(70 days)
Not Found
No
The summary describes a mechanical device for needle disposal and protection, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a needle protection and disposal device, not designed for diagnosing, treating, or preventing disease, but rather for safety in handling medical sharps.
No
This device is described as a "single use needle protection device" and "disposal cup," designed to prevent sharps injuries. Its intended use is to cover needles after use and facilitate safe disposal, not to diagnose medical conditions.
No
The device description and performance studies clearly indicate a physical, hardware-based device designed to cover needles. There is no mention of software components or functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cover used needles to minimize the risk of needle sticks. This is a physical safety device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces its function as a physical barrier for sharps.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information
- Using reagents or assays
The Arrow SharpsAway II™ Locking Disposal Cup is a sharps disposal accessory designed for safety in clinical procedures.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
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.
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)
The following tests were performed to demonstrate substantial equivalence:
• Simulated Use Study
• Puncture Resistance
• Gripping Mechanism Functionality Test
• Water Leak
The results of the performance tests demonstrate that the device is substantially equivalent to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
JUL 1 2 2004 510(k) Summary:
p
K04 1153
SharpsAway II™ Locking Disposal Cup
| Submitter: | Arrow International Inc.
2400 Bernville Road
Reading, PA 19605 |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Elizabeth Price
Regulatory Associate |
| | Phone: 1-800-233-3187 Ext. 3220
Fax: (610)-478-3172
E-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 classification
name: | Needle, Hypodermic, Single Lumen |
| Legally marketed devices
to which the device is
substantially equivalent | Devon Industries - Point-Lok® Neeedle Protection Device
(K946289) |
| Description of device: | 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. |
| Intended use of the
device: | 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. |
| Technological
characteristics: | The technological characteristics are unchanged from the
predicate device. |
1
510(k) Summary:
SharpsAway II™ Locking Disposal Cup
| Performance tests: | The following tests were performed to demonstrate substantial
equivalence:
• Simulated Use Study
• Puncture Resistance
• Gripping Mechanism Functionality Test
• Water Leak |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions: | The results of the performance tests demonstrate that the
device is substantially equivalent to the legally marketed
predicate device. |
2
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.
3
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
4
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