← Product Code [FAS](/submissions/GU/subpart-e%E2%80%94surgical-devices/FAS) · K971512 # AMS COAGULOOP RESECTION ELECTRODE (K971512) _American Medical Systems, Inc. · FAS · Jul 24, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAS/K971512 ## Device Facts - **Applicant:** American Medical Systems, Inc. - **Product Code:** [FAS](/submissions/GU/subpart-e%E2%80%94surgical-devices/FAS.md) - **Decision Date:** Jul 24, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.4300 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use The AMS Coaguloop™ Resection Electrode is intended to be used for the resection, ablation, and fulguration in the prostate gland. ## Device Story The AMS Coaguloop™ Resection Electrode is a single-use, sterile electrosurgical accessory designed for use with standard endoscopic resectoscopes and monopolar electrosurgical generators. The device features a cutting loop (single or double conductor) with shallow grooves at the tip to enhance current density. During operation, the loop acts as an antenna, transmitting radio frequency (RF) current (500 KHz - 3.3 MHz) from the generator through the patient to a return electrode. The device utilizes tissue impedance to generate heat, causing vaporization for cutting and coagulation of resected tissue. It is operated by a surgeon in a clinical setting. The device benefits patients by providing a controlled method for prostate tissue resection and hemostasis. ## Clinical Evidence Bench testing only. Testing included fit, destructive, biocompatibility, dielectric/continuity, metallurgical analysis, loop area calculations, current distribution, and packaging tests. Animal testing included histopathology analysis of lapine and canine tissue samples to evaluate performance. Results confirmed the electrodes performed per specification. ## Technological Characteristics Materials: Molybdenum and Tungsten wire, non-conducting shrink wrap insulation. Energy: Monopolar RF (500 KHz - 3.3 MHz). Form factor: Flat loop with shallow grooves. Connectivity: Accessory to standard endoscopic resectoscopes and generators. Sterilization: Gamma radiation. Single-use. ## Regulatory 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. ## Predicate Devices - Olympus™ Resectoscope Loop Electrode ([K903323](/device/K903323.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ American Medical Systems, Inc Pfizer Hospital Products Gre 2 933 4666 Fax 612 930 6592 Coll Free 800 328 388 1971512 P 1 87 4 Image /page/0/Picture/3 description: The image shows the Pfizer logo. The logo is in black and white and features the word "Pfizer" in a stylized font. The word is set inside of an oval shape. merican Medical Systems # SUMMARY OF SAFETY AND EFF #### SUBMITTER JUL 2 4 1997 I. Name and Address: American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 USA Establishment Registration Number: Contact Person: John M. Otto April 25, 1997 2183959 Date of Summary Preparation: ## II. MANUFACTURER Name and Address: Establishment Registration Number: #### III. DEVICE NAME Device Common or Usual Name: Pemstar, Inc. 2535 Highway 14 West Rochester, MN 55901 USA 2133786 Unit, Electrosurgical, Endoscopic (With or Without Accessories) Device Trade Name: AMS Coaguloop™ Resection Electrode ## IV. PREDICATE DEVICE Olympus™ Resectoscope Loop Electrode K903323 ## DEVICE DESCRIPTION V. The Coaguloop™ consists of either a single or double conductor. The conductor(s) either form or are in electrical communication with a cutting loop that is designed to concentrate the current and cut and coagulate soft tissue as it is drawn along. The grooves at the tip of the electrode are designed with the intent to further enhance the current density at the tip of the grooves. This allows for cutting, and the utilization of the larger surface area on the underside of the grooves and loop, which generates the heat required for the coagulation of resected tissue. {1}------------------------------------------------ P294 The AMS Coaguloop™ Resection Electrode is designed for use in several resectoscope designs with general purpose monopolar electrosurgical generators. The AMS Coaguloop™ Resection Electrode is manufactured in four (4) configurations designed for use with the following manufactured resectoscopes: Storz™, Circon/ACMI™, Olympus™, and Richard Wolf™. The components of each configuration follows: #### INDICATION FOR USE VI. The AMS Coaguloop™ Resection Electrode has the same intended use as the Olympus™ Resectoscope Loop Electrode. These products are intended to be used for the resection, ablation, and fulguration of soft tissue. #### COMPARISON TO PEDICATE DEVICE VII. American Medical Systems' Coaguloop™ Resection Electrode is similar in indications, design, and features to various resectoscope electrodes that are in commercial distribution. The predicate device that AMS is claiming substantial equivalence to is the Olympus™ Resectoscope Loop Electrode (K903323). #### Intended Use a. The AMS Coaguloop™ Resection Electrode has the same intended use as the Olympus™ Resectoscope Loop Electrode. These products are intended to be used for the resection, ablation, and fulguration of soft tissue. #### Principles of Operation b. The basic principle of the function of the Coaguloop™ resection electrode involves developing a circuit consisting of a power generator and an active electrical circuit. The power generator is the source of electron flow and voltage. The active electrical circuit is composed of the generator , the active resecting electrode, the patient, and the patient return electrode (grounding pad). The electrode or loop acts as an antenna which transmits electrical current (power in Watts/cm2) of a specific wave form from the generator in a range from 500 KHz - 3.3 MHz (Radio Frequency range). The natural impedance of living