(102 days)
The Isolyser Sharps Management Systems SMSm is a single-use, disposable, over-the-counter sharps container intended for use in clinical and non-clinical settings for the disposal of contaminated sharps and/or medical/red-bag wastes. The SMSm is marketed in five (5) different models: (1) Home Sharps Management (HSM) 800m, .98 liters, 3.45 x 2.72 x 7.29 (in.); (2) Sharps Management System (SMS) 2400m, 3.3 liters, 5 x 5x 10 (in.); (3) Sharps Mariagement System (SMS) 4000m, 5.97 liters, 8.47 x 5.99 x 8.87 (in.); (4) Sharps Management System (SMS) 10000m, 10.47 liters, 8.51 x 5.99 x 14.32 (in.); and (5) Sharps Management System (SMS) 5.3m, 21.1 liters, 11.93 x 9.87 x 14.68 (in.). Each SMSm model is designed to safely and securely contain used medical sharps and/or medical/red-bag wastes prior to removal and subsequent disposal. The SMS 5.3m is intended only for the storage and disposal of filled approved sharps containers and/or medical/red-bag wastes. Once an empty SMSm container has been filled with used medical sharps and/or medical/red-bag wastes, the entire SMSm container is intended to be packaged and mailed-back to WCM Waste and Compliance Management, Inc. for proper disposal. The HSM 800m, SMS 2400m, SMS 4000m, SMS 10000m, and SMS 5.3m are intended for home use by home health care providers and for use by small quantity health care providers such as dentists, medical doctors, veterinarians, and laboratories. The SMSm sharps containers are not intended for reuse.
The Isolyser Home Sharps Management (HSM) 800m; Sharps Management System (SMS) 2400m; Sharps Management System (SMS) 4000m; Sharps Management System (SMS) 10000m are disposable non-reusable sharps containers that are intended to provide for safe and effective disposal of medical sharps and/or medical/red-bag wastes. The Isolyser Sharps Management System (SMS) 5.3m is intended only for the storage and disposal of filled approved sharps containers and/or medical/red-bag wastes. The SMS 5.3m is not intended for the direct disposal of used medical sharps. The HSM 800m, SMS 2400m, SMS 4000m, SMS 10000m, and SMS 5.3m are marketed for home use by home healthcare providers and for use in the offices, exam. and patient rooms of small quantity generators such as medical doctors, dentists, veterinarians, and laboratories.
The SMSm container is stable, puncture resistant (SMS 5,3m not tested) and leak-proof on the sides and bottom. Used medical sharps and/or medical/red-bag wastes are placed vertically into the opening on the top of the container. Once placed into the container, the SMSm does not require users to reach by hand into the container to retrieve contaminated sharps and/or medical/red-bag wastes. Once the container is full, the SMSm is intended to be mailed back to WCM Waste and Compliance Management, Inc. for proper disposal. The overall design and specifications for the Isolyser SMSm meet OSHA Bloodborne Pathogens Standard as well as the American Society for Testing and Materials Standard F2132-01(2008) (SMS 5.3m not tested). All SMSm containers have BIOHAZARD warning labels clearly visible with lettering in contrasting color and are affixed by adhesives to the sides of the SMSm container.
The provided text describes a 510(k) submission for Isolyser SMSm Sharps Containers. This is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance through a detailed clinical study with acceptance criteria.
Therefore, many of the requested elements (acceptance criteria, specific study design, sample sizes, ground truth establishment, MRMC studies, standalone performance) are not applicable in the context of this 510(k) application. This submission aims to show that the new device is as safe and effective as a legally marketed predicate device, primarily through descriptive data and compliance with standards, rather than generating new performance data in a clinical trial setting.
