(119 days)
Not Found
No
The summary describes a physical surgical device (scleral plugs) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
Explanation: The device is used to maintain patency of an incision during ophthalmic surgical procedures, which is an intraoperative function, not a therapeutic one for a disease or condition. The "Indications for Use" specifies its role "during ophthalmic surgical procedures" for "maintaining patency," not treating a medical condition.
No
The device description clearly states its purpose is to "maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures." This indicates a surgical tool used for maintaining an opening, not for identifying a disease, condition, or injury.
No
The device description clearly states the device is a physical object (scleral plugs made of stainless steel) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the scleral plugs are used during ophthalmic surgical procedures to maintain the patency of an incision in the sclera. This is a surgical intervention performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
This device is a surgical tool used in vivo (within the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
To provide single-use scleral plugs, to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures performed by a certified clinician in a clinical setting.
The scleral plugs are provided as part of single- and multiple-use surgical component kits/packs, or as kit replacements, in order to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures, performed by a certified clinician in a clinical setting.
Product codes
86 LXP
Device Description
Scleral plugs, 19 and 20 ga., for use in ophthalmic surgical procedures. Both as stainless steel, with the 19 ga. plugs gold plated, and the 20 ga. plugs silver plated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sclera of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
certified clinician in a clinical setting
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4155 Scleral plug.
(a)
Identification. A scleral plug is a prescription device intended to provide temporary closure of a scleral incision during an ophthalmic surgical procedure. These plugs prevent intraocular fluid and pressure loss when instruments are withdrawn from the eye. Scleral plugs include a head portion remaining above the sclera, which can be gripped for insertion and removal, and a shaft that fits inside the scleral incision. Scleral plugs are removed before completing the surgery.(b)
Classification. Class II (special controls). The special controls for the scleral plug are as follows:(1) The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9 if the material is a surgical grade stainless steel with or without a gold, silver, or titanium coating. The special controls for the surgical grade stainless steel scleral plug (with or without a gold, silver, or titanium coating) are:
(i) The device must be demonstrated to be sterile during the labeled shelf life;
(ii) The device must be demonstrated to be biocompatible; and
(iii) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device.
(2) The device is not exempt from premarket notification procedures if it is composed of a material other than surgical grade stainless steel (with or without a gold, silver, or titanium coating). The special controls for scleral plugs made of other materials are:
(i) The device must be demonstrated to be sterile during the labeled shelf life;
(ii) The device must be demonstrated to be biocompatible;
(iii) Characterization of the device materials must be performed;
(iv) Performance data must demonstrate acceptable mechanical properties under simulated clinical use conditions including insertion and removal of the device;
(v) Performance data must demonstrate adequately low levels of the extractables or residues from manufacturing (or processing) of the device; and
(vi) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device.
0
SUMMARY 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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- DEVICE NAME (Trade, common, and classification): Scleral Plug.
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- PREDICATE DEVICE(s): K854507, et al, submissions, information attached, which were determined to be SE.
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- DESCRIPTION: Scleral plugs, 19 and 20 ga., for use in ophthalmic surgical procedures. Both as stainless steel, with the 19 ga. plugs gold plated, and the 20 ga. plugs silver plated.
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- INTENDED USE: To provide single-use scleral plugs, to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures performed by a certified clinician in a clinical setting.
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- We believe this submission should be found substantially equivalent by virtue of the following points, expanded upon elsewhere in this submission:
- 5.1. No substantitive change in materials, basic components, or method of manufacture between this device and the predicate(s); the raw materials/components used have been used in the medical industry on similiar/identical products and for similiar/ identical uses since pre-amendment, without any record of patient problems or adverse reactions;
- 5.2. No change in basic configuration or construction;
- 5.3. These devices and their components have been tested by an indevendent lab for biocompatability (cyctotoxicity, hemolysis), and will be subjected to inspection/ testing at IQC, and during/after manufacture and prior to release to the field.
- 5.4. The function and use of this product will be no different than that of the predicate devices, and countless other similiar devices in the marketplace since pre-amendment.
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- There are no substantive differences between the products defined in this 510(k) submission and the predicate devices.
Prepared 03/09/99 Ammended 04/19/99
Signed: Lusty H. Baker Dated: 3/11/99
Timothy Barker, President/CEO, Director of Sales/Marketing OPHTHALMIC CONSULTANTS, INC. P O Box 2728 11232 120th Avenue Northeast, Suite 109 Kirkland WA 98083-2728 fx 425-803-1881 ph 425-803-6868 510(k): SCLERAL PLUG
Tab 4 -1
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe or sphere.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 11:3 1999
Ophthalmic Consultants, Inc. c/o Mr. John E. Lincoln ]. E. Lincoln and Associates 65 N. Main Suite 101 P.O. Box 154 Tooele, UT 84074
Re: K990872
Trade Name: Scleral Plugs, 19 and 20 Gauge Regulatory Class: II Product Code: 86 LXP Dated: March 11, 1999 Received: March 16, 1999
Dear Mr. Lincoln:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. John E. Lincoln
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on. the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
SCLERAL PLUG Device Name:___
.
Indications For Use:
The scleral plugs are provided as part of single- and multiple-use surgical component kits/packs, or as kit replacements, in order to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures, performed by a certified clinician in a clinical setting.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODB)
L. Romane
(Division Sign-Off)
Division of Ophthalmic Devices 510(k) Number.
Prescription Use_ XX (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)