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 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.

AI/ML Overview

I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance results, or any study conducted for the "2 Gallon Alternate Care Sharps Container."

The document is a 510(k) Pre-Market Notification summary, which focuses on:

Company and Device Identification: Identifying Sage Products Inc. and the specific sharps container.
General Description: Describing the device's basic characteristics (injection molded, single-use, non-sterile, disposable, designed to hold sharps).
Substantial Equivalence: Listing predicate devices to which the current device is deemed substantially equivalent. This is a key part of the 510(k) process, arguing that the new device is as safe and effective as a legally marketed device.
Design Features and Safety/Effectiveness Basis: This section lists the design features like impact resistance, puncture resistance, leak resistance, etc., and cites regulatory references (OSHA Bloodborne Pathogens 21 CFR 1910.1030) as the basis for these features. It does not provide acceptance criteria values or test results of the device against these features. It only states why these features are important.
FDA Clearance Letter: Confirming that the FDA has reviewed the notification and determined the device is substantially equivalent, allowing it to be marketed.
Indications For Use: Stating the intended purpose of the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information regarding:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample size used for the test set and the data provenance: No test set or study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no study is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size: Not applicable as this is a physical medical device, not an AI or imaging diagnostic tool.
If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document focuses on regulatory clearance based on substantial equivalence to existing devices, not on detailed performance study results against specific acceptance criteria.

Summary

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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

A.	Company Name	Sage Products Inc.
	B. Applicants Name	Karen PintoRegulatory Affairs Manager
	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
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(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

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 toretain solid contents, following lid closure and locking, in the event it is droppedduring handling/transport.
PunctureResistance	Contaminated sharps shall be discarded immediately or as soon as feasible incontainers that are puncture resistant. Ref: OSHA Bloodborne Pathogens 21CFR 1910.1030, d, 4, iii, A, 1, ii
Overfill Detection	During use, containers for contaminated sharps shall be replaced routinely andnot be allowed to overfill. Ref: OSHA Bloodborne Pathogens 21 CFR1910.1030, d, 4, iii, A, 2, iii
Leak Resistance	Contaminated sharps shall be discarded immediately or as soon as feasible incontainers that are Leak Proof on sides and bottom. Ref: OSHA BloodbornePathogens 21 CFR 1910.1030, d, 4, iii, A, 1, iii.
Sharps Access andClosure	Contaminated sharps shall be discarded immediately or as soon as feasible incontainers that are closable. Ref: OSHA Bloodborne Pathogens 21 CFR1910.1030, d, 4, iii, A, 1, i
Stability	During use, containers for contaminated sharps shall be maintained uprightthroughout use. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii,A, 2, ii
MountingAccessories	During use, containers for contaminated sharps shall be easily accessible topersonnel and located as close as is feasible to the immediate area where sharpsare used or can be reasonably anticipated to be found. Ref: OSHA BloodbornePathogens 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 (301) 594-4618. 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,

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:

[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)

Regulation Number and Section

§ 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).