(58 days)
JMS CAVEO A.V. Fistula Needle Set is intended for temporary cannulation to vascular access for extracorporeal blood treatment for hemodialysis. This device is intended for single use only. The anti-needlestick safety feature aids in prevention of needle stick injuries when removing and discarding the needle after dialysis. The device also has an integrated safety mechanism that is designed to automatically generate a partial occlusion of the internal fluid path and trigger the hemodialysis machine to alarm and shut off if a complete dislodgement of the venous needle from the arm inadvertently occurs. In vitro testing supports that this feature triggers the hemodialysis machine to alarm and shut off.
The subject device is the JMS CAVEO A.V. Fistula Needle Set (CAVEO) with an anti-needlestick safety feature. The Caveo is predicted to protect patients from the risks associated with venous needle dislodgement (VND) based on bench testing results. It contains an integrated stainless steel torsion spring mechanism and bottom footplate that provides an open/fluid path when the AV fistula set is fully cannulated into the access site. When the venous needle becomes completely dislodged from the patient's arm, this mechanism enables the footplate to partially occlude the blood path, generating an increased venous line pressure high enough to trigger automatic alarm and halt further blood pumping of the hemodialysis machine. In vitro testing supports that this feature triggers the hemodialysis machine to alarm and shut off. Based on bench testing results, this may significantly reduce patient blood loss in the event of a complete VND. The Caveo has a pre-attached anti-stick needle guard for prevention of needlestick injury at the time of needle withdraw after completion of a hemodialysis procedure.
In vitro performance testing using dialysis machine Fresenius 2008K supports the function of the Caveo VND feature with a venous pressure limit set to 200mmHg symmetric mode, a maximum dialyzer membrane surface area of 2.5 m2, minimum blood flow rate of 200 mL/min, maximum ultrafiltration rate of 4000 mL/hour, and simulated treatment duration of 8 hours. If different machine and/or setting are used, before introducing the device, refer to Directions for Use.
This document describes the FDA 510(k) clearance for the JMS CAVEO A.V. Fistula Needle Set. This device is a physical medical device, specifically a needle set for hemodialysis, and does not involve Artificial Intelligence (AI). Therefore, many of the requested criteria related to AI/software performance, ground truth establishment, expert adjudication, MRMC studies, and training datasets are not applicable.
The document primarily focuses on bench testing (in vitro performance) and a simulated clinical usability study to demonstrate device safety and effectiveness.
Here's a breakdown based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily demonstrated through various performance tests, with "Passed" as the acceptance. The document doesn't explicitly state numerical acceptance thresholds for all tests (e.g., how much "Force to Depress the Footplate" is acceptable), but it implies successful completion. For some, like needle penetration resistance and retraction lock strength, numerical criteria are provided.
| Acceptance Criterion (Test) | Reported Device Performance |
|---|---|
| Needle Penetration Resistance | |
| 14G | ≤ 40g (Predicate: ≤ 40g) |
| 15G | ≤ 35g (Predicate: ≤ 35g) |
| 16G | ≤ 30g (Predicate: ≤ 30g) |
| 17G | ≤ 30g (Predicate: ≤ 30g) |
| Needle Retention Strength | > 6.0kgf (Predicate: > 6.0kgf) |
| Needle Surface (Visually) | No dented/damaged needle (Predicate: No dented/damaged needle) |
| Product Leak | No air bubble should appear when subjected to air pressure 0.40 kgf/cm2 and immersed in water. (Predicate: Same) |
| Needle Retraction Final Lock Strength | ≤ 2.0kgf (Predicate: ≤ 2.0kgf) |
| Connector (Air tightness, Luer fit) | Passed (ISO 80369-7 compliant) |
| Connection Strength (Tube to Connector/Joint, Tube to Pivot Valve Core) | > 6.0kgf (Predicate: > 3.0kgf for Tube to Connector/Joint, > 6.0kgf for Tube to Hub) |
| Leakage by Pressure Decay (Female Luer Lock) | Passed |
| Positive Pressure Liquid Leakage (Female Luer Lock) | Passed |
| Sub-atmospheric Pressure Air Leakage (Female Luer Lock) | Passed |
| Stress Cracking (Female Luer Lock) | Passed |
| Resistance to Separation from Axial Load (Female Luer Lock) | Passed |
| Resistance to Separation from Unscrewing (Female Luer Lock) | Passed |
| Resistance to Overriding (Female Luer Lock) | Passed |
| Tube to Connector Pull Test (Female Luer Lock) | Passed |
| Luer Lock Cover Open Torque Test (Female Luer Lock) | Passed |
| Testing Activation of the Sharps Injury Protection Feature | Passed |
| Needle Pushback Strength Test | Passed |
| Needle Guard Detachment Strength Test | Passed |
