(12 days)
The Diagnostic Lenses are intended to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures. Diagnostic lenses are indicated for use during vitreoretinal surgical procedures.
Allow visualization of the ocular fundus, vitreous, and retinal structures during vitreoretinal surgery.
The Super View Disposable BIOM Lens Set(s) consists of multiple sterile, disposable, thermoplastic lenses for both contact and non-contact use in conjunction with an operating microscope equipped with a BIOM wide-angle viewing system.
This 510(k) premarket notification for the "Super View Disposable BIOM Lens Set" from Insight Instruments, Inc. does not contain a study to prove acceptance criteria in the traditional sense of a clinical trial or performance study with defined metrics.
Instead, the submission relies on demonstrating substantial equivalence to a predicate device. This is a common pathway for Class II medical devices, where the focus is on showing that the new device is as safe and effective as a legally marketed device, rather than proving novel efficacy.
Therefore, many of the requested elements for a study proving acceptance criteria are not explicitly present in this document. I will fill in the table and address the other points based on the information provided, highlighting where data is absent due to the nature of the 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (If Defined in this Document) | Reported Device Performance (If Defined in this Document) |
|---|---|
| Design Equivalence: The device should have equivalent design characteristics to the predicate device. | The device's "Materials" (PMMA, Polystyrene, other thermoplastics) and "Design" (Contact lens with concave surface and corneal radius, flat surface; Non-contact lenses with spheric and aspheric surfaces and thermoplastic housings) are compared to the predicate. No specific performance metrics for these design elements are provided, only a descriptive comparison. |
| Material Equivalence: The device should use materials equivalent to the predicate device. | The materials are listed as PMMA, Polystyrene, other thermoplastics, which are similar to the predicate's PMMA, Silicone, Glass, Quartz. The equivalence is descriptive, not quantitative. |
| Sterility Equivalence: The device should have equivalent sterility characteristics to the predicate device. | The device is "Sterile disposable," similar to some versions of the predicate. |
| Intended Use & Indications Equivalence: The device should have the same intended use and indications for use as the predicate device. | The device is intended "to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures" and is "indicated for use during vitreoretinal surgical procedures," which is stated to be equivalent to the predicate. |
Important Note: The concept of "acceptance criteria" in this context is implicitly about demonstrating substantial equivalence across these characteristics. There are no quantitative performance metrics (e.g., optical resolution, magnification, field of view metrics) or statistical thresholds explicitly stated as acceptance criteria for the performance of the device itself. The "performance" being reported is the similarity to the predicate device.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable. This document does not describe a performance study with a test set of data. The "test" is the comparison of characteristics against the predicate device.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable. No ground truth was established by experts for a test set in this submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set was analyzed by multiple reviewers requiring adjudication.
5. 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
- MRMC Study: No. This device is a diagnostic lens, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This device is a physical diagnostic lens. It does not involve an algorithm or AI component to have a "standalone" performance in that sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the context of a performance study. The "ground truth" for this 510(k) submission is the characteristics and established safety/effectiveness of the predicate device. The new device's characteristics are compared against the predicate as the benchmark.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document does not describe the development or training of an algorithm or AI model.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable.
{0}------------------------------------------------
JUN 2 9 2005
Insight Instruments, Inc.
Image /page/0/Picture/3 description: The image shows a diagram with overlapping concepts. On the left side of the diagram, the words "insight" and "instruments" are written. On the right side of the diagram, the words "instruments" and "insight" are written, but they are oriented vertically. The diagram is composed of lines and circles.
3. 510(k) Summary
| 3.1 Date Prepared: | April 19, 2005 |
|---|---|
| 3.2 Applicant: | Insight Instruments, Inc.5400 S. Bryant AvenueSanford, FL 32773, USAPhone: (407) 324 0388Fax: (407) 324 0522Contact: Michael Annen, VP Engineering & Mfg. |
| 3.3 Device Name | Proprietary Name: Super View Disposable BIOM Lens SetCommon Name: Diagnostic LensClassification Name: Lens, Contact, Polymethylmethacrylate, Diagnostic |
| 3.4 Device Classification | HJK, Class II, 21 CFR 886.1385 |
| 3.5 Device Description | The Super View Disposable BIOM Lens Set(s) consists of multiple sterile,disposable, thermoplastic lenses for both contact and non-contact use inconjunction with an operating microscope equipped with a BIOM wide-angle viewing system. |
| 3.6 Intended Use | The Diagnostic Lenses are intended to be used in conjunction with anoperating microscope as a surgical optic to improve visualization of theocular fundus, vitreous and retinal structures. Diagnostic lenses areindicated for use during vitreoretinal surgical procedures. |
3.7 Summary and comparison of technological characteristics:
| Insight Instruments, Inc.Diagnostic Lenses | Ocular Instrument, Inc. VitrectomyLenses | |
|---|---|---|
| Materials | PMMA, Polystyrene, other thermoplastics | PMMA, Silicone, Glass, Quartz |
| Design | Contact lens has concave surface with cornealradius on one side, flat surface on other side.Non-contact lenses have spheric and asphericsurfaces and thermoplastic housings. | Contact lens has concave surface withcorneal radius on one side, flat surfaceon other side.Other designs include biconcave, 20°and 30° prism lenses. Some designs maybe used with a handle or scleral ring. |
| Sterility | Sterile disposable | Sterile disposable and Non-sterilereusable |
{1}------------------------------------------------
The Insight Instruments, Inc. Diagnostic Lenses are equivalent in design, 3.6 Substantial Equivalence The might interamions, and intended use and indications to vitrectorny materials, chasilibation on the ments, Inc. cleared via 510(k) number K012096, 8/24/01.
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
JUN 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Insight Instruments, Inc. c/o Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Rd. Boxborough, MA 01719
Re: K051630
Trade/Device Name: Super View Disposable BIOM Lens Set Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate (PMMA) diagnostic contact lens Regulatory Class: Class II Product Code: HJK Dated: June 16, 2005 Received: June 17, 2005
Dear Lehtonen:
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 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}------------------------------------------------
Page 2 - Daniel W. Lehtonen
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,
David M. Whipple
David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
2. Statement of Indications for Use
510(k) Number (if known): _ KO SKO SKO SKO
Device Name: Diagnostic Lenses
Indications for Use:
Allow visualization of the ocular fundus, vitreous, and retinal structures during vitreoretinal surgery.
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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Soveria
tvision Sign-Off ision of Ophthalmic Ear. Nose and Throat Devise
510(k) Number K051630
§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.