(91 days)
Use for providing access to a donor's blood for apheresis. This device is intended to single use only and is for temporary catheterization less than 30 days. The safety feature (foldable wing and WingEater) aids in prevention of needlestick injuries when removing and discarding needle after blood collection.
JMS Apheresis Needle Set "WingEater" V2 is a device whereby an antineedlestick feature (WingEater guard) is assembled with predicate device under 510(k), K00845.
Needlestick injury can be prevented by pulling the PVC tube to retract the needle and wing into WingEater guard when removing needle so as to encapsulate the whole needle within the WingEater guard.
Modifications to JMS Apheresis Needle Set "WingEater®" V2 in this special 510(k) are:
- Additional new polypropylene (PP) materials used for WingEater a) guard, needle cover, luer lock cover and clamp (non fluid pathway)
There are other non-significant changes which were made to 510(k) -K010410 in the past. These changes are listed under Attachment 004 List of Past Changes of this special 510(k).
Evaluation of the new packaging configuration was performed accordingly to stimulated conditions experienced during transportation. New design and material used for the WingEater guard was evaluated accordingly with folded wing in order to realize the actual device usage. Reviews of the modifications were documented within this special 510(k) submission.
The provided document is a 510(k) summary for the JMS Apheresis Needle Set "WingEater®" V2. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a comprehensive study report with specific performance metrics against those criteria. Clinical trial data or detailed performance studies with human subjects are typically not required for these types of submissions where substantial equivalence is being argued based on technological characteristics and bench testing.
Therefore, the following information cannot be fully extracted or is not applicable to this specific submission type:
- 1. A table of acceptance criteria and the reported device performance: Not explicitly provided in this format for functional acceptance of the device beyond compliance with referenced ISO and USP standards.
- 2. Sample size used for the test set and the data provenance: Not explicitly stated for performance testing; the document refers to "bench testing."
- 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 not a study assessing diagnostic accuracy or expert consensus.
- 4. Adjudication method for the test set: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "ground truth" for this device's performance would be successful adherence to the referenced standards during bench testing.
- 8. The sample size for the training set: Not applicable as this is a medical device, not an AI/ML algorithm requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable.
However, based on the provided text, here's what can be gathered regarding the "acceptance criteria" (in the sense of standards compliance) and the "study" (bench testing and standards adherence):
Acceptance Criteria and Device Performance for JMS Apheresis Needle Set "WingEater®" V2
The acceptance criteria for the JMS Apheresis Needle Set "WingEater®" V2 are implicitly defined by its adherence to a series of international and national standards for medical devices, particularly those related to biocompatibility, sterility, packaging, and specific device component performance. The "study" proving the device meets these criteria primarily involved bench testing to verify performance and compliance with these standards, alongside a review of material modifications.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards and Evaluations) | Reported Device Performance |
|---|---|
| Material Safety & Biocompatibility: | |
| - ISO 10993-4:2002 Biological Evaluation of Medical Devices Part 4 – Selection of Tests for Interactions with Blood | Materials used for non-fluid pathway components (WingEater guard, needle cover, luer lock cover, clamp) are compliant. |
| - ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5 – Tests for In Vitro Cytotoxicity | Device passes tests for in vitro cytotoxicity. |
| - ISO 10993-10 Biological Evaluation of Medical Devices Part 10 – Tests for Irritation and Delayed-Type Hypersensitivity | Device passes tests for irritation and delayed-type hypersensitivity. |
| - ISO 10993-11 Biological Evaluation of Medical Devices Part 11 – Tests for Systemic Toxicity | Device passes tests for systemic toxicity. |
| - USP 33:2010 Bacterial Endotoxins | Device passes bacterial endotoxins test. |
| Device Connection & Dimensions: | |
| - ISO 594-1: 1986 Conical Fittings with 6% (Luer) Taper for Syringes, Needles and C... – Part 1 – General Requirements | Device fittings meet general requirements. |
