(116 days)
Not Found
No
The summary describes a biological patch graft made from porcine tissue and does not mention any computational or software components, let alone AI/ML.
Yes
The device is intended to reinforce sclera and aid the physical reconstruction of the ocular surface, which falls under therapeutic intervention.
No
The device is described as an implantable patch graft for physical reconstruction, not for diagnosis. Its intended use is to reinforce sclera and aid physical reconstruction, and it is made of laminated porcine small intestinal submucosa. There is no mention of it being used to detect, monitor, or identify a medical condition.
No
The device description clearly states it is a physical patch graft constructed from porcine tissue, supplied as a sterile, dehydrated device. This indicates it is a hardware medical 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 for "implantation to reinforce sclera and aid the physical reconstruction of the ocular surface." This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The device is a "Bioengineered Lamellar Patch Graft" made from porcine tissue, designed for implantation. This is consistent with a surgical implant, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze samples (like blood, urine, tissue) to provide information about a patient's health status, disease, or condition. There is no mention of reagents, assays, or any other components typically associated with IVD tests.
Therefore, the KaraSys Bioengineered Lamellar Patch Graft is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KeraSys Bioengineered Lamellar Patch Graft is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface.
The KaraSys Bioengineered Lamellar Patch Graft is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface. KaraSys is labeled for single use.
Product codes
NXM
Device Description
The KeraSys Bioengineered Lamellar Patch Graft is constructed from four layers of laminated porcine small intestinal submucosa (SIS). The dchydrated device is supplied sterile sealed in a double peel pouch system. Unit size is 1x1.5cm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sclera, ocular surface, eyelid, face, head
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 Surgisis family of devices has undergone extensive biocompatibility testing, viral inactivation testing and mechanical testing. Outcomes demonstrate safety and efficacy for soft tissue reconstruction.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.3130 Ophthalmic conformer.
(a)
Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ](b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
0
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92
| The assigned 510(k) number is: | K090078 |
|---|---|
| Contact Person: | Jason Malecka |
| President | |
| IOP, Inc. | |
| 3184-B Airway Ave. | |
| Costa Mesa, CA 92626 | |
| Phone: 714-549-1185 | |
| FAX: 714-549-0557 | |
| Date Prepared: | December 29, 2008 |
MAY - 8 2009## Device Name and Classification
ﻣﺴﺮﺣﺎ
| Proprietary Name: | KeraSys Bioengineered Lamellar Patch Graft |
|---|---|
| Common Name: | Ophthalmic Implant Biologic |
| Regulation Name: | Ophthalmic Conformer |
| Regulatory Class: | Class II (Exempt from Premarket notification procedures) |
| Product Code: | NXM |
| Proposed Classification No.: | 886.3130 |
Device Description
The KeraSys Bioengineered Lamellar Patch Graft is constructed from four layers of laminated porcine small intestinal submucosa (SIS). The dchydrated device is supplied sterile sealed in a double peel pouch system. Unit size is 1x1.5cm
Indications for Use
The KeraSys Bioengineered Lamellar Patch Graft is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface.
Summary of Testing
The Surgisis family of devices has undergone extensive biocompatibility testing, viral inactivation testing and mechanical testing. Outcomes demonstrate safety and efficacy for soft tissue reconstruction.
Substantial Equivalence Claim
KcraSys Bioengineered Lamellar Patch Graft is similar with respect to intended use, materials and technical characteristics to predicate devices.
1
. .
:
Predicate Device Equivalence
ي المقابل المنتج
من القرن
.
:
| Company | Innovative Ophthalmic
Products Inc. | Cook Biotech Inc. | Innovative Ophthalmic
Products, Inc. |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Name(s) | SURGISIS Ocular Graft
tarSys Bioengineered Eyelid
prosthesis | SIS Facial Implant | keraSys Bioengineered Patch
Graft 1x1.5cm |
| 510(k) | K053622 | K050246 | Applied for 510(k) K090078
Pending |
| Product Specifications | | | |
| Material
Indications for
Use | Processed porcine submucosa
The SURGISIS Ocular Graft
is intended for implantation to
reinforce and aid
reconstruction of eyelid and is
labeled for single use | Processed porcine submucosa
Reinforcement of tissue where
weakness exists in patients
requiring soft tissue repair or
reinforcement in face, head
and plastic and reconstructive
surgery | Processed porcine submucosa
The KeraSys Bioengineered
Lamellar Patch Graft is
intended for implantation to
reinforce sclera and aid the
reconstruction of the ocular
surface. |
| Supplied | Sterile | Sterile | Sterile |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Recommended
Usage | Single Use | Single Use | Single Use |
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing strength and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAY - 8 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
IOP, Inc. c/o Mr. Jason Malecka, President 3184-B-Airway Ave. Costa Mesa, CA 92626
Re: K090078
Trade/Device Name: keraSys Bioengineered Lamellar Patch Graft Regulation Number: 21 CFR 886.3130 Regulation Name: Ophthalmic Conformer Regulatory Class: Class II Product Code: NXM Dated: April 15, 2009 Received: April 17, 2009
Dear Mr. Malecka:
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 Foond, Or ug, 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.
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, FTDA 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 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 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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. B. Egleston, MD
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
4
Indications for Use
510(k) Number (if known): K090078
Device Name: KeraSys Bioengineered Lamellar Patch Graft
Indications For Use:
The KaraSys Bioengineered Lamellar Patch Graft is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface. KaraSys is labeled for single use.
X 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)
R. S. Rowe
(Division Sign-Off) (Division Sign-OII)
Division of Ophthalmic and Ear, Division of Open Devices
Page 1 of 1
510(k) Number