(266 days)
The Pristine™ Hemodialysis Catheter is indicated for acute and chronic hemodialysis, apheresis and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40cm implant length are indicated for femoral placement.
Pristine™ Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables a long-term vascular access for hemodialysis and apheresis. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter junction and suture wings (hub). The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical split tip. The design of the catheter's distal tip includes a split, symmetric tip with notches and without side-holes nor slots. The symmetric tip design allows a spatial separation between the distal ends of the two lumens. The Pristine™ Hemodialysis Catheter is packed along with a Tunneler and two sealing caps in a vented blister tray and lid, sealed within a Tyvek pouch. The packed catheter and accessories set is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process.
The provided text describes a 510(k) premarket notification for the Pristine™ Hemodialysis Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria in a clinical study against a defined ground truth.
Therefore, many of the requested points, such as detailed acceptance criteria with reported device performance numbers, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable or not provided in this type of regulatory document.
However, based on the information given, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All tests passed and met the predefined acceptance criteria," but it does not provide the specific numerical acceptance criteria or the quantitative reported performance for most of the tests. It only lists the tests performed.
| Test Type | Acceptance Criteria (Not explicitly stated numerically, but implied as "met predefined acceptance criteria") | Reported Device Performance (Not explicitly stated numerically, but implied as "passed") |
|---|---|---|
| Biocompatibility Testing | Compliance with ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-17, ANSI/AAMI T72:2011/(R)2016 and ASTM F 756 standards. | All tests completed with passing results. |
| Cytotoxicity Study | Compliance with ISO 10993-5: 2009 | Passed |
| Sensitization Test | Compliance with ISO 10993-10: 2010 | Passed |
| Irritation Study | Compliance with ISO 10993-10:2010 | Passed |
| Acute Systemic Injection Study | Compliance with ISO 10993-11: 2010 | Passed |
| Pyrogen Study | Compliance with ISO 10993-11:2010 and ANSI/AAMI T72:2011/(R)2016 | Passed |
| Hemocompatibility | Compliance with ASTM F 756, ISO 10993-12:2012 | Passed |
| Complement Activation | Compliance with ANSI/AAMI/ISO 10993-12 | Passed |
| Thrombogenicity | Compliance with ISO 10993-4 | Passed |
| Implantation (13 weeks) | Compliance with ISO 10993-6 | Passed |
| Extractable/leachable Analysis | Compliance with ISO 10993-17 | Passed |
| Subacute/subchronic toxicity, Genotoxicity, Chronic toxicity and Carcinogenicity | Evaluation by extractable/leachable analysis according to ISO 10993-17 | Passed |
| Tunneler and Caps Biocompatibility | Same applicable ISO standards as above for individual tests with similar nature | All tests completed with passing results. |
| Sterilization, Packaging, Shelf Life | Compliance with ISO 11135 and support of labeled shelf life. | All tests successfully completed. |
| Bench Testing (Per FDA guidance Implanted Blood Access Devices for Hemodialysis, 2016) | Predefined acceptance criteria for: Dimensional Attributes, Distal Tip Visual Inspection, Luer Dimensions, Shaft Radiopacity, Flow vs. Pressure, Nominal Flow vs. Pressure, Air leakage during aspiration, Leak, Chemical resistance (Conditioning), Clamp fatigue (Conditioning), Tensile, Kink resistance, Priming volume, Tip recirculation, Mechanical Hemolysis, Hydration, Accessories compatibility analysis. | All tests passed and met the predefined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "testing" and "performance data" without detailing the number of devices or components tested for each bench or biocompatibility test.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The tests performed are laboratory/bench tests and biocompatibility studies, not clinical studies on human subjects. The data would be generated in a lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable in the context of this document. The "ground truth" for the tests mentioned (biocompatibility, bench testing) is defined by established engineering and biological standards (e.g., ISO, ASTM). These are objective measurements against specified criteria, not subjective expert interpretations that require consensus.
4. Adjudication Method for the Test Set
- Not applicable. As described above, the tests are objective measurements against defined standards, not subjective assessments requiring an adjudication process.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices, especially those involving human interpretation of images, to assess the impact of AI on reader performance. The Pristine Hemodialysis Catheter is a physical medical device, not a diagnostic AI system.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone performance assessment (in the context of an algorithm) was not done. This device does not involve an algorithm for performance, but rather physical and biological performance characteristics.
7. The Type of Ground Truth Used
- The "ground truth" for the performance data in this submission is based on adherence to international and national standards (e.g., ISO, ASTM, ANSI/AAMI) for medical device performance and biocompatibility. For bench testing, this means meeting predefined engineering specifications and functional requirements. For biocompatibility, it means demonstrating that the materials are safe for biological contact as per established protocols.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No training set is used for this type of device submission.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".
