(64 days)
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.
The Needle-Trap™ Needle Safety devices are substantially equivalent to the current marketed products
This 510(k) submission for the Needle-Trap™ / Needle Safety Label (K073206) is a pre-market notification for a medical device that claims substantial equivalence to previously marketed devices. It does not contain a study demonstrating acceptance criteria or device performance in the way typically expected for an AI/software as a medical device (SaMD) submission.
Instead, the submission focuses on demonstrating that the device (a syringe anti-needle stick accessory) has similar technological characteristics and performance to existing, legally marketed predicate devices. The "Performance Data" section in the 510(k) summary explicitly states: "Verification and Validation testing confirmed the products meet their specifications." However, it does not provide details on these specifications, acceptance criteria, or the study results themselves.
Therefore, many of the requested items related to a performance study (especially for AI/SaMD) cannot be extracted from this document, as this is a much older and different type of device submission.
Here's an attempt to address your points based on the provided text, while highlighting the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specifications (not detailed in the document) | "Verification and Validation testing confirmed the products meet their specifications." (Specific results not provided.) |
| Substantial Equivalence to Predicate Devices: BD SafetyGlide™ Needle (K951254), Portex® Needle-Pro® EDGE™ Safety Device with Syringe (K061194), BD Eclipse™ Hypodermic Needle (K010188) | The FDA's substantial equivalence determination allows the device to be marketed, implying it meets the criteria for equivalence to the stated predicates. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided documents. The verification and validation testing mentioned would have used a sample, but the size is not disclosed.
- Data Provenance: Not specified. This type of device (physical accessory) generally undergoes bench testing and possibly human factor studies, rather than relying on patient data in the same way an AI device would.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable or not specified. For a physical device like this, ground truth would typically be established through engineering specifications, material testing, and functional performance tests rather than expert interpretation of data.
- Qualifications: Not applicable or not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or not specified. This typically applies to studies where multiple readers assess cases, which is not described here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done or at least not described in these documents. This type of study is relevant for diagnostic imaging or similar AI applications where human readers' performance is augmented.
6. If a Standalone Study (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: Not applicable. This device is a physical accessory, not an algorithm. Its function is to cover a needle after use, preventing needle sticks. Its performance is inherent to its mechanical design and materials, not a standalone algorithmic output.
7. The Type of Ground Truth Used
- Ground Truth Type: Not explicitly stated as "ground truth" in these documents. For a device like this, the "ground truth" would likely be defined by engineering specifications, functional requirements (e.g., ability to reliably cover the needle, resistance to accidental re-exposure), and safety standards (e.g., ISO standards for sharps injury prevention devices). Performance would be measured against these predefined specifications.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As it's not an AI/ML device, there is no training set or ground truth in that context.
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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
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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.
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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
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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
§ 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).