(64 days)
No
The description focuses on a mechanical needle safety mechanism and does not mention any AI or ML components.
No.
The document describes a safety device designed to prevent accidental needle sticks, not to treat or diagnose any medical condition.
No
The device is described as a safety mechanism to prevent accidental needle sticks, not to diagnose a condition. Its function is to cover the needle after use.
No
The device description clearly indicates a physical mechanism ("mechanism that is used to cover the needle point") and refers to "products" which are physical devices. There is no mention of software as the primary or sole component.
Based on the provided information, the Needle-Trap™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to cover a needle point after the syringe and needle have been used for their intended functions. This function is related to safety and preventing accidental needle sticks, not to performing a diagnostic test on a sample taken from the body.
- Device Description: The description focuses on the mechanism for covering the needle and its equivalence to other marketed safety devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment.
The Needle-Trap™ is a safety device designed to prevent injuries related to the handling of used needles.
N/A
Intended Use / Indications for Use
The Needle-Trap™ contains a mechanism that is used to cover the needle point after use of the syringe and needle for their intended functions. In the activated position the Needle-Trap™ guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
Product codes
80MEG
Device Description
The Needle Trap™ Needle Safety devices are substantially equivalent to the current marketed products. The Needle-Trap™ contains a mechanism that is used to cover the needle point after use of the syringe and needle for their intended functions.
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)
Verification and Validation testing confirmed the products meet their specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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- 510(K) SUMMARY
Submitted By:
- 510(K) SUMMARY
JAN 16 2008 Date Prepared: November 05, 2007
SUMMARY OF SAFETY AND EFFECTIVENESS
Robert Licha Director Product and Process Management Schreiner MediPharm
- Needle Trap™ / Needle Safety Label 9.1 Trade/Proprietary Name:
- 9.2 Common/Usual Name Syringe Anti-Needle Stick Accessory
- 9.3 Classification Name Antistick Syringe
- 9.4 Substantial Equivalence The Needle Trap™ Needle Safety devices are substantially equivalent to the BD SafetyGlide™ Needle (K951254), Portex® Needle-Pro® EDGE™ Safety Device with Syringe (K061194) and/or the BD Eclipse™ Hypodermic Needle (K010188)
- 0.5 Classification: Class II Panel: 80 Product Code: 80MEG Cite: 21CFR 880.5860 Piston syringe FMF - Piston Syringe MEG - Antistick Syringe FMI - Hypodermic Single Lumen Needle
- 9.6 Technological Characteristics The technological characteristics of the Needle Safety devices are similar to the current marketed products
- 9.7 Performance Data Verification and Validation testing confirmed the products meet their specifications.
- ರಿ.8 Conclusion Schreiner MediPharm concludes based on the information presented that the new products lines are substantially equivalent to products currently legally marketed in the USA
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2008
Schreiner MediPharm C/O Mr. Lee Leichter President P/L Biomedical 7609 Cameron Circle Fort Myers, Florida 33912
Re: K073206
Trade/Device Name: Needle-Trap™ Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: November 8, 2007 Received: November 13, 2007
Dear Mr. Leichter:
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.
2
Page 2 -- Mr. Leichter
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.
Clrs
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
3
INDICATIONS FOR USE
510(k) Number:
HO73206
Device Name: Indications for Use: Needle-Trap™
The Needle-Trap™ contains a mechanism that is used to cover the needle point after use of the syringe and needle for their intended functions. In the activated position the Needle-Trap™ guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use (Per 21 CFR 801.109)
or
Over-the-Counter Use
Charles Zink for A.W.
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073206