(294 days)
Not Found
No
The device is described as an assemblage of medical materials in a kit, with no mention of software, algorithms, or any technology that would incorporate AI/ML.
No
The device is described as an assemblage of medical materials for use during procedures, not for treatment or therapy itself.
No
The device is described as an assemblage of medical materials for procedures like cardiac catheterization, angiography, or arteriorgram, which are typically interventional or diagnostic procedures, but the "trays/kits/packs" themselves are not stated to perform diagnosis. They facilitate the procedures.
No
The device is described as 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 medical professionals during procedures like cardiac catheterization, angiography, and arteriorgram. These are invasive procedures performed directly on the patient.
- Device Description: The device is an assemblage of medical materials used during these procedures. It does not involve testing samples in vitro (outside the body) to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Medline Catheterization Laboratory 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 Catheterization Laboratory 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 (comma separated list FDA assigned to the subject device)
DOO
Device Description
Medline Catheterization Laboratory Trays/Kits/Packs are an assemblage of medical materials to be used by medical professionals during cardiac catheterization, angiography, or arteriorgram procedures. These procedures may include actual catheterization, implantation of pacemakers, or other procedures that are specific to the Catheterization Laboratory. 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 catheterization laboratory 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
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
licensed physicians
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.
Not Found
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a logo with the word "REDLINE" in bold, stylized letters. Above the word, there is a sharp, triangular shape resembling a compass needle pointing upwards. Below the word, a similar but smaller triangular shape points downwards, creating a vertical line effect through the text. The logo is black and white.
Medline Industries, Inc.
One Medline Place Mundelein, Illinois 60060.4486
K96 5112
.708.949.5500
Toll Free 1.800.323.5886
SUMMARY OF SAFETY AND EFFECTIVENESS
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
OCT 1997
December 18, 1996
Catheterization Laboratory Trays/Kits/Packs DEVICE NAME: PROPRIETARY NAME: Medline Catheterization Laboratory Trays/Kits/Packs COMMON NAME: Catheterization Laboratory Trays/Kits/Packs PERFORMANCE STANDARDS: None per Section 514.
CLASSIFICATION NAME:
We have been unable to locate specific classifications for these devices. The contents of each tray are either Class I or Class II medical devices, drugs or non-medical materials (i e. packaging, cartons and labels).
PRODUCT SPECIFICATIONS
Medline Catheterization Laboratory Trays/Kits/Packs are an assemblage of medical materials to be used by medical professionals during cardiac catheterization, angiography, or arteriorgram procedures. These procedures may include actual catheterization, implantation of pacemakers, or other procedures that are specific to the Catheterization Laboratory. 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 catheterization laboratory 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 Catheterization Laboratory 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
SUMMARY - CONTINUED
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.
The component list attached as Exhibit A includes the name and regulatory status of the intended components used in these trays. We do not expect this list to change, however, if additional components and/or manufacturers must be added, we will certify the regulatory compliance of the added devices, and keep the information in our Master Device Record.
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 either manufacturer, however, Medline Industries, Inc. has approved 510(k)'s for similar kits under K962826.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is composed of three curved lines that suggest the shape of a bird in flight. The text is in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms •Lara N. Simmons Corporate Regulatory Affairs Manager Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060-4486
OCT 10 1997
Re : K965112 Catheterization Laboratory Trays/Kits/Packs Requlatory Class: II Product Code: DOO Dated: June 24, 1997 Received: June 15, 1997
Dear Ms. Simmons:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the trays, kits and packs have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray/pack. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance
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Page 2 - Ms. Lara N. Simmons
with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
FDA notes that your device will contain sutures for which you have provided evidence that the suture characteristics are not altered by the sterilization process used for the device. However, you should be aware of the following additional information regarding the inclusion of a suture as a component of your device:
-
- The labeling, packaging and method of sterilization of the suture cannot be changed without prior notification, . review and clearance by FDA.
-
- The supplier of the sutures used in your device cannot be chanqed without prior notification, review and clearance by FDA.
In addition, we have determined that your device kit contains components (see highlighted items on the attached lists) which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the
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Page 3 - Ms. Lara N. Simmons
drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
This letter will allow you to begin marketing your device as described in your 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 and additionally 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
17 and the land the land the land the been and the been and the best of the formation of the formation of the formation of the formation of the formation of the formation of the
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INTENDED USE
Page _1
510(k) Number (if known): (N/A)
Device Name: Medline Catheterization Laboratory Trays/Kits/Packs
Indications for Use:
Medline Catheterization Laboratory 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Tha. A. Ph
(Division Sign-Off) Division of Cardiovascular Respiratory. and Neurological Devices 510(k) Number _