(359 days)
The Dimesol Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. This device is for inhospital or hemodialysis center use only.
The Dimesol Disposable A.V. Fistula Needle Sets (Safety Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Protective Shield aids in the prevention of accidental needlesticks. This device is for inhospital or hemodialysis center use only.
The Dimesol Disposable A.V. Fistula Needle Sets are intended for use as a nonimplantable (i.e., less than 30 days use) vascular/blood access device for temporary cannulation in procedures requiring an extracorporeal circuit, such as hemodialysis.
The Dimesol Disposable A.V. Fistula Needle Sets are intended for use as a nonimplantable (less than 30 days use) vascular access device for temporary cannulation in procedures requiring an extracorporeal circuit, such as hemodialysis.
The Dimesol Disposable A.V. Fistula Needle Sets are intended for use as a nonimplantable (i.e., less than 30 days use) vascular/blood access device for temporary cannulation in procedures requiring an extracorporeal circuit, such as hemodialysis. The cannula (needle) of the device is used to puncture the appropriate area of a patient and the opposite end of the device is attached to a blood tubing set. Typically, two needle sets are used for each treatment. The first set is used to access the patient's artery to transfer blood to the dialyzer and the second set is used to access the patient's vein to transfer filtered blood back to the patient's body. The AV fistula needle sets are available in two main variants: (i) needle sets that do not include a safety feature; and (ii) needle sets that do include a safety feature. The safety feature is a protective shield that covers the cannula after use and requires physical action by the clinician to activate. Both variants are sterile and intended for single use only. Both variants are provided in a fixed-wing design (stationary) and a rotatable wing design (rotatable). The major components of these AV fistula needle sets are manufactured from medical-grade polyvinyl chloride, polypropylene, fire-retardant polyethylene, and other medical-grade macromolecule materials and innocuous stainless steel. These AV fistula needle sets are latex-free and can be inserted into a patient's vein and then connected to a hemodialysis bloodline tubing set. The tubing is soft, transparent, smooth and non-kink. The wings of the needle set are suitably rigid, and the on/off clamps are simple and convenient with regard to use. The wing for 15G is Blue, 16G is Green, and 17G is Red. The tip of the cannula is sharpened to reduce the pain for the patient. The backeye is slender and close to the cannula tip and is slipresistant for smooth puncturing.
The Dimesol Disposable A.V. Fistula Needle Sets without safety shield includes the following structural components: (1) a protective cap for the cannula; (2) a cannula (arterial or venous); (3) a hub; (4) a color-coded fixed or rotatable gripping wing; (5) flexible tubing; (6) a small on/off hemostatic clamp; (7) a connective female luer lock; and (8) a cap for the female luer lock. These AV fistula needle sets are sterilized using gamma radiation. The patient and/or blood contacting components are the cannula, the tubing segment, and the luer lock.
The Dimesol Disposable A.V. Fistula Needle Sets with safety shield includes the following structural components: (1) a protective polypropylene cap for the cannula; (2) a cannula (arterial or venous); (3) a hub; (4) a color-coded fixed or rotatable gripping wing; (5) a safety shield for encapsulating the cannula after use; (6) flexible tubing; (7) a small on/off hemostatic clamp; (8) a connective female luer lock; and (9) a cap for the female leur lock. These AV fistula needle sets are sterilized using gamma radiation. The patient and/or blood contacting components are the cannula, the hub, the tubing segment, and the luer lock.
The protective shield component is generally tubular in shape and includes a locking mechanism that is adapted to secure the hub inside the protective shield when the hub is in its retracted position. The locking mechanism prevents the needle from inadvertently protruding out of the protective shield, thereby ensuring safe disposal of the cannula after use. The oppositely placed axial slots on the protective shield are adapted to receive the wings when the hub moves into the protective shield, thereby ensuring a correct rotational position of the protective shield relative to the hub. The axial length of the slots is long enough to receive both the hub and the cannula, particular the sharp tip of the cannula, thereby preventing accidental exposure to the tip of the needle. The locking mechanism includes two locking aspects. With regard to the first locking aspect, the tubular wall is spread apart when the hub moves into the protective shield. The lower portion of the tubular wall includes a curve that facilitates the insertion of the upper tubular wall includes a locking hoot that maintains the wings in a downward position when the hub moves into the slot. This aspect facilitates the continuous transition of the hub and wings from the minimum width regions of the slots toward the enlarged regions of the slots. With regard to the second locking aspect, two asymmetric locking hooks extend from the tubular walls. These hooks maintain the hub and winds in the enlarged slot. The cannula and hub are thus fully received and locked inside the protective shield and the device may be disposed of in a safe manner. An audible click indicates to the user that the device is in its final locked position.