| Appearance Check (Caveo) | Passed |
| Cover Pull with Hub (Caveo) | Passed |
| Air Leak Test (Caveo) | Passed |
| Positive Pressure Leak Test (Caveo) | Passed |
| Negative Pressure Leak Test (Caveo) | Passed |
| Needle Guard Retraction Final Lock Test (Caveo) | Passed |
| Tube to Hub Pull Test (Caveo) | Passed |
| Cannula to Hub Tensile Test (Caveo) | Passed |
| Dimensional Analysis of Footplate to Pivot Valve Core (Caveo) | Passed |
| TPE Front & Back Ends Internal Diameter (Y-axis) Measurements (Caveo) | Passed |
| TPE Surface Roughness (Caveo) | Passed |
| Cannulation at 15 and 45-Degree Angles (Caveo) | Passed |
| Occlusion After Taping (Caveo) | Passed |
| VND Performance (Venous Needle Dislodgement) | Passed |
| Baseline Pressure Comparison (Caveo) | Passed |
| Force to Depress the Footplate (Caveo) | Passed |
| Mechanical Hemolysis Testing (Caveo) | Passed |
| Simulated Clinical Usability Study | Successful |
| Transportation Test | Passed |
| Human Factors Testing | Passed |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Hemocompatibility, Pyrogenicity, Acute Systemic Toxicity, Subacute Toxicity, Genotoxicity) | Passed (for all, per ISO 10993 standards) |
2. Sample Size for Test Set and Data Provenance
- Test Set (Clinical Trial): 15 subjects (2 females, 13 males).
- Data Provenance: The document does not explicitly state the country of origin. It describes the recruitment from "the general hemodialysis population," and mentions racial/ethnic demographics, but not geographic. Given the company is "JMS North America Corporation" (Hayward, CA), it is highly probable the study was conducted in the US. The study appears to be prospective as it involves recruitment and device use to confirm safety, performance, and usability.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is largely not applicable as the device is a physical medical device. The "ground truth" for performance is established through bench testing (objective physical measurements) and the success of the device in a simulated clinical setting. There is no mention of human experts establishing a "ground truth" for diagnostic or AI-related interpretations.
For the simulated clinical usability study, the "ground truth" is whether the device performed as intended and was usable, as observed by clinicians/researchers during the study. The qualifications of those assessing the usability are not specified, beyond the implication that they are competent to conduct a clinical trial for hemodialysis devices.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiology reads) where there might be disagreement in expert opinions needing a tie-breaker. This is not applicable here as:
- The primary "test set" involves objective performance characteristics (bench testing).
- The clinical usability study likely involved observing successful function and user feedback, not a diagnostic interpretation needing adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is relevant for evaluating the performance of AI systems or diagnostic tools where multiple human readers interpret cases, often with and without AI assistance, to see if the AI improves human performance. This device is a physical hemodialysis needle set, not an AI or diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to the performance of an AI algorithm on its own. The device is a physical product. Its "standalone" performance is assessed through bench testing (e.g., VND Performance, Mechanical Hemolysis Testing, Needle Penetration Resistance). These tests evaluate the device's inherent functional characteristics independent of human interaction during the critical failure modes.
7. The Type of Ground Truth Used
- Bench Testing: The ground truth is based on objective physical measurements and engineering specifications (e.g., force measurements, leak tests, dimensional analyses) and functional success/failure (e.g., did the VND feature trigger the alarm?).
- Simulated Clinical Usability Study: The ground truth is based on observed device performance during simulated use and the successful delivery of hemodialysis without impedance by the device's novel features. This is akin to outcomes data in a controlled simulated environment.
8. The Sample Size for the Training Set
Not applicable. The device is a physical product and does not involve AI or machine learning models that require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI model.
In summary, the provided document details the non-clinical and limited clinical testing of a physical medical device (hemodialysis needle set). The acceptance criteria are largely met through rigorous bench testing demonstrating physical and functional robustness, and a small simulated clinical study confirming usability and safety in a controlled environment. AI-specific criteria are not relevant to this type of device.
