E3 MICROPROBE

• K Number: K974878
• Device Name: E3 MICROPROBE
• Manufacturer: MARTIN URAM, MD
• Date Cleared: 1998-03-27 ( 87 days)
• Product Code: GEX
• Regulation Number: 878.4810

Intended Use

Contact and non-contact excision, hemostasis, incision and vaporization for the following soft tissue applications: General Surgery Ophthalmology / Oculoplastic Urology Gastroenterology Gynecology Otorhinolaryngology Pulmonary / Thoracic Dermatology / Plastic Surgery Neurosurgery Orthopedic

Device Description

The Endo Optiks E3 MicroProbe System consists of a laser, endoscope, console and footpedal. The treatment laser is a solid state diode laser system operating at 810 nanometers ± 2 nanometers and continuous wave power of up to 60 Watts. A visible solid state diode laser operating at a nominal wavelength of 640 nm and a variable continuous wave output from 0 to 1.5 milliwatts is incorporated as an aiming device. The end of the endoscope consists of a 0.25 milimeter diameter fiberoptic for viewing, a 0.10 millimeter diameter fiberoptic for delivery of the laser energy and fiberoptics that transmit the illumination light. Laser energy is delivered via a single timed continuous wave pulse with the time preset at the operator console and the pulse initiated by the footpedal. Laser power is also preset at the console. The E3 MicroProbe is a modification to the maximum power output rating of the original MicroProbe. Labeling: The MicroProbe will be renamed (relabeled) the E3 MicroProbe. This change is being made to be consistant with the industry practice of designating a laser's power based on the output power at the laser port rather than that at the tissue site. There is no change in construction or performance of this device. Power Output: An additional model will be created by increasing the output power to produce the E3 MicroProbe. The same basic design is retained. The 60 Watt model uses sixteen 4 Watt laser diodes. The power supply and cooling designs of the new model have been appropriately scaled, while the mechanical design and user interface remain unchanged.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the laser technology, endoscope components, and power output modifications, with no mention of AI or ML.

Therapeutic

Yes
This device is clearly described as being used for various surgical applications such as excision, hemostasis, incision, and vaporization, which are therapeutic interventions.

Diagnostic

No

Explanation: The device description and intended use clearly state that this is a surgical laser system used for excision, hemostasis, incision, and vaporization of soft tissues, not for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components including a laser, endoscope, console, and footpedal, and discusses modifications to the laser's power output and physical design elements like the power supply and cooling.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly describes a surgical laser system for contact and non-contact excision, hemostasis, incision, and vaporization of soft tissues in various medical specialties. This is a therapeutic and surgical application, not a diagnostic one performed in vitro (outside the body).
• Device Description: The description details a laser system, endoscope, console, and footpedal used for delivering laser energy to tissue. This aligns with a surgical device.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.

The device is a surgical laser system used for treating tissues directly within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Contact and non-contact excision, hemostasis, incision and vaporization for the following soft tissue applications:

General Surgery Ophthalmology / Oculoplastic Urology Gastroenterology Gynecology

Otorhinolaryngology Pulmonary / Thoracic Dermatology / Plastic Surgery Neurosurgery Orthopedic

Product codes (comma separated list FDA assigned to the subject device)

GEX

Device Description

The Endo Optiks E3 MicroProbe System consists of a laser, endoscope, console and footpedal. The treatment laser is a solid state diode laser system operating at 810 nanometers ± 2 nanometers and continuous wave power of up to 60 Watts. A visible solid state diode laser operating at a nominal wavelength of 640 nm and a variable continuous wave output from 0 to 1.5 milliwatts is incorporated as an aiming device. The end of the endoscope consists of a 0.25 milimeter diameter fiberoptic for viewing, a 0.10 millimeter diameter fiberoptic for delivery of the laser energy and fiberoptics that transmit the illumination light. Laser energy is delivered via a single timed continuous wave pulse with the time preset at the operator console and the pulse initiated by the footpedal. Laser power is also preset at the console.

