(77 days)
Not Found
No
The description focuses on the device's function (hemostasis using diathermy) and physical components (handle, disposable tip) and does not mention any computational or algorithmic features indicative of AI/ML. The "Not Found" entries for AI/ML mentions, image processing, training/test sets, and performance metrics further support this conclusion.
Yes
The device is used to achieve hemostasis (the stopping of blood flow), which is a therapeutic action.
No
The device is used to achieve hemostasis (stop bleeding) through diathermy, which is a therapeutic procedure, not a diagnostic one.
No
The device description explicitly states it is a hand-held bipolar probe consisting of a handle and a disposable tip (electrode), which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to achieve hemostasis (stop bleeding) during surgical procedures on the episclera and within the eye. This is a therapeutic/surgical application, not a diagnostic one.
- Device Description: The device is a hand-held bipolar probe that uses diathermy (RF energy) for coagulation. This is a surgical tool, not a device used to examine specimens from the human body to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to directly interact with tissue to achieve hemostasis during surgery.
N/A
Intended Use / Indications for Use
The Mentor® Gemini™ Hemostatic Eraser™ is used to achieve episcleral and or intraocular hemostasis utilizing diathermy.
Product codes
86 HQO
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.
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 determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4115 Thermal cautery unit.
(a)
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.(b)
Classification. Class II.
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
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)