The Excelsior Medical Saline pre-filled Syringe(s) in Sterile Field Packaging will contain 10ml of 0.9% sodium chloride solution, USP in a 10 ml syringe. This device will be marketed as one or two syringes packaged in a sterile pouch. Each syringe will contain a white tip cap and associated label with a clear backeround. In addition, the syringe label will contain a lot number, expiration date and graduation marking. Each filled and labeled syringe will be packaged in a pouch which is a two part envelope that contains printed information on one side and is clear on the other side.

AI/ML Overview

The provided document describes the predicate device and the new device being submitted for 510(k) clearance, which is the "Excelsior Saline pre-filled Syringe(s) In Sterile Field Packaging."

Here's an analysis of the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred)	Reported Device Performance
Equivalence to Predicate:	The Excelsior Medical Saline pre-filled Syringe(s) in Sterile Field Packaging performed in an equivalent manner to the predicate device.
Safety:	The device is safe when used as intended. (Inferred from the statement "safe and effective when used as intended" and the FDA's substantial equivalence determination which implies safety.)
Effectiveness:	The device is effective when used as intended (flushing IV catheters and IV tubing). (Inferred from the statement "safe and effective when used as intended" and the FDA's substantial equivalence determination which implies effectiveness for its intended use.)
Solution Content:	Each syringe contains 10ml of 0.9% sodium chloride solution, USP. (Explicitly stated in device description)
Sterility:	The device is provided in sterile field packaging. (Explicitly stated in device description and name, and 'sterilization' is listed as a similarity to the predicate.)
Shelf-Life:	Shelf-life is similar to the predicate devices. (Explicitly stated as a similarity to the predicate). Demonstrated by the "Stability Study."
Labeling:	Labeling is similar to the predicate devices. (Explicitly stated as a similarity to the predicate). Syringe label contains lot number, expiration date, and graduation marking.
Packaging:	Packaged in a sterile pouch, a two-part envelope with printed information on one side and clear on the other. (Explicitly stated in device description).
Intended Use:	Intended for use in flushing IV catheters and IV tubing. (Explicitly stated, and confirmed in "Indications for Use Statement").
Substantial Equivalence:	The device is substantially equivalent to the predicate devices (Excelsior Medical Heparin Lock Flush Syringe and Excelsior Sterile Field Saline Flush Syringe K053120) in terms of solution, sterilization, shelf-life, and labeling, and for the stated indications for use. (Overall conclusion of the 510(k) process).

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

The document does not explicitly state a specific test set sample size in terms of the number of devices or units tested for the "Stability Study" mentioned.
The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.

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

This information is not applicable to this type of submission. This device is a medical product (saline syringe), not an AI or diagnostic imaging device that requires interpretation by experts to establish ground truth for a test set. The performance is assessed through laboratory and stability testing, not expert interpretation of data.

4. Adjudication method for the test set:

This information is not applicable for the same reasons as point 3. There is no expert interpretation or consensus required for typical performance testing of a pre-filled saline syringe.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs. without AI assistance:

A MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not the case for a pre-filled saline syringe.

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

A standalone performance study of an "algorithm" was not done as this device is a physical medical product, not a software algorithm.

7. The type of ground truth used:

For this device, the "ground truth" is established through physical and chemical testing against predetermined specifications and industry standards for saline solutions, sterility, and syringe performance. This includes:
- Chemical composition analysis: Verifying the 0.9% sodium chloride concentration (USP).
- Sterility testing: Ensuring the product is sterile.
- Physical performance testing: Checking syringe integrity, dose accuracy, flush mechanics, and packaging efficacy.
- Stability testing: Evaluating the product's integrity and sterility over time.

8. The sample size for the training set:

The concept of a "training set" is not applicable here as this is not an AI or machine learning device. The "training" for such a device would refer to its design and manufacturing process adhering to established specifications and quality control.

