(262 days)
No
The device description and performance studies focus on the physical components and mechanical performance of a needle set, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a needle set used for vein puncture during hemodialysis, which is a treatment for kidney failure. While essential for the treatment, the needle itself is a component that enables the treatment rather than providing the therapy directly.
No
This device is a medical device for vein puncture during hemodialysis treatment, which is a therapeutic procedure, not a diagnostic one.
No
The device description clearly outlines physical components like needles, adaptors, and flexible tubes, and the performance studies focus on mechanical and material properties. There is no mention of software as a component or function of the device.
Based on the provided information, the DORA Disposable A.V. Fistula Needle Sets are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "vein puncture for hemodialysis treatment." This is a procedure performed directly on a patient to access their bloodstream for treatment.
- Device Description: The device is described as a "non-implantable blood access device" consisting of a needle, tube, and adaptor. It is used in conjunction with hemodialysis blood tubing sets.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of a specimen. It is a tool for accessing the body for treatment.
Therefore, the DORA Disposable A.V. Fistula Needle Sets are a medical device used for a therapeutic procedure, not an IVD device.
N/A
Intended Use / Indications for Use
The DORA 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.
The DORA Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment.
Product codes
FIE
Device Description
The proposed device, DORA Disposable A.V. Fistula Needle Sets, is a non-implantable blood access device, which mainly consists of an adaptor, flexible tube and sharp needle. It is available in two types, 1) Needle sets with safety feature and 2) Needle sets without safety feature. Both the two types of proposed device are provided sterile and are for single use only.
The two types of proposed devices are offered in difference configurations with options that include needle gauge, needle length, wing types (fixed wing or rotatable wing).
The proposed device and its package are designed to be provided in Gamma sterilization. The package could maintain the sterility of the device for three years.
The Protective Shield for injury prevention requires physical action by the clinician to activate and is designed to cover the cannula after treatment. Correct use of this safety feature will eliminate accidental needlestick injuries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A ISO/FDIS 9626:2016, Stainless steel needle tubing for the manufacture of medical devices --Requirements and test methods;
- ASTM F88/F88M - 15, Standard Test Method for Seal Strength of Flexible Barrier Materials;
- ASTM F1929 – 15, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
- USP Bacterial Endotoxin Limit;
- ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements;
- ISO 594-2:1998, Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment - Part 2: Lock Fittings;
- ISO 10993-3:2014, Biological evaluation of medical devices- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
- ISO 10993-4:2002 A1:2006, Biological evaluation of medical devices- Part 4: Selection of tests for interactions with blood.
- ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity;
- A ISO 10993-6:2007, Biological evaluation of medical devices- Part 6: Tests for local effects after implantation;
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization:
- ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity:
- ASTM F756-13, Standard Practice for Assessment of Hemolotic Properties of Materials.
- ISO 10555-1:2013, Intravascular catheters – Sterile and single-use cathethers – Part 1: General requirements
- ASTM D4169-16, Standard Practice For Performance Testing Of Shipping Containers And Systems.
The following side-by-side performance testing between the proposed device and predicate device have been conducted, and test results demonstrate that the performance of proposed device is similar as that of the predicate device.
- A Simulated Use Needlestick Prevention Testing;
- Needle Performance Testing;
- A Female Conical Fitting Testing;
- Mechanical Testing, including wing torque test, final lock test, needle pushback test and mechanical hemolysis test;
- Tensile Strength Testing, including tube to wing pull test, tube to joint test, needle to cover pull test and cannula to hub test;
- Tubing Kinking Test;
- A Leakage Testing, including liquid leakage test and air leakage test;
- A Clamp Stop Testing;
- Flow Rate Testing;
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K161582, K952631, K934803, K013634, K992930, K000451, K001107, K012242, K801016, K063290, K982340, K032975, K873516, K953823, K001465, K010264, K072024, K112628, K090255, K014140, K955277, K770691, K082719, K972206
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 20, 2017
Bain Medical Equipment (Guangzhou) Co., Ltd. % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K163025
Trade/Device Name: DORA Disposable A.V. Fistula Needle Sets Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood Access Device and Accessories Regulatory Class: II Product Code: FIE Dated: June 8, 2017 Received: June 9, 2017
Dear Diana Hong:
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. You must comply
1
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Charles Viviano -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
510(k) Number (if known) K163025
Device Name DORA Disposable A.V. Fistula Needle Sets
Indications for Use (Describe)
The DORA 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.
