(52 days)
Not Found
No
The summary describes a passive laser delivery device and explicitly states that it does not generate, intensify, or significantly reduce energy. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
The device is used for "photocoagulation during ophthalmic surgery," which is a medical procedure to treat a condition (e.g., retinal tears, diabetic retinopathy) by causing coagulation of tissue, indicating a therapeutic intent.
No
The device is described as an ophthalmic laser delivery device used for photocoagulation during ophthalmic surgery, which is a therapeutic function, not a diagnostic one. It delivers laser energy to target tissue for coagulation.
No
The device description explicitly states it is an "ophthalmic laser delivery device" consisting of physical components like a connector, glass fiber, acrylic fiber, PVC jacket, Delrin handpiece, and stainless needle. This indicates 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:
- Intended Use: The intended use is for "photocoagulation during ophthalmic surgery" and "illumination during ophthalmic surgery." This describes a surgical procedure performed directly on a patient's eye, not a test performed on a sample taken from the body.
- Device Description: The device is a "laser delivery device" that connects to a laser source to deliver energy for photocoagulation and illumination. It does not analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on analysis of biological samples.
The device is clearly intended for direct surgical intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
For photocoagulation during ophthalmic surgery. To be used with (specified equipment).
For photocoagulation and illumination during ophthalmic surgery. This Indications for Use: r or photoougaliation, as well as laser energy, to target tissue causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.
Product codes (comma separated list FDA assigned to the subject device)
HQF, GEX
Device Description
The Innovatech Illuminating Laser Probe is an ophthalmic laser delivery device. By its design, it does not generate, intensify or significantly reduce energy. It consists of a connector that is plugged into an existing laser source, a glass fiber for laser delivery and acrylic fiber for illumination with PVC jacket, a Delrin handpiece and 304 stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ophthalmic
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.
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.
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Image /page/0/Picture/0 description: The image shows the logo for Innovatech Surgical, Inc. The logo features a stylized sunburst graphic to the left of the word "Innovatech" in large, bold font. To the right of "Innovatech" is the text "SURGICAL, INC." in a smaller, but still prominent font. The text "KO32704 1 of 2" is at the top right of the image.
OCT 2 4 2003
August 26, 2003
Premarket Notification [510(k)] Summary
Submitter: Innovatech Surgical Inc. 1000 Atlantic Avenue, Suite 514 Camden, NJ 08104 Phone: 800-240-3123 856-225-1203 Fax:
Official Correspondent: Michael J. McGowan, Sr.
Trade Name: Innovatech Illuminating Laser Probe
Common Name: Ophthalmic Laser Probe
Registration Number: 3003988504
Classification: Class II
- Class Name: We were unable to find the device listed in the Disposable classification regulations, 21 CFR Parts 862-892 [807.87 (c)]
Panel: Ophthalmic
Product Code: HQF
- Device Description: The Innovatech Illuminating Laser Probe is an ophthalmic laser delivery device. By its design, it does not generate, intensify or significantly reduce energy. It consists of a connector that is plugged into an existing laser source, a glass fiber for laser delivery and acrylic fiber for illumination with PVC jacket, a Delrin handpiece and 304 stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."
Statement of Indications for use: For photocoagulation during ophthalmic surgery. To be used with (specified equipment).
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1000 Atlantic Avenue, Suite 514, Camden, New Jersey 08104 800-240-3123 innovatechsurgical.com
1
K032704 2 of 2
Substantial Equivalence Comparison
| Application for 510(k) | Substantial Equivalence to: | ||
|---|---|---|---|
| Innovatech | Peregrine Illuminated | HGM Illuminating | Peregrine Straight |
| Illuminating Laser | Laser Probe | Laser Probe (Gamp | |
| & Associates) | Laser Probe | ||
| Probe | Product: PD600.10 | 510(k): K931784 | Product: PD600.00 |
| Product: 420-30 | Manufactured by | Manufactured by | |
| Peregrine Surgical Ltd | Peregrine Surgical Ltd | ||
| 510(k): K031023 | 510(k): K024061 | ||
| Illumination and Light | Illumination and Light | Illumination and Light | Light transmission for |
| transmission for | transmission for | transmission for | photocoagulation |
| photocoagulation | photocoagulation | photocoagulation | |
| Aluminum connector | Aluminum connector | Aluminum connector | Aluminum connector |
| Delrin Handpiece | Delrin Handpiece | Delrin Handpiece | Delrin Handpiece |
| Optical Fiber | Optical Fiber | Optical Fiber | Optical Fiber |
| Glass - Silica Core | Glass - Silica Core | Glass - Silica Core | Glass - Silica Core |
| .008" (200 microns) | .008" (200 microns) | .008" (200 microns) | .008" (200 microns) |
| PVC Jacket | PVC Jacket | Teflon Jacket | PVC Jacket |
| Length 101 inches | Length 101 inches | Length 96 inches | Length 101 inches |
| 304 Stainless Needle | 304 Stainless Needle | 304 Stainless Needle | 304 Stainless Needle |
| 20 Gauge | 20 Gauge | 20 Gauge | 20 Gauge |
| Max power output | Max power output | Max power output | Max power output |
| 1 watt | 1 watt | 1 watt | 1 watt |
| Illumination | Illumination | Illumination | No illumination |
| Acrylic Optical fiber | Acrylic Optical fiber | Acrylic Optical fiber | N/A |
Sterility
The Device will be ETO Sterilized.
The method used to validate the sterilization cycle is AAMI Overkill Method.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2003
Mr. Michael J. McGowan, Sr. Innovatech Surgical, Inc. 1000 Atlantic Avenue, Suite 514 Camden, New Jersey 08104
Re: K032704
Trade/Device Name: Innovatech Illuminating Laser Probe Regulation Number: 21 CFR 878.4810, 886.4390 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology, Ophthalmic laser Regulatory Class: II Product Code: GEX, HQF Dated: August 26, 2003 Received: September 2, 2003
Dear Mr. McGowan:
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. Michael J. McGowan, Sr.
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 (301) 594-4659. 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,
Miriam C. Provost
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
4
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Innovatech Illuminating Laser Probe
For photocoagulation and illumination during ophthalmic surgery. This Indications for Use: r or photoougaliation, as well as laser energy, to target tissue causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use xx_______________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use
Musiam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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