(136 days)
Not Found
No
The description focuses on a kit of standard, legally marketed medical devices and commodity products for cardiovascular procedures, with no mention of AI or ML capabilities.
No.
The device, a surgical drape, is intended to prevent contamination of the surgical site, which is a protective function rather than a therapeutic one that directly treats or cures a disease or condition.
No
Explanation: The device is a surgical drape kit intended for protecting patients during cardiovascular procedures, not for diagnosing medical conditions.
No
The device is a kit containing physical medical devices (surgical drape, disposable devices) and potentially other commodity products, not solely software.
Based on the provided text, the Medline Cardiovascular Procedure Kit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is described as a "protective patient covering" and for "preparing the operating environment for, and performing cardiovascular procedures and surgeries." This is a surgical and procedural use, not a diagnostic use involving testing samples from the human body.
- Device Description: The components are described as "standard for cardiovascular procedures" and include items like surgical drapes and other disposable devices used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
Therefore, the Medline Cardiovascular Procedure Kit falls under the category of surgical/procedural devices, not IVDs.
N/A
Intended Use / Indications for Use
The Medline Cardiovascular Procedure Kit contains a single-use sterile surgical drape intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is packaged and sterilized with disposable devices intended for professional use/used by licensed physicians in preparing the operating environment for, and performing cardiovascular procedures and surgeries. 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)
LRO
Device Description
The Medline Cardiovascular Procedure Kit is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits are assembled for customer convenience using Medline and other manufacturer's currently manufactured/marketed components. Customers specify the kit contents, quantity, and placement of individual components in the kit. A component listing is provided within this submission, which includes the name and regulatory status of components that can be selected for placement in various configurations of the final Medline Cardiovascular Kits. The BOM provides the corresponding FDA product codes, and reference to respective marketing clearances (as applicable). These included components are standard for cardiovascular procedures.
The intended use of the products assembled in the final Medline Cardiovascular Procedure Kit will not be changed. These components are all legally marketed drug products, and/or medical devices that are either: (1) pre-amendment devices; (2) 510(k)-cleared devices; or (3) 510(k) exempt devices. Commodity products, not regulated by FDA, are additionally included in the proposed kit. The customer may also specify a certain brand of similar items or minor variations of items. If additional components and/or manufacturers must be added to this list, we certify the regulatory compliance of the added components and maintain the information in our internal Device Master Record.
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 in preparing the operating environment for, and performing cardiovascular procedures and surgeries.
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)
The safety and performance evaluation of the subject Medline Cardiovascular Procedure Kit was conducted based upon a risk assessment and evaluated in accordance with applicable recognized standards and FDA guidance documents, including:
- ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process
- AAMI/ANSI/ISO 10993-7, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals.
- FDA's Convenience Kits, Interim Regulatory Guidance: 20 May 1997
- FDA's Sterilized Convenience Kits for Clinical and Surgical Use: 7 January 2002
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.
Not Found
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
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
December 3, 2021
Medline Industries, Inc. Claire Pigman Sr. Manager, Regulatory Affairs Three Lakes Drive Northfield, Illinois 60093
Re: K212258
Trade/Device Name: Medline Cardiovascular Procedure Kit Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: Class II Product Code: LRO Dated: September 13, 2021 Received: September 15, 2021
Dear Claire Pigman:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K212258
Device Name Medline Cardiovascular Procedure Kit
Indications for Use (Describe)
The Medline Cardiovascular Procedure Kit contains a single-use sterile surgical drape intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is packaged and sterilized with disposable devices intended for professional use/used by licensed physicians in preparing the operating environment for, and performing cardiovascular procedures and surgeries. The intended use of the medical products assembled in these kits will not be changed from the manufacturer's original intended use.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Image /page/3/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked on top of a white star-like symbol with four points. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a recognizable symbol.
Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
510(k) SUMMARY [AS REQUIRED BY 21 CFR 807.92]
SUMMARY PREPARATION DATE
November 19, 2021
SUBMITTER / 510(k) SPONSOR
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592
SUBMISSION CORRESPONDENTS
Claire Pigman Sr. Manager, Regulatory Affairs Phone: 224-327-9204 Email: cpigman(@medline.com
Stephanie Augsburg Director, Regulatory Affairs Phone: 847-643-3690 Email: saugsburg@@medline.com
TYPE OF SUBMISSION Traditional 510(k)
DEVICE NAME / CLASSIFICATION
Trade Name: Medline Cardiovascular Procedure Kits Common Name: Cardiovascular Procedure Kit Classification Name: General Surgery Tray Product Code: LRO Classification Panel: General & Plastic Surgery Regulatory Class: Class II Regulation Number: 21 CFR 878.4370
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Image /page/4/Picture/2 description: The image is a logo for Medline. The logo consists of the word "MEDLINE" in a sans-serif font, with a white cross-like symbol behind the text. The background of the logo is a dark blue square. The logo is simple and professional, and it is likely used to represent a medical or healthcare-related company.
Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
PREDICATE DEVICES
K962826 - Medline Radiology-Diagnostic Kits
INDICATIONS FOR USE
The Medline Cardiovascular Procedure Kit contains a single-use sterile surgical drape intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is packaged and sterilized with disposable devices intended for professional use/used by licensed physicians in preparing environment for, and performing cardiovascular procedures and surgeries. The intended use of the medical products assembled in these kits will not be changed from the manufacturer's original intended use.
DEVICE DESCRIPTION
The Medline Cardiovascular Procedure Kit is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits are assembled for customer convenience using Medline and other manufacturer's currently manufactured/marketed components. Customers specify the kit contents, quantity, and placement of individual components in the kit. A component listing is provided within this submission, which includes the name and regulatory status of components that can be selected for placement in various configurations of the final Medline Cardiovascular Kits. The BOM provides the corresponding FDA product codes, and reference to respective marketing clearances (as applicable). These included components are standard for cardiovascular procedures.
The intended use of the products assembled in the final Medline Cardiovascular Procedure Kit will not be changed. These components are all legally marketed drug products, and/or medical devices that are either: (1) pre-amendment devices; (2) 510(k)-cleared devices; or (3) 510(k) exempt devices. Commodity products, not regulated by FDA, are additionally included in the proposed kit. The customer may also specify a certain brand of similar items or minor variations of items. If additional components and/or manufacturers must be added to this list, we certify the regulatory compliance of the added components and maintain the information in our internal Device Master Record.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The Medline Cardiovascular Procedure Kit containing single-use sterile surgical drapes, has the same intended use and utilizes similar components, assembly practices, component sourcing evaluation procedures, and sterilization processes as the predicate device, K962826 - Medline Radiology-Diagnostic Kit, was cleared as a convenience kit similar in nature to the proposed device.
K962826 is similarly classified under product code LRO and contains surgical drapes assembled for customer convenience with currently manufactured components based on the customer's specifications (i.e. placement of items in the kit, item quantities, and specific brand of similar components or variation of components). The intended use and design of components assembled in the subject and predicate kits are not altered in any way.
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Image /page/5/Picture/2 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters in the upper left corner of the square. A white, stylized starburst shape is positioned behind the text, with its center aligned with the center of the word "MEDLINE".
Medline Industries, Inc Three Lakes Drive Northfield. IL 60093
SUMMARY OF NON-CLINICAL TESTING
The safety and performance evaluation of the subject Medline Cardiovascular Procedure Kit was conducted based upon a risk assessment and evaluated in accordance with applicable recognized standards and FDA guidance documents, including:
- ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a ● Risk Management Process
- AAMI/ANSI/ISO 10993-7, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide ● Sterilization Residuals.
- FDA's Convenience Kits, Interim Regulatory Guidance: 20 May 1997 ●
- FDA's Sterilized Convenience Kits for Clinical and Surgical Use: 7 January 2002 ●
STERILIZATION
The Medline Cardiovascular Procedure Kit is terminally sterilized by ethylene oxide (EO) to deliver a minimum sterility assurance level of 106. Medline ensures sterility of the components in the final Medline Cardiovascular Procedure Kit, and that the sterilization process does not adversely or unintentionally impact the materials that would affect the functionality of the kit components.
SUMMARY OF CLINICAL TESTING
Not applicable.
SUMMARY OF ANIMAL TESTING
Not applicable.
CONCLUSION
In accordance with 21 CFR Part 807, and based on a comparison of 'Indications for Use,' technological characteristics and performance data, Medline Industries, Inc. concludes that the proposed Medline Cardiovascular Procedure Kit is substantially equivalent to the predicate devices.