The M & M Industries, Inc. Life-Latch® Sharps & Biohazard Containers are indicated for single use containment of medical waste, including, but not limited to, hypodermic needles, syringes, lancets, and blood needles. The containers can be used in a variety of health settings, such as hospitals, physician offices, dental offices, patient rooms, laboratories, home health and other generators of contaminated sharps or infectious waste. The sizes of containers that are the subject of this submission are the 3.5 gallon, 5.0 gallon and 6.5 gallon, in either white or black color.

Device Description

The Life Latch Sharps & BioHazard Container is a round white high density polyethylene (HDPE)) container. It has a flexible handle that rests at the side when not in use. The top of the container has one inch ridges all around the top, which fit into a slot around the inside of the lid. The container is fitted with an insert that snaps into four slots on the container near the top. This insert has a three inch opening in the center. Emanating from that opening are slots that remind one of six slices of pie. This allows the opening to be enlarged when necessary to add a large sharps product. I till and as a safety feature to allow visual checking of the extent that the container is filled while discouraging hands from touching the sharps. The lid has a safety lever to help prevent accidental opening of the container.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Life Latch® Sharps & BioHazard Container." This is a medical device application for substantial equivalence to a predicate device, not a study evaluating device performance against pre-defined acceptance criteria in the way a clinical trial or a novel technology assessment would.

Therefore, many of the requested points, such as sample size for test sets, expert adjudication, MRMC studies, and standalone performance, are not applicable in this context. The document focuses on demonstrating that the new device is "substantially equivalent" to an already legally marketed device by meeting relevant industrial standards.

Here's a breakdown of the information that can be extracted and a clear statement of what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Standard	Acceptance Criteria	Reported Device Performance
Material	Round white high-density polyethylene (HDPE) container with flexible handle.	Confirmed: Round white HDPE container with flexible handle.
Puncture Resistance	ASTM F2132-01 Standard Specification for Puncture Resistance of Materials Used in containers for Discarded Medical Needles and Other Sharps, Direct Method.	M&M Industries, Inc. Life Latch® Sharps & BioHazard Container production meets this standard.
Impact Resistance	Department of Transportation (DOT) Title 49 CFR Section 178.603 (Impact Resistance).	M&M Industries, Inc. Life Latch® Sharps & BioHazard Container production meets this standard.
International Transport Regulations	- U.N. Recommendations on the Transport of Dangerous Goods- International Maritime Dangerous Goods (IMDG) Code- International Civil Aviation Organization (ICAO) Technical Instructions- International Air Transport Association (IATA) Dangerous Goods Regulations	The Life Latch® Sharps & BioHazard Container is certified in accordance with the requirements set forth in these regulations.
Indications for Use (Equivalence)	Substantially equivalent to Sage Products, Inc. Sharps Disposal Containers with Screw Top Caps (K980490) for single-use containment of medical waste (hypodermic needles, syringes, lancets, blood needles) in various healthcare settings.	The device's indications for use are stated to be substantially equivalent to the predicate device.
Technological Characteristics (Equivalence)	Substantially equivalent in all areas impacting safety and effectiveness and technological characteristics to Sage Products, Inc. Sharps Disposal Containers with Screw Top Caps (K980490).	The conclusion states the device meets appropriate standards and raises no safety/efficiency issues or claims that differ from the predicate device.

2. Sample size used for the test set and the data provenance

Not Applicable. This document is a premarket notification (510(k)) demonstrating substantial equivalence to an existing device. It does not describe a study involving a particular "test set" of patient data or samples to evaluate clinical performance in the way a diagnostic or therapeutic device might. The "testing" referred to is against engineering standards for the physical product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No ground truth established by experts is mentioned or required for this type of device submission, which focuses on manufacturing standards and equivalence to a predicate device.

4. Adjudication method for the test set

Not Applicable. As no "test set" in the sense of patient data is described, there is no adjudication method.

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. This device (a sharps container) does not involve AI or human readers, so an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a physical container, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. The "ground truth" in this context is the adherence to established industry and transport standards (ASTM, DOT, U.N., IMDG, ICAO, IATA) for sharps disposal containers and the demonstration of substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

Not Applicable. There is no "training set" or corresponding ground truth.

Summary of the Study/Evidence:

The "study" in this context is the demonstration by M & M Industries, Inc. that their "Life Latch® Sharps & BioHazard Container" meets a series of established engineering and safety standards and is substantially equivalent to a predicate device.

Predicate Device: Sage Products, Inc. Sharps Disposal Containers with Screw Top Caps (K980490).
Demonstration Method: The manufacturer submitted evidence (implied through the 510(k) summary) that their product's characteristics and performance align with:
- ASTM F2132-01 (Puncture Resistance)
- DOT Title 49 CFR Section 178.603 (Impact Resistance)
- U.N. Recommendations on the Transport of Dangerous Goods
- International Maritime Dangerous Goods (IMDG) Code
- International Civil Aviation Organization (ICAO) Technical Instructions
- International Air Transport Association (IATA) Dangerous Goods Regulations
Conclusion: The FDA reviewed this evidence and determined that the device is "substantially equivalent" to the legally marketed predicate device, meaning it is as safe and effective and can be marketed.

