(79 days)
Not Found
No
The device description focuses on thermal coagulation via infrared light and a user-controlled timer, with no mention of AI or ML algorithms for analysis, decision-making, or control.
Yes
The device is intended for the "treatment of genital condylomas (condyloma accuminata) and general warts," which implies a therapeutic purpose.
No
The device is described as an Infrared Coagulator used for treatment (coagulative necrosis of tissue) of genital condylomas and general warts, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components: a control unit, hand piece, removable light guide, and disposable contact tip, which deliver light pulses for thermal coagulation.
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 samples) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside the body (in vitro).
- Device Function: The CooperSurgical Infrared Coagulator directly applies light to tissue on the body to cause thermal coagulation. It is a therapeutic device used for treatment, not a diagnostic device used for analyzing samples.
- Intended Use: The intended use is for "coagulative necrosis of tissue" and "treatment of genital condylomas (condyloma accuminata) and general warts." This is a therapeutic purpose.
- Device Description: The description details how the device delivers light to tissue for treatment, not how it analyzes biological samples.
Therefore, the CooperSurgical Infrared Coagulator is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CooperSurgical Infrared Coagulator ("IRC") is intended for coagulative necrosis of tissue. It is indicated for the treatment of genital condylomas (condyloma accuminata) and general warts.
For the treatment of genital condylomas (condyloma accuminata) and general warts.
Product codes (comma separated list FDA assigned to the subject device)
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. 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 lesion is coagulated, waiting at least five seconds between exposures.
The CooperSurgical IRC consists of the following main components: (1) a control 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
Not Found
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 is based on: (1) Redfield IRC's premarket clearances for the treatment of hemorrhoids and chronic rhinitis, and for tattoo removal; (2) the long history of use of lasers for the treatment of genital condylomas and general warts; and (3) two recent clinical studies demonstrating that the IRC is equivalent to its predicate devices for the treatment of genital condylomas and general warts.
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.
K842810/A, K950836, K911648, K913758, K951165, K861688
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
§ 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
JAN 2 3 1998
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
| Contact: | John Grasso |
|---|---|
| President, CooperSurgical, Inc. | |
| Phone: | (203) 925-6621 |
| Facsimile: | (203) 925-0135 |
Name of the Device
CooperSurgical Infrared Coagulator
Common or Usual Name
Infrared Coagulator
Predicate Devices
- Redfield Corporation's Redfield Infrared Coagulator for the (1) treatment of hemorrhoids (K842810/A) and chronic rhinitis (K950836), and for tattoo removal (K911648).
- Laserscope's KTP/YAG Surgical Laser Systems (K913758) (2)
- Sharplan Lasers, Inc.'s Model 3100 Nd:YAG Surgical Laser (3) (K951165)
- Xanar Surgical Laser Systems' Xanar CO2 Surgical Laser System (4) Model XAP-15 (K861688).
Intended Use
The CooperSurgical Infrared Coagulator ("IRC") is intended for coagulative necrosis of tissue. It is indicated for the treatment of genital condylomas (condyloma accuminata) and general warts.
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.
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 lesion is coagulated, waiting at least five seconds between exposures.
Technical Characteristics
The CooperSurgical IRC consists of the following main components: (1) a control unit; (2) a hand piece; (3) a removable light guide; and (4) a disposable contact tip. With the exception of two features, 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 (K842810/A) and chronic rhinitis (K950836), and for tattoo removal (K911648).
Summary of the Basis for the Finding of Substantial Equivalence
The safety and effectiveness of the CooperSurgical IRC is based on: (1) Redfield IRC's premarket clearances for the treatment of hemorrhoids and chronic rhinitis, and for tattoo removal; (2) the long history of use of lasers for the treatment of genital condylomas and general warts; and (3) two recent clinical studies demonstrating that the IRC is equivalent to its predicate devices for the treatment of genital condylomas and general warts.
With the exception of two features, the CooperSurgical IRC is practically the same device as the Redfield IRC, which has already received premarket clearance for the treatment of hemorrhoids (K842810/A) and chronic rhinitis (K950836) and for tattoo removal (K911648). The primary differences between the devices are (1) the indications for use; (2) the inclusion of single use/sterile (as opposed to reusable) contact tips with an integral sheath to protect the light guide from tissue contact; and (3) the use of a different 15 volt halogen bulb.
2
In addition, the CooperSurgical IRC is substantially equivalent to several lasers that have received premarket clearance for genital condylomas (condyloma accuminata) and general warts: Laserscope's KTP/YAG Surgical Laser Systems (K913758), Sharplan Lasers, Inc.'s Model 3100 Nd:YAG Surgical Laser (K951165) and Xanar Surgical Laser Systems' Xanar CO2 Surgical Laser System Model XAP-15 (K861688).
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the department's mission. 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
JAN 2 3 1998
CooperSurgical. Incorporated C/O Mr. Jonathan S. Kahan Hogan & Hartson 555 13th Street. N.W. Washington, DC 20004-1109
K974168 Re:
Trade Name: CooperSurgical Infrared Coagulator Regulatory Class: II Product Code: KNS Dated: November 4, 1997 Received: November 5, 1997
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 eompliance with the … current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) 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 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
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Page 2 - Mr. Kahan
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing vour 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 vours.
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
5
510(k) Number (if known): K 97 4/6 P
Device Name: Cooper Surgical Infrared Coagulator
Indications For Use:
For the treatment of genital condylomas (condyloma accuminata) and general warts.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||||
|---|---|---|---|---|
| (Division Sign-Off) | ||||
| Division of General Restorative Devices | ||||
| 510(k) Number | K974168 | |||
| Prescription Use | ||||
| Per 21 CFR 801.109) | OR | Over-The-Counter Use | ||
| (Optional Format 1-2-96) |