(83 days)
The MicroVision Scleral Buckling Components are solid silicone and silicone sponge implants intended for intrascleral and episcleral buckling in the surgical treatment of retinal detachments.
The MicroVision Scleral Buckling Components are molded solid silicone and silicone sponge devices available in a variety of shapes and sizes. The components are provided as sterile for single use only. Biocompatibility testing conducted according to ISO 10993 confirmed that the components are biocompatible and nontoxic.
The provided text is a 510(k) summary for the MicroVision Scleral Buckling Components. This document outlines the device's characteristics, intended use, and its substantial equivalence to previously cleared predicate devices. However, it does not contain information about acceptance criteria, detailed study designs, or performance metrics in the way one might find for more complex diagnostic or therapeutic algorithms.
Here's a breakdown of why the requested information cannot be fully provided from this document:
-
Nature of the Device: Scleral buckling components are physical implants used in surgery. Their regulatory clearance relies heavily on material biocompatibility, physical properties, and equivalence to existing, established predicate devices, rather than clinical performance metrics in the same way a diagnostic AI would. There are no "performance metrics" in terms of sensitivity, specificity, accuracy, or reader improvement for this type of device.
-
Type of Regulatory Submission: A 510(k) submission generally focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This often involves bench testing (physical and chemical properties), material characterization, and a comparison of intended use, rather than extensive clinical efficacy studies with ground truth established by experts.
Based on the provided text, here's what can be extracted and why other information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use Equivalence | The MicroVision Scleral Buckling Components have the same intended use as the listed predicate products: for scleral buckling in retinal reattachment surgery. |
| Material Equivalence | All products are made of molded silicone, either in solid or sponge form, demonstrating equivalence in material composition to predicates. |
| Sterilization & Packaging Equivalence | All products are provided sterile for single use only, demonstrating equivalence in sterility and packaging. |
| Form/Availability Equivalence | All products are available in a wide variety of shapes and sizes, demonstrating equivalence in available forms. |
| Biocompatibility & Toxicity | Biocompatibility testing conducted according to ISO 10993 confirmed that the components are biocompatible and nontoxic. All predicate products have also been demonstrated to be biocompatible and non-toxic. |
| Dimensional & Physical Properties | Bench testing was conducted to demonstrate that the MicroVision products are substantially equivalent to the predicates with respect to dimensional and physical properties. (Specific values or thresholds are not provided in this summary, but the conclusion of equivalence is stated.) |
Explanation for Missing Information: For devices like these, "acceptance criteria" are typically met by demonstrating that the new device is "substantially equivalent" to predicate devices across several key attributes (materials, intended use, performance, safety). The "reported device performance" here describes how it meets those equivalence criteria rather than numerical performance metrics like those for an AI algorithm.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable/Not provided. This device is a physical implant, not a diagnostic algorithm that uses a "test set" of data. The "testing" involved bench testing for physical and material properties, and biocompatibility testing. The document does not specify sample sizes for these types of tests, or where their data originated from (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable/Not provided. "Ground truth" established by experts is relevant for diagnostic or AI-driven devices where human assessment is the reference standard. For a medical device implant, ground truth regarding its material properties or biocompatibility is established through standardized laboratory tests (e.g., ISO 10993), not by expert consensus on clinical cases.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided. As there's no "test set" of clinical cases requiring expert interpretation, no adjudication method (like 2+1 or 3+1) was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is designed to compare human reader performance, often with and without AI assistance, on a set of clinical cases. This is not relevant for a physical implant device designed for surgical treatment. Therefore, no effect size of human reader improvement with AI assistance is applicable or reported.
6. Standalone (Algorithm Only) Performance:
- Not applicable/Not provided. This is not an algorithm or AI device; it's a physical medical implant. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used:
- Regulatory/Bench Testing Standards: The "ground truth" for this device's acceptance is based on adherence to recognized standards for biocompatibility (ISO 10993) and demonstration of equivalent physical and dimensional properties through bench testing, compared to legally marketed predicate devices. It's not based on expert consensus on clinical cases, pathology, or outcomes data in the traditional sense for diagnostic tools.
