The ophthalmic laser endoscope is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, visualization of the internal ocular structures in retinal detachment, and for visualization of the anterior segment which do not allow a posterior view.

Glaucoma
This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or other cyclodestructive procedures.
The endophotocoagulation of ciliary processes under direct endoscopic view is a recognized procedure and has been demonstrated to be effective in the treatment of glaucoma.

Vitreoretinal Surgery
The endoscopically controlled endophotocoagulation that is possible with the MicroProbe is also useful for endophotocoagulation:

To produce chorioretinal scar around retinal breaks or retinotomy sites
To perform intraoperative panretinal photocoagulation (PRP) in proliferative retinopathies
To perform intraoperative retinal photocoagulation on a scleral buckle
To perform intraoperative photocoagulation around focal neovascularization

Device Description

The Endo Optiks E2 MicroProbe™ is the principal component in a new portable laser and endoscopy system. The complete system consists of the therapeutic laser, the endoscope, the monitor and the footswitch. This compact unit creates the opportunity to simultaneously image and photocoagulate the ciliary processes through a corneal incision. It is especially indicated for the safe and effective treatment of glaucoma in combination with cataract surgery. Important vitreo-retinal applications can be realized. It can be used for the contact and non-contact excision, hemostatis, incision and vaporization of soft tissue. The E2 MicroProbe is a modification to the packaging of the original MicroProbe.

AI/ML Overview

Based on the provided documents for the Endo Optiks E2 MicroProbe, here's a summary of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated)	Reported Device Performance
System specifications are satisfied.	The nonclinical tests showed that "all system specifications are satisfied." (Page 2)
Performance is substantially equivalent to predicate device.	"The testing of the modified device demonstrates that the performance is substantially equivalent to the predicate device." (Page 2)
Image quality meets requirements for endoscopic visualization.	While not explicitly stated as an "acceptance criterion" in a table within the document, the device description and intended use imply adequate imaging. The device is a "principal component in a new portable laser and endoscopy system" and creates "the opportunity to simultaneously image and photocoagulate." (Page 1) The intended use specifies "video imaging" for endoscopic procedures. The fact that the device was found substantially equivalent to the predicate (which performs these functions) means it met these implied criteria.
Laser output meets requirements for photocoagulation.	The intended use specifies "photocoagulation using up to 1.2 watt of continuous wave radiation for endoscopic procedures." (Page 2) The nonclinical testing found all system specifications satisfied and substantial equivalence to the predicate, which also performs photocoagulation. This indicates the device met its specified laser output for its intended therapeutic procedures.
Conformity with recognized standards.	The E2 MicroProbe "has also been tested and found to be in conformity with recognized standards." (Page 2) Specific standards are not listed.

2. Sample Size Used for the Test Set and Data Provenance

The documents do not specify a test set sample size or data provenance (e.g., country of origin, retrospective or prospective data) for any clinical or nonclinical studies. The assessment for this 510(k) relies on nonclinical testing to demonstrate substantial equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the documents. The submission emphasizes nonclinical testing and substantial equivalence, not clinical validation based on expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the documents. As the submission focuses on nonclinical testing for substantial equivalence, a clinical adjudication method is not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not mentioned in the provided documents. The submission relies on nonclinical testing for substantial equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the E2 MicroProbe is a medical device (laser and endoscopy system), not an AI algorithm. Its performance is inherent in its physical and functional capabilities, not in an independent algorithm.

7. The Type of Ground Truth Used

The ground truth used for this submission appears to be engineering specifications and established performance characteristics of the predicate device. The testing demonstrated that the E2 MicroProbe satisfied its own system specifications and that its performance was substantially equivalent to the legally marketed predicate device (Uram Ophthalmic Laser Endoscope - MicroProbe).

8. The Sample Size for the Training Set

This information is not applicable as the E2 MicroProbe is a medical device, not an AI or machine learning model that requires a training set. The evaluation is based on the device's physical and functional performance, not learned data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as #8.