May 31, 2019
Pristine Access Technologies Ltd. % Orly Maor Company Consultant Orly Maor 25A Sirkin Street Kfar Saba. 4442156 Israel
Re: K182443
Trade/Device Name: Pristine Hemodialysis Catheter Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood Access Device and Accessories Regulatory Class: II Product Code: MSD Dated: April 30, 2019 Received: May 2, 2019
Dear Orly Maor:
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.
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.
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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-regulatoryinformation/postmarketing-safety-reporting-combination-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,
Carolyn Y. Neuland, Ph.D. Assistant Division 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
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Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page
510(k) Number (if known)
Device Name Pristine Hemodialysis Catheter
Indications for Use (Describe)
The Pristine™ Hemodialysis Catheter is indicated for acute and chronic hemodialysis, apheresis and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40cm implant length are indicated for femoral placement.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
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K182443 Page 1 of 7
Image /page/3/Picture/1 description: The image is a logo for Pristine Access Technologies. The word "Pristine" is written in a bold, blue font, with a red arrow curving over the "P" and a blue arrow curving under the "e". Below "Pristine" is the phrase "Access Technologies" in a smaller, gray font.
Traditional Premarket Notification Submission - 510(k) Pristine™ Hemodialysis Catheter 510(k) Number K182443
Date Prepared: August 23, 2018
I. SUBMITTER
Pristine Access Technologies Ltd. 21 Habarzel Street Tel-Aviv 6971029 Israel Tel: +972-77-5055645 Fax: +972-153-77-5055438
Contact Person
Orly Maor 25A Sirkin Street Kfar Saba 44421, Israel Tel: +972-9-7453607 Fax: +972-153-9-7453607 oram.ma@gmail.com
II. DEVICE
Name of Device: Pristine™ Hemodialysis Catheter Common or Usual Name: Hemodialysis Catheter Classification Name: Blood Access Device and Accessories (21 CFR 876.5540) Regulatory Class: II Product Code: MSD
III. PREDICATE DEVICE
Pristine Access Technologies Ltd. believes that the Pristine™ Hemodialysis Catheter is substantially equivalent to the following predicate device:
- Covidien TAL Palindrome Symmetric Tip Dual Lumen Catheter cleared under K111372 (product code MSD, Regulation No. 876.5540).
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Image /page/4/Picture/1 description: The image contains the logo for Pristine Access Technologies. The logo features the word "Pristine" in a bold, blue font, with a stylized red arrow curving over the "P" and a blue arrow curving under the "P". Below the word "Pristine" is the phrase "Access Technologies" in a smaller, gray font. The logo is clean and modern, suggesting a technology-oriented company.
IV. DEVICE DESCRIPTION
Pristine™ Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables a long-term vascular access for hemodialysis and apheresis.
The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter junction and suture wings (hub). The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical split tip. The design of the catheter's distal tip includes a split, symmetric tip with notches and without side-holes nor slots. The symmetric tip design allows a spatial separation between the distal ends of the two lumens. The Pristine™ Hemodialysis Catheter is packed along with a Tunneler and two sealing caps in a vented blister tray and lid, sealed within a Tyvek pouch. The packed catheter and accessories set is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process.
The catheter should be inserted and removed by a qualified licensed physician or other healthcare practitioner authorized by and under the direction of such physician.
V. INDICATIONS FOR USE
The Pristine™ Hemodialysis Catheter is indicated for acute and chronic hemodialysis, apheresis and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40cm implant length are indicated for femoral placement.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Pristine™ Hemodialysis Catheter have the same intended use as the predicate device. Their indications for use are similar to that of the Palindrome predicate device. The dimensions of the Pristine™ Hemodialysis Catheter, are comparable to the predicate's. Similar tests and tests methods performed in accordance with the same standards and FDA guidance were used in both Pristine™ Hemodialysis Catheter and the predicate device to validate the design. The testing results showed that the minor differences in device characteristics between the subject device and predicate device do not raise any new questions of safety or effectiveness.
