(52 days)
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.
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."
The provided text does not contain detailed information about acceptance criteria or a study proving the device meets those criteria. Instead, it is a 510(k) premarket notification summary for the "Innovatech Illuminating Laser Probe," primarily focused on demonstrating substantial equivalence to predicate devices and outlining the device's characteristics and intended use.
Here's what can be extracted and what is not available based on your request:
1. A table of acceptance criteria and the reported device performance
- Not available. The document does not specify quantitative acceptance criteria or provide performance data from a study. It focuses on comparing physical and functional specifications to predicate devices.
2. Sample sized used for the test set and the data provenance
- Not available. No test set or study data is presented. The submission relies on a comparison to predicate devices rather than a performance study of the Innovatech device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not available. Since no test set or performance evaluation study is described, there's no mention of experts establishing ground truth.
4. Adjudication method for the test set
- Not available. No adjudication method is mentioned as there is no test set described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not available. This device is an ophthalmic laser probe, not an AI-assisted diagnostic or imaging system involving human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not available. This is a hardware device for surgical procedures, not an algorithm.
7. The type of ground truth used
- Not available. No ground truth is mentioned because no performance study is detailed. The "ground truth" for this submission is effectively the established performance and safety of its predicate devices, implying that if the new device is sufficiently similar, it should perform equivalently.
8. The sample size for the training set
- Not applicable/Not available. This is a physical device, not a machine learning model, so there is no training set in the context of AI.
9. How the ground truth for the training set was established
- Not applicable/Not available. As above, this is not an AI/ML device.
Summary of available information related to equivalence, which is a form of "acceptance" for 510(k):
The submission demonstrates "Substantial Equivalence" by comparing the Innovatech Illuminating Laser Probe to three predicate devices: Peregrine Illuminated Laser Probe (PD600.10, K031023), HGM Illuminating Laser Probe (K931784), and Peregrine Straight Laser Probe (PD600.00, K024061).
Table of Comparison (from the document):
| Feature/Criterion | Innovatech Illuminating Laser Probe | Peregrine Illuminated Laser Probe | HGM Illuminating Laser Probe | Peregrine Straight Laser Probe |
|---|---|---|---|---|
| Primary Function | Illumination and Light transmission for photocoagulation | Illumination and Light transmission for photocoagulation | Illumination and Light transmission for photocoagulation | Light transmission for photocoagulation |
| Connector Material | Aluminum connector | Aluminum connector | Aluminum connector | Aluminum connector |
| Handpiece Material | Delrin Handpiece | Delrin Handpiece | Delrin Handpiece | Delrin Handpiece |
| Fiber Type | Optical Fiber (Glass - Silica Core) | Optical Fiber (Glass - Silica Core) | Optical Fiber (Glass - Silica Core) | Optical Fiber (Glass - Silica Core) |
| Fiber Diameter | .008" (200 microns) | .008" (200 microns) | .008" (200 microns) | .008" (200 microns) |
| Jacket Material | PVC Jacket | PVC Jacket | Teflon Jacket | PVC Jacket |
| Length | 101 inches | 101 inches | 96 inches | 101 inches |
| Needle Material | 304 Stainless Needle | 304 Stainless Needle | 304 Stainless Needle | 304 Stainless Needle |
| Needle Gauge | 20 Gauge | 20 Gauge | 20 Gauge | 20 Gauge |
| Max Power Output | 1 watt | 1 watt | 1 watt | 1 watt |
| Illumination | Illumination (Acrylic Optical fiber) | Illumination (Acrylic Optical fiber) | Illumination (Acrylic Optical fiber) | No illumination (N/A) |
"Study" Proving Acceptance (Substantial Equivalence):
The "study" here is a design and materials comparison between the Innovatech device and multiple legally marketed predicate devices. The acceptance is based on the argument that because the Innovatech Illuminating Laser Probe shares the same indications for use, fundamental technological characteristics, and similar materials and design specifications (e.g., fiber type, diameter, maximum power output, connector, handpiece, needle material and gauge) with its predicates, it is substantially equivalent and therefore presumably as safe and effective. The minor differences (like jacket material from Teflon to PVC in one comparison, and the inclusion of illumination compared to a non-illuminating predicate) are implied to not raise new questions of safety or effectiveness.
Sterilization: The device will be ETO Sterilized, and the method used to validate the sterilization cycle is the AAMI Overkill Method, which is a standard method. This is a crucial aspect of safety and effectiveness that is mentioned.
In summary, for a 510(k) submission like this, "acceptance criteria" are generally met by demonstrating that the new device does not raise new questions of safety and effectiveness compared to predicate devices, rather than through a direct performance study with quantitative metrics against predefined thresholds.
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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).
Page 3-1
1000 Atlantic Avenue, Suite 514, Camden, New Jersey 08104 800-240-3123 innovatechsurgical.com
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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.
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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.
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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
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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_________________________________________________________________________________________________________________________________________________________________
Page 3-3
§ 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.