(191 days)
No
The device description and performance studies focus on the biomaterial properties and clinical outcomes of a surgical graft, with no mention of AI or ML technology.
Yes.
The device is intended to aid in surgical repairs and the natural healing process in otologic procedures, which classifies it as a therapeutic device.
No
Explanation: The device description and intended use clearly state that the Biodesign Otologic Repair Graft is "intended for use as an implant to aid in surgical repairs and as an adjunct to aid in the natural healing process." It functions as an absorbable biomaterial scaffold for tissue repair, not for diagnosing conditions or diseases.
No
The device description clearly states it is a physical biomaterial graft made of porcine small intestinal submucosa (SIS), supplied as discs and sheets. It is intended for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is an "implant to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures." This describes a device used within the body during surgery to support tissue repair.
- Device Description: The description details a "multi-layer biomaterial composed of four layers of laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS)." It explains that it acts as a "scaffold for these cells during the body's natural repair process." This is consistent with an implantable surgical device.
- Anatomical Site: The anatomical sites mentioned are related to surgical procedures within the ear (myringoplasty, tympanoplasty, stapes and mastoid surgery).
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function. It is a physical implant used during surgery.
The information provided describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Biodesign Otologic Repair Graft is intended for use as an implant to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty. The device is supplied sterile and is intended for one-time use.
Product codes
KHJ
Device Description
The Biodesign Otologic Repair Graft is an absorbable multi-layer biomaterial composed of four layers of laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). The SIS material is lyophilized and then punched into the desired shape. The device is available in 4 mm, 6 mm and 9 mm diameter discs, as well as 2.5 x 2.5 cm and 5 x 5 cm square sheets. Upon implantation, the Biodesign Otologic Repair Graft is infiltrated by the host cells and acts as a scaffold for these cells during the body's natural repair process.
Additionally, the circular configurations of the device are packaged in a dried state and supplied sterile in a tray inside a sealed Tyvek® pouch. The square configurations of the device are also packaged sterile in a dried state inside a sealed Tyvek® pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Middle ear and external canal
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 are identical in composition to the Biodesign Otologic Repair Graft (according to the ISO 10993-1 standard):
- Genotoxicity
- Direct contact in vitro hemolysis
- Cytotoxicity
- Muscle implantation
- Acute intracutaneous reactivity
- ISO sensitization
- Acute systemic toxicity
- Pyrogenicity
- LAL endotoxins
- Subchronic systemic toxicity
The results of these tests provide evidence that the Biodesign Otologic Repair Graft meets the biocompatibility requirements of the ISO standard.
Mechanical Testing
The Biodesign Otologic Repair Graft material was tested for burst strength and the results compared with its predicates.
The results of this mechanical test provide evidence that the Biodesign Otologic Repair Graft has adequate mechanical strength for its application.
Animal Testing
The SIS material that comprises the Biodesign Otologic Repair Graft was tested in animal studies that included an efficacy study using a chinchilla model and an implant study using a mouse model to characterize cellular response and device degradation. The efficacy study, which compared SIS repair with autologous tissue repair, suggested that SIS was a viable alternative to autologous tissue for tympanic membrane perforation repair. Additionally, the mouse implant study compared the Biodesign Otologic Repair Graft against the MeroGel Otologic Pack and showed that the subject device performed similarly to the predicate in terms of device degradation, and non-inflammatory host responses. These animal studies provide evidence that the Biodesign Otologic Repair Graft is biocompatible and safe for its application.
Clinical Testing
Prospective data was collected on the use of the SIS material (labeled as Surgisis), the same material that comprises the Biodesign Otologic Repair Graft (D'Eredita, 2012, abstract). In this 404 patient study, the SIS material was used in 217 myringoplasty procedures and compared to 215 temporalis fascia (PTF) repairs performed by the same surgeon. Follow- up was from 2-11 years (average 7.7 years) (data from manuscript submitted by invitation to the International Journal of Pediatric Otorhinolaryngology (February 5, 2013) by D'Eredita). Data analysis included safety, efficacy and procedure duration. No adverse reactions were observed with either type of repair. Stable tympanic membrane closures were seen in 212/217 (97.2%) of SIS repairs compared to 204/215 (94.8%) of PTF procedures. The difference in procedural times between the two (2) arms was not statistically significant.
