(200 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a disposable needle set, with no mention of AI/ML capabilities or data processing.
No.
The device is a needle set used for vein puncture during hemodialysis treatment, which is a supportive procedure rather than a direct therapeutic intervention by the device itself.
No
Explanation: The device is a needle set for vein puncture during hemodialysis treatment, which is a therapeutic procedure, not a diagnostic one. It is used to access the bloodstream for treatment, not to identify or monitor a medical condition.
No
The device description clearly states it is a physical medical device consisting of flexible tubes and sharp needles, with different configurations and a protective shield. There is no mention of software as a component or the primary function.
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 explicitly stated as "vein puncture for hemodialysis treatment." This is a procedure performed directly on the patient's body to access their bloodstream for treatment.
- Device Description: The device is described as a "non-implantable blood access device" consisting of a flexible tube and sharp needle. This aligns with a device used for direct patient intervention.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of the DORA Disposable A.V. Fistula Needle Sets does not involve any such in vitro examination of specimens.
Therefore, the DORA Disposable A.V. Fistula Needle Sets are a medical device used for a therapeutic procedure (hemodialysis access), not an IVD device used for diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
The DORA Disposable A.V. Fistula Needle Sets (Safety Needle Series) are sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Protective Shield is used for protecting from needlestick imiury.
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 DORA Disposable A.V. Fistula Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Scab Remover is used for remove the scab at puncture position.
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 flexible tube and sharp needle. It is available in three types, 1) Needle sets with safety feature, 2) Needle sets without safety feature and 3 > Dull Needle sets. Both the three types of proposed device are provided sterile and are for single use only.
The three 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 Ebeam 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
Not Found
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:
- ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices --Requirements and test methods;
- Implanted Blood Access Devices for Hemodialysis, January 21, 2016. Guidance for Industry and Food and Drug Administration Staff
- 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 80369-7, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications;
- ISO 10993-3:2014, Biological evaluation of medical devices- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
- ISO 10993-4:2017 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:
- ISO 10993-6:2016. 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 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity:
- ASTM F756-17, 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 testings 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 Side-by-Side Parallel Tubing Kinking Test Report;
- A Side-by-Side Parallel Leakage Test Report;
- A Side-by-Side Parallel Clamp Stop Test Report;
- Side-by-Side Parallel Flow Rate Test Report;
- A Report for Wing Torque and Final Lock;
- Side-by-Side Parallel Recirculation Rates for Both Forward and Reverse Flow Test Report;
- A Side-by-Side Parallel Priming Volume Test Report
The following performance testings on the proposed device have been conducted.
- A Pull Force Between Needle Protective Cap and Scab Remover
- Sharpness Test of The Scab Remover
- Bending Strength Test When Using Scab Remover
- Shear Fracture Test of Scab Remover
- Mechanical Hemolysis Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 8, 2022
Bain Medical Equipment (Guangzhou)Co., Ltd. Zoe Zeng Regulatory Supervisor No.10, Juncheng Road, Eastern Area, Economic and Technological Development Guangzhou, Guangdong 510760 CHINA
Re: K213015
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: Class II Product Code: FIE Dated: March 7, 2022 Received: March 14, 2022
Dear Zoe Zeng:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Gema Gonzalez Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213015
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 sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Protective Shield is used for protecting from needlestick imiury.
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 DORA Disposable A.V. Fistula Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Scab Remover is used for remove the scab at puncture position.
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: K213015
-
- Date of Preparation: 31/03/2022
2. Sponsor Identification
Bain Medical Equipment (Guangzhou) Co., Ltd.
No.10 Juncheng Road, No.10, Juncheng Road, Eastern Area, Economic and Technological Development, 510760, Guangdong, P.R.China
Establishment Registration Number: 3013217742
Contact Person: Mu Fangzhen Position: Management Representative Tel: +86-20-66856868 ext. 287 Fax: +86-20-32067500 Email: mufangzhen@baingz.com
3. Designated Submission Correspondent
Bain Medical Equipment (Guangzhou) Co., Ltd
No.10 Juncheng Road, No.10, Juncheng Road, Eastern Area, Economic and Technological Development, 510760, Guangdong, P.R.China
Ms. Zoe Zeng (Primary Contact Person) Tel: +86-20-66856868 ext.290 Fax: +86 20 3206 7500 Email: zoe@baingz.com
Ms. Sophia Shao (Alternative Contact Person) Tel: +86-20-66856868 ext.218 Fax: +86 20 3206 7500 Email: sophia@baingz.com
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page 2 of 6
4. Identification of Proposed Device
Trade Name: DORA Disposable A.V. Fistula Needle Sets Common Name: AVF Needle Models: See Tab 5 Cover Letter
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 is used for protecting from needlestick injury.
