PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)

K972749 · C.M. Chance , Ltd. · HQR · Mar 13, 1998 · Ophthalmic

Device Facts

• Record ID: K972749
• Device Name: PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
• Applicant: C.M. Chance , Ltd.
• Product Code: HQR · Ophthalmic
• Decision Date: Mar 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pao Bipolar Coaxial Coagulator is for cauterizing microscopic vessels on the conjunctiva and sclera. It is for extraocular surgery and it is not to be used for intraocular surgery (within the anterior or posterior segment of the eye).

Device Story

The Pao Bipolar Coaxial Coagulator is a surgical instrument used for cauterizing microscopic vessels on the conjunctiva and sclera. It operates via bipolar coagulation technology, delivering electrical energy to target tissue to achieve hemostasis. The device is intended for use by surgeons in an extraocular surgical setting. It is strictly contraindicated for intraocular procedures. By providing precise coagulation, the device assists in managing bleeding during ophthalmic surgeries, potentially improving surgical outcomes and patient safety.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bipolar coaxial coagulation instrument; electrical energy source; designed for extraocular surgical application.

Indications for Use

Indicated for cauterization of microscopic vessels on the conjunctiva and sclera during extraocular surgery. Contraindicated for intraocular surgery.

Regulatory Classification

Identification

A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 1998

David S.C. Pao, M.D. C.M. Chance Ltd. 1018 Street Road, Suite 201 Southampton, PA 18966

Re: K972749 Trade Name: PAO BIPOLAR COAXIAL COAGULATOR Regulatory Class: II Product Code: 86 HOR Dated: January 20, 1998 Received: January 29, 1998

Dear Dr. Pao :

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 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 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- David S.C. Pao, M.D.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K972749

Device Name: Pao Bipolar Coaxial Coagulator

Indications For Use:

The Pao Bipolar Coaxial Coagulator is for cauterizing microscopic vessels on the conjunctiva and sclera. It is for extraocular surgery and it is not to be used for intraocular surgery (within the anterior or posterior segment of the eye).

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Huynh Hoang

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K972749

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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(Optional Format 1-2-96)