(108 days)
No
The 510(k) summary describes a mechanical device for vascular access with a safety feature to prevent needlestick injuries. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
No
The device is described as being for "temporary cannulation for vascular access for extracorporeal blood treatment" and mentions its use "after dialysis session." While related to medical treatment, it serves as an access device rather than directly performing a therapeutic action on the patient. Its primary function is to facilitate the connection for a treatment, not to deliver the treatment itself.
No
The "Intended Use / Indications for Use" states the device is for "temporary cannulation for vascular access for extracorporeal blood treatment" and "temporary catheterization". It is a needle set used for access, not for diagnosing a condition or disease.
No
The device description clearly indicates it is a physical medical device (needle set) with an anti-needlestick feature, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary cannulation for vascular access for extracorporeal blood treatment." This describes a procedure performed directly on a patient to access their bloodstream for treatment (like dialysis).
- Device Description: The description details a needle set designed for accessing blood vessels and includes a safety feature for preventing needlestick injuries. This aligns with a device used for direct patient intervention.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health. The description of this device does not mention any analysis of specimens or diagnostic purposes.
Therefore, this device is a medical device used for direct patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Use for temporary cannulation for vascular access for extracorporeal blood treatment. This device is intended to single use only and is for temporary catheterization less than 30 days. The safety feature (foldable wing and Wing Eater) aids in prevention of needlestick injury when removing and discarding needle after dialysis session.
Product codes
FIE
Device Description
JMS A.V. Fistula Needle Set "WingEater®V2 is a device whereby an antineedlestick feature (WingEater guard) is assembled with predicate device under 510(k), K000845.
Needlestick injury can be prevented when removing needle so as to encapsulate the whole needle within the WingEater guard.
Modifications to JMS A.V. Fistula Needle Set "WingEater®V2 in this special 510(k) are:
a) Additional new polypropylene (PP) materials used for WingEater guard, needle cover, luer lock cover and clamp (non fluid pathway)
There are other non-significant changes which were made to 510(k) - K010406 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 simulated 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 the special 510(k) submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to verify performance of JMS A.V. Fistula Needle Set "WingEater®V2 and it was found to be safe and effective. The following data and reports were enclosed within this submission document.
- ISO 10993-4:2002 Biological Evaluation of Medical Devices Part 4 .
- Selection of Tests for Interactions with Blood
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5 .
- Tests for In Vitro Cytotoxicity
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10 Tests for Irritation and Delayed-Type Hypersensitivity
- ISO 10993-11 Biological Evaluation of Medical Devices Part 11 -. Tests for Systemic Toxicity
- ISO 594-1: 1986 Conical Fittings with 6% (Luer) Taper for Syringes, . Needles and Certain Other Medical Equipment - Part 1 - General Requirements
- ISO 594-2: 1998 Conical Fittings with 6% (Luer) Taper for Syringes, . Needles and Certain Other Medical Equipment - Part 2 - General Requirements
- ISO 1135-4 4th Edition 2010-04-15, Transfusion Equipment for . Medical Use _ Part 4 - Transfusion Sets for Single Use
- ISO 11135-1:2007 Sterilization of Health Care Products Ethylene . Oxide - Part 1 - Requirements for Development, Validation and routine control of a sterilization process for medical devices. (Sterility)
- ISO 11137-1 Sterilization of Health Care Products Radiation Part . 1 - Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices. (Sterility)
- ISO 11137-2:2006 Sterilization of Health Care Products Radiation -. Part 2 - Establishing the Sterilization Dose
- ISO 11137-3:2006 2010 Sterilization of Health Care Products -. Radiation - Part 3 - Guidance on Dosimetric Aspects
- ISO 11607-2: 2006 Packaging for Terminally Sterilized Medical . Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes
- USP 32:2009 Sterility Tests .
- USP 33:2010 Bacterial Endotoxins
- ISO 14971:2007 Medical Devices Application of Risk Management . to Medical Devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
K111948 page 1 of 4
OCT 24 2011
510(k) Summary
Date Prepared: October 20, 2011 Manufacturer: JMS Singapore Pte Ltd 440, Ang Mo Kio Industrial Park 1 Singapore, 569620 Sponsor: JMS North America Corporation 22320 Foothill Blvd., Suite 350 Hayward, CA 94541 Contact Information: Mr. Sho Kosoki Coordinator of Product Management and Regulatory Affairs JMS North America Corporation 22320 Foothill Blvd., Suite 350 Hayward, CA 94541 Email: SHosoki@jmsna.net Telephone: (510) 888-9090 Fax: (510) 888-9099
Trade Name:
JMS A.V. Fisula Needle Set "WingEater®"
JMS North America Corp will continue to name the new modified device as "JMS A.V. Fistula Needle Set "WingEater®". For the purpose of this submission, we will refer our predicate and new modified device as:
| Predicate Device | JMS Fistula Needle Set |
|---|---|
| "WingEater®V1 | |
| New Modified Device | JMS Fistula Needle Set |
| "WingEater®V2 |
Device Classification Name:
Gastroenterology Devices Panel has classified modified device of JMS A.V. Fistula Needle Set "WingEater®V2 (21 CFR 876-5540) as Class II.
