(42 days)
No
The description focuses on the physical properties and function of a laser fiber for delivering energy, with no mention of AI or ML capabilities.
No
The device is described as an accessory (laser fiber) used with cleared laser systems for surgical procedures like incision, excision, ablation, and coagulation. While these procedures are part of therapy, the device itself is a tool for delivering energy rather than directly providing therapy or a therapeutic effect on its own.
No
The device description indicates its use for delivering laser energy for incision/excision, ablation, and coagulation, all of which are treatment-oriented functions, not diagnostic ones. There is no mention of analysis, measurement, or identification of a disease or condition.
No
The device description explicitly states it is a "fiber delivery system" made of "glass silica fiber," 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 states that the device is for "incision/excision, ablation, and coagulation (homeostasis)" when attached to cleared laser systems. These are surgical procedures performed directly on the patient's body.
- Device Description: The description details how the fiber delivers laser energy for surgical purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical intervention.
N/A
Intended Use / Indications for Use
Indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode, Ho:YAG and ER:YAG wavelengths for the indications for which the lasers have been cleared.
Product codes
GEX
Device Description
The OptiLite™ Holmium Laser Fibers are intended to be used with legally cleared laser systems to deliver laser energy. The fiber delivery system is typically used in conjunction with a rigid or flexible endoscope to access the surgical site. The laser fibers work on the principle of total internal reflection. Laser energy is focused into a glass silica fiber at the proximal end and traverses the length of the fiber by means of total reflection. The fiber is able to contain the laser beam and funnels the laser energy from the proximal end to the distal end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration quidance's and recognized international standards. Testing data and information is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
OptiLite™ Holmium Laser Fiber STED 510(k) submission Cook Urological, Incorporated November 26, 2007
510(k) SUMMARY
JAN 23 2008
| Submitted by: | Cindy Foote
Regulatory Affairs Specialist
Cook Urological, Incorporated
1100 West Morgan Street
Spencer, IN 47460
November 20, 2007 |
| --------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Device:
| Trade Name: | OptiLite™ Holmium Laser Fibers |
|---|---|
| Proposed Classification Name: | Laser Instrument, Surgical, Powered |
| 21 CFR Part 878.4810 | |
| Class II, GEX |
K073496#### Predicate Devices:
The OptiLite™ Holmium Laser Fibers are similar with respect to indications for use and technology to existing predicate devices in commercial distribution. Specifically, the Optilite™ Holmium Laser Fibers are similar to the AccuFlex™ Holmium Laser Fibers (K994010) manufactured by InnovaQuartz, Incorporated, distributed by Boston Scientific Corporation. The OptiLite™ Holmium Laser Fibers are identical to the OptiLITE™ IX Laser Surgery Accessories (K992866) manufactured by Convergent Laser Technologies and distributed by Cook Urological. Incorporated.
Device Description:
The OptiLite™ Holmium Laser Fibers are intended to be used with legally cleared laser systems to deliver laser energy. The fiber delivery system is typically used in conjunction with a rigid or flexible endoscope to access the surgical site. The laser fibers work on the principle of total internal reflection. Laser energy is focused into a glass silica fiber at the proximal end and traverses the length of the fiber by means of total reflection. The fiber is able to contain the laser beam and funnels the laser energy from the proximal end to the distal end.
Substantial Equivalence:
The Cook® Cervical Ripening Balloon is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.
Test Data:
Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration quidance's and recognized international standards. Testing data and information is included in this submission.
Company Confidential Cook Urological
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with three curved lines above them.
JAN 23 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cook Urological, Inc. % Ms. Cindy Foote Regulatory Affairs Specialist 1100 W. Morgan Street Spencer, Indiana 47460
Re: K073496 Trade/Device Name: OptiLite™ Holmium Laser Fibers Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: November 26, 2007 Received: December 12, 2007
Dear Ms. Foote:
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
2
Page 2 - Ms. Cindy Foote
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Mulhern
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | 073496 |
|---|---|
| Device Name: | OptiLiteTM Holmium Laser Fibers |
| Indications for Use: | Indicated for incision/excision, ablation, and coagulation |
| (homeostasis) when attached to cleared laser systems such | |
| as KTP, Nd:YAG, Argon, Diode, Ho:YAG and ER:YAG | |
| wavelengths for the indications for which the lasers have | |
| been cleared. |
Prescription Use?_____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K073496