(31 days)
Not Found
No
The summary describes a laser and endoscopy system for ophthalmic procedures and does not mention any AI or ML components or capabilities.
Yes.
The device uses photocoagulation to treat medical conditions like glaucoma and proliferative retinopathies, which directly addresses disease processes.
No
Explanation: The device is described as an "ophthalmic laser endoscope" used for "intraoperative photocoagulation" and "visualization" of ocular structures, primarily for treatment of glaucoma and proliferative retinopathies. This indicates a therapeutic and interventional purpose, not a diagnostic one. While it offers visualization, this is presented as a means to guide treatment rather than to diagnose a condition.
No
The device description explicitly states that the complete system consists of a therapeutic laser, endoscope, monitor, and footswitch, indicating hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an ophthalmic laser endoscope used for intraoperative photocoagulation and visualization of internal ocular structures. This is a therapeutic and visualization device used during a surgical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended uses listed are all related to surgical treatment (photocoagulation) and visualization within the eye.
Therefore, the device's function and intended use fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Ocular Endoscopy
Cylophophotocoagulation for glaucoma
Photocoagulation of the Retina
The E2 MicroProbe's intended use is for video imaging, illumination and photocoagulation using up to 1.2 watt of continuous wave radiation for endoscopic procedures.
The ophthalmic laser endoscope is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, and for observation of the internal ocular structures in retinal detachment, and to observe lesions 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 known procedure and has been demonstrated to be effective in the treatment of glaucoma.
Vitreoretinal Surgery
The endoscopically controlled endophotocoagulation that is possible with this system 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
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video imaging
Anatomical Site
ciliary processes, internal ocular structures (retinal detachment), anterior segment, chorioretinal, retinal
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
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.
Conclusions From Nonclinical Testing
The testing of the modified device demonstrates that the performance is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for Endo Optiks. The logo consists of the words "ENDO OPTIKS" in a bold, sans-serif font. There is a curved line above the word "ENDO". The text is black and the background is white.
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 |
1
Image /page/1/Picture/0 description: The image shows the logo for Endo Optiks. The logo consists of the word "ENDO" stacked on top of the word "OPTIKS". Above the words is a curved line. The text is in a bold, sans-serif font.
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
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.
Labeling: The MicroProbe will be renamed (relabeled) the E2 MicroProbe. (Please see labels on Pages 2 & 3 of Attachment 1).
2
Image /page/2/Picture/0 description: The image shows the logo for Endo Optiks. The logo consists of the words "ENDO OPTIKS" in a bold, sans-serif font. Above the text is a curved line. The text is black and the background is white.
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.
-
- 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.
- Nonclinical Used Tests in Determination of Substantial Equivalence
-
- 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
- Conclusions From Nonclinical Testing The testing of the modified device demonstrates that the performance is substantially equivalent to the predicate device.
10-18-2004
Date
Date
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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.
4
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,
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
5
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 |
|---|---|
| --------------- | --------- |