(171 days)
Not Found
None
No
The summary explicitly states that the electronic system is equivalent to the predicate and the only difference is the geometry of the disposable tips. There are no mentions of AI, ML, or related concepts.
Yes
The device is intended for the "treatment of primary open-angle glaucoma," indicating a therapeutic purpose.
No
This device is described as a "thermocauterization" device used for treating glaucoma, specifically for "sclerostomy." Its function appears to be interventional (surgical) rather than for diagnosing a condition.
No
The device description explicitly states it is an "entire electronic system" and mentions "disposable incision tips," indicating hardware components are involved.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Sclerostomy for the treatment of primary open-angle glaucoma where maximum tolerated medical therapy and trabeculoplasty have failed." This describes a surgical procedure performed directly on a patient's tissue (sclera) for therapeutic purposes.
- Device Description: The device is described as an "electronic system of Fugo Blade for thermocauterization." Thermocauterization is a method of using heat to cut or seal tissue, which is a surgical technique.
- Anatomical Site: The anatomical site is the "Sclera," which is part of the eye.
- 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) 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 a surgical procedure.
N/A
Intended Use / Indications for Use
Sclerostomy for the treatment of primary open- angle glaucoma where maximum tolerated medical therapy and trabeculoplasty have failed.
Product codes
NCR
Device Description
Not Found
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
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
The Fugo Blade for anterior capsulotomy
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4100 Radiofrequency electrosurgical cautery apparatus.
(a)
Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.(b)
Classification. Class II.
0
OCT 8 - 2004
K 04/019
MediSURG Ltd. 100 West Fornance Street Norristown, PA 19401 Phone (610) 277-3937 Fax (610)277-7256
Premarket Notification [510(k)] Summary
Submitters name: Richard J. Fugo M.D., Ph.D. Contact person: Richard J. Fugo M.D., Ph.D. Date: March 8, 2004
Names:
- D) Classification name: apparatus, cutting, radiofrequency, electrosurgical, battery powered.
- E) Common/usual name: The Fugo Blade for Thermocauterization in Glaucoma
- F) Proprietary Name: The Fugo Blade
Equivalence/ predicate device:
- The Fugo Blade for anterior capsulotomy
- . Description of device: included in prior section of this document.
Intended use of device:
HCFA Current Procedure Terminology (2004) # 66155- Fistulization of sclera for glaucoma; thermocauterization with iridectomy.
Summary of the technological characteristics: as demonstrated in the prior section, the entire electronic system of Fugo Blade for thermocauterization in glaucoma is equivalent to the predicate system. The only difference in the two systems is the geometry of the disposable incision tips as delineated in detail above.
Determination of substantial equivalence: as stated, the electronic circuit is exactly the same for the two systems. Both systems produce the exact same electronic output signal characteristics. Therefore, both systems react
1
identically when placed in contact with tissue since they are the same electronic system.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 8 - 2004
Medisurg Ltd. c/o Richard J. Fugo 100 West Fornance St. The Fugo Building Norristown, Pa 19401
Re: K041019 Trade/Device Name: The Fugo Blade for Glaucoma Regulation Number: 21 CFR 886.4100 Regulation: Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered Regulatory Class: II Product Code: NCR Dated: September 29, 2004 Received: October 1, 2004
Dear Dr. Fugo:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your botton 3 re(s) presentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars actment date of the Medical Device Amendments, or to comments prior to may 20, 1978, in eccordance with the provisions of the Federal Food, Drug, devices that have been rechasined in assee approval of a premarket approval application (PMA). and Costicule Act (10) that as novice, subject to the general controls provisions of the Act. The Tou may, dicierole, manel and act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is oldsbirou (600 above) of ols. Existing major regulations affecting your device can hay oe subject to sacci 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 I lease to actived that I Drivination that your device complies with other requirements of the Act that I Dr Has Intact a statutes and regulations administered by other Federal agencies. You must of ury Federal babates requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Partiality 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.
3
Page 2- Richard J. Fugo
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) 594-4613. 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,
A Kalpi Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(K) Number (if known): K041019
Device Name: Fugo Blade for Glaucoma
Indications for use: Sclerostomy for the treatment of primary open- angle glaucoma where maximum tolerated medical therapy and trabeculoplasty have failed.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR Over-The
(21 CFR 8
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)
Bruce Drum
Division Sign-Off
Nose and Throat Davis
510(k) Number K041019