow rate, residual volume, material/device characteristics): These were prospective laboratory tests.

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

The document mentions "medical professionals participated" in the RMS Clinical Simulated Use Study. However, it does not specify the number or qualifications of these medical professionals, nor does it explicitly define their role in establishing a "ground truth" in the way one might for diagnostic accuracy studies. Their role was to evaluate the device during simulated use, and their subjective and statistical data contributed to the safety determination.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth from multiple experts. For the "Clinical Simulated Use Study," it states, "An analysis of all subjective and statistical data concludes that the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets met the criteria set." This implies an analysis of the collected data rather than a consensus or adjudication process among multiple reviewers to determine a 'truth' independently.

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

No MRMC Comparative Effectiveness Study: This device is a medical device (subcutaneous needle set), not an AI/diagnostic software. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed. The studies focus on the physical performance, biocompatibility, and safety of the needle set itself.

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

Not applicable: As this is a physical medical device and not an AI algorithm, a standalone performance study in the context of AI is not relevant. The device's performance is standalone in the sense that its physical properties (flow rate, material, etc.) are tested without human intervention impacting the measurement of those properties, but it is ultimately used by a human.

7. The Type of Ground Truth Used

The concept of "ground truth" in the context of this device's evaluation is primarily based on:

Established Scientific Standards: For biocompatibility (ISO standards), pyrogenicity (USP limits), and sterilization (ISO 11137).
Pre-defined Acceptance Criteria: For the Clinical Simulated Use Study, criteria were "set" and the device "met the criteria."
Direct Measurement and Comparison: For flow rates, residual volumes, material characteristics, device dimensions, and mechanical properties, the "ground truth" is the measured physical data, which is then compared against predicate devices and internal performance expectations.

8. The Sample Size for the Training Set

Not applicable: This device is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable: As there is no training set for an AI algorithm, this question is not relevant.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for RMS Medical Products. The logo consists of three hexagons arranged in a triangular shape on the left, followed by the text "RMS" in bold, sans-serif font. Below the "RMS" text is the phrase "MEDICAL PRODUCTS" in a smaller, sans-serif font. The letters "TM" are in superscript to the right of the letter S.

MAY 0 6 2013

Section 5 510(k) Summary

[As required by 21 CFR 807.92(c )]

Owner Name and Contact Details:

Andrew I. Sealfon, CEO & President Repro-Med Systems, Inc. dba RMS Medical Products 24 Carpenter Road Chester, NY 10918 USA Local: 845-469-2042 Fax: 845-469-5518

FDA Establishment Registration Number: 1318360

Prepared on: August 2, 2012

510k Number: K122404

Trade Name:

RMS HIgH-Flo™ Subcutaneous Safety Needle Sets

Classification Name:

Intravascular Administration Set

Classification Code: FPA (per 21 CFR 880.5440)

Classification: Class II

Section 5, Page 1

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Image /page/1/Picture/0 description: The image shows the logo for RMS Medical Products. The logo consists of three hexagons arranged in a cluster on the left side. To the right of the hexagons is the text "RMS" in large, bold letters, with "TM" in superscript next to the "S". Below "RMS" is the text "MEDICAL PRODUCTS" in a smaller font.

Substantial Equivalence to Predicate Devices:

RMS Medical Products Subcutaneous Needle Set K102512

Evans Medical, Inc. Evans Winged Sub-q MC4206 K020530

MarCal Medical, Inc. Subcutaneous Needle Infusion Set K082818

Device Description:

Indications for Use:

RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue. There are no differences in the indications for use between the current RMS HIgH-Flo™ Safety Subcutaneous Needle Sets and the predicate RMS subcutaneous needles in K102512, or other predicate devices.

Section 5, Page 2

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ア

Summary of Data:

As stated in the cover letter and pertaining to the seven modifications to an already legally marketed RMS device (K102512), the additional test data that is included in this new submission to support new claims is summarized below:

Biocompatibility:

To remove the 24 hour (short-term) use limitation of the previous RMS subcutaneous needle set submission K102512, studies were performed in accordance with internationally recognized standards including: (1) ISO Systemic Toxicity Study-Extract (Sodium Chloride), (2) ISO Systemic Toxicity Study-Extract (Sesame Oil), and (3) ISO Subcutaneous Implantation Study in Rabbits-6 weeks. Results meet acceptable ISO criteria.

To include the term "non-pyrogenic" two studies were performed in accordance with internationally recognized standards: (1) Pyrogen Study - Material Mediated; (2) Limulus Amebocyte Lysate. Results of both studies were within acceptable USP limits, USP<151> and USP<85>, respectively.

We are including the studies submitted for the predicate RMS Subcutaneous Needle Set (K102512) that include cytotoxicity; irritation; sensitization, and hemocompatibility.

All studies, new and predicate, show the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are considered equal to, or better than, predicate devices.

