(90 days)
No
The 510(k) summary describes a passive fiber optic laser delivery system and does not mention any AI or ML components or functionalities.
Yes
The device is described as a fiber optic laser delivery system used for various surgical procedures, including vaporization, cutting, ablation, and coagulation of soft tissue, which are all therapeutic interventions.
No
The device description and intended use clearly state that it is a surgical tool used for vaporization, cutting, ablation, and coagulation of soft tissue, not for diagnosis.
No
The device description explicitly states it is a "fiber optic laser delivery system consisting of a 3 meter long silica fiber, clad in fluorinated doped silica, buffered with a fluorinated acrylate and a shaped tip," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical procedures involving the vaporization, cutting, ablation, and coagulation of soft tissue. This is a therapeutic and surgical application, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details a fiber optic laser delivery system used as part of a laser system for surgical procedures. This aligns with a surgical tool, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to perform surgical interventions on the body itself.
N/A
Intended Use / Indications for Use
The Optical Integrity General Shaped Fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, arthroscopes, cystoscopes, cystoscopes, gastroscopes, and colonoscopes, or for contact or non-contact surgery with or without handpieces for use in coagulation, incision/excision, ablation and vaporization of soft tissue.
The Optical Integrity GS Fiber is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT, General and Vascular Surgery, Lithotripsy, Arthroscopy, Podiatry, Orthopedics and Neurosurgery.
Product codes
GEX
Device Description
The Optical Integrity General Shaped (GS) Fiber is a fiber optic laser delivery system consisting of a 3 meter long silica fiber, clad in fluorinated doped silica, buffered with a fluorinated acrylate and a shaped tip. As an integral part of a laser system, the GS fiber may be used for a wide variety of surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT, General and Vascular Surgery, Lithotripsy, Arthroscopy, Podiatry, Orthopedics and Neurosurgery.
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)
Bench testing was performed to demonstrate that the device will perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K020673, K954904, K994010, K001243, K990947
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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ATTACHMENT 6 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Optical Integrity General Shaped Fiber
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Optical Integrity, Inc. 8317 Front Beach Road, Suite 21 Panama City Beach, FL 32407 Contact: Joe D. Brown
Phone: 850-233-5512 Facsimile: 850-233-3658 Email: jbrown@opticalintegrity.com
Name of Device and Name/Address of Sponsor
Trade Name: Optical Integrity General Shaped Fiber Classification Name: Laser Surgical Instrument Accessories
Predicate Devices
Wave Form Manufacturing Prolase General Shaped Fiber (K020673) InnovaOuartz General Shaped Fiber (K954904), single use InnovaQuartz General Shaped Fiber (K994010), reuse Dornier Medilas H Fibers (K001243) Lumenis Slimline Fibers (K990947)
Device Description
The Optical Integrity General Shaped (GS) Fiber is a fiber optic laser delivery system consisting of a 3 meter long silica fiber, clad in fluorinated doped silica, buffered with a fluorinated acrylate and a shaped tip. As an integral part of a laser system, the GS fiber may be used for a wide variety of surgical procedures.
Indications for Use
The Optical Integrity General Shaped Fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, arthroscopes, cystoscopes, cystoscopes, gastroscopes, and colonoscopes, or for contact or non-contact surgery with or without handpieces for use in coagulation, incision/excision, ablation and vaporization of soft tissue.
The Optical Integrity GS Fiber is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT, General and Vascular Surgery, Lithotripsy, Arthroscopy, Podiatry, Orthopedics and Neurosurgery.
Technological Characteristics and Performance Data
Design changes made to the Optical Integrity GS Fiber are the addition of an internal proprietary quartz sleeve reflector which protects the laser focusing lens from back splatter of vaporized metal from the connector ferrule and the addition of an optical secondary memory cladding to help guide a steerable endoscope with the optical fiber.
Bench testing was performed to demonstrate that the device will perform as intended.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized human profiles facing right, with three curved lines above them, resembling a bird in flight. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Public Health Service
OCT 1 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Optical Integrity, Inc. Joe D. Brown President 8317 Front Beach Road, Suite 21 Panama City Beach, Florida 32407-4893
Re: K022338
Trade/Device Name: Optical Integrity General Shaped Fiber Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Accessories Regulatory Class: Class II Product Code: GEX Dated: July 15, 2002 Received: July 18, 2002
Dear Mr. Brown:
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.
2
Page 2 -- Mr. Joe D. Brown
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" (21 CFR 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,
Stypt Rlurdu
Célia 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
3
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(k) Number:
K022-338
Device Name: Optical Integrity General Shaped Fibers
Indications for Use:
The Optical Integrity General Shaped Fiber is intended to be used in vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, arthroscopes, cystoscopes, cystoscopes, ureteroscopes, gastroscopes and colonoscopes, or for contact or non-contact surgery with or without handpiece for use in coagulation, incision/excision, ablation and vaporization of soft tissue.
The Optical Integrity General Shaped Fiber is indicated for use in medicine and surgery in the following medical specialties:
- Urology .
- Plastic Surgery .
- Radiology .
- Dermatology .
- . Pulmonology
- Gastroenterology .
- Gynecology .
- ENT .
- Lithotripsy ●
- General and Vascular Surgery ●
- Arthroscopy ●
- . Podiatry
- Orthopedics .
- Neurosurgery
Concurrence of CDRH, Office of Evaluation (ODE)
or Over-the-Counter Use Prescription Use
Stupt Rlurdu
ion of General, Restorative and Neurological Devices
510(k) Number_KOZZ338