(52 days)
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.
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."
The Innovatech Straight Laser Probe is an ophthalmic laser delivery device, and its acceptance criteria and the study proving it meets these criteria are outlined in the provided text, primarily through a substantial equivalence comparison to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Innovatech Straight Laser Probe are implicitly defined by its substantial equivalence to predicate devices, meaning its performance characteristics are comparable to those already legally marketed. The table below summarizes the key features and their performance (or characteristics) for the Innovatech device and its primary predicate, the Peregrine Straight Laser Probe (Product: PD600.00, 510(k): K024061).
| Acceptance Criteria (Characteristic) | Innovatech Straight Laser Probe Performance | Peregrine Straight Laser Probe Performance (Predicate) |
|---|---|---|
| Intended Use | Light transmission for photocoagulation | Light transmission for photocoagulation |
| Connector Material | Aluminum connector | Aluminum connector |
| Handpiece Material | Delrin Handpiece | Delrin Handpiece |
| Optical Fiber Type | Optical Fiber Glass - Silica Core | Optical Fiber Glass - Silica Core |
| Optical Fiber Diameter | .008" (200 microns) | .008" (200 microns) |
| Jacket Material | PVC Jacket | PVC Jacket |
| Length | 101 inches | 101 inches |
| Needle Material | 304 Stainless Needle | 304 Stainless Needle |
| Needle Gauge | 20 Gauge | 20 Gauge |
| Max Power Output | 1 watt | 1 watt |
| Sterilization Method | ETO Sterilized | (Implied equivalent for ETO sterilized devices) |
| Sterilization Validation | AAMI Overkill Method | (Implied equivalent for devices validated by AAMI) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information about a specific "test set" in the context of clinical or performance testing with human subjects or a defined dataset for AI evaluation. The substantial equivalence claim is based on a comparison of device specifications and intended use against existing predicate devices. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since there is no mention of a "test set" in the context of clinical performance or AI evaluation, there is no information provided on the number of experts or their qualifications used to establish ground truth.
4. Adjudication Method for the Test Set
As there is no described test set involving expert review, there is no adjudication method mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned. The submission focuses on device characteristics and substantial equivalence, not comparative effectiveness with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a physical ophthalmic laser probe, not an artificial intelligence algorithm. Therefore, no standalone (algorithm only) performance study was conducted or is relevant.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on engineering specifications and functional characteristics being substantially equivalent to legally marketed predicate devices. This is a technical and regulatory comparison, not a clinical "ground truth" derived from expert consensus, pathology, or outcomes data in the typical sense of diagnostic or treatment efficacy studies.
8. The Sample Size for the Training Set
Since this is a physical medical device and not an AI algorithm, there is no concept of a "training set" as understood in machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
{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).
Page 3-1
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 StraightLaser ProbeProduct: 420-10 | Peregrine StraightLaser ProbeProduct: PD600.00 | Endo Ocular LaserProbe (Gamp &Associates)510(k): K954307 | Endo Illuminator 25ga.Manufactured byPeregrine Surgical LtdFamilied under 510(k):K980797 |
| Manufactured byPeregrine Surgical Ltd | |||
| 510(k): K024061 | |||
| Light transmission forphotocoagulation | Light transmission forphotocoagulation | Light transmission forphotocoagulation | Light transmission forillumination |
| Aluminum connector | Aluminum connector | Aluminum connector | Delrin connector |
| Delrin Handpiece | Delrin Handpiece | Delrin Handpiece | Delrin Handpiece |
| Optical FiberGlass - Silica Core | Optical FiberGlass - Silica Core | Optical FiberGlass- Silica Core | Optical FiberGlass - 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 output1 watt | Max power output1 watt | Max power output1 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
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.