(51 days)
Not Found
No
The summary describes a standard electrosurgical device and its intended use, with no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
Yes
The device is used for surgery (tissue resection, ablation, excision) and hemostasis, which are therapeutic procedures.
No
The device is intended for surgical procedures such as resection, ablation, excision, and hemostasis. While "Bladder Tumor Diagnosis" is mentioned in the intended use, the device itself, a bipolar loop electrode, is a surgical tool used for tissue manipulation and not for generating diagnostic information or images. Its role in diagnosis would be as a tool to acquire tissue for pathology, which is a separate diagnostic step.
No
The device description clearly states it is a "double loop bipolar electrosurgical device" and works with hardware components like an electrosurgical generator, cable, and resectoscope system. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures (resection, ablation, excision, hemostasis) performed directly on the patient's tissue within the body.
- Device Description: The description details an electrosurgical device designed to work with electrosurgery systems for surgical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health status.
IVDs are devices used to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device is a surgical tool used for treatment and intervention in vivo.
N/A
Intended Use / Indications for Use
Intended for use in patients requiring endoscopic surgery for general urological tissue resection, ablation, and excision and hemostasis of blood vessels. These procedures include Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resection, Removal of Ureteral Calculus, and Treatment of Vesical Neck Constriction.
Product codes
78 FAS
Device Description
The Vista CTR Bipolar Loop Electrode is a double loop bipolar electrosurgical device, designed to work with currently marketed Electrosurgery Systems. These systems consist of an electrosurgical generator (the Controller), a reusable or disposable Cable (Bipolar Active Cord) and a Bipolar Resectoscope System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological tissue
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Ko 31001
MAY 21 2003
510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI VISTA CTR BIPOLAR LOOP ELECTRODE (Page 1 of 2)
General Information
Manufacturer:
ACMI Corporation 136 Turnpike Rd. Southborough, MA. 01772-2104
2020483
March 28, 2003
FDA Establishment Registration:
Contact Person:
Gabriel J. Muraca, Jr. Senior Regulatory Affairs Specialist
Date Prepared:
Device Description
Classification Name:
21CFR 878.4400 -Electrosurgical cutting and coagulation device and accessories.
Trade Name:
Generic/Common Name:
ACMI Vista CTR Bipolar Loop Electrode
Electrosurgical cutting and Coagulation device and Accessories
Predicate Devices
| ACMI USA Elite System Right Angle Cutting Loop Electrode | K973820 |
|---|---|
| ACMI Bipolar Resectoscope & Loop Electrode | K021166 |
Intended Uses
Intended for use in patients requiring endoscopic surgery for general urological tissue resection, ablation, and excision and hemostasis of blood vessels. These procedures include Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resection, Removal of Ureteral Calculus, and Treatment of Vesical Neck Constriction.
1
510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI VISTA CTR BIPOLAR LOOP ELECTRODE (Page 2 of 2)
Product Description
The Vista CTR Bipolar Loop Electrode is a double loop bipolar electrosurgical device, designed to work with currently marketed Electrosurgery Systems. These systems consist of an electrosurgical generator (the Controller), a reusable or disposable Cable (Bipolar Active Cord) and a Bipolar Resectoscope System.
Summary of Safety and Effectiveness
This Special 510(k) proposes a modification in two materials of the electrode, a change in the packaging, sterilization method, and a change in the labeling to indicate the new sterilization method. The indications for use, principles of operation, of the Vista CTR Bipolar Loop Electrode remain the same as in the predicate devices.
The proposed modifications for the Vista CTR Bipolar Loop Electrode, as described in this submission, are substantially equivalent to the predicate devices. The proposed modification in materials, packaging, sterilization, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
2
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" around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 21 2003
Gabriel J. Muraca, Jr. Senior Regulatory Affairs Specialist ACMI Corporation 136 Turnpike Road SOUTHBOROUGH MA 01772-2104
Re: K031001
Trade/Device Name: ACMI® Vista CTR Bipolar Loop Electrode Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: 78 FAS Dated: April 30, 2003 Received: May 1, 2003
Dear Mr. Muraca:
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 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.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 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,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Device Name: ACMI VISTA CTR BIPOLAR LOOP ELECTRODE 03/001 510(k) Number:
Indications for Use:
Intended for use in patients requiring endoscopic surgery for general urological tissue resection, ablation, and excision and hemostasis of blood vessels. These procedures include Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resection, Removal of Ureteral Calculus, and Treatment of Vesical Neck Constriction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: __ X _
OR Over-the-Counter Use:
(Per 21 CFR 801.109)
Nancy C. Brogdon
(Division (Division of Reproductive, Abdominal, and Radiological Device 510(k) Number