(175 days)
Not Found
No
The summary describes a standard surgical laser device with illumination and aspiration/backwash capabilities, without mentioning any AI or ML components or functions.
Yes
The device performs "endo-ocular laser photocoagulation treatments," which is a medical treatment.
No
The device is used for laser photocoagulation treatments and facilitates surgical interventions, which are therapeutic actions, not diagnostic ones. It helps in viewing the surgical site and managing fluids during surgery, but it does not diagnose a condition.
No
The device description explicitly details physical components like a handpiece, fibers, tubes, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is used for "endo-ocular laser photocoagulation treatments" and is used during surgical interventions inside the eye (intraocular). This is a therapeutic and surgical device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use is for performing a medical procedure (laser photocoagulation) directly on the patient's eye, not for analyzing a sample from the patient.
Therefore, this device falls under the category of a surgical or therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For use to perform endo-ocular laser photocoaguation treatments, with illumination, aspiration and back-wash during surgical interventions. The operating wavelength is 500 nm to 1,100 nm
Product codes
HQF
Device Description
This device consists of the following parts already connected to each other:
- Handpiece with a 20G extension that holds the tip of the fibers and tubes, and guides it inside the eye.
- 8 ft fiber.
- A special connector that attaches the laser fiberoptic end to the laser source.
- A special connector that attaches the illumination fiberoptic end to the illumination source
- Luer lock that attaches the aspiration/ back-wash tube to the vitrectomy machine
- A flexible plastic jacket covers the length of the fiberoptics and tubes.
Laser fiberoptic provides the function of laser photocoagulation treatment. Illumination fiberoptic (by providing illumination) provides the physician with the view at the surgical site, while aspiration/backwash tube allows suction of intraocular fluids at the surgical site to facilitate the laser photocoagulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraocular fluids
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / surgical interventions
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
0
SEP 2 1 2005
K050807
510(k) Summary As Required by 21 section 807.92 ( c )
1-Submitter Name: OphthalMed LLC 1308 Morningside Park Dr 2-Address: Alpharetta, GA 30022 USA (678) 908- 8180 3-Phone: (678) 623- 3765 4-Fax: 5-Contact Person: Jay Mansour 6-Date summary prepared: July 14th, 2005
7-Device Trade or Proprietary Name: 20g SMA Laser/Illumination/Aspiration/Back-wash probes. Model LF100
8-Device Common or usual name: (1) Ophthalmic laser, (2) Endoillumination probe and (3) vitreous aspiration
(1) Ophthalmic laser, (2) Light, surgical, fiberoptic and 9-Device Classification Name: (3) Instrument, vitrous aspiration and cutting
10-Substantial Equivalency is claimed against the following device:
20g and 25g SMA Laser Fibers, Model LF20 and LF25 from OPHTHALMED LLC (510k #K021696), as well as 510k #K982462 and K946135.
11-Description of the Device:
This device consists of the following parts already connected to each other:
-
Handpiece with a 20G extension that holds the tip of the fibers and tubes, and guides it inside the eye.
-
8 ft fiber.
-
A special connector that attaches the laser fiberoptic end to the laser source.
-
A special connector that attaches the illumination fiberoptic end to the illumination source
-
Luer lock that attaches the aspiration/ back-wash tube to the vitrectomy machine
-
A flexible plastic jacket covers the length of the fiberoptics and tubes.
Laser fiberoptic provides the function of laser photocoagulation treatment. Illumination fiberoptic (by providing illumination) provides the physician with the view at the surgical site, while aspiration/backwash tube allows suction of intraocular fluids at the surgical site to facilitate the laser photocoagulation.
