(77 days)
No
The description focuses on a mechanical modification (a scraper tool) to a blunt needle set and does not mention any computational or data-driven features indicative of AI/ML.
No.
The device is described as a needle set intended for temporary cannulation for extracorporeal blood treatment and removal of scabs, which are procedural steps rather than therapeutic end goals.
No
The device is a needle set intended for temporary cannulation for extracorporeal blood treatment and scab removal, not for diagnosing a condition or disease.
No
The device description clearly indicates it is a physical needle set with a site preparation tool, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The JMS Blunt AV Fistula Needle Set with Site Preparation Tool is used for cannulation (inserting a needle into a blood vessel) and removing scabs from a vascular access site. These are direct interventions on the patient's body, not tests performed on specimens outside the body.
- Intended Use: The intended use clearly states "temporary cannulation... for extracorporeal blood treatment" and "removal of scabs." This describes a procedural device, not a diagnostic test.
Therefore, this device falls under the category of a medical device used for treatment and access, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The JMS Blunt A.V. Fistula Needle Set with Site Preparation Tool is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment and for the removal of scabs that have developed over the constant site prior to cannulation. The device is intended for single use only. The JMS A.V. Fistula Blunt Needle Set is for use on developed 'constant site' access sites.
Product codes
FIE
Device Description
JMS A.V. Fistula Blunt Needle Set with Site Preparation Tool is a modification of the previously cleared JMS A.V. Fistula Blunt Needle Set (K082882). The modification is the replacement of the standard needle cover with a site preparation tool "scraper" feature that removes the scabs that have developed over the constant site prior to cannulation.
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
A clinical usability study was performed to verify ease of use and label comprehension.
Key Metrics
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.
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K093637
Page 1 of 3
510(k) Summary 807.92(c)
FEB - 9 2010
P
SPONSOR
Telephone:
Contact Person:
Fax:
807.92(a)(1)
Company Name: Company Address
JMS North America Corporation 22320 Foothill Blvd., Suite 350 Hayward, CA 94541 USA (210) 888-9090 (210) 888-9099 Shinya Nagase
Summary Preparation Date: November 23, 2009
DEVICE NAME
Trade Name:
807.92(a)(2)
Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class: Panel:
JMS Blunt A.V. Fistula Needle Set with Site Preparation Tool Fistula Needle Fistula Needle 876.5540 FIE Class II Gastroenterology/Urology
PREDICATE DEVICE
807.92(a)(3)
807.92(a)(4)
| Legally Marketed Equivalent Device | ||
|---|---|---|
| Company | Product | 510(k) # |
| JMS North America Corp. | A.V. Fistula Blunt Needle Set | K082882 |
DEVICE DESCRIPTION
JMS A.V. Fistula Blunt Needle Set with Site Preparation Tool is a modification of the previously cleared JMS A.V. Fistula Blunt Needle Set (K082882). The modification is the replacement of the standard needle cover with a site preparation tool "scraper" feature that removes the scabs that have developed over the constant site prior to cannulation.
DEVICE INTENDED USE
807.92(a)(5)
The JMS Blunt A.V. Fistula Needle Set with Site Preparation Tool is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment and for the removal of scabs that have developed over the constant site prior to cannulation. The device is intended for single use only. The JMS AV Fistula Blunt Needle Set is for use on developed 'constant site' access sites.
1
| COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6) | ||
|---|---|---|
| New Device | Predicate Device | |
| A.V. Fistula Blunt Needle Set with | ||
| Site Preparation Tool | A.V. Fistula Blunt Needle Set | |
| Manufacturer | JMS Singapore Pte Ltd | JMS Singapore Pte Ltd |
| 510k Number | K082882 | |
| Intended Use | Device is used for needle insertion into | |
| a previously mature access site for | ||
| dialysis procedure using a constant-site | ||
| technique of needle insertion. The | ||
| modification of the predicate device | ||
| consists of a Site Preparation Tool | ||
| incorporated into the needle cover that | ||
| allows for site preparation through the | ||
| use of a “scraper” feature to remove the | ||
| scabs that have developed over the | ||
| constant site prior to cannulation. | Device is used for needle insertion into | |
| a previously mature access site for | ||
| dialysis procedure using a constant-site | ||
| technique of needle insertion. | ||
| Similarities | ||
| Material | Same | Same |
| Physical | ||
| Specification | Same | Same |
| Mechanical/ | ||
| Performance | ||
| Specification | Met established acceptance criteria | Met established acceptance criteria |
| Packaging | Same | Same |
| Sterilization | Same | Same |
| Biocompatibility | All patient contacting materials meet | |
| biocompatibility standards for ISO- | ||
| 10993 for non-implanted blood access | ||
| contacting device less than 30 days | All patient contacting materials meet | |
| biocompatibility standards for ISO- | ||
| 10993 for non-implanted blood access | ||
| contacting device less than 30 days | ||
| Differences | ||
| Needle Cover | Needle Cover with Site Preparation | |
| Tool | Needle Cover |
SAFETY and EFFECTIVENESS
807.92(b)
Testing information demonstrating safety and effectiveness of JMS A.V. Fistula Blunt Needle Set in the intended environment of use is supported by testing that was conducted in accordance with the following standards:
| ISO 11135:1994 | Medical Devices - Validation and | |
|---|---|---|
| Routine control of ethylene oxide | ||
| sterilization | ||
| ISO 14971:2000 | Medical Device – Application of risk | |
| management to medical devices |
2
BIOCOMPATIBILITY
We have assessed all of our patient contacting materials for biocompatibility requirements in accordance with the May 1, 1995 FDA Biocompatibility Guidance, the FDA-modified matrix of the "International Standard ISO-10993", Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", including the flow chart entitled "Biocompatibility Flow Chart for the Selection of Toxicity Tests for 510(k)s.
STERILIZATION
The device is sterilized using ETO, utilizing the ISO International Standard 11135 (EN 550). The validations were performed in accordance with EN-550 and ISO 11135.
PERFORMANCE DATA
A clinical usability study was performed to verify ease of use and label comprehension.
CONCLUSION
807.92(b)(3)
The JMS Blunt A.V. Fistula Needle Set with Site Preparation Tool is a modification of the predicate, JMS Blunt AV Fistula Needle Set (K K082882) and is the same device in its technological and performance characteristics. The addition of a site preparation tool incorporated into the needle cover has changed the Indications for Use to include this feature. Risk Analysis, Design Control and a Clinical Usability Study has verified its safe and effective use.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is black and white and appears to be a scanned or reproduced image.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002
JMS North America Corporation c/o E. J. Smith, President Smith Associates 1468 Harwell Avenue CROFTON MD 21114
FEB - 9 2010
K093637 Re:
Trade/Device Name: JMS Blunt AV Fistula Needle Set with Site Preparation Tool Regulation Name: Blood access device and accessories Regulation Number: 21 CFR §876.5540 Regulatory Class: II Product Code: FIE Dated: November 23, 2009 Received: November 24, 2009
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 (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. 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
4
Page 2 -
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _K 09 3637
Device Name: JMS Blunt AV Fistula Needle Set with Site Preparation Tool
Indications for Use:
The JMS Blunt AV Fistula Needle Set with Site Preparation Tool is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment and for the removal of scabs that have developed over the constant site prior to cannulation. The device is intended for single use only. The JMS AV Fistula Blunt Needle Set is for use on developed 'constant site' access sites.
(Check appropriate designation below)
Prescription Use N (Part 21 CFR 801 Subpart D)
510(k) Number ________________________________________________________________________________________________________________________________________________________________
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)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices 11002
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