Clinical Evaluation:

To claim "Safety" for the Needle Sets, medical professionals participated in an RMS Clinical . Simulated Use Study, per FDA guidance documents with FDA review of the proposed protocol. An analysis of all subjective and statistical data concludes that the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets met the criteria set and thus may be classified as safety sets. Furthermore, all critical and essential tasks (as specified in the protocol) and difficulties with use of the product during the study were evaluated as part of this safety determination. No adverse effects or complications were reported during the study. Consequently, the device is known as "Safety" Needle Sets and has a safety design equal to, or better than, predicate devices.

Section 5, Page 3

24 Carpenter Road Chester, NY 10918 • USA

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Device Characteristics:

Additional 4mm and 14mm needle lengths are used for children and obese adult patients, respectively, and are substantially equivalent in physical properties, material grade, and have similar indications for use as the predicate devices Evans (K020530) and MarCal (K082818). Both of these predicates include 14mm, and K020530 also includes 4mm. Thus, no new issues of safety or effectiveness are introduced.

	Predicate Device Comparison Chart
Characteristic	RMS HIgH-Flo™SubcutaneousSafety Needle Sets(New)	RMSSubcutaneousNeedle SetK102512(Predicate)	EMED®/EvansSub-q SetK020530	MarCal MedicalSub-q SetK082818
Tubing Length(inches)	20, 24, *44	20	2, 4, 3.5, 5, 36, 42	36, 42
TubingMaterial	Medical Grade PVCPlastic	Medical GradePVC Plastic	Medical GradePolyethylenePlastic	Medical GradePVC Plastic
NeedleMaterial	Stainless Steel	Stainless Steel	Stainless Steel	Stainless Steel
Needle Gauge	24, 26	26	24, 27	24, 27
Needle Length(mm)	4, 6, 9, 12, 14	6, 9, 12	4, 6, 9, 12, 14	6, 9, 12, 14
SterilizationMethod	Gamma	Gamma	ETO	ETO
Indications forUse	RMS HIgH-Flo™SubcutaneousSafety Needle Setsare intended forthe delivery ofmedication to thesubcutaneoustissue.	RMSSubcutaneousNeedle Sets areintended for thedelivery ofmedication to thesubcutaneoustissue.	Evans WingedSubcutaneousInfusion Set isintended toprovidesubcutaneousinfusion ofmedicine froman externalinfusion pump or	TheSubcutaneousInfusion Set isdesignedspecifically forthe delivery ofmedication tothesubcutaneoustissue.

*-- 44" is the full length with the optional convenience 24″ Extension Set added

Section 5, Page 4

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Image /page/4/Picture/0 description: The image shows the logo for RMS Medical Products. The logo consists of three hexagons arranged in a cluster on the left side. To the right of the hexagons, the letters "RMS" are displayed in a bold, sans-serif font, with the letters slightly overlapping each other. Below the letters, the words "MEDICAL PRODUCTS" are printed in a smaller, sans-serif font.

Material Characteristics:

RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are comprised of either identical or equivalent medical grade materials as used in the RMS sets cleared under K102512, the Evans sets cleared under K020530, and the MarCal sets cleared under K082818. Thus, no new issues of safety or effectiveness are introduced.

Materials Comparison Chart
	Female Luer	Tubing	Butterfly	AdhesiveDressing
RMS HIgH-Flo™SubcutaneousSafety NeedleSets	PVC	PVC	Polypropylene	Dressing by 3M
RMSSubcutaneousNeedle Set	PVC	PVC	Polypropylene	Dressing by 3M
Evans Sub-q Set	PVC	Polyethylene	PVC	Hypoallergenicdressing
MarCal Sub-q Set	NA	PVC	Polyethylene	NA

Performance Testing (flow rate):

Fluid flow rate testing was performed on the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets to determine performance with: (1) the addition of 7-needle sets; (2) the addition of a 24 gauge needle set; (3) the addition of an optional convenience 24" Extension Set. Testing was completed in accordance with an RMS internal procedure (SOP 8001). Results were compared with the predicate devices and are summarized below:

Overall Flow Comparison Results
Average Flow Rate (mL/hr) using D50 @ 5psi
	1	2	3	4	5	6	7	8	Total
RMS Medical Products 26G	48.55	49.87	48.47	48.02	48.42	50.48	48.89	47.04	389.74
RMS Medical Products 24G	239.72	238.01	239.31	240.55	239.84	239.67	240.65	239.77	1917.52
Evans Medical 27G	24.64	22.55	12.97	24.33	27.96	26.57	n/a	n/a	139.02
Evans Medical 24G	50.32	50.18	49.18	48.40	n/a	n/a	n/a	n/a	198.09
Marcal Medical 24G	101.86	101.48	103.76	100.10	n/a	n/a	n/a	n/a	407.21
Marcal Medical 27G	34.36	67.82	95.56	126.04	n/a	n/a	n/a	n/a	323.78

Overall Flow Comparison Results

Section 5, Page 5

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Image /page/5/Picture/0 description: The image shows the logo for RMS Medical Products. The logo consists of three hexagons arranged in a cluster 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, simpler font. The logo is black and white.

To determine the effects of the two additional insertion needles, a comparison test was completed using 26 gauge sets of all configurations up to 8-needles. The data was compared with a single 26 gauge needle set for total fluid flow output. Results of this comparison test show that the measured and compared data demonstrates that there is no degradation of flow when the 7th and 8th needles are added.