FDA 510(k) Clearance Letter - JMS CAVEO A.V. Fistula Needle Set
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 15, 2025
JMS North America Corporation
Sho Hososki
Director QA/RA
22320 Foothill Blvd. Suite 350
Hayward, California 94541
Re: K251877
Trade/Device Name: JMS CAVEO A.V. Fistula Needle Set
Regulation Number: 21 CFR 876.5540
Regulation Name: Blood Access Device And Accessories
Regulatory Class: Class II
Product Code: FIE
Dated: June 18, 2025
Received: June 18, 2025
Dear Sho Hososki:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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Sincerely,
Maura Rooney -S
Maura Rooney
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K251877
Device Name: JMS CAVEO A.V. Fistula Needle Set
Indications for Use (Describe):
JMS CAVEO A.V. Fistula Needle Set is intended for temporary cannulation to vascular access for extracorporeal blood treatment for hemodialysis. This device is intended for single use only. The anti-needlestick safety feature aids in prevention of needle stick injuries when removing and discarding the needle after dialysis. The device also has an integrated safety mechanism that is designed to automatically generate a partial occlusion of the internal fluid path and trigger the hemodialysis machine to alarm and shut off if a complete dislodgement of the venous needle from the arm inadvertently occurs. In vitro testing supports that this feature triggers the hemodialysis machine to alarm and shut off.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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Section 05: 510(k) Summary [807.92(c)]
Owner [807.92(a)(1)]:
Company Name: JMS North America Corp.
Company Address: 22320 Foothill Blvd., Suite 350
Hayward, CA 94541
Telephone: 510-888-9090
Fax: 510-888-9099
Contact Person: Sho Hosoki
Summary Preparation Date: 08/07/2025
Device of Submission [807.92(a)(2)]
Classification Name: Blood access device and accessories
Common/Usual Name: Needle, Fistula
Proprietary Name: JMS CAVEO A.V. Fistula Needle Set
Classification: Class II
Product Code: FIE
Code of Federal Regulations: 21 CFR 876.5540
Predicate Device [807.92(a)(3)]
| K Number | Product | Company | Predicate/Reference |
|---|---|---|---|
| K111948 | JMS A.V. Fistula Needle Set WingEater® | JMS North America Corporation | Predicate |
| K142564 | SysLoc® MINI (V4) | JMS North America Corporation | Reference |
Device Description [807.92(a)(4)]
The subject device is the JMS CAVEO A.V. Fistula Needle Set (CAVEO) with an anti-needlestick safety feature. The Caveo is predicted to protect patients from the risks associated with venous needle dislodgement (VND) based on bench testing results. It contains an integrated stainless steel torsion spring mechanism and bottom footplate that provides an open/fluid path when the AV fistula set is fully cannulated into the access site. When the venous needle becomes completely dislodged from the patient's arm, this mechanism enables the footplate to partially occlude the blood path, generating an increased venous line pressure high enough to trigger automatic alarm and halt further blood pumping of the hemodialysis machine. In vitro testing supports that this feature triggers the hemodialysis machine to alarm and shut off. Based on bench testing results, this may significantly reduce patient blood loss in the event of a complete VND. The Caveo has a pre-attached anti-stick needle guard for prevention of needlestick injury at the time of needle withdraw after completion of a hemodialysis procedure.
In vitro performance testing using dialysis machine Fresenius 2008K supports the function of the Caveo VND feature with a venous pressure limit set to 200mmHg symmetric mode, a maximum dialyzer membrane surface area of 2.5 m2, minimum blood flow rate of 200 mL/min, maximum ultrafiltration rate of 4000 mL/hour, and simulated treatment duration of 8 hours. If
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different machine and/or setting are used, before introducing the device, refer to Directions for Use.
Intended Use [807.92(a)(5)]
Indications for Use:
JMS CAVEO A.V. Fistula Needle Set is intended for temporary cannulation to vascular access for extracorporeal blood treatment for hemodialysis. This device is intended for single use only. The anti-needlestick safety feature aids in prevention of needle stick injuries when removing and discarding the needle after dialysis. The device also has an integrated safety mechanism that is designed to automatically generate a partial occlusion of the internal fluid path and trigger the hemodialysis machine to alarm and shut off if a complete dislodgement of the venous needle from the arm inadvertently occurs. In vitro testing supports that this feature triggers the hemodialysis machine to alarm and shut off.
