(367 days)
Not Found
No
The summary describes a substance applied to electrodes to reduce sticking, with no mention of AI or ML technology.
No
The device is described as being used on electrodes to reduce sticking, which is not a therapeutic function.
No
The device is described as a substance used on electrodes to reduce sticking, not to diagnose a condition. Its intended use is to facilitate the function of electrodes, not to provide diagnostic information.
No
The device description clearly states it is a "yellow-brown substance" available on a sponge or in a bottle, indicating a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use on electrodes to reduce sticking." This describes a function related to the physical interaction of a device (electrodes) with tissue, not the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details a substance applied to electrodes. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes
- Using reagents for testing
Therefore, the Patton Surgical PolarCoat, as described, functions as a lubricant or coating for surgical electrodes and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Patton Surgical PolarCoat is a single patient use device which is intended for use on electrodes to reduce sticking.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Candidate Device is a yellow-brown substance, Lecithin with soy protein removed. The Candidate Device is a single patient device, available on sponge or in bottle, to be used on electrodes to reduce sticking. The Candidate Device is sterilized by the Irradiation method and packaged individually within a shipper container of 20 units per container.
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
Not Found
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)
Not Found
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
Patton Surgical PolarCoat, K052907 510(k) Notification
510(k) Summary
This 510(K) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21CFR § 807.92
| The assigned 510(K) number is: | K052907 |
|---|---|
| Submitted by: | Michael Patton |
| 6300 Bridgepoint Parkway | |
| Bldg. 2, Ste. 420 | |
| Austin, Texas, 78730 | |
| Phone: 512 329 0469 | |
| Fax: 512 328 9113 | |
| Email: mpatton@pattonsurgical.com | |
| Date Prepared: | October 13, 2006 |
| Establishment Registration Number: | Patton Surgical is located at 6300 Bridgepoint Parkway, Bldg. |
| 2, Suite 420 in Austin, Texas 78730. We are registered with | |
| the Food and Drug Administration as Establishment Number |
-
|
| Classification Name: | Electrosurgical, Cutting and Coagulation and Accessories |
| Common/Usual Name: | Anti-sticking solution |
| Proprietary Name: | PolarCoat |
| Indication for Use: | Patton Surgical PolarCoat is a single patient use device which
is intended for use on electrodes to reduce sticking. |
| Device Description: | The Candidate Device is a yellow-brown substance, Lecithin
with soy protein removed. The Candidate Device is a single
patient device, available on sponge or in bottle, to be used on
electrodes to reduce sticking. The Candidate Device is
sterilized by the Irradiation method and packaged individually
within a shipper container of 20 units per container. |
| Substantial Equivalence Claim: | The principles of operation and technology in the candidate
device are similar to other devices such as the Mectra Labs,
Inc.'s Electro-Lube, which the FDA has found to be
substantially equivalent to preamendment devices as outlined
below: |
| Product:
Manufacturer:
510(K) Number:
Substantial Equivalence Date: | Electro-Lube
Mectra Labs, Inc.
K033880
3/10/04 |
-End of summary-
6300 Bridgepoint Parkway Bldg. 2, Ste. 420
Austin TX 78730
Page 5 of 8
1
.
OC1 16 2006
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body, representing the three levels of government: federal, state, and local. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2006
Patton Surgical, Corp. % Ms. Vikki Ballesteros 6300 Bridgepoint Parkway Building Two, Suite 420 Austin, Texas 78730
Re: K052907
Trade/Device Name: PolarCoat Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 3, 2006 Received: October 6, 2006
Dear Ms. Ballesteros:
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 such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Ms. Vikki Ballesteros
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.
sincerely, yours,
Raubaypneelup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Patton Surgical PolarCoat, K052907 510(k) Notification
| 510(K) Number: | K052907 |
|---|---|
| Device Name: | PolarCoat |
| Indications for Use: | Patton Surgical PolarCoat is a single patient use device which is intended for use on electrodes to reduce sticking. |
| Intended Use: | Patton Surgical PolarCoat is a single patient use device which is intended for use on electrodes to reduce sticking. |
Prescription Use × (Per 21 CFR 801Subpart D)
Over-the-Counter (Per 21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dorbaie Buelum
(Division Sig ... Off) Division of General, Restorative, and Neurological Devices
510(k) Number: K052907
6300 Bridgepoint Parkway Bldg. 2, Ste. 420 Austin TX 78730
Page 3 of 8