An additional test demonstrated no negative effect upon leg-to-leg consistency from adding the 7th and 8th needles.

To support the addition of a 24 gauge needle set, 24 gauge needle sets were flow tested, up to and including 8-needle set configurations, and compared with flow data from predicate devices which were measured up to six needle sites. Results indicate that the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets have equal or better flow performance than both the Evans and MarCal predicate devices. In comparison, the 26 gauge RMS HIgH-Flo™ Subcutaneous Safety Needle Sets flow better than the 27 gauge needles from the Evans and MarCal predicates. Also, the 26 gauge flows somewhat better than the Evans 24 gauge needle, but slower than the MarCal 24 gauge. In comparison, the 24 gauge RMS HigH-Flo™ Subcutaneous Safety Needle Sets flow as well as, or better than, any of the listed predicate devices.

To further support this conclusion, a second test was completed in which the 24 gauge needle set was tested using the same method as the 26 gauge comparison test above, and a single 24 gauge needle set was compared with subsequent configurations with respect to total flow output. The test results indicate there was no degradation of flow rates with the additions of the 7th and 8th needles and the variation of flow from leg to leg was less than 7% for the 24 gauge needle sets.

In addition, the 24 gauge was tested using a 5cp viscosity fluid to simulate the flow of certain viscous drugs. Results confirm that these thicker drugs will flow as designed in the 24 gauge needle assemblies.

To support the addition of an optional convenience 24" Extension Set to provide additional length for the convenience of patients who are using the RMS 26 gauge needles, we conducted a flow test. This was to determine that the addition of the optional convenience 24" Extension Set would have (at most) a minor impact on flow rate and for most patients, and therefore would not be noticeable.

Section 5, Page 6

24 Carpenter Road Chester, NY 10918 - USA

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Image /page/6/Picture/0 description: The image shows the logo for RMS Medical Products. The logo consists of three hexagons arranged in a triangular pattern on the left side. To the right of the hexagons is the text "RMS" in large, bold letters, with the trademark symbol next to the "S". Below "RMS" is the text "MEDICAL PRODUCTS" in smaller letters.

Residual Volume Testing:

Priming/residual volumes were also measured for the use of additional sites and 24 gauge needles and data was compared with the predicate devices. The performance testing indicates that the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets have similar performance to the predicate devices specifically indicating substantially equivalency.

Data Revised:

Data revised since the predicate RMS submission K102512 that is included in this new submission, but does not affect the claims as stated in the cover letter, includes:

Sterilization and Shelf Life:

In accordance with ISO 11137, aging of the RMS High-Flo™ Subcutaneous Safety Needle Sets' packaging and product was completed for a three-year determination from a one year determination. Tests performed on the aged packaging and product included: dye migration; bag seal integrity; multi-port luer function and brittleness; needle/hub bond test; flexibility of [butterfly] wings; butterfly wing performance; luer/tube integrity. All results indicate that the integrity of the packaging and seal is acceptable and protects the device from degradation during three year aging and there is no degradation of the product. See Section 14 for details.

Data Unchanged:

Data unchanged since the predicate RMS submission K102512 and that is included in this new submission, but does not affect the claims as stated in the cover letter, includes:

Needle Tip Measurements:

A comparison of the needle tip dimensions indicates there is no substantial difference between the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets and the predicate devices.

Performance Testing:

Needle tip, stiffness, resistance to breakage and corrosion, conical fitting, and fatigue tests were completed for the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets and compared with the predicate devices.

Conclusion:

Considering all clinical and non-clinical data included in this 510(k) submission, the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are as safe, as effective, and perform equally to, or better than, predicate devices from RMS, Evans, and MarCal.

Section 5, Page 7

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Substantial Equivalence Statement:

All data presented demonstrates that the RMS HigH-Flo™ Subcutaneous Safety 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 HIgH-Flo™ Subcutaneous Safety Needle Sets and the predicate devices do not raise any new issues of safety or effectiveness.

Section 5, Page 8

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 6, 2013

Mr. Andrew I. Sealfon Chief Executive Officer & President Repro-Med Systems, Incorporated, DBA RMS Medical Products 24 Carpenter Road Chester, New York 10918

Re: K122404

Trade/Device Name: RMS High-Flo Subcutaneous Safety Needle Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 14, 2013 Received: March 21, 2013

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 - Mr. 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industrv/default.htm.

Sincerely yours.

Image /page/9/Picture/8 description: The image shows a handwritten note or signature. The text "For" is visible at the top left, followed by a stylized signature that includes the word "with". The signature is underlined with a decorative flourish. The overall impression is that of a personalized message or autograph.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit I

Section 4 Indications for Use Statement

510(k) Number (if known):

K122404

Device Name:

Indications for Use:

RMS HigH-Flo™ Subcutaneous Safety Needle Sets

RMS HigH-Flo™ Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
FDA Logo
Richard C. Chapman
2013.05.02 11:14:26
-04'00'
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K122404
----------------	---------

4-1

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.