Additional unpublished data are available in which the device was implanted in:
- a) 18 patients (Hsu, DuPage Medical Group, 2015);
- b) 19 patients (Toh C. et al., Birmingham Heartland Hospital, UK, 2003);
- c) 32 patients (Ofo E. et al., North West London Hospital, UK, 2009); and
- d) 8 patients (Lalwani A. San Francisco, CA, COSM 2003).
No significant adverse events were reported.
Results of these clinical studies show that the Biodesign Otologic Repair Graft is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Stable tympanic membrane closures were seen in 212/217 (97.2%) of SIS repairs compared to 204/215 (94.8%) of PTF procedures.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
Cook Biotech Incorprated Katie Molland, Ph.D. Regulatory Affairs Specialist 1425 Innovation Place West Lafayette, IN 47906
Re: K150594
Trade/Device Name: Biodesign Otologic 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: August 14, 2015 Received: August 17, 2015
Dear Dr. Molland:
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.
1
Page 2 - Katie Molland, Ph.D.
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 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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. Deborah L. Falls -5
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
2
Indications for Use
510(k) Number (if known) K150594
Device Name Biodesign(R) Otologic Repair Graft
Indications for Use (Describe)
The Biodesign Otologic Repair Graft is intended for use as an implant to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty. The device is supplied sterile and is intended for one-time use.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ 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)
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3
510(k) Summary
March 4, 2015
Cook Biotech Incorporated
Biodesign® Otologic 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: | Biodesign Otologic Repair Graft |
|---|---|
| Common Name | Surgical implant polymer material/Surgical |
| adjunct polymer material | |
| Classification Regulations: | Class II, 21 CFR §874.3620 (KHJ) |
INDICATIONS FOR USE:
The Biodesign Otologic Repair Graft is intended for use as an implant to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty. The device is supplied sterile and is intended for one-time use.
| PREDICATE DEVICES: | EpiFilm® Otologic Lamina, K982870 |
|---|---|
| MeroGel®Otologic Pack, K001148 |
DEVICE DESCRIPTION:
The Biodesign Otologic Repair Graft is an absorbable multi-layer biomaterial composed of four layers of laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). The SIS material is lyophilized and then punched into the desired shape. The device is available in 4 mm, 6 mm and 9 mm diameter discs, as well as 2.5 x 2.5 cm and 5 x 5 cm square sheets. Upon implantation, the Biodesign Otologic Repair Graft is infiltrated by the host cells and acts as a scaffold for these cells during the body's natural repair process.
Additionally, the circular configurations of the device are packaged in a dried state and supplied sterile in a tray inside a sealed Tyvek® pouch. The square
4
configurations of the device are also packaged sterile in a dried state inside a sealed Tyvek® pouch.
EQUIVALENCE TO MARKETED DEVICES
The Biodesign Otologic Repair Graft is similar with respect to intended use, materials (naturally occurring constituents of the extracellular matrix) and technological characteristics of the predicate devices in terms of section 510(k) substantial equivalence. Substantial equivalence is supported by 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 are identical in composition to the Biodesign Otologic Repair Graft (according to the ISO 10993-1 standard):
- Genotoxicity ●
- Direct contact in vitro hemolysis ●
- Cytotoxicity ●
- Muscle implantation ●
- Acute intracutaneous reactivity ●
- ISO sensitization
- Acute systemic toxicity ●
- Pyrogenicity
- LAL endotoxins ●
- Subchronic systemic toxicity
The results of these tests provide evidence that the Biodesign Otologic Repair Graft meets the biocompatibility requirements of the ISO standard.
Mechanical Testing
The Biodesign Otologic Repair Graft material was tested for burst strength and the results compared with its predicates.
The results of this mechanical test provide evidence that the Biodesign Otologic Repair Graft has adequate mechanical strength for its application.
Animal Testing
The SIS material that comprises the Biodesign Otologic Repair Graft was tested in animal studies that included an efficacy study using a chinchilla model and an implant study using a mouse model to characterize cellular response and device degradation. The efficacy study, which compared SIS repair with autologous tissue repair, suggested that SIS was a viable alternative to autologous tissue for tympanic
5
membrane perforation repair. Additionally, the mouse implant study compared the Biodesign Otologic Repair Graft against the MeroGel Otologic Pack and showed that the subject device performed similarly to the predicate in terms of device degradation, and non-inflammatory host responses. These animal studies provide evidence that the Biodesign Otologic Repair Graft is biocompatible and safe for its application.
Clinical Testing
Prospective data was collected on the use of the SIS material (labeled as Surgisis), the same material that comprises the Biodesign Otologic Repair Graft (D'Eredita, 2012, abstract). In this 404 patient study, the SIS material was used in 217 myringoplasty procedures and compared to 215 temporalis fascia (PTF) repairs performed by the same surgeon. Follow- up was from 2-11 years (average 7.7 years) (data from manuscript submitted by invitation to the International Journal of Pediatric Otorhinolaryngology (February 5, 2013) by D'Eredita). Data analysis included safety, efficacy and procedure duration. No adverse reactions were observed with either type of repair. Stable tympanic membrane closures were seen in 212/217 (97.2%) of SIS repairs compared to 204/215 (94.8%) of PTF procedures. The difference in procedural times between the two (2) arms was not statistically significant.
Additional unpublished data are available in which the device was implanted in:
- a) 18 patients (Hsu, DuPage Medical Group, 2015);
- b) 19 patients (Toh C. et al., Birmingham Heartland Hospital, UK,2003);
- c) 32 patients (Ofo E. et al.,North West London Hospital, UK, 2009); and
- d) 8 patients (Lalwani A. San Francisco, CA, COSM 2003).
No significant adverse events were reported.
Results of these clinical studies show that the Biodesign Otologic Repair Graft is safe and effective for its intended use.
SUBSTANTIAL EQUIVALENCE
Table 1 below provides a comparison of the subject device and its predicates.
6
| Device | Biodesign Otologic Repair
Graft (subject) | EpiFilm Otologic Lamina
(Predicate) | MeroGel™ Otologic Pack
(Predicate) |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Cook Biotech Incorporated | Xomed Surgical Products | Medtronic Xomed |
| 510(k) Number | Not assigned | K982870 | K001148 |
| Intended Use | The Biodesign Otologic Repair
Graft is intended for use as an
implant to aid in surgical
repairs and as an adjunct to aid
in the natural healing process
in various otologic procedures,
including but not limited to
myringoplasty and
tympanoplasty. | Intended for use as an implant to
aid in surgical repairs and as an
adjunct to aid in the natural
healing process in various
otologic procedures. EpiFilm
Otologic Lamina is indicated for
use in myringoplastic and
tympanoplastic surgical
procedures. | MeroGel™ Otologic Pack is a
space occupying dressing and/or
stent intended to separate
mucosal surfaces, help control
minimal bleeding and act as an
adjunct to aid in the natural
healing process. The device is
indicated for use in the middle
ear and external canal following
canalplasty, myringoplasty,
tympanoplasty, and stapes and
mastoid surgery. |
| Material | Small intestinal submucosa
(SIS)
Primarily Types I, III, IV and
VI collagen (constituents of the
extracellular matrix) | HYAFF® (ester of hyaluronic
acid, a naturally occurring
constituent of the extracellular
matrix.) | HYAFF® (ester of hyaluronic
acid, a naturally occurring
constituent of the extracellular
matrix.) |
| Method of action | Has a scaffold structure which
is infiltrated with host cells,
forms gel as the process of
remodeling occurs | Has micro-perforation providing
permeable surface and acts as a
scaffold for migrating host cells | Hygroscopic, forms gelatinous
mass in contact with fluids |
| Dimensions | 4 mm, 6mm, 9 mm diameter
2.5 x 2.5 cm
5 x 5 cm | 8 mm diameter (EpiDisc)*
2.5 cm x 2.5 cm | 1 cm x 5 cm, 4 cm x 4 cm |
| Thickness | 100 μm to 500 μm | NA | 340 μm† |
| Sterilization | Ethylene oxide | Gamma irradiation | Gamma irradiation |
| Shelf life | 18 months | NA | 48 months |
Table 1 – Substantial Equivalence Comparison
NA – Not available
†N=2
*EpiDisc and EpiFilm Otologic Lamina are the same material and sold under the same 510(k). EpiDisc is a smaller sized device than EpiFilm
CONCLUSION: The biocompatibility, pre-clinical and clinical tests performed on the Biodesign Otologic Repair Graft show that the device is substantially equivalent to its predicates.