(147 days)
Not Found
No
The device description and performance studies focus on mechanical properties, biocompatibility, and sterility, with no mention of AI or ML.
No
The device is described as a disposable syringe used to inject or withdraw fluids, specifically insulin. While it delivers a therapeutic substance (insulin), the device itself is a delivery mechanism, not a therapeutic device.
No
The device description states its purpose is to "inject fluids into or withdraw fluids from the body," which is a therapeutic or delivery function, not a diagnostic one.
No
The device description clearly states it is a "Disposable Syringes with Needle," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To inject fluids into or withdraw fluids from the body" and "For Injection of Insulin U-100 only." This describes a device used for administering substances directly into the body, which is an in vivo (within the living body) application, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description reinforces this by stating it's used "to inject fluids into or withdraw fluids from the body."
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, etc.) outside the body to diagnose a condition, which is the core function of an IVD.
Therefore, the FORSURE™ Disposable Syringes with Needle are a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To inject fluids into or withdraw fluids from the body.
For Injection of Insulin U-100 only.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMF, FMI
Device Description
The FORSURE™ Disposable Syringes with Needle are Single Use, Sterile, Non-Pyrogenic devices used to inject fluids into or withdraw fluids from the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
1
510(k) Number: HO62753
510(k) SUMMARY (As Required by 21 CFR 807. 92)
ﺴﻴ
| Submitted by: | Fernando Lavoi
President
SURGIMED, INC
1303 NW 78 Avenue
Miami, Florida 33126
Tel: 305 594-1121
Fax: 305 594-4343 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | March 15, 2006 |
| Device Name: | FORSURE™ Disposable Syringes with Needle
FORSURE™ Disposable Syringes for Insulin with
Needle (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 that
affect safety and effectiveness for its intended use. |
| Device Description | The FORSURE™ Disposable Syringes with Needle are
Single Use, Sterile, Non-Pyrogenic devices used to inject
fluids into or withdraw fluids from the body. |
1
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
2
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.
3
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
4
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_×
OR
Over- The Counter Use:
Suse Jasa
(Division Sian-Off) Division of Anesthesioiogy, General Hospital, Infection Control, Dental Devices
510(k) Number: K062753
5
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______________________________________________________________________________________________________________________________________________________________
OR
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