(88 days)
No
The device description and performance studies focus on thermal coagulation via infrared light and user-controlled pulse duration, with no mention of AI or ML technologies.
Yes
The device is indicated for the treatment of hemorrhoids through thermal coagulation, which directly addresses a medical condition.
No
The device description and intended use clearly state that the device is used for treatment (coagulation and hemostasis) of hemorrhoids, not for diagnosing them.
No
The device description explicitly lists hardware components such as a console unit, hand piece, removable light guide, and disposable contact tip, indicating it is a hardware-based medical device that delivers light pulses for treatment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The CooperSurgical IRC directly treats hemorrhoids by applying light to the tissue within the body (in vivo) to cause thermal coagulation. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it is for the "treatment of hemorrhoids" and "hemostasis," which are therapeutic actions.
- Device Description: The description details how the device delivers light to tissue for coagulation, which is a physical treatment method.
The device's function and intended use are entirely focused on treating a condition within the body, not on analyzing samples taken from the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The CooperSurgical IRC is indicated for the treatment of hemorrhoids, especially bleeding, non-prolapsed internal hemorrhoids, as a means of hemostasis in the treatment of hemorrhoids by routine excision, or to coagulate external thrombotic hemorrhoids that have been removed ("collectively referred to as hemorrhoids") through the coagulative necrosis of the mucosa proximal to the base of the hemorrhoid.
Product codes
78 KNS
Device Description
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.
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, waiting at least five seconds between exposures. 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.
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
mucosa proximal to the base of the hemorrhoid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician (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
The safety and effectiveness of the CooperSurgical IRC for the treatment of hemorrhoids is based on FDA's clearance of: (1) Redfield's Infrared Coagulator for the treatment of hemorrhoids; (2) CooperSurgical's InfraRed Coagulator for the treatment of genital condylomas and general warts; and (3) CooperSurgical's testing of the PVC contact tips.
Key Metrics
Not Found
Predicate Device(s)
- (1) Redfield Corporation's Redfield Infrared Coagulator for the treatment of hemorrhoids, especially bleeding, non-prolapsed internal hemorrhoids, as a means of hemostasis in the treatment of hemorrhoids by routine excision, or to coagulate external thrombotic hemorrhoids that have been removed; and
- (2) CooperSurgical's InfraRed Coagulator for the treatment of genital condylomas (condyloma accuminata) and general warts.
Reference Device(s)
Not Found
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
JUN 11 1999
510(K) SUMMARY FOR COOPERSURGICAL, INC.'S INFRARED COAGULATOR
Submitter's Name, Address, Telephone Number, and Contact Person
CooperSurgical, Inc. 15 Forest Parkway Shelton, Connecticut 06484
| Contact: | Deb Pekar
Manager, Regulatory Affairs, CooperSurgical, Inc. |
|------------|----------------------------------------------------------------|
| Phone: | (203) 929-6321 |
| 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 hemorrhoids, especially bleeding, non-prolapsed internal hemorrhoids, as a means of hemostasis in the treatment of hemorrhoids by routine excision, or to coagulate external thrombotic hemorrhoids that have been removed; and
- (2) CooperSurgical's InfraRed Coagulator for the treatment of genital condylomas (condyloma accuminata) and general warts.
Intended Use
The CooperSurgical IRC is indicated for the treatment of hemorrhoids, especially bleeding, non-prolapsed internal hemorrhoids, as a means of hemostasis in the treatment of hemorrhoids by routine excision, or to coagulate external thrombotic hemorrhoids that have been removed ("collectively referred to as hemorrhoids") through the coagulative necrosis of the mucosa proximal to the base of the hemorrhoid.
1
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.
Page 2 of 2
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, waiting at least five seconds between exposures. 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.
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. 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 hemorrhoids. 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 hemorrhoids is based on FDA's clearance of: (1) Redfield's Infrared Coagulator for the treatment of hemorrhoids; (2) CooperSurgical's InfraRed Coagulator for the treatment of genital condylomas and general warts; and (3) CooperSurgical's testing of the PVC contact tips.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 1999
CooperSurgical, Inc. c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004
Re: K990852 CooperSurgical InfraRed Coaqulator Dated: March 15, 1999 Received: March 15, 1999 Requiatory Class: II 21 CFR §876.4300/ Procode : 78 KNS
Dear Mr. Kahan:
We have reviewed vour 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 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult 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.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiance at (301) 594-4613. 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/dsma/dsmamain.html".
Sincerely yours.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: CooperSurgical InfraRed Coagulator
Indications for Use:
The CooperSurgical InfraRed Coagulator is indicated for the treatment of hemorrhoids, especially bleeding, non-prolapsed internal hemorrhoids, as a means of hemostasis in the treatment of hemorrhoids by routine excision, or to coagulate external thrombotic hemorrhoids that have been removed through coagulative necrosis of the mucosa proximal to the base of the hemorrhoid.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use | (Per 21 C.F.R. 801.109)
(Division Sign-Off)
and Radiological Dev 510(k) Number.
Division of Reproductive, Abdominal, B
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)