Predicate Comparison [807.92(a)(6)]
| Modified Device | Predicate | |
|---|---|---|
| Device Name | JMS CAVEO A.V. Fistula Needle Set | WingEater® |
| 510(k) # | K233685 | K111948 |
| Classification | Class II | Class II |
| Indication for use/Intended Use | Intended Use: Symptoms requiring blood purification such as acute renal failure and chronic renal failure.Indications for Use: JMS CAVEO A.V. Fistula Needle Set is intended for temporary cannulation to vascular access for extracorporeal blood treatment for hemodialysis. This device is intended for single use only. The anti-needlestick safety feature aids in prevention of needle stick injuries when removing and discarding the needle after dialysis. The device also has an integrated safety mechanism that is designed to automatically generate a partial occlusion of the internal fluid path and trigger the hemodialysis machine to alarm and shut off if a complete dislodgement of the venous needle from the arm inadvertently occurs. In vitro testing supports that this feature triggers the hemodialysis machine to alarm and shut off. | Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended to single use only and is for temporary catheterization less than 30 days. The safety feature (foldable wing and WingEater guard) aids in prevention of needlestick injuries when removing and discarding needle after dialysis session |
| Physical Specification | ||
| Distal End Configuration | Cannula | Cannula |
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| Modified Device | Predicate | |
|---|---|---|
| Cannula Gauge | 14G, 15G, 16G, 17G | 14G, 15G, 16G, 17G, 18G |
| Cannula Exposed Length | 1'' & 1 ¼" | 1'' & 1 ¼" |
| Cannula Type | Sharp & BluntWith & without Back Eye (BE) | SharpWith & without Back Eye (BE) |
| Wing Colour | 14G: Translucent White15G: Translucent Blue16G: Translucent Green17G: Translucent Orange | 14G: White15G: Blue16G: Green17G: Orange18G: Pink |
| Clamp Colour | White, Blue | White, Red, Blue |
| Tube Length | 270mm (12") & 400mm (16") | 135mm (6") & 270mm (12") |
| Proximal End Configuration | Female Luer Lock | Female Luer Lock |
| Special Features | Caveo contains an internal core with a flexible membrane, an underlying footplate and a torsion spring that enable the VND detection and machine shut-off functionality.Anti-needlestick safety feature of Caveo is a needle guard pre-attached onto tubing to encapsulate needle within the guard upon completion of hemodialysis session. | Retract wing into WingEater guard after removing needle. Wing and needle slides into the WingEater and lock in position to prevent needle stick. |
| Performance Specification | Upon complete VND, the opening of Caveo footplate partially occluded the internal flow path, increased venous line pressure and triggered upper alarm limit of dialysis machine.Caveo required very minimum force when retraction and needle is locked after use.Caveo needle guard will not be punctured by needle when properly used. | WingEater guard will not be punctured by needle when properly used.WingEater guard is able to be operated by one hand and two-handed techniques. |
| Technical Characteristic of Anti-stick | Retract needle into Caveo needle guard. Needle slides into the needle guard and locks in position to prevent needle stick. | Retract wing into WingEater guard after removing needle.Wing and needle slides into the WingEater guard and lock in position to prevent needle stick. |
| Material | Described in biocompatibility section | |
| Labeling | Attached in "Substantial Equivalence Comparison – Label" | |
| Sterilization | ETO sterilization | ETO sterilization |
| Functional Specification | ||
| Needle Penetration Resistance | 14G: ≤ 40g15G: ≤ 35g16G: ≤ 30g17G: ≤ 30g | 14G: ≤ 40g15G: ≤ 35g16G: ≤ 30g17G: ≤ 30g18G: ≤ 25g |
| Needle Retention Strength | > 6.0kgf | > 6.0kgf |
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| Modified Device | Predicate | |
|---|---|---|
| Needle Surface (Visually) | No dented / damaged needle | No dented / damaged needle |
| Product Leak | When subjected to air pressure 0.40 kgf/cm2 and immersed in water, air bubble should not appear. | When subjected to air pressure 0.40 kgf/cm2 and immersed in water, air bubble should not appear. |
