(15 days)
Not Found
No
The device description and performance studies indicate a simple mechanical device for cleaning cautery tips, with no mention of AI or ML.
No
The device is described as an electrosurgical accessory used to clean electrosurgical cauterization blades, not to treat a medical condition or disease.
No
Explanation: The device is described as an electrosurgical accessory used to clean cautery tips during surgery, and its function is to remove eschar buildup, not to provide diagnostic information about a patient's condition.
No
The device description clearly outlines physical components (foam pad, abrasive surface, adhesive back layer, barium monofilament) and does not mention any software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body (in vitro).
- Device Function: This device is used to clean the tip of a surgical instrument during a surgical procedure. It does not interact with patient specimens or provide diagnostic information.
- Intended Use: The intended use clearly states it's an "electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures." This is a functional, non-diagnostic purpose.
- Device Description: The description details its physical characteristics and how it's used to clean the cautery tip. There is no mention of analyzing biological samples.
- Lack of Diagnostic Information: The provided information does not include any metrics or studies related to diagnostic performance (like sensitivity, specificity, etc.). The performance studies focus on sterility, functional requirements, and packaging integrity.
This device is a surgical accessory used to maintain the functionality of another surgical instrument. It does not fit the definition or purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The disposable cautery tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The disposable cautery tip cleaner is a 50mm by 50mm small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel', with a polyurethane foam pad and polyurethane adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The product is usually placed somewhere on the sterile field, typically on the mayo stand. This product does not come in contact with the patient.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data Summary:
Requirement: Sterility
Specification: SAL 10-6
Method: ISO 11137-2
Result: Pass
Requirement: Functional Requirements
Specification: Product adhesive backing must be easily removed
Method: Removed adhesive backing from tip cleaner
Result: Pass
Requirement: Packaging
Specification: Vacuum leak test
Method: ISO 11607, ASTMF 1980
Result: Pass
Requirement: Packaging
Specification: Dye penetration test
Method: ASTMF 1929, ASTMF 1980
Result: Pass
Requirement: Packaging
Specification: Agar contact-attack test
Method: ISO 11607, ASTMF 1980
Result: Pass
Requirement: Packaging
Specification: Tensile seal strength test
Method: ASTMF 88, ASTMF 1980
Result: Pass
Requirement: Packaging
Specification: Accelerated aging test
Method: ASTMF 1980, ISO 11737
Result: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2015
Key Surgical Incorporated Ms. Amy Yanta Regulatory Affairs 8101 Wallace Road Eden Prairie, Minnesota 55344
Re: K151222
Trade/Device Name: Key Surgical® Cautery Tip Cleaner Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 6, 2015 Received: May 13, 2015
Dear Ms. Yanta:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151222
Device Name
Key Surgical® Cautery Tip Cleaner
Indications for Use (Describe)
The disposable cautery tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
Image /page/3/Picture/0 description: The image shows the logo for Key Surgical. The logo consists of a blue circle with a white "K" inside, followed by the word "KEY" in gray and "SURGICAL" in blue. There is a registered trademark symbol to the right of the word "SURGICAL".
SECTION 5: 510(k) Summary
Key Surgical® Cautery Tip Cleaners
The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements as required by 21 CFR 807.92.
| Date: | May 06, 2015 |
|---|---|
| ------- | -------------- |
Administrative Information
| Submitter: | Key Surgical, Inc. |
|---|---|
| Establishment Registration Number: | 2183785 |
| Contact Person: | Amy Yanta |
| 8101 Wallace Road | |
| Eden Prairie, MN 55344 | |
| Regulatory Affairs | |
| 952.288.2269 |
Device Identification
| Device Name: | Cautery Tip Cleaners |
|---|---|
| Common Name: | Cautery Tip Cleaners |
| Device Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Device Classification: | Class II |
| Panel: | General & Plastic Surgery |
| Classification Regulation: | 878.4400 |
| Product Code: | GEI |
| Performance Standards: | No Recognized Consensus Standards |
| Predicate Device: | Cautery Tip Cleaner, cleared on 01/19/2006 via K053433 |
| Trade Name: | None |
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Image /page/4/Picture/0 description: The image shows the logo for Key Surgical. The logo consists of a blue circle with a white "K" inside, followed by the word "KEY" in gray and "SURGICAL" in blue. There is a registered trademark symbol to the right of the word "SURGICAL".
