The FORSURE™ Disposable Syringes with Needle are Single Use, Sterile, Non-Pyrogenic devices used to inject fluids into or withdraw fluids from the body.

AI/ML Overview

The provided text describes a 510(k) submission for "FORSURE™ Disposable Syringes with Needle" and "FORSURE™ Disposable Insulin Syringes". This is for a relatively simple medical device (a syringe), and the information typically required for sophisticated AI/ML devices regarding acceptance criteria and studies (like those involving image analysis or diagnostic aid) is not applicable or detailed in this type of submission.

Therefore, many of the requested fields regarding AI/ML performance metrics, ground truth establishment, expert adjudication, and large-scale clinical studies will not be found as they are not relevant to approving a disposable syringe.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of quantitative acceptance criteria for device performance in the way one would see for an AI/ML diagnostic. Instead, the acceptance is based on meeting safety and performance standards equivalent to a predicate device.

Acceptance Criterion	Reported Device Performance	Comments
Mechanical Properties and Functioning	"The FORSURE™ Disposable Syringes with Needle have been subjected to performance and safety testing to verify mechanical properties and functioning, as well as biocompatibility and sterility, using FDA recognized Standards, where applicable"	The specific standards and their compliance levels are not detailed in this summary document, but it states they were met.
Biocompatibility	Tested and verified.	Specific test results are not provided.
Sterility	Tested and verified.	Specific test results are not provided.
Substantial Equivalence	Determined by FDA to be substantially equivalent to the Becton Dickinson® Disposable Syringe (K980580).	This is the overarching acceptance by the FDA for market clearance.

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

Not applicable in the context of this 510(k) summary for a disposable syringe. The "test set" here refers to physical product samples subjected to laboratory testing (e.g., for sterility, structural integrity, fluid delivery accuracy), not a data set for an AI/ML model. The document does not specify the number of syringes tested.

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

Not applicable. Ground truth, in the context of AI/ML, refers to the verified correct answer for a given input. For a syringe, "ground truth" would be inherent in the physical properties and functionality observed through standard engineering and laboratory tests, not subjective expert assessment.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human annotators or experts establishing ground truth for complex AI/ML tasks. For a physical device like a syringe, the "adjudication" would be based on objective measurement against established engineering standards.

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 study design specific to AI/ML devices that assist human interpretation (e.g., radiologists reading images). This device is a disposable syringe, not an AI assistant.

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

Not applicable. This device is a manual medical instrument, not an algorithm.

7. The type of ground truth used

For a disposable syringe, the "ground truth" refers to established engineering standards for mechanical properties, biocompatibility, and sterility. These are typically defined by recognized standards organizations (e.g., ISO, ASTM) and are measured using objective laboratory methods. The summary states that "FDA recognized Standards, where applicable" were used.

8. The sample size for the training set

Not applicable. There is no AI/ML model requiring a "training set" for a disposable syringe.

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

Not applicable. As there is no training set, there is no need to establish ground truth for it.

Summary

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510(k) Number: HO62753

510(k) SUMMARY (As Required by 21 CFR 807. 92)

ﺴﻴ

Submitted by:	Fernando LavoiPresidentSURGIMED, INC1303 NW 78 AvenueMiami, Florida 33126Tel: 305 594-1121Fax: 305 594-4343
Date of Summary:	March 15, 2006
Device Name:	FORSURE™ Disposable Syringes with NeedleFORSURE™ Disposable Syringes for Insulin withNeedle (1ml/U-100 30G x ½")
Common Name:	Hypodermic Syringe with Needle
Classification Name:	Piston Syringe
Class:	2
Product Code:	FMF
Regulation Number:	21 CFR 880. 5860
Predicative Device:	Becton Dickinson® Disposable Syringe(K980580)
Modifications:	There are no modifications to the device design thataffect safety and effectiveness for its intended use.
Device Description	The FORSURE™ Disposable Syringes with Needle areSingle Use, Sterile, Non-Pyrogenic devices used to injectfluids into or withdraw fluids from the body.

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KOLATE

Intended Use: To inject fluids into or withdraw fluids from the body.

Technological The FORSURE™ Disposable Syringes with Needle have the Characteristics same technological characteristics as the legally marketed Becton Dickinson Syringes.

Testing: The FORSURE™ Disposable Syringes with Needle have been subjected to performance and safety testing to verify mechanical properties and functioning, as well as biocompatibility and sterility, using FDA recognized Standards, where applicable

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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 features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Fernando Lavoi President Surgimed, Incorporated 1303 NW 78 Avenue Miami, Florida 33126

$ 2007 FEB

Re: K062753

Trade/Device Name: FORSURE™ Disposable Syringes with Needle; FORSURE™ Disposable Insulin Syringes (1ml/U-100 30G x ½") Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: January 11, 2007 Received: January 12, 2007

Dear Mr. Lavoi:

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. Lavoi

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 (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.

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 Office of Compliance at (240) 276-0115. Also, please note the regulation 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 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/industry/support/index.html.

Sincerely yours,

sids Cunne

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_ 306275 3 (To be assigned by FDA)

Device Name: FORSURE™ Disposable Syringes with Needle

INDICATIONS FOR USE: To inject fluids into or withdraw fluids from the body.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_×

Over- The Counter Use:

Suse Jasa

(Division Sian-Off) Division of Anesthesioiogy, General Hospital, Infection Control, Dental Devices

510(k) Number: K062753

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INDICATIONS FOR USE STATEMENT

510(k) Number 062753 (To be assigned by FDA)

Device Name: FORSURE™ Disposable Insulin Syringes (1ml/U-100 30G x ½")

INDICATIONS FOR USE: For Injection of Insulin U-100 only.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over- The Counter Use:_X

Anten V.m

(Division Sign-Oid) Division of Anesthestology, General Hospital, Infection Control, Dental Devices

S.O.O.K. Number: K 462253

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).