(74 days)
No
The device description and performance studies focus on the mechanical design and safety features of a syringe, with no mention of AI or ML technologies.
No.
The device is a syringe for aspirating and injecting insulin, which is primarily a delivery mechanism for a therapeutic substance rather than a therapeutic device itself. Its secondary function is needlestick protection.
No
This device is a syringe for aspirating and injecting insulin, not for diagnosing medical conditions. Its primary function is therapeutic/delivery, not diagnostic.
No
The device description explicitly states it consists of a "syringe assembly and a needle assembly," which are physical hardware components. The summary also details material testing and simulated use studies related to the physical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is for "aspirating and injecting insulin fluid." This is a direct interaction with the patient's body for therapeutic purposes (delivering medication).
- Device Description: The description focuses on the physical components of a syringe and needle, designed for injection.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. This device is used inside the body to administer a substance.
N/A
Intended Use / Indications for Use
The primary intended use for the 1cc Insulin SafePro* Safety Syringe is aspirating and infusing insulin fluid.
The secondary intended use for the 1cc Insulin SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
Product codes (comma separated list FDA assigned to the subject device)
MEG
Device Description
The 1cc Insulin SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries. Other than scale graduation for use with U-100 strength insulin, the 1cc Insulin SafePro* Safety Syringe is essentially identical to the legally marketed 1cc SafePro* Safety Syringe in design and materials of construction.
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)
SUMMARY OF MATERIAL TESTING
The materials of construction of the 1cc Insulin SafePro* Safety Syringe are identical to those for the SafePro* Safety Syringe and 1cc SafePro Safety Syringe. Those materials were already tested for material safety and biocompatibility as indicated in previous 510(K) submissions, K012726 and K022063. Therefore, no new biocompatibility tests are necessary.
SUMMARY OF SIMULATED USE STUDY
The safety feature and other functional and performance characteristics of the Icc Insulin SafePro* Safety Syringe are identical to those for the SafePro* Safety Syringe and 1cc SafePro* Safety Syringe. Those features and characteristics were already verified and validated as shown in the two previous 510(k) notifications K012726 and K022063. Therefore, no new tests are necessary.
CONCLUSION
The results obtained indicate that the 1cc Insulin SafePro* Safety Syringe is safe and effective for its intended use.
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.
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
APR 5 2005
SECTION VIII
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS for 1cc Insulin SafePro* Safety Syringe
REGULATORY AUTHORITY 1.
Safe Medical Device Act of 1990, CFR 807.92.
CONTACT PERSON 2.
C. Y. Lin (Ms) Manager, Quality Assurance & Regulatory Affairs FORMOSA MEDICAL DEVICES, INC.
U.S. Liaison Office 11497 Columbia Park Drive West, Suite #9 Jacksonville, FL 32258
NAME OF MEDICAL DEVICE 3.
Classification Name: Syringe, Antistick Classification Code: MEG Common/Usual Name: Syringe 1cc Insulin SafePro* Safety Syringe Proprietary Name:
DEVICE CLASSIFICATION 4.
The General Hospital Panel has classified Antistick Syringes (21CFR880.5860) into Class II, Special Controls under section 513 of the Act.
STATEMENT OF SUBSTANTIAL EQUIVALENCE 5.
The 1cc Insulin SafePro* Safety Syringe is essentially equivalent to:
- A) B-D Conventional hypodermic and insulin syringe, K980580, and
- B) The 1cc SafePro Safety Syringe, K022063, in design, materials, instructions for use, and product claims.
Page VIII - 1
*Trademark
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INTENDED USE 6.
The primary intended use for the 1cc Insulin SafePro* Safety Syringe is aspirating and infusing insulin fluid.
The secondary intended use for the 1cc Insulin SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
DESCRIPTION OF DEVICE 7.
The 1cc Insulin SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries. Other than scale graduation for use with U-100 strength insulin, the 1cc Insulin SafePro* Safety Syringe is essentially identical to the legally marketed 1cc SafePro* Safety Syringe in design and materials of construction.