The provided text is a 510(k) Summary for the Dimesol Disposable AV Fistula Needle Set. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving specific performance metrics against pre-defined acceptance criteria in the context of an AI/ML device.
Therefore, the requested information regarding acceptance criteria, study findings against those criteria, sample sizes, expert involvement, and ground truth establishment, typically associated with performance studies for AI/ML medical devices, is not present in this document.
The document primarily focuses on:
- Device Description: What the device is, its variants (safety and non-safety), and components.
- Indications for Use: What the device is intended for (vein puncture for hemodialysis).
- Substantial Equivalence: A comparison of the Dimesol device's materials, dimensions, intended use, indications for use, configuration, and other factors to legally marketed predicate devices (NIPRO SafeTouch Tulip Safety Fistula Needle, JMS A.V. Fistula Needle Set, EXEL A.V. Fistula Needle Set).
- Performance Testing: A statement that specific performance tests were conducted and found "substantially equivalent" to predicate devices, but without providing the specific acceptance criteria or the reported device performance values for these tests.
However, I can extract the general "performance" aspects that the manufacturer claims are substantially equivalent:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, while specific numerical acceptance criteria and reported performance values are not detailed, the document states that the Dimesol Disposable AV Fistula Needle Sets underwent various performance tests and were found to be "substantially equivalent" to the predicate device (K071145). The table below reflects the types of performance criteria assessed, as indicated in Table 7 of the document. The "Acceptance Criteria" here are implicitly "demonstrates substantial equivalence to K071145 for this test," and the "Reported Device Performance" is consistently stated as "substantially equivalent."
| Performance Test Type | Acceptance Criteria (Implicit) | Reported Device Performance (as stated) |
|---|---|---|
| Needle Performance Testing | Substantially equivalent to K071145 | substantially equivalent |
| Female Conical Fitting Testing | Substantially equivalent to K071145 | substantially equivalent |
| Mechanical Testing (wing torque, final lock, needle pushback, mechanical hemolysis) | Substantially equivalent to K071145 | substantially equivalent |
| Tensile Strength Testing (tube to wing pull, tube to joint, needle to cover pull, cannula to hub) | Substantially equivalent to K071145 | substantially equivalent |
| Tubing Kinking Test | Substantially equivalent to K071145 | substantially equivalent |
| Leakage Testing (liquid, air) | Substantially equivalent to K071145 | substantially equivalent |
| Clamp Stop Testing | Substantially equivalent to K071145 | substantially equivalent |
| Flow Rate Testing | Substantially equivalent to K071145 | substantially equivalent |
2. Sample size used for the test set and the data provenance:
- The document does not specify the sample sizes used for any of the performance tests.
- The data provenance is for a physical medical device (AV fistula needle set) and the testing would have been conducted by the manufacturer (Bain Medical Equipment (Guangzhou) Co., Ltd.) or a contracted lab. The document does not specify the country of origin of the test data. The product manufacturing is in Guangzhou, China. The application is submitted from the US.
- The document describes premarket testing of a physical device, not an AI/ML model. Therefore, the concepts of "retrospective or prospective" data sets in the context of AI models (which refer to how data was collected for the AI model's training/testing) do not directly apply here in the usual sense. These are engineering performance tests on manufactured product samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document is for a physical medical device. The concept of "ground truth" established by experts (e.g., radiologists for imaging) is not applicable here. The performance tests are engineering and biological validations (e.g., tensile strength, flow rate, biocompatibility) against established standards (e.g., ISO 10993) and comparison to predicate devices, not subjective expert interpretations of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- As this is a physical device being tested against engineering and biological standards, adjudication methods (common in expert consensus for AI/ML ground truth) are not applicable. The results would be quantitative measurements.
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 question is not applicable. The device is an AV fistula needle set, a physical medical instrument, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a physical medical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For physical devices like this, "ground truth" typically refers to adherence to pre-defined engineering specifications, international standards (e.g., ISO 10993 for biocompatibility), and physical performance measurements rather than a subjective or pathological "truth." The document states conformance to ISO 10993 for biocompatibility.
8. The sample size for the training set:
- This question is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- This question is not applicable. There is no "training set."
