(41 days)
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No
The device description focuses on the assembly and sterilization of standard medical materials for orthopedic procedures, with no mention of AI or ML capabilities.
No
The device is described as an assemblage of medical materials for use during orthopedic procedures, not for treating a condition itself.
No
The divine description states that the product is an "assemblage of medical materials to be used by medical professionals during orthopedic procedures." These trays/kits/packs contain materials for surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is an assemblage of physical medical materials and devices, 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 licensed physicians to use the assembled medical products during orthopedic procedures. This involves direct use on or within the patient's body during surgery.
- Device Description: The device is an assemblage of medical materials (devices and/or drugs) used during orthopedic procedures. These are tools and supplies for surgical intervention.
- Lack of IVD Characteristics: An IVD is a medical device intended to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The description of the Medline Orthopedic Trays/Kits/Packs does not mention any such use or analysis of specimens.
The device described is a collection of surgical supplies and instruments intended for use in vivo (within the body) during surgical procedures.
N/A
Intended Use / Indications for Use
Medline Orthopedic Trays/Kits/Packs are intended for use by licensed physicians. The intended use of the medical products assembled in these kits will not be changed from the manufacturer's original intended use.
Product codes
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Device Description
Medline Orthopedic Travs/Kits/Packs are an assemblage of medical materials to be used by medical professionals during orthopedic procedures such as total hip replacement, upper or lower extremity surgery, podiatry, and total knee replacement procedures. These packs may be produced for other procedures that are considered orthopedic surgery. The trays will be assembled using Medline and other manufacturer's materials, medical devices and/or drugs.
The devices are custom to our customers who specify the contents, quantity and placement of the individual items in the tray, kit, or pack. Attached is a list of individual components that are likely to be in any of these devices. These items are standard for Orthopedic procedures and we expect that only quantities will change from one tray to another. The customer may also specify a specific brand of similar items or minor variations of items.
Medline intends to assemble these kits in a class 10,000 clean room or controlled environment and to sterilize using either EtO or gamma radiation at a contracted sterilization facility.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
licensed physicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
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Image /page/0/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a stylized, sans-serif font. Above and below the word are two triangular shapes that resemble the top and bottom points of a compass. The logo is in black and white.
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
SUMMARY OF SAFETY AND EFFECTIVENESS
MAY 13 1997
Medline Industries, Inc. One Medline Place Mundelein, IL 60060 Registration #: 1417592 (847) 949-2639 Phone: (847) 949-2643 Fax: Lara N. Simmons Corporate Regulatory Affairs Manager
March 31, 1997
DEVICE NAME: Orthopedic Trays/Kits/Packs PROPRIETARY NAME: Medline Orthopedic Trays/Kits/Packs COMMON NAME: Orthopedic Trays/Kits/Packs PERFORMANCE STANDARDS: None per Section 514.
CLASSIFICATION NAME:
The contents of each We have been unable to locate specific classifications for these devices. trav are either Class I or Class II medical devices, drugs or non-medical materials (i e. packaging, cartons and labels).
PRODUCT SPECIFICATIONS
Medline Orthopedic Travs/Kits/Packs are an assemblage of medical materials to be used by medical professionals during orthopedic procedures such as total hip replacement, upper or lower extremity surgery, podiatry, and total knee replacement procedures. These packs may be produced for other procedures that are considered orthopedic surgery. The trays will be assembled using Medline and other manufacturer's materials, medical devices and/or drugs.
The devices are custom to our customers who specify the contents, quantity and placement of the individual items in the tray, kit, or pack. Attached is a list of individual components that are likely to be in any of these devices. These items are standard for Orthopedic procedures and we expect that only quantities will change from one tray to another. The customer may also specify a specific brand of similar items or minor variations of items.
Medline intends to assemble these kits in a class 10,000 clean room or controlled environment and to sterilize using either EtO or gamma radiation at a contracted sterilization facility.
INTENDED USE/INDICATIONS FOR USE
Medline Orthopedic Trays/Kits/Packs are intended for use by licensed physicians. The intended use of the medical products assembled in these kits will not be changed from the manufacturer's original intended use.
1
SUBSTANTIAL EQUIVALENCE
We certify that components or individual items of the assembled device have been on the market prior to May 28, 1976, or have been shown by their manufacturer to be substantially equivalent to pre-amendment devices, or to be exempt from 510(k) notification requirements.
Many companies assemble various medical devices into a kit or tray for specific medical procedures. Similar procedure specific kits are in commercial distribution and are marketed by Baxter Healthcare, located in Waukegan, Illinios, and Sterile Concepts located in Richmond, VA .
We are unable to locate 510(k)s for this category of kits for Baxter.