The E3 MicroProbe is a modification to the maximum power output rating of the original MicroProbe.

Labeling: The MicroProbe will be renamed (relabeled) the E3 MicroProbe. This change is being made to be consistant with the industry practice of designating a laser's power based on the output power at the laser port rather than that at the tissue site. There is no change in construction or performance of this device.

Power Output: An additional model will be created by increasing the output power to produce the E3 MicroProbe. The same basic design is retained. The 60 Watt model uses sixteen 4 Watt laser diodes. The power supply and cooling designs of the new model have been appropriately scaled, while the mechanical design and user interface remain unchanged.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Soft tissue applications: General Surgery, Ophthalmology / Oculoplastic, Urology, Gastroenterology, Gynecology, Otorhinolaryngology, Pulmonary / Thoracic, Dermatology / Plastic Surgery, Neurosurgery, Orthopedic

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)

Nonclinical Tests Used in Determination of Substancial Equivalence: The design of the E3 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 devices demonstrates that the performance is substantially equivalent to the predicate prior to the modifications.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

MARTIN URAM, M.D. Disorders of the Retina

39 Sycamore Avenue Little Silver, New Jersey 07739 [phone] Fax [phone]

225 East 64th Street New York, New York 10021 [phone]

K97487P

MAR 2 7 1998

Summary 510 (k) For the E3 MicroProbe

1. • Date Summary Prepared:

December 15, 1997

2. • Submitter's Name and Address:

Martin Uram, MD

39 Sycamore Avenue

Little Silver, NJ 07739-1208

Contact Person: Keith Hertz

Fax: [phone] Tel.: [phone]

E-mail: [e-mail]

3. - Device Name:

Trade / Proprietary Name: E3 MicroProbe / 2

e

David Zoser

Common Name: Integrated Surgical Laser and Endoscope System

Classification Name: Surgical Diode Laser Fiber Optic Endoscope

1

39 Sycamore Avenue Little Silver, New Jersey 07739 [phone] Fax [phone]

225 East 64th Street New York, New York 10021 [phone]

10 (K) Probe For

4. - Predicate Devices:

The legally marketed devices to which equivalence is being claimed are:

Pentax Video Colonoscope MicroProbe Pentex Video Duodenoscope Family of Endoscopes Pentax Video Gastroscope Value Pack Pentax Video Sigmoidoscope Endoscope w. Cannula Pentax Bronchofiberscope Transtympanic Endoscope Storz Flexible Fiberscope Diomed (15, 30, 60) Surgical Diode Laser Storz Flexible Rhino-Pharyngo-Coherent Surgical Laser Laryngo-Fiberscope Storz Flexible Hysteroscope ASI Uroplasty Cystoscope Storz Hopkins Telescope Olympus Arthroscopy System Stryker Arthroscopy System Olympus Laparo-Thoraco Videoscope Stryker Sinuscope Olympus Oratracheal Intubation Endoscope Olympus Endoscope System

2

39 Sycamore Avenue Little Silver, New Jersey 07739 [phone] Fax [phone]

225 East 64th Street New York, New York 10021 [phone]

510 (k) Summarv For the E3 MicroProbe

5. - Device Description:

The Endo Optiks E3 MicroProbe System consists of a laser, endoscope, console and footpedal. The treatment laser is a solid state diode laser system operating at 810 nanometers ± 2 nanometers and continuous wave power of up to 60 Watts. A visible solid state diode laser operating at a nominal wavelength of 640 nm and a variable continuous wave output from 0 to 1.5 milliwatts is incorporated as an aiming device. The end of the endoscope consists of a 0.25 milimeter diameter fiberoptic for viewing, a 0.10 millimeter diameter fiberoptic for delivery of the laser energy and fiberoptics that transmit the illumination light. Laser energy is delivered via a single timed continuous wave pulse with the time preset at the operator console and the pulse initiated by the footpedal. Laser power is also preset at the console.

The E3 MicroProbe is a modification to the maximum power output rating of the original MicroProbe.

