(30 days)
Not Found
No
The document describes a laser system for tissue treatment and mentions a software modification, but there is no indication or mention of AI or ML being used in the device's operation or functionality.
Yes
The device is indicated for the treatment of various medical conditions, including symptoms due to urinary outflow obstruction, tumors, fibroids, urethral strictures, bladder neck contractures, and condylomata, which aligns with the definition of a therapeutic device.
No
The device is a laser system indicated for the treatment of various conditions (e.g., BPH, tumors, fibroids) and for surgical procedures, not for diagnosing them.
No
The device description explicitly states it consists of a treatment diode laser, fiberoptic energy delivery devices, a footswitch, and an optional cart with printer, which are all hardware components. While there is a mention of a "software modification," this is in the context of a modification to a hardware component (the fiberoptic) and does not indicate the device itself is solely software.
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, including benign prostatic hyperplasia (BPH), tumors, fibroids, urethral strictures, bladder neck contractures, and condylomata. It directly interacts with and modifies tissue within the body.
- Lack of Sample Analysis: The description does not mention the device analyzing any samples taken from the patient's body. Its function is to deliver energy to tissue.
Therefore, the Indigo OPTIMA Laser System is a therapeutic 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 hyperplasia (BPH) in men over the age of 50 with prostates with median and/or Jateral 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). The fiberoptics (fibers) are designed to be sterile, single patient use, disposable devices.
Modifications to design of the Diffuser-Tip Fiberoptic have been made to improve manufacturability. Changes include removal of the inner sleeve, use of a new non patient-contacting adhesive, and a software modification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostates, soft tissues, urethral, bladder neck
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)
Design verification and validation testing confirms the modified Diffuser-Tip Fiberoptic performs as intended and is equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 2 4 2002
K 023182
Ethicon Endo-Surgery, Inc. Special 510(k) Premarket Notification for Índigo® OPTIMA Laser System
Índigo® OPTIMA Laser System 510(k) Summary of Safety & Effectiveness
Company
Contact Carol Sprinkle Regulatory Affairs Specialist
Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242
Date Prepared
September 23, 2002
Name of Device
Trade Name: Índigo® OPTIMA Laser System Classification Name: Laser powered surgical instrument
Predicate Device
İndigo® OPTIMA Laser System (K013493)
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). The fiberoptics (fibers) are designed to be sterile, single patient use, disposable devices.
Modifications to design of the Diffuser-Tip Fiberoptic have been made to improve manufacturability. Changes include removal of the inner sleeve, use of a new non patient-contacting adhesive, and a software modification.
Intended Use
The Indigo OPTIMA Laser System when used with the Diffuser-Tip Fiberoptic is intended for the safe and effective treatment of symptoms of benign prostatic hyperplasia (BPH).
Comparison of Technological Characteristics
The technological features of the modified Diffuser-Tip Fiberoptic are the same as the predicate with exception of the above design changes. The operating parameters of the laser have been adjusted slightly to accommodate the design changes with no loss in performance. No new issues of safety and effectiveness have been raised by these modifications.
Performance Data
Design verification and validation testing confirms the modified Diffuser-Tip Fiberoptic performs as intended and is equivalent to the predicate.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle, with three curved lines forming its body and wings. The eagle faces to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carol Sprinkle Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K023182
Trade/Device Name: Indigo® OPTIMA Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: GEX Dated: September 23, 2002 Received: September 24, 2002
Dear Ms. Sprinkle:
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 - Ms. Carol Sprinkle
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,
Miriam C. Provost
fel 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
3
Page __ of
510(k) Number (if known): K023182
Device Name: Índigo® OPTIMA Laser System
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 hyperplasia (BPH) in men over the age of 50 with prostates with median and/or Jateral 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.
Miriam C. Provost
eral. Restorative
510(k) Number Ko23182
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription use