(70 days)
The Arrow SharpsAway II™ Locking Disposal Cup is intended as a single use needle protection device, which covers the end of needles after use to minimize the risk of needle sticks. This device is designed for use with 15 Ga. to 30 Ga. needles for various clinical procedures.
The proposed SharpsAway II™ Locking Disposal Cup was created to help prevent needle sticks by providing a means of moving used sharps from procedure to sharps container.
The SharpsAway II™ Locking Disposal Cup is a device designed to prevent needle sticks by covering used sharps. The provided text outlines the performance tests conducted to demonstrate its substantial equivalence to a legally marketed predicate device (Devon Industries - Point-Lok® Needle Protection Device, K946289).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the performance tests were designed to demonstrate substantial equivalence to the predicate device. Therefore, the "reported device performance" is that the device met the requirements such that it was deemed substantially equivalent.
| Acceptance Criteria (Implied) | Reported Device Performance Statement |
|---|---|
| Prevention of needle sticks (General functionality) | "The results of the performance tests demonstrate that the device is substantially equivalent to the legally marketed predicate device." |
| Effective locking mechanism (Simulated Use Study) | Passed (implied by overall substantial equivalence conclusion) |
| Resistance to punctures (Puncture Resistance Test) | Passed (implied by overall substantial equivalence conclusion) |
| Reliable gripping (Gripping Mechanism Functionality Test) | Passed (implied by overall substantial equivalence conclusion) |
| Containment of fluids (Water Leak Test) | Passed (implied by overall substantial equivalence conclusion) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample sizes used for any of the performance tests (Simulated Use Study, Puncture Resistance, Gripping Mechanism Functionality Test, Water Leak). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not contain any information about experts used to establish a ground truth for the test set. The tests appear to be physical or mechanical performance tests rather than clinical studies requiring expert interpretation.
4. Adjudication Method for the Test Set
The provided text does not mention any adjudication method. Given the nature of the performance tests (e.g., puncture resistance, water leak), it is unlikely that a human adjudication method like 2+1 or 3+1 would be applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This device, the SharpsAway II™ Locking Disposal Cup, is a medical device for sharps disposal, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study comparing AI assistance with human readers was not done, and there is no mention of AI in the provided documentation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
As stated above, this device is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm-only performance study was not done.
7. The Type of Ground Truth Used
For a physical device like the SharpsAway II™ Locking Disposal Cup, "ground truth" would typically be established by:
- Engineering specifications and standards: For tests like Puncture Resistance, there would be predefined standards or internal specifications for resistance levels.
- Functional requirements: For tests like Simulated Use and Gripping Mechanism, the "ground truth" is whether the device successfully performs its intended function (e.g., locks a needle, grips effectively) under simulated use conditions.
- Physical properties: For the Water Leak test, the ground truth is simply the absence of a leak.
The document implicitly suggests that these tests were performed against such established criteria to determine if the device functioned as intended and was substantially equivalent to the predicate.
8. The Sample Size for the Training Set
This device is not an AI/ML product, so there is no concept of a training set in this context.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of medical device, this question is not applicable.
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JUL 1 2 2004 510(k) Summary:
p
K04 1153
SharpsAway II™ Locking Disposal Cup
| Submitter: | Arrow International Inc.2400 Bernville RoadReading, PA 19605 |
|---|---|
| Contact person: | Elizabeth PriceRegulatory Associate |
| Phone: 1-800-233-3187 Ext. 3220Fax: (610)-478-3172E-mail: Elizabeth.Price@arrowintl.com | |
| Date summary prepared: | April 30, 2004 |
| Date summary revised: | July 6, 2004 |
| Device trade name: | SharpsAway II™ Locking Disposal Cup |
| Device common name: | Accessory to a Needle, Hypodermic, Single Lumen |
| Device classificationname: | Needle, Hypodermic, Single Lumen |
| Legally marketed devicesto which the device issubstantially equivalent | Devon Industries - Point-Lok® Neeedle Protection Device(K946289) |
| Description of device: | The proposed SharpsAway II™ Locking Disposal Cup wascreated to help prevent needle sticks by providing a means ofmoving used sharps from procedure to sharps container. |
| Intended use of thedevice: | The Arrow SharpsAway II™ Locking Disposal Cup is intendedas a single use needle protection device, which covers theend of needles after use to minimize the risk of needle sticks.This device is designed for use with 15 Ga. to 30 Ga. needlesfor various clinical procedures. |
| Technologicalcharacteristics: | The technological characteristics are unchanged from thepredicate device. |
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510(k) Summary:
SharpsAway II™ Locking Disposal Cup
| Performance tests: | The following tests were performed to demonstrate substantialequivalence:• Simulated Use Study• Puncture Resistance• Gripping Mechanism Functionality Test• Water Leak |
|---|---|
| Conclusions: | The results of the performance tests demonstrate that thedevice is substantially equivalent to the legally marketedpredicate device. |
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble an abstract representation of a human figure or a symbol of health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2004
Ms. Elizabeth Price Regulatory Affairs Arrow International 2400 Bernville Road Reading, Pennsylvania 19605
Re: K041153
Trade/Device Name: SharpsAway II TM Locking Disposable Cup Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 30, 2004 Received: May 3, 2004
Dear Ms. Price:
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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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 (301) 594-4618. 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/dsma/dsmamain.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: K041153
Device Name: SharpsAway IITM Locking Disposal Cup
Indications For Use:
The Arrow SharpsAway II™ Locking Disposal Cup is intended as a single use needle protection device, which covers the end of needles after use to minimize the risk of needle sticks. This device is designed for use with 15 Ga. to 30 Ga. needles for various clinical procedures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Aton Dm
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K441153
§ 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).