(192 days)
Not Found
No
The summary describes a physical device (a cover for vessels) and mentions biocompatibility and mechanical testing, with no indication of software, image processing, or AI/ML terms.
No
The device is described as a "cover for vessels" and its function is to physically protect vessels following surgery. It does not actively treat a disease or condition, but rather serves as a protective barrier.
No
The device is described as a "cover for vessels" and its function is to guard or protect vessels after surgery, not to diagnose a condition or disease.
No
The device description explicitly states it is manufactured from biocompatible materials and is available in several sizes, indicating it is a physical implantable device, 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 "as a cover for vessels following anterior vertebral surgery." This describes a device used in vivo (within the body) during or after a surgical procedure.
- Device Description: The description reinforces this by stating it's a "cover for vessels following anterior vertebral surgery" and is made from "biocompatible materials," suggesting implantation or direct contact with internal tissues.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health, diagnose a condition, or monitor treatment.
IVDs are typically used in laboratories or point-of-care settings to analyze biological samples. This device is clearly intended for surgical use within the body.
N/A
Intended Use / Indications for Use
The Replication Medical Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery.
Product codes (comma separated list FDA assigned to the subject device)
MFX; OMR
Device Description
The Replication Medical Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery. The Vessel Guard is available in several sizes and is manufactured from biocompatible materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels following anterior vertebral surgery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Biocompatibility testing was conducted and the testing indicated that the material is suitable for long term implantation. Suture pullout testing was also performed and the testing confirmed that the Vessel Guard is equivalent to predicate devices.
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
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).
0
Replication Medical Vessel Guard 510(k) Summary K082782
APR - 2 2009
| Device Manufacturer: | Replication Medical, Inc.
7 Clarke Drive
Cranbury, NJ 08512 | |
|----------------------|-------------------------------------------------------------------|--|
| Submission Date: | September 11, 2008 | |
| Contact Person: | Ann Prewett
Tel: 609-860-0330 Fax: 609-860-0343 | |
| Proprietary Name: | Replication Medical Vessel Guard | |
| Common Name: | Vessel Guard | |
| Device Class: | Class III | |
| Product Codes: | MFX | |
Device Description and Intended Use:
The Replication Medical Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery. The Vessel Guard is available in several sizes and is manufactured from biocompatible materials.
Technological Characteristics
The Replication Medical Vessel Guard is similar to legally marketed devices as listed below in that they share similar indications for use and incorporate similar technological characteristics. Biocompatibility testing was conducted and the testing indicated that the material is suitable for long term implantation. Suture pullout testing was also performed and the testing confirmed that the Vessel Guard is equivalent to predicate devices.
Substantial Equivalence Information:
| Trade/Proprietary Name | Manufacturer | 510(K) # | Clearance Date |
|---|---|---|---|
| PRECLUDE Vessel Guard | W.L. Gore & Associates, Inc | K061727 | 8/7/2006 |
| PRECLUDE IMA Sleeve | W.L. Gore & Associates, Inc | K960532 | 5/23/1996 |
The Replication Medical Vessel Guard is similar to the devices listed in the table below.
The safety and effectiveness of Vessel Guard is based upon the determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 2009
Replication Medical Inc. c/o M Squared Associates, Inc. 901 King Street Suite 200 Alexandria, VA 22314 Attn: Mr. Marcos Velez-Duran
Re: K082782
Trade Name: EnGuard™ Vessel Guard Regulation Number: 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: II Product Code: OMR Dated: February 24, 2009 Received: February 25, 2009
Dear Mr. Velez-Duran:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section-513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling and any promotional materials:
The safety and effectiveness of this device for reducing the incidence, severity, and extent of post-operative adhesion formation have not been established.
2
Furthermore, the indication for use as a cover for vessels following anterior vertebral r urthermore, the mersanntly displayed in all labeling, including pouch box, and carton sures, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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 (1 will) with and be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. Jour device TDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does r loase of that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not I vartal to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276your device (2) OF R Party of regulation entitled, "Misoranding by reference to premarket of 20. "Thise note the the regard". You may obtain other general information on your
3
responsibilities under the Act from the Division of Small Manufacturers, International, and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Christy Foreman for
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 4 - Mr. Marcos Velez-Duran
Indications for Use
510(k) Number (if known):_K082782
Device Name: EnGuard™ Vessel Guard
Indications For Use: The EnGuard™ Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery.
Prescription Use _ V
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. v. Ames
summer (Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices K08278
510(k) Number.