12-Intended use of the device:
For use to perform endo-ocular laser photocoagulation treatments, with illumination, aspiration and backwash during surgical interventions. The operating wavelength is 500 nm to 1,100 nm
13-Safety and Effectiveness of the device:
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with other predicate device:
1
Please find below a tabulated comparison supporting that this device is substantially equivalent
and submit and the supportion distribution I fease find before a laes in commercial distribution.
| FDA file reference
number | TECHNOLOGICAL
CHARACTERISTICS | 510k #K021696 for
laser
Comparison result | 510k #K982462 for
illumination
Comparison result | 510k #K946135 for
aspiration/back-wash
Comparison result |
|--------------------------------------------------------|----------------------------------|-------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------|
| Indications for use | Identical | Identical | Identical | |
| Target population | Identical | Identical | Identical | |
| Design | Similar | Similar | Similar | |
| Materials | Similar | Similar | Similar | |
| Performance | Similar | Similar | Similar | |
| Sterility | Similar (Ethylene
Oxide) | Similar (Ethylene Oxide) | Similar (Ethylene Oxide) | |
| Biocompatibility | Similar | Identical | Identical | |
| Mechanical safety | Similar | Similar | Similar | |
| Chemical safety | Similar | Similar | Similar | |
| Anatomical sites | Identical | Identical | Identical | |
| Human factors | Identical | Identical | Identical | |
| Energy used and/or
delivered | Identical | Similar | Similar | |
| Compatibility with
environment and other
devices | Identical | Identical | Identical | |
| Where used | Identical | Identical | Identical | |
| Standards met | Identical | Identical | Identical | |
| Electrical safety | Identical (not
applicable) | Identical (not applicable) | Identical (not applicable) | |
| Thermal safety | Identical (not
applicable) | Identical (not applicable) | Identical (not applicable) | |
| Radiation safety | Identical (not
applicable) | Identical (not applicable) | Identical (not applicable) | |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and head. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OphthalMed LLC c/o Mr. Jay Mansour Director, QA and Regulatory Affairs 1308 Morningside Park Dr. Alpharetta, GA 30022
Re: K050807
KU50807
Trade/Device Name: OphthalMed 20G SMA Laser/Illumination/Aspiration/A Back-wash probe, Model LF100
Regulation Number: 21 CFR 886.4390 Regulation: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: August 31, 2005 Received: September 1, 2005
Dear Mr. Mansour:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premaintly equivalent (for the indications
referenced above and have determined the device is substantially interstate referenced above and nave determined the arrested predicate devices marketed in interstate for use stated in the enclosure) to regally manced promotions of the Federal Food. Device American Food. Drug commerce prior to May 28, 1970, the charger with the provisions of the Federal Food, Drug, devices that have been reculted in accordance with as proval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls of the Act. The Act. The Act. The
You may, therefore, market the device, subject to the gener You may, therefore, market the device, subject to annual registration, listing of
general controls provisions of the Act include requirements michronding and general controls provisions of the net network of the measure misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) the existing major regulations affecting your device and may be subject to such additional controlls. Existing may of to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Peachar Ingerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualice of a backers on the other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decernmanon that Jour access as agencies. You must of of any Federal statutes and regulations as including, but not limited to: registration and listing comply with all the Act 3 requirements, meaths, good manufacturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing the ologtrop (2) CFR Part 807); labelling (21 CFR Part 820); good art 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Party 11 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2- Mr. Jay Mansour
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket nothication. The PDA miding of bassification 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
s antiled If you desire specific advice for your don'ter at (301) 827-8910. Also, please note the regulation entitled,
contact the Office of Compliance at (301) 827-8910. Also, pleas contact the Office of Complance at (501) 627 627 627 67 67 807.97). You may obtain " Misbranding by relectice to premance notifical varies and er the Act from the Division of Small other general Information on your responsible and its toll-free number (800) 638-2041 or Manufacturers, International and Oolisanter : 15566777 or and 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
Indications for Use
510(k) Number (if known): K050807
Device Name: Laser/Illumination/Aspiration/Back-wash probe, LF100
Indications For Use:
For use to perform endo-ocular laser photocoaguation treatments, with illumination,
the sub-For use to perform endo-ocular laser photocoaguation area.home, while havelength is 500nm
aspiration and back-wash during surgical interventions. The operating wavelength is to 1,100nm.
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
C. C. Claussen
(Division Sign-Off)
Division of Ophthalmic Ear
Division of Ophthalmic Ear, Nose and Throat Devises
K050807 510(k) Number _
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