SUMMARY OF MATERIAL TESTING 8.
The materials of construction of the 1cc Insulin SafePro* Safety Syringe are identical to those for the SafePro* Safety Syringe and 1cc SafePro Safety Syringe. Those materials were already tested for material safety and biocompatibility as indicated in previous 510(K) submissions, K012726 and K022063. Therefore, no new biocompatibility tests are necessary.
SUMMARY OF SIMULATED USE STUDY 9.
The safety feature and other functional and performance characteristics of the Icc Insulin SafePro* Safety Syringe are identical to those for the SafePro* Safety Syringe and 1cc SafePro* Safety Syringe. Those features and characteristics were already verified and validated as shown in the two previous 510(k) notifications K012726 and K022063. Therefore, no new tests are necessary.
CONCLUSION 10.
The results obtained indicate that the 1cc Insulin SafePro* Safety Syringe is safe and effective for its intended use.
2
COMPARISON MATRIX 1cc Insulin SafePro* Safety Syringe, B-D Conventional Syringe, and 1cc SafePro* Safety Syringe
This matrix was developed in accordance with the ODE Guidance titled "Supplementary Guidance on the Content of Premarket Notification [510(K)] Submissions for Medical Device with Sharp Injury Prevention Features (March, 1995)".
| Factor | 1cc Insulin SafePro*
Safety Syringe | B-D Conventional
Insulin Syringe | 1cc SafePro*
Safety Syringe |
|---------------------------------------------------------------|----------------------------------------|-------------------------------------|-------------------------------------------------------------------------------------|
| 510(K) Number | To Be Assigned | K980580 | K012726 |
| Intended Use and Claims | | | |
| • Same Intended Use | Yes | Yes | Yes |
| • Tissue Puncture Device | Yes | Yes | Yes |
| • Sharps Injury Prevention Feature | Yes | No | Yes |
| • Reduces Risks of Accidental Needlesticks | Yes | No | Yes |
| • Delivers fluid to or draw blood from
patient, short term | Yes | Yes | Yes |
| • Conventional Insertion Technique with
minimal training | Yes | Yes | Yes |
| Technological Features | | | |
| • Same Technology Features | No | No | Yes |
| • Safety Mechanism | | | |
| - Manual Actuation | Yes | Not Applicable | Yes |
| • Safety Mechanism Remains Activated
During Disposal | Yes | Not Applicable | Yes |
| • Safety Mechanism is an Integral Part of
the Device | Yes | Not Applicable | Yes |
| Material of Construction | | | |
| • Needle
• Needle Hub | • Stainless Steel
•PP* | • Stainless Steel
•PP | •Stainless Steel
•PP* with more
needle gauges
(Different hub
colorants) |
| • Barrel, Plunger, Sheath | PP | PP | PP |
| • Gasket | Synthetic Rubber | Synthetic Rubber | Synthetic Rubber |
*PP - Polypropylene resin
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.
APR 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. C.Y. Lin Manager, Quality Assurance & Regulatory Affairs FORMOSA MEDICAL DEVICES, INCORPORATED 16F. No. 182. Section 2 Tunhua South Road Taipei TAIWAN, R.O.C. 106
Re: K050134
Trade/Device Name: 1cc Insulin* SafePro Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: January 21, 2005 Received: January 24, 2005
Dear Ms. Lin:
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.
ff 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.
4
Page 2 - Ms. Lin
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 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 vours.
Chiu Lin, Ph D
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
5
Indications for Use
510(k) Number (if known):
Device Name:
1cc Insulin SafePro* Safety Syringe
Indications For Use:
The primary indicated use for the 1cc Insulin SafePro* Safety Syringe is for aspirating and injecting insulin fluid.
The secondary indicated use for the 1cc Insulin SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
- 6 / h ----------------------------------------------------------------------------------------------------------------------------------------------------------------------
Jaron Gign Cirit ് In schon Control Liental Devices
2/2 Mar 1.0 - 1.0 1.34 5.40134
*Trademark
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