(383 days)
No
The description focuses on the physical design and function of a bipolar coagulation probe for laparoscopic procedures, with no mention of AI or ML capabilities.
Yes
The device is used in medical procedures for coagulation, dissection, irrigation, and aspiration, which are therapeutic interventions.
No
The device is described as a surgical probe used for coagulation, dissection, irrigation, and aspiration during laparoscopic procedures, which are therapeutic actions, not diagnostic ones.
No
The device description clearly details a physical probe with a bipolar tip, designed for laparoscopic procedures involving coagulation, irrigation, and aspiration. This involves hardware components and physical interaction with tissue.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used in laparoscopic procedures for bipolar coagulation, blunt dissection, irrigation, and aspiration. These are all surgical procedures performed on the patient, not tests performed on samples taken from the patient.
- Device Description: The description details a surgical probe used for direct interaction with tissue within the body. It talks about RF current, suction-irrigation, and accessing anatomical areas. This is consistent with a surgical instrument, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for treatment and manipulation of tissue during a procedure.
N/A
Intended Use / Indications for Use
The BICAP COAG Bipolar Laparoscopy Probe is indicated for use in laparoscopic procedures to provide bipolar coagulation, blunt dissection, irrigation, and aspiration. The BICAP COAG Probe may be used in a variety of gastrointestinal, urological and gynecological procedures.
Product codes
GEI
Device Description
The 5 mm ACMI BICAP COAG Bipolar Laparoscopy Probe (32 cm working leneth) is designed for laparoscopic coagulation, irrigation, and aspiration. The RF current path within the patient is identical to standard bipolar; consequently, the need for a patient dispersive electrode is eliminated. The current flow through the tissue is localized to help prevent a thermal effect distant from the surgical site.
The BICAP COAG Bipolar Laparoscopy Probe connects to ACMI Surgiflex WAVE suction-irrigation tubing sets. Use of the BICAP COAG Probe can help reduce operating room time by reducing the number of instrument exchanges. With a bipolar tip at the end of the suction-irrigation shaft, hemostasis, blunt dissection, irrigation, and aspiration may be readily performed withdrawing the instrument. The oval tip design of the probe provides easy, less traumatic access to ovarian and tubal cysts and other difficult to reach areas. BICAP COAG instruments are compatible with most bipolar generators. allowing them to be used with existing equipment.
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)
Not Found
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.
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JUL 1 6 2002
Image /page/0/Picture/1 description: The image shows the text "ACMI" in a stylized font. The letters are black and have a textured appearance, as if they were created with small dots or grains. To the left of the letter "A", there are three diagonal lines that are also black and textured, adding a design element to the logo.
Premarket Notification 510(k) Summary
(as required by section 807.92(c))
| 510K Number: | K012018 |
|---|---|
| Submitter: | Frank J. Fucile, Director, Regulatory Affairs |
| ACMI Corporation | |
| 136 Turnpike Road | |
| Southborough, MA 01772 USA | |
| Phone: 508-804-2600, FAX: 598-804-2624 | |
| Date prepared: | July 10, 2002 |
| Proprietary Name: | ACMI BICAP COAG Bipolar Laparoscopy Probe |
| Common Name: | Laparoscopy Probe |
| Classification Name: | Endoscopic electrosurgical unit and accessories, |
| 21 CFR 876.4300 |
Substantially Equivalent Devices:
The BICAP COAG Bipolar Laparoscopy Probe to the ACMI Bipolar Hemostatic Electrode (K803214) and the Cabot Medical Surgiflex Suction-Irrigation Probe (K932626).
Description of Device:
The 5 mm ACMI BICAP COAG Bipolar Laparoscopy Probe (32 cm working leneth) is designed for laparoscopic coagulation, irrigation, and aspiration. The RF current path within the patient is identical to standard bipolar; consequently, the need for a patient dispersive electrode is eliminated. The current flow through the tissue is localized to help prevent a thermal effect distant from the surgical site.
The BICAP COAG Bipolar Laparoscopy Probe connects to ACMI Surgiflex WAVE suction-irrigation tubing sets. Use of the BICAP COAG Probe can help reduce operating room time by reducing the number of instrument exchanges. With a bipolar tip at the end of the suction-irrigation shaft, hemostasis, blunt dissection, irrigation, and aspiration may
1
be readily performed withdrawing the instrument. The oval tip design of the probe provides easy, less traumatic access to ovarian and tubal cysts and other difficult to reach areas. BICAP COAG instruments are compatible with most bipolar generators. allowing them to be used with existing equipment.
Intended Use:
The BICAP COAG Bipolar Laparoscopy Probe is indicated for use in laparoscopic procedures to provide bipolar coagulation, blunt dissection, and aspiration. The BICAP COAG Probe may be used in a variety of gastrointestinal, urological and gynecological procedures.
Summary Comparison of Technological Characteristics Compared to Predicate Devices:
The ACMI Bipolar Hemostatic Electrode is virtually identical to the BICAP COAG Bipolar Laparoscopy Probe in design and functions (coagulation, blunt dissection, suction, irrigation) except that the Bipolar Hemostatic Electrode was intended for use only in gastrointestinal procedures, while the BICAP COAG Probes are intended for general laparoscopic use including gastrointestinal, urological and gynecological procedures.
The Cabot Medical Surgiflex Suction-Irrigation Probe is similar to the BICAP COAG Probe in regard to functions (coagulation, blunt dissection, irrigation) and both are intended for general laparoscopic use including gastrointestinal, urological and gynecological procedures. The primary difference is that the Surgiflex Probe is monopolar while the BICAP COAG operates as a bipolar device.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized design featuring three human profiles, with a triple-line design above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 6 2002
ACMI Corporation Frank J. Fucile Director, Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts 01722
Re: K012018
Trade Name: ACMI BICAP COAG Bipolar Laparoscopy Probe Regulation Number: 878.4400 Regulation Name: Electrosurgical Device, Cutting & Coagulation & Accessories Regulatory Class: II Product Code: GEI Dated: May 2, 2002 Received: May 3, 2002
Dear Mr. Fucile:
We have reviewed your Section 510(k) premarket 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) 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 such 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 may 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); 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 - Mr. Frank J. Fucile
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Stip Rhodes
ia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KO12018
BICAP COAG Bipolar Laparoscopy Probe
INDICATIONS FOR USE STATEMENT
Premarket Notification Number K012018
Device Name: BICAP COAG Bipolar Laparoscopy Probe
The BICAP COAG Bipolar Laparoscopy Probe is indicated for use in laparoscopic procedures to provide bipolar coagulation, blunt dissection, irrigation, and aspiration. The BICAP COAG Probe may be used in a variety of gastrointestinal, urological and gynecological procedures.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styt Murdu
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KO12018 510(k) Number -