(78 days)
Not Found
No
The device description and intended use clearly describe a physical container for medical waste, with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
No
The device is a container for medical waste; it does not directly treat or diagnose a medical condition.
No
The device is a sharps and biohazard containment unit, not a device used to diagnose medical conditions. Its purpose is to safely store medical waste.
No
The device is a physical container made of high-density polyethylene (HDPE) for the containment of medical waste, including sharps. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the containment of medical waste, specifically sharps and biohazards. This is a physical containment function, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description details a physical container designed for safe disposal. There is no mention of reagents, assays, or any components used for analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays
- Measuring analytes
The device is a medical device, specifically a sharps and biohazard container, but it falls under a different regulatory classification than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
80 FMI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
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
1
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
2
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.
3
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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Image /page/4/Picture/0 description: The image shows an exclamation point inside of a document icon on the left side of the image. To the right of the icon, the word "CONFIDENTIAL" is written in all capital letters. The text and icon are in black and the background is white.
ATTACHMENT A
Indications for Use 510(k) Number (if known): _ KO7 | 088
Device Name: Life-Latch® Sharps & Biohazard Containers
Indications for Use:
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.
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) ___________________________________________________________________________________________________________________________________________________
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