(296 days)
Not Found
No
The device description and performance studies focus on the material properties and biological interaction of the graft, with no mention of AI or ML technology.
Yes
The device is intended to aid in the natural healing process and separate compromised tissues, which are therapeutic functions.
No
The device is described as an "ENT Repair Graft" intended to "separate tissue or structures compromised by surgical trauma, help control minimal bleeding, and act as an adjunct to aid in the natural healing process." Its function involves physical intervention and support for healing, not the identification or assessment of a medical condition.
No
The device description clearly states it is a physical graft composed of a bioabsorbable membrane matrix (SIS) and is supplied as a physical product in a sealed pouch. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for separating tissue, controlling bleeding, and aiding in healing within the body following surgery. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a bioabsorbable implantable material (extracellular collagen membrane matrix) that is incorporated into the body. This is consistent with a surgical implant or dressing, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide information about a patient's health status or disease.
- Anatomical Site: The device is used in the nasal and sinus cavities, not to test samples from these cavities.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Biodesign ENT Repair Graft is intended to separate tissue or structures compromised by surgical trauma, help control minimal bleeding, and act as an adjunct to aid in the natural healing process. The device is indicated for use where an open wound dressing material is required in the nasal and/or sinus cavities following nasal and/or sinus surgery where separation of tissues or structures is desired. The device is supplied sterile and is intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
KHJ
Device Description
The Biodesign ENT Repair Graft is composed of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS). The Biodesign ENT Repair Graft is similar to its predicate MeroGel Control Gel ENT Surgical Dressing (K002972) which is a biomaterial composed of HYAFF®, an ester of hyaluronic acid, a natural occurring constituent of extracellular matrix. The device is available in multilayered sheets with sizes from 1 cm by 2 cm to 20 cm x 40 cm. The Biodesign ENT Repair Graft is a scaffold which becomes infiltrated by the host cells during the body's natural repair process. The Biodesign ENT Repair Graft can be shaped by the physician to the appropriate size for the desired indication.
The Biodesign ENT Repair Graft is similar to its MeroGel predicate in its technology in that it has the ability to be incorporated into the body. The device is packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal and/or sinus cavities
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)
Biocompatibility testing: The following biocompatibility tests were performed on sterilized SIS devices (which have already been cleared in multiple applications), which are identical in composition to the Biodesign ENT Repair Graft (according to the ISO 10993-1 standard): Genotoxicity, Direct contact in vitro hemolysis, Cytotoxicity, Muscle implantation, Acute intracutaneous reactivity, Skin irritation, ISO Sensitization, Acute systemic toxicity, Pyrogenicity, LAL endotoxins, Subchronic systemic toxicity. The results of these tests provided evidence that the Biodesign ENT Repair Graft meets biocompatibility requirements of the ISO standard.
Mechanical Testing: The Biodesign ENT Repair Graft material was tested for the following: Suture retention strength, Ultimate tensile strength. The results of the mechanical testing provided evidence that the Biodesign ENT Repair Graft provided adequate mechanical strength in its application.
Preclinical Testing: A mouse subcutaneous study confirmed that the Biodesign ENT Repair Graft was able to help maintain tissue separation, is quickly populated with cells, and degrades during cellular ingrowth. This animal study provides evidence that the Biodesign ENT Repair Graft is biocompatible and safe in its application.
Clinical Testing: A clinical study was performed using the SIS material (Surgisis) for nasal septal perforation repair. The clinical study provides evidence that the Biodesign ENT Repair Graft is substantially equivalent to its predicate in nasal and/or sinus procedures.
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
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.
0
121360
510(k) Summary
21 February 2013
FEB 2 7 2013
Cook Biotech Incorporated
Biodesign® ENT Repair Graft
Manufacturer Name:
Cook Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906 Telephone: +1 (765) 497-3355 FAX: +1 (765) 807-7709
Official Contact:
Perry W. Guinn
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations:
Biodesign ENT Repair Graft Ear, nose and throat synthetic polymer material Class II, 21 CFR §874.3620 (KHJ)
INTENDED USE:
The Biodesign ENT Repair Graft is intended to separate tissue or structures compromised by surgical trauma, help control minimal bleeding, and act as an adjunct to aid in the natural healing process. The device is indicated for use where an open wound dressing material is required in the nasal and/or sinus cavities following nasal and/or sinus surgery where separation of tissues or structures is desired. The device is supplied sterile and is intended for one-time use.
DEVICE DESCRIPTION:
The Biodesign ENT Repair Graft is composed of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS). The Biodesign ENT Repair Graft is similar to its predicate MeroGel™ Control Gel ENT Surgical Dressing (K002972) which is a biomaterial composed of HYAFF®, an ester of hyaluronic acid, a natural occurring constituent of extracellular matrix. The device is available in multilayered sheets with sizes from 1 cm by 2 cm to 20 cm x 40 cm. The Biodesign ENT Repair Graft is a scaffold which becomes infiltrated by the host cells during the body's natural repair process. The Biodesign ENT Repair Graft can be shaped by the physician to the appropriate size for the desired indication.
The Biodesign ENT Repair Graft is similar to its MeroGel predicate in its technology in that it has the ability to be incorporated into the body. The device is packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.
