MODEL 20 BIPOLAR COAGULATOR by BOSTON SURGICAL PRODUCTS, INC.

The Boston Surgical Products, Inc. Model 20 Coagulation Generator is a solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where low impedance or wetfield conditions exist.

Device Description

The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply. Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines. RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) bipolar coagulators. This device is technically identical to an existing approved device (Kirwan Model 25 1000, 510k K880863) but repackaged in e new style enclosure and relabeled Boston Surgical Products Model 20.

AI/ML Overview

The provided documentation is a 510(k) submission for a medical device (Model 20 Bipolar Coagulator) and a related FDA clearance letter. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study of the device's performance against specific acceptance criteria in the manner typically seen for novel AI/machine learning devices.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement is not available in the provided text, as it describes a different type of regulatory submission primarily based on technical similarity to an existing device.

However, I can extract the relevant information that is present:

Here's the information that can be extracted or deduced from the provided documents:

Category	Information Provided
1. Acceptance Criteria and Device Performance	Acceptance Criteria (Implied by Predicate Device Equivalence): The device is considered to have met acceptance criteria because it is deemed "technically identical" to an existing approved device (Kirwan Model 25 1000, 510k K880863) in terms of its core functionality as a solid-state bipolar generator for RF signal to electrosurgical handpieces. Specific Performance Statements: - Handswitch Power: Powered by an independent low voltage (7 Vdc) isolated power supply. - Monitors: Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines. - Leakage: RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guidelines for isolated (body floating) bipolar coagulators. Reported Device Performance: The document states that the observed performance meets the mentioned guidelines, implying compliance with these technical standards, which serve as direct, stated performance criteria.
2. Sample size and data provenance (test set)	Not applicable. This submission doesn't describe a clinical or performance study with a test set of data samples. The demonstration of equivalence is based on technical specifications and regulatory standards.
3. Number of experts and qualifications (ground truth)	Not applicable. Ground truth as typically understood in AI/machine learning studies is not relevant here. The evaluation is against engineering standards and a predicate device.
4. Adjudication method (test set)	Not applicable. No test set requiring expert adjudication is involved.
5. MRMC comparative effectiveness study	No. This is not an AI/machine learning device, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
6. Standalone performance	The device's performance is inherently standalone in its function as a bipolar coagulator generator. The document describes compliance with specific technical and safety standards (IEC 601-1-2, ANSI HF-18) for its operation, implying standalone performance evaluation against these standards.
7. Type of ground truth	The "ground truth" for this submission is regulatory compliance and technical equivalence to a predicate device. This is established by demonstrating adherence to international and national safety standards (IEC 601-1-2, ANSI HF-18) for electrical medical equipment, and by asserting "technical identity" to a previously approved device.
8. Sample size for training set	Not applicable. This device is not an AI/machine learning device and does not involve a training set.
9. How ground truth for training set established	Not applicable.

Summary of the Study:

The "study" in this context is a 510(k) Pre-market Notification which aims to demonstrate Substantial Equivalence (SE) to a legally marketed predicate device.

Study Design: Not a traditional clinical or performance study. It's a regulatory submission where the applicant asserts and provides documentation to support that their new device (Boston Surgical Products Model 20) is "technically identical" to an already approved predicate device (Kirwan Model 25 1000, 510k K880863), with only cosmetic changes (repackaged enclosure and relabeling).
Proof of Meeting Acceptance Criteria: The proof relies on:
- Assertion of technical identity: The submission explicitly states the device is "technically identical" to the predicate, implying it performs to the same standards.
- Compliance with recognized standards: The document highlights adherence to specific safety and performance standards for electrical medical equipment:
  - IEC 601-1-2 (likely referring to the general requirements for safety and electromagnetic compatibility for medical electrical equipment).
  - ANSI HF-18 (likely referring to a standard for high-frequency electrical equipment).
- Specific technical specifications: Statements about the isolated power supply for the handswitch (7 Vdc) and the leakage levels within safety guidelines act as specific performance claims that presumably align with the predicate device and the referenced standards.

In essence, the "study" is a regulatory comparison, not an experimental one, focusing on technical specifications and safety standards rather than a performance evaluation against a dataset.

Summary

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U.S. Food and Drug Administration 510K Document Mail Center HFZ-401 Center for Medical Devices 1390 Piccard Drive Rockville, Maryland 20850

K972311

SEP 1 8 1997

To: Document Control Clerk

This summary of 510K safety and effectiveness for the Model 20 generator is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807,92.

The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply.

Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines.

RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) bipolar coagulators.

This device is technically identical to an existing approved device (Kirwan Model 25 1000, 510k K880863) but repackaged in e new style enclosure and relabeled Boston Surgical Products Model 20.

Sincerely,

Charles Vassallo

Charles Vassallo Boston Surgical Supply, Inc. 17 Old Country Road Oxford, Connecticutt 06478 Telephone/FAX (203) 888 0149

( 17 JUN 97

Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Charles Vassallo Boston Surgical Supply, Inc. 17 Old Country Road Oxford. Connecticut 06478

SFP 1 8 1997

Re: K972311 Trade Name: Model 20 Bipolar Coagulator Regulatory Class: II Product Code: GEI Dated: June 17, 1997 Received: June 20, 1997

Dear Mr. Vassallo:

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, 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 (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 requirements , 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Charles Vassallo

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) 594-4595. 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,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page____ l_of_____ 1

510(k) Number (if known)

Device Name: Model 20 Bipolar Coagulation Generator

Indications for use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

celly

(Division Sign-O

Division of General Restorative Devices K972311
510(k) Number

Prescription Use √
(Per 21 CFR 801.109)

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.