(156 days)
Not Found
No
The description focuses on the physical characteristics and disposal mechanism of a sharps container, with no mention of AI or ML technology.
No.
The device is a sharps container for the disposal of contaminated sharps, not for therapeutic use.
No
The device is a sharps container for disposal of contaminated sharps, not a diagnostic device.
No
The device is a physical sharps container, which is a hardware device, not software.
Based on the provided text, the Isolyser SDS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "disposal of contaminated sharps" in non-clinical settings. This is a waste management function, not a diagnostic test performed on a biological sample.
- Device Description: The description focuses on the physical characteristics of a sharps container (closable, puncture resistant, leakproof) and its function in safely containing sharps waste. It also describes a system for solidifying the contents for disposal. None of these functions relate to diagnosing a condition or analyzing a biological sample.
- Lack of IVD Characteristics: The text does not mention any components or processes related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions
The Isolyser SDS is clearly described as a device for the safe disposal of medical waste, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Isolyser SDS is a sharps container intended for use in non-clinical settings for the disposal of contaminated sharps.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Isolyser Syringe Disposal System (SDS) has the same uses as other sharps containers in commercial distribution: to provide safe and effective disposal of medical sharps. The major difference between the Isolyser SMS 1000 and the SDS relate to the setting in which the device will be used. The SDS is intended for use in non-clinical settings while the Isolyser SMS 1000 is used in clinical settings.
As is true for the Isolyser SMS 1000, the SDS is closable, puncture resistant The fluorescent orange and leakproof on the sides and the bottom. BIOHAZARD warning labels are clearly visible with lettering in contrasting color and are affixed by adhesive to the SDS containers. Like the SMS 1000, the SDS container maintains a stable and upright position. There is no feature to bend, break, or shear the needle off the hub of the syringe.
When the SDS is full, the user adds water to the SDS to activate the "Gel-loc" system. After replacing the cap on the SDS, the user shakes the container well. The user then places the SDS into the carton provided and seals it with tape. The user then disposes of the sealed carton according to local, state and federal laws.
The disposal methods for the SMS 1000 and the SDS are quite similar. As is true for SMS 1000, the SDS containers are designed so that no user is required to reach by hand into the container to retrieve the contaminated reusable sharps. As indicated on all labels for SDS containers, safe and effective disposal of the waste is easily accomplished.
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
non-clinical settings / home use
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 data demonstrate that the performance of the Isolyser SDS is substantially equivalent to other legally marketed sharps containers.
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
The Isolyser Co., Inc.
JUL 1 8 1997
510(k) SUMMARY
As required by 21 C.F.R. § 807.92 the following is a 510(k) Summary for the Isolyser SDS container:
(1) Submitter's Name/Contact Person:
Tom Bonner Vice President, Regulatory Affairs and Quality Assurance The Isolyser Company, Inc. 650 Engineering Drive Technology Park Norcross, GA 30092 (800) 777-7977 Date Prepared: February 11, 1997
(2) Device Name and Classification:
Isolyser Syringe Disposal System Sharps Container without Secondary Container Accessory to hypodermic needle
(3) Legally Marketed Device to Which Claim Equivalence:
Isolyser Sharps Management System ("SMS") 1000 (K943626) cleared March 14, 1995 by FDA.
(4) Device Description:
The Isolyser Syringe Disposal System (SDS) has the same uses as other sharps containers in commercial distribution: to provide safe and effective disposal of medical sharps. The major difference between the Isolyser SMS 1000 and the SDS relate to the setting in which the device will be used. The SDS is intended for use in non-clinical settings while the Isolyser SMS 1000 is used in clinical settings.
396109.1
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1
The Isolyser Co., Inc.
As is true for the Isolyser SMS 1000, the SDS is closable, puncture resistant The fluorescent orange and leakproof on the sides and the bottom. BIOHAZARD warning labels are clearly visible with lettering in contrasting color and are affixed by adhesive to the SDS containers. Like the SMS 1000, the SDS container maintains a stable and upright position. There is no feature to bend, break, or shear the needle off the hub of the syringe.
When the SDS is full, the user adds water to the SDS to activate the "Gel-loc" system. After replacing the cap on the SDS, the user shakes the container well. The user then places the SDS into the carton provided and seals it with tape. The user then disposes of the sealed carton according to local, state and federal laws.
The disposal methods for the SMS 1000 and the SDS are quite similar. As is true for SMS 1000, the SDS containers are designed so that no user is required to reach by hand into the container to retrieve the contaminated reusable sharps. As indicated on all labels for SDS containers, safe and effective disposal of the waste is easily accomplished.
(5) Intended Use for Isolyser SDS
The Isolyser SDS is intended for use in non-clinical settings for the disposal of contaminated sharps.
(6) Technical Characteristics for Isolyser SDS
The SDS container has essentially the same technical characteristics as the Isolyser SMS 1000. The materials and method of manufacturing the SDS container itself is nearly identical to the methods used to manufacture the SMS 1000. The only technical difference for the SDS product relates to the method of disposal. To dispose of the SDS, the user applies the Isolyser disposal Gel-Loc System for disposal. To dispose of the Isolyser SMS 1000, the user adds a catalyst to the contents before disposal. This change does not materially affect the safety or effectiveness of the device.
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(7) Conclusions Drawn from Studies
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. .
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The data demonstrate that the performance of the Isolyser SDS is substantially equivalent to other legally marketed sharps containers.
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Image /page/3/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 three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom Bonner ·Vice President The Isolyser Company, Incorporated 4320 International Boulevard, NW Norcross, Georgia 30093
JUL | 8 1997
Re: K970547 Isolyser SDS Sharps Container Trade Name: Requlatory Class: II Product Code: FMI Dated: May 19, 1997 Received: May 20, 1997
Dear Mr. Bonner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
4
Page 2 - Mr. Bonner
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page
510(k) Number (if known): _
Device Name: Isolyser Syringe Disposal System (SDS)
Indications for Use:
The Isolyser SDS is a sharps container intended for use in non-clinical settings for the disposal of contaminated sharps.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Chis S. t
(Division Sign-Off Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K970547
Prescription Use __ OR Over-The-Counter Use✓
(Per 21 CFR 801.109)
(Optional Format 1-2-96)