The Heparin Flush Syringe (the DEVICE) is a single dose, disposable, sterile, plastic pre-filled syringe. The DEVICE consists of a hypodermic syringe with a hypodermic barrel, stopper plunger, plunger rod, tip cap and Heparin Lock Flush Solution USP. Heparin I. V. Flush Syringe is manufactured in three different concentrations - 1 Unit/mL; 10 Units/mL and 100 Units/mL. Two different sizes (6 mL, 12 mL) of hypodermic syringes will be utilized in manufacturing. The DEVICE will be marketed in the following dosage forms:

1 mL fill in 6 mL Syringe LL
2 mL fill in 6 mL Syringe LL
2.5 mL fill in 6 mL Syringe LL
3 mL fill in 6 mL Syringe LL
3 mL fill in 12 mL Syringe LL
5 mL fill in 6 mL Syringe LL
5 mL fill in 12 mL Syringe LL
10 mL fill in 12 mL Syringe LL

The barrel of the syringe is the reservoir for the product. It shall be overfilled during repackaging as per Pharmacopoeial Forum, Volume 26, Number 2: page 471. Plunger and plunger rod are the two moving parts of the DEVICE. The solution is delivered by pressing down on the plunger rod, resulting in the expulsion of the fluid from the luer tip.

The DEVICE will be filled using aseptic technique utilizing pre-sterilized components in a Class 100 environment. The sterile components of the DEVICE (hypodermic syringe, tip cap, Heparin Sodium Injection and 0.9% Sodium Chloride Injection, USP) will be purchased from qualified vendors.

The DEVICE is used to maintain patency of in-dwelling intravenous access devices (IVAD). The solution is delivered by pressing down on the plunger rod. resulting in the expulsion of the fluid from the luer tip.

AI/ML Overview

This document is a 510(k) summary for Medefil's Heparin Flush Syringe, submitted to the FDA in 2002. It outlines the device's description, intended use, and claims of substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device conformance:

The provided document is not about an AI/ML-driven medical device or a diagnostic system that would typically have the kind of "acceptance criteria" and "study" you're asking for (e.g., sensitivity, specificity, clinical outcome studies).

This document describes a physical medical device (a pre-filled syringe with Heparin flush solution) and a 510(k) submission, which is a premarket submission made to the FDA to demonstrate that the new device is as safe and effective, or "substantially equivalent," to a legally marketed predicate device.

Therefore, many of your requested points regarding acceptance criteria, study design for AI, expert numbers, ground truth, etc., do not apply to this type of device and submission.

However, I can extract information relevant to "acceptance criteria" in the context of a physical medical device and how its performance is "proven" for a 510(k) submission:

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

In the context of this physical device and a 510(k) substantial equivalence submission, "acceptance criteria" are not reported as specific clinical performance metrics (like sensitivity/specificity for a diagnostic). Instead, the acceptance criteria are implicitly that the modified device is substantially equivalent to the predicate device in terms of safety and effectiveness, and that its changes do not raise new questions of safety or effectiveness.

The document demonstrates this by comparing various attributes of the new device to the predicate device.

Acceptance Criterion (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance (Comparison to Predicate)
Intended Use Equivalence	The DEVICE has the same intended use: to maintain patency of in-dwelling intravenous access devices (IVAD).
Solution Equivalence	Both have the same pre-filled solution: Heparin Lock Flush Solution, USP.
Principle of Operation Equivalence	Both function under the same principle of operation including independent moving parts like stopper and plunger rods.
Nozzle Compatibility	Both nozzle tips are compatible with female luer fitting.
Biocompatibility & Chemical Compatibility of Materials	Both fluid container materials are biocompatible and chemically compatible with heparin lock flush solution. The fluid container material is same for both devices: polypropylene.
Sterility & Pyrogen-Free Status	Both have a sterile, pyrogen free heparin lock flush solution and fluid path. The DEVICE shall be pyrogen free per the LAL test method for bacterial endotoxin.
Lubricant Material	Both devices use silicone as a lubricant.
Fluid Expulsion Mechanism	The fluid is expelled out of the syringe barrel of both devices by pressing on the plunger for a hypodermic syringe.
Filling Technique	Both devices are filled using aseptic technique. The DEVICE will be filled using aseptic technique utilizing pre-sterilized components in a Class 100 environment.
Safety/Effectiveness of Differences	Dead space: DEVICE has more dead space than the predicate, but this is implicitly deemed not to adversely affect safety/efficacy for this 510(k). Concentrations: DEVICE offered in 1, 10, 100 U/mL vs. predicate in 10, 100 U/mL. Barrel Size: DEVICE 6mL, 12mL vs. predicate 3mL. Barrel Diameter: DEVICE has a larger diameter (advantageous for pediatrics due to lower infusion pressure). Manufacturing: DEVICE uses fully automated vs. semi-automated (decreases contamination opportunity). All presented as not adversely affecting safety/efficacy.

