(211 days)
Codman Mirror Finish Bipolar Forceps, Seedling Enterprises, LLC, Cool-Tec Reusable Bipolar Electrodes and Cool-Tec Bipolar Electrodes, Link Technology Non-Stick Bipolar Forceps
Not Found
No
The document describes a standard electrosurgical forceps and does not mention any AI or ML capabilities.
Yes
It is indicated for cauterizing and coagulating tissue during various surgical procedures, which are therapeutic actions.
No
The device is indicated for cauterizing, coagulating, grasping, and manipulating tissue, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it consists of physical components: "insulated, reusable handle" and "sterile, disposable tips." This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cauterizing, coagulating, grasping and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial/plastic surgery procedures." This describes a device used on the patient's body during a surgical procedure.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health.
- No mention of specimen analysis: The description focuses on the device's function in directly interacting with tissue during surgery, not on analyzing samples.
Therefore, the ISOCOOL Bipolar Forceps are a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The ISOCOOL Bipolar Forceps (handles and tips) when used as part of a system including a bipolar electrosurgical generator are indicated for cauterizing. coagulating, grasping and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial/plastic surgery procedures.
Indications for use in OB/GYN surgery exclude contraceptive coagulation of fallopian tube tissue.
Product codes
GEI
Device Description
ISOCOOL Bipolar Forceps consist of an insulated, reusable handle in irrigating and non-irrigating styles and sterile, disposable tips.
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)
Substantial equivalence for this device was based upon comparison to predicate device characteristics and performance testing. All testing results demonstrated the substantial equivalence of the product to commercially distributed devices for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Codman Mirror Finish Bipolar Forceps, Seedling Enterprises, LLC, Cool-Tec Reusable Bipolar Electrodes and Cool-Tec Bipolar Electrodes, Link Technology Non-Stick Bipolar Forceps
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
EXHIBIT A
K023566
510(k) Summary CODMAN ISOCOOL Bipolar Forceps
Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Contact Person
Elizabeth Dolan Regulatory Affairs Specialist Telephone Number: (508) 828-3262 Fax Number: (508) 828-3212
Name of Device
| Proprietary Name: | CODMAN ISOCOOL Bipolar Forceps |
|---|---|
| Common Name: | Bipolar Forceps |
| Classification Name: | Electrosurgical Cutting and Coagulation Device |
Device Classification
Electrosurgical Cutting and Coagulation Device and Accessories are Class II devices per 21 CFR § 878.4400 (79 GEI).
Statement of Substantial Equivalence
CODMAN ISOCOOL Bipolar Forceps are substantially equivalent to Codman Mirror Finish Bipolar Forceps, Seedling Enterprises, LLC, Cool-Tec Reusable Bipolar Electrodes and Cool-Tec Bipolar Electrodes, and Link Technology Non-Stick Bipolar Forceps based on the subject device's similarity to the predicate devices in intended use, materials, design, and principles of operation.
Indications for Use
The ISOCOOL Bipolar Forceps (handles and tips) when used as part of a system including a bipolar electrosurgical generator are indicated for cauterizing. coagulating, grasping and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial/plastic surgery procedures.
1
Indications for use in OB/GYN surgery exclude contraceptive coagulation of fallopian tube tissue.
Physical Description
ISOCOOL Bipolar Forceps consist of an insulated, reusable handle in irrigating and non-irrigating styles and sterile, disposable tips.
Device Testing________________________________________________________________________________________________________________________________________________________________
Substantial equivalence for this device was based upon comparison to predicate device characteristics and performance testing. All testing results demonstrated the substantial equivalence of the product to commercially distributed devices for the same intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
MAY 22 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Dolan Regulatory Affairs Specialist Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K023566
Trade/Device Name: Codman IsoCool Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 1, 2003 Received: May 2, 2003
Dear Ms. Dolan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality 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.
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Page 2 - Ms. Elizabeth Dolan
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) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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 vours.
Mark N. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation
Center for Devices and Radiological Health
· Enclosure
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510(k) Number (if known):
Device Name:
CODMAN ISOCOOL Bipolar Forceps
. . . . . .
Indications For Use:
The ISOCOOL Bipolar Forceps (handles and tips) when used as part of a system including a bipolar electrosurgical generator are indicated for cauterizing, coagulating, grasping and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial/plastic surgery procedures.
Indications for use in OB/GYN surgery exclude contraceptive coagulation of fallopian tube tissue.
(Please do not write below this line - Continue on another page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)
leo Charles N. Mellem
(Division Sign-Off) Dision of General, Restorative and Neurological Devices
510(k) Number K023566
Prescription Use
(Per 21 CFR §801.109)
OR
Over-the-Counter Use