(52 days)
No
The description focuses on the physical components and function of a laser delivery probe, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is described as delivering laser energy for photocoagulation during ophthalmic surgery, which is a therapeutic medical procedure.
No
This device is a laser delivery system used for photocoagulation during ophthalmic surgery. It does not perform any diagnostic functions or provide information about a patient's health status.
No
The device description clearly outlines physical components such as a connector, glass fiber, PVC jacket, Delrin handpiece, and stainless needle, indicating it is a hardware device.
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." This describes a surgical procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The device is described as a laser delivery device that connects to a laser source to deliver energy to target tissue. This is a therapeutic device used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to deliver therapeutic laser energy during surgery.
N/A
Intended Use / Indications for Use
For photocoagulation during ophthalmic surgery. To be used with (specified equipment).
For photocoagulation during ophthalmic surgery. This device delivers 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)
GEX, HQF
Device Description
The Innovatech Straight 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 with PVC jacket, a Delrin handpiece and a 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.
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
Image /page/0/Picture/0 description: The image shows the logo for Innovatech Surgical, Inc. The logo is black and white and features a stylized sunburst design on the left. Above the logo is the text "OCT 2 4 2003" and "K032703 1 of 2".
August 25, 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 Straight Laser Probe
Common Name: Ophthalmic Laser Probe
Registration Number: 3003988504
Classification: Class II
- We were unable to find the device listed in the Disposable classification regulations, 21 Class Name: CFR Parts 862-892 [807.87 (c)]
Ophthalmic Panel:
Product Code: GEX, HQF
- Device Description: The Innovatech Straight 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 with PVC jacket, a Delrin handpiece and a 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
K03 2703 2 of 2
Substantial Equivalence Comparison
| Application for 510(k) | Substantial Equivalence to: | ||
|---|---|---|---|
| Innovatech Straight | |||
| Laser Probe | |||
| Product: 420-10 | Peregrine Straight | ||
| Laser Probe | |||
| Product: PD600.00 | Endo Ocular Laser | ||
| Probe (Gamp & | |||
| Associates) | |||
| 510(k): K954307 | Endo Illuminator 25ga. | ||
| Manufactured by | |||
| Peregrine Surgical Ltd | |||
| Familied under 510(k): | |||
| K980797 | |||
| Manufactured by | |||
| Peregrine Surgical Ltd | |||
| 510(k): K024061 | |||
| Light transmission for | |||
| photocoagulation | Light transmission for | ||
| photocoagulation | Light transmission for | ||
| photocoagulation | Light transmission for | ||
| illumination | |||
| Aluminum connector | Aluminum connector | Aluminum connector | Delrin connector |
| Delrin Handpiece | Delrin Handpiece | Delrin Handpiece | Delrin Handpiece |
| Optical Fiber | |||
| Glass - Silica Core | Optical Fiber | ||
| Glass - Silica Core | Optical Fiber | ||
| Glass- Silica Core | Optical Fiber | ||
| Glass - Silica Core | |||
| .008" (200 microns) | .008" (200 microns) | .008" (200 microns) | 400 micron |
| PVC Jacket | PVC Jacket | Teflon Jacket | Teflon Jacket |
| Length 101 inches | Length 101 inches | Length 96 inches | Length 81 inches |
| 304 Stainless Needle | 304 Stainless Needle | 304 Stainless Needle | 304 Stainless Needle |
| 20 Gauge | 20 Gauge | 20 Gauge | 25 Gauge |
| Max power output | |||
| 1 watt | Max power output | ||
| 1 watt | Max power output | ||
| 1 watt | N/A |
Sterility
The Device will be ETO Sterilized.
:二
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 shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures representing individuals or populations served by the department. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
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: K032703
Trade/Device Name: Innovatech Straight 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 25, 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 (OS) 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): | K03270 |
|---|---|
| --------------------------- | -------- |
Device Name:
Innovatech Straight Laser Probe
Indications for Use:
For photocoagulation during ophthalmic surgery. This device delivers 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__________
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032703
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