(236 days)
Not Found
No
The device description and intended use are for simple, non-electronic, stainless steel scleral plugs. There is no mention of software, image processing, AI, or ML.
No
The device is described as a surgical instrument (scleral plug) intended to maintain the patency of an incision during ophthalmic surgery, not to treat, diagnose, mitigate, or prevent disease.
No
The device is described as a scleral plug, intended to maintain the patency of an incision during surgical procedures, not to diagnose a condition. Its function is interventional, not diagnostic.
No
The device description clearly states it is a physical product made of stainless steel (scleral plugs) and does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the scleral plugs are intended to "maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures." This is a surgical tool used during a procedure on the body, not a device used to test samples outside the body.
- Lack of Diagnostic Information: The device does not provide any diagnostic information about a patient's condition. Its purpose is purely mechanical and procedural.
Therefore, based on the provided information, this device falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The scleral plugs are intended to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures.
Product codes
LXP
Device Description
Scleral plugs, 19 and 20 gauge, for use in ophthalmic surgical procedures. Both 19 and 20 gauge plugs are stainless steel. The 19 gauge plugs are gold 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
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)
This device has been tested by an independent lab for biocompatibility and will be subjected to inspection and during/after manufacture and prior to release to the field.
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
§ 886.4155 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
APR 1 6 2019
Microvision, Inc. Leonard Kastrilevich President 34 Folly Mill Rd. Suite 200 P.O. Box 1651 Seabrook. New Hampshire 03874-1651
Re: K022186
Trade/Device Name: Scleral Plugs, 19 And 20 Gauge Regulation Number: 21 CFR 886.4155 Regulation Name: Scleral plug Regulatory Class: Class II Product Code: LXP Dated: July 2, 2002 Received: July 5, 2002
Dear Leonard Kastrilevich:
This letter corrects our substantially equivalent letter of February 26, 2003.
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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K022186 - Leonard Kastrilevich
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kesia Clexander
for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K022186
Scleral Plug Device Name:_
Indication For Use:
The scleral plugs are intended to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna D. Kirchner
(Division Sign-Off) Division of Ophthalmic Devices
510(k) K022186
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
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022186
FEB 2 6 2003
510(k) Summary Scleral Plugs (per 21 CFR 807.92)
SUBMITTER NAME AND ADDRESS l.
MicroVision, Inc. 34 Folly Mill Road, Suite 200 P.O. Box 1651 Seabrook, NH 03874-1651
Leonard Kastrilevich, President Contact Person: Telephone: 603-474-5566 Fax: 603-474-9336 Email: Ikast@micro-vision.net
| Date Prepared: | July 01, 2002 |
|---|---|
| Date Revised: | December 20, 2002 |
DEVICE NAME 2.
Trade Name: Scieral Plug Scieral Plugs, 19 and 20 Gauge Proprietary Name: Plug, Scieral Classification Name:
3. PREDICATE DEVICE
(K854507) Storz MVS 19 & 20 Gauge Scieral Plug Storz Instrument Co., St. Louis
DEVICE DESCRIPTION 4.
Scleral plugs, 19 and 20 gauge, for use in ophthalmic surgical procedures. Both 19 and 20 gauge plugs are stainless steel. The 19 gauge plugs are gold plated.
5. INTENDED USE
The scleral plugs are intended to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures.
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BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The Micro Vision Scleral Plugs are substantially equivalent to the predicate device by virtue of the following points:
6.1 No change in materials, basic components, or methods of manufacture between this device and the predicate; the raw materials used have been used in the medical industry on similar/identical products since pre-amendment, without any record of patient problems or adverse reactions:
6.2 No change in basic configuration or construction;
6.3 This device has been tested by an independent lab for biocompatibility and will be subjected to inspection and during/after manufacture and prior to release to the field.
6.4 The function and use of this product will be no different then that of the predicate device.
Predicate device is a Class II device, granted FDA marketing clearance under K854507, issued to Storz Instrument Co., St. Louis, Missouri. Substantial equivalency is being claimed to predicate device.
MicroVision, Inc. believes that based on the above comparison, the Micro Vision Scleral Plug is substantially equivalent to the above cited device, that any differences are minor and do not raise new issues of safety and effectiveness.
Signe
| Signed: | Leonard Rase |
|---|---|
| --------- | -------------- |
Dated: 12-23-02
Leonard Kastrilevich President MicroVision, Inc.
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