The DORA Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K163025
-
- Date of Preparation: 7/13/2017
2. Sponsor Identification
Bain Medical Equipment (Guangzhou) Co., Ltd.
No.10 Juncheng Road, Eastern Zone of Guangzhou Economic&Technological Development District, 510760, Guangdong, P.R.China
Establishment Registration Number: Not yet registered
Contact Person: Sophia Shao Position: Assistant Manager Tel: +86-20-66856868 Fax: +86-20-32067500 Email: sophia@baingz.com
3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: DORA Disposable A.V. Fistula Needle Sets
Common Name: AVF Needle
Models:
| AVF needle sets without safety feature | BAIN-A.V.F-001G, BAIN-A.V.F-002G, BAIN-A.V.F-003G,
BAIN-A.V.F-004G, BAIN-A.V.F-005G, BAIN-A.V.F-006G,
BAIN-A.V.F-007G, BAIN-A.V.F-008G, BAIN-A.V.F-009G,
BAIN-A.V.F-010G, BAIN-A.V.F-011G, BAIN-A.V.F-012G |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AVF needle sets with safety feature | BAIN-A.V.F-001SG, BAIN-A.V.F-002SG, BAIN-A.V.F-003SG,
BAIN-A.V.F-004SG, BAIN-A.V.F-005SG, BAIN-A.V.F-006SG,
BAIN-A.V.F-007SG, BAIN-A.V.F-008SG, BAIN-A.V.F-009SG,
BAIN-A.V.F-010SG, BAIN-A.V.F-011SG, BAIN-A.V.F-012SG |
Regulatory Information
Classification Name: Blood access device and accessories Classification: II Product Code: FIE Regulation Number: CFR 876.5540 Review Panel: Gastroenterology/Urology
Indications for Use:
The DORA 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.
The DORA Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment.
Device Description
The proposed device, DORA Disposable A.V. Fistula Needle Sets, is a non-implantable blood access device, which mainly consists of an adaptor, flexible tube and sharp needle. It is available in two types, 1) Needle sets with safety feature and 2) Needle sets without safety feature. Both the two types of proposed device are provided sterile and are for single use only.
The two types of proposed devices are offered in difference configurations with options that include needle gauge, needle length, wing types (fixed wing or rotatable wing).
The proposed device and its package are designed to be provided in Gamma sterilization. The package could maintain the sterility of the device for three years.
5
The Protective Shield for injury prevention requires physical action by the clinician to activate and is designed to cover the cannula after treatment. Correct use of this safety feature will eliminate accidental needlestick injuries.
The proposed device is used in conjunction with following hemodialysis blood tubing sets during clincial use.
| K Number | Product Name | Manufacturer |
|---|---|---|
| K161582 | DORA 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. | |
| 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. |
5. Identification of Predicate Device
510(k) Number: K071145 Product Name: NIPRO SafeTouch TULIP™ Safety Fistula Needle Manufacturer: NIPRO Medical Corporation
-
Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
A ISO/FDIS 9626:2016, Stainless steel needle tubing for the manufacture of medical devices --Requirements and test methods;
-
ASTM F88/F88M - 15, Standard Test Method for Seal Strength of Flexible Barrier Materials;
6
-
ASTM F1929 – 15, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
-
USP Bacterial Endotoxin Limit;
-
ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements;
-
ISO 594-2:1998, Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment - Part 2: Lock Fittings;
-
ISO 10993-3:2014, Biological evaluation of medical devices- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
-
ISO 10993-4:2002 A1:2006, Biological evaluation of medical devices- Part 4: Selection of tests for interactions with blood.
-
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity;
- A ISO 10993-6:2007, Biological evaluation of medical devices- Part 6: Tests for local effects after implantation;
-
ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization:
-
ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity:
-
ASTM F756-13, Standard Practice for Assessment of Hemolotic Properties of Materials.
-
ISO 10555-1:2013, Intravascular catheters – Sterile and single-use cathethers – Part 1: General requirements
-
ASTM D4169-16, Standard Practice For Performance Testing Of Shipping Containers And Systems.