In summary: The provided text is a regulatory submission for a physical medical device (AV fistula needle set) under the 510(k) pathway, which focuses on demonstrating substantial equivalence to existing devices. It does not contain the specific information typically found in performance studies for AI/ML medical devices, which would detail precise acceptance criteria and quantitative performance results, or involve concepts like ground truth establishment by experts, human-in-the-loop studies, or training/test sets for algorithms. The "acceptance criteria" here are implicitly linked to demonstrating equivalence and meeting relevant device standards.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 17, 2018
Dimesol, Inc. % Courtnev J. Miller. J.D., LL.M. Partner Frost Brown Todd LLC 10 West Broad Street, Suite 2300 Columbus, OH 43215
Re: K171505
Trade/Device Name: Dimesol Disposable AV Fistula Needle Set (Non-Safety Series), Dimesol Disposable AV Fistula Needle Sets (Safety Needle Series) Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood Access Device and Accessories Regulatory Class: II Product Code: FIE Dated: April 17, 2018 Received: April 18, 2018
Dear Courtney J. Miller:
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.
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.
{1}------------------------------------------------
(Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
INDICATIONS FOR USE STATEMENT
510(k) Number: K171505
FORM: FDA 3881
Device Name: Dimesol Disposable AV Fistula Needle Set (Non-Safety Series)
Indications for Use:
The Dimesol Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. This device is for inhospital or hemodialysis center use only.
X AND/OR Over-The-Counter Use 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)
{3}------------------------------------------------
INDICATIONS FOR USE STATEMENT
510(k) Number: K171505
FORM: FDA 3881
Device Name: Dimesol Disposable AV Fistula Needle Sets (Safety Needle Series)
Indications for Use:
The Dimesol Disposable A.V. Fistula Needle Sets (Safety Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Protective Shield aids in the prevention of accidental needlesticks. This device is for inhospital or hemodialysis center use only.
AND/OR Over-The-Counter Use ________________ Prescription Use x (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)
{4}------------------------------------------------
510(K) SUMMARY UNDER 21 CFR 807.92
This 510(k) summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content in this 510(k) summary has been provided in conformance with 21 CFR Part 807.92.
A. Submitter's Information
| (1) Name: | Frost Brown Todd, LLC |
|---|---|
| (2) Address: | 10 W. Broad Street, Suite 2300 Columbus, OH 43215 USA |
| (3) Phone: | 614-559-7288 |
| (4) Fax: | 614-464-1737 |
| (5) Contact Person: | (Mr.) Courtney J. Miller, J.D., LL.M. |
| (6) Preparation Date: | May 22, 2017 |
On Behalf of Applicant Entity (owner of 510(k))
| (1) Applicant Name: | DIMESOL, INC. |
|---|---|
| (2) Applicant Address: | 509 Fishing Creek Rd., Lewisberry, PA 17339 USA |
| (3) Applicant Phone: | 717-938-8391 |
| (4) Applicant Fax: | 717-938-3957 |
Manufactured for Dimesol, Inc. by:
| (1) Manufacturer Name: | Bain Medical Equipment (Guangzhou) Co., Ltd. |
|---|---|
| (2) Manufacturer Address: | 10 Juncheng Road, Eastern Area, Guangzhou Economic &Technological Development District, Guangzhou, China510760 |
| (3) Manufacturer Phone: | 0086-20-82265249 |
| (4) Manufacturer Fax: | 0086-20-32067500 |
B. Device Name Dimesol Disposable AV Fistula Needle Set
| (1) Trade Name: | Dimesol Disposable AV Fistula Needle Sets (Safety Needle Series) and Dimesol Disposable AV Fistula Needle Sets (Non-Safety Series) |
|---|---|
| (2) Common Name: | AV Fistula Needle Sets |
| (3) Classification: | Class II, per 21 CFR 876.5540 (Blood access device and accessories) |
| (4) Product Code: | FIE: Blood access device and accessories (non-implantable fistula needles) |
| (5) Standard(s): | ISO 10993 |
K171505-510(k) Premarket Notification for Dimesol, Inc. Dimesol Disposable AV Fistula Needle Sets (Safety and Non-Safety Versions) Revised 510(k) Summary
{5}------------------------------------------------
510(K) SUMMARY UNDER 21 CFR 807.92
C. Legally Marketed Predicate Device
| Primary Predicate: | NIPRO SafeTouch Tulip Safety Fistula Needle (K071145) |
|---|---|
| Reference Device 1: | JMS A.V. Fistula Needle Set (K990470) |
| Reference Device 2: | EXEL A.V. Fistula Needle Set (K013037) |
D. Indications for Use
(1) Safety Series
The Dimesol Disposable A.V. Fistula Needle Sets (Safety Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Protective Shield aids in the prevention of accidental needlesticks. This device is for inhospital or hemodialysis center use only.