Labeling: The MicroProbe will be renamed (relabeled) the E3 MicroProbe. This change is being made to be consistant with the industry practice of designating a laser's power based on the output power at the laser port rather than that at the tissue site. There is no change in construction or performance of this device.

Power Output: An additional model will be created by increasing the output power to produce the E3 MicroProbe. The same basic design is retained. The 60 Watt model uses sixteen 4 Watt laser diodes. The power supply and cooling designs of the new model have been appropriately scaled, while the mechanical design and user interface remain unchanged.

3

MARTIN URAM, M.D. Disorders of the Retina

39 Sycamore Avenue Little Silver, New Jersey 07739 [phone] Fax [phone]

225 East 64th Street New York, New York 10021 [phone]

737

510 (k) Summary For the E3 MicroProbe

Indication For Use: The indications are expanded to include both contact and non-contact ablation, incision, excision, coagulation and vaporization for the following soft tissue applications:

• General Surgery ●
• . Ophthalalmology / Oculoplastic
• . Urology
• . Gastroenterology
• . Gynecology
• Otorhinolaryngology .
• . Pulmonary / Thoracic
• Dermatology / Plastic Surgery �
• Neurosurgery ●
• . Orthopedic

6. - Intended Use:

The E3 MicroProbe delivers up to 60 Watts of continuous wave radiation to a flexible optical fiber for use in open and endoscopic procedures.

7 . - Comparison of Technological Charateristics

This modification replaces the original MicroProbe with four models, the Full Featured MicroProbe, the E3 MicroProbe - 15, the E3 MicroProbe - 30 and the E3 MicroProbe - 60. Modifications are to offer models with different maximum output powers (15, 30 and 60 Watts at the output port), in order to provide sufficient power when it is required, and to provide a more cost effective device for applications that do not require the higher power capabilities. The original MicroProbe currently operates with a maximum power of 15 Watts. In addition, indications for use have been expanded to include both contact and non-contact treatment of soft tissue applications for which leqally marketed lasers are currently available.

4

39 Svcamore Avenue Little Silver, New Jersey 07739 [phone] Fax [phone]

225 East 64th Street New York, New York 10021 [phone]

Summarv 510 (k) E3 MicroProbe For

8. - Nonclinical Tests Used in Determination of Substancial Equivalence

The design of the E3 MicroProbe has been thoroughly validated at the unit and system level. The tests showed that all system specifications are satisfied.

9. - Conclusions From Nonclinical Testing

The testing of the modified devices demonstrates that the performance is substantially equivalent to the predicate prior to the modifications.

5

Image /page/5/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 symbol, which is a stylized human figure with three arms or lines extending from the head. The symbol is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. The text is in all caps and is arranged to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 27 1998

Martin Uram, M.D. Disorders of the Retina 39 Sycamore Avenue 07739 Little Silver, New Jersey

Re: K974878 E3 MicroProbe Series of Diode Lasers Trade Name: and Accessories Regulatory Class: II Product Code: GEX Dated: December 22, 1997 December 30, 1997 Received:

Dear Dr. Uram:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

6

Page 2 - Dr. Uram

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Radiological Health

Enclosure

7

K974878/12
DUPLICATE
225 East 64th Street
New York, New York 10021
[phone]

39 Sycamore Avenue a Silver, New Jersey 07739 [phone] Fax [phone]

510(k) Number: K974878

Device Name: E3 MicroProbe

Indications For Use

Contact and non-contact excision, hemostasis, incision and vaporization for the following soft tissue applications:

General Surgery Ophthalmology / Oculoplastic Urology Gastroenterology Gynecology

Otorhinolaryngology Pulmonary / Thoracic Dermatology / Plastic Surgery Neurosurgery Orthopedic

Concurrent of CDRH, Office of Device Evaluation (ODE)

---

Prescription Use (Per21 CFR 801.109)

OR
Over-The-Counter-Use
(Optional Format 1-2-96)

(Division Sign-Off)

Division of General Restorative Devices צרף רק צוצרף 510(k) Number -