(201 days)
No
The description focuses on the material properties and biological performance of a bovine pericardium graft, with no mention of AI or ML.
Yes
The device is indicated as a dura substitute for the repair of dura mater, which is a therapeutic intervention.
No
Explanation: The device is indicated as a dura substitute for the repair of dura mater, which is a therapeutic function, not a diagnostic one. It is used to replace tissue, not to identify a disease or condition.
No
The device description clearly states it is composed of bovine pericardium, a physical material, and describes its processing and physical properties. This indicates it is a physical medical device, not software-only.
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 dura substitute for the repair of dura mater." This describes a surgical implant used directly in the body to replace or repair tissue.
- Device Description: The description details a processed bovine pericardium material designed for implantation.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment.
- Using reagents or calibrators.
IVDs are used outside the body to examine specimens and provide diagnostic information. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The device is indicated as a dura substitute for the repair of dura mater.
Product codes (comma separated list FDA assigned to the subject device)
GXQ
Device Description
The proposed device is composed of bovine pericardium processed through a proprietary tissue preservation and sterilization process which includes gamma irradiation. The proposed device is composed of collagenous connective tissue with three-dimensional intertwined fibers and can be fixed regardless of the direction of the device. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue. The proposed device in its unopened, undamaged package is sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dura mater
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 proposed device is equivalent to the predicate devices in intended use, material, design, and function. The biomechanical properties of the proposed and predicate devices were evaluated in a series of in vitro tests and implantation in an animal model. Burst strength, uniaxial strength and suture pullout strength were substantially equivalent for the proposed and predicate devices. Pyrogenicity of the device was evaluated using the Limulus Amoebocyte Lysate (LAL) assay on the final sterilized device. The device did not elicit a response. All device lots will be tested to ensure the endotoxin level is
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in a square with rounded corners, followed by the word "surgical" in a simple, sans-serif font. The letters "rti" are in a bold, blocky font, while the word "surgical" is in a lighter, more open font.
MAR 3 1 2014
. .
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05 510(k) Summary
Date: March 315, 2014
Submitted By:
Esther Carbon Manager, Global Regulatory Labeling RTI Surgical, Inc. 11621 Research Circle Alachua, FL 32615 Tel: 386-418-8888 Fax: 386-418-1627
Trade Name:
Bovine Pericardium Suturable Dural Graft, Tutopatch™ DM Graft, Tutoplast® Bovine Pericardium DM
Classification Name and Code:
Dura substitute (21 CFR 882.5910, product code GXQ)
Substantial Equivalence:
The proposed device is substantially equivalent to the predicate device Dura-Guard (K950956 and K982282) and Lyoplant (K970851) in intended use, material, design and function. The proposed device is substantially equivalent to the predicate device Dura-Matrix (K061487) in intended use, design and function. The proposed device is similar in design, function, materials and processing to reference devices Tutopatch™ bovine pericardium (K991296, K073097, K081538 and K091142) and similar to intended use, function, design and processing to reference device Tutoplast® Dura Mater (K910555).
Device Description:
The proposed device is composed of bovine pericardium processed through a proprietary tissue preservation and sterilization process which includes gamma irradiation. The proposed device is composed of collagenous connective tissue with three-dimensional intertwined fibers and can be fixed regardless of the direction of the device. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue. The proposed device in its unopened, undamaged package is sterile.
Indications for Use:
The device is indicated as a dura substitute for the repair of dura mater.
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Summary of Technological Characteristics
Summary of Tachnological Characteristics:
The device is composed of non-crosslinked bovine pericardium that has ben material, design del production as listed in the blo
belo
| Characteristic | Proposed Device | Predicate Device,
Dura-Guard
(K950956 and
K982282) | Predicate Device,
DuraMatrix
(K061487) | Predicate Device,
Lyoplant
(K970851) | Reference Device,
Tutopatch
(K991296,
K081538, K091142) | Reference Device,
Tutodent
(K073097) | Reference Device,
Tutoplast
processed human
dura
mater(K910555) |
|-------------------------|-----------------------------------------------------|-------------------------------------------------------------|----------------------------------------------|--------------------------------------------|------------------------------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------|
| Intended Use | Dura substitute | SAME | SAME | SAME | Surgical mesh | Barrier, Animal
Source, Intraoral | SAME |
| Material | Bovine pericardium | SAME | Bovine collagen | Collagen from
bovine pericardium | SAME | SAME | Human dura |
| Design | Terminally sterilized
sheets in various
sizes | Aseptically
processed sheets
in various sizes | Resorbable,
suturable
membrane | Absorbable,
suturable
membrane | SAME | SAME | SAME |
| Function | Dura substitute | SAME | SAME | SAME | Scaffold for soft
tissue repair | Scaffold for soft
tissue repair | SAME |
| Processing | Proprietary tissue
sterilization process | Apex processing | Proprietary
processing | Proprietary
processing | SAME | SAME | SAME |
| Chemical
composition | | | | | | | Not applicable to these devices |
| Energy Source | | | | | | | Not applicable to these devices |
ਟ
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Performance Data Supporting Substantial Equivalence Determination:
The proposed device is equivalent to the predicate devices in intended use, material, design, and function. The biomechanical properties of the proposed and predicate devices were evaluated in a series of in vitro tests and implantation in an animal model. Burst strength, uniaxial strength and suture pullout strength were substantially equivalent for the proposed and predicate devices. The table below summarizes the testing used to determine substantial equivalence of the proposed device.
| Test | Results | Conclusions |
|---|---|---|
| Cytotoxicity - Inhibition | ||
| of Cell Growth Assay | No leachable materials were released in cytotoxic | |
| concentrations from the device. The proposed device is | ||
| non-cytotoxic. | Substantially | |
| equivalent | ||
| Suture Pull out (N) | The proposed device suture pull-out max load is comparable | |
| to the DuraMatrix predicate device. | Substantially | |
| equivalent | ||
| Burst Strength (N) | The proposed device burst strength is greater than the | |
| DuraMatrix predicate device. | Substantially | |
| equivalent | ||
| Shrink temperature (°C) | The shrink temperature of the proposed device is | |
| comparable to the Lyoplant predicate device. | Substantially | |
| equivalent | ||
| Max Load (N) | The maximum load at failure of the proposed device is | |
| comparable to the DuraMatrix predicate device. | Substantially | |
| equivalent |
Pyrogenicity of the device was evaluated using the Limulus Amoebocyte Lysate (LAL) assay on the final sterilized device. The device did not elicit a response. All device lots will be tested to ensure the endotoxin level is 3, Filipi, R., et al., Bovine pericardium for duraplasty: clinical results in 32 patients. Neurosurg Rev, 2001. 2042-3): g 103-7.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2014
RTI Surgical, Inc. Ms. Esther Carbon Manager, Global Regulatory Labeling 11621 Research Cir. Alachua, FL 32615
Re: K132850
Trade/Device Name: Bovine Pericardium Suturable Dural Graft, Tutopatch™ DM Graft, or Tutoplast® Bovine Pericardium DM Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: February 24, 2014 Received: February 26, 2014
Dear Ms. Esther Carbon:
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. 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 addional in the 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 that I Dri has made a acceministered by other Federal agencies. You must comply
4
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 (reporting of medical devicerelated adverse events) (21 CFR 803); 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K132850
Device Name
Bovine Pericardium Suturable Dural Graft Tutoplast® Bovine Pericardium DM Tutopatch™ DM Graft
Indications for Use (Describe)
The device is indicated as a dura substitute for the repair of dura mater.
Type of Use (Select one or both, as applicable)
区Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Joyce M. Whang -S
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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