(186 days)
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No
The summary describes a physical medical device (needle set) with a mechanical safety feature (anti-stick). There is no mention of software, data processing, or any terms related to AI/ML.
No
The device is used for "temporary cannulation for vascular access for extracorporeal blood treatment" and "temporary catheterization," which are procedures rather than direct therapeutic treatments. Its function is to facilitate blood treatment, not to treat a disease or condition itself.
No
The device is used for temporary cannulation for vascular access for extracorporeal blood treatment, not for diagnosing a condition.
No
The device description explicitly mentions "Needle Set" and "catheterization," indicating a physical, hardware-based medical device for vascular access. There is no mention of software as the primary or sole component.
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 outside the body (like dialysis or apheresis).
- Device Description: The device is a "Fistula Needle Set" and "Apheresis Needle Set." These are physical devices used to access blood vessels.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. The description of this device and its use does not involve the analysis of specimens.
Therefore, this device is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The device has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries when withdrawing and discarding the needle after treatment.
Product codes
78 FIE, 80 FOZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features a stylized eagle or bird-like symbol in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
AUG 1 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mrs. Swee Cheau, Chong Manager of Regulatory Affairs & Quality Assurance JMS North America Corporation 22320 Foothill Blvd., Suite 350 HAYWARD CA 94541
Re: K030479
Trade/Device Name: JMS SysLoc A.V. Fistula Needle Set and JMS SysLoc Apheresis Needle Set Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Product Code: 78 FIE Regulation Number: 21 CFR $880.5200 Regulation Name: Intravascular catheter Product Code: 80 FOZ Regulatory Class: II Dated: May 19, 2003 Received: May 21, 2003
Dear Mrs. Chong:
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.
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); 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.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
l'age 2
2
INDICATIONS FOR USE STATEMENT
510(K) Number:
Needle, Fistula Device Name:
Use for temporary cannulation for vascular access for extracorporeal blood Indications For Use: treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The device has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries when withdrawing and discarding the needle after treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use _
(Per 21 CFR Section 801.109)
Over-The-Counter Use _
David A. Syneron
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
and Radiological Devi 510(k) Number