Summary

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K042918 1/3

39 Sycamore Ave. Little Silver, NJ 07739 Tel: 732 530 6762 Fax: 732 530 5344

Attachment 11

510(k) Summary For the E2 MicroProbe

.1 - Date Summary Prepared

NOV 2 2 2004

October 18, 2004

2. - Submitter's Name and Address

Endo Optiks, Inc. 39 Sycamore Avenue Little Silver, NJ 07739-1208 Contact Person: Keith Hertz

Tel.: 732-530-6762 Fax: 732-530-5344

E-mail: info@endo-optiks.com khertz@monmouth.com

- Device Name

Trade / Proprietary Name:	E2 MicroProbe Laser and Endoscopy System
Common Name:	Various Laser and Endoscopy Systems
Classification Name:	Laser, Ophthalmic

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Ko42918 2/3

39 Sycamore Ave. Little Silver, NJ 07739 Tel: 732 530 6762 Fax: 732 530 5344

510(k) Summary For the E2 MicroProbe

4. - Predicate Devices

The legally marketed device to which equivalence is being claimed is:

Uram Ophthalmic Laser Endoscope - MicroProbe

5. - Device Description

Labeling: The MicroProbe will be renamed (relabeled) the E2 MicroProbe. (Please see labels on Pages 2 & 3 of Attachment 1).

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K042918 3/3

39 Sycamore Ave. Little Silver, NJ 07739 Tel: 732 530 6762 Fax: 732 530 5344

510(k) Summary For the E2 MicroProbe

Indications For Use:

Ocular Endoscopy Cylophophotocoagulation for glaucoma Photocoagulation of the Retina

6. - Intended Use

MicroProbe's intended use The E2 is for video imaging, illumination and photocoagulation using up to 1.2 watt of continuous wave radiation for endoscopic procedures. This is the same intended use as the previously cleared ophthalmic laser endoscope, K910532.

7. - Comparison of Technological Characteristics

This modification replaces the original MicroProbe with the E2 MicroProbe. The E2 MicroProbe has a different model of laser diode and has been repackaged without the video monitor in a smaller, streamlined cabinet. It has also been tested and found to be in conformity with recognized standards.

1. Nonclinical Used Tests in Determination of Substantial Equivalence
  The design of the E2 MicroProbe has been thoroughly validated at the unit and system level. The tests showed that all system specifications are satisfied.
1. Conclusions From Nonclinical Testing The testing of the modified device demonstrates that the performance is substantially equivalent to the predicate device.
  Keitz Herta
  Signature, Keith Hertz

10-18-2004
Date

Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2004

Mr. Keith Hertz Regulatory Affairs Endo Optiks, Inc. 39 Sycamore Avenue Little Silver, New Jersey 07739

Re: K042918

Trade/Device Name: E2 Microprobe Laser and Endoscopy System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 18, 2004 Received: October 27, 2004

Dear Mr. Hertz:

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.

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Page 2 - Mr. Hertz

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 (240) 276-0115. 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/dsma/dsmamain.html

Sincerely yours,

L. Salin M. Witte, PhD, M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number : K042918

Device Name: E2 MicroProbe laser and endoscopy system.

Indications for Use:

The ophthalmic laser endoscope is indicated for intraoperative photocoagulation The opiltianine lasser onwooders is mant of glaucoma, proliferative retinopathies, of the chiary processes in the creatuation of the internal ocular structures in retilial detachinent, and tox everances of the anterior segment which do allow a posterior view.

Glaucoma

This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or process as a ther cyclodestructive procedures.

The endophotocoagulation of ciliary processes under direct endoscopic view is I he endophotocoaganation of onlaas and has been demonstrated to be effective in the treatment of glaucoma.

Vitreoretinal Surgery

Vita eoretinal Darger >
The endoscopically controlled endophotocoagulation that is possible with the File endoscopically secone is also useful for endophotocoagulation:

It it it is the concess to produce chorioretinal scar around retinal breaks . or retinotomy sites
of retirem intraoperative panretinal photocoagulation (PRP) in . proliferative retinopathies
promerative revinopatiiss
To perform intraoperative retinal photocoagulation on a scleral buckle . ro perform intracperative photocoagulation around focal neovascularization

Prescription Use(Part 21 CFR 801 Subpart D)	X
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)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number	K042918
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Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.