(41 days)
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.
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.
Here's a breakdown of the requested information based on the provided text, though it's important to note that this document is not about a device that uses AI or sophisticated performance metrics. It's about orthopedic trays/kits/packs. As such, many of the requested categories (like AI-specific studies, ground truth establishment, training sets, etc.) are not applicable.
Acceptance Criteria and Device Performance (Not Applicable for this Submission)
The provided document for K971208 for "Orthopedic Trays/Kits/Packs" does not detail performance criteria or a study demonstrating the device meets those criteria in the way a medical device utilizing AI or a specific diagnostic/therapeutic function would. This submission is for an assemblage of existing medical materials, not a novel device requiring performance validation against specific metrics.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from this document. The document focuses on the contents being existing, approved components and the assembly process.
Non-Applicable Sections for K971208:
The following sections are not relevant to K971208 as it is a submission for orthopedic trays/kits/packs, which are assemblages of existing medical devices, not a new device with specific performance characteristics or AI components.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This submission doesn't involve a test set for performance evaluation of a novel device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. There is no ground truth, test set, or expert evaluation in the context of device performance.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI-assisted diagnostic or therapeutic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of K971208 (Based on the Provided Text)
The K971208 submission from Medline Industries, Inc. is for "Orthopedic Trays/Kits/Packs."
- Device Description: These are assemblages of medical materials (components from Medline and other manufacturers) intended for use by medical professionals during orthopedic procedures (e.g., total hip replacement, upper/lower extremity surgery, podiatry, total knee replacement). The contents, quantity, and placement of individual items are custom-specified by customers.
- Intended Use: The trays/kits/packs are for use by licensed physicians. The intended use of the individual components remains unchanged from their original manufacturer's intended use.
- Classification: The individual components within the trays are either Class I or Class II medical devices, drugs, or non-medical materials. Medline was unable to locate specific classifications for the assembled trays/kits/packs themselves.
- Manufacturing/Sterilization: Medline intends to assemble these kits in a class 10,000 clean room or controlled environment and sterilize them using either EtO or gamma radiation at a contracted sterilization facility.
- Substantial Equivalence: Medline certifies that the components or individual items within the assembled device were on the market prior to May 28, 1976, or have been shown by their manufacturer to be substantially equivalent to pre-amendment devices, or are exempt from 510(k) notification requirements. They also refer to similar procedure-specific kits already in commercial distribution by companies like Baxter Healthcare and Sterile Concepts.
This document serves as a 510(k) premarket notification for an assembled kit of existing, approved components, rather than a submission for a novel device requiring extensive performance testing against specific criteria.
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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.
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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.
§ 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.