(54 days)
Not Found
No
The summary describes a surgical instrument for grasping and coagulation, with no mention of AI/ML, image processing, or data-driven algorithms.
No
The device is used for grasping and coagulating tissue during surgery, but it does not treat or prevent a disease, injury, or condition in the way a therapeutic device would. It is a surgical instrument.
No
The device description and intended use clearly state that it is for grasping and coagulation of soft tissue and blood vessels during surgical procedures, not for diagnosis.
No
The device description clearly states it is an "instrument" and describes physical components and materials, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing happens outside the body (in vitro).
- MicroGRASP Monopolar Coagulator Function: The description clearly states the device is used for "grasping and coagulation of soft tissue and blood vessels... during open and guidance-assisted surgical procedures." This is a surgical instrument used directly on the patient's body during a procedure.
The device's function is therapeutic and surgical, not diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
The MicroGRASP Monopolar Coagulator is indicated for use in the grasping and coagulation of soft tissue and blood vessels up to 3 mm during open and guidance-assisted surgical procedures.
Product codes
GEI
Device Description
The MicroGRASP Monopolar Coagulator is an instrument designed for grasping and coagulation of soft tissue and blood vessels during surgical procedures. The MicroGRASP Monopolar Coagulator contains materials similar to those used in the predicate device, is of similar design and has the same operating principle as the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical procedures
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 MicroGRASP Monopolar Coagulator has been designed and tested to applicable standards (ANSI/AAMI HF-18/1993). The MicroGRASP Monopolar Coagulator does not raise any new issues of safety, effectiveness, or performance of the product.
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
§ 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
August 10, 1999 Premarket Notification
OCT 5 1999
SECTION 15
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
-
- Submitter's name, address, telephone number, contact person, and date summary prepared;
| a. Submitter: | HysteRx, Inc. |
|---|---|
| 32236-E Paseo Adelanto | |
| San Juan Capistrano, CA 92675 USA | |
| (949) 488-8701 |
- b. Contact Person: Judy F. Gordon, D.V.M. Official Correspondent for HysteRx, Inc. (949) 854-6314
- Date Summary Prepared: August 10, 1999 C.
- Name of device, including trade name and classification name:
- a. Trade/Proprietary Name: MicroGRASP Monopolar Coagulator
- Electrosurgical cutting and coagulation device Classification Name: b.
3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
| Company: | Microsurge, Inc. |
|---|---|
| Device: | Microsurge Front-End Grasping Devices |
| 510(k) : | K922802 |
| Date Cleared: | January 29, 1993 |
- A description of the device that is the subject of the 510(k), including explanation of 4. how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
1
The MicroGRASP Monopolar Coagulator is an instrument designed for grasping and coagulation of soft tissue and blood vessels during surgical procedures. The MicroGRASP Monopolar Coagulator contains materials similar to those used in the predicate device, is of similar design and has the same operating principle as the predicate device.
ട. Statement of intended use:
The MicroGRASP Monopolar Coagulator is indicated for use in the grasping and coagulation of soft tissue and blood vessels up to 3 mm during open and guidanceassisted surgical procedures.
Statement of how the technological characteristics of the device compare to those 6. of the predicate or legally marketed device.
A comparison of the technological characteristics of the device and its predicate is shown in the following table:
| CHARACTERISTICS | Microsurge Front-End Grasping
Devices | MicroGRASP Monopolar
Coagulator |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To remove tissue or control bleeding
during general surgical endoscopic or
laparoscopic procedures | For grasping and coagulation of soft
tissue and blood vessels up to 3 mm
during open and guidance-assisted
surgical procedures |
| Operating Principle | Electrosurgical handpiece for
coagulation; electro-cautery | Electrosurgical handpiece for
coagulation |
| Bipolar/Monopolar | Monopolar | Monopolar |
| Bench Testing | ANSI/AAMI HF-18/1986 | ANSI/AAMI HF-18/1993 |
| Handpiece Configuration(s) | Scissor-type handpiece | Articulating jaws design, with 2 or 4
jaw grasper, or blunt electrode |
| Materials:
Handle
Inner shaft
Outer shaft
Tips
Connector | Plastic, with stainless steel pin,
washer, and spring
Stainless steel
Teflon sheath (implant grade)
Stainless steel (implant grade)
Nickel plated brass | Plastic, with stainless steel pins and
gears
Stainless steel
Nylon 11 sheath (implant grade - USP
Class VI)
Stainless steel (implant grade)
Nickel plated brass |
| Disposable/Reusable | Single use, disposable | Single use, disposable |
Comparative Technological Characteristics
2
Brief summary of nonclinical tests and results: 7.
The MicroGRASP Monopolar Coagulator has been designed and tested to applicable standards (ANSI/AAMI HF-18/1993). The MicroGRASP Monopolar Coagulator does not raise any new issues of safety, effectiveness, or performance of the product.
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 image of a human face in profile, with three wavy lines representing hair or flowing fabric. The face is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT -5 1599
HysteRx, Inc. c/o Judy F. Gordon, D.V.M. ClinReg Consulting Services 18732 Saginaw Irvine, California 92612
K992714 Re: Trade Name: MicroGRASP Monopolar Coagulator Regulatory Class: II Product Code: GEI Dated: August 10, 1999 Received: August 12, 1999
Dear Dr. Gordon:
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 (OS) 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 - Judy F. Gordon, D.V.M.
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
5
HysteRx, Inc. MicroGrasp Monopolar Coagulator
August 10, 1999 Premarket Notification
Page_____of___
510(k) Number (if known): K99 2714
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
: 上一
t
The MicroGRASP Monopolar Coagulator is indicated for use in the grasping and coagulation of soft tissue and blood vessels up to 3 mm during open and guidance-assisted surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K992714 |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |