(97 days)
No
The description focuses on the mechanical features and material properties of a reusable sharps disposal container, with no mention of AI or ML.
No.
The device is a sharps disposal container designed to safely contain contaminated sharps, not to treat a medical condition or perform a therapeutic function on a patient.
No
This device is a container designed for the safe disposal of sharps, not for diagnosing medical conditions. Its function is containment and safety, not diagnostic assessment.
No
The device description clearly states it is a "reusable plastic sharps disposal container" and details its physical features and construction, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to safely contain sharps waste generated by healthcare providers. This is a waste management function, not a diagnostic one.
- Device Description: The device is a container for sharps disposal. It does not perform any tests on biological samples or provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting analytes, or providing any kind of diagnostic result.
- Performance Studies: The performance studies focus on the physical integrity and safety features of the container (puncture resistance, leak resistance, etc.), which are relevant to its function as a sharps container, not a diagnostic device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Enviro Sharp Solutions 3 reusable container is intended for use by healthcare providers, such as hospitals, laboratories, medical clinics, veterinary clinics und other facilities where needles, sharps waste und other infectious waste are generated. The containers are designed to suffely contain sharps waste prior to removal from generating facility and until ultimate treatment and disposal of waste. Containers are of such a design and materials as to withstand craptying, unloading washing and disinfecting for reuse according to 49 CFR 55 178,603, 173,44655(d), 173465(e) and 178.608.
The container is intended for use by healthcare providers, such as hospitals, laboratories, medical clinics, veterinary clinics and other facilities where needles are generated. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps.
Product codes
MMK
Device Description
The Eaviro Sharp Solutions 3 is a reusable plustic sharps disposal compiner. Il icatures a mail drop, torturous path tumbler lid for Rale and casy disposal of sharps. Simply deposit syringes horizomally into the opening of the lid, and they are deposited automatically into the container. When the container is full, the tumbler will indicate that it is time to replace the unit. Just insert the locking tobs to secure the container in a closed position and replace it with a clean samitized unit. Using our proprietary equipment, Sci-Med Waste comployees will empry and sanitize the unit and relum it to the facility to use for the next switch out. The durable highdensity polychylone construction of the Enviro Sharp Solutions 3 makes it loakproof, puncture resistant and sinble. It meets or oxcocds all OSTIA recommendations for sharps containers, and because it is rewaible, it is more crivironmentully friendly and less expensive than disposable alternatives.
A label will be attached in the outside of the container specifying the intended use of the container. A sample of this lubel is attached at the end of this document. (Sec Attachment 1)
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
healthcare providers, such as hospitals, laboratories, medical clinics, veterinary clinics und other facilities
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
Over a two-day poriod from November 5, 2008 to November 5, 2008, all components of a randon sampling of the Enviro Sharp Solutions 3 container were subjected to a simulated life-use of elming, filling, depositing waste, one in an one in an onlying washing and subtizing. After simulated use, there were no visible signs of Inilure. Containces tested and passed (Scc helow )
The Enviro Sharp Solutions 3 meets und exceeds the primary design churacteristics needed to comply with the OSILA Blood borno Pathogens Standard. Date for the following tests have been provided and are as follows:
- Puncture: Health Devices 22, Needle penetration force, Pass
- Leak Resistance: Health Devices 22, 24 Hours filled with water, Pass
- Vibration: 49 CFR 178.608, 1 hour repetition bounce, Pass
- Free Fall Drop: 49 CFR 178.603, 5 drops 3.9 feet, Pass
- Stacking: 49 CFR 178.606, 24 hours under 65 lbs, Pass
"The package, us submitted und tested, visually appents to satisfy the test critchi und is capable of preventing the loss or Ilspersal of the contents for continues normal to transport" (Container Testing Laboratory, Inc.) (See Attischnered 2)
Key Metrics
Not Found
Predicate Device(s)
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
FDA 510(k) Premarket Notification
K083SII
Industrial Water Solutions, Inc. October 28, 2008
807.92(a)(1)
:
1.0.00
COMPANY NAME:
COMPANY ADDRESS:
TELEPHONE NUMBER: FACSIMILE NUMBER:
CONTACT PERSON:
SUMMARY PREPARATION DATE:
807.92(a)(2)
TRADE or PROPRIET ARY NAME:
COMMON NAME:
CLASSIFICATION:
807.92(a)(3)
EQUIVALENT DEVICE #1:
CONTAINER LID:
EQUIVALENT IDEVICE #2:
CONTAINER BASE:
807.92(a)(4)
DESCRIPTION:
510(k) SUMMARY
Industriul Willer Solinions, Inc.
2692 Willowlawn Street Rounoke, Virginia 24018
340/772-0599 540/772-7944
Thomas P. Stewart
November 24, 2008
Enviro Sharp Solutions 3
Reusable Sharps Disposal Container
Class II - Accessory Device
Bernis Sharp Schringlos
The Bornis Sharp Sentinal@ container lid ("lid") is used on the top of the Enviro Sharp Solutions 3 container. This Remis Sharp Sentinato container lid has been upproved under 510(k) #K953797.
SteriSharp™ 3 Gallon RSDC (510(k) #K020664
The bottom portion of the unit (the "comminer") is a rensable polychylene cavity with a wall thickness of 0.125" ± 0.002" similar to that of the StoriSharp™ 3. "The SteriSharp™ 3 comainer has been approvod under 510(k) #K020664
The Eaviro Sharp Solutions 3 is a reusable plustic sharps disposal compiner. Il icatures a mail drop, torturous path tumbler lid for Rale and casy disposal of sharps. Simply deposit syringes horizomally into the opening of the lid, and they are deposited automatically into the container. When the container is full, the tumbler will indicate that it is time to replace the unit. Just insert the locking tobs to secure the container in a closed position and replace it with a clean samilized unit. Using our proprietary equipment, Sci-Med Waste comployees will empry and sanitize the unit and relum it to the facility to use for the next switch out. The durable highdensity polychylone construction of the Enviro Sharp Solutions 3 makes it loakproof, puncture resistant and sinble. It meets or oxcocds all OSTIA recommendations for sharps containers, and because it is rewaible, it is more crivironmentully friendly and less expensive than disposable alternatives.
A label will be attached in the outside of the container specifying the intended use of the container. A sample of this lubel is attached at the end of this document. (Sec Attachment 1)
1
807.92(n)(5)
INTENDED USE:
The Haviro Sharp Solutions 3 reusable container is intended for use by healthcare providers, such as hospitals, luboratories, medical clinics, versinary clinics und other facilities where needles, sharps waste und other infectious waste are generated. The containers are designed to suffely contain sharps waste prior to removal from generating facility and until ultimate treatment and disposal of waste. Containers are of such a design and materials as to withstand craptying, unloading washing and disinfecting for reuse according to 49 CFR 55 178,603, 173,44655(d), 173465(e) and 178.608.
807.92(a)(6)
The Enviro Sharp Shiple on Inchiner is substantially equivalent to the SteriSharp™ 3, and west the Benting Nectination (510k)/K953797 lid that is a Remi-transpirent nuil drop, 10/voronylene muil drop, 10/0rous path tunbler lid. It is injection molded and varies in thickness from 0.0.5" to 0.07". The base vontainer is similar in design and ergonomic characteriales to the SteriShurp™ 3. While the base of the Starish is manufactured using polypropying, the Enviro Sharines is unit is manufactured viri a thicker wall (0.125" ±0,002" as compared to 0.06" ±0.01") and stronger polymer (HDPE) to help contier reusable qualities.
| COMPARISON TABLE (IIJ) | BEMIS SHARP SENTINAL® | NAME OF YOUR CONTAINER |
|---|---|---|
| Indications for use | Healthcare Sharps | Same |
| Target population | Healthcare Professionals | Same |
| Design | Torturous path, mail-drop | Same |
| Materials | Polypropylene | Same |
| Performance | Multiple Use | Same |
| Mechanical safety | Mail-drop | Same |
| Where used | Healthcare facilities/labs | Same |
| Standards met | 49 CFR/HD 22 (multi-use) | Same |
The Laviro Shap Solidions 3 reusable contuner is also submantially equivelent to the Steckliner They are Inch a combination of a polypropylane turnhir lid with upolyedrylone hase. The SteriShap™ 3 base is a road continuel motion lower under liner low dersity Polyethylone cavity, while the Enviro Sharp Solutions 3 is a roll, injection nolded high density.
| COMPARISON TABLE (container) | SteriSharp™ 3 | NAME OF YOUR CONTAINER |
|---|---|---|
| Indications for use | Healthcare Sharps | Same |
| Target population | Healthcare Professionals | Same |
| Design | Injection mold tapered | Same |
| Materials | HDPE | Same |
| Performance | Multiple Use | Same |
| Where used | Healthcare facilities/labs | Same |
| Standards met | 49 CFR/HD 22 | Same |
807.92(b)(1)
Over a two-day poriod from November 5, 2008 to November 5, 2008, all components of a randon sampling of the Enviro Sharp Solutions 3 container were subjected to a simulated life-use of elming, filling, depositing waste, one in an one in an onlying washing and subtizing. After simulated use, there were no visible signs of Inilure. Containces tested and passed (Scc helow )
807.92(b)(2) and (3)
The Enviro Sharp Solutions 3 meets und exceeds the primary design churacteristics neceded to comply with the OSILA Blood borno Pathogens Standard. Date for the following tests have been provided and are as follows:
| Puncture | Health Devices 22 | Needle penetration force | Pass |
|---|---|---|---|
| Leak Resistance | Health Devices 22 | 24 Hours filled with water | Pass |
| Vibration | 49 CFR 178.608 | 1 hour repetition bounce | Pass |
| Free Fall Drop | 49 CFR 178.603 | 5 drops 3.9 feet | Pass |
| Stacking | 49 CFR 178.606 | 24 hours under 65 lbs | Pass |
"The package, us submitted und tested, visually appents to satisfy the test critchi und is capable of preventing the loss or Ilspersal of the contents for continues normal to transport" (Container Testing Laboratory, Inc.) (See Attischnered 2)
2
Image /page/2/Picture/2 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 circular pattern around the eagle. The eagle is facing to the right, and its wings are angled upwards. The text is in all capital letters and is evenly spaced around the circle.
6 2009 MAR
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom Stewart Industrial Water Solutions, Incorporated 2692 Willowlawn Street Roanoke, Virginia 24018
Re: K083511
Trade/Device Name: Enviro Sharp Solution 3 Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: January 15, 2009 Received: February 11, 2009
Dear Mr. Stewart:
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
Page 2 - Mr. Stewart
Please be advised that FDA's issuance of a substantial equivalence determination does not rnean 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact: CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 D. Austin for
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K08351)
Device Name: Enviro Sharp Solutions 3
Indication For Use:
The container is intended for use by healthcare providers, such as hospitals, laboratories, medical clinics, veterinary clinics and other facilities where needles are generated. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps.
Prescription Use (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety
Division Sign-Off Office of In Vitro Diagnostic Device
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083511
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