(103 days)
Not Found
No
The summary describes a mechanical device for vascular access with safety features, and there is no mention of AI or ML in the intended use, device description, or any other section.
No
The device is described as a non-implantable device for temporary vascular access during extracorporeal blood treatment, but it does not perform a therapeutic function itself. It facilitates blood treatment, but is not therapeutic.
No
The document describes a device used for temporary cannulation for vascular access during extracorporeal blood treatment, not for diagnosis.
No
The device description explicitly states it consists of a flexible tube and needle with integrated sharp safety features, indicating it is a physical medical device, not software-only.
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...to vascular access for extra corporeal blood treatment." This describes a device used to access the bloodstream for procedures like dialysis or apheresis, which are performed on the patient's blood outside the body.
- Device Description: The description details a "non-implanted blood access device" consisting of a tube and needle. This aligns with a device used for accessing the vascular system directly.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status. The description of this device does not mention any analysis or testing of specimens.
The device described is a vascular access device, specifically a fistula needle set, used for connecting a patient's circulatory system to an external blood treatment system. This is a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
Use for temporary cannulation non-implantable, less than 30 days) to vascular access for extra corporeal blood treatment. The device is intended for single use only and has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries
Product codes (comma separated list FDA assigned to the subject device)
FIE, FOZ
Device Description
SysLoc® MINI (V4) is intended as non-implanted blood access device, which consists of flexible tube and needle with integrated sharp safety features as described in 21 CFR 876.5540. SysLoc® MINI (V4) comes with a rotational feature and the needle is retracted with the wing sheath after deliberate release of secured external lock, and final locking is assured by an audible 'click' sound when the hub/tube is pulled rearwards.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access
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 that the SysLoc® MINI (V4) device is performing as intended to be a safe and effective medical device. Evaluation data and reports are enclosed within this submission document.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2014
JMS North America Corporation Sho Hosoki Regulatory 22320 Foothill Blvd., Suite 350 Hayward, CA 94541
Re: K142564
Trade/Device Name: JMS SysLoc® MINI A.V. Fistula Needle Set (V4) JMS SysLoc® MINI Apheresis Needle Set (V4) Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: FIE Dated: November 20, 2014 Received: December 1, 2014
Dear Sho Hosoki,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
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 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 go to 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 Division 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/1/Picture/6 description: The image shows the name "Herbert P. Lerner -S" in a large, sans-serif font. The text is black and appears to be centered on a white background. The letters are evenly spaced and the text is easy to read.
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 04: Indications for Use
| 510(K) Number (if known): K142564 | |
|---|---|
| Device Name: | JMS SysLoc® MINI A.V.Fistula Needle Set (V4) |
| JMS SysLoc® MINI Apheresis Needle Set (V4) | |
| Indications for Use: | Use for temporary cannulation non-implantable, less than 30 days) to |
| vascular access for extra corporeal blood treatment. The device is | |
| intended for single use only and has an anti-stick feature integrated as | |
| part of the Needle Set which aids in prevention of needle-stick injuries |
Prescription Use ______________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
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: 08/01/2014
Device of Submission [807.92(a)(2]]
| Classification Name: | Needle, Fistula
Intravascular Catheter |
|------------------------------|-----------------------------------------------------------------------------------|
| Proprietary Name: | JMS SysLoc® MINI A.V. Fistula Needle Set
JMS SysLoc® MINI Apheresis Needle Set |
| Classification: | Class II |
| Product Code: | FIE, FOZ |
| Code of Federal Regulations: | 21 CFR 876.5540 |
Note: Same trade name is to be used for both modified and predicate device, thus for clearer differentiation, the modified device will be denoted as SysLoc® MINI (V4) and the predicate device as SysLoc® MINI (V3).
Predicate Device [807.92(a)(3)]
| K Number | Product | Company |
|---|---|---|
| K110157 | JMS SysLoc® MINI A.V. | |
| Fistula Needle Set & JMS | ||
| SysLoc® MINI Apheresis | ||
| Needle Set (V3) | JMS North America | |
| Corporation |
Device Description [807.92(a)(4)]
SysLoc® MINI (V4) is intended as non-implanted blood access device, which consists of flexible tube and needle with integrated sharp safety features as described in 21 CFR 876.5540. SysLoc® MINI (V4) comes with a rotational feature and the needle is retracted with the wing sheath after deliberate release of secured external lock, and final locking is assured by an audible 'click' sound when the hub/tube is pulled rearwards.
Intended Use [807.92(a)(5)]
SysLoc® MINI (V4) is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device is intended for single use only and has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries.
4
Section 05: 510(k) Summary [807.92(c)]
Predicate Comparison [807.92(a)(6)] & [807.92(b)(1)]
| Predicate Comparison [807.92(a)(6)] & [807.92(b)(1)] | ||
|---|---|---|
| Modified Device | Predicate | |
| Device Name | SysLoc® MINI (V4). | SysLoc® MINI (V3). |
| 510(k) # | --- | K110157 |
| Classification | Class II | Class II |
| Intended Use | Remains the same as (V3). | SysLoc® MINI (V3) is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device is intended for single use only and has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries. |
| Technical Characteristic of Anti-stick | Remains the same as (V3). | Retract needle into SysLoc® MINI (V3) Wing Sheath after releasing external lock. Needle slides into the sheath and locks in position to prevent needle stick |
| Physical Specification | Remains the same as (V3) except: Reduction in filter paper of PE pouch | SysLoc® MINI (V3) (with safety feature) is integrated into the wing design. There is no pre-attached component to the device that may interfere the dialysis session. |
| Material | See Section 15 for material comparison | |
| Labeling | See Section 13 for Labeling | |
| Biocompatibility | See Section 15 for biocompatibility | |
| Sterilization | ETO sterilization | |
| Performance Specification | Remains the same as (V3) | ETO sterilization |
| SysLoc® MINI (V3) device required very minimum force when retraction and needle is locked after use. SysLoc® MINI (V3) sheath will not be punctured by needle when properly used. SysLoc® MINI (V3) device is able to be operated by one hand and two-handed |
Conclusion [807.92(b)(3)]
SysLoc® MINI (V4) has the same intended usage as the predicate device SysLoc® MINI (V3) K110157. Bench testing was conducted to verify that the SysLoc® MINI (V4) device is performing as intended to be a safe and effective medical device. Evaluation data and reports are enclosed within this submission document. The information provided in this submission clearly demonstrates the substantial equivalence of SysLoo® MINI (V4) to the predicate device JMS SysLoc® MINI A.V. Fistula Needle Set (V3) & JMS SysLoc® MINI Apheresis Needle Set (V3) K110157.