(15 days)
The Sage Sharps Disposal Containers with Screw Top Caps is intended for single use disposal of used or contaminated medical sharps, including, but not limited to, hypodermic needles, syringes, lancets, and Blood Needles. The containers can be used in variety of healthcare settings. The containers are suitable for physician offices, dental offices, laboratories, home health and other generators of medical waste. The containers are also appropriate for patient room applications.
The Sage Products, Inc. Sharps Containers with Screw Top Caps are molded, single use, non-sterile, disposable, sharps disposal containers. The containers are designed to hold used sharps such as angio-caths, blood needles, lancets and various sized syringes. Various sizes of the container will be offered to meet customer disposal needs. The shape of the container will either be rectangular or circular depending upon its size. The only access to the container is through the screw top closure. Products will be available with or without a neck insert at the opening to limit the ability of the sharps to exit the container after disposal.
The provided text describes a Pre-Market Notification (510K) for Sharps Containers with Screw Top Caps and does not contain information about the acceptance criteria or a study that proves the device meets specific performance metrics in the way typically associated with AI/ML medical devices. The document focuses on regulatory compliance, design features, and substantial equivalence to predicate devices.
However, I can extract the "Design Features" and their "Safety and Effectiveness Basis" which can be interpreted as the functional requirements or "acceptance criteria" that the device is intended to meet. The "study" in this context refers to the rationale and regulatory references provided for each design feature, rather than a formal clinical or technical performance study with quantitative results.
Here's the information extracted from the document, framed to best answer your request:
Acceptance Criteria and Documented Device "Performance"
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Design Feature) | Safety and Effectiveness Basis (Reported "Performance" / Rationale) |
|---|---|
| Impact Resistance | The impact resistance test will provide information about the container's ability to retain solid contents, following lid closure and locking, in the event it is dropped during handling/transport. |
| Puncture Resistance | Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are puncture resistant. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, ii |
| Overfill Detection | During use, containers for contaminated sharps shall be replaced routinely and not be allowed to overfill. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 2, iii |
| Leak Resistance | Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are Leak Proof on sides and bottom. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, iii. |
| Sharps Access and Closure | Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are closable. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, i |
| Stability | During use, containers for contaminated sharps shall be maintained upright throughout use. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 2, ii |
| Mounting Accessories | During use, containers for contaminated sharps shall be easily accessible to personnel and located as close as is feasible to the immediate area where sharps are used or can be reasonably anticipated to be found. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 2, i |
| Handling | Sharps containers should be safe and easy to handle in transport. |
| Capacity | This value gives the user an estimate or comparison of volume. |
| Mailability | Per the Domestic Mail Manual, Section 2.2, "No item may be packaged so that its contents could harm employees, equipment, or other mail." |
Additional Information Not Present in the Document:
The provided text is a summary for a traditional medical device (sharps containers) and does not involve AI/ML. Therefore, the following points are not applicable or cannot be answered from the provided text:
- Sample sized used for the test set and the data provenance: Not applicable. The document discusses design features and regulatory compliance for physical sharps containers. It does not refer to a "test set" in the context of data for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not relevant for this device.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI algorithm.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for these containers is their physical adherence to safety standards and regulations (e.g., puncture resistance, leak-proof).
- The sample size for the training set: Not applicable. There is no training set for a physical sharps container.
- How the ground truth for the training set was established: Not applicable.
Summary of the "Study" and "Proof" within this context:
The "study" that proves the device meets the "acceptance criteria" (design features) is implicitly the Pre-Market Notification (510K) submission process itself. This process requires the manufacturer to demonstrate that their device is "substantially equivalent" to predicate devices already on the market. The provided "Safety and Effectiveness Basis" for each design feature serves as the manufacturer's justification and commitment that the device meets these functional requirements, usually through adherence to established standards (like OSHA regulations) or through internal testing (e.g., "impact resistance test will provide information...").
The FDA's letter (K980490) confirms that, based on the information provided in the 510(k) submission, the device is considered substantially equivalent and can be marketed, implying that the detailed justification for each design feature (which would have included test reports or validated design specifications) was satisfactory.
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Image /page/0/Picture/0 description: The image shows the logo for Sage Products Inc. The logo is in black and white and features a stylized font. The word "SAGE" is in large, bold letters, and below it, in smaller letters, is "PRODUCTS INC" with a line above it.
815 TEK DRIVE
Pre-Market Notification: Sharps Containers with Screw Top Caps
510K Summary
K980490
| 1 Identification of Applicant | |
|---|---|
| P.O. Box 9693 | |
| A. Company Name | Sage Products Inc. |
| B. Applicants Name | Christine FalkstromRegulatory Affairs Associate |
| CRYSTAL LAKE, | |
| C. Street Address | 815 Tek DriveCrystal Lake, IL 60014 |
| D. Address(es) of Manufacturing Site(s) | Sage Products, Inc.815 Tek DriveCrystal Lake, IL 60014 |
| ILLINOIS | |
| E. Address(es) of Sterilizing Site(s) | N/A-Product is non-sterile |
| 039-9693 | |
| F. Date of Application | February 6, 1998 |
2 Cover Letter
| A. Trade or Proprietary Name | Sage Products, Inc. Sharps DisposalContainers with Screw Top Caps |
|---|---|
| B. Common Name | Sharps Containers |
| 815-455-4700 | |
| C. Classification Name | Accessory to Hypodermic Single LumenNeedle (CFR: 880.5570) |
| D. Classification | II |
| 800-323-2220 | |
| E. Panel | 80 |
| F* *815-455-5599 | |
| F. Procodes | FMI |
Page 18 of 20 of Submission
Page 1 of 3 of Summary
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Image /page/1/Picture/0 description: The image shows the logo for SAGE Products Inc. The logo is in black and white, with the word "SAGE" in large, bold letters. Below the word "SAGE" is the phrase "PRODUCTS INC" in smaller letters. There is a registered trademark symbol to the right of the letter E in SAGE.