Regarding the other points, as they are largely inapplicable to this type of device and submission, here's why, or how they might be interpreted in a non-AI context:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for an AI device. For a physical device like this, "data" often refers to engineering tests (e.g., LAL test for pyrogenicity mentioned), material compatibility studies, or sterility validations. The document provides no details on sample sizes for such tests, nor their provenance, which are usually part of the underlying design and manufacturing validation, not typically summarized in this specific 510(k) document unless specifically requested or if it's the core focus of the submission.

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. There is no "ground truth" in the diagnostic sense here. The "truth" is established by adherence to USP standards for the Heparin solution, validated manufacturing processes, and accepted engineering principles for medical devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication process is detailed or expected for this type of device.

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. This is a physical medical device, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the diagnostic sense. The "ground truth" for this device's safety and efficacy relies on adherence to pharmaceutical standards (USP for Heparin solution, pyrogenicity testing), material science (biocompatibility, chemical compatibility), mechanical engineering (plunger function, luer compatibility), and manufacturing quality control (aseptic technique, Class 100 environment).

8. The sample size for the training set

Not applicable. There is no AI model or algorithm being "trained" for this device.

9. How the ground truth for the training set was established

Not applicable. There is no AI model or algorithm being "trained" for this device.

In summary: The provided document is a 510(k) submission for a modified pre-filled Heparin flush syringe. The "acceptance criteria" and "proof" of meeting them are primarily demonstrated through a detailed comparison to a legally marketed predicate device, asserting "substantial equivalence" based on similar intended use, solution, principle of operation, materials, and manufacturing practices, with differences explicitly addressed as not adversely affecting safety or effectiveness. The detailed requirements for AI/ML performance studies you listed are not relevant here.

Summary

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Medefil's Response to FD

Image /page/0/Picture/1 description: The image shows the logo for MEDEFIL, INC. The text "MEDEFIL, INC." is in a bold, sans-serif font. Below the text is a circular logo with a stylized lowercase "m" inside. The "m" is white against a black background, and there is a small white circle above the "m", possibly representing an eye.

510(k) Summary

Medefil's Heparin Flush Syringe

May 9, 2002

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

1. Reason for Special 510(k):
  Introduction of a modified product
1. Name of Device:
  Classification Name

Common Name Proprietary Name

1. Classification:
  Name/Class Panel Product Code Catheter Intravascular, Small Volume Heparin Lock Flush Solution, USP. Medefil's Heparin I. V. Flush Syringe 1 Unit/mL or 10 Units/mL or 100 Units/mL

21 CFR 880.5200 Class II General Hospital NGT

1. Establishment Registration Number: 1423982
રું. Submitter's Name and Address:

Medefil, Inc. 492 Lunt Avenue Schaumburg, Illinois 60193

1. Repackaging and sterilization facilities: Medefil, Inc. 250 Windy Point Drive Glendale Heights, Illinois 60139
1. Performance Standards:

No performance standard(s) applicable to this device has been promulgated under Section 514 of the Food, Drug and Cosmetic Act.

492 LUNT AVENUE, SCHAUMBURG, ILLINOIS 60193 • TEL: (847) 895-3000 • FAX: (847) 352-3100

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Image /page/1/Picture/0 description: The image shows the text "Medefil's Response to FDA comments on 510 (k) # K020996" on the left side of the image. On the right side of the image, the text "MEDEFIL, INC." is shown above a logo. The logo is a stylized letter "m" inside of a circle. The text and logo are likely the letterhead for a document.