Predicate Device Name
Predicate device used in this submission is JMS A.V. Fistula Needle Set "WingEater®V1 (510(k) number - K010406, cleared on June 20, 2001).
1
Device Intended Use
Use for temporary cannulation for vascular access for extracorporeal blood treatment. This device is intended to single use only and is for temporary catheterization less than 30 days. The safety feature (foldable wing and Wing Eater) aids in prevention of needlestick injury when removing and discarding needle after dialysis session.
Device Description
JMS A.V. Fistula Needle Set "WingEater®V2 is a device whereby an antineedlestick feature (WingEater guard) is assembled with predicate device under 510(k), K000845.
Needlestick injury can be prevented when removing needle so as to encapsulate the whole needle within the WingEater guard.
Modifications to JMS A.V. Fistula Needle Set "WingEater®V2 in this special 510(k) are:
a) Additional new polypropylene (PP) materials used for WingEater guard, needle cover, luer lock cover and clamp (non fluid pathway)
There are other non-significant changes which were made to 510(k) - K010406 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 simulated 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 the special 510(k) submission.
Technological Characteristics and Substantial Equivalence JMS A.V. Fistula Needle Set "WingEater®V2 has the same intended use and identical fundamental scientific technology as JMS A.V. Fistula Needle Set "WingEater@V1. Bench testing was conducted to verify performance of JMS A.V. Fistula Needle Set "WingEater®V2 and it was found to be safe and effective. The following data and reports were enclosed within this submission document.
- ISO 10993-4:2002 Biological Evaluation of Medical Devices Part 4 .
- Selection of Tests for Interactions with Blood
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5 .
- Tests for In Vitro Cytotoxicity
2
K111948 page 3 of 4
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10 Tests for Irritation and Delayed-Type Hypersensitivity
- ISO 10993-11 Biological Evaluation of Medical Devices Part 11 -. Tests for Systemic Toxicity
- ISO 594-1: 1986 Conical Fittings with 6% (Luer) Taper for Syringes, . Needles and Certain Other Medical Equipment - Part 1 - General Requirements
- ISO 594-2: 1998 Conical Fittings with 6% (Luer) Taper for Syringes, . Needles and Certain Other Medical Equipment - Part 2 - General Requirements
- ISO 1135-4 4th Edition 2010-04-15, Transfusion Equipment for . Medical Use _ Part 4 - Transfusion Sets for Single Use
- ISO 11135-1:2007 Sterilization of Health Care Products Ethylene . Oxide - Part 1 - Requirements for Development, Validation and routine control of a sterilization process for medical devices. (Sterility)
- ISO 11137-1 Sterilization of Health Care Products Radiation Part . 1 - Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices. (Sterility)
- ISO 11137-2:2006 Sterilization of Health Care Products Radiation -. Part 2 - Establishing the Sterilization Dose
- ISO 11137-3:2006 2010 Sterilization of Health Care Products -. Radiation - Part 3 - Guidance on Dosimetric Aspects
- ISO 11607-2: 2006 Packaging for Terminally Sterilized Medical . Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes
- USP 32:2009 Sterility Tests .
- USP 33:2010 Bacterial Endotoxins �
- ISO 14971:2007 Medical Devices Application of Risk Management . to Medical Devices
3
K111948 page 4 of 4
Thus, the information provided in this submission clearly demonstrated Substantial Equivalence of the JMS A.V. Fistula Needle Set "WingEater®V2 to the predicate device JMS A.V. Fistula Needle Set "WingEater®V1.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JMS North America Corporation % Mr. E.J. Smith Consultant Smith Associates 1468 Harwell Ave. CROFTON MD 21114
OCT 2 4 2011
Re: K111948
Trade/Device Name: Needle, Fistula Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: FIE Dated: September 29, 2011 Received: September 30, 2011
Dear Mr. Smith:
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 (PM), 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 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
5
Page 2
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 n 10 http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Tou inay of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and · Radiological Health
Enclosure
6
Attachment 006 - Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(K) Number:
"
K 111948
Device Name:
Needle, Fistula
Indications For Use:
for temporary cannulation Use 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.
റി
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓ OR Over-The-Counter Use
(Per 21 CFR Section 801.109)
ve. Gastro-Renal, and