| - ISO 594-2: 1998 Conical Fittings with 6% (Luer) Taper for Syringes, Needles and C... – Part 2 – General Requirements | Device fittings meet specific requirements. |
| - ISO 1135-4 4th Edition 2010-04-15, Transfusion Equipment for Medical Use – Part 4 - Transfusion Sets for Single Use | Device complies with requirements for transfusion sets for single use. |
| - ISO 9626: 1991 + (Amd1:2001) Stainless Steel Needle Tubing for the Manufacture of Medical Devices | Stainless steel needle tubing meets specified standards. |
| Sterility & Packaging: | |
| - ISO 11135-1:2007 Sterilization of Health Care Products Ethylene Oxide – Part 1 – Requirements for Development, Validation and r... | Sterilization process meets requirements for development, validation, and routine control. |
| - ISO 11137-1 Sterilization of Health Care Products Radiation Part 1 – Requirements for Development, Validation... | Sterilization process meets requirements for development, validation, and routine control. |
| - ISO 11137-2:2006 Sterilization of Health Care Products Radiation Part 2 – Establishing the Sterilization Dose | Sterilization dose is established according to the standard. |
| - ISO 11137-3:2006 2010 Sterilization of Health Care Products – Radiation - Part 3 – Guidance on Dosimetric Aspects | Complies with guidance on dosimetric aspects. |
| - ISO 11607-1:2007 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials | Packaging materials meet requirements. |
| - ISO 11607-2: 2006 Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes | Packaging processes (forming, sealing, assembly) meet validation requirements. |
| - USP 32:2009 Sterility Tests | Device passes sterility tests. |
| Manufacturing Environment & Risk Management: | |
| - ISO 14644-1: 1999 Clean rooms and associated controlled environments- Part 1: Classification of air cleanliness | Manufacturing environments comply with air cleanliness classification. |
| - ISO 14644-2: 2000 Clean rooms and associated controlled environments -- Part 2: Specifications for testing and monitoring to prove continued compliance... | Monitoring of manufacturing environments proves continued compliance. |
| - ISO 14971:2007 Medical Devices Application of Risk Management to Medical Devices | Risk management principles applied during device development. |
| Functional Safety (Needlestick Prevention): | |
| - Safe removal and discarding of needle to prevent needlestick injuries (Intended Use Statement) | The safety feature (foldable wing and WingEater guard) aids in preventing needlestick injuries by encapsulating the needle upon retraction. |
| Performance with new materials/design: | |
| - Evaluation of WingEater guard with folded wing (due to new polypropylene materials and design) | Evaluated accordingly with folded wing to realize actual device usage; reviews of modifications documented. "Found to be safe and effective." |
| - Evaluation of new packaging configuration for transportation | Performed accordingly to simulated conditions experienced during transportation; reviews of modifications documented. "Found to be safe and effective." |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each bench test performed. It generally states that "Bench testing had been conducted to verify performance." The data provenance is implied to be internal testing conducted by the manufacturer (JMS Singapore Pte Ltd) or contract labs adhering to international standards. No country of origin for specific test data is given beyond the manufacturer's location. The testing would be considered prospective as it evaluates the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert consensus for diagnostic accuracy or clinical judgment. Compliance with engineering and safety standards is determined through objective measurements and test procedures.
4. Adjudication method for the test set
Not applicable. Test results are typically objective measurements against defined standard limits, not subjective assessments requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This type of study is for evaluating human performance (e.g., diagnostic accuracy) with or without AI assistance, which is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" implicitly refers to the specific, measurable requirements and limits set forth by each referenced ISO and USP standard for device performance, material safety, sterility, and packaging integrity. For example, specific cytotoxicity levels, luer taper dimensions, or sterility assurance levels would serve as the ground truth for their respective tests. The "safety feature" performance against needlestick injury prevention would be assessed through functional testing and design verification.
8. The sample size for the training set
Not applicable. This is a 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.
§ 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.