Device Description and Indicated Use: 8.
The Heparin Flush Syringe (the DEVICE) is a single dose, disposable, sterile, plastic pre-filled syringe. The DEVICE consists of a hypodermic syringe with a hypodermic barrel, stopper plunger, plunger rod, tip cap and Heparin Lock Flush Solution USP. Heparin I. V. Flush Syringe is manufactured in three different concentrations - 1 Unit/mL; 10 Units/mL and 100 Units/mL. Two different sizes (6 mL, 12 mL) of hypodermic syringes will be utilized in manufacturing. The DEVICE will be marketed in the following dosage forms:

1 mL fill in 6 mL Syringe LL 2 mL fill in 6 mL Syringe LL 2.5 mL fill in 6 mL Syringe LL 3 mL fill in 6 mL Syringe LL 3 mL fill in 12 mL Syringe LL 5 mL fill in 6 mL Syringe LL 5 mL fill in 12 mL Syringe LL 10 mL fill in 12 mL Syringe LL

1. Packaging:
  The DEVICE provided is individually packaged in a plastic pouch (dust cover). There are six individually packaged DEVICES in a "strip". Twenty such strips (120 individually packed syringes) or 30 individually packed devices will be packed in a card board box.

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Medefil's Response to FDA comments on 510 (k) # K020996

Image /page/2/Picture/1 description: The image shows the logo for MEDEFIL, INC. The text is in a bold, sans-serif font. Below the text is a circular logo with a stylized lowercase "m" inside. There is some noise at the top of the image.

The DEVICE shall be pyrogen free per the LAL test method for bacterial endotoxin.

Substantial Equivalence: 10.

The Heparin Flush Syringe DEVICE is substantially equivalent to the legally marketed predicate device listed below:

Medefil, Inc. Heparin I. V. Flush Syringe (K993518)

The Medefil's Heparin Flush Syringe Device is similar to the legally marketed predicate device in that:

a) both have the same intended use: to maintain patency of indwelling IVAD
b) both have the same pre filled solution Heparin Lock Flush Solution, USP.
both function under the same principle of operation including independent moving c) parts like stopper and plunger rods.
d) both nozzle tips are compatible with female luer fitting.
both fluid container materials are biocompatible and chemically compatible with e) heparin lock flush solution.
both have a sterile, pyrogen free heparin lock flush solution and fluid path. f)
the fluid container material is same for both devices polypropylene g)
h) both devices use silicone as a lubricant
the fluid is expelled out of the syringe barrel of both the devices by pressing on the i) plunger for hypodermic syringe
both the devices are filled using aseptic technique. i)

The DEVICE is different from the predicate device, without adverse affect to safety or efficacy, in that:

a) the dead space (distance between plunger tip and end of the luer lock nozzle tip, when the plunger is fully depressed) of the DEVICE is more than that of Medefil's I. V. Flush Syringe.

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Medefil's Response to FDA comments on 510 (k) # K020996

Image /page/3/Picture/1 description: The image shows the logo for MEDEFIL, INC. The text "MEDEFIL, INC." is in a bold, sans-serif font. Below the text is a circular logo with a stylized lowercase "m" inside. There is a small circle above and to the right of the "m", within the larger circle.

b) the DEVICE is available in three different concentrations 1 units/mL; 10 units/mL or 100 units/mL where as the predicate device is only available in 10 units/mL or 100 units/mL concentration.
c) the DEVICE is available in two different syringe barrel size -- 6 mL and 12 mL where as predicate device is also available in 3 mL size.
d) the diameter of the DEVICE syringe barrel is more than that of the predicate device. This is due to the fact that diameter of the barrel is inversely proportional to the amount of "infusion pressure" generated when the plunger is pushed for expulsion of fluid. The larger diameter of the barrel is advantageous so that damage is not done to the patient veins especially pediatric patients.
e) the DEVICE will be manufactured using fully automated syringe filling machine whereas the predicate device is manufactured using semi - automated syringe filling machine. But both the machines work on the same mechanism. Semi - automated syringe filling process is very labor intensive during the filling and sealing process but a fully automated process decreases operator contact and opportunity for product contamination.

END OF SUMMARY

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2002

Mr. Pradeep Aggarwal Medefil, Incorporated 492 Lunt Avenue Schaumburg, Illinois 60193

Re: K020996

Trade/Device Name: Heparin I.V. Flush Syringe Regulation Number: 880.5200 Regulation Name: Device, Flush, Vascular Access Regulatory Class: II Product Code: NGT Dated: May 28, 2002 Received: May 31, 2002

Dear Mr. Aggarwal:

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 such 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.

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Page 2 - Mr. Aggarwal

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 (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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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). 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,

Timothy A. Ulatowski Director Division of Dental. Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Medefil, Inc. March, 2002

Sterile Heparin I. V. Flush Syringe Indications For Use

Page 1

K020996 510(k) Number (if known):

Heparin I. V. Flush Syringe Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) (Division Sign-of Sign-of Control, Division of Dospital Devices 510(k) Number -

(Optional Format 3-10-98)

000016

Regulation Number and Section

§ 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).