Here's a breakdown of the information that is available and a clear statement regarding what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (N/A): As a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, not to meet specific quantitative performance acceptance criteria from a primary clinical study. The device is assessed against existing standards and the characteristics of the predicate. | Meets OSHA Bloodborne Pathogens Standard: The overall design and specifications meet this standard. |
| Meets American Society for Testing and Materials Standard F2132-01(2008): (SMS 5.3m not tested against this specific standard). This standard likely relates to sharps container design and performance characteristics. | |
| Stable: (Implied by design and compliance with standards). | |
| Puncture Resistant: (SMS 5.3m not tested). | |
| Leak-proof on the sides and bottom. | |
| Does not require users to reach by hand into the container to retrieve contaminated sharps and/or medical/red-bag wastes. | |
| Has BIOHAZARD warning labels clearly visible with lettering in contrasting color and affixed by adhesives. | |
| Identical technological characteristics to predicate Isolyser SMS containers (K943626) for HSM 800m, SMS 2400m, SMS 4000m, and SMS 10000m in terms of size, composition, and design. | |
| Similar technological characteristics to predicate Sharps Disposal by Mail 15000 for SMS 5.3m (receptacle for filled sharps containers and/or medical/red-bag wastes). |
2. Sample size used for the test set and the data provenance
- Not Applicable (N/A): This submission does not describe a traditional "test set" from a clinical or performance study with a defined sample size. The substantial equivalence is based on engineering design, material properties, and comparison to predicate devices and standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable (N/A): No ground truth establishment by experts for a test set is described. The evaluation is based on design specifications, material properties, and compliance with recognized standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable (N/A): No test set requiring expert adjudication is 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 (N/A): This device is a physical sharps container, not an AI-powered diagnostic tool. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A): This device is a physical sharps container, not an algorithm, so standalone performance in this context is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable (N/A): As explained, traditional "ground truth" derived from clinical data is not applicable here. The "truth" or validation relies on:
- Compliance with recognized industry standards: OSHA Bloodborne Pathogens Standard and ASTM F2132-01(2008).
- Comparison to predicate device characteristics: Identity or similarity in intended use, function, basic composition, size, and design.
8. The sample size for the training set
- Not Applicable (N/A): There is no "training set" as this is not an AI/machine learning device. The development process would have involved engineering design, prototyping, and testing of physical units to ensure compliance with standards, but not a data-driven training set in the computational sense.
9. How the ground truth for the training set was established
- Not Applicable (N/A): No training set as per explanation in point 8.
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Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
MAY - 4 2009
Re: Isolyser SMSm 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
January 15, 2009
Name of Device
Common Name: Proprietary Name:
Sharps Container
Isolyser SMSm: Home Sharps Management (HSM) 800m; Sharps Management System (SMS) 2400m; Sharps Management System (SMS) 4000m; Sharps Management System (SMS) 10000m; and Sharps Management System (SMS) 5.3m.
Establishment Registration Number: 2032810 (2008) Classification Name: Regulation: Classification: Product Code: Panel:
Accessory to hypodermic single lumen needles 880.5570 Class II MMK General Hospital
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Device Uses and Description
The Isolyser Home Sharps Management (HSM) 800m; Sharps Management System (SMS) 2400m; Sharps Management System (SMS) 4000m; Sharps Management System (SMS) 10000m are disposable non-reusable sharps containers that are intended to provide for safe and effective disposal of medical sharps and/or medical/red-bag wastes. The Isolyser Sharps Management System (SMS) 5.3m is intended only for the storage and disposal of filled approved sharps containers and/or medical/red-bag wastes. The SMS 5.3m is not intended for the direct disposal of used medical sharps. The HSM 800m, SMS 2400m, SMS 4000m, SMS 10000m, and SMS 5.3m are marketed for home use by home healthcare providers and for use in the offices, exam. and patient rooms of small quantity generators such as medical doctors, dentists, veterinarians, and laboratories.
The SMSm container is stable, puncture resistant (SMS 5,3m not tested) and leak-proof on the sides and bottom. Used medical sharps and/or medical/red-bag wastes are placed vertically into the opening on the top of the container. Once placed into the container, the SMSm does not require users to reach by hand into the container to retrieve contaminated sharps and/or medical/red-bag wastes. Once the container is full, the SMSm is intended to be mailed back to WCM Waste and Compliance Management, Inc. for proper disposal. The overall design and specifications for the Isolyser SMSm meet OSHA Bloodborne Pathogens Standard as well as the American Society for Testing and Materials Standard F2132-01(2008) (SMS 5.3m not tested). All SMSm containers have BIOHAZARD warning labels clearly visible with lettering in contrasting color and are affixed by adhesives to the sides of the SMSm container.
