(81 days)
No
The device description and intended use clearly state that the device is an assemblage of standard medical and non-medical materials in a kit format. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device description clearly states that these kits are for 'protection' and consist of an 'assemblage of medical and non-medical materials' for 'employee protection from body fluids or other potentially hazardous situations'. This indicates a preventative or protective function, not a therapeutic one.
No
The device description indicates that it is a collection of protective materials and devices (e.g., masks, gloves) for employee protection, not for diagnosing medical conditions.
No
The device description clearly states it is an "assemblage of medical and non-medical materials" and lists physical components like masks and gloves, indicating it is a hardware-based device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for personal protection from body fluids and hazardous situations, not for the diagnosis of diseases or conditions using in vitro methods (testing samples like blood, urine, etc.).
- Device Description: The device is an assemblage of medical and non-medical materials for personal protection. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes (substances in the body)
- Providing diagnostic information
The device is clearly intended for personal protective equipment (PPE) purposes, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Medine Personal Protection Kits are intended for use by, but not limited to, hospitals and medical centers. The original intended use of the medical products assembled in these kits will not be changed.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Medline Employee Protection Kits are an assemblage of medical and non-medical materials to be used by employees who may need protection from body fluids or other potentially hazardous situations where employee protection may be needed. The kits will be assembled using Medline and other manufacturer's medical devices and materials.
The devices are custom to our customers who specify the contents, quantity and placement of the individual items kit. Attached is a list of individual components that are likely to be in any of these kits. These items are standard and we expect that only quantities will change from one kit to another. The customer may also specify a specific brand of similar items or minor variations of items.
These kits are non-sterile and are shrink-wrapped to maintain kit integrity and cleanliness.
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
hospitals and medical centers
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
Image /page/0/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a stylized, italicized font. Below the text is a symbol that resembles a stylized compass or star. The symbol has a sharp, pointed shape at the top and a curved shape at the bottom.
Medline Industries, Inc.
One Medline Place Mundelein, Illinois 60060.4486 1.847.949.3109 1.800.950.0128 Fax 1.847.949.2643
Corporate Quality Assurance/Regulatory A
February 19, 1997
-
- Submitters Information: MAR | | 1997 Medline Industries, Inc. Dynacor Division One Medline Place Mundelein. IL 60060 Phone: 847-949-5500 Fax: 847-949-2643 Contact: - - Christine Galea Corporate Regulatory Affairs
- Device Information: 2.
A.
- Trade Name: Medline Employee Protection Kit
- Employee Protection Kit B. Common Name:
-
- Substantial Equivalence Claim: Medline claims substantial equivalence to K952962, EZ Personal Protection Kit, made by Safetec of America, Inc.
-
- Device Description: Medline Employee Protection Kits are an assemblage of medical and non-medical materials to be used by employees who may need protection from body fluids or other potentially hazardous situations where employee protection may be needed. The kits will be assembled using Medline and other manufacturer's medical devices and materials.
The devices are custom to our customers who specify the contents, quantity and placement of the individual items kit. Attached is a list of individual components that are likely to be in any of these kits. These items are standard and we expect that only quantities will change from one kit to another. The customer may also specify a specific brand of similar items or minor variations of items.
These kits are non-sterile and are shrink-wrapped to maintain kit integrity and cleanliness.
1
1
Image /page/1/Picture/0 description: The image shows the Medline logo. The word "MEDLINE" is in bold, sans-serif font. A symbol that resembles a compass is below the text. The compass symbol has a thick, black outline.
Medline Industries, Inc.
...
One Medline Place Mundelein, Illinois 60060.4486
1.847.949.3109 1.800.950.0128 Fax 1.847.949.2643
Corporate Quality Assurance/Regulatory Affairs
510(K) SUMMARY (CONT)
K9669107
P2/3
Page 8.1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
-
ട. Intended Use:
Medine Personal Protection Kits are intended for use by, but not limited to, hospitals and medical centers. The original intended use of the medical products assembled in these kits will not be changed. -
- Technological Characteristics:
网址
- Technological Characteristics:
. .
- . . . .
There are no technological differences between the new device and the predicate device, -- - - - -
From the above data, we have determined that the Medline Employee Protection Kits are substantially equivalent in design and performance to K952962, EZ Personal Protection Kit marketed by Safetec of America, Inc.
The safety and effectiveness of Medline Employee Protection Kit is dependent upon proper usage of the products and medical devices that are present in each type of kit.
2
EXHIBIT 1
Medline Component List of items most likely to be used in our Employee Protection Kit.
...
... .. .. .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
K965107
p3/3.
COMPONENT LIST
| COMPONENT | REGULATORY STATUS |
|---|---|
| Glass Free Mask | K875172 |
| Glove, Exam Latex | K962094 |
| Goggles, Vents Standard | Not A Medical Device |
| Isolation Gown | Pre-Amendment Exempt |
| Latex Glove Powder Free | K962095 |
| Liner 7 X 17 W/Polymer | Not A Medical Device |
| Sheer Fit Cap, Blue 24" (bouffant cap) | Pre-Amendment Exempt |
| Shieldmate Mask W/Ties | Pre-Amendment Exempt |
| Shoe Cover Impervious, White Bulk | Pre-Amendment Exempt |
| Shoe Cover Spunbond Non-Conductive | Pre-Amendment Exempt |