tissue provides heat build-up in the tissues as the electron flow through the electrode overcomes the tissue impedance. When the electrode is brought into contact with the tissue, effectively completing the circuit, and power is applied, current builds along the cutting element of the electrode until the tissue impedance is overcome and energy arcs from the loop to the tissue. This produces intense heat and subsequent tissue vaporization along the cut line. This arching produces maximum current concentration at the cut site. K 9715 12 {2}------------------------------------------------ #### Device Performance C. Resectoscope electrodes have an extensive history of use in the medical device community. The Coaguloop™ device, and other manufacturer's resectoscope electrodes, are manufactured from materials that are widely used in the medical device industry. The materials have undergone extensive biocompatibility testing. The devices are manufactured primarily of Molybdenum. All components are manufactured using rigid conformance standards to ensure the safe and effective performance of the finished product. Frequent, detailed quality checks are carried out at each phase of the assembly process to verify that only those units meeting all parameters are released for sale. Table 1 on the folowing page provides a comparison of the proposed device to the predicate device. # d. Bench Testing The following tests were performed to demonstrate electrode reliability and adherence to performance specifications: - Fit Test a. - Destructive Test b. - C. Biocompatibility Test - Dielectric/Continuity Test d. - e. Metallurgical Analysis - f. Loop Area Calculations - Animal Test g. - Coaguloop Histopathology Analysis of Lapine and Canine Tissue Samples h. - i. Current Distribution Test - Packaging Test I .1. - k. Packaging Test II The results of the testing determined that the elctrodes performed per specification. In summary, American Medical Systems has provided information within this 510(k) Premarket Notification to indicate that the AMS Coaguloop™ Resection Electrode is safe and effective for its intended use (for the resection, ablation, and fulguration of soft tissue). Additionally, the AMS Coaguloop™ Resection Electrode has been shown to be comparable in terms of intended use and technological characteristics to the Olympus™ Resectoscope Loop Electrode which has been cleared for commercial distribution. The data and information provided within this 510(k) Premarket Notification adequately support that the Coaguloop™ Resection Electrode is substantially equivalent to the Olympus™ Resectoscope Loop Electrode. {3}------------------------------------------------ # TABLE 1 Image /page/3/Picture/1 description: The image contains two lines of text. The first line reads "K971512". The second line reads "P41074". # COMPARISON OF PROPOSED DEVICE | Use and Feature | AMS Coaguloop™ Resection
Electrode | Olympus™ Resectoscope
Loop Electrode | |-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | To resect, ablate, and fulgurate
soft tissue. | To resect, ablate, and fulgurate
soft tissue. | | Mode of Operation | Electrocautery current
conducted through loop allows
fulguration or cutting by the
surgeon | Electrocautery current
conducted through loop allows
fulguration or cutting by the
surgeon | | Application | 1. Device to be utilized in
conjunction with and as an
accessory to a standard
endoscopic electroscope.
2. Standard electro-surgical
power source is used for the
current generation through the
electrode. | 1. Device to be utilized in
conjunction with and as an
accessory to a standard
endoscopic electroscope.
2. Standard electro-surgical
power source is used for the
current generation through the
electrode. | | Material | Tungsten/Molybdenum wire
insulated with non-conducting
shrink wrap. | Tungsten wire insulated with
non-conducting shrink wrap. | | Design | Flat loop with multiple shallow
grooves. | A circular loop | | Sterility | The electrode is delivered
sterile and is designed for
single-use only. The device is
sterilized by Gamma radiation | Sterile/disposable | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 2 4 1997 Mr. John M. Otto Senior Regulatory Affairs Associate ... . ... .. American Medical Systems, Inc. Pfizer Hospital Products Group 10700 Bren Road West Minnetonka, Minnesota 55343 Re: K971512. AMS Coaguloop™ Resection Electrode Dated: April 25, 1997 Received: April 28, 1997 Regulatory class: II 21 CFR §876.4300/Product code: 78 FAS Dear Mr. Otto: 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 inclosure) 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 misbranion. If your device is classified (see above) into either 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 OS 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 \$31 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations. 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 h. William Yu Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health {5}------------------------------------------------ Page of 510(k) Number (if Known): K971512 Device Name: _AMS Coaguloop™ Resection Electrode_ Indications For Use: The AMS Coaguloop™ Resection Flectrode is intended to be used for the resection, ablation, and fulguration in the prostate gland. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Reter R. Silling/ (Division Sign-Off) ');vision of Reproductive, Abdominal, ENT, nd Radiological Devices 1 ) 710(k) Number Prescription Use (Per 21 CFR 801.109) OR Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ t:\\vp\510k\ifuform.doc 1 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAS/K971512](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAS/K971512) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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