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

As "training set" doesn't apply directly, the "ground truth" for the design and manufacturing of such a device is established by adherence to regulations (e.g., 21 CFR 880.5200), international standards (e.g., ISO standards for medical devices and sterility), pharmacopoeial monographs (e.g., USP for sodium chloride injection), and internal company specifications based on scientific principles and predicate device performance. These standards and specifications define what constitutes a safe and effective saline flush syringe.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states that "Design Verification is based on the Stability Study." This study, along with other unspecified tests implied by the claim of substantial equivalence, demonstrated that the Excelsior Medical Saline Syringe(s) in Sterile Field Packaging performed equivalently to the predicate devices. This equivalence was specifically noted in terms of solution (0.9% sodium chloride), sterilization, shelf-life, and labeling. The conclusion drawn is that the device is safe and effective when used as intended, which led to the FDA's determination of substantial equivalence. The FDA letter confirms that the device has met the requirements for clearance to market under the general controls provisions of the Act.

Summary

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DEC 1 8 2008

Manufacturer Name:	Excelsior Medical Corporation
Contact Name:	John Linfante
Title:	VP, Regulatory & Quality Assurance
Postal Address:	1933 Heck AvenueNeptune, NJ 07753
Phone Number:	732-776-7525
Fax:	732-776-7600
Date:	November 19, 2008

510(k) Summary of Safety and Effectiveness

Device Proprietary Name:	Sterile Field Saline Flush Syringe
Device Common or Usual Name:	Saline Flush Syringe
Classification Name:	Catheter, Intravascular, Therapeutic, Short-Term, Less Than 30 Days
Classification Code	NGT
Classification Panel	Infection Control
Regulation Number	880.5200

Predicate Device:

Substantial equivalence is claimed to the following devices:

. Excelsior Medical Heparin Lock Flush Syringe (1 U/mL and 2 U/mL)
. Excelsior Sterile Field Saline Flush Syringe (K053120)

Description of the Device

Each syringe will contain a white tip cap and associated label with a clear backeround. In addition, the syringe label will contain a lot number, expiration date and graduation marking.

Each filled and labeled syringe will be packaged in a pouch which is a two part envelope that contains printed information on one side and is clear on the other side.

Intended Use of the Device

The Saline pre-filled Syringe(s) in Sterile Field Packaging is intended for use in flushing IV catheters and IV tubing

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Performance

Design Verification is based on the Stability Study. The results of these tests demonstrate that the Excelsior Medical Saline Syringe(s) in a Sterile Field Packaging performed in an equivalent manner to the predicate device and is safe and effective when used as intended.

Substantial Equivalence

The Sterile Field Saline Flush Syringes are similar to the predicate devices in terms of solution, sterilization, shelf-life and labeling.

Conclusion

Based on the information provided in this 510(k) premarket notification, the Excelsior Medical Sterile Field Saline pre-filled Flush Syringe is substantially equivalent in terms of safety and effectiveness to the predicate devices identified above.

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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 or bird-like symbol with three distinct, curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

DEC 1 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Linfante Vice President, Regulatory Affairs and Quality Assurance Excelsior Medical Corporation 1933 Heck Avenue Neptune, New Jersey 07753

Re: K082837

Trade/Device Name: Excelsior Saline Pre-Filled Syringe(s) In Sterile Field Packaging Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: November 19, 2008 Received: November 20, 2008

Dear Mr. Linfante:

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.

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Page 2 - Mr. Linfante

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); 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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

Enclosure

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Indications for Use Statement

510(k) Number:

Device Name: Excelsior Saline pre-filled Syringe(s) in Sterile Field Packaging Indication for Use: Excelsior Sterile Field Saline Flush Syringe(s) are intended for use in flushing IV catheters and IV tubing.

The product is provided as:

One 10mL syringe containing 10mL of 0.9% saline solution .
Two 10mL syringes each containing 10mL of 0.9% saline . solution

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shala A. Murphy, R

Division Sign-Off Office of Device Evaluation

510(k)

(Division Sign-Üff) Division of Anesthesioingy General Hospital Infection Control, Dental Devices

510(k) Number: K082837

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).