Summary

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K071088

STRIES. INC.

ISO 9001:2000

316 CORPORATE PLACE CHATTANOOGA, TN 37419 (423) 821-3302 · (800) 331-5305 FAX (423) 821-9017 EMAIL pails@mmcontainer.com BSITE www.mmcontainer.com

SUMMARY OF SAFETY AND EFFECTIVENE 3.

SPONSOR IDENTIFICATION A.

M & M Industries, Inc. 316 Corporate Place Chattanooga, TN 37419 Office: 423.821.3302 Toll Free: 800.331.5305 Fax: 423.821.9017

JUL - 5 2007

ESTABLISHMENT REGISTRATION NUMBER: 1065324 B.

OFFICIAL CONTACT PERSON C.

Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group. Inc. 9109 Copenhaver Drive Potomac, MD 20854 estrin(@yourFDAconsultant.com

Tel: (301) 279 -2899 Fax: (301) 294-0126

DATE OF PREPARATION OF THIS SUMMARY* November 13, 2006 D.

PROPRIETARY (TRADE) NAME: E.

Life Latch® Sharps & BioHazard Container

Sharps collection and disposal system COMMON NAME: F.
CLASSIFICATION NAME: Accessory to needle, hypodermic, single lumen G.
REGULATION NUMBER: 21 CFR 880.5570 H.
PROPOSED REGULATORY CLASS: Class 2 I.
DEVICE PRODUCT CODE: 80 FMI J.
MEDICAL SPECIALTY: General Hospital K.

DESCRIPTION OF DEVICE L.

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Image /page/1/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "KC71088". The characters are handwritten and appear to be part of a code or identification number. The writing style is simple and clear, making the characters easily distinguishable.

center. Emanating from that opening are slots that remind one of six slices of pie. This allows the opening to be enlarged when necessary to add a large sharps product. I till and as a safety feature to allow visual checking of the extent that the container is filled while discouraging hands from touching the sharps. The lid has a safety lever to help prevent accidental opening of the container.

INDICATIONS FOR USE: M.

The M & M Industries, Inc. Life-Latch Sharps & Biohazard Containers are indicated for single use containment of medical waste, including, but not limited to, hypodermic needles, syringes, lancets, and blood needles. The containers can be used in a variety of health settings, such as hospitals, physician offices, dental offices, m a varrooms, laboratories, home health and other generators of contaminated sharps or infectious waste.

PREDICATE DEVICE: Sage Products, Inc. Sharps Disposal Containers with N. Screw Top Caps (K980490).

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: 0.

The Life Latch Sharps & BioHazard Container are substantially equivalent products in all areas impacting safety and effectiveness and technological characteristics to Sage Products, Inc., sharps Disposal Containers with Screw Top Caps (K980490).

TECHNOLOGICAL CHARACTERISTICS SUMMARY: P.

M & M Industries, Inc. Life Latch® Sharps & BioHazard Container production meets the following standards:

ASTM F2132-01 Standard Specification for Puncture Resistance of Materials Used in containers for Discarded Medical Needles and Other Sharps, Direct Method.

Department of Transportation (DOT) Title 49 CFR Section 178.603 (Impact Resistance).

The Life Latch® Sharps & BioHazard Container is certified in accordance with the requirements set forth in:

U.N. Recommendations on the Transport of Dangerous Goods .
International Maritime Dangerous Goods (IMDG) Code .
International Civil Aviation Organization (ICAO) Technical Instructions .
International Air Transport Association (IATA) Dangerous Goods .
Regulations :

CONCLUSION Q.

M & M Industries, Inc. Life Latch Sharps & BioHazard Container meets appropriate standards and raises no safety/efficiency issues or claims that differ from the predicate device cited.

6-0054

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

M&M Industries, Incorporated C/O Dr. Norman F. Estrin President Estrin Consulting Group, Incorporated 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K071088

Trade/Device Name: Life-Latch® Sharps & Biohazard Containers Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: June 11, 2007 Received: June 15, 2007

Dear Dr. Estrin:

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.

JUL - 5 2007

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,

Sincerely yours,

Sujette Y. Michie PhD

Chiu Lin, Ph.D. 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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ATTACHMENT A

Indications for Use 510(k) Number (if known): _ KO7 | 088

Device Name: Life-Latch® Sharps & Biohazard Containers

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shade H. Murphy, K2

ision Sign-Off) L'ivision of Anesthesiology, General Hospital, Intection Control, Dental Devices

510(k) Number :_

Page of

(Posted November 13, 2003) ___________________________________________________________________________________________________________________________________________________

0 0004

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).