Valley Forge bipolar loop electrodes are designed for electrosurgical excisions in a dry, infiltrated or wet field. Gynecological indications are as follows:

loop excisions of the cervix
cervical conizations
external anogenital lesions
large vaginal intraepithelial neoplastic lesions

Device Description

Valley Forge Scientific Corp, the manufacturer of several Malis bipolar coagulation/cutting systems, now plans to introduce Bipolar Loop Electrodes for gynecological procedures.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study that rigorously proves the device meets specific performance metrics in the format requested. Instead, it offers a summary of safety and effectiveness information for the Bipolar Loop Electrode, focusing on its design principles, historical use in neurosurgery, and perceived advantages over monopolar systems, particularly for gynecological procedures.

The information provided is primarily qualitative and relies on expert opinions and prior clinical experience rather than a structured study with quantifiable acceptance criteria.

Here's an analysis based on the available text:

Acceptance Criteria and Device Performance (Based on provided text, these are general claims rather than specific quantitative criteria):

Acceptance Criterion (Implicit/Claimed)	Reported Device Performance (as stated in the document)
Safety: Elimination of grounding pad requirement and associated burns.	Bipolar Technology eliminates the need for grounding pads and the possibility of patient burns.
Safety: Minimal damage to adjacent tissue.	Bipolar Coagulation minimizes damage to adjacent tissue since the patient is no longer the return path for the electrical current.
Safety: Lower operating voltage.	Bipolar Technology works at voltages approximately 1/4th the voltage required for a monopolar technique.
Control/Precision: Precise control of electric current at the tissue site.	Localized Bipolar Coagulation gives the surgeon precise control of the electric current at the tissue site.
Effectiveness: Superior coagulation and absence of charring/sticking.	The system's patented waveform and exceedingly low output impedance provide superior coagulation and the absence of charring and sticking even in a dry field.
Effectiveness: Functionality in irrigated/bloody fields.	Bipolar electrosurgery provides smooth, progressive coagulation with the option of precise, flow-controlled irrigation. Permits the physician to coagulate in an irrigated field thereby minimizing heat build-up or thermal damage to adjacent tissues. (Unlike monopolar systems, which short-out).
Pathology Quality: Production of excellent, undamaged pathology specimens.	Used to core all types of brain and spinal cord neoplasms "bloodlessly, while the contiguous tissues remain functioning normally, and the removed specimens show no damage whatsoever." "The use of these bipolar loops has produced excellent pathology specimens in a wide variety of benign and malignant tumor types, without the confusing thermal damage produced by monopolar loops."
Clinical Efficacy (Gynecology): Adequate specimens, minimal blood loss, short operating time for CIN.	Dr. Martin Weisberg concludes that "Bipolar loop excision allows for adequate specimens to be obtained with minimal blood loss and short operating time."
General Effectiveness: Smooth, gentle, precise, and efficient cutting and coagulation.	The waveform parameters... are programmed for the smoothest, most gentle, precise and efficient cutting and coagulation of tissue during any surgical procedure.

Study Information:

The document refers to expert opinions and historical use rather than a singular, dedicated study with clear methodology for proving device performance against acceptance criteria.

Sample size used for the test set and the data provenance:
- No specific "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective) is explicitly stated for a formal study validating the device against acceptance criteria.
- The document references:
  - Dr. Leonard I. Malis's extensive use in neurosurgery since 1981, stating he has used bipolar loops to "core all types of brain and spinal cord neoplasms." This implies a large, but unspecified, number of cases over years, likely retrospective clinical experience.
  - Dr. Martin Weisberg's "Thomas Jefferson University Hospital Study" for gynecological procedures, reporting on "bipolar loop excision." The sample size for this specific study is not provided, nor is its retrospective or prospective nature explicitly mentioned, though it sounds like a clinical summary of cases rather than a controlled trial.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The "ground truth" seems to be established through the collective experience and opinions of leading experts in the field of electrosurgery.
- Dr. Leonard I. Malis: Described as "the world's foremost authority on bipolar electrosurgery" and a neurosurgeon who has used bipolar loops since 1981. His expertise is in neurosurgery, and he provides observations on bloodlessness, contiguous tissue function, and specimen integrity.
- Dr. Martin Weisberg: Associated with "Thomas Jefferson University Hospital" and quoted on the benefits of bipolar loop excision for gynecological procedures, specifically CIN. His specific qualifications (e.g., specialty, years of experience) are not detailed beyond his affiliation and role in the study mentioned.
- These experts are cited for their clinical observations and conclusions, rather than formally establishing "ground truth" for a predefined test set in a study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No formal adjudication method is described. The information presented is based on expert statements and observed clinical outcomes, not a blinded review of a dataset by multiple adjudicators.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC or AI-assisted study is mentioned. This device is an electrosurgical tool, and the context is traditional surgical efficacy and safety, not diagnostic imaging with AI.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (electrosurgical electrode), not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is primarily based on:
  - Expert Clinical Observation and Consensus: Dr. Malis's and Dr. Weisberg's long-term clinical experience and qualitative observations on surgical outcomes (e.g., blood loss, operating time, tissue damage, specimen quality).
  - Pathology: Dr. Malis explicitly states "The use of these bipolar loops has produced excellent pathology specimens... without the confusing thermal damage produced by monopolar loops." This indicates pathology review was part of the clinical assessment.
  - Outcomes Data: References to "minimal blood loss and short operating time" and "safe and complete removal of tumors" indirectly point to clinical outcomes as a measure of effectiveness.
The sample size for the training set:
- Not applicable. This is an electrosurgical device, not a machine learning model requiring a training set. The "training" for its development comes from years of surgical practice and engineering refinement.
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the AI/ML sense. The "ground truth" for the device's development and claimed performance is derived from the established principles of bipolar electrosurgery and the clinical experience of expert surgeons over many years.

Summary

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510(k) Number K971986 Device Name: Bipolar Loop Electrode

Page 1 of 2

AUG 26 1997

SUMMARY OF SAFETY AND EFFECTIVE INFORMATION

Valley Forge Scientific Corp, the manufacturer of several Malis bipolar coagulation/cutting systems, now plans to introduce Bipolar Loop Electrodes for gynecological procedures. As the world's foremost authority on binolar electrosurgery Dr. Leonard I. Malis has used bipolar loops to core all types of brain and spinal cord neoplasms such as meningiomas, and gliomas bloodlessly, while the contiguous tissues remain functioning normally, and the removed specimens show no damage whatsoever. Dr. Malis further states that "Bipolar cutting loops restrict cutting current to the very small space between the paired loops. There is no current flow outside of the loops to any other tissues and no current to any ground. Accordingly, there is no heat spread."

Bipolar electrosurgery has been used successfully to cut tissue or coagulate blood vessels for over 30 years. Dr. Malis says that "Bipolar cutting loops have been used in neurosurgery since 1981, and have made possible the safe and complete removal of tumors previously considered unresectable ... The use of these bipolar loops has produced excellent pathology specimens in a wide variety of benign and malignant tumor types, without the confusing thermal damage produced by monopolar loops."

In his Thomas Jefferson University Hospital Study, Dr. Martin Weisberg concludes that "Bipolar loop excision allows for adequate specimens to be obtained with minimal blood loss and short operating time. Because of the characteristics of bipolar loop excision may represent a safer treatment for CIN because no grounding pad or insulated speculum is required for bipolar procedures." In a recent Philadelphia Business Journal (August 8-14, 1997) article, Dr. Weisberg said "The main thing about bipolar technology is the safety issue... the bipolar technology is much safer."

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14971986 A 2012

Page 2 of 2

Some of the effective safety features of Bipolar Electrosurgery are:

- Bipolar Technology eliminates the need for grounding pads and the possibility of patient burns.
- Bipolar Coagulation minimizes damage to adjacent tissue since the patient is no longer the return path for the electrical current.
- Bipolar Technology works at voltages approximately 1/4th the voltage required for monopolar technique.
- Localized Bipolar Coagulation gives the surgeon precise control of the electric current at the tissue site.
- The system's patented waveform and exceedingly low output impedance provide superior coagulation and the absence of charring and sticking even in a dry field.
- Because of the high output impedance of monopolar and other bipolar systems, instruments short-out in an irrigated or bloody field.
- Unlike monopolar systems, bipolar electrosurgery provides smooth, progressive coagulation with the option of precise, flow-controlled irrigation.
- Bipolar technology permits the physician to coagulate in an irrigated field thereby minimizing heat build-up or thermal damage to adjacent tissues.
- The waveform parameters of the Valley Forge Bipolar Electrosurgery Systems are programmed for the smoothest, most gentle, precise and efficient cutting and coagulation of tissue during any surgical procedure.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN" is written around the left side of the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 26 1997

Mr. Thomas J. Gilloway Executive Vice President Valley Forge Scientific Corporation 136 Green Tree Road Oaks, Pennsylvania 19456

Re: K971986 Valley Forge Bipolar Loop for Gynecological Indications Dated: May 27, 1997 Received: May 29, 1997 Regulatory class: II 21 CFR §884.4120/Product code: 85 HGI

Dear Mr. Gilloway:

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, 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 II (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 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 yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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.

h7 Tiau Yui

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

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EXHIBIT XII.

Page 1 of_1

510(k) Number (if known): _ K971986

Device Name: __ Bipolar Loop Electrodes

Indications for Use: (revised)

Valley Forge bipolar loop electrodes are designed for electrosurgical excisions in a dry, infiltrated or wet field. Gynecological indications are as follows:

loop excisions of the cervix
cervical conizations
external anogenital lesions
large vaginal intraepithelial neoplastic lesions

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED} -

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ruler Q. Ratting

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 884.4120 Gynecologic electrocautery and accessories.

(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).