The Pristine™ Hemodialysis Catheter have the same technological characteristics as the predicate device as demonstrated in the SE table below:
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Image /page/5/Picture/1 description: The image contains the logo for Pristine Access Technologies. The logo features the word "Pristine" in a bold, blue font. Above the word "Pristine" is a graphic of two curved arrows, one red and one blue, that appear to be intertwined. Below the word "Pristine" is the phrase "Access Technologies" in a smaller, gray font.
| Pristine™ HemodialysisCatheter | Palindrome Symmetric TipDual Lumen Catheter | SEJUSTIFICATION | |
|---|---|---|---|
| 510(k) Number | TBD | K111372 | |
| Manufacturer | Pristine Access TechnologiesLtd. | Covidien | |
| Product Code | MSD | MSD | Same |
| CFR | 876.5540 | 876.5540 | Same |
| Intended Use | The Pristine HemodialysisCatheter is indicated foracute and chronichemodialysis, apheresis andinfusion. It may be insertedpercutaneously or by cutdown. Catheters with greaterthan 40cm implant length areindicated for femoralplacement. | The Tal Palindrome™Symmetric Tip Dual LumenCatheter is indicated for acuteand chronic hemodialysis,apheresis, and infusion. It maybe inserted percutaneously orby cut down. Catheters withgreater than 40 can implantlength are indicated for femoralplacement | Same |
| Catheter Type | Implanted Vascular Access | Implanted Vascular Access | Same |
| LumenConfiguration | 2 Kidney Shaped Lumens | 2 Kidney Shaped Lumens | Same |
| Catheter O.D. | 15.5 Fr. | 14.5 Fr. | SE |
| Duration of use | Long-term | Long-term | Same |
| Number ofapplications | Single | Single | Same |
| Insertion Sites | Internal/external jugular,subclavian and femoral(55cm only) | Internal/external jugular,subclavian and femoral (55cmonly) | Same |
| Side Holes | Without side holes | With side holes | SESuccessful testingand verificationand validationtesting confirmedthe equivalence. |
| TipConfiguration | Pre-formed split, symmetrical | Symmetrical | SESuccessful testingand verificationand validationtesting confirmedthe equivalence. |
| Pristine™ HemodialysisCatheter | Palindrome Symmetric TipDual Lumen Catheter | SEJUSTIFICATION | |
| GuidewireCompatibility | 0.038" | 0.038" | Same |
| Sheath Size | 16 Fr. | 16 Fr. | Same |
| Implant Lengths(cm) | 19, 23, 28, 33, 55 | 19, 23, 28, 33, 55 | Same |
| Arterial/VenousAccess Lumens | Yes | Yes | Same |
| Color-CodedFemale Luers | Yes: Red (Arterial) and Blue(Venous) | Yes: Red (Arterial) and Blue(Venous) | Same |
| Suture Wing onCatheter Hub | Yes | Yes | Same |
| Catheter Cuff forTissue Ingrowth | Yes | Yes | Same |
| RadiopaqueCatheter Lumen | 20% barium sulfate | 20% barium sulfate | Same |
| Hub Junction forCatheter Lumen /hubExtension Tubing | Injection molded, one-piece/hub | Injection molded, one-piecehub | Same |
| Priming VolumePrinted on Device | Yes: printed on female Luer | Yes: printed on female Luer | Same |
| Catheter ID andSize Printed onDevice | Yes, name and length ofcatheter printed on hub | Yes, name of catheter printedon clamp and length and OD onluer | SE |
| Patient-ContactingMaterials (Shaft) | Polyurethane(Quadrathane™) | Polyurethane (Carbothane™) | SE |
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Image /page/6/Picture/1 description: The image is a logo for Pristine Access Technologies. The logo features the word "Pristine" in a bold, blue font, with a stylized "P" that incorporates a red arrow pointing upwards and a blue arrow pointing downwards. Below "Pristine" is the phrase "Access Technologies" in a smaller, gray font. The logo is clean and modern, suggesting a company that is both innovative and reliable.
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Image /page/7/Picture/1 description: The image is a logo for Pristine Access Technologies. The logo features the word "Pristine" in a bold, dark blue font. Above the word "Pristine" is a stylized graphic of two arrows, one red and one blue, curving around each other. Below the word "Pristine" is the phrase "Access Technologies" in a smaller, lighter blue font.
| Pristine™ HemodialysisCatheter | Palindrome Symmetric TipDual Lumen Catheter | SEJUSTIFICATION | |
|---|---|---|---|
| Patient-ContactingMaterials(Extensions) | Thermoplastic Urethane(Quadraflex™) | Silicone | SESuccessfulbiocompatibilitytesting,mechanicalhemolysis andverification andvalidation testingconfirmed theequivalence.Biocompatibilitydemonstrates thesafety and V&Vthe performanceequivalence. |
| Tunneling Tool | Provided forCatheter Insertion | Provided forCatheter Insertion | Same |
| Packaging | Pouch and box | Pouch and box | Same |
| Environments ofUse | Hospitals | Hospitals | Same |
| Sterilization | Sterile for single use (EtO) | Sterile for single use (EtO) | Same |
| Prescription Use | The catheter should be usedby a qualified, licensedphysician or other healthcarepractitioner authorized byand under the direction ofsuch physician. | The catheter should be used bya qualified, licensed physicianor other healthcare practitionerauthorized by and under thedirection of such physician. | Same |
Based on the above analysis, Pristine Access Technologies Ltd. believes that the Pristine™ Hemodialysis Catheter is substantially equivalent to the legally marketed predicate device.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
- Risk analysis per ISO 14971:2012 -
- Biocompatibility testing -
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Image /page/8/Picture/1 description: The image shows the logo for Pristine Access Technologies. The logo features a stylized letter "P" in blue, with a red arrow pointing upwards and a blue arrow pointing downwards. Below the "P" is the text "Pristine" in blue, and below that is the text "Access Technologies" in gray.