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 DORA Disposable A.V. Fistula Needle Sets (Dull Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Scab Remover is used for remove the scab at puncture position.
Device Description
The proposed device, DORA Disposable A.V. Fistula Needle Sets, is a non-implantable blood access device, which mainly consists of flexible tube and sharp needle. It is available in three types, 1) Needle sets with safety feature, 2) Needle sets without safety feature and 3 > Dull Needle sets. Both the three types of proposed device are provided sterile and are for single use only.
The three 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 Ebeam 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.
5
Conditions of Use
The proposed device is provided sterile and is for single use only. It allows for vein puncture access to an Arterial-Venous Fistula (AVF) and the bloodstream of a patient undergoing Hemodialysis and other treatments requiring an extracorporeal circuit of larger volumes of blood.
It shall be used with a FDA cleared hemodialysis blood tubing sets. This product should be used under medical supervision in a medical environment.
| Components | Material | Type of Contact | Contact
Duration | Applicable
standard |
|------------------|-------------------------------------------|---------------------|---------------------|------------------------|
| Cannula | Stainless steel | Circulating Blood | ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices --Requirements and test methods;
-
Implanted Blood Access Devices for Hemodialysis, January 21, 2016. Guidance for Industry and Food and Drug Administration Staff
-
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 80369-7, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications;
6
-
ISO 10993-3:2014, Biological evaluation of medical devices- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
-
ISO 10993-4:2017 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:
-
ISO 10993-6:2016. 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 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity:
-
ASTM F756-17, 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 testings 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 Side-by-Side Parallel Tubing Kinking Test Report;
- A Side-by-Side Parallel Leakage Test Report;
- A Side-by-Side Parallel Clamp Stop Test Report;
-
Side-by-Side Parallel Flow Rate Test Report;
- A Report for Wing Torque and Final Lock;
-
Side-by-Side Parallel Recirculation Rates for Both Forward and Reverse Flow Test Report;
- A Side-by-Side Parallel Priming Volume Test Report
The following performance testings on the proposed device have been conducted.
- A Pull Force Between Needle Protective Cap and Scab Remover
-
Sharpness Test of The Scab Remover
-
Bending Strength Test When Using Scab Remover
-
Shear Fracture Test of Scab Remover
-
Mechanical Hemolysis Test
Clinical Test Conclusion 7.
No clinical study is included in this submission.
7
8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device
K201888
Dora Disposable A.V. Fistula Needle Sets | Predicate Device
K163025
Dora Disposable A.V. Fistula Needle Sets |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 is used for protecting from needlestick injury.
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 DORA Disposable A.V. Fistula Needle Sets (Dull Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Scab Remover is used for remove the scab at puncture position. | 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. |
| Configuration | Disposable A.V. Fistula Needle Sets (Safety Needle Series)
Disposable A.V. Fistula Needle Sets
Disposable A.V. Fistula Needle Sets (Dull Needle Series) | AVF Needle sets with safety feature
AVF Needle sets without safety feature |
| Sterile | Ebeam Sterilized
SAL: 10-6 | Gamma Sterilized
SAL: 10-6 |
| Single Use | Yes | Yes |
| Biocompatibility | Comply with ISO 10993 series standards | Comply with ISO 10993 series standards |
| AV Fistula
Needle Set
Performance
Testing | Flow rate testing;
Leakage testing;
Particulate contamination testing;
Tensile strength testing | Flow rate testing;
Leakage testing;
Particulate contamination testing;
Tensile strength testing |
| Needle
Performance | Complied with ISO/FDIS 9626:2016 | Complied with ISO/FDIS 9626:2016 |
| Product
Specification | available in numerous combinations with the following options
Gauge: 14G,15G, 16G, 17G | available in numerous combinations with the following options
Gauge: 15G, 16G, 17G |
| Materials of Use | Stainless steel, PP, PC, PVC, PE, HDPE, ABS | Stainless steel, PP, PC, PVC, PE, HDPE, ABS |
| Additive | Silicon Oil | Silicon Oil |
The proposed device has the similar configuration, intended use and safety feature as the
8
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.
-
- 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.
- Substantially Equivalent (SE) Conclusion