(78 days)
Not Found
Not Found
No
The document describes a device that uses infrared coagulation and explicitly states "Mentions AI, DNN, or ML: Not Found". The description focuses on the physical components and predicate devices, with no mention of AI/ML capabilities.
Yes
The device is indicated for tattoo removal through "coagulative necrosis," which is a medical treatment.
No
The device is indicated for tattoo removal through coagulative necrosis, which is a treatment, not a diagnostic process.
No
The device description explicitly lists hardware components: a console unit, hand piece, removable light guide, and disposable contact tip.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "tattoo removal through the coagulative necrosis of tattoo pigmented tissue." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a physical instrument (console, hand piece, light guide, contact tip) used to deliver infrared energy to the tissue.
- Mechanism of Action: The mechanism is "coagulative necrosis," which is a physical effect on tissue.
- Anatomical Site: The anatomical site is "tattoo pigmented tissue," which is part of the patient's body.
IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of any such specimens.
N/A
Intended Use / Indications for Use
The CooperSurgical InfraRed Coagulator ("IRC") is indicated for tattoo removal through the coagulative necrosis of tattoo pigmented tissue.
Product codes (comma separated list FDA assigned to the subject device)
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. The CooperSurgical IRC is essentially the same device as Redfield Corporation's Infrared Coagulator that has already been cleared by FDA for tattoo removal. With the exception of four minor changes, the CooperSurgical IRC is identical to the CooperSurgical IRC that is cleared for the treatment of genital condylomas and general warts.
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 for tattoo removal is based on: (1) Redfield Corporation's Infrared Coagulator that has already been cleared by FDA for tattoo removal; (2) CooperSurgical's IRC that has already received clearance for the treatment of genital condylomas and general warts; and (3) CooperSurgical's testing of the PVC contact tips.
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.
Redfield Corporation's Redfield Infrared Coagulator for tattoo removal, CooperSurgical, Inc.'s InfraRed Coagulator for the treatment of (2) genital condylomas (condyloma accuminata) and general warts.
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
510(K) SUMMARY FOR COOPERSURGICAL, INC.'S INFRARED COAGULATOR
N99085D
Submitter's Name, Address, Telephone Number, And Contact Person
CooperSurgical, Inc. 15 Forest Parkway Shelton, Connecticut 06484
| Contact: | Debra Pekar |
|---|---|
| Manager, Regulatory Affairs | |
| CooperSurgical, Inc. | |
| Phone: | (203) 929-6321 |
| Facsimile: | (203) 925-0135 |
March 15, 1999 Date Prepared:
Name of the Device
CooperSurgical InfraRed Coagulator
Common or Usual Name
Infrared Coagulator
Predicate Devices
- (1) Redfield Corporation's Redfield Infrared Coagulator for tattoo removal; and
- CooperSurgical, Inc.'s InfraRed Coagulator for the treatment of (2) genital condylomas (condyloma accuminata) and general warts.
Intended Use
The CooperSurgical InfraRed Coagulator ("IRC") is indicated for tattoo removal through the coagulative necrosis of tattoo pigmented tissue.
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
1
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 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 tattoo removal. With the exception of four minor changes, 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 tattoo removal is based on: (1) Redfield Corporation's Infrared Coagulator that has already been cleared by FDA for tattoo removal; (2) CooperSurgical's IRC that has already received clearance for the treatment of genital condylomas and general warts; and (3) CooperSurgical's testing of the PVC contact tips.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three overlapping, curved lines forming its body and wings. The bird faces to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1999 JUN
Coopersurgical, Inc. c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street. N.W. Washington, D.C. 20004
Re: K990850
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 (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 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
K990850 510(k) Number (if known):___
Device Name: CooperSurgical InfraRed Coagulator
Indications for Use:
The CooperSurgical InfraRed Coagulator is indicated for tattoo removal through coagulative necrosis of tattoo pigmented tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
to alee
(Division Sign-Off)
Division of General Restorative Devices / 6990850
510(k) Number.
Prescription Use (Per 21 C.F.R. 801.109)
· OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)