(192 days)
The EnGuard™ Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery.
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.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving device performance:
Overview:
This 510(k) submission for the Replication Medical Vessel Guard is primarily based on substantial equivalence to legally marketed predicate devices, rather than a novel clinical effectiveness study with specific performance metrics. Therefore, explicit "acceptance criteria" in the sense of predefined numerical thresholds for a new study's performance are not presented. Instead, the substantial equivalence argument itself serves as the "proof" that the device meets the necessary safety and effectiveness standards, as demonstrated by the predicates.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) submission (substantial equivalence), the "acceptance criteria" are predominantly related to demonstrating similar technological characteristics, biocompatibility, and mechanical integrity to the predicate devices. Explicit numerical performance metrics for a novel clinical study are not specified.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| Indications for Use Equivalence | "indicated as a cover for vessels following anterior vertebral surgery" - matches predicate's indication. |
| Similar Technological Characteristics | "similar to legally marketed devices... in that they share similar indications for use and incorporate similar technological characteristics." |
| Biocompatibility | "Biocompatibility testing was conducted and the testing indicated that the material is suitable for long term implantation." |
| Mechanical Integrity (Suture Pullout) | "Suture pullout testing was also performed and the testing confirmed that the Vessel Guard is equivalent to predicate devices." |
| Safety and Effectiveness | "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." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of a new clinical test set. The submission relies on preclinical testing (biocompatibility, suture pullout) and the established safety and effectiveness of predicate devices. There is no mention of a human test set in this summary for the purpose of demonstrating device performance against specific clinical efficacy criteria.
- Data Provenance: The preclinical data (biocompatibility, suture pullout) would have been generated internally by Replication Medical, Inc. The basis for substantial equivalence is "legally marketed predicate devices" which would be subject to FDA regulations in the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This submission does not describe a clinical study where human experts would establish a "ground truth" for a test set. The "ground truth" for the device's acceptable performance is established through equivalence to the predicate devices and standard preclinical testing.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set described that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. There is no mention of an MRMC study or any clinical comparative effectiveness study in this 510(k) summary. This type of study is more common for diagnostic imaging devices or devices where human interpretation plays a key role in effectiveness.
6. If a Standalone (Algorithm Only) Performance Study Was Done
No. This device is a physical implant (vessel cover), not an algorithm or software. Therefore, an "algorithm only" or "standalone" performance study is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (W.L. Gore & Associates, Inc.'s PRECLUDE Vessel Guard and PRECLUDE IMA Sleeve).
- Biocompatibility Standards: Adherence to established standards for biocompatibility testing for long-term implants.
- Mechanical Performance Standards: Equivalence to predicate devices in mechanical tests like suture pullout, implying an acceptable level of mechanical integrity.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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Replication Medical Vessel Guard 510(k) Summary K082782
APR - 2 2009
| Device Manufacturer: | Replication Medical, Inc.7 Clarke DriveCranbury, NJ 08512 | |
|---|---|---|
| Submission Date: | September 11, 2008 | |
| Contact Person: | Ann PrewettTel: 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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
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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.
§ 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).