(15 days)
KNS
No
The device description details a system that delivers light pulses based on user-set parameters and a built-in timer. There is no mention of algorithms that learn or adapt from data, process images, or make decisions based on complex patterns, which are characteristic of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are also marked as "Not Found".
Yes
The device is indicated for the "treatment of chronic rhinitis through the coagulative necrosis of the submucosal tissue of the inferior turbinate," which clearly describes a therapeutic purpose.
No
The device is indicated for the "treatment of chronic rhinitis through the coagulative necrosis of the submucosal tissue of the inferior turbinate," which describes a therapeutic function, not a diagnostic one. It delivers light to cause "thermal coagulation that results in tissue necrosis."
No
The device description explicitly lists hardware components: a console unit, a hand piece, a removable light guide, and a disposable contact tip. It describes the physical delivery of light and thermal coagulation, which are hardware-dependent functions.
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.
- Device Function: The CooperSurgical InfraRed Coagulator directly treats tissue within the body (the inferior turbinate) using light and heat to cause coagulation. It is a therapeutic device, not a diagnostic one that analyzes samples outside the body.
- Intended Use: The intended use is for the "treatment of chronic rhinitis," which is a therapeutic application.
Therefore, the device described is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CooperSurgical InfraRed Coagulator ("IRC") is indicated for the treatment of chronic rhinitis through the coagulative necrosis of the submucosal tissue of the inferior turbinate.
Product codes
KNS
Device Description
The CooperSurgical IRC consists of the following main components: (1) a console unit: (2) a hand piece: (3) a removable light guide; and (4) a disposable contact tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
submucosal tissue of the inferior turbinate
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)
The safety and effectiveness of the CooperSurgical IRC for the treatment of chronic rhinitis is based on: (1) Redfield IRC's premarket clearances for the treatment of chronic rhinitis; and (2) CooperSurgical IRC's clearance for the treatment of genital condylomas and general warts.
The CooperSurgical IRC is substantially equivalent to Redfield Corp.'s Infrared Coagulator and is essentially the same device in all but four minor features. In addition, bench testing demonstrates that the CooperSurgical performs similarly to the Redfield IRC in terms of photocoagulation and non-stick characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Redfield Corporation's Redfield Infrared Coagulator for the treatment of chronic rhinitis, CooperSurgical's InfraRed Coagulator for the treatment of genital (2) condylomas (condyloma accuminata) and general warts.
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
3/30/99
990855
510(K) SUMMARY FOR COOPERSURGICAL, INC.'S INFRARED COAGULATOR
Submitter's Name, Address, Telephone Number, And Contact Person
CooperSurgical, Inc. 15 Forest Parkway Shelton, CT 06484
Debra Pekar Contact: Manager, Regulatory Affairs (203) 929-6321 Phone: Facsimile: (203) 925-0135
Date Prepared: March 15, 1999
Name of the Device
CooperSurgical InfraRed Coagulator
Common or Usual Name
Infrared Coagulator
Predicate Devices
- (1) Redfield Corporation's Redfield Infrared Coagulator for the treatment of chronic rhinitis; and
- CooperSurgical's InfraRed Coagulator for the treatment of genital (2) condylomas (condyloma accuminata) and general warts.
Intended Use
The CooperSurgical InfraRed Coagulator ("IRC") is indicated for the treatment of chronic rhinitis through the coagulative necrosis of the submucosal tissue of the inferior turbinate.
Principles of Operation
The Cooper IRC delivers short pulses of visible and infrared light through a small contact tip applicator that is applied to the tissue. This light causes thermal coagulation that results in tissue necrosis. The user sets the pulse duration control knob depending on the depth of the tissue necrosis required. The depth of coagulation is directly related to the pulse length delivered to a given area of tissue. The area(s) to be treated may be locally anesthetized at the physician's discretion.
1
Contact photocoagulation requires direct contact of the entire optical window of the disposable contact tip. The physician applies light mechanical pressure to the optical window against the tissue to be treated before depressing the activation trigger of the hand piece. To achieve coagulation, the user depresses the activation trigger. A built-in digital timer deactivates the lamp automatically according to the pulse duration setting preselected by the physician. If the desired treatment site is larger than the optical window, the physician may use overlapping exposures until the entire area is coagulated. waiting at least five seconds between exposures.
Technical Characteristics
The CooperSurgical IRC consists of the following main components: (1) a console unit: (2) a hand piece: (3) a removable light guide; and (4) a disposable contact tip. With the exception of four minor differences, the CooperSurgical IRC is essentially the same device as Redfield Corporation's InfraRed Coagulator that has already been cleared by FDA for the treatment of chronic rhinitis. In addition, with the exception of four features, the CooperSurgical IRC is identical to the CooperSurgical IRC that is cleared for the treatment of genital condylomas and general warts.
Summary of the Basis for the Finding of Substantial Equivalence
The safety and effectiveness of the CooperSurgical IRC for the treatment of chronic rhinitis is based on: (1) Redfield IRC's premarket clearances for the treatment of chronic rhinitis; and (2) CooperSurgical IRC's clearance for the treatment of genital condylomas and general warts.
The CooperSurgical IRC is substantially equivalent to Redfield Corp.'s Infrared Coagulator and is essentially the same device in all but four minor features. In addition, bench testing demonstrates that the CooperSurgical performs similarly to the Redfield IRC in terms of photocoagulation and non-stick characteristics.
Additionally, the CooperSurgical IRC is substantially equivalent to the CooperSurgical IRC which has already been cleared by FDA for the treatment of genital condylomas (condyloma accuminata) and general warts (K974168). With the four minor exceptions, the device is identical to the CooperSurgical device that has been cleared for genital condylomas and general warts. These differences do not raise new questions of safety or effectiveness.
2
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 stylized caduceus, which is a symbol of medicine and health, with three horizontal lines representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 30 1999
CooperSurgical, Inc. c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109
Re: K990855
Trade Name: CooperSurgical InfraRed Coagulator Regulatory Class: II Product Code: KNS Dated: March 15, 1999 Received: March 15, 1999
Dear Mr. Kahan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections. the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Jonathan S. Kahan
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: CooperSurgical InfraRed Coagulator ("IRC")
Indications for Use:
The CooperSurgical InfraRed Coagulator ("IRC") is indicated for the treatment of chronic rhinitis through the coagulative necrosis of the submucosal tissue of the inferior turbinate.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use _ 3 (Per 21 C.F.R. 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)