Predicate Devices
The Isolyser SMSm sharps containers are substantially equivalent in intended use, function and basic composition to the Isolyser SMS sharps containers approved in 510(k) K943626 and Sharps Compliance, Inc.'s Sharps Disposal by Mail System 15000 [510(k) unknown], Specifically, the HSM 800m, SMS 2400m, SMS 4000m, and SMS 10000m have identical technological characteristics to the Isolyser SMS containers approved in 510(k) K943626; the containers are identical in size, composition, and design. In contrast to the Isolyser SMS approved in 510(k) K943626, the Isolyser SMSm is marketed as an empty container and does not contain the ingredients necessary to create a polymer to encapsulate used medical sharps. The SMS 5.3m has technological characteristics similar to Sharp Compliance. Inc.'s Sharps Disposal by Mail 15000. Both containers are closable plastic 5-gallon receptacles intended for the disposal of filled approved sharps containers and/or medical/red-bag wastes. The SMS 5.3m and the Sharps Disposal by Mail 15000 are not intended for the direct disposal of used medical sharps. Once filled, the Isolyser SMSm containers are mailed to WCM Waste and Compliance Management, Inc. for proper disposal. This disposal is substantially equivalent to Sharps Compliance, Inc.'s Sharps Disposal By Mail System.
Conclusion
The Isolyser SMSm is substantially equivalent to the predicate devices based on the descriptive data, compliance with standards, and indications for use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/16 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The eagle is positioned to the right of the circular text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
WCM Waste & Compliance Management, Incorporated C/o Ms. Sara Beth Watson Attorney ` Steptoe & Johnson LLP 1330 Connecticut Avenue, NW Washington, District of Columbia 20036
Re: K090157
Trade/Device Name: Isolyser SMSm Sharps Containers, Including Models: Home Sharps Management (HSM) 800m; Sharps Management System (SMS) 2400m; Sharps Management System (SMS) 4000m; Sharps Management System (SMS) 10000m, and Sharps Sharps Management System (SMS) 5.3m.
Regulation Number: 21 CFR 880.5570
Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II
Product Code: MMK
Dated: April 9, 2009
Received: April 10, 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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Canton V. Martin Jr.
S. B. B. S. M. A.
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K090157
Device Name: Isolyser SMSm Sharps Containers, including models: Home Sharps Management (HSM) 800m; Sharps Management System (SMS) 2400m; Sharps Management System (SMS) 4000m; Sharps Management System (SMS) 10000m, and Sharps Management System (SMS) 5.3m.
Indications For Use: The Isolyser Sharps Management Systems SMSm is a single-use, disposable, over-the-counter sharps container intended for use in clinical and non-clinical settings for the disposal of contaminated sharps and/or medical/red-bag wastes. The SMSm is marketed in five (5) different models: (1) Home Sharps Management (HSM) 800m, .98 liters, 3.45 x 2.72 x 7.29 (in.); (2) Sharps Management System (SMS) 2400m, 3.3 liters, 5 x 5x 10 (in.); (3) Sharps Mariagement System (SMS) 4000m, 5.97 liters, 8.47 x 5.99 x 8.87 (in.); (4) Sharps Management System (SMS) 10000m, 10.47 liters, 8.51 x 5.99 x 14.32 (in.); and (5) Sharps Management System (SMS) 5.3m, 21.1 liters, 11.93 x 9.87 x 14.68 (in.). Each SMSm model is designed to safely and securely contain used medical sharps and/or medical/red-bag wastes prior to removal and subsequent disposal. The SMS 5.3m is intended only for the storage and disposal of filled approved sharps containers and/or medical/red-bag wastes. Once an empty SMSm container has been filled with used medical sharps and/or medical/red-bag wastes, the entire SMSm container is intended to be packaged and mailed-back to WCM Waste and Compliance Management, Inc. for proper disposal. The HSM 800m, SMS 2400m, SMS 4000m, SMS 10000m, and SMS 5.3m are intended for home use by home health care providers and for use by small quantity health care providers such as dentists, medical doctors, veterinarians, and laboratories. The SMSm sharps containers are not intended for reuse.
Shula M. Murphy MD
ivision Sign-Off) ··vision of Anesthesiology, General Hospital *ection Control. Dental Devices
:0(k) Number: K090157
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).