| Needle Retraction Final Lock Strength | ≤ 2.0kgf | ≤ 2.0kgf |
| Connector | 1. Air tightness is tested by ISO 80369-7.2. Luer meets ISO 80369-7. | 1. Air tightness is tested by ISO 594-2.2. Luer meets ISO 594-1. |
| Connection Strength | 1. Tube to Connector/Joint: > 6.0kgf2. Tube to Pivot Valve Core: > 6.0kgf | 1. Tube to Connector/Joint: > 3.0kgf2. Tube to Hub: > 6.0kgf |
Nonclinical Tests [807.92(b)(1)]
Biocompatibility
| Requirement | Applicable Standard | Result |
|---|---|---|
| Cytotoxicity | ISO 10993-5 | Passed |
| Sensitization | ISO 10993-10 | Passed |
| Irritation or Intracutaneous reactivity | ISO 10993-10 | Passed |
| Hemocompatibility | ISO 10993-4 | Passed |
| Material-mediated pyrogenicity | ISO 10993-11 | Passed |
| Acute systemic toxicity | ISO 10993-11 | Passed |
| Subacute toxicity | ISO 10993-11 | Passed |
| Genotoxicity | ISO 10993-3 | Passed |
Performance
| Test | Result |
|---|---|
| For Female Luer Lock Connector (ISO 80369-7) | |
| 1) Leakage by Pressure Decay | Passed |
| 2) Positive Pressure Liquid Leakage | Passed |
| 3) Sub-atmospheric Pressure Air Leakage | Passed |
| 4) Stress Cracking | Passed |
| 5) Resistance to Separation from Axial Load | Passed |
| 6) Resistance to Separation from Unscrewing | Passed |
| 7) Resistance to Overriding | Passed |
| 8) Tube to Connector Pull Test | Passed |
| 9) Luer Lock Cover Open Torque Test | Passed |
| For Anti-Needlestick Safety Feature of Caveo | |
| 1) Testing Activation of the Sharps Injury Protection Feature | Passed |
| 2) Needle Pushback Strength Test | Passed |
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| Test | Result |
|---|---|
| 3) Needle Guard Detachment Strength Test | Passed |
| For Caveo | |
| 1) Appearance Check | Passed |
| 2) Cover Pull with Hub | Passed |
| 3) Air Leak Test | Passed |
| 4) Positive Pressure Leak Test | Passed |
| 5) Negative Pressure Leak Test | Passed |
| 6) Needle Guard Retraction Final Lock Test | Passed |
| 7) Tube to Hub Pull Test | Passed |
| 8) Cannula to Hub Tensile Test | Passed |
| 9) Dimensional Analysis of Footplate to Pivot Valve Core | Passed |
| 10) TPE Front & Back Ends Internal Diameter (Y-axis) Measurements | Passed |
| 11) TPE Surface Roughness | Passed |
| 12) Cannulation at 15 and 45-Degree Angles | Passed |
| 13) Occlusion After Taping | Passed |
| 14) VND Performance | Passed |
| 15) Baseline Pressure Comparison | Passed |
| 16) Force to Depress the Footplate | Passed |
| 17) Mechanical Hemolysis Testing | Passed |
| 18) Simulated Clinical Usability Study | Successful |
| 19) Transportation Test | Passed |
| 20) Human Factors Testing | Passed |
Clinical Trial Test [807.92(b)(2)]
Clinical trial testing was conducted on patients to confirm the safety, performance and usability of CAVEO.
A total of 15 subjects were recruited from the general hemodialysis population. 2 females (both are not Hispanic or Latino; one is native Hawaiian or other Pacific Islander and the other is White) and 13 males (10 of them are Hispanic or Latino and the rest are not; one is Black or African American and the rest are White).
Based on results of this trial, the CAVEO is capable of delivering prescribed hemodialysis. The novel components of the CAVEO designed to protect against VND (particularly the underlying footplate) did not impede the safe, normal, and efficacious delivery of prescribed hemodialysis.
Conclusion [807.92(b)(3)]
JMS CAVEO A.V. Fistula Needle Set has substantial equivalence with the predicate in intended use and technological characteristics. However, Caveo has additional novel VND safety mechanism and different anti-needlestick safety feature as well as some other minor differences. Clinical, human factors, biocompatibility and bench performance testing was conducted to verify that CAVEO is as safe, as effective, and performs equivalent to the
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predicate if used as intended. Evaluation data and reports are enclosed within this submission document.
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§ 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.