(2) Non-Safety Series
The Dimesol Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. This device is for inhospital or hemodialysis center use only.
E. Device Description
[0001] The Dimesol Disposable A.V. Fistula Needle Sets are intended for use as a nonimplantable (i.e., less than 30 days use) vascular/blood access device for temporary cannulation in procedures requiring an extracorporeal circuit, such as hemodialysis. The cannula (needle) of the device is used to puncture the appropriate area of a patient and the opposite end of the device is attached to a blood tubing set. Typically, two needle sets are used for each treatment. The first set is used to access the patient's artery to transfer blood to the dialyzer and the second set is used to access the patient's vein to transfer filtered blood back to the patient's body. The AV fistula needle sets are available in two main variants: (i) needle sets that do not include a safety feature; and (ii) needle sets that do include a safety feature. The safety feature is a protective shield that covers the cannula after use and requires physical action by the clinician to activate. Both variants are sterile and intended for single use only. Both variants are provided in a fixed-wing design (stationary) and a rotatable wing design (rotatable). The major components of these AV fistula needle sets are manufactured from medical-grade polyvinyl chloride, polypropylene, fire-retardant polyethylene, and other medical-grade macromolecule materials and innocuous stainless steel. These AV fistula needle sets are latex-free and can be inserted into a patient's vein and then connected to a hemodialysis bloodline tubing set. The tubing is soft, transparent, smooth and non-kink. The wings of the needle set are suitably rigid, and the on/off clamps are simple and convenient with regard to use. The wing for 15G is Blue, 16G is Green, and 17G is Red. The tip of the cannula is sharpened
K171505-510(k) Premarket Notification for Dimesol, Inc. Dimesol Disposable AV Fistula Needle Sets (Safety and Non-Safety Versions) Revised 510(k) Summary
{6}------------------------------------------------
510(K) SUMMARY UNDER 21 CFR 807.92
to reduce the pain for the patient. The backeye is slender and close to the cannula tip and is slipresistant for smooth puncturing.
[0002] The Dimesol Disposable A.V. Fistula Needle Sets are intended for use with polyethersulfone hollow-fiber hemodialyzers (i.e., cartridges) or other dialyzer types that are indicated for hemodialysis treatment of acute and chronic renal failure. There are no known absolute contraindications for hemodialysis treatment with regard to this device; however, strict monitoring should be undertaken for patients who have bleeding disorders. In the event of any complication resulting from use of the subject device, treatment should be terminated. This AV fistula needle set is patient-contacting and is intended for use in a healthcare facility and/or hospital. As stated above, blood is drawn out from a patient through the disposable AV needle set and delivered to a hemodialyzer by a blood line set. Blood exiting the hemodialyzer is then directed back through the blood line set and returned to the patient using the disposable AV fistula needle set. The duration of treatment using this AV fistula needle set is about four (4) hours. Each arteriovenous fistula needle set/assembly is packaged either individually or in a two-pack. Each package is sterile and nonpyrogenic. The device has historically been marketed outside of the United States under the trademark DORA. Each fistula needle set is sterilized using gamma radiation.
The Dimesol Disposable A.V. Fistula Needle Sets encompass the Model Codes [0003] listed in Tables 1-4 below. Key features of each product code are also listed in these tables, including: needle gauge (15G, 16G, and 17G); needle length (25±2.2mm and 32±2.2mm); fixed or rotatable wing configuration; tubing length (3.3x5.2x300mm or (3.2x5.0x290mm); with or without a safety shield; and sterilized by gamma ray/gamma radiation.
