(135 days)
The On the Go Sharps Transport & Disposal is intended as a single use, needle protection device. The device is intended to hold only one contaminated sharp. The device is designed for use with Insulin syringes. It is intended to be sold Over-the-Counter for personal use only; not for professional use or use in professional healthcare facilities.
On the Go Sharps Container is designed as a single use device that holds a single contaminated sharp. The contaminated sharp is placed into the container and immediately locked using the Safe-Lock Lid. Once closed the device can not be opened thereby minimizing the risk of contamination.
This regulatory filing describes a medical device, not an AI/ML powered device, therefore the requested information for acceptance criteria and study that proves the device meets the acceptance criteria is not applicable in the context of AI/ML performance. The filing does not contain the specific information requested regarding AI/ML models or studies.
However, based on the provided text for the "On the Go Sharps Transport and Disposal with Safe-Lock™" device, here's an interpretation of the performance characteristics and the supporting study, framed to answer as much as possible from your request, acknowledging the non-AI nature:
Acceptance Criteria and Study for On the Go Sharps Transport and Disposal with Safe-Lock™ (Non-AI Device)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ease of Use for General Public | Simulated use studies confirmed that people with different educational backgrounds can successfully use the On The Go Sharps Container in accordance with instructions provided. |
| Tamper-Proof After Locking | Once locked, the device cannot be opened. The contaminated sharp does not penetrate the plastic. |
| Protection Against Needle Penetration | The contaminated sharp does not penetrate the plastic, thereby providing a safe method for transporting contaminated sharps to a site for disposal. |
| Containment of Contaminated Sharps | Provides a safe method for transporting contaminated sharps to a site for disposal. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated. The description mentions "people with different educational background," implying a diverse user group for the simulated use study, but no specific number of participants is provided.
- Data Provenance: The study was a "simulated use study." The location or country of origin is not specified, but given the US FDA filing, it's reasonable to infer a US context, though this is not explicitly stated. The study was likely prospective in nature, as it involved actively testing the device with users.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This concept is not applicable here as the device is not AI-powered and thus does not rely on "ground truth" derived from expert interpretation in the way an AI model would. The "ground truth" for this device's performance would be direct observation of its physical characteristics (e.g., whether it locks, whether a sharp penetrates it) and user behavior. No experts were used to establish "ground truth" in the AI sense.
4. Adjudication Method for the Test Set
- Not applicable in the context of an AI study. The "simulated use study" would likely involve direct observation of participants' ability to use the device and direct testing of the device's physical properties. There would be no "adjudication method" in the sense of reconciling disagreements between multiple human readers or experts for an AI model.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of an AI system on human reader performance, which is not relevant for this non-AI device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone algorithm study was not done. This device is a physical product and does not involve an algorithm.
7. Type of Ground Truth Used
- For this physical device, the "ground truth" is established through direct observation and empirical testing of the device's physical properties and functionalities. For instance:
- Whether the device locks once closed.
- Whether a contaminated sharp penetrates the plastic.
- Whether users can follow instructions to correctly operate the device.
- This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to AI models.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a non-AI device.
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510 (K) SUMMARY
Date of Summary
July 12, 2007
Product Name:
On the Go Sharps Transport and Disposal with Safe-Lock™
Sponsor & Manufacturer:
MedPort, LLC 23 Acorn Street Providence, RI 02903
Correspondent:
Fran WhitE MDC Associates, LLC 163 Cabot Street Beverly, MA 01915
Substantially Equivalent Device: K041153 Sharps Away™ Locking Disposal Cup
Product Description:
On the Go Sharps Container is designed as a single use device that holds a single contaminated sharp. The contaminated sharp is placed into the container and immediately locked using the Safe-Lock Lid. Once closed the device can not be opened thereby minimizing the risk of contamination.
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Intended Use:
The On the Go Sharps Transport & Disposal is intended as a single use, needle protection device. The device is intended to hold only one contaminated sharp. The device is designed for use with Insulin syringes. It is intended to be sold Over-the-Counter for personal use only; not for professional use or use in professional healthcare facilities.
Performance Characteristics:
Simulated use studies confirmed that people with different educational background can successfully use the On The Go Sharps Container in accordance with instructions provided.
Once locked the device can not be opened. The contaminated sharp does not penetrate the plastic, thereby providing a safe method for transporting contaminated sharps to a site for disposal.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.
Public Health Service
JUL 1 3 2007
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDport, Incorporated C/O Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, Massachusetts 01915
Re: K070577
Trade/Device Name: On the Go Sharps Transport & Disposal with Safe-LockTM Lid Single Use Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: June 28, 2007 Received: July 2, 2007
Dear Ms. White:
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 - Ms. White
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 (OS) 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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: K070577
Device Name: On the Go Sharps Transport & Disposal with Safe-Lock™ lid Single use sharps container
Indications For Use:
The On the Go Sharps Transport & Disposal is intended as a single use, needle protection device. The device is intended to hold only one contaminated sharp. The device is designed for use with Insulin syringes. It is intended to be sold Over-the-Counter for personal use only; not for professional use or use in professional healthcare facilities.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shuli A. Murphy, MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K021522
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).