8. Sample Size for the Training Set:
- Not applicable/Not provided. This device is not an AI algorithm, so there is no concept of a "training set" for machine learning.
9. How Ground Truth for the Training Set Was Established:
- Not applicable/Not provided. Since there's no training set, this question is not relevant.
In summary, the 510(k) summary for MicroVision Scleral Buckling Components demonstrates substantial equivalence primarily through bench testing and material characterization to established predicate devices, which aligns with the regulatory pathway for this type of device. The extensive clinical study details, expert consensus, and AI-specific metrics requested are not applicable or provided in this document given the nature of the device and the regulatory submission.
{0}------------------------------------------------
KO23481
510(k) Summary
for
MicroVision Scleral Buckling Components
1. SPONSOR
MicroVision, Inc. 34 Folly Mill Road, Suite 200 P.O. Box 1651 Seabrook, NH 03874
Contact Person: Leonard Kastrilevich 603-474-5566 Telephone:
Date Prepared: October 16, 2002
2. DEVICE NAME
| Proprietary Name: | MicroVision Scleral Buckling Components |
|---|---|
| Common/Usual Name: | Scleral Buckling Components |
| Classification Name: | Nonresorbable Extraocular Orbital Implants |
3. PREDICATE DEVICES
MicroVision, Inc. claims substantial equivalence to the solid silicone and silicone sponge implants cleared for marketing under the following 510(k)s:
- Mira, Inc. . (K950806)
- Storz Ophthalmics, Inc. (K832481, K950599) .
- Labtician Ophthalmics, Inc. (K875014) .
INTENDED USE 4.
The MicroVision Scleral Buckling Components are solid silicone and silicone sponge implants intended for intrascleral and episcleral buckling in the surgical treatment of retinal detachments.
5. DEVICE DESCRIPTION
The MicroVision Scleral Buckling Components are molded solid silicone and silicone sponge devices available in a variety of shapes and sizes. The components
{1}------------------------------------------------
KO23481
are provided as sterile for single use only. Biocompatibility testing conducted according to ISO 10993 confirmed that the components are biocompatible and nontoxic.
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The MicroVision Scleral Buckling Components have the same intended use as the listed predicate products, that is, for scleral buckling in retinal reattachment surgery. All of the products are made of molded silicone, either in solid or sponge form, are provided sterile for single use only, and are available in a wide variety of shapes and sizes. All products have been demonstrated to be biocompatible and non-toxic. Bench testing was conducted to demonstrate that the MicroVision products are substantially equivalent to the predicates with respect to dimensional and physical properties.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem depicts a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The overall design is simple and conveys a sense of authority and professionalism.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 8 2003
MicroVision, Inc. Sheila Hemeon-Heyer, JD, RAC c/o Medical Device Consultants, Inc. (MDCI) 49 Plain Street North Attleboro, MA 02760
Re: K023481
Trade Name: MicroVision Scleral Buckling Components Classification Regulation Number: 886.3340 Regulatory Class: II Product Code: HQX Dated: October 16, 2002 Received: October 17, 2002
Dear Dr. Hemeon-Heyer:
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. 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 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
{3}------------------------------------------------
Page 2 - Sheila Hemeon-Heyer, JD, RAC
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. 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) 594-4692. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
{4}------------------------------------------------
510(k) Number (if known): ¥02 348 |
Device Name: MicroVision Scleral Buckling Components
Indications for Use:
The MicroVision Scleral Buckling Components are solid silicone and silicone sponge implants intended for intrascleral and episcleral buckling in the surgical treatment of retinal detachment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ausannand Jones
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K 033981
L Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
October 16, 2002
§ 886.3340 Extraocular orbital implant.
(a)
Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.(b)
Classification. Class II.