SECTION 5: 510(k) Summary
Device Description
The disposable cautery tip cleaner is a 50mm by 50mm small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel', with a polyurethane foam pad and polyurethane adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.
Statement of Intended Use
The disposable cautery tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.
Substantial Equivalence Discussion
The Key Surgical Cautery Tip Cleaner predicate device is the Xodus Medical, Inc., K053433, cleared on January 19, 2006. The following illustrates the similarities in the product design.
| | Proposed Device: | Predicate Device:
Cautery Tip Cleaner | |
|----------------------------------|--------------------------------------|------------------------------------------|--|
| Property or Characteristic | Key Surgical® Cautery Tip Cleaner | | |
| Intended Use/Indications for Use | A device intended to be used to aid | The disposable Cautery Tip Cleaner | |
| | in the removal of eschar buildup on | is a single use sterile product. Its | |
| | electrosurgical blades during | intended use is as an electrosurgical | |
| | surgical procedures. The cautery tip | accessory to clean uncoated cautery | |
| | cleaner is sterile and a single use | blades that are part of an | |
| | device. | electrosurgical pencil. The cautery | |
| | | blade is "scratched" on the cautery | |
| | | tip cleaner to remove eschar build- | |
| | | up during surgical procedures to | |
| | | allow the cautery blade to function | |
| | | effectively throughout the | |
| | | procedure. The product is usually | |
| | | placed somewhere on the sterile | |
| | | field, typically on the mayo stand. | |
| | | This product does not come in | |
| | | contact with the patient. | |
| Conditions of Use | Single Use, disposable | Single Use, disposable | |
| Materials | Aluminum oxide 'gravel', with a | Square polyurethane foam pad | |
| | polyurethane foam pad and | featuring a textile abrasive layer | |
| | polyurethane adhesive layer | with an adhesive backing containing | |
| | containing a barium monofilament | an x-ray detectable radiopaque | |
| | for x-ray detection | strip. | |
| Adhesive back | Yes, for universal placement and aid | Yes, for universal placement and aid | |
| | in keeping the device in place | in keeping the device in place | |
Table 2: Substantial Equivalence
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Image /page/5/Picture/0 description: The image shows the logo for Key Surgical. The logo consists of a blue circle with a white "K" inside, followed by the text "KEY" in gray and "SURGICAL" in blue. A registered trademark symbol is located to the right of the word "SURGICAL".
SECTION 5: 510(k) Summary
| Sterility | Provided Sterile | Provided Sterile |
|---|---|---|
| Principle of Operation | The cautery tip cleaner is used to | |
| aid in the removal of eschar on | ||
| electrosurgical blades during | ||
| surgical procedures | Electrosurgical accessory to clean | |
| uncoated blades that are part of a | ||
| electrosurgical pencil | ||
| Interface with Electrosurgical | ||
| Cauterization Blade | The Cautery Tip Cleaner does not | |
| impact the function of the | ||
| electrosurgical cauterization blades. | ||
| It is not required for use with the | ||
| blades, but an accessory that aids in | ||
| the removal of eschar buildup. | Used for the cleaning of | |
| electrosurgical cautery tips during | ||
| surgical procedures. |
Performance Data Summary
Table 3: Performance Data Summary of Cautery Tip Cleaners
| Requirement | Specification | Method | Result |
|---|---|---|---|
| Sterility | SAL 10-6 | ISO 11137-2 | Pass |
| Functional | |||
| Requirements | Product adhesive backing must | ||
| be easily removed | Removed adhesive backing | ||
| from tip cleaner | Pass | ||
| Packaging | Vacuum leak test | ISO 11607, ASTMF 1980 | Pass |
| Dye penetration test | ASTMF 1929, ASTMF 1980 | Pass | |
| Agar contact-attack test | ISO 11607, ASTMF 1980 | Pass | |
| Tensile seal strength test | ASTMF 88, ASTMF 1980 | Pass | |
| Accelerated aging test | ASTMF 1980, ISO 11737 | Pass |
Substantial Equivalence Conclusion
The differences between the Cautery Tip Cleaners and the predicate device do not constitute a new intended use, and do not raise different questions of safety and effectiveness. They are both designed to aid in the cleaning of electrosurgical blades during surgical procedures.
The Cautery Tip Cleaners are substantially equivalent to the predicate device cleared under K053433.
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