1
EQUIVALENCE TO MARKETED DEVICES
The Biodesign ENT Repair Graft is similar with respect to intended use, materials and technological characteristics to the predicate device in terms of section 510(k) substantial equivalence, as shown biocompatibility testing (conducted in accordance to ISO 10993-1 standards), mechanical, pre-clinical and clinical testing.
Biocompatibility testing
The following biocompatibility tests were performed on sterilized SIS devices (which have already been cleared in multiple applications), which are identical in composition to the Biodesign ENT Repair Graft (according to the ISO 10993-1 standard):
- . Genotoxicity
- Direct contact in vitro hemolysis .
- Cytotoxicity ●
- Muscle implantation .
- Acute intracutaneous reactivity .
- Skin irritation ●
- ISO Sensitization ●
- . Acute systemic toxicity
- Pyrogenicity
- LAL endotoxins ●
- Subchronic systemic toxicity .
The results of these tests provided evidence that the Biodesign ENT Repair Graft meets biocompatibility requirements of the ISO standard.
Mechanical Testing
The Biodesign ENT Repair Graft material was tested for the following:
- . Suture retention strength
- Ultimate tensile strength .
The results of the mechanical testing provided evidence that the Biodesign ENT Repair Graft provided adequate mechanical strength in its application.
Preclinical Testing
A mouse subcutaneous study confirmed that the Biodesign ENT Repair Graft was able to help maintain tissue separation, is quickly populated with cells, and degrades during cellular ingrowth. This animal study provides evidence that the Biodesign ENT Repair Graft is biocompatible and safe in its application.
2
Clinical Testing
A clinical study was performed using the SIS material (Surgisis) for nasal septal perforation repair. The clinical study provides evidence that the Biodesign ENT Repair Graft is substantially equivalent to its predicate in nasal and/or sinus procedures.
Substantial Equivalence
See Table 1 for a comparison of the subject device and its predicate.
| Device | Biodesign ENT Repair | MeroGel™ Control Gel |
|---|---|---|
| Graft | ENT Surgical Dressing | |
| Manufacturer | Cook Biotech | Medtronic Xomed |
| Incorporated | ||
| 510(k) Number | K121360 | K002972 |
| Intended Use | The Biodesign® ENT | MeroGel Control Gel |
| Repair Graft is intended to | ENT Surgical Dressing is | |
| separate tissue or | a dressing and/or stent | |
| structures compromised | intended to separate tissue | |
| by surgical trauma, help | or structures compromised | |
| control minimal bleeding, | by surgical trauma, help | |
| and act as an adjunct to | control minimal bleeding, | |
| aid in the natural healing | and act as an adjunct to | |
| process. The device is | aid in the natural healing | |
| indicated for use where an | process. The device is | |
| open wound dressing | indicated for use in ear, | |
| material is required in the | nose, and throat, head and | |
| nasal and/or sinus cavities | neck surgical procedures | |
| following nasal and/or | where an open wound | |
| sinus surgery where | dressing material is | |
| separation of tissues or | required including the | |
| structures is desired. | middle ear and external | |
| The device is supplied | ear canal following | |
| sterile and is intended for | myringoplasty, | |
| one-time use. | tympanoplasty, | |
| canalplasty, stapes and | ||
| mastoid surgery, also for | ||
| use in the nasal and/or | ||
| sinus cavities following | ||
| nasal, sinus, and/or throat | ||
| surgery where separation | ||
| of tissues or structures is | ||
| desired. | ||
| Material | Small intestinal | HY AFF® (ester of |
| submucosa | hyaluronic acid, a | |
| Primarily Types I, III, IV | naturally occurring | |
| and VI collagen | constituent of the | |
| (constituents of the | extracellular matrix) | |
| extracellular matrix) | ||
| Dimensions | 1 cm x 2 cm to | N/A |
| 20 x 40 cm | ||
| Thickness | 100 um to 500 um | N/A |
Table 1 - Substantial Equivalence Comparison
3
CONCLUSION: The biocompatibility, mechanical, pre-clinical and clinical tests performed on the Biodesign ENT Repair Graft show that the device is substantially equivalent to its predicate.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
February 27, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cook Biotech Incorporated % Mr. Perry W. Guinn VP of OA and Regulatory Affairs 1425 Innovation Place West Lafayette, IN 47906-1000
Re: K121360
Trade/Device Name: Biodesign® ENT Repair Graft Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: KHJ Dated: February 4. 2013 Received: February 7, 2013
Dear Mr. Guinn:
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 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 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
5
Page 2 - Mr. Perry W. Guinn
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia YAlexander -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Biodesign® ENT Repair Graft Device Name:
Indications For Use:
The Biodesign® ENT Repair Graft is intended to separate tissue or structures compromised by surgical trauma, help control minimal bleeding, and act as an adjunct to aid in the natural healing process. The device is indicated for use where an open wound dressing material is required in the nasal and/or sinus cavities following nasal and/or sinus surgery where separation of tissues or structures is desired.
The device is supplied sterile and is intended for one-time use.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _
Vasant G.
Malshet
Digitally signed by Vasant G.
Malshet
DN: c=US/o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
cn=Vasant G. Malshet,
0.9.2342:19200300.100.1.1=130
0087851
Date: 2013.02.26 13:13:30 -05'00'