Who is the manufacturer of MENTOR GEMINI HEMOSTATIC ERASER?

Mentor Ophthalmics, Inc. filed the 510(k) submission for MENTOR GEMINI HEMOSTATIC ERASER (K971538).

What is the FDA product code for MENTOR GEMINI HEMOSTATIC ERASER?

HQO. It is classified under 21 CFR 886.4115 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for MENTOR GEMINI HEMOSTATIC ERASER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MENTOR GEMINI HEMOSTATIC ERASER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MENTOR GEMINI HEMOSTATIC ERASER

K971538 · Mentor Ophthalmics, Inc. · HQO · Jul 14, 1997 · Ophthalmic

Device Facts

Record ID	K971538
Device Name	MENTOR GEMINI HEMOSTATIC ERASER
Applicant	Mentor Ophthalmics, Inc.
Product Code	HQO · Ophthalmic
Decision Date	Jul 14, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4115
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Mentor® Gemini™ Hemostatic Eraser™ is used to achieve episcleral and or intraocular hemostasis utilizing diathermy.

Device Story

Hand-held bipolar probe for surgical coagulation; consists of reusable 6061-T6 aluminum handle and disposable electrode tip. Interfaces with Mentor Wet-Field Coagulator system via bipolar cable. Handle transfers RF energy (445-455 kHz) to tip. Used by surgeons in ophthalmic procedures to achieve hemostasis. Tip is single-use; handle is reusable (1-50 uses). Output is bipolar radiofrequency energy for tissue coagulation.

Clinical Evidence

No clinical data provided; substantial equivalence determination is not based on an assessment of performance data.

Technological Characteristics

Bipolar probe; 304/302 stainless steel electrodes; Teflon insulation; 6061-T6 aluminum handle. RF energy source (445-455 kHz, 400 Vpp). Tip sterilized via ETO; handle steam sterilized by user. Connectivity via proprietary bipolar cable to Mentor Wet-Field Coagulator.

Indications for Use

Indicated for achieving episcleral and intraocular hemostasis via diathermy in patients requiring surgical coagulation.

Regulatory Classification

Identification

A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.

Predicate Devices

MENTOR® WET-FIELD® HEMOSTATIC ERASER™ BIPOLAR INSTRUMENTS

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Submission Summary (Full Text)

{0}------------------------------------------------ JUL 1 4 1997 # 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: k911538 Submitted By: David Downey Director, Quality Assurance and Regulatory Affairs Mentor Ophthalmics, Inc. 3000 Longwater Drive Norwell, MA 02061 Tel: (617) 871-8184 Fax: (617) 871-7785 #### Date Prepared: #### Device Name | Proprietary Name: | MENTOR® GEMINI™ HEMOSTATIC ERASER™ | |----------------------|-------------------------------------------------------------------| | Common Name: | Coagulator | | Classification Name: | Apparatus, Cautery, Radiofrequency, AC-Powered or Battery Powered | ## Indications For Use The Mentor® Gemini™ Hemostatic Eraser™ is used to achieve episcleral and or intraocular hemostasis utilizing diathermy. ## Substantial Equivalence MENTOR® GEMINI™ HEMOSTATIC ERASER™ is similar in indications, design and features to MENTOR® WET-FIELD® HEMOSTATIC ERASER™ BIPOLAR INSTRUMENTS. #### Device Description The MENTOR® GEMINI™ HEMOSTATIC ERASER™ is a hand-held bipolar probe used for coagulation which consists of (a) a handle and (b) a disposable tip (electrode). The handle transfers RF energy to the disposable tip via a unique electrical contact system located in the internal cavity of the handle. After a single use, the Tip is intended to be disposed of in a safe and cost effective manner. The handle is intended to be used 1-50 times before discarding. #### 0000009 {1}------------------------------------------------ # 1971538 # Substantial Equivalence Comparison | | MENTOR® WET-FIELD® HEMOSTATIC ERASER™ | MENTOR® GEMINI™ HEMOSTATIC ERASER ™ | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | Indication | Replicates all functions for hemostasis, delivered through standard eraser products, for episcleral and intraocular diathermy. | Same | | Design | Single use disposable, hand-held one-piece bipolar probe. | Hand-held bipolar probe consisting of (a) disposable tip (b) a reusable handle. | | Material | Tube: Outer: 304 Stainless Steel Tubing. 18ga: .050 OD x .004" wall 20ga: .0355 OD x .004" wall 23ga: .0355 OD x .0025" wall | Same | | | Center Electrode: 18ga: .020" 302 Stainless Steel wire 20 and 23ga: .012" 302 Stainless Steel wire | Same | | | Insulation: 18ga: Teflon extruded onto .020" Stainless Steel wire 20ga: Teflon extruded onto .012" Stainless Steel wire 23ga: Teflon shrink tubing, .002"-.003" wall | Same | | | Connector Pin: 302 Stainless Steel | Same | | Tip Interface | Permanently attached | Removable / Disposable | | Cautery Tip Configuration | 18, 20 and 23 gauge with various bend angles for user preference. | Same | | Handle | ABS Plastic | 6061-T6 Aluminum | | Cautery Function | Hemostasis utilizing bipolar radio frequency | Same | | Handle | ABS Plastic | 6061-T6 Aluminum | | Cautery Function | Hemostasis utilizing bipolar radio frequency | Same | | User Interface | Hand-held instrument that interfaces with the electrically isolated front panel of the MENTOR® WET-FIELD® Coagulator system via the MENTOR® BIPOLAR CABLE. | Same | | Electrical Supply Source | MENTOR® WET-FIELD® Coagulator | Same | | | Frequency: 445-455 Khz | Same | | | Voltage: 400 Vpp ± 20V | Same | | | Resistance (for erasers): >20meg OHMS | Same | | Electrical Supply Connection | WET-FIELD® Bipolar Cable | Same | | Sterilization Method | ETO | Tip: ETO Handle: Shipped non-sterile Steam sterilized by user. | | Packaging | Tyvek pouch in box | Blister pack inside Tyvek pouch in box | {2}------------------------------------------------ The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical. D~ D **Submitter's Signature** 4-18-97 k971538 Date {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or body. The bird is positioned to the right of the text, which is arranged in a circular pattern around the bird. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA". Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 1 4 1997 Mr. David M. Downey Director, Quality Assurance and Regulatory Affairs Mentor Ophthalmics, Inc. 3000 Longwater Drive Norwell, MA 02061-1672 Re: K971538 Trade Name: Mentor Gemini Hemostatic Eraser Regulatory Class: II Product Code: 86 HQO Dated: April 18, 1997 Received: April 28, 1997 Dear Mr. Downey: 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 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. {4}------------------------------------------------ #### Page 2 - Mr. David M. Downey 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) 594-4613. 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/dsmamain.html". Sincerely yours, A. Ralph Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 510(k) Number (if known): L971538 Mentor® GEMINI™ HEMOSTATIC ERASER™ Device Name: Indications For Use: The Mentor® Gemini™ Hemostatic Eraser™ is used to achieve episcleral and or intraocular hemostasis utilizing diathermy. Evelyn R. Reem (Division Sign-Off) Division of Ophthalmic Dev 510(k) Number . Prescription Use (Per 21 CFR 801.109)