(116 days)
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.
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
The provided document, K090078, is a 510(k) summary for a medical device called the KeraSys Bioengineered Lamellar Patch Graft. It does not contain details about acceptance criteria, device performance from a study, or the methodology of such a study.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is claiming their new device is as safe and effective as a device already legally marketed, rather than presenting new performance data from a clinical or analytical study.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's how to interpret the document based on your request:
Acceptance Criteria and Study Details (Not Applicable as per 510(k) Summary)
The K090078 submission focuses on demonstrating substantial equivalence, not on providing a new study with acceptance criteria and measured device performance. As such, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this 510(k) summary.
The summary states: "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." This refers to general testing on the material (porcine SIS) used in the device and its predicate devices, rather than a specific performance study of the KeraSys Bioengineered Lamellar Patch Graft itself against predefined acceptance criteria for its intended use.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this 510(k) summary. The submission relies on substantial equivalence to predicate devices, which implies the device meets the safety and effectiveness standards demonstrated by those predicates. | Not explicitly reported for the KeraSys Bioengineered Lamellar Patch Graft in this 510(k) summary. The document states that 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." This is a general statement about the material, not specific performance data for this particular device. |
Study Details (Not Applicable for this 510(k) Summary)
Most of the following categories are not applicable (N/A) because the provided 510(k) summary does not describe a new performance study that would generate this type of data.
- Sample size used for the test set and the data provenance: N/A (No specific test set or study described for the KeraSys device).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No test set or ground truth established for this device's performance in this document).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No test set requiring adjudication described).
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (This device is a physical implant, not an AI diagnostic tool. No MRMC study is relevant or mentioned).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an algorithm or software device).
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A (No specific ground truth for performance evaluation described for this device).
- The sample size for the training set: N/A (Not an AI/algorithm device requiring a training set).
- How the ground truth for the training set was established: N/A (Not an AI/algorithm device).
Summary of 510(k) K090078 Content:
- Device Name: KeraSys Bioengineered Lamellar Patch Graft
- Intended Use: Implantation to reinforce sclera and aid the physical reconstruction of the ocular surface.
- Material: Four layers of laminated porcine small intestinal submucosa (SIS).
- Sterilization: Ethylene Oxide.
- Substantial Equivalence Claim: The device claims substantial equivalence to predicate devices based on similar intended use, materials, and technical characteristics. The predicate devices listed are SURGISIS Ocular Graft (K053622) and SIS Facial Implant (K050246).
- Testing Mentioned (General): "The Surgisis family of devices has undergone extensive biocompatibility testing, viral inactivation testing and mechanical testing." This refers to the core material, not a specific performance study of the KeraSys device itself.
This 510(k) provides evidence for market clearance primarily through a demonstration of similarity to already-approved devices, rather than through presenting novel performance study results against detailed acceptance criteria.
{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 MaleckaPresidentIOP, Inc.3184-B Airway Ave.Costa Mesa, CA 92626Phone: 714-549-1185FAX: 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 OphthalmicProducts Inc. | Cook Biotech Inc. | Innovative OphthalmicProducts, Inc. |
|---|---|---|---|
| ProductName(s) | SURGISIS Ocular GrafttarSys Bioengineered Eyelidprosthesis | SIS Facial Implant | keraSys Bioengineered PatchGraft 1x1.5cm |
| 510(k) | K053622 | K050246 | Applied for 510(k) K090078Pending |
| Product Specifications | |||
| MaterialIndications forUse | Processed porcine submucosaThe SURGISIS Ocular Graftis intended for implantation toreinforce and aidreconstruction of eyelid and islabeled for single use | Processed porcine submucosaReinforcement of tissue whereweakness exists in patientsrequiring soft tissue repair orreinforcement in face, headand plastic and reconstructivesurgery | Processed porcine submucosaThe KeraSys BioengineeredLamellar Patch Graft isintended for implantation toreinforce sclera and aid thereconstruction of the ocularsurface. |
| Supplied | Sterile | Sterile | Sterile |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| RecommendedUsage | 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
§ 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.