An evaluation of biocompatibility was performed in compliance with ISO 10993-
-
- Biocompatibility evaluation included:
Pristine™ Hemodialysis Catheter
| # | Test | Standard |
|---|---|---|
| 1 | Cytotoxicity Study Using the ISOElution Method | ISO 10993-5: 2009 |
| 2 | ISO Maximization Sensitization Test | ISO 10993-10: 2010 |
| 3 | Irritation - ISO Intracutaneous Study –Extract | ISO 10993-10:2010 |
| 4 | ISO Acute Systemic Injection Study | ISO 10993-11: 2010 |
| 5 | Pyrogen Study - Material Mediated | ISO 10993-11:2010 |
| 6 | -Bacterial Endotoxin (BET) | ANSI/AAMIT72:2011/(R)2016 |
| 7 | Hemocompatibility (extract) | ASTM F 756ISO 10993-12:2012 |
| 8 | Hemocompatibility (direct) | ASTM F 756ISO 10993-12:2012 |
| 9 | Complement Activation | ANSI/AAMI/ISO 10993-12 |
| 10 | Thrombogenicity | ISO 10993-4 |
| 11 | Implantation(13 weeks) | ISO 10993-6 |
| 12 | Extractable/leachable Analysis | ISO 10993-17 |
| 13 | Subacute/subchronic toxicity,Genotoxicity, Chronic toxicity andCarcinogenicity | Was evaluated byextractable/leachableanalysis according to ISO10993-17 |
Tunneler and Caps
| # | Test | Standard |
|---|---|---|
| 1 | Cytotoxicity Study Using the ISOElution Method | ISO 10993-5: 2009 |
| 2 | ISO Maximization Sensitization Test | ISO 10993-10: 2010 |
| 3 | Irritation - ISO Intracutaneous Study -Extract | ISO 10993-10:2010 |
| 4 | ISO Acute Systemic Injection Study -Extract | ISO 10993-11: 2010 |
| 5 | Pyrogen Study - Material Mediated | ISO 10993-11:2010 |
| 6 | ASTM F756Hemolysis for the caps only | ISO 10993-4:2009 |
All tests were completed with passing results.
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Image /page/9/Picture/1 description: The image shows the logo for Pristine Access Technologies. The logo features the word "Pristine" in a bold, blue font, with a stylized red and blue arrow graphic above the "P". Below "Pristine" is the text "Access Technologies" in a smaller, gray font. The logo is clean and modern, with a focus on the company name.
Sterilization, Packaging and Shelf Life Testing
Sterilization validation testing of the Pristine™ Hemodialysis Catheter was performed to demonstrate compliance with ISO 11135. In addition, shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.
Bench Testing -
Bench testing was performed in accordance with FDA guidance Implanted Blood Access Devices for Hemodialysis, 2016 and applicable standards. Bench testing included the following:
| Tests | |
|---|---|
| • Dimensional Attributes | • Clamp fatigue (Conditioning) |
| • Distal Tip Visual Inspection | • Tensile |
| • Luer Dimensions | • Kink resistance |
| • Shaft Radiopacity | • Priming volume |
| • Flow vs. Pressure | • Tip recirculation |
| • Nominal Flow vs. Pressure | • Mechanical Hemolysis |
| • Air leakage during aspiration | • Hydration |
| • Leak | • Accessories compatibility analysis |
| • Chemical resistance (Conditioning) |
All tests passed and met the predefined acceptance criteria.
VIII. CONCLUSION
The Pristine™ Hemodialysis Catheter have the same intended use as the predicate device. The principal features of the device that were described, as well as the testing provided, show that the minor differences in device characteristics between the subject device and predicate device do not raise any new questions of safety or effectiveness. Performance data have been provided, establishing that the Pristine™ Hemodialysis Catheter perform as intended and in a manner that is substantially equivalent to the predicate.
Therefore, the device may be found substantially equivalent.
§ 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.