(425 days)
No
The 510(k) summary describes a physical medical device (hemostasis probe) used for coagulation and irrigation. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts in the intended use, device description, or other sections. The device appears to be a traditional electrosurgical instrument.
Yes
The device is used for coagulation of active bleeding lesions in the gastrointestinal tract, which implies a therapeutic intervention.
No
The device is described as being used for "coagulation of active bleeding lesions" and for "irrigation," which are therapeutic and procedural functions, not diagnostic ones.
No
The device description clearly states it is a "probe" with physical dimensions (10 Fr and 7 Fr outer diameter) and a central irrigation port, indicating it is a physical medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Gyrus ACMI Inc. BiCoag Hemostasis Probe is a device used during an endoscopic procedure to directly coagulate bleeding lesions within the gastrointestinal tract. It is a therapeutic device used in vivo (within the body) to treat a condition.
The description clearly indicates its use for a therapeutic procedure within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Gyrus ACMI Inc. BiCoag Hemostasis Probe is intended for coagulation of active bleeding lesions in the upper or lower gastrointestinal tract during endoscopic procedures. The device also can be used for irrigation.
Product codes
KNS
Device Description
The BiCoag Hemostasis Probe is intended to be used for coagulation of active bleeding lesions in the upper or lower gastrointestinal tract when used with a bipolar high frequency generator. It contains a central irrigation port. The probe is to be available in 10 Fr and 7 Fr (3.3mm and 2.3mm respectively) outer diameter configurations to allow its use through a minimum 3.7mm and 2.8mm endoscope working channel, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower gastrointestinal tract
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Biosearch Hemostatic probe cleared under K912129, Everest Hemostatic Bipolar Probe cleared under K892895, Bard Biprobe cleared under K912601
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
Gyrus ACMI Inc. BiCoag Hemostasis Probe Gyrus ACMI Inc 136 Turnpike Road Southborough, MA 01772
Traditional 510(k) Notification Summary of Safety and Effectiveness
| 510(k) Summary of Safety and Effectiveness |
|---|
| Gyrus ACMI Incorporated |
| Gyrus ACMI Inc. BiCoag Hemostasis Probe |
General Information
Manufacturer:
UCT 2 0 2010
Gyrus ACMI Incorporated 136 Turnpike Rd. Southborough, MA 01772-2104
Lorraine Calzetta
August 19, 2009
Contact Person:
Date Prepared:
Device Description
Classification Name:
Endoscopic electrosurgical unit and accessories (21CFR 876.4300) Class II Gastroenterology/Urology
Trade Name:
Gyrus ACMI Inc. BiCoag Hemostasis Probe
Generic/Common Name:
Endoscopic electrosurgical accessories.
Predicate Device
Biosearch Hemostatic probe cleared under K912129
Everest Hemostatic Bipolar Probe cleared under K892895
Bard Biprobe cleared under K912601
Intended Uses
The Gyrus ACMI Inc. BiCoag Hemostasis Probe is intended for coagulation of active bleeding lesions in the upper or lower gastrointestinal tract during endoscopic procedures. The device also can be used for irrigation.
Device Description
The BiCoag Hemostasis Probe is intended to be used for coagulation of active bleeding lesions in the upper or lower gastrointestinal tract when used with a bipolar high frequency generator. It contains a central irrigation port. The probe is to be available in 10 Fr and 7 Fr (3.3mm and 2.3mm respectively) outer diameter configurations to allow its use through a minimum 3.7mm and 2.8mm endoscope working channel, respectively.
Technological Characteristics and Substantial Equivalence
The Gyrus ACMI Inc. BiCoag Hemostasis Probe, as described in this submission, is substantially equivalent to the predicates in intended use, materials, principles of operation and fundamental scientific technology.
1
/
Summary of Safety and Effectiveness
The Gyrus ACMI Inc. BiCoag Hemostasis Probe, as described in this submission, is substantially equivalent to the predicates in intended use, materials, principles of operation and fundamental scientific technology and raises no new issues of safety and effectiveness.
2
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Gyrus ACMI Incorporated % Ms. Lorraine Calzetta 136 Turnpike Road Southborough, Massachusetts 01772
Re: K092571
Trade/Device Name: Gyrus ACMI Inc. BiCoag Hemostasis Probe Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KNS Dated: October 14, 2010 Received: October 15, 2010
OCT 2 0 2010
Dear Ms. Calzetta:
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 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 mav 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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. Lorraine Calzetta
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Gyrus ACMI Inc. BiCoag Hemostasis probe Gyrus ACMI Inc 136 Turnpike Road Southborough, MA 01772
Traditional 510(k) Notification Statement of Intended Use
Device Name: Gyrus ACMI Inc. BiCoag Hemostasis Probe 510(k) Number: OCT 2 0 2010 Indications for use: The Gyrus ACMI Inc. BiCoag Hemostasis Probe is intended for coagulation of active bleeding lesions in the upper or lower gastrointestinal tract during endoscopic procedures.
Prescription Use: __ X
Over-the-Counter Use:
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Only, Orthopedic, Division of Suices
510(k) Number K092571