(222 days)
The Isolyser Sharps Management System (SMS) is a disposable overthe-counter sharps container that is intended for the safe and effective disposal of used medical sharps. The SMS sharps containers are designed to safely and securely contain used medical sharps prior to removal and subsequent disposal. The SMS is marketed in four (4) different models: (1) Sharps Room System (SRS) 800. .98 liters: (2) Sharps Management System (SMS) 2400, 3.3 liters; (3) Sharps Management System (SMS) 4000, 5.97 liters; and (4) Sharps Management System (SMS) 10000, 10.47 liters. Each SMS model includes a water-based acrylamide solution that, when mixed with the provided catalysts, creates a polymer that encapsulates used medical sharps. Once the polymer has formed, the entire SMS container, including its contents, may be disposed in a user's ordinary trash in most states. It is the user's responsibility to dispose of the SMS container in accordance with Federal. State and Local regulations. The SRS 800, SMS 2400, SMS 4000, SMS 10000 are intended for use by small quantity health care providers such as dentists, medical doctors, veterinarians, and laboratories. The SMS sharps containers are not intended for reuse.
The Isolyser SMS is a disposable over-the-counter sharps container that is intended for the safe and effective disposal of used medical sharps. The SMS is marketed in four (4) different models: (1) Sharps Room System (SRS) 800. .98 liters: (2) Sharps Management System (SMS) 2400, 3.3 liters; (3) Sharps Management System (SMS) 4000, 5.97 liters; and (4) Sharps Management System (SMS) 10000, 10.47 liters. The SMS containers are marketed for use in the offices, exam, and patient rooms of small quantity healthcare providers such as medical doctors, dentists, veterinarians, and laboratories. The SMS sharps containers are not intended for reuse. The SMS's container is stable, puncture resistant, and leak-proof on the sides and bottom. Used medical sharps are placed vertically into the opening on the top of the container and dropped into an acrylamide solution that is contained inside the container. Once the SMS container has been filled with used medical sharps. users: add the provided catalyst packages to the acrylamide solution inside the container; securely place the lid onto the container; shake the container for ten (10) seconds; and allow the polymer to form overnight. Once the polymer has formed, the entire SMS container, including its contents, may be disposed in a user's ordinary trash in most states. It is the user's responsibility to dispose of the SMS container in accordance with Federal, State and Local regulations. The overall design and specifications for the Isolyser SMS meet OSHA Bloodborne Pathogens Standard as well as the American Society for Testing and Materials Puncture Resistance Standard F2132-01(2008). All SMS containers have BIOHAZARD warning labels clearly visible with lettering in contrasting color and are affixed by adhesives to the sides of the SMS container.
The provided document describes a medical device, the Isolyser SMS Sharps Container, and its 510(k) submission to the FDA. However, the document does not contain specific information about acceptance criteria, efficacy studies, or performance metrics in the way that would typically be presented for a diagnostic or AI-powered device.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval. This means the manufacturer is asserting their device is as safe and effective as a device already legally marketed, rather than presenting a novel study proving efficacy against specific performance targets.
Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will address what can be extracted or inferred:
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria with corresponding reported device performance metrics in the way a clinical trial or performance study would. Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to existing predicate devices and compliance with relevant standards.
| Acceptance Criteria (Inferred from 510(k)) | Reported Device Performance (as stated in document) |
|---|---|
| Intended Use: Safe and effective disposal of used medical sharps. | "The Isolyser SMS is a disposable over-the-counter sharps container that is intended for the safe and effective disposal of used medical sharps." |
| Puncture Resistance: Meets established standards. | "The overall design and specifications for the Isolyser SMS meet... the American Society for Testing and Materials Puncture Resistance Standard F2132-01(2008)." |
| Leak-Proof: Sides and bottom are leak-proof. | "The SMS's container is stable, puncture resistant, and leak-proof on the sides and bottom." |
| Stability: Container is stable. | "The SMS's container is stable, puncture resistant, and leak-proof on the sides and bottom." |
| Encapsulation Functionality: Sharps encapsulated by polymer. | "Used medical sharps are placed vertically into the opening on the top of the container and dropped into an acrylamide solution... add the provided catalyst packages... and allow the polymer to form overnight. Once the polymer has formed, the entire SMS container, including its contents, may be disposed..." |
| Compliance with OSHA Bloodborne Pathogens Standard: | "The overall design and specifications for the Isolyser SMS meet OSHA Bloodborne Pathogens Standard..." |
| Substantial Equivalence to Predicate Device: Similar intended use, function, basic composition, and technological characteristics to K943626. | "The Isolyser SMS sharps containers are substantially equivalent in intended use, function, and basic composition to the sharps containers approved under 510(k) number K943626. ...the containers are identical in size, composition, and design. Further, both the Isolyser SMS and the sharps containers approved in 510(k) K943626 contain acrylamide solutions that, once the provided catalysts have been added, create a polymer that encapsulates used medical sharps." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of device performance evaluation with a specific sample size. This 510(k) is based on descriptive data and comparison to a predicate device, rather than a clinical or performance study with a test dataset. Therefore, there is no information about data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As described above, there was no "test set" requiring ground truth establishment by experts in the context of device performance in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no "test set" or adjudication method described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical sharps container, not an AI-powered diagnostic tool, and therefore an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical sharps container, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" relates to compliance with engineering standards (e.g., puncture resistance, leak-proof design) and regulatory requirements, rather than a diagnostic accuracy assessment. The "ground truth" for the claim of substantial equivalence is based on the characteristics and performance of the legally marketed predicate device (K943626).
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of physical medical device in the context of performance study described in the document.
9. How the ground truth for the training set was established
Not applicable.
