(79 days)
Single-use electrosurgical accessory used to provide coagulation therapeutic energy to tissue and suction to aspirate blood, coagulum and small bits of tissue debris from the surgical site. The coagulation effect is achieved by the passage of high frequency current through the tissue of interest.
This suction coagulator has applications in general surgical procedures to provide a means of coagulation using electrosurgical current and also provide a means of suction using the vent on the handle. Suction and coagulation can be performed independently or simultaneously. The device consists of a cable for connection to the output of an electrosurgical generator unit, to carry high-frequency (HF) electrosurgical current to the distal end of the handpiece. gonerater and as either a hand-switching or foot-switching conduit in delivering the HF energy from the electrosurgical generator unit through the cannula tube to produce the therapeutic affect. Current is activated by the coagulation switching element buttons on the handpiece or by using the footswitch. The devices contain a non-stick (UltraClean™) coating on the cannula tip. The devices will be distributed sterile and non-sterile for single-use applications.
The provided text describes a 510(k) premarket notification for the CONMED UltraClean™ Suction Coagulator. This document focuses on demonstrating substantial equivalence to a predicate device and does not include detailed acceptance criteria or a dedicated study proving device performance against such criteria as would typically be found for a novel device or AI/software-as-a-medical-device (SaMD).
Instead, the submission primarily relies on:
- Technological Characteristics Comparison: Stating that the proposed device is "equivalent to the identified predicate device with respect to technological characteristics and function."
- Compliance with Standards: Designed to comply with applicable sections of ANSI/AAMI HF-18, IEC 60601-2-2, ISO 11137, ISO 14971, and ISO 10993.
- Biocompatibility Testing: Focusing on the new silicone coating (UltraClean™) added to the cannula tip, confirming it meets established biocompatibility requirements.
Therefore, many of the requested points regarding acceptance criteria, study design, and ground truth for performance evaluation are not applicable to this type of submission.
Here's a breakdown of what can be extracted and what is not present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for "device performance" in the context of diagnostic accuracy/AI (e.g., sensitivity, specificity). The acceptance criteria are implicitly met by:
- Demonstrating substantial equivalence to a legally marketed predicate device (K033003).
- Complying with relevant medical device standards (ANSI/AAMI HF-18, IEC 60601-2-2, ISO 11137, ISO 14971, ISO 10993).
- Passing biocompatibility tests for the new component.
- Reported Device Performance: No specific performance metrics (like sensitivity, specificity, or precision) are reported for the device in a clinical study context. The "performance" is considered equivalent to the predicate device and safe for its intended use.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K033003) | The device is found substantially equivalent. |
| Compliance with ANSI/AAMI HF-18 (Electrosurgical Devices) | The device has been designed to comply. |
| Compliance with IEC 60601-2-2 (Electrosurgical Devices) | The device has been designed to comply. |
| Compliance with ISO 11137 (Radiation Sterilization) | The device has been designed to comply. |
| Compliance with ISO 14971 (Medical Devices Risk Management) | The device has been designed to comply. |
| Compliance with ISO 10993 (Biocompatibility) for all materials | All original materials tested per ISO 10993. |
| Biocompatibility of new UltraClean™ coating (silicone) | Successfully completed Cytotoxicity, Hemolysis, Pyrogen, Intracutaneous Reactivity, Sensitization, and Acute Systemic Injection testing. |
| Functionality (coagulation and suction) | Stated to operate independently or simultaneously, equivalent to predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This submission does not involve a "test set" in the context of evaluating a diagnostic or AI algorithm. Biocompatibility testing typically involves in vitro and in vivo animal studies, but specific sample sizes and detailed provenance are not provided in this summary.
- Data Provenance: Not applicable for a clinical test set. Biocompatibility reports are referenced but their details (e.g., specific test animal origins, retrospective/prospective) are not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical "ground truth" establishment by experts is described as this is not a diagnostic device or AI algorithm requiring such validation. Biocompatibility testing follows standardized protocols, with interpretation by qualified toxicologists/biologists typically, though specific numbers/qualifications are not provided here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is described as there is no diagnostic test set requiring human review and consensus.
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 accessory, not an AI or diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical electrosurgical accessory, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable for clinical performance. For biocompatibility, the "ground truth" is defined by established scientific principles and regulatory standards (e.g., ISO 10993) interpreted by lab results regarding cytotoxicity, hemolysis, etc. For functional performance, the "ground truth" is assumed to be equivalent to the predicate device's established safe and effective performance in surgical contexts.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. No training set exists for this device.