| Model Code* | NeedleGauge | NeedleLength | Tube DimensionsIDxODxLength | Wing | SafetyShield | Sterilization |
|---|---|---|---|---|---|---|
| EDIM-AVF-001SG | 16G | 25±2mm | 3.3x5.2x300mm | Fixed | With | Gamma Ray |
| EDIM-AVF-002SG | 16G | 25±2mm | 3.3x5.2x300mm | Rotatable | With | Gamma Ray |
| EDIM-AVF-003SG | 16G | 32±2mm | 3.3x5.2x300mm | Fixed | With | Gamma Ray |
| EDIM-AVF-004SG | 16G | 32±2mm | 3.3x5.2x300mm | Rotatable | With | Gamma Ray |
| EDIM-AVF-005SG | 17G | 25±2mm | 3.3x5.2x300mm | Fixed | With | Gamma Ray |
| EDIM-AVF-006SG | 17G | 25±2mm | 3.3x5.2x300mm | Rotatable | With | Gamma Ray |
| EDIM-AVF-007SG | 17G | 32±2mm | 3.3x5.2x300mm | Fixed | With | Gamma Ray |
| EDIM-AVF-008SG | 17G | 32±2mm | 3.3x5.2x300mm | Rotatable | With | Gamma Ray |
| EDIM-AVF-009SG | 15G | 25±2mm | 3.3x5.2x300mm | Fixed | With | Gamma Ray |
| EDIM-AVF-010SG | 15G | 25±2mm | 3.3x5.2x300mm | Rotatable | With | Gamma Ray |
| EDIM-AVF-011SG | 15G | 32±2mm | 3.3x5.2x300mm | Fixed | With | Gamma Ray |
| EDIM-AVF-012SG | 15G | 32±2mm | 3.3x5.2x300mm | Rotatable | With | Gamma Ray |
TABLE 1. AV Fistula Needle Sets - With Safety Shield / Gamma Ray Sterilization
K171505-510(k) Premarket Notification for Dimesol, Inc.
Dimesol Disposable AV Fistula Needle Sets (Safety and Non-Safety Versions) Revised 510(k) Summary
{7}------------------------------------------------
510(K) SUMMARY UNDER 21 CFR 807.92
- All models include back eye feature
| Model Code* | Needle | Needle | Tube Dimensions | Wing | Safety | Sterilization |
|---|---|---|---|---|---|---|
| Gauge | Length | IDxODxLength | Shield | |||
| EDIM-AVF-001G | 16G | 25±2mm | 3.3x5.2x300mm | Fixed | W/O | Gamma Ray |
| EDIM-AVF-002G | 16G | 25±2mm | 3.3x5.2x300mm | Rotatable | W/O | Gamma Ray |
| EDIM-AVF-003G | 16G | 32±2mm | 3.3x5.2x300mm | Fixed | W/O | Gamma Ray |
| EDIM-AVF-004G | 16G | 32±2mm | 3.3x5.2x300mm | Rotatable | W/O | Gamma Ray |
| EDIM-AVF-005G | 17G | 25±2mm | 3.3x5.2x300mm | Fixed | W/O | Gamma Ray |
| EDIM-AVF-006G | 17G | 25±2mm | 3.3x5.2x300mm | Rotatable | W/O | Gamma Ray |
| EDIM-AVF-007G | 17G | 32±2mm | 3.3x5.2x300mm | Fixed | W/O | Gamma Ray |
| EDIM-AVF-008G | 17G | 32±2mm | 3.3x5.2x300mm | Rotatable | W/O | Gamma Ray |
| EDIM-AVF-009G | 15G | 25±2mm | 3.3x5.2x300mm | Fixed | W/O | Gamma Ray |
| EDIM-AVF-010G | 15G | 25±2mm | 3.3x5.2x300mm | Rotatable | W/O | Gamma Ray |
| EDIM-AVF-011G | 15G | 32±2mm | 3.3x5.2x300mm | Fixed | W/O | Gamma Ray |
| EDIM-AVF-012G | 15G | 32±2mm | 3.3x5.2x300mm | Rotatable | W/O | Gamma Ray |
- All models include back eye feature
The Dimesol Disposable A.V. Fistula Needle Sets without safety shield includes [0004] the following structural components: (1) a protective cap for the cannula; (2) a cannula (arterial or venous); (3) a hub; (4) a color-coded fixed or rotatable gripping wing; (5) flexible tubing; (6) a small on/off hemostatic clamp; (7) a connective female luer lock; and (8) a cap for the female luer lock. These AV fistula needle sets are sterilized using gamma radiation. The patient and/or blood contacting components are the cannula, the tubing segment, and the luer lock.
[0005] The Dimesol Disposable A.V. Fistula Needle Sets with safety shield includes the following structural components: (1) a protective polypropylene cap for the cannula; (2) a cannula (arterial or venous); (3) a hub; (4) a color-coded fixed or rotatable gripping wing; (5) a safety shield for encapsulating the cannula after use; (6) flexible tubing; (7) a small on/off hemostatic clamp; (8) a connective female luer lock; and (9) a cap for the female leur lock. These AV fistula needle sets are sterilized using gamma radiation. The patient and/or blood contacting components are the cannula, the hub, the tubing segment, and the luer lock.
