The Oral/Enteral Syringes are intended for the delivery of liquid medication, formula, and breast milk. The syringes incorporate safety connectors that mate with the Respironics Enteral Only Extension Set, but will not mate with Luer lock or Luer slip fittings. The safety connectors prevent inadvertent connection of the enteral system to an IV system or an IV system to the enteral system. The Oral/Enteral Syringe barrels, plungers and end caps are comprised of Polypropylene, and the pistons are comprised of Silicone.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Oral/Enteral Syringes." However, it is a submission for a medical device (syringes), not an AI/ML powered device. As such, the information you requested regarding acceptance criteria and studies that apply to AI/ML powered devices, such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, and standalone performance, are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through design verification tests related to the physical and functional properties of the syringes.

Here's the information that is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (as much as can be extracted):

Test	Acceptance Criteria	Reported Device Performance
Volume Measurement Accuracy Testing	Not explicitly stated, implied to meet product requirements	Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria.
Enteral Feeding Extension Set Interface Testing	Not explicitly stated, implied to meet product requirements	Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria.
Size and Material Inspection	Not explicitly stated, implied to meet product requirements	Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria.
Biocompatibility Testing	Not explicitly stated, implied to meet product requirements	Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria.
Sterility Testing	Not explicitly stated, implied to meet product requirements	Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria.
Reliability Inspection	Not explicitly stated, implied to meet product requirements	Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria.
Labeling Inspection	Not explicitly stated, implied to meet product requirements	Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria.
Environmental Operating Testing	Not explicitly stated, implied to meet product requirements	Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria.
Storage Testing	Not explicitly stated, implied to meet product requirements	Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria.
ISTA Testing	Not explicitly stated, implied to meet product requirements	Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria.

2. Sample size used for the test set and the data provenance: Not applicable (this is a physical device, not an AI/ML model evaluated on a test set of data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device would be its physical properties and functional performance as described by engineering and regulatory standards, not expert consensus on data interpretation.

8. The sample size for the training set: Not applicable.

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

Summary

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K100099 Page 1 of 2

Oral/Enteral Syringes

Premarket Notification 510(k) Tab 5 – 510(K) Summary

TAB 5

510(K) SUMMARY

JUN 1 4 2010

Date of Submission	11/9/09
Official Contact / Addressof Manufacturing facility	Matthew YoungManager, Quality Assurance and Regulatory AffairsChildren's Medical Ventures191 Wyngate DriveMonroeville, PA 15146Phone: 724-387-4012Fax: 412-380-8850Email: matthew.young@philips.com
Proprietary Name	Oral/Enteral Syringes
Common/Usual Name	Gastrointestinal tubes and accessories
Classification Reference	21 CFR 876.5980
Classification	Class II
Appropriate Classification Panel	Gastroenterology / Urology
Product Code	FPD
Predicate Devices	Vygon Corp. Nutrisafe 2 System Transparent Syringes(K060944)Respironics, Inc. Enteral Only Extension Set (K082654)

Intended Use/Indications for Use

The Oral/Enteral Syringes is intended for the delivery of liquid medication, formula, and breast milk.

Patient Population/Environment of Use

The patient population is neonates and infants. The environments for use are hospital and home environments by trained caregivers only. The Oral/Enteral Only Syringes is disposable and for single patient use only.

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K1000 Y9 Page 2 of 2

Premarket Notification 510(k) Tab 5 – 510(K) Summary

I/Enteral Syringes

Substantial Equivalence

This traditional 510(k) submittal demonstrates that the Oral/Enteral Syringes are substantially equivalent to the Respironics, Inc. Enteral Only Extension Set (K082654) and the Vygon Corp. Nutrisafe 2 System Transparent Syringes (K060944).

Design verification tests were performed on the Oral/Enteral Syringes as a result of the risk analysis and product requirements. The following tests were conducted:

. Volume Measurement Accuracy Testing
. Enteral Feeding Extension Set Interface Testing
. Size and Material Inspection
. Biocompatibility Testing
. Sterility Testing
Reliability Inspection .
. Labeling Inspection
Environmental Operating Testing .
. Storage Testing
. ISTA Testing

Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria. Children's Medical Ventures has determined that the Oral/Enteral Syringes are substantially equivalent to the predicate devices.

Device Description

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem that features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus has a staff with two snakes winding around it, and a pair of wings at the top.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002

Philips Children's Medical Ventures c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

JUN 1 4 2010

Re: K100099

Trade/Device Name: Oral/Enteral Syringes Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FPD Dated: June 3, 2010 Received: June 4, 2010

Dear Mr. Job:

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

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Page 2 -

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.html 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

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Indications for Use

510(k) Number (if known):

K100077

Device Name:

Oral/Enteral Syringes

Intended Use/Indications for Use:

Oral/Enteral Syringes are intended for the delivery of liguid medication, formula, and breast milk.

Patient Population/Environment of Use:

The patient population is neonates and infants. The environments for use are hospital and home environments by trained caregivers only. The Oral/Enteral Syringes are disposable and for single patient use only.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.