(90 days)
Not Found
No
The summary describes a handpiece for ophthalmic laser treatments, focusing on mechanical and optical components. There is no mention of AI, ML, image processing, or any data-driven decision-making capabilities.
Yes
The device is described as "intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye," which directly indicates its role in medical therapy.
No
The device is intended for ophthalmic laser treatments, aspiration, and illumination within the eye, all of which are interventional or treatment-related functions rather than diagnostic ones.
No
The device description explicitly lists physical components such as a universal SMA style input connector, a glass fiber optic, a PVC jacket, a handle, and a medical grade stainless steel needle. These are hardware components, not 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 the device is a handpiece used to deliver laser energy inside the eye for ophthalmic treatments. It also has functions for aspiration and illumination within the eye.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient. Its function is directly therapeutic (laser treatment) and supportive (aspiration and illumination) in vivo.
Therefore, the IRIS Medical EndoProbe handpiece is an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The family of IRIS Medical EndoProbe handpieces is intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the aspiration function is indicated for use when unwanted fluid is present in the eye causing refraction or scattering of the laser beam from the intended treatment site, and the illumination function is indicated for use to illuminate the interior of the eye. The handpieces are offered in straight or angled styles, and with a universal SMA connector that allows the family of EndoProbe handpieces to be used with compatible laser systems, such as IRIS Medical and Lumenis. The handpieces are cleared for use for the particular indications of the laser system to which they are attached.
Product codes (comma separated list FDA assigned to the subject device)
HQF, GEX
Device Description
The family of IRIS Medical EndoProbe handpieces is comprised of the following main components: a universal SMA style input connector, a glass fiber optic protected by a PVC (vinyl) jacket, a handle, and a medical grade stainless steel needle. The Illuminating EndoProbe has an additional illumination fiber optic with jacket.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inside the eye
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)
Not Found
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.
K020374, K962592, K931784, K925663, K921488, K946135
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
§ 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
510(k) Summary xnaza20 IRIDEX® Corporation Family of IRIS Medical® EndoProbe® Handpieces
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043
| Contact Person: | John D'Angelo
(650) 962-8848 ext. 3905 |
| ----------------- | ------------------------------------------- |
|---|
July 9, 2002 Date Prepared:
Device Information
| Trade Name: | Family of IRIS Medical EndoProbe Handpiece |
|---|---|
| Classification Name: | Laser, Ophthalmic, Accessory |
| CFR Section: | 886.4390 |
| Product Code: | HQF |
Predicate Devices
The family of IRIS Medical EndoProbe handpieces is substantially equivalent in intended use and/or method of operation to other currently legally marketed laser probes including IRIDEX Corporation's IRIS Medical EndoProbe (K020374), the Alcon Endolaser Probes (K962592), the HGM Illuminating and Aspirating Probes (K931784 and K925663), the STI Aspirating Endo Ocular Probe with Illumination (K921488), and the Infinitech Aspirating Laser Probe (K946135).
Device Description
The family of IRIS Medical EndoProbe handpieces is comprised of the following main components: a universal SMA style input connector, a glass fiber optic protected by a PVC (vinyl) jacket, a handle, and a medical grade stainless steel needle. The Illuminating EndoProbe has an additional illumination fiber optic with jacket.
Intended Use
The family of IRIS Medical EndoProbe handpieces is intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the aspiration function is indicated for use when unwanted fluid is present in the eye causing refraction or scattering of the laser beam from the intended treatment site, and the illumination function is indicated for use to illuminate the interior of the eye. The handpieces are offered in straight or angled styles, and with a universal SMA connector that allows the family of EndoProbe handpieces to be used with compatible laser systems, such as IRIS Medical and Lumenis. The handpieces are cleared for use for the particular indications of the laser system to which they are attached.
1
Conclusion
The family of IRIS Medical EndoProbe handpieces shares similar indications for use, materials, and similar performance characteristics as, and thus is substantially equivalent to, the currently marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure. The logo is black and white.
OCT 0 8 2002
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .
Mr. John D'Angelo Vice President, Regulatory Affairs and Quality Assurance IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, California 94043
Re: K02228
Trade/Device Name: Family of IRIS Medical EndoProbe Handpieces Regulation Number: 886.4390 Regulation Name: Opthalmic Laser Regulatory Class: II Product Code: GEX Dated: July 9, 2002 Received: July 10, 2002
Dear Mr. D'Angelo:
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 - Mr. John D'Angelo
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Styph Ewdn
A. Galis M. Witter, Ph.D., M.D.
elia 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
4
INDICATIONS FOR USE STATEMENT
Krizadd 510(k) Number (if known): Pending
Device Name: Family of IRIS Medical® EndoProbe® Handpieces
Indications For Use:
The family of IRIS Medical EndoProbe handpieces is intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the aspiration function is indicated for use when unwanted fluid is present in the eye causing refraction or scattering of the laser beam from the intended treatment site, and the illumination function is indicated for use to illuminate the interior of the eye. The handpieces are offered in straight or angled styles, and with a universal SMA connector that allows the family of EndoProbe handpieces to be used with compatible laser systems, such as IRIS Medical and Lumenis. The handpieces are cleared for use for the particular indications of the laser system to which they are attached.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Neurological Devices
KOZZZZ 8 510(k) Number -
Prescription Use
OR (Per 21 CFR 801.109) Over-The-Counter Use