(76 days)
The AMSURE® Disposable Syringe with/without Needle is intended for the injection of fluids into, or the withdrawal of fluids from parts of the body below the skin. Needles are intended to mote with mace nozzles of piston syringes or administration sets.
The AMSure® Disposable Syringe is a sterile, single-use hypodermic syringe with or without an attachable hypodermic needle. It consists of a syringe barrel, a plunger rod, a piston, a nozzle cap and/or a single lumen hypodermic needle. The AMSure® Needle is comprised of a metal tube sharpened at one end and joined to a female connector (hub) at the other end.
The provided document is a 510(k) summary for the AMSure® Disposable Syringe with/without Needle. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. While it states that "Performance and biocompatibility testing has demonstrated that the AMSure® Disposable Syringe with/without Needle is safe and effective for its intended use," it does not provide specific details about the acceptance criteria or the study results that prove the device meets those criteria in the format requested.
Therefore, many of the requested details cannot be extracted from this document alone.
Here's an attempt to answer based on the available information, with clear indications where information is not provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "Performance and biocompatibility testing has demonstrated that the AMSure® Disposable Syringe with/without Needle is safe and effective for its intended use." (Specific quantitative performance data is not provided.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified in the document.
- Data provenance: Not specified in the document. This would typically be from the manufacturer's testing, but details like country of origin or whether it was retrospective/prospective are not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not specified. This type of information is usually relevant for studies involving human interpretation (e.g., medical imaging AI). For a device like a syringe, the "ground truth" would be established by predefined engineering and performance standards, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified. Adjudication methods are typically used in clinical or imaging studies where there's a need to resolve discrepancies in human readings. For a mechanical device, performance is typically assessed against objective thresholds, not through adjudication of expert opinions.
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
- No. An MRMC study is not mentioned, nor would it be relevant for a disposable syringe. This type of study focuses on the impact of AI systems on human performance in diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm or AI system. Its performance is inherent to its physical properties and function, not an algorithm running independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for a disposable syringe would be based on established engineering standards and design requirements (e.g., ISO standards for syringes, biocompatibility standards). The document states "Performance and biocompatibility testing," implying adherence to such standards, but specific "ground truth" types like pathology or outcomes data are not relevant or mentioned.
8. The sample size for the training set
- Not applicable / Not specified. This device is not an AI/ML model that requires a "training set." Performance is evaluated through physical and material testing.
9. How the ground truth for the training set was established
- Not applicable. As the device is not an AI/ML model, there is no "training set" or ground truth for it in that context.
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KC6'039
AMSINO
Disposable syringe w/wo Needle 510(k) Submission
20 112
510(K) Summary of Safety and Effectiveness
AMSure® Disposable Syringe with/without Needle
JUN 2 9 2006
| Company: | Amsino International, Inc.855 Towne Center DrivePomona, CA 91767(909) 626-5888 |
|---|---|
| Contact: | Ching Ching Seah, Ph.D.Director of Regulatory Affairs |
| Date Prepared: | January 20, 2006 |
| Classification Name: | Syringe, Piston (880.5860)Hypodermic Single Lumen Needle (880.5570) |
| Common/Usual Name:Proprietary Name:Product Code:Medical Specialty:Device Class: | Disposable hypodermic syringeAMSure® Disposable Syringe with/without NeedleFMF and FMIGeneral HospitalClass II |
| Predicate Devices: | Monoject® Piston Syringes (K945715)Nipro® Disposable Hypodermic Syringes with or without Needle (K051574) |
| Device Description: | The AMSure® Disposable Syringe is a sterile, single-use hypodermic syringewith or without an attachable hypodermic needle. It consists of a syringebarrel, a plunger rod, a piston, a nozzle cap and/or a single lumen hypodermicneedle. The AMSure® Needle is comprised of a metal tube sharpened at oneend and joined to a female connector (hub) at the other end. |
| Intended Use: | The AMSure® Disposable Syringe with/without Needle is intended for theinjection of fluids into, or the withdrawal of fluids from parts of the bodybelow the skin. AMSure® Needles are intended to mate with male nozzles ofpiston syringes or administration sets. |
| Comparison to Predicate: | The AMSure® Disposable Syringe with/without Needle is similar to thepredicate devices in operational principle, materials, design, technicalcharacteristics and intended use. Any existing differences do notaffect safety and effectiveness of the device. |
| Non-Clinical Testing: | Performance and biocompatibility testing has demonstrated that theAMSure® Disposable Syringe with/without Needle is safe and effectivefor its intended use. |
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Image /page/1/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a bold, sans-serif font. The text is black and the background is white.
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol. The seal is black and white.
JUN 2 9 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Ching Ching Seah Director of Research & Development and Regulatory Affairs Amsino International, Incorporated 855 Towne Center Drive Pomona, California 91767
Re: K061039
Trade/Device Name: AMSURE® Disposable Syringe with/without Needle Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: April 14. 2006 Received: April 14, 2006
Dear Dr. Seah:
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 H (PMA), it may be subject to such additional controls. Existing major regulations affècting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 tinfo98. In addition. FDA may publish further announcements concerning your device in the Federal Register.
.. ...
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Page 2 -Dr. Seah
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 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.
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
510(k) Number (if known): K061039
Device Name: AMSURE® Disposable Syringe with/without Needle
Indications For Use:
The AMSURE® Disposable Syringe with/without Needle is intended for the injection of fluids into, or the withdrawal of fluids from parts of the body below the skin. Needles are intended to mote with mace nozzles of piston syringes or administration sets.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chinta (S)
"estology, General Hospital. Mul Dental Devices
Page 1 of
§ 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).