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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for Dr. Li's MFA Syringe with Needle, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Claim	MFA Syringe with Needle Performance
Prevention of fluid spreading into syringe lumen (for liquid samples > 50 µl)	Significantly prevented fluid spreading compared to predicate devices.
Prevention of solid tissue samples spreading into syringe lumen	Significantly prevented solid tissue spreading compared to predicate devices.
Part of the needle penetrating skin is the same as 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.
Aspirates fluid and tissue samples in a manner equivalent to predicate devices	The MFA device aspirates fluid and tissue samples from the human body in a manner equivalent to that used by the predicate devices.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a numerical sample size of individual tests. The study was described as "using different animal organs and tissues." This implies a qualitative comparison rather than a statistically powered clinical trial.
Data Provenance: The study was a "non-clinical Device Function Test." It involved "different animal organs and tissues." Therefore, the data provenance is from animal models, not human subjects, and it was a prospective test designed to compare function.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not mentioned. Given it was a non-clinical device function test on animal organs/tissues, a formal adjudication process between experts is unlikely to have been part of this specific test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done? No. This was a non-clinical device function test, not a comparative effectiveness study involving human readers or cases.
Effect Size of Human Readers Improvement with/without AI: Not applicable, as no human-in-the-loop study was performed, and the device is a medical instrument, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Done

Standalone Study Done? Yes, in a sense. The described "non-clinical Device Function Test" that compared the MFA device's performance against predicate devices using animal organs/tissues can be considered a standalone performance evaluation of the device itself. It did not involve human users in a clinical context; it focused solely on the device's functional characteristics (fluid and tissue retention).

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth was based on direct observation and measurement of the device's functional performance in retaining liquid and solid tissue samples within the hub and preventing them from spreading into the syringe lumen, in experiments miming human procedures on animal organs/tissues. This is best described as experimental observation/measurement of device function.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a physical medical instrument, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Summary

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K110112

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:

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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.

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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)

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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

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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

Regulation Number and Section

§ 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).