2 GALLON ALTERNATE CARE SHARPS CONTAINER

K973911 · Sage Products, Inc. · FMI · Oct 29, 1997 · General Hospital

Device Facts

• Record ID: K973911
• Device Name: 2 GALLON ALTERNATE CARE SHARPS CONTAINER
• Applicant: Sage Products, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Oct 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Sage 2 Gallon Alternate Care Sharps Container is intended for single use disposal of used or contaminated medical sharps, including, but not limited to, hypodermic needles, syringes, lancets, IV Cassettes, and Blood Needles. Sage 2 Gallon Alternate Care Sharps Containers are used in both clinical and nonclinical settings.

Device Story

Injection-molded, single-use, non-sterile, disposable plastic container; designed for safe collection and transport of contaminated medical sharps (needles, syringes, lancets, IV cassettes). Features include one-handed disposal mechanism and secure lid closure. Used in clinical and non-clinical settings; operated by healthcare personnel or users requiring sharps disposal. Provides puncture-resistant, leak-proof containment to prevent accidental injury and ensure safe handling/transport. Complies with OSHA Bloodborne Pathogens standards for stability, impact resistance, and accessibility.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness are based on compliance with OSHA Bloodborne Pathogens standards (21 CFR 1910.1030) regarding puncture resistance, leak resistance, stability, and closure mechanisms.

Technological Characteristics

Injection-molded plastic container; non-sterile; single-use. Features include hinged lid/rotor for one-handed disposal. Designed for impact resistance, puncture resistance, and leak-proof containment. Complies with OSHA 21 CFR 1910.1030 standards for sharps disposal containers.

Indications for Use

Indicated for the disposal of used or contaminated medical sharps, including hypodermic needles, syringes, lancets, IV cassettes, and blood needles in clinical and non-clinical settings.

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

• 2 Gallon Sharps Container with Hinged Lid and Rotor #8535 (Sage Products, Inc.)
• 5 Quart Sharp Star #8508 (Sage Products, Inc.)
• 2 Quart Sharps Disposal Container #1522 (Sage Products, Inc.)

Submission Summary (Full Text)

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Image /page/0/Picture/1 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. The logo is simple and modern.

# Pre-Market Notification: 2 Gallon Alternate Care Sharps Container

510K Summary

1

| A. | Company Name | Sage Products Inc. |
|----|-----------------------------------------|---------------------------------------------------------------|
| | B. Applicants Name | Karen Pinto<br>Regulatory Affairs Manager |
| | 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 |
| E. | Address(es) of Sterilizing Site(s) | N/A-Product is non-sterile |
| F. | Date of Application | October 13, 1997 |

#### Device 2

| A. Trade or Proprietary Name | 2 Gallon Alternate Care Sharps Container |
|------------------------------|----------------------------------------------------------------|
| B. Common Name | Sharps Container |
| C. Classification Name | Accessory to Hypodermic Single Lumen Needle<br>(CFR: 880.5570) |
| D. Classification | II |
| E. Panel | 80 |
| F. Procodes | FMI |

Section 10, page 17 of 19 of Submission

page 1 of 3 of Summary

"Innovative health care products since 1971"

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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. A horizontal line is placed above the phrase "PRODUCTS INC".

### Pre-Market Notification: 2 Gallon Alternate Care Sharps Container 510K Summary

#### 3 General Description

The Sage 2 Gallon Alternate Care Sharps Container is an injection molded, single use, non-sterile, disposable, sharps disposal container. The product is designed to hold sharps such as angio-caths, blood needles, lancets and various sized syringes and non-sharps such as drug infusion cassettes.

#### Substantial Equivalence ব

#### Predicate Devices for Sage Products, Inc. 2 Gallon Alternate Care Sharps Container A.

- 2 Gallon Sharps Container with Hinged Lid and Rotor #8535 by Sage Products, Inc. A
- > 5 Ouart Sharp Star #8508 by Sage Products, Inc.
- > 2 Quart Sharps Disposal Container #1522 by Sage Products, Inc.

#### Rationale Discussion B.

In summary, all four products are plastic, non-sterile, disposable, sharps transport containers. All the devices allow for one-handed disposal of sharps and offer a means of closure.

Section 10, page 18 of 19 of Submission

page 2 of 3 of Summary

"Innovative health care products since 1971"

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Image /page/2/Picture/0 description: The image shows the logo for SAGE PRODUCTS INC. The word "SAGE" is in large, bold, sans-serif font, with a horizontal line extending from either side. Below the line, the words "PRODUCTS INC" are written in a smaller, sans-serif font. The logo is in black and white.

## Pre-Market Notification: 2 Gallon Alternate Care Sharps Container 510K Summary

#### Design Features 5

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

Section 10, page 19 of 19 of Submission

page 3 of 3 of Summary

"Innovative health care products since 1971"

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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Pinto Requlatory Affairs Manager Sage Products, Incorporated 815 Tek Drive Crystal Lake, Illinois 60014

OCT 2 9 1997

K973911 Re : 2 Gallon Alternate Care Sharps Container Trade Name: Requlatory Class: II Product Code: FMI Dated: October 13, 1997 October 14, 1997 Received:

Dear Ms. Pinto:

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. ਉ 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 regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Ms. Pinto

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 diaqnostic 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,

Timc Hy 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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510(k) Number (if known): Unknown

Device Name:

Indications For Use:

The Sage 2 Gallon Alternate Care Sharps Container is intended for single use disposal of used or contaminated medical sharps, including, but not limited to, hypodermic needles, syringes, lancets, IV Cassettes, and Blood Needles. Sage 2 Gallon Alternate Care Sharps Containers are used in both clinical and nonclinical settings.

[Section 9, Page 16 o19]

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chin S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Format 1-2-96)