The following side-by-side performance testing between the proposed device and predicate device have been conducted, and test results demonstrate that the performance of proposed device is similar as that of the predicate device.
- A Simulated Use Needlestick Prevention Testing;
-
Needle Performance Testing;
- A Female Conical Fitting Testing;
-
Mechanical Testing, including wing torque test, final lock test, needle pushback test and mechanical hemolysis test;
-
Tensile Strength Testing, including tube to wing pull test, tube to joint test, needle to cover pull test and cannula to hub test;
-
Tubing Kinking Test;
- A Leakage Testing, including liquid leakage test and air leakage test;
- A Clamp Stop Testing;
-
Flow Rate Testing;
7. Clinical Test Conclusion
No clinical study is included in this submission.
7
Substantially Equivalent (SE) Comparison 8.
| | Proposed Device | Predicate Device
K071145 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | | |
| Product Code | FIE | FIE |
| Regulation Number | CFR 876.5540 | CFR 876.5540 |
| Intended Use | The DORA 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.
The DORA Disposable A.V. Fistula Needle Sets are
single-use sterile medical devices intended to be
used as vein puncture for hemodialysis treatment. | The NIPRO SafeTouch TULIPTM
Safety Fistula Needle is intended for
use as a blood access device for bloodpurification and for other treatments
requiring an extracorporeal circuit of
larger volumes of blood. Secondly, it is
designed with an anti-stick needle
protector requiring physical action by
the clinican to aid in the prevention of
accidental needlesticks. The
compatibility of available
configurations is the responsibility of
the physician in charge. |
| Configuration | AVF Needle sets with
safety feature
- Protective Cap,
- Cannula,
- Rotatable Hub,
- Fixed / Rotatable
Wing, - Tubing,
- On-off Clamp,
- Female Luer Lock
- Cap for FLL.
- Protective Shield | AVF Needle sets without safety feature
- Protective Cap,
- Cannula,
- Rotatable Hub,
- Fixe / Rotatable
Wing, - Tubing,
- On-off Clamp,
- Female Luer Lock
- Cap for FLL. |
| Sterile | Gamma Sterilized
SAL: 10-6 | EO/Gamma Sterilized
SAL: 10-6 |
| Single Use | Yes | Yes |
| Biocompatibility | Comply with ISO 10993 series standards;
Cytotoxicity;
Sensitization
Irritation sensitivity
Systemic toxiicity
Pyrogen
Hymodialysis | Comply with ISO 10993 series
standards. |
| Item | Proposed Device | Predicate Device
K071145 |
| | Thromboresistance | |
| | Partial thromboplastin time | |
| | Complement activation | |
| | Bacterial reverse mutation | |
| | Mammalian chromosome aberration | |
| | Mouse bone marrow micronucleus | |
| | Activated clotting time of whole blood | |
| | Platelet adhesion | |
| | Muscle implantation | |
| | Subchronic systemic toxicity | |
| AV Fistula Needle Set
Performance Testing | Flow rate testing;
Leakage testing;
Particulate contamination testing;
Tensile strength testing | Unknown |
| Needle Performance | Complied with ISO/FDIS 9626:2016 | Complied with ISO 9626:1991,
AMENDMENT 1 2001 |
| Product Specification | available in numerous combinations with the
following options | available in numerous combinations
with the following options |
| | Gauge
15G, 16G, 17G | Gauge
14G, 15G, 16G,
17G |
| | Cannula length
25 mm, 32 mm | Cannula length
25 mm, 32 mm
Tube length
150 mm, 300 mm |
| Safety Feature | 1, Color: White locking Protective Shield;
2, Shape: two tubular walls
3, Method: slide the protective shield forward until
the wings are locked in the slot of the two tubular
walls. | 1, Color: Transparent locking safety
shield;
2, Shape: four tubular wall (petals)
3, Method: slide the protective shield
forward until the wings are locked in
the slot of the 2 petals. |
Table 1 Comparison of Technology Characteristics
8
The proposed device has the similar configuration, intended use and safety feature as the predicated device. The non-clinical testing demonstrates the product performance of proposed device is similar as that of the predicate device or the product performance of proposed device is acceptable. The biocompatibility of the proposed device comply with ISO 10993 series standards.
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.