(65 days)
The primary indicated use for the 1cc SafePro* Safety Syringe is for general purpose use in aspirating and injecting fluid. The secondary indicated use for the 1cc SafePro * Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
The 1cc SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature which may aid in the reduction of the risk of accidental needlestick injuries.
Here's an analysis of the provided text regarding the 1cc SafePro Safety Syringe, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria for the simulated use study. Instead, it describes the outcome of the study as supporting the claim.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| No sharps injuries occurred | No sharps injuries occurred |
| No failure of the safety mechanism occurred | No failure of the safety mechanism occurred |
| Meets customer requirements (functional/performance) | Positive responses from Evaluators regarding functional and performance aspects |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Size: 500 1cc SafePro® Safety Syringes were evaluated by 50 participants. This implies a test set of 500 syringes, evaluated by users.
- Data Provenance: The study was a "Simulated Use Study." The document does not specify the country of origin of the data or if it was retrospective or prospective, but "simulated use" generally implies a prospective study conducted in a controlled environment designed to mimic real-world usage.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
No external experts are mentioned as establishing ground truth for the simulated use study results. The study directly assessed the performance of the device (occurrence of sharps injuries, safety mechanism failure, and user feedback). The "evaluators" were the participants, whose direct experience constituted the data for this specific study.
4. Adjudication Method for the Test Set
No adjudication method is mentioned for the simulated use study. The outcomes (sharps injuries, mechanism failure) appear to be direct observations, and customer requirements were assessed through "positive responses from the Evaluators." This suggests direct reporting rather than a consensus or adjudicated process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No MRMC comparative effectiveness study is mentioned. This device is a medical instrument (syringe), not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable here.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is a physical medical instrument, not an algorithm. Its performance is intrinsically linked to human interaction (human-in-the-loop, in this context meaning operation by a user).
7. The Type of Ground Truth Used
For the simulated use study, the "ground truth" was established by direct observation of events (sharps injuries, safety mechanism failure) and user feedback on functional and performance aspects. This can be categorized as observed outcomes and user satisfaction data.
8. The Sample Size for the Training Set
No training set is mentioned. This device is a physical product, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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AUG 2 9 2002
Ko22063
SECTION VIII
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS for 1cc SafePro* Safety Syringe
REGULATORY AUTHORITY 1-
Safe Medical Device Act of 1990, CFR 807.92.
2. CONTACT PERSON
Joseph J. Chang, Ph.D., PE 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: |
|---|
| Classification Code: |
| Common/Usual Name: |
| Proprietary Name: |
Syringe, Antistick MEG Syringe 1cc SafePro* Safety Syringe
4. DEVICE CLASSIFICATION
The General Hospital Panel has classified Antistick Syringes (21CFR880 5860) into Class II, Special Controls under section 513 of the Act.
ર. STATEMENT OF SUBSTANTIAL EQUIVALENCE
The 1cc SafePro* Safety Syringe is substantially equivalent to:
A) B-D Luet Lok syringe in terms of normal syringe function for fluid transport.
and
B) Retractable Technology, Inc. VanishPoint, and SafePro * Safety Syringe for needlestick protection feature. See also the attached table.
*Trademark
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INTENDED USE 6.
The primary intended use for the 1cc SafePro* Safety Syringe is for general purpose use in aspirating and injecting fluid.
The secondary intended use for the lec SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
DESCRIPTION OF DEVICE 7.
The 1cc SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature which may aid in the reduction of the risk of accidental needlestick injuries.
SUMMARY OF MATERIAL TESTING 8.
The entire SafePro* Safety Syringe was already tested for material safety and biocompatibility as indicated in a previous 510(K) submission, K012726. Since the 1cc SafePro* Safety Syringes have different gauge size needles, the colorant used are different. Therefore, the hubs molded with all of the colorants for all gauges were tested for biocompatibility. Test results indicated that the hub and thus the entire 1cc SafePro* Safety Syringe meets ISO 10993-1 and US FDA G-95 requirements.
9. SUMMARY OF SIMULATED USE STUDY
A total of 500 1cc SafePro* Safety Syringes were evaluated by 50 participants. No sharps injuries or failure of the safety mechanism occurred. Successful completion of the study supports the claim that 1cc SafePro* Safety Syringe can reduce the risk of accidental needlestick injuries. The positive responses from the Evaluators regarding functional and performance aspects also indicated that the 1cc SafePro* Safety Syringe meets customer requirements.
10. CONCLUSION
The results obtained from bench testing, material safety, and simulated use tests indicate that the 1cc SafePro* Safety Syringe is safe and effective for it's intended use.
*Trademark
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, arranged in a cascading manner.
AUG 2 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Formosa Medical Devices, Incorporated C/O Mr. Joseph J. Chang SafePro USA. Incorporated 11497 Columbia Park Drive West, Suite #9 Jacksonville, Florida 32258
Re: K022063
Trade/Device Name: 1cc SafePro* Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: June 24, 2002 Received: June 25, 2002
Dear Mr. Chang
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.
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.
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Page 2 -- Mr. Chang
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours.
Timothy A. Ulatowski
Timothy/A. Ulatowski 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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510(K) - Icc SafePro* Safety Syringe
063
INDICATIONS FOR USE
Device Name
1cc SafePro* Safety Syringe
Indication for Use
The primary indicated use for the 1cc SafePro* Safety Syringe is for general purpose use in aspirating and injecting fluid.
The secondary indicated use for the 1cc SafePro * Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
(Please don not write below this line-Continue on another page if needed) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109 (Optional Fornat 1-2-96) OR Over-the-Counter _____________________________________________________________________________________________________________________________________________________________
Patricia Cusente
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K022063
*Trademark
§ 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).