[0006] The protective shield component is generally tubular in shape and includes a locking mechanism that is adapted to secure the hub inside the protective shield when the hub is in its retracted position. The locking mechanism prevents the needle from inadvertently protruding out of the protective shield, thereby ensuring safe disposal of the cannula after use. The oppositely placed axial slots on the protective shield are adapted to receive the wings when the hub moves
K171505-510(k) Premarket Notification for Dimesol, Inc.
Dimesol Disposable AV Fistula Needle Sets (Safety and Non-Safety Versions) Revised 510(k) Summary
{8}------------------------------------------------
510(K) SUMMARY UNDER 21 CFR 807.92
into the protective shield, thereby ensuring a correct rotational position of the protective shield relative to the hub. The axial length of the slots is long enough to receive both the hub and the cannula, particular the sharp tip of the cannula, thereby preventing accidental exposure to the tip of the needle. The locking mechanism includes two locking aspects. With regard to the first locking aspect, the tubular wall is spread apart when the hub moves into the protective shield. The lower portion of the tubular wall includes a curve that facilitates the insertion of the upper tubular wall includes a locking hoot that maintains the wings in a downward position when the hub moves into the slot. This aspect facilitates the continuous transition of the hub and wings from the minimum width regions of the slots toward the enlarged regions of the slots. With regard to the second locking aspect, two asymmetric locking hooks extend from the tubular walls. These hooks maintain the hub and winds in the enlarged slot. The cannula and hub are thus fully received and locked inside the protective shield and the device may be disposed of in a safe manner. An audible click indicates to the user that the device is in its final locked position.
[0007] The Dimesol Disposable A.V. Fistula Needle Sets are intended for use as a nonimplantable (less than 30 days use) vascular access device for temporary cannulation in procedures requiring an extracorporeal circuit, such as hemodialysis. These AV fistula needle sets are sterile and intended for single use only.
[0008] For clinical use, the Dimesol Disposable A.V. Fistula Needle Sets are compatible with the hemodialysis blood tubing sets listed below.
| K Number | Product Name | Manufacturer |
|---|---|---|
| K161582 | DORA (Dimesol) Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co. Ltd |
| K952631 | Braun Hemodialysis Blood Circuits | B. Braun Medical, Inc. |
| K934803 | Arterial & Venous Blood Tubing Sets for Hemodialysis | Baxter Healthcare Corp. |
| K013634 | Bioteque 3 in 1 Hemodialysis Blood Tubing Pack | Bioteque Corp. |
| K992930 | Bioteque Hemodialysis Blood Tubing Set | Bioteque Corp. |
| K000451 | Fresenius Combillines Single Needle Blood Tubing Set, Catalog#03-2290 | Fresenius Medical Care North America |
| K001107 | Fresenius Combilines Low Volume Blood Tubing Set, Models03-2291 (Post Pump) and 03-2292 (Pre-Pump) | Fresenius Medical Care North America |
| K012242 | Fresenius Arterial Bloodline Sets for Hemodialysis, FreseniusCombi Sets Hemodialysis Blood Tubing Sets | Fresenius Medical Care North America |
| K801016 | Gambro G Series Blood Line Sets for Hem. | Gambro, Inc. |
| K063290 | Gambro Quickset Bloodlines | Gambro Renal Products |
| K982340 | Extracorporeal Blood Circuit | Haidylena Medical Egypt |
| K032975 | JMS Blood Tubing Sets | JMS North America Corp. |
| K873516 | Kawasumi Blood Tubing Line | Kawasumi Laboratories Co., Ltd. |
| K953823 | Arterial Venous Blood Tubing Set | Medisystems Corp. |
| K001465 | Nipro Blood Tubing Set for Hemodialysis with TransducerProtectors and Priming Set | Nipro Medical Corp. |
TABLE 3. Device Compatibility with Blood Tubing Sets
K171505-510(k) Premarket Notification for Dimesol, Inc. Dimesol Disposable AV Fistula Needle Sets (Safety and Non-Safety Versions) Revised 510(k) Summary
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510(K) SUMMARY UNDER 21 CFR 807.92
| K Number | Product Name | Manufacturer |
|---|---|---|
| K010264 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set | Nipro Medical Corp. |
| K072024 | Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693 | Nipro Medical Corp. |
| K112628 | Nipro Blood Tubing Set with Transducer Protector and Priming Set | Nipro Medical Corporation |
| K090255 | Blood Tubing Sets (Sterile Fluid Path) | Nxstage Medical, Inc. |
| K014140 | Renax Hemodialysis Blood Tubing Set; Sunder Hemodialysis Blood Tubing Set | Sunder Biomedical Tech. Co., Ltd. |
| K955277 | Arterial Blood Tubing Set for Single Needle Hemodialysis | Baxter Healthcare Corp. |
| K770691 | Gambro Venous Blood Line | Gambro, Inc. |
| K082719 | Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-P | Nikkiso Co. Ltd. |
| K972206 | Nipro Blood Tubing Set with Transducer and Solution Set for Hemodialysis | Nipro Medical Corp. |
F. Substantial Equivalence
[0009] The Dimesol Disposable A.V. Fistula Needle Sets are considered by the Submitter to be substantially equivalent in construction, design, materials, performance, and intended use to the NIPRO SafeTouch Tulip Safety Fistula Needle (K071145); JMS A.V. Fistula Needle Set (K990470); and/or the EXEL A.V. Fistula Needle Set (K013037), as described below (continued on following page).
