(73 days)
Not sure, as the section "Reference Device(s)" is clearly labelled "Not Found".
No
The summary describes a physical device (cannula with probe) for delivering RF energy and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is described as "intended for use in Radio-Frequency (RF) heat lesion procedures for relief of pain," which indicates it is used for treatment, making it a therapeutic device.
No
The device is described as an instrument for performing a therapeutic procedure (heat lesion procedures for pain relief) by delivering RF energy, not for diagnosing conditions.
No
The device description explicitly states it is a "sterile, single-use cannula with an integrated probe," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Radio-Frequency (RF) heat lesion procedures for relief of pain." This describes a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "sterile, single-use cannula with an integrated probe used to deliver Radio-Frequency (RF) energy." This further reinforces its role in a therapeutic intervention, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the Pain Management Optima is a therapeutic device used in a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pain Management Optima is intended for use in Radio-Frequency (RF) heat lesion procedures for relief of pain.
Product codes
GXI
Device Description
The Pain Management Optima is a sterile, single-use cannula with an integrated probe used to deliver Radio-Frequency (RF) energy.
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)
Reference Device(s)
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
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).
0
Pain Management Optima
6. 510(k) Summary
Submitter Information
A. Company Name: Baylis Medical Company Inc.
B. Company Address: 2645 Matheson Blvd. East Mississauga, Ontario L4W 5S4 Canada
C. Company Phone: (905) 602-4875; ext 252
D. Company Facsimile: (905) 602-5671
E. Contact Person: Meghal Khakhar
F. Summary Prepared on: 27-July-2009
Device Identification
A. Device Trade Name: Pain Management Optima
B. Device Common Name: Radiofrequency Probe
C. Classification Name: Radiofrequency Lesion Probe, 21 CFR 882.4725
D. Device Class: Class II
E. Device Code: GXI
Identification of Predicate Device
Predicate device is the BMC RF Cannula, which is cleared under 510(k) Premarket Notification Number K972846
Device Description
The Pain Management Optima is a sterile, single-use cannula with an integrated probe used to deliver Radio-Frequency (RF) energy.
Intended Use
The Pain Management Optima is intended for use in Radio-Frequency (RF) heat lesion procedures for relief of pain.
Special 510(k)
OCT 1 6 2009
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Substantial Equivalence
,被
The indications for use of the Pain Management Optima are identical to the BMC RF Cannula. Both the Optima and the Cannula are used to create radiofrequency lesions for relief of pain. The fundamental scientific technology of both these devices is also the same.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Baylis Medical Company, Inc. c/o Mr. Meghal Khakhar Regulatory Affairs Manager 2645 Matheson Blyd. East Mississauga, Ontario Canada L4W 5S4
OCT 1 6 2009
Re: K092337
Trade/Device Name: Pain Management Optima Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: September 15, 2009 Received: September 24, 2009
Dear Mr. Khakhar:
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 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.
3
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.fda.gov/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,
Kesia Alexander Jr
Malvina B. Eydelman, M.D Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Pain Management Optima
Indications For Use:
The Pain Management Optima is intended for use in radiofrequency (RF) heat lesion procedures for relief of pain
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _1
(Division Signature)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K092337