(52 days)
Not Found
No
The 510(k) summary describes a laser system for tissue treatment and does not mention any AI or ML components or functionalities. The description focuses on the hardware (laser, fiberoptics, footswitch) and its physical mechanism of action (delivering laser energy).
Yes
The device is indicated for the treatment of various medical conditions, including urinary outflow obstruction secondary to benign prostatic hypertrophy, and for general surgical procedures involving incision, excision, ablation, or coagulation of tissues. These applications directly relate to alleviating or curing disease, which falls under the definition of a therapeutic device.
No
The device is indicated for treatment (e.g., treatment of BPH symptoms, incision, excision, ablation, coagulation), not for diagnosis.
No
The device description clearly outlines hardware components including a treatment diode laser, fiberoptic energy delivery devices, a footswitch, and an optional cart with printer. It is a physical laser system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Indigo OPTIMA Laser System is a therapeutic device that uses laser energy to treat various conditions by directly interacting with tissues (coagulation, incision, excision, ablation). It is not used to analyze samples taken from the body.
- Intended Use: The intended use clearly describes treatment procedures for conditions like BPH, tumors, fibroids, strictures, and condylomata. These are all direct interventions on the patient's body.
Therefore, the Indigo OPTIMA Laser System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Índigo OPTIMA Laser System with Diffuser-Tip Fiberoptic is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic thyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 20-85 cc; and for general surgery, general urological, general gynecological and general gastroenterological procedures; and coagulative necrosis and interstitial laser coagulation of soft tissues such as tumors and fibroids.
The Indigo OPTIMA Laser System, when used in conjunction with the Bare-Tip Fiberoptic, is indicated for the incision, excision, and ablation or coagulation of tissues with hemostasis during general surgery, and general gastroenterological and urological procedures, including those involving urethral strictures, bladder neck contractures, and condylomata.
Product codes
GEX
Device Description
The Indigo® OPTIMA Laser System consists of a treatment diode laser, fiberoptic energy delivery devices, a footswitch, and an optional cart with printer. The treatment laser allows delivery of controlled doses of laser energy in wavelengths between 800 and 850 nanometers (nm). When used with the OPTIMA Diffuser-Tip Fiberoptic, this laser energy is diffused radially at 360° to the affected tissue to provide interstitial thermotherapy (ITT), or interstitial laser coagulation (ILC). When used with the OPTIMA Bare-Tip or cutting fiber, the laser beam directly contacts the tissue to provide incision, excision, ablation, or coagulation of tissues with hemostasis. Both the OPTIMA Diffuser-Tip and Bare-Tip Fiberoptics are designed to deliver energy from the Índigo OPTIMA diode laser only and bear unique, proximal connectors to the OPTIMA laser. The fiberoptics (fibers) are designed to be sterile, single patient use, disposable devices. In addition, there are several accessories to the laser system including laser goggles, a traveling case, and fiberoptic instruments for servicing and demonstration (for sales representatives only and not for human use).
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
men over the age of 50
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)
Preclinical testing was performed to ensure that the laser system performs as intended when used according to the instructions for use. Bench testing has indicated that the system demonstrates satisfactory performance for its intended applications. Electrical safety and electromagnetic compatibility have been demonstrated and are certified by VDE Testing and Certification Institute. The Indigo OPTIMA System bears the CSA International label for UL-2601-1, CSA 601.1, and IEC 60601-1.
The Indigo OPTIMA Laser System meets U.S. Federal Safety and Performance Standards for light emitting products (21 CFR 1040.10/11).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K963969, K954195, K955758, K963081, K990851, K003952, K003953
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
Índigo® OPTIMA Laser System DEC 1 3 2001 510(k) Summary of Safety & Effectiveness
Company
Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242
Contact
Linda G. Hill Regulatory Affairs Manager
Date Prepared
August 21, 2001
Device Name
Trade Name: Índigo® OPTIMA Laser System Classification Name: Laser powered surgical instrument
Predicate Device
The Índigo OPTIMA Laser System is substantially equivalent to the current Índigo LaserOptic® Treatment System cleared by FDA on December 23, 1997 (K963969), as well as the following submissions:
- K954195, cleared January 25, 1996, Indigo Portable Laser System Model IDL 830 and ● Indigo Fiberoptics
- K955758, cleared February 27, 1996, Índigo Portable Laser System with Temperature . Feedback Model 830e
- K963081, cleared February 21, 1997, Índigo Models IDL 830 and IDL 830e Laser Systems ●
- . K990851, cleared March 30, 1999, Indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option
- K003952, cleared March 16, 2001, Indigo LaserOptic Treatment System ●
- K003953, cleared March 16, 2001, Indigo Diffuser-Tip Fiberoptic with Temperature . Sensing Option
Device Description
The Indigo® OPTIMA Laser System consists of a treatment diode laser, fiberoptic energy delivery devices, a footswitch, and an optional cart with printer. The treatment laser allows delivery of controlled doses of laser energy in wavelengths between 800 and 850 nanometers (nm). When used with the OPTIMA Diffuser-Tip Fiberoptic, this laser energy is diffused radially at 360° to the affected tissue to provide interstitial thermotherapy (ITT), or interstitial laser coagulation (ILC). When used with the OPTIMA Bare-Tip or cutting fiber, the laser beam directly contacts the tissue to provide incision, excision, ablation, or coagulation of tissues with hemostasis. Both the OPTIMA Diffuser-Tip and Bare-Tip Fiberoptics are designed to deliver
1
energy from the Índigo OPTIMA diode laser only and bear unique, proximal connectors to the OPTIMA laser. The fiberoptics (fibers) are designed to be sterile, single patient use, disposable devices. In addition, there are several accessories to the laser system including laser goggles, a traveling case, and fiberoptic instruments for servicing and demonstration (for sales representatives only and not for human use).