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OCT 2 1 2005 Traditional 510(k) CONMED UltraClean™ Suction Coaguiator
52104
Summary of Safety and Effectiveness
| Submitted by: | CONMED Electrosurgery Division14603 East Fremont AvenueCentennial, CO 80112 USATelephone: 303-699-7600Facsimile: 303-699-9854 |
|---|---|
| Contact Person: | Pamela L. Vetter |
| Date Prepared: | August 1, 2005 |
| Proprietary Name: | UltraClean™ Hand Controlled Suction Coagulator and Foot ControlledSuction Coagulator or other trade names as established |
| Common Name: | Suction Coagulator |
| Classification Name: | Electrode, Flexible Suction Coagulator(21 CFR 878.4400)79 GEI |
| Predicate Device: | Suction Coagulator510(k) # K033003 |
Device Description: This suction coagulator has applications in general surgical procedures to provide a means of coagulation using electrosurgical current and also provide a means of suction using the vent on the handle. Suction and coagulation can be performed independently or simultaneously. The device consists of a cable for connection to the output of an electrosurgical generator unit, to carry high-frequency (HF) electrosurgical current to the distal end of the handpiece. gonerater and as either a hand-switching or foot-switching conduit in delivering the HF energy from the electrosurgical generator unit through the cannula tube to produce the therapeutic affect. Current is activated by the coagulation switching element buttons on the handpiece or by using the footswitch. The devices contain a non-stick (UltraClean™) coating on the cannula tip. The devices will be distributed sterile and non-sterile for single-use applications.
Intended Use of Device: Single-use electrosurgical accessory used to provide coagulation therapeutic energy to tissue and suction to aspirate blood, coagulum and small bits of tissue debris from the surgical site. The coagulation effect is achieved by the passage of high frequency current through the tissue of interest.
Technological Characteristics: The proposed device is equivalent to the identified predicate device with respect to technological characteristics and function. The device has been designed to comply with the applicable sections of ANSI/AAMI American National Standard for Electrosurgical Devices HF-18, the International Electrotechnical Commission Standard for Electrosurgical Devices, IEC 60601-2-2, Sterilization of health care products - Requirements for validation and routine control -Radiation Sterilization, ISO 11137, Medical Devices Risk Management, ISO 14971 and Biocompatibility, ISO 10993.
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<052104
BIOCOMPATIBILITY:
510(k) Premarket Notification
Page 2 of 2
CONMED ELECTROSURGERY
The materials and processes used in the construction of the CONMED UltraClean Suction Coagulator are identical to those of the predicate device with the addition of a silicone-coat (Ultraclean™) on the cannula tip. The original materials have been tested in accordance with accepted biocompatibility test methods and guidance such as ISO 10993 and the General Program Memorandum #G95-1, dated May 1, 1995 and were found to be compatible with the human body. The silicone coating added by ConMed Electrosurgery meets these same requirements and has successfully completed the following biocompatibility testing: Cytotoxicity, Hemolysis, Pyrogen, Intracutaneous Reactivity. Sensitization and Acute Systemic Injection testing (see attached biocompatibility reports).
Table M.1 provides a list of materials used in the construction of the CONMED UltraClean™ Suction Coagulator and identifies the devices and applications where those materials are now in use. Please note that this device is not indicated for prolonged direct contact with patient tissue. The distance between the cannula and tissue undergoing coagulation is normally maintained at 1 cm or less and only in temporary contact with tissue undergoing suction.
| Component/Material | Tissue Contact | Preamendment or 510(k)Reference where cleared |
|---|---|---|
| HandpieceABS Plastic | No | Predicate Device: K033003Suction Coagulator |
| Cable Wire/JacketCopper wire/PVC jacket | No | Predicate Device: K033003Suction Coagulator |
| Cable ContactsBrass | No | Predicate Device: K033003Suction Coagulator |
| CannulaAluminum | Yes | Predicate Device: K033003Suction Coagulator |
| Cannula InsulatorPolyolefin | Yes | Predicate Device: K033003Suction Coagulator |
| TipSilicone (UltracleanTM) | Yes | Biocompatibility test reportsattached |
Table M.1: Material Biocompatibility Summary
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 2005
Pamela Vetter Manager of Regulatory Affairs ConMed Electrosurgery 14603 East Fremont Avenue Centennial, Colorado 80112
Re: K052104/S1
Trade/Device Name: Ultraclean Suction Coagulator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 27, 2005 Received: September 28, 2005
Dear Ms. Vetter:
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 forchered above and may sure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prior to rialy 20, 2018 11:11 accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). and Cosmeter For (110) that 30 nevice, subject to the general controls provisions of the Act. The r ou may, ateres, mains 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 If your device is enabilitional controls. Existing major regulations affecting your device can may or subject to back as 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 f that FDA has made a determination that your device complies with other requirements of the Act that I Dr heal statutes and regulations administered by other Federal agencies. You must or any I carated and 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 Of K Fat 6077; labeling (21 CFR Part 820); and if applicable, the electronic form in the quality byeving (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Vetter
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manteeing your antial equivalence of your device to a legally premits that includion. The PDF micing of cassification 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 If you ucare specific acrite ior your accel (240) 276-0115. Also, please note the regulation entitled, Colliable of Comptance to premarket notification" (21CFR Part 807.97). You may obtain Misolanding of reference to premailonsibilities under the Act from the Division of Small other general miorination on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Barbara Bouieund
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
K059.104
Device Name:
Indications for Use:
Single-use electrosurgical accessory used to provide coagulation therapeutic energy to tissue and suction to aspirate blood, coagulum and small bits of tissue debris from the surgical site. The coaqulation effect is achieved by the passage of high frequency current through the tissue of interest.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter____
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Breen for mayor
(Division Signral. Restorative, Division of Gen and Neurological Devices
510(k) Number K052104
§ 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.