(272 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, flow rates, and safety features of a subcutaneous needle set. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML.
No.
This device is intended for the delivery of medication to the subcutaneous tissue, acting as a conduit rather than providing any therapeutic effect itself. Its purpose is to facilitate the administration of therapeutic substances, but it is not a therapeutic device by its own function.
No
The device is a needle set intended for the delivery of medication to the subcutaneous tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components such as needles, tubing, luer locks, and a butterfly assembly, indicating it is a hardware device. The performance studies also focus on physical characteristics like biocompatibility, flow rate, and needle properties.
No, 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 describes a device used in vivo (within the body) for therapeutic purposes (delivering medication).
- Device Description: The description details a needle set, tubing, luer lock, and other components designed for administering fluids directly into the subcutaneous tissue. This is consistent with an infusion device used for treatment.
- Lack of IVD Characteristics: An IVD is a device intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This device does not perform any such examination of specimens.
The device is classified as a Class II Intravascular Administration Set, which is a category for devices used to administer fluids into the body, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
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.
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
children and obese adult patients
Intended User / Care Setting
medical professionals
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility:
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 and USP, respectively.
The studies submitted for the predicate RMS Subcutaneous Needle Set (K102512) that include cytotoxicity; irritation; sensitization, and hemocompatibility were also included.
All studies, new and predicate, show the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are considered equal to, or better than, predicate devices.
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.
A comparison test was completed using 26 gauge sets of all configurations up to 8-needles, and the data was compared with a single 26 gauge needle set for total fluid flow output. Results demonstrate 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.
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.
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.
A flow test was conducted to determine the impact of the optional convenience 24" Extension Set on flow rate. This was to confirm 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.
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.
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.
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 (Mechanical Properties):
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image 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
24 Carpenter Road Chester, NY 10918 - USA
800-624-9600 toll free 845-469-2042 local 845-469-5518 fax
==============================================================================================================================================================================
1
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:
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.
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
24 Carpenter Road Chester, NY 10918 · USA
800-624-9600 toll free 845-469-2042 local 845-469-5518 fax
2
Image /page/2/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. To the right of the hexagons, the letters "RMS" are displayed in a bold, sans-serif font, with a trademark symbol in the upper right corner. Below the letters, the words "MEDICAL PRODUCTS" are printed in a smaller, sans-serif font.
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 and USP, 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
800-624-9600 toll free 845-469-2042 local 845-469-5518 fax
3
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™ | |||
| Subcutaneous | ||||
| Safety Needle Sets | ||||
| (New) | RMS | |||
| Subcutaneous | ||||
| Needle Set | ||||
| K102512 | ||||
| (Predicate) | EMED®/Evans | |||
| Sub-q Set | ||||
| K020530 | MarCal Medical | |||
| Sub-q Set | ||||
| K082818 | ||||
| Tubing Length | ||||
| (inches) | 20, 24, *44 | 20 | 2, 4, 3.5, 5, 36, 42 | 36, 42 |
| Tubing | ||||
| Material | Medical Grade PVC | |||
| Plastic | Medical Grade | |||
| PVC Plastic | Medical Grade | |||
| Polyethylene | ||||
| Plastic | Medical Grade | |||
| PVC Plastic | ||||
| Needle | ||||
| Material | 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 |
| Sterilization | ||||
| Method | Gamma | Gamma | ETO | ETO |
| Indications for | ||||
| Use | RMS HIgH-Flo™ | |||
| Subcutaneous | ||||
| Safety Needle Sets | ||||
| are intended for | ||||
| the delivery of | ||||
| medication to the | ||||
| subcutaneous | ||||
| tissue. | 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 | The | |||
| Subcutaneous | ||||
| Infusion Set is | ||||
| designed | ||||
| specifically for | ||||
| the delivery of | ||||
| medication to | ||||
| the | ||||
| subcutaneous | ||||
| tissue. |
*-- 44" is the full length with the optional convenience 24″ Extension Set added
Section 5, Page 4
24 Carpenter Road Chester, NY 10918 - USA
800-624-9600 toll free 845-469-2042 local 845-469-5518 fax
www.rmsmedicalproducts.com . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
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 | Adhesive | |
| Dressing | ||||
| RMS HIgH-Flo™ | ||||
| Subcutaneous | ||||
| Safety Needle | ||||
| Sets | PVC | PVC | Polypropylene | Dressing by 3M |
| RMS | ||||
| Subcutaneous | ||||
| Needle Set | PVC | PVC | Polypropylene | Dressing by 3M |
| Evans Sub-q Set | PVC | Polyethylene | PVC | Hypoallergenic |
| dressing | ||||
| 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
24 Carpenter Road Chester, NY 10918 - USA
800-624-9600 toll free 845-469-2042 local 845-469-5518 fax
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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
800-624-9600 toll free 845-469-2042 local 845-469-5518 fax
6
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
24 Carpenter Road Chester, NY 10918 · USA
800-624-9600 toll free 845-469-2042 local 845-469-5518 fax
7
Image /page/7/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 bold, sans-serif font, with the letters slightly overlapping. Below "RMS" is the text "MEDICAL PRODUCTS" in a smaller, sans-serif font.
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
24 Carpenter Road Chester, NY 10918 - USA
800-624-9600 toll free 845-469-2042 local 845-469-5518 fax
www.rmsmedicalproducts.com ==============================================================================================================================================================================
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Image /page/8/Picture/1 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
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.
9
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
10
Exhibit I
Section 4 Indications for Use Statement
510(k) Number (if known):
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)
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 |
|---|---|
| ---------------- | --------- |
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