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510(K) SUMMARY UNDER 21 CFR 807.92
TABLE 4. Substantial Equivalence Comparison Table: Materials and Dimensions
| Component(Dimesol) | Material(Dimesol) | Supplier(Dimesol) | NIPROSafeTouchTulip(K071145)PRIMARYPREDICATE | JMSAVF Needle Set(K990470)REFERENCEDEVICE | EXELAVF Needle Set(K013037)REFERENCEDEVICE | |
|---|---|---|---|---|---|---|
| 1 | cap for cannula | polypropylene$(C_3H_6)_n$ | ShanghaiPetrochemical | - protective cap | - needle cover- polypropylene | - protection cap- polypropylene |
| 2 | cannula (arterialor venous)15G, 16G, 17G25±2mm32±2mm+ backeye | medical gradestainless steelFe | KanekoJapan | - cannula- 14-17G- 25mm- 32mm | - stainless steelneedle- 14-18G- 4/5 inch, 1inch, and 1.25inch length+/- backeye | - stainless steelcannula- 14-17G- 1 inch or1.25 inch length+ backeye |
| 3 | needle hub | polycarbonate | LG Chemical | - rotatable hub | - Hub- polycarbonate | - needle hub |
| 4 | - gripping wingfixed / rotatable- red, blue, orgreen color | polyvinylchloride$(C_2H_3Cl)_n$ | SGP SPC(fixed)DongguanJieda(rotatable) | - fixed wing- rotatablewing | - fixed orrotatable- polyvinylchloride- color coded | - fixed or rotatinggripping wing- polyvinylchloride- color coded |
| 5 | safetysleeve/shield | polypropylene$(C_3H_6)_n$ | Bain Medical | - protective shield | - safety shield(Platypus device)- polypropylene | - safety shieldversion available |
| 6 | tubing segment3.2x5.0x300mm3.2x5.0x290mm | or ABSpolyvinylchloride$(C_2H_3Cl)_n$ | Bain Medical | - tubing- 150mm-300mm | - tubing- polyvinylchloride- 3.0x5.0x80-400mm | - plastic tubing- polyvinylchloride- 12 inches |
| 7 | - on/offhemostaticclamp- white, red, orblue color | polypropylene$(C_3H_6)_n$ | GuangzhouPetrochemical | - on/off clamp | - clamp- polypropylene | - plastic clamp |
| 8 | female luer lock | polyvinylchloride$(C_2H_3Cl)_n$ | Bain Medical | - female luer lock | - connector- polycarbonate | - female luer lock- polycarbonate |
| 9 | cap for femaleluer lock | polyethylene$(C_2H_4)_n$ | Bain Medical | - cap for female luerlock | - connector cover- polypropylene | - luer lock cover- polypropylene |
| 10 | needle to hubattachment | ерохуadhesive | Bain Medical | - | - epoxy adhesive | - |
| 11 | hub to tubingattachment | cyclohexanone | Bain Medical | - | - cyclohexanone | - |
| FACTOR | DimesolAVF Needle Set | NIPROSafeTouch | JMSAVF Needle Set | EXELAVF Needle Set | ||
| Tulip(K071145)PRIMARYPREDICATE | (K990470)REFERENCEDEVICE | (K013037)REERENCEDEVICE | ||||
| 1 | intended use | hemodialysis | SE | SE | SE | |
| 2 | indications for use | acute and chronicrenal failure | SE | SE | SE | |
| 3 | instructions for use | - remove cap- insert needle into patient'svein- connect with blood tubingset | SEsingle use | SEsingle use | SEsingle use | |
| 4 | configuration ofdevice | see table 4 above | SE | SE | SE | |
| 5 | implantable device | non-implantable | SE | SE | SE | |
| 6 | target population | dialysis patients | SE | SE | SE | |
| 7 | anatomical sites | arterial / venous access | SE | SE | SE | |
| 8 | location of use | hospital use | SE | SE | SE | |
| 9 | energy used and/ordelivered | electric peristalticblood pump | SE | SE | SE | |
| 10 | human factors | used by medicalprofessionals | SE | SE | SE | |
| 11 | design factors | hemodialysis circuitarterial and venous lines | SE | SE | SE | |
| 12 | performance | single use | SE | SE | SE | |
| 13 | materials | PP, stainless steel, PC,PVC, PE, ABS | SE | SE | SE | |
