The Suction Coagulator is a single use device intended for use in surgical procedures (such as general and ENT procedures) where the coagulation of tissue and suction of fluids are desired.

Device Description

The Valleylab Suction Coagulators are hand held electrosurgical devices used for the coagulation of tissue and aspiration of fluids during electrosurgical procedures. The devices are activated by a plastic button with a spring contact located in the handle of the device. The suction is activated by the surgeon placing a finger over the suction vent hole also in the handle.

The Suction Coagulators are a disposable, hand held device used in electrosurgical procedures. It provides control of both monopolar coagulation of tissue and suction of fluids in a single handle. The coagulation mode of operation is activated by a depressing a plastic button located on the top of the body. The activation of suction is activated by the surgeon's finger covering the suction port. Coagulation takes place at the uninsulated end of the suction tube. The Suction coagulator consists of four main elements:
-a metal, insulated, French sized tube
-a switching mechanism
-a two piece molded plastic body
-a cord with plug
The Suction Coagulator is supplied sterile and can be used with various electrosurgical generators.

AI/ML Overview

The provided text describes a 510(k) summary for the Valleylab Suction Coagulators. It details the device, its intended use, and non-clinical as well as clinical testing.

Here's the analysis of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria with numerical thresholds. Instead, it states that:

Acceptance Criteria	Reported Device Performance
Proper Device Function	Bench Testing and verification testing was conducted to ensure proper device function. This included testing to the relevant electrical standards (IEC 60601-1 and IEC 60601-2-2).
Safe and Effective Use	No clinical testing was conducted. The use of Electrosurgical Suction Coagulators has been documented in the published literature and indicates safe and effective use in ENT procedures.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. No clinical testing was performed for this 510(k) submission to establish the safety and effectiveness of the new device itself. The submission relies on prior documented use of similar devices.
Data Provenance: Not applicable for a test set specific to this device. The document mentions "published literature" documenting the use of similar Electrosurgical Suction Coagulators, implying retrospective evidence from various sources.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No new clinical test set was created for this submission. The effectiveness is based on existing published literature for similar devices.

4. Adjudication Method for the Test Set

Not applicable. No new clinical test set was created for this submission.

5. 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

Not applicable. This device is an electrosurgical instrument, not an AI-assisted diagnostic or interpretative tool. No MRMC study or AI assistance is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an electrosurgical instrument, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly define "ground truth" in the context of this device's performance. Instead, it relies on:

Engineering Standards Compliance: IEC 60601-1 and IEC 60601-2-2 as benchmarks for electrical safety and performance.
Published Literature: "Documented in the published literature" indicating "safe and effective use" of Electrosurgical Suction Coagulators in ENT procedures. This implies a reliance on clinical outcomes and expert observation from previously published studies on similar devices.

8. The Sample Size for the Training Set

Not applicable. This device is an electrosurgical instrument, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device is an electrosurgical instrument, not a machine learning model.

Summary

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510/k) Summary or 510(k) Statement

510(k) Summary

Submitter Information: 1.

Covidien LP

Formerly known as Valleylab, a Division of Tyco Healthcare Group LP 5920 Longbow Drive Boulder, CO Contact: Philip E. Ake Senior Regulatory Associate Phone: 303-581-6934 Fax: 303-516-8516 Email: Philip.Ake@Covidien.com

Name of Device

Trade name: Valleylab Suction Coagulators Common/Classification name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400)

Predicate Devices

The Valleylab Suction Coagulators are substantially equivalent to the following legally marketed medical devices:

Valleylab Lectrovac (K791752) .
Megadyne Suction Coagulator (K072559) .

Device Description 4.

5. Intended Use

The Suction Coagulator is a single use device intended for use in surgical procedures (such as general and ENT procedures) where the coagulation of tissue and suction of fluids are desired.

Summary of Technology Characteristics 6.

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-a metal, insulated, French sized tube

-a switching mechanism
-a two piece molded plastic body
-a cord with plug

The Suction Coagulator is supplied sterile and can be used with various electrosurgical generators.

1. Summary Non-clinical testing
  Bench Testing and verification testing was conducted to ensure proper device function. This included testing to the relevant electrical standards (IEC 60601-1 and IEC 60601-2-2).

Summary of Clinical testing 8.

No clinical testing was conducted. The use of Electrosurgical Suction Coagulators has been documented in the published literature and indicates safe and effective use in ENT procedures.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

SEP 1 1 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Covidien LP % Mr. Philip E. Ake Senior Regulatory Associate 5920 Longbow Drive Boulder, Colorado 80301

Re: K091223

Trade Name: Suction Coagulator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 27, 2009 Received: July 29, 2009

Dear Mr. Ake:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Philip E. Ake

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fdagov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A Wilkerson

Mark N. Melkerson Director . Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): _K091223

Device Name: Suction Coagulator

Indications for Use:

The Suction Coagulator is a single use device intended for use in surgical procedures (such as general and ENT procedures) where the coagulation of tissue and suction of fluids are desired.

Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ 11cscription osc _____________________________________________________________________________________________________________________________________________________________ D) C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091223

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.