SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS

K980490 · Sage Products, Inc. · MMK · Feb 24, 1998 · General Hospital

Device Facts

• Record ID: K980490
• Device Name: SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
• Applicant: Sage Products, Inc.
• Product Code: MMK · General Hospital
• Decision Date: Feb 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended 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.

Device Story

Molded, single-use, non-sterile, disposable plastic containers for sharps disposal; rectangular or circular shapes; screw top closure; optional neck insert to prevent sharps exit. Used in healthcare settings (physician/dental offices, labs, home health, patient rooms) for one-handed disposal of used sharps (angio-caths, needles, lancets, syringes). Provides puncture-resistant, leak-proof containment for medical waste; ensures safe handling and transport. Healthcare providers or patients deposit sharps into container; container is closed/locked when full to prevent injury or exposure.

Clinical Evidence

Bench testing only. No clinical data provided. Performance evaluated against OSHA Bloodborne Pathogens standards (21 CFR 1910.1030) for puncture resistance, leak resistance, closure, and stability.

Technological Characteristics

Plastic construction; screw top closure; optional neck insert; rectangular or circular form factor; non-sterile; manual operation; no energy source; no software.

Indications for Use

Indicated for single-use disposal of used or contaminated medical sharps (e.g., hypodermic needles, syringes, lancets, blood needles) in healthcare settings including physician/dental offices, laboratories, home health, and patient rooms.

Regulatory Classification

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.

Predicate Devices

• Large Volume Sharps Container by Sage Products, Inc.
• 3 Quart Sharps Container by OnGard Systems, Inc.

Submission Summary (Full Text)

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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 Falkstrom<br>Regulatory Affairs Associate |
| CRYSTAL LAKE, | |
| C. Street Address | 815 Tek Drive<br>Crystal Lake, IL 60014 |
| D. Address(es) of Manufacturing Site(s) | Sage Products, Inc.<br>815 Tek Drive<br>Crystal 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 Disposal<br>Containers with Screw Top Caps |
|------------------------------|-----------------------------------------------------------------------|
| B. Common Name | Sharps Containers |
| 815-455-4700 | |
| C. Classification Name | Accessory to Hypodermic Single Lumen<br>Needle (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

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Page 2 of 3 of Summary

www.sageproducts.com

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Image /page/2/Picture/0 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and white and features a bold, sans-serif font. The word "SAGE" is in large letters, and the words "PRODUCTS INC" are in smaller letters below. 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

**5 Design Features**

| | Design<br>Feature | Safety and Effectiveness Basis |
|---------------|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CRYSTAL LAKE, | Impact<br>Resistance | The impact resistance test will provide information about the<br>containers ability to retain solid contents, following lid closure and<br>locking, in the event it is dropped during handling/transport. |
| ILLINOIS | Puncture<br>Resistance | Contaminated sharps shall be discarded immediately or as soon as<br>feasible in containers that are puncture resistant. Ref: OSHA<br>Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, ii |
| 39-9693 | Overfill<br>Detection | During use, containers for contaminated sharps shall be replaced<br>routinely and not be allowed to overfill. Ref: OSHA Bloodborne<br>Pathogens 21 CFR 1910.1030, d, 4, iii, A, 2, iii |
| | Leak<br>Resistance | Contaminated sharps shall be discarded immediately or as soon as<br>feasible in containers that are Leak Proof on sides and bottom. Ref:<br>OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, iii. |
| | Sharps<br>Access and<br>Closure | Contaminated sharps shall be discarded immediately or as soon as<br>feasible in containers that are closable. Ref: OSHA Bloodborne<br>Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, i |
| | Stability | During use, containers for contaminated sharps shall be maintained<br>upright throughout use. Ref: OSHA Bloodborne Pathogens 21 CFR<br>1910.1030, d, 4, iii, A, 2, ii |
| 815-455-4700 | Mounting<br>Accessories | During use, containers for contaminated sharps shall be easily<br>accessible to personnel and located as close as is feasible to the<br>immediate area where sharps are used or can be reasonably anticipated<br>to be found. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030,<br>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 be<br>packaged so that its contents could harm employees, equipment, or<br>other mail." |

## Page 20 of 20 of Submission

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three profiles overlapping to create a sense of depth and movement. The figure is positioned within a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" encircling the top half of the circle.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)