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.

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.

AI/ML Overview

The provided document, a 510(k) Summary for the DORA Disposable A.V. Fistula Needle Sets, details the premarket notification of intent to market the device and its substantial equivalence to a legally marketed predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as an already approved device, rather than proving novel effectiveness through extensive clinical trials.

As such, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of:

A table of acceptance criteria and reported device performance for an AI/ML or diagnostic device. This document is for a physical medical device (AV fistula needle sets).
Sample sizes for a test set (for AI/ML validation). The testing described is for physical characteristics and biocompatibility, not for a 'test set' in the AI/ML sense.
Data provenance for a test set (for AI/ML validation). Not applicable to a physical medical device.
Number of experts and their qualifications for establishing ground truth. Not applicable.
Adjudication method for a test set. Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Not applicable.
Standalone (algorithm only) performance. Not applicable.
Type of ground truth used (expert consensus, pathology, outcomes data). Not applicable.
Sample size for training set. Not applicable.
How ground truth for training set was established. Not applicable.

Instead, the document focuses on non-clinical testing and substantial equivalence to a predicate device.

Here's what the document does provide regarding acceptance criteria and performance:

1. Acceptance Criteria (via Standards Compliance and Performance Testing) and Reported Device Performance:

The acceptance criteria for this device are demonstrated through adherence to various international and national standards, as well as the successful completion of specific non-clinical performance tests. The reported performance is that the device "met all design specifications" and "is similar as that of the predicate device" or "acceptable."

Acceptance Criteria Category	Specific Criterion/Standard	Reported Device Performance
Material/Component Standards	ISO/FDIS 9626:2016 (Stainless steel needle tubing)	Complies with ISO/FDIS 9626:2016 (Needle Performance)
Packaging Integrity	ASTM F88/F88M - 15 (Seal Strength)	Complies
	ASTM F1929 – 15 (Seal Leaks by Dye Penetration)	Complies
Biological Safety (Biocompatibility)	USP <85> (Bacterial Endotoxin Limit)	Complies
	ISO 10993-3:2014 (Genotoxicity, carcinogenicity, reproductive toxicity)	Complies with ISO 10993 series standards; tests performed (Cytotoxicity;Sensitization; Irritation sensitivity; Systemic toxicity;Pyrogen; Hemolysis; 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)
	ISO 10993-4:2002 A1:2006 (Interactions with blood)	Complies
	ISO 10993-5:2009 (Vitro Cytotoxicity)	Complies
	ISO 10993-6:2007 (Local effects after implantation)	Complies
	ISO 10993-10:2010 (Irritation and skin sensitization)	Complies
	ISO 10993-11:2006 (Systemic toxicity)	Complies
	ASTM F756-13 (Hemolytic Properties)	Complies
Functional/Mechanical Performance	ISO 594-1:1986 (Luer Taper - General)	Complies (Female Conical Fitting Testing)
	ISO 594-2:1998 (Luer Taper - Lock Fittings)	Complies (Female Conical Fitting Testing)
	ISO 10555-1:2013 (Intravascular catheters – General requirements)	Complies
Shipping/Packaging Performance	ASTM D4169-16 (Performance Testing Of Shipping Containers)	Complies
Specific Device Performance	Simulated Use Needlestick Prevention Testing	Test results demonstrated similarity to predicate device
	Needle Performance Testing	Test results demonstrated similarity to predicate device
	Mechanical Testing (Wing torque, final lock, needle pushback, mechanical hemolysis)	Test results demonstrated similarity to predicate device
	Tensile Strength Testing (Tube to wing pull, tube to joint, needle to cover pull, cannula to hub)	Test results demonstrated similarity to predicate device
	Tubing Kinking Test	Test results demonstrated similarity to predicate device
	Leakage Testing (Liquid leakage, air leakage)	Test results demonstrated similarity to predicate device
	Clamp Stop Testing	Test results demonstrated similarity to predicate device
	Flow Rate Testing (Also listed as an AV Fistula Needle Set Performance Test)	Test results demonstrated similarity to predicate device
	Particulate Contamination Testing (Also listed as an AV Fistula Needle Set Performance Test)	Test results demonstrated similarity to predicate device
Sterility Assurance	SAL: 10-6 (Sterility Assurance Level) via Gamma Sterilization	Achieved 10-6 SAL

2. Sample sizes used for the test set and the data provenance:

Sample Sizes: Not explicitly stated with specific numbers (e.g., "n=X needles were tested"). The document generally states "Non clinical tests were conducted" and "The test results demonstrated...". For a 510(k) submission for a physical device, detailed sample sizes for each specific test are typically found in the full technical documentation, not summarized in the 510(k) summary as it is here.
Data Provenance: The tests were conducted internally by Bain Medical Equipment (Guangzhou) Co., Ltd. or by test labs they contracted. The document implicitly indicates the tests originate from China (Guangzhou) as that's the manufacturer's location. The tests are "non-clinical" and likely conducted in laboratory settings, not on patient data or retrospective/prospective human studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is a physical medical device. "Ground truth" in this context refers to compliance with established engineering and biocompatibility standards, not expert human interpretation for a diagnostic or AI device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, a MRMC study was not done. This device is a physical medical instrument, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

For physical devices, the "ground truth" is adherence to predefined engineering specifications, internationally recognized standards (ISO, ASTM, USP), and established safety and performance benchmarks (e.g., sterilization effectiveness, material strength, biocompatibility profiles). It's a truth based on physical and chemical properties and their interaction, rather than clinical outcomes or diagnostic interpretations.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that uses a "training set."

