The modification which is the subject of this Special 510(k) is substitution of the current dust cover packaging with Sterile Field packaging. All other aspects of the product design remain unchanged.

AI/ML Overview

The provided text describes a 510(k) submission for Excelsior Sterile Field Saline Flush and Heparin Lock Flush Syringes. However, it does not provide acceptance criteria and detailed study information as requested. The submission is for a modification involving a change in packaging (from dust cover to Sterile Field packaging), with all other aspects of the product design remaining unchanged.

The document highlights that the "technological characteristics... do not differ" from the predicate device and that "The results of testing conducted to verify the design modifications demonstrate acceptable performance of the device." This implies that the acceptance criteria would be based on demonstrating that the new packaging maintains sterility and does not compromise the device's existing performance, but specific quantified criteria and a detailed study report are not present in this document.

Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text.

Here is what I can glean and what is missing:

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

Acceptance Criteria	Reported Device Performance
Maintain sterility of the device (implied by "Sterile Field" packaging)	Demonstrated acceptable performance (general statement)
No compromise to the current device's performance for flushing IV catheters and IV tubing (implied by "All other aspects of the product design remain unchanged" and "do not differ from currently marketed devices")	Demonstrated acceptable performance (general statement)
(Likely other physical/functional tests related to packaging integrity, shelf-life, etc., but not specified)	Not specified

Missing: Specific, quantifiable acceptance criteria (e.g., sterility assurance level, packaging integrity test results, shelf-life data with new packaging).

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified.
Data Provenance: Not specified, but likely from Excelsior Medical Corporation's internal testing. The tests are "Non-Clinical Tests," so they would not involve human participants or specific geographic data provenance in the way clinical studies do.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is a packaging/device modification submission, not a diagnostic or AI-driven device. Therefore, the concept of "experts to establish ground truth" (in the medical diagnostic sense) is not applicable to the non-clinical tests mentioned. The "ground truth" here would be established by validated test methods and passing criteria for physical and performance characteristics.

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

Not applicable as this is not a diagnostic study requiring expert adjudication of cases.

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 not an AI-assisted device or a diagnostic device involving human readers.

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

Not applicable. This is not an algorithmic device.

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

For the non-clinical tests, the "ground truth" would be objective measurements against pre-defined specifications (e.g., sterility test results, material strength tests, leak tests, etc.). The document only states "acceptable performance."

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

In summary: The provided 510(k) summary is for a minor device modification (packaging change) and focuses on demonstrating substantial equivalence. It does not contain the detailed study results, acceptance criteria, or specific methodologies that would be presented for a novel device or a device with clinical efficacy claims, especially those involving AI or human interpretation. The "tests conducted to verify the design modifications" are described as "non-clinical tests," implying laboratory or engineering evaluations.

Summary

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JEL 9 2005

K053/20

510(k) SUMMARY

Submitted by:

Ruben Martinez Director, Regulatory/Quality Excelsior Medical Corporation 1923 Heck Avenue Neptune, NJ 97753

Proposed Device:

Excelsior Sterile Field Saline Flush and Heparin Lock Flush Syringes

Predicate Device:

Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes

Device Description and Statement of Intended Use:

Excelsior Sterile Field Saline Flush and Heparin Lock Flush Svringes are intended for flushing IV catheters and IV tubing. This is the same intended use previously cleared for the currently marketed Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes.

Summary of Technological Characteristics of New Device to Predicate Device

The technological characteristics of Excelsior Sterile Field Saline Flush and Heparin Lock Flush Syringes do not differ from the currently marketed Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes. The devices use the same fundamental scientific technology and have the same intended use.

Discussion of Non-Clinical Tests; Conclusions Drawn from Nonclinical Tests

The results of testing conducted to verify the design modifications demonstrate acceptable performance of the device.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 9 2005

Mr. Ruben Martinez Director Regulatory/Quality Excelsior Medical Corporation 1923 Heck Avenue Neptune, New Jersey 07753

Re: K053120

K005120
Trade/Device Name: Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: November 28, 2005 Received: November 30, 2005

Dear Mr. Martinez:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave roviewed younge 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 Interstate conmisive prior to realism the been reclassified in accordance with the provisions of Amendinents, or to do rouses and metic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin application (the Act. The general controls provisions of the Act include controls provisions or tregistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (FMA), it may of subject to tach ade 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 -Mr. Martinez

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 mean that I DA mas made a deters and regulations administered by other Federal agencies. of the Act of ally I ederal buter and suggest to reguirements, including, but not limited to: registration 1 ou must comply with an the Piece s ong (21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 007), idoeling systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality ajons of (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) I mis letter whi anow you to oegal finding of substantial equivalence of your device to a premarket notification. The PDF 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), IT you desire specific at rioe for Jour at (240) 276-0115. Also, please note the regulation i entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Drisker (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Gretti Y. Michael Omd.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

510(k) Number (if known):

Device Name: Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes

Indications For Use:

Excelsior Sterile Field Saline Flush Syringes and Heparin Lock Flush Excelsfor Stonio Piola Salino in flushing IV catheters and IV tubing.

Shula K. Murthy, M.D. 12/7/15

Anesthesiology General Hospital
on Control, Dental Devices
K 05/3/20

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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).