(77 days)
No
The summary describes a biological graft material for tissue reconstruction and does not mention any computational or analytical capabilities that would suggest the use of AI/ML.
No
The device is a graft used for reconstruction and reinforcement of soft tissue, not for therapeutic treatment.
No
The device is an implantable graft for reinforcing and supporting soft tissue reconstruction, not for diagnosis.
No
The device description clearly states it is a physical graft derived from porcine tissue, not software.
Based on the provided information, the SURGISIS Ocular Graft is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "implantation to reinforce and support the reconstruction of the soft tissue of the eyelid." This is a surgical implant used directly on a patient's body.
- Device Description: The description details a biological material (porcine small intestinal submucosa) prepared into sheets for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. The SURGISIS Ocular Graft is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Surgisis Ocular Graft is intended for implantation to reinforce and support the reconstruction of the soft tissue of the eyelid.
The SURGISIS Ocular Graft is intended for implantation to reinforce and aid reconstruction of the eyelid and is labeled for single use.
Product codes (comma separated list FDA assigned to the subject device)
NXM
Device Description
The SURGISIS Ocular Graft is derived from porcine small intestinal submucosa (SIS). The material is prepared into sheets of various sizes and thicknesses appropriate for the reconstruction and repair of soft tissues. The device is supplied sterile in a dry lyophilized state sealed in a double peel pouch system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyelid, ocular
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 ocular graft is identical in material composition to predicate Surgisis devices and has undergone extensive biocompatibility testing, viral inactivation testing and mechanical testing. Outcomes demonstrate safety and efficacy for soft tissue reconstruction and repair.
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.
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
§ 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
MAR 1 5 2006
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: KOS 3622
| Contact Person: | Jason Malecka
President
IOP, Inc.
3184-B Airway Ave.
Costa Mesa, CA 9262 |
|-----------------|--------------------------------------------------------------------------------------|
| | Phone: 714-549-1185
FAX: 714-549-0557 |
December 22, 2005 Date Prepared:
Device Name and Classification
| Proprietary Name: | SURGISIS Ocular Graft |
|---|---|
| Common Name: | Ophthalmic Implant Biologic |
| Classification Name: | Prosthesis, Eyelid Spacer Graft, Biologic |
| Classification: | Class II (Exempt from Premarket notification procedures) |
| Product Code: | NXM |
| Classification No.: | 21 CFR 886.3130 |
Device Description
The SURGISIS Ocular Graft is derived from porcine small intestinal submucosa (SIS). The material is prepared into sheets of various sizes and thicknesses appropriate for the reconstruction and repair of soft tissues. The device is supplied sterile in a dry lyophilized state sealed in a double peel pouch system
Indications for Use
The Surgisis Ocular Graft is intended for implantation to reinforce and support the reconstruction of the soft tissue of the eyelid.
Summary of Testing
The Surgisis ocular graft is identical in material composition to predicate Surgisis devices and has undergone extensive biocompatibility testing, viral inactivation testing and mechanical testing. Outcomes demonstrate safety and efficacy for soft tissue reconstruction and repair.
Substantial Equivalence Claim
Surgisis Ocular Graft is similar with respect to intended use, materials and technical characteristics to predicate devices.
1
Predicate Device Equivalence
:
| Company | Innovative
Ophthalmic
Products Inc. | Cook Biotech Inc. | Bio-Tissue, Inc. |
|------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name(s) | SURGISIS Ocular
Graft | Surgisis Soft Tissue Graft
SIS Plastic Surgery Matrix
SIS Facial Implant | ProKera™ Ophthalmic Conformer with
Amniotic Membrane |
| 510(k) | Applied For | K980431
K034039
K050246 | K032104 |
| Product Specifications | | | |
| Material | Processed porcine
submucosa | Processed porcine
submucosa | Amniotic Membrane with ophthalmic
conformer used as an epithelial insert |
| Indications for Use | General
reconstruction of
the eyelid.
Eyelid Spacer
Graft | Implantation to reinforce
soft tissue where weakness
exists in patients requiring
soft tissue repair or
reinforcement in face and
head and plastic and
reconstructive surgery | Intended for use in eyes in which the
ocular surface cells have been damaged
or underlying stoma is inflamed and
scarred. The device in inserted
between the eyeball and eyelid to
maintain space in the orbital cavity and
prevent closure or adhesions |
| Supplied | Sterile | Sterile | Unknown |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Unknown |
| Recommended
Usage | Single Use | Single Use | Single Use |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2006
IOP, Inc. Mr. Jason Malecka, President 3184 Airway Avenue, Bldg. B Costa Mesa, CA 92626
Re: K053622
Kooso22
Trade/Device Name: Prosthesis, eyelid spacer/graft, biologic Regulation Number: 21 CFR 886.3130 Regulation Name: Ophthalmic Conformer Regulatory Class: Class II Product Code: NXM Dated: December 22, 2005 Received: December 28, 2005
Dear Mr. Malecka:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared on (d the device is substantially equivalent (for the indications ferenced above and have sure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conimer of pror to ria) 2011-12-12, 10:00 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetter For (110) market the device, subject to the general controls provisions of the Act. The r ou may, diere, mains 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 such 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 CFR Part 807); labeling (21 CFR Part 801); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
MB Egelund - MT
Malvina B. Eydelman, M.D. Acting Division Director Division of Ophthalmic and Ear, Nosc and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 3 - Mr. Jason Malecka
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K053622
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The SURGISIS Ocular Graft is intended for implantation to reinforce and aid reconstruction of the eyelid and is labeled for single use.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Usc (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)
A
(Division Sign-Off) Division of Ophthalmig Ear, Nose and Throat Devises
510(k) Number K053622
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