| 14 | biocompatibility | Compatible with ISO10993 series standards | Compatible with ISO10993 series standards | Compatible withISO 10993 seriesstandards | Compatible withISO 10993 seriesstandards | |
| 15 | environmentalcompatibility | disposable | SE | SE | SE | |
| 16 | sterilizationmethod | gamma ray | sterile | sterile | sterile | |
| 17 | Non-pyrogenic | Non-pyrogenic | SE | SE | SE |
K171505-510(k) Premarket Notification for Dimesol, Inc. Dimesol Disposable AV Fistula Needle Sets (Safety and Non-Safety Versions)
Revised 510(k) Summary
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510(K) SUMMARY UNDER 21 CFR 807.92
TABLE 5. Substantial Equivalence Comparison Table: General Factors
"SE"- Substantially equivalent
K171505-510(k) Premarket Notification for Dimesol, Inc. Dimesol Disposable AV Fistula Needle Sets (Safety and Non-Safety Versions) Revised 510(k) Summary
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510(K) SUMMARY UNDER 21 CFR 807.92
TABLE 6. Biocompatibility Comparison with K071145
| Dimesol Disposable AV Fistula Needle Sets (K171505) | Predicate Device (K071145) | |
|---|---|---|
| Cytotoxicity | Conforms to ISO 10993 | Biocompatible |
| Sensitization | Conforms to ISO 10993 | Conforms to ISO |
| Systemic Toxicity | Conforms to ISO 10993 | 10993-1 |
| Pyrogenicity | Conforms to ISO 10993 | |
| Hemolysis | Conforms to ISO 10993 | |
| Thromboresistance | Conforms to ISO 10993 | |
| Partial Thromboplastin Time | Conforms to ISO 10993 | |
| Complement Activation | Conforms to ISO 10993 | |
| Bacterial Reverse Mutation | Conforms to ISO 10993 | |
| Mammalian Chromosome Aberration | Conforms to ISO 10993 | |
| Mouse Bone Marrow Micronucleus | Conforms to ISO 10993 | |
| Activated Clotting Time of Whole Blood | Conforms to ISO 10993 | |
| Platelet Adhesion | Conforms to ISO 10993 | |
| Muscle Implantation | Conforms to ISO 10993 | |
| Subchronic Systemic Toxicity | Conforms to ISO 10993 |
TABLE 7. Performance Comparison with K071145
| Dimesol Disposable AV Fistula Needle Sets (K171505)Specific Tests Performed | Predicate Device(K071145) |
|---|---|
| Needle Performance Testing | substantially equivalent |
| Female Conical Fitting Testing | substantially equivalent |
| Mechanical Testing, including wing torque test, final lock test,needle pushback test and mechanical hemolysis test | substantially equivalent |
| Tensile Strength Testing, including tube to wing pull test, tubeto joint test, needle to cover pull test and cannula to hub test | substantially equivalent |
| Tubing Kinking Test | substantially equivalent |
| Leakage Testing, including liquid leakage test and air leakagetest | substantially equivalent |
| Clamp Stop Testing | substantially equivalent |
| Flow Rate Testing | substantially equivalent |
K171505-510(k) Premarket Notification for Dimesol, Inc. Dimesol Disposable AV Fistula Needle Sets (Safety and Non-Safety Versions) Revised 510(k) Summary
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510(K) SUMMARY UNDER 21 CFR 807.92
G. Conclusion
[0010] Based on the information presented above, the Dimesol Disposable AV Fistula Needle Sets are considered by the Submitter to be substantially equivalent in construction, design, materials, performance, and intended use to the NIPRO SafeTouch Tulip Safety Fistula Needle (K071145); JMS A.V. Fistula Needle Set (K990470); and/or the EXEL A.V. Fistula Needle Set (K013037).
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.