9. How the ground truth for the training set was established:

Not applicable.

Summary

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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

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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

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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 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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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

1. 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

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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 are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment.

Device Description

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.

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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, Models03-2291 (Post Pump) and 03-2292 (Pre-Pump)	Fresenius Medical Care North America
K012242	Fresenius Arterial Bloodline Sets for Hemodialysis, FreseniusCombi Sets Hemodialysis Blood Tubing Sets	Fresenius Medical Care North America
K801016	Gambro G Series Blood Line Sets for Hem.	Gambro, Inc.
K063290	Gambro Quickset Bloodlines	Gambro Renal Products
K982340	Extracorporeal Blood Circuit	Haidylena Medical Egypt
K032975	JMS Blood Tubing Sets	JMS North America Corp.
K873516	Kawasumi Blood Tubing Line	Kawasumi Laboratories Co., Ltd.
K953823	Arterial Venous Blood Tubing Set	Medisystems Corp.
K001465	Nipro Blood Tubing Set for Hemodialysis with TransducerProtectors and Priming Set	Nipro Medical Corp.
K010264	Nipro Blood Tubing Set for Hemodialysis with TransducerProtectors and Priming Set	Nipro Medical Corp.
K072024	Nipro Blood Tubing Set with Transducer Protector and PrimingSet, Model A201-A219, V801-V806, 5M9634, 5M9693	Nipro Medical Corp.
K112628	Nipro Blood Tubing Set with Transducer Protector and PrimingSet	Nipro Medical Corporation
K090255	Blood Tubing Sets (Sterile Fluid Path)	Nxstage Medical, Inc.
K014140	Renax Hemodialysis Blood Tubing Set; Sunder HemodialysisBlood 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 forHemodialysis	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;

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ASTM F1929 – 15, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
USP <85> 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.

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Substantially Equivalent (SE) Comparison 8.

	Proposed Device	Predicate DeviceK071145
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 sterilemedical devices intended to be used as veinpuncture for hemodialysis treatment. ProtectiveShield aids in the prevention of accidentalneedlesticks.The DORA Disposable A.V. Fistula Needle Sets aresingle-use sterile medical devices intended to beused as vein puncture for hemodialysis treatment.	The NIPRO SafeTouch TULIPTMSafety Fistula Needle is intended foruse as a blood access device for bloodpurification and for other treatmentsrequiring an extracorporeal circuit oflarger volumes of blood. Secondly, it isdesigned with an anti-stick needleprotector requiring physical action bythe clinican to aid in the prevention ofaccidental needlesticks. Thecompatibility of availableconfigurations is the responsibility ofthe physician in charge.
Configuration	AVF Needle sets withsafety feature1) Protective Cap,2) Cannula,3) Rotatable Hub,4) Fixed / RotatableWing,5) Tubing,6) On-off Clamp,7) Female Luer Lock8) Cap for FLL.9) Protective Shield	AVF Needle sets without safety feature1) Protective Cap,2) Cannula,3) Rotatable Hub,4) Fixe / RotatableWing,5) Tubing,6) On-off Clamp,7) Female Luer Lock8) Cap for FLL.
Sterile	Gamma SterilizedSAL: 10-6	EO/Gamma SterilizedSAL: 10-6
Single Use	Yes	Yes
Biocompatibility	Comply with ISO 10993 series standards;Cytotoxicity;SensitizationIrritation sensitivitySystemic toxiicityPyrogenHymodialysis	Comply with ISO 10993 seriesstandards.
Item	Proposed Device	Predicate DeviceK071145
	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 SetPerformance 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 thefollowing options	available in numerous combinationswith the following options
	Gauge15G, 16G, 17G	Gauge14G, 15G, 16G,17G
	Cannula length25 mm, 32 mm	Cannula length25 mm, 32 mmTube length150 mm, 300 mm
Safety Feature	1, Color: White locking Protective Shield;2, Shape: two tubular walls3, Method: slide the protective shield forward untilthe wings are locked in the slot of the two tubularwalls.	1, Color: Transparent locking safetyshield;2, Shape: four tubular wall (petals)3, Method: slide the protective shieldforward until the wings are locked inthe slot of the 2 petals.

Table 1 Comparison of Technology Characteristics

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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.

Regulation Number and Section

§ 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.