(359 days)
No
The device description and performance studies focus on the mechanical and physical properties of a disposable needle set for hemodialysis, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
Explanation: This device is a fistula needle set used for vascular access during hemodialysis treatment, which is a supportive procedure, not a direct treatment for a disease or condition itself.
No
Explanation: The device is an A.V. Fistula Needle Set used for vein puncture in hemodialysis treatment, which is a therapeutic procedure involving extracorporeal circulation, not a diagnostic one. Its stated intended use is for temporary cannulation for blood access, not for detecting or identifying a medical condition.
No
The device description clearly details physical components made of medical-grade materials like polyvinyl chloride, polypropylene, and stainless steel, intended for physical insertion into a patient. This is a hardware medical device.
Based on the provided text, the Dimesol Disposable A.V. Fistula Needle Sets are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as "vein puncture for hemodialysis treatment" and "vascular/blood access device for temporary cannulation in procedures requiring an extracorporeal circuit, such as hemodialysis." This describes a device used for accessing the circulatory system for a medical procedure (hemodialysis), not for examining specimens in vitro (outside the body) to obtain diagnostic information.
- Device Description: The description details the physical components of a needle set designed for accessing blood vessels and connecting to an extracorporeal circuit. It does not mention any components or functions related to analyzing blood or other biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Measurement of analytes
- Diagnostic interpretation of results
- Use with biological specimens for testing
The device is a medical device used for a therapeutic procedure (hemodialysis) by providing vascular access.
N/A
Intended Use / 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.
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.
Product codes
FIE
Device Description
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 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 listed in Tables 1-4. 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.
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 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.
For clinical use, the Dimesol Disposable A.V. Fistula Needle Sets are compatible with the hemodialysis blood tubing sets listed in TABLE 3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arterial / venous access
Indicated Patient Age Range
Not Found
Intended User / Care Setting
inhospital or hemodialysis center use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Comparison with 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, tube to 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 leakage test - substantially equivalent
Clamp Stop Testing - substantially equivalent
Flow Rate Testing - substantially equivalent
Biocompatibility Comparison with K071145:
Cytotoxicity - Conforms to ISO 10993, Biocompatible
Sensitization - Conforms to ISO 10993, Conforms to ISO 10993-1
Systemic Toxicity - Conforms to ISO 10993
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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, China | |
| 510760 | |
| (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* | Needle
Gauge | Needle
Length | Tube Dimensions
IDxODxLength | Wing | Safety
Shield | 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
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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
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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, Models | |
| 03-2291 (Post Pump) and 03-2292 (Pre-Pump) | Fresenius Medical Care North America | |
| K012242 | Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius | |
| Combi 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 Transducer | |
| Protectors and Priming Set | Nipro Medical Corp. |
TABLE 3. Device Compatibility with Blood Tubing Sets
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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) | NIPRO
SafeTouch
Tulip
(K071145)
PRIMARY
PREDICATE | JMS
AVF Needle Set
(K990470)
REFERENCE
DEVICE | EXEL
AVF Needle Set
(K013037)
REFERENCE
DEVICE |
|----|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| 1 | cap for cannula | polypropylene
$(C_3H_6)_n$ | Shanghai
Petrochemical | - protective cap | - needle cover
- polypropylene | - protection cap
- polypropylene |
| 2 | cannula (arterial
or venous)
15G, 16G, 17G
25±2mm
32±2mm
- backeye | medical grade
stainless steel
Fe | Kaneko
Japan | - cannula
- 14-17G
- 25mm
- 32mm | - stainless steel
needle - 14-18G
- 4/5 inch, 1
inch, and 1.25
inch length
+/- backeye | - stainless steel
cannula - 14-17G
- 1 inch or
1.25 inch length
- backeye |
| 3 | needle hub | polycarbonate | LG Chemical | - rotatable hub | - Hub
- polycarbonate | - needle hub |
| 4 | - gripping wing
fixed / rotatable - red, blue, or
green color | polyvinyl
chloride
$(C_2H_3Cl)_n$ | SGP SPC
(fixed)
Dongguan
Jieda
(rotatable) | - fixed wing - rotatable
wing | - fixed or
rotatable - polyvinyl
chloride - color coded | - fixed or rotating
gripping wing - polyvinyl
chloride - color coded |
| 5 | safety
sleeve/shield | polypropylene
$(C_3H_6)_n$ | Bain Medical | - protective shield | - safety shield
(Platypus device) - polypropylene | - safety shield
version available |
| 6 | tubing segment
3.2x5.0x300mm
3.2x5.0x290mm | or ABS
polyvinyl
chloride
$(C_2H_3Cl)_n$ | Bain Medical | - tubing - 150mm
-300mm | - tubing - polyvinyl
chloride - 3.0x5.0x80-
400mm | - plastic tubing - polyvinyl
chloride - 12 inches |
| 7 | - on/off
hemostatic
clamp - white, red, or
blue color | polypropylene
$(C_3H_6)_n$ | Guangzhou
Petrochemical | - on/off clamp | - clamp - polypropylene | - plastic clamp |
| 8 | female luer lock | polyvinyl
chloride
$(C_2H_3Cl)_n$ | Bain Medical | - female luer lock | - connector - polycarbonate | - female luer lock
- polycarbonate |
| 9 | cap for female
luer lock | polyethylene
$(C_2H_4)_n$ | Bain Medical | - cap for female luer
lock | - connector cover - polypropylene | - luer lock cover
- polypropylene |
| 10 | needle to hub
attachment | ероху
adhesive | Bain Medical | - | - epoxy adhesive | - |
| 11 | hub to tubing
attachment | cyclohexanone | Bain Medical | - | - cyclohexanone | - |
| | FACTOR | Dimesol
AVF Needle Set | NIPRO
SafeTouch | JMS
AVF Needle Set | EXEL
AVF Needle Set | |
| | | | Tulip
(K071145)
PRIMARY
PREDICATE | (K990470)
REFERENCE
DEVICE | (K013037)
REERENCE
DEVICE | |
| 1 | intended use | hemodialysis | SE | SE | SE | |
| 2 | indications for use | acute and chronic
renal failure | SE | SE | SE | |
| 3 | instructions for use | - remove cap - insert needle into patient's
vein - connect with blood tubing
set | SE
single use | SE
single use | SE
single use | |
| 4 | configuration of
device | 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/or
delivered | electric peristaltic
blood pump | SE | SE | SE | |
| 10 | human factors | used by medical
professionals | SE | SE | SE | |
| 11 | design factors | hemodialysis circuit
arterial 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 ISO
10993 series standards | Compatible with ISO
10993 series standards | Compatible with
ISO 10993 series
standards | Compatible with
ISO 10993 series
standards | |
| 15 | environmental
compatibility | disposable | SE | SE | SE | |
| 16 | sterilization
method | gamma ray | sterile | sterile | sterile | |
| 17 | Non-pyrogenic | Non-pyrogenic | SE | SE | SE | |
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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
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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, tube
to 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 leakage
test | substantially equivalent |
| Clamp Stop Testing | substantially equivalent |
| Flow Rate Testing | substantially equivalent |
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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).