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Food and Drug Administration Center for Devices and Radiological Health Document Mail Center-WO66-0609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
Re: 510(k) Number K090156 Isolyser SMS Traditional 510(k) WCM Waste and Compliance Management, Inc. Carlsbad, CA 92011
510(k) Summary
Owner of Device
WCM Waste & Compliance Management, Inc. 6054 Corte Del Cedro Carlsbad, CA 92009-1514
Contact
Sara Beth Watson Steptoe & Johnson LLP 1330 Connecticut Ave., NW Washington, DC 20036 Phone (202) 429-6460 Fax (202) 429-3902 swatson@steptoe.com
Date Prepared
August 13, 2009
Name of Device
Common Name: Proprietary Name:
Sharps Container
Isolyser SMS: Sharps Room System (SRS) 800; Sharps Management System (SMS) 2400; Sharps Management System (SMS) 4000; and Sharps Management System (SMS) 10000.
Establishment Registration Number: 2032810 (2008) Accessory to hypodermic single lumen needles Classification Name: Regulation: Class II Classification: Product Code: Panel:
880.5570 MMK and/or FMI General Hospital
SEP - 1 2009
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Device Uses and Description
The Isolyser SMS is a disposable over-the-counter sharps container that is intended for the safe and effective disposal of used medical sharps. The SMS is marketed in four (4) different models: (1) Sharps Room System (SRS) 800. .98 liters: (2) Sharps Management System (SMS) 2400, 3.3 liters; (3) Sharps Management System (SMS) 4000, 5.97 liters; and (4) Sharps Management System (SMS) 10000, 10.47 liters. The SMS containers are marketed for use in the offices, exam, and patient rooms of small quantity healthcare providers such as medical doctors, dentists, veterinarians, and laboratories. The SMS sharps containers are not intended for reuse.
The SMS's container is stable, puncture resistant, and leak-proof on the sides and bottom. Used medical sharps are placed vertically into the opening on the top of the container and dropped into an acrylamide solution that is contained inside the container. Once the SMS container has been filled with used medical sharps. users: add the provided catalyst packages to the acrylamide solution inside the container; securely place the lid onto the container; shake the container for ten (10) seconds; and allow the polymer to form overnight. Once the polymer has formed, the entire SMS container, including its contents, may be disposed in a user's ordinary trash in most states. It is the user's responsibility to dispose of the SMS container in accordance with Federal, State and Local regulations. The overall design and specifications for the Isolyser SMS meet OSHA Bloodborne Pathogens Standard as well as the American Society for Testing and Materials Puncture Resistance Standard F2132-01(2008). All SMS containers have BIOHAZARD warning labels clearly visible with lettering in contrasting color and are affixed by adhesives to the sides of the SMS container.
Predicate Devices
The Isolyser SMS sharps containers are substantially equivalent in intended use, function, and basic composition to the sharps containers approved under 510(k) number K943626. The Isolyser SMS sharps containers have similar technological characteristics to the sharps containers approved in 510(k) K943626; the containers are identical in size, composition, and design. Further, both the Isolyser SMS and the sharps containers approved in 510(k) K943626 contain acrylamide solutions that, once the provided catalysts have been added, create a polymer that encapsulates used medical sharps. Once polymerization is complete, the entire SMS container, including its contents, may be disposed in the user's ordinary trash in most states if acceptable under Federal, State and Local regulations.
Conclusion
The Isolyser SMS is substantially equivalent to the predicate devices based on the descriptive data, compliance with standards, and indications for use.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's seal, which includes an emblem of an eagle with three stylized lines representing the department's mission of promoting health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
WCM Waste & Compliance Management, Incorporated C/O Ms. Sara Beth Watson Steptoe & Johnson L.L.P. 1330 Connecticut Avenue, N.W. Washington, D.C. 20036
Re: K090156
Trade/Device Name: ISOLYSER SMS Sharps Container. Models: Sharps Room System (SRS) 800; Sharps Management System (SMS) 2400; Sharp Management System (SMS) 4000; and Sharps Management System (SMS) 1000
Regulation Number: 21 CFR 880. 5570
Regulation Name: Hypodermic Single Lumen Needle
Regulatory Class: II
Product Code: FMI
Dated: August 13, 2009
Received: August 14, 2009
Dear Ms. Watson:
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.
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Page 2 - Ms. Watson
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 (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.
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 D. Arata Jr.
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K090156
Device Name: Isolyser SMS Sharps Containers, including models: Sharps Room System (SRS) 800; Sharps Management System (SMS) 2400; Sharps Management System (SMS) 4000; and Sharps Management System (SMS) 10000.
Indications For Use: The Isolyser Sharps Management System (SMS) is a disposable overthe-counter sharps container that is intended for the safe and effective disposal of used medical sharps. The SMS sharps containers are designed to safely and securely contain used medical sharps prior to removal and subsequent disposal. The SMS is marketed in four (4) different models: (1) Sharps Room System (SRS) 800. .98 liters: (2) Sharps Management System (SMS) 2400, 3.3 liters; (3) Sharps Management System (SMS) 4000, 5.97 liters; and (4) Sharps Management System (SMS) 10000, 10.47 liters. Each SMS model includes a water-based acrylamide solution that, when mixed with the provided catalysts, creates a polymer that encapsulates used medical sharps. Once the polymer has formed, the entire SMS container, including its contents, may be disposed in a user's ordinary trash in most states. It is the user's responsibility to dispose of the SMS container in accordance with Federal. State and Local regulations. The SRS 800, SMS 2400, SMS 4000, SMS 10000 are intended for use by small quantity health care providers such as dentists, medical doctors, veterinarians, and laboratories. The SMS sharps containers are not intended for reuse.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Shula H. Murphy MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital of CDRH, Office of Device Evaluation (ODE) Infection Control, Dental Devices
510(k) Number: K091156
§ 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).