(96 days)
Not Found
No
The description focuses on the mechanical design and function of a syringe and needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is intended for aspirating specimens for pathologic examination, not for treating a condition or disease.
No
The device is intended for aspirating a specimen of fluid or tissue for pathologic examination, which is a step in the diagnostic process, but the device itself does not perform the diagnostic analysis.
No
The device description clearly describes a physical syringe and needle, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aspirate a specimen of fluid or tissue out of the human body for pathologic examination." This describes a device used for specimen collection, not for performing a diagnostic test in vitro (outside the body).
- Device Description: The description focuses on the physical characteristics of the syringe and needle, designed for efficient and controlled sample collection. It does not mention any components or functionalities related to analyzing the collected sample.
- Performance Studies: The performance study described is a "Device Function Test" comparing the MFA device to predicates in terms of preventing sample spread during collection. This is a test of the device's ability to collect a sample effectively, not its ability to perform a diagnostic test on the sample.
IVD devices are typically used to examine specimens after they have been collected from the body, to provide information about a patient's health status. This device's role is solely in the collection of the specimen.
N/A
Intended Use / Indications for Use
The MFA Syringe with Needle is intended for use in aspirating a specimen of fluid or tissue out of the human body for pathologic examination.
The MFA Syringe/Needle Device is a syringe with needle intended for use in aspirating a specimen of fluid or tissue out of the human body for pathologic examination.
Product codes
FMF, FMI, KNW
Device Description
The MFA and predicate devices have substantially similar technological characteristics in terms of design and materials. Although there are minor difference in the characteristics of the MFA device and its predicate devices, those differences do not raise new questions of safety or efficacy. MFA differs from some predicates in the range of syringe and needle sizes but is similar to those of other predicates. Compared with the predicates, the MFA Device has a different size and shape of the hub of the needle: the size of the hub is larger and has a larger lumen to allow the collected samples to be picked up and transferred to other containers. In additional, the inner end of the needle that is located in the lumen of the hub has a cover above the opening of the needle to prohibit the collected sample getting up into the lumen of the syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human body
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
Non-clinical Device Function Test was performed using different animal organs and tissues to compare MFA device and predicate devices in a manner of mimicking a procedure in human projects. The test demonstrates that the larger capacity of the hub and the cover of the needle in the MFA devices significantly prevented the fluid from spreading into the lumen of the syringe in cases where more than 50 µl of liquid samples were collected when compared with the predicate devices, and the larger capacity of the hub and the cover of the needle in the MFA devices significantly prevented the collected solid tissue samples from spreading into the lumen of the syringe when compared with the predicate devices. The part of the needle that will penetrate the skin into the body is the same as that of predicate devices; therefore there is no additional risk of the MFA for patients when compared with the predicates. The MFA device aspirates fluid and tissue samples from the human body in a manner equivalent to that used by the predicate devices. In vitro diagnostic tests are NOT part of this needle/syringe 510(k) application.
Key Metrics
Not Found
Predicate Device(s)
K980580, K002381, K083514, K962077, K970872
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY Dr. Li's MFA Svringe with Needle
APR 2 0 2011
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Rongshan Li, MD, Ph.D. 11 Georgetown Ct. Basking Ridge, NJ 07920
Name of Device and Name/Address of Sponsor
Rongshan Li, MD, Ph.D. 11 Georgetown Ct. Basking Ridge, NJ 07920
Common or Usual Names and Classification Names:
| Common Names: | Piston Syringe | Hypodermic Needle | Biopsy Needle |
|---|---|---|---|
| Classification | Piston Syringe | Hypodermic single | Biopsy Instrument |
| Name: | lumen needle | ||
| Regulation: | 880.5860 | 880.5570 | 21CFR876.1075 |
| Class: | 2 | 2 | 2 |
| Product Codes: | FMF | FMI | KNW |
Predicate Devices
The MFA Syringe with needle has the same intended use as the following predicate devices:
- Syringes and needles: DB Brand (K980580), Pentaferte® (K002381) and Terumo® . (K083514)
- Biopsy needles: Bard Biopty-Cut (K962077) and Pan® (K970872) .
Intended Use: The MFA Syringe with Needle is intended for use in aspirating a specimen of fluid or tissue out of the human body for pathologic examination.
Technological Characteristics and Substantial Equivalence:
The MFA and predicate devices have substantially similar technological characteristics in terms of design and materials. Although there are minor difference in the characteristics of the MFA device and its predicate devices, those differences do not raise new questions of safety or efficacy. MFA differs from some predicates in the range of syringe and needle sizes but is similar to those of other predicates. Compared with the predicates, the MFA Device has a different size and shape of the hub of the needle: the size of the hub is larger and has a larger lumen to allow the collected samples to be picked up and transferred to other containers. In
1
additional, the inner end of the needle that is located in the lumen of the hub has a cover above the opening of the needle to prohibit the collected sample getting up into the lumen of the syringe. In order to test the function of the cover, a non-clinical Device Function Test was performed using different animal organs and tissues to compare MF A device and predicate devices in a manner of mimicking a procedure in human projects. The test demonstrates that the larger capacity of the hub and the cover of the needle in the MFA devices significantly prevented the fluid from spreading into the lumen of the syringe in cases where more than 50 µl of liquid samples were collected when compared with the predicate devices, and the larger capacity of the hub and the cover of the needle in the MFA devices significantly prevented the collected solid tissue samples from spreading into the lumen of the syringe when compared with the predicate devices. The part of the needle that will penetrate the skin into the body is the same as that of predicate devices; therefore there is no additional risk of the MFA for patients when compared with the predicates. The MFA device aspirates fluid and tissue samples from the human body in a manner equivalent to that used by the predicate devices. In vitro diagnostic tests are NOT part of this needle/syringe 510(k) application.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Rongshan Li. MD. Ph.D. 11 Georgetown Court Basking Ridge, New Jersey 07920
APR 2 0 2011
Re: K110112
Trade/Device Name: Multifunction Aspiration (MFA) Syringe with Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW, FMF, FMF, FMI Dated: April 11, 2011 Received: April 11, 2011
Dear Dr. Li:
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)
3
Page 2 - Rongshan Li, MD, Ph.D.
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related 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,
A.S. B. R. tc
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment J
Indications for Use Statement
510(k) Number (if known): Not available
Device Name: MFA Syringe with Needle
Indications for Use:
The MFA Syringe/Needle Device is a syringe with needle intended for use in aspirating a specimen of fluid or tissue out of the human body for pathologic examination.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER LINE IF NECESSARY0
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
| Prescription Use_X_ | or | Over-The-Counter Use_ |
|---|---|---|
| (Optional Format 1-2) | ||
| April 20, 2011 | Page 1 of 1 | |
| Nelke Osden for mxm | ||
| (Division Sign-Off) |
(Division Sign of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110112