The device is indicated for use as a dispenser, a measuring device and an oral fluid transfer device. It is used to inject fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.

Device Description

The NeoMed Sterile Syringe is specifically designed for administration of enteral liquids to neonatal patients. The NeoMed Sterile Syringe is a standard piston syringe which is incompatible with luer-lock and intravenous devices. The NeoMed Sterile Syringes are compatible with NeoMed enteral-only connectors, the NeoMed orange extension sets and feeding tubes to form a dedicated system that prevents wrong-route administration of non-IV fluids and other competitive enteralfeeding tube, extension set type products that do not utilize a luer-lock system. They possess translucent barrels to provide visualization of fluid contents and volume, and patented orange lettering/gradient markings which coordinate with NeoMed orange extension sets and feeding tubes. NeoMed Sterile Syringes are manufactured as a single piece molded barrel that does not rely on adapters to create an oral tip. The NeoMed Sterile Syringes possess design features that prevent connectivity to luer type devices, and hence prevents the chance that a feeding tube could be infused into the IV line. The NeoMed Sterile Syringes will be available in 1ml, 3ml, 6ml, 35ml, and 60ml individual packs.

The NeoMed Sterile Syringe device consists of the following components:

Syringe Barrel
Syringe Plunger
Svringe Gasket
Syringe Tip
Syringe Cap

AI/ML Overview

This document describes the NeoMed Sterile Syringe and its substantial equivalence to a predicate device. However, it does not contain the specific detailed information typically found in an acceptance criteria study report for an AI/ML medical device.

Therefore, I cannot populate the table and answer all the questions as requested based on the provided text. The document focuses on performance testing to demonstrate functional equivalence to a predicate device rather than on specific clinical study results with acceptance criteria in the context of an AI/ML algorithm.

Here's what can be extracted and what cannot:

Information that CANNOT be extracted from the provided text:

A table of acceptance criteria and the reported device performance: No specific acceptance criteria are defined in terms of metrics (e.g., sensitivity, specificity, accuracy) for a study. The performance is described as "functionally equivalent" and performing its "intended use."
Sample sized used for the test set and the data provenance: No information on specific test sets, sample sizes, or data provenance (country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a clinical study using expert ground truth.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no external ground truth beyond standard device testing is mentioned.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Information that CAN be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance
Functional equivalence to predicate device (Baxa Syringe K951871)	"Bench testing has demonstrated that the NeoMed Sterile Syringe is functionally equivalent to predicate Baxa Syringe and that any minor differences do not affect safety or effectiveness.""Design verification performance test results demonstrate that the NeoMed Sterile Syringe performs its intended use and that any minor differences from the predicate do not affect safety or effectiveness."
Biocompatibility	"The NeoMed Sterile Syringe materials that come in direct contact with the patient have a long history of use in syringe manufacturing and are biocompatible according to ISO 10993 test results."
Safe and effective performance for intended use	"Bench testing... demonstrated that... any minor differences do not affect safety or effectiveness.""Design verification performance test results demonstrate that the NeoMed Sterile Syringe performs its intended use and that any minor differences from the predicate do not affect safety or effectiveness."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "Bench testing" and "Design verification performance test results." However, it does not specify sample sizes for these tests, data provenance, or whether the study was retrospective or prospective. It refers to standard laboratory testing rather than real-world patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is a medical device, not an AI/ML algorithm that relies on expert ground truth for performance evaluation in a clinical setting. The "ground truth" for this device would be defined by engineering specifications and objective performance measurements for fluid delivery, measurement accuracy, and material properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is not a study involving human interpretation or subjective assessments requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This is a physical medical device (syringe), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or reported here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this device, the "ground truth" for performance would be based on engineering specifications, established standards, and objective physical measurements during bench testing. For example, volume accuracy, force required for operation, material integrity, and secure connection with intended enteral devices.

8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:
Not applicable.

In summary, the provided text describes a 510(k) submission for a traditional medical device (syringe) that relies on bench testing and material biocompatibility to demonstrate substantial equivalence, not an AI/ML device that would require the specified types of studies and acceptance criteria.

Summary

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. .

SUMMARY OF SAFETY & EFFECTIVENESS

Image /page/0/Picture/2 description: The image shows the logo for NeoMed Incorporated. The logo is in black and white and features the company name in a stylized font. The "O" in NeoMed is replaced with a circle containing a small, abstract image. Below the company name, the word "incorporated" is written in a smaller, simpler font.

MAR 1 0 2010

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT	NeoMed, Inc.FDA Owner/Operator #10022926Establishment Registration#3006520777100 Londonderry CourtSuite 112Woodstock, GA 30188Tony Lair, PresidentTel: 770-516-2225Fax: 770-516-2448Email: lair1@concentric.net
OFFICIALCORRESPONDENT	Penny Northcutt, RAC, CQARegulatory Consultant for NeoMed, Inc.REGSolutions, LLCTel: 678-428-6978Fax: 678-513-0937Email: pennynorthcutt@theregsolutions.com
TRADE NAME:	NeoMed Sterile Syringe
CLASSIFICATIONNAME:	Piston Syringe
DEVICECLASSIFICATIONAND PRODUCTCODE	Class II per 21 CFR §880.5560Product Code: FMF
PREDICATEDEVICE NAME	Baxa Syringe (K951871)

SUBSTANTIAL EQUIVALENCE:

The NeoMed Sterile Syringe is substantially equivalent to the Baxa Syringe cleared under K951871.

... .. ..

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Both devices have the same method of operation to dispense, measure and transfer fluids through the use of a plunger type syringe. The materials used in both devices are similar as well the indications for use.

Bench testing has demonstrated that the NeoMed Sterile Syringe is functionally equivalent to predicate Baxa Syringe and that any minor differences do not affect safety or effectiveness.

DESCRIPTION OF THE DEVICE:

ジュ・・

The NeoMed Sterile Syringe device consists of the following components:

Syringe Barrel A
Syringe Plunger
Svringe Gasket
Syringe Tip
Syringe Cap

INDICATIONS FOR USE:

The device is indicated for use as a dispenser, a measuring device and an oral fluid transfer device. It is used to iniect fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.

PERFORMANCE DATA:

The NeoMed Sterile Syringe materials that come in direct contact with the patient have a long history of use in syringe manufacturing and are biocompatible according to ISO 10993 test results. Design verification performance test results demonstrate that the NeoMed Sterile Syringe performs its intended use and that any minor differences from the predicate do not affect safety or effectiveness.

CONCLUSION: ·

Based on the method of operation, indications for use, materials of construction and performance testing, it can be concluded that the NeoMed Sterile Syringe is equivalent to the predicate Baxa Syringe with respect to intended use and technological characteristics.

Traditional 510(k) NeoMed, Inc.

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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 is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

AUG 1 0 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NeoMed, Incorporated C/O Ms. Penny Northcutt Regulatory Consultant REGSolutions, LLC 717 Lakeglen Drive Suwanee, Georgia 30024

Re: K092908

Trade/Device Name: NeoMed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S6EO, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: February 5, 2010 Received: February 16, 2010

Dear Ms. Northcutt:

This letter corrects our substantially equivalent letter of March 10, 2010.

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.

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Page 2 - Ms. Northcutt

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 (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" (21 CFR 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 as 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,

Susan Runos

Anthony D. Watson, B.S., M.S., M.B.A Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: NeoMed Sterile Syringe

Indications For Use:

× Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

hn Stow. for CLZ

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K092908

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).