Kol 3493
2/2
Intended Use
The Indigo OPTIMA Laser System,as a surgical instrument, is intended to be used in the noncontact mode to photocoagulate, vaporize/ablate soft tissue (muscle, connective tissue, organ), for cutting, excision, incision, and for coagulation of soft tissue in the contact mode (open/closed) surgical procedures. When used with bare fiberoptics, the Indigo diode laser can be used for the excision of external tumors and lesions, complete and partial resection of internal organs, treatment of tumors and lesions, skin incision and tissue dissection and ablation. The Diffuser-Tip Fiberoptic is intended for the safe and effective treatment of Benign Prostatic Hyperplasia (BPH).
Comparison of Technological Characteristics
The Índigo OPTIMA Laser System is a modification of the currently marketed Índigo LaserOptic Treatment System. While it represents a refinement to the predicate system, the overall technology and the intended use of the two systems are the same. Both the predicate and the modified systems are designed to treat Benign Prostatic Hyperplasia (BPH) when used with the Diffuser-Tip Fiber. and as a general surgical tool for cutting tissue when used with the Bare-Tip Fiber. The design modifications include upgrades to the software and electronic components, as well as modifications to the fibers to permit use with smaller cystoscopes, having a working channel of 5 FR. New accessories to the system include a laser cart, providing storage and mobility, and a printer to record procedure data for patient records.
The OPTIMA laser unit contains two, diode lasers that convert electrical energy to optical energy in narrow wavelength bands. The treatment laser produces red light in the near infra-red spectrum with a wavelength of 800-850 nm and is classified as a Class IV laser by the U.S. Center for Devices and Radiological Health (CDRH) and according to DIN VDE 0837. The marker laser produces light in the visible light range (approximately 633 nm) and is classified as a Class II laser by CDRH. This is identical to the predicate laser system.
Performance Data
Preclinical testing was performed to ensure that the laser system performs as intended when used according to the instructions for use. Bench testing has indicated that the system demonstrates satisfactory performance for its intended applications. Electrical safety and electromagnetic compatibility have been demonstrated and are certified by VDE Testing and Certification Institute. The Indigo OPTIMA System bears the CSA International label for UL-2601-1, CSA 601.1, and IEC 60601-1.
The Indigo OPTIMA Laser System meets U.S. Federal Safety and Performance Standards for light emitting products (21 CFR 1040.10/11).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wing shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2001
Ethicon Endo-Surgery c/o Mr. Mark Job 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
Re: K013493
Trade/Device Name: Índigo® OPTIMA Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 4, 2001 Received: December 5, 2001
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass based in 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 rou may a may a royisions 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 Of It 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. Mark Job
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" (21CFR 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,
Susan Walker, un
Image /page/3/Picture/5 description: The image shows a handwritten signature. The signature is in cursive and appears to be a stylized version of the letters 'sv'. The 's' is formed with a large loop at the top and a smaller loop at the bottom. The 'v' is connected to the 's' and has a sharp angle at the bottom. The signature is written in black ink on a white background.
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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510 (k) Number (if known): K013493
İndigo® OPTIMA Laser System Device Name :
Indications for Use :
The Índigo OPTIMA Laser System with Diffuser-Tip Fiberoptic is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic thyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 20-85 cc; and for general surgery, general urological, general gynecological and general gastroenterological procedures; and coagulative necrosis and interstitial laser coagulation of soft tissues such as tumors and fibroids.
The Indigo OPTIMA Laser System, when used in conjunction with the Bare-Tip Fiberoptic, is indicated for the incision, excision, and ablation or coagulation of tissues with hemostasis during general surgery, and general gastroenterological and urological procedures, including those involving urethral strictures, bladder neck contractures, and condylomata.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) number |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-the-Counter Use
| (Division Sign-Off) | |
| Division of General, Restorative | |
| and Neurological Devices |
| DEC 03 2001 | 510(k) Number K013493 |
|---|---|
| ------------- | ----------------------- |