(48 days)
Not Found
No
The device description and intended use are for a simple, passive sharps container with no mention of any computational or analytical capabilities.
No.
The device is a sharps container used for the collection and disposal of medical sharps, not for treating a disease or condition.
No
The device is a sharps container, intended for the collection and disposal of medical sharps. It does not perform any diagnostic function.
No
The device is a physical sharps container made of injection molded polypropylene, clearly describing hardware components and their function. There is no mention of software.
Based on the provided information, the Sharp Chute TM is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to collect and contain medical sharps (needles, syringes, etc.) for safe disposal. This is a physical containment function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the physical characteristics of the container (material, size, design for puncture resistance, disposability). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of Diagnostic Function: IVD devices are used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Sharp Chute TM does not perform any such analysis.
- Predicate Devices: The predicate devices listed are all other types of sharps containers, which are also not IVD devices.
In summary, the Sharp Chute TM is a medical device used for the safe handling and disposal of sharps, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sharp Chute (TM) is an over-the-counter, single-use, disposable, non-sterile sharps container intended to be used with medical sharps including, but not limited to, hypodermic needles, syringes, lancets, and blood needles. The containers can be used in any area requiring sharps collection prior to their final disposal. When the container is filled to the max-capacity indicator, it is intended to be permanently locked and ultimately disposed of.
Product codes
MMK
Device Description
- The Sharp Chute (TM) is a portable, 1.5 quart sharps container designed to be used in environments where larger containers are not desired. In addition, it is designed to fit into Heathrow Scientific's Droplet (TM) Blood Collection Tray.
- The Sharp Chute (TM) is available in either translucent red or translucent yellow.
- Each component of the container assembly is made of injection molded polypropylene.
- The end user will be required to attach the dome assembly to the base by inserting the connection tabs into their corresponding slots.
- The Sharp Chute (TM) is designed to withstand punctures by syringes, pen needles, and lancets.
- The Sharp Chute (TM) is autoclavable and incineratable.
- The Sharp Chute (TM) is NOT reusable.
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 Sharp Chute (TM) has passed all tests against various standards by third party review. The third party involved in review was: Intertek, 4700 Broadmoor Ave SE, Suite 200, Grand Rapids, MI 49512
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K943139, K990936, K980490, K964387
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
eathrow Scientific LLC
1901 8 8 2008
510 (k) Notification
Section 5: 510 (k) Summary
Date of Preparation:
| Device Names: | Sharp Chute TM |
|---|---|
| Model number(s): | HS21001A - Red color material |
| HS21001B - Yellow color material |
Common Name:
Sharps Container
Accessory to needles, hypodermic, single lumen, lancets Classification Name:
21 CFR 880.5570 Regulation Number:
Proposed Regulatory Class: Class II
80 MMK Device Product Code:
General Hospital Medical Specialty:
Manufacturer:
Predicates:
A
Heathrow Scientific LLC. 620 Lakeview Parkway Vernon Hills, IL 60061
Official Contact Person: Peter Hadjis Product Development Manager
Predicate devices to which Sharp Chute ™ is substantially equivalent:
K943139 – B-D, Guardian One Piece-Sharps Collectors o
- K990936 Stik Stoppers, The Vault 0
- K980490 Sage Products, Sharps Containers with ೧ Screw Top Caps
- K964387 Graphic Controls, Point of use II Sharps-A-Gator
Device Description:
- The Sharp Chute ™ is a portable, 1.5 quart sharps container designed to be used in . environments where larger containers are not desired. In addition, it is designed to fit into Heathrow Scientific's Droplet™ Blood Collection Tray.
- The Sharp Chute ™ is available in either translucent red or translucent yellow.
- Each component of the container assembly is made of injection molded polypropylene.
1
Image /page/1/Picture/0 description: The image contains the logo for Heathrow Scientific LLC. The logo features a stylized atom-like graphic on the left, followed by the text "Heathrow Scientific" in a bold, sans-serif font. To the right of "Scientific" is the superscripted trademark symbol and the letters "LLC" in a smaller font size.
- The end user will be required to attach the dome assembly to the base by inserting the . connection tabs into their corresponding slots.
- The Sharp Chute "1 is designed to withstand punctures by syringes, pen needles, and . lancets.
- The Sharp Chute "M is autoclavable and incineratable. .
- The Sharp Chute TM is NOT reusable. .
Intended Use:
- The Sharp Chute TM is an over-the-counter, single-use, disposable, non-sterile sharps 0 container intended to be used with medical sharps including, but not limited to, hypodermic needles, syringes, lancets, and blood needles. The containers can be used in any area requiring sharps collection prior to their final disposal.
- When the container is filled to the max-capacity indicator, it is intended to be . permanently locked and ultimately disposed of.
Technological Characteristics:
- Predicate devices and new device is made from same material; polypropylene. .
- All predicate devices feature a close functions prior to permanent lock. The new device . also has this feature. In addition to a close position, the new device also provides close icons on the outer dome to show the close position to avoid confusion from false locking.
- Predicate devices feature detailed labels with warning cautions. The new devices feature . similar cautions with additional warnings for added safety.
- Predicate devices offer handle for transport. The new device offers a similar handle and t has been tested to be able to support the full capacity of the unit.
- The new device has a unique rotating dome. Predicate units have screw top lids. Screw . top lids and the new device rotating dome has lid on rail system as well to enclose device. Both methods of the screw top and rotating dome lid provide lock and close mechanisms during transport and engage in lock.
- The Sharp Chute " has passed all tests against various standards by third party review. . The third party involved in review was:
Intertek
4700 Broadmoor Ave SE, Suite 200 Grand Rapids, MI 49512
Discussion:
The Sharp Chute™ has similar materials of construction and indications for fill and lock as the predicate devices. The new device has similar technological characteristics as compared to predicate devices for safety, function, and uses. There are safety precautions that both the predicate devices and the new device used to display cautionary warnings to users. These safety precautions are listed on unit labels and instructional sheets.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 8 2009
Heathrow Scientific, LLC C/O Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087
Re: K091690
Trade/Device Name: Sharp Chute™ Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: July 13, 2009 Received: July 15, 2009
Dear Mr. Kogoma:
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 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
Page 2- Mr. Kogoma
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Anthony V. Norton for
S. Rep. DDS. Mass.
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for Heathrow Scientific LLC. The logo features the company name in bold, black font. To the left of the name is a graphic of three intersecting circles.
510 [k] Notification
Section 4: Indications for Use Statement
510 (K) Number (if known):
Device Name: Sharp Chute TM HS21001A – Red color material Model number(s): HS21001B – Yellow color material
Indications For Use:
The Sharp Chute TM is an over-the-counter, single-use, disposable, non-sterile sharps container intended to be used with medical sharps including, but not limited to, hypodermic needles, syringes, lancets, and blood needles. The containers can be used in any area requiring sharps collection prior to their final disposal.
When the container is filled to the max-capacity indicator, it is intended to be permanently locked and ultimately disposed of.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stalin A. Murgules
Ton Sign-Off) n of Anesthesiology, General Hospital ·· Control, Dental Devices
ber: Kng1690