Pre-Market Notification: Sharps Containers with Screw Top Caps 510K Summary 815 TEK DRIVE P.O. Box 9693 The Sage Products, Inc. Sharps Containers with Screw Top Caps are molded, single use, non-sterile, disposable, sharps disposal containers. The containers are designed to hold used sharps such as angio-caths, blood needles, lancets and various sized syringes. Various sizes of the container will be offered to meet customer disposal CRYSTAL LAKE needs. The shape of the container will either be rectangular or circular depending upon its size. The only access to the container is through the screw top closure. Products will be available with or without a neck insert at the opening to limit the ability of the sharps to exit the container after disposal. ILUNOIS .39-9693 Predicate Devices for Sage Products, Inc. Sharps Containers with Screw A. Top Caps > Large Volume Sharps Container by Sage Products, Inc. A 3 Quart Sharps Container by OnGard Systems, Inc. B. Rationale Discussion In summary, all products are plastic, non-sterile, disposable, sharps transport containers intended for use where medical waste is generated. All the devices 815-455-4700 allow for one handed disposal of sharps and offer a means of closure. 800-323-2220
5 . 815-455-5599
Page 19 of 20 of Submission
Page 2 of 3 of Summary
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Pre-Market Notification: Sharps Containers with Screw Top Caps 510K Summary
815 Tek Drive
5 Design Features
| DesignFeature | Safety and Effectiveness Basis | |
|---|---|---|
| CRYSTAL LAKE, | ImpactResistance | The impact resistance test will provide information about thecontainers ability to retain solid contents, following lid closure andlocking, in the event it is dropped during handling/transport. |
| ILLINOIS | PunctureResistance | Contaminated sharps shall be discarded immediately or as soon asfeasible in containers that are puncture resistant. Ref: OSHABloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, ii |
| 39-9693 | OverfillDetection | During use, containers for contaminated sharps shall be replacedroutinely and not be allowed to overfill. Ref: OSHA BloodbornePathogens 21 CFR 1910.1030, d, 4, iii, A, 2, iii |
| LeakResistance | Contaminated sharps shall be discarded immediately or as soon asfeasible in containers that are Leak Proof on sides and bottom. Ref:OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, iii. | |
| SharpsAccess andClosure | Contaminated sharps shall be discarded immediately or as soon asfeasible in containers that are closable. Ref: OSHA BloodbornePathogens 21 CFR 1910.1030, d, 4, iii, A, 1, i | |
| Stability | During use, containers for contaminated sharps shall be maintainedupright throughout use. Ref: OSHA Bloodborne Pathogens 21 CFR1910.1030, d, 4, iii, A, 2, ii | |
| 815-455-4700 | MountingAccessories | During use, containers for contaminated sharps shall be easilyaccessible to personnel and located as close as is feasible to theimmediate area where sharps are used or can be reasonably anticipatedto be found. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030,d, 4, iii, A, 2, i |
| Handling | Sharps containers should be safe and easy to handle in transport. | |
| 800-323-2220 | Capacity | This value gives the user an estimate or comparison of volume. |
| 815-455-5599 | Mailablitiy | Per the Domestic Mail Manual, Section 2.2, "No item may bepackaged so that its contents could harm employees, equipment, orother mail." |
Page 20 of 20 of Submission
Page 3 of 3 of Summary
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1998
Ms. Christine Falkstrom Requlatory Affairs Associate Sage® Products Incorporated 815 Tek Drive Crystal Lake, Illinois 60014
Re : K980490 Sage Products Incorporated, Sharps Disposal Trade Name: Containers with Screw Top Caps Requlatory Class: II Product Code: FMI February 6, 1998 Dated: February 9, 1998 Received:
Dear Ms. Falkstrom:
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 regulations affecting your device can be found in the Code of Federal Requiations, Title 21, Parts 800 to 895. ਜੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in this response to your the Federal Register. Please note: premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Ms. Falkstrom
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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,
K. Uelker
Timot wy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): Unknown
Sharps Disposal Containers with Screw Top Caps Device Name:
Indications For Use:
The Sage Sharps Disposal Containers with Screw Top Caps is intended for single use disposal of used or contaminated medical sharps, including, but not limited to, hypodermic needles, syringes, lancets, and Blood Needles. The containers can be used in variety of healthcare settings. The containers are suitable for physician offices, dental offices, laboratories, home health and other generators of medical waste. The containers are also appropriate for patient room applications.
[Section 